Every finding on record at Home Nursing Services Inc

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: An immediate jeopardy (IJ) related to comprehensive assessment and re-assessment of patients was identified on 12/18/2020. The administrator was notified on 12/18/20 at 5:09 PM. The immediate jeopardy remained unremoved after exit on 1/12/21. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients. Based on record review and interview, agency failed to ensure the registered nurse (RN) completed comprehensive assessment/re-assessment accurately to describe the patient's status, to measure or describe wounds; failed to include current health of wound status and functional limitations due to wounds; failed to include interventions regarding the patient's wounds; failed to evidence progress towards measurable outcomes by describing/measuring wounds in the assessment; failed to evidence medical, and nursing needs were met by including all pertinent diagnoses and identifying the patient's needs in a comprehensive assessment/re-assessment that led to new or worsening wounds, urinary tract infection, hospitalization, amputation, and/or death. Additionally, the registered nurse failed to ensure all comprehensive assessments included patients' current health status (See Tag G 528); included progress towards goals (See Tag G 530, the patients' medical needs (See Tag G 534), a review of all medications (See Tag G 536), primary caregiver willingness, availability, and schedule (See Tag G 538), completed updated comprehensive re-assessment for worsening in health status (See Tag G 544), and completed updated comprehensive re-assessment during the last five days of the certification period (See Tag G 546). This practice affected all agency patients. Findings include: 1. Review of an undated agency policy C-155 titled "Comprehensive Client Assessment" stated "... A thorough, well-organized, comprehensive and accurate assessment, consistent with the client's immediate needs will be completed ... no later than five (5) calendar days after start of care ... To determine the appropriate care, treatment and services to meet initial needs and his/her changing needs ...." Review of an undated agency policy C-155 copyright Briggs Healthcare titled "Client Reassessment/Update of Comprehensive Assessment" stated "... Comprehensive Assessment will be updated and revised as often as the client's condition warrants due to a major decline or improvement in health status ... To identify decline or improvement ... are reassessed when significant changes occur in their condition ... [or] diagnosis ...." Review of an undated agency policy C-155 copyright Briggs Healthcare titled "Skilled Nursing Services" stated "... Skilled nursing services will be provided ... In determining whether a service requires the skills of a Nurse, the inherent complexity of the service, condition of the client ... Regularly reevaluates the client needs ... Provides services requiring specialized nursing skill and initiates appropriate preventive and rehabilitative nursing procedures ...." 2. The clinical record of patient #1, start of care 12/10/2019, was reviewed on 12/18/2020, and again on 1/12/2021. Review of a document received on 12/28/2020 titled "SN [skilled nurse] SOC [start of care] OASIS [outcome and assessment information set] and Comprehensive Assessment" dated 12/10/2019 evidenced the patient had no wounds, and was alert and oriented to person, place, and time, without confusion or disruptive behaviors. Review of a document titled "SN Re-Cert [Recertification/Re-Assessment] OASIS and Comprehensive Assessment" dated 10/3/2020 (for certification period 10/5/2020-12/3/2020) evidenced the patient was fully oriented and able to make own decisions, normal behavior, and had a wound on his right groin area. The document stated "... Right groin ... Irtritation [sic] from brief rubbing on the area ... scabbed over area ... measurements: 1x2 ... MD to evaluate wound ... Wound care orders already in place: No ... Orders need to be obtained: Yes ... Overall, the level of function has been: Slowly deteriorating ... Does the physician-ordered plan of care include the following ... Interventions to prevent pressure ulcer (wound) ... [box checked] Yes ... now has home attendant from entity B [personal care services] ... and they are responsible for these services ... heavy smoker ... observed foul smelling wound to the groin. Area appears dark red in color with puss [sic]-like drainage present. Advised POA [power of attorney- family member] to keep all follow-up appointments with the wound clinic due to possible infection to the area ... complete depandence [sic] on nece [sic] for all care ... Any immediate concerns or issues to be resolved before next visit: No ... Next visit [skilled nurse] planned to occur: 11/3/2020 [one month later] ...." The document also evidenced a Braden scale was completed, with a score of 16 (patients with a total score of 16 or less are considered to be at risk for developing pressure ulcers; 15 or 16 = low risk, 13 or 14 = moderate risk, and 12 or less = high risk.) The assessment evidenced (but not limited to) the patient's skin was occasionally moist, requiring a linen change approximately once a day (score of 3), and evidenced the patient moved in bed and chair independently and could maintain good positioning in bed or chair (score 3). However, the assessment also evidenced the patient was incontinent of stool more often than once daily, which would require linen changes more than once daily (score 2 - skin is often, but not always moist), and he was a bilateral amputee and unable to sit unsupported, major physical limitations, was dependent for all personal care, and was unable to transfer self from bed to chair (score 1 - requires moderate to maximum assistance in moving). The adjusted score would have been 13 (moderate risk). The document also evidenced the plan of care included interventions to prevent pressure ulcers but were not evidenced on the plan of care. The document failed to evidence wound diagnoses, failed to evidence the physician was contacted to report wound assessment findings (with possible infection), and wound treatment orders, failed to evidence entity B was contacted for care coordination regarding the wound and possible incorrect application of brief (too tight causing pressure/friction), and failed to evidence the niece (primary caregiver) was educated on signs or symptoms of infection (redness, heat, pain, foul odor, pus-like drainage, fever), wound care/treatment, or correct application of briefs, and failed to evidence a timely skilled nursing follow up visit was scheduled to re-assess the wound, ensure treatment orders were received, and the family member was competent in performing the treatment(s). No other wounds were identified during this assessment. The clinical record contained a plan of care for the certification period of 12/4/2020 - 2/1/2021 which indicated orders for skilled nursing once per month for indwelling catheter change and system assessment with vital signs. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/3/2020 stated "... Client has a pressure ulcer on the bottom of his left stump and a friction ulcer from in his right groin from where his brief rubs. These are both being treated by the [entity C- wound clinic]. At time of assessment, the wounds were covered and not able to be assessed ...." The document failed to evidence wound diagnoses and failed to evidence care coordination with entity C or the physician for new home care orders, which included but not limited to wound care orders. During an interview on 12/16/2020 at 2:16 PM, when asked if their clinic records evidenced communication or care coordination with Home Nursing Services, a staff member at entity C stated, "I don't see any communication with home care ... not sure we even knew he had home health care." Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). During an interview on 12/17/2020 at 3:44 PM, the comprehensive assessment for patient #1 dated 12/3/2020 was completed today (12/17/2020), and the plan of care was completed today (12/17/2020) and sent to the physician. Both were reviewed and approved by employee M (registered nurse) It was verified by the clinical director and the administrator that employee L (registered nurse) initiated the comprehensive assessment on 12/3/2020 but didn't complete it, and she did not assess the wounds. When asked, the clinical director agreed the certifying physician would not be able to provide/approve orders to meet the patient's needs without complete and accurate assessment findings. During this time, the administrator asked the director of nursing if the agency obtained wound clinic follow up. The director of nursing stated "No." During an interview on 12/18/2020 at 1:00 PM, when asked who finished the comprehensive assessment dated 12/3/2020, the director of nursing stated "[employee N- registered nurse]." When asked if she was the nurse that initiated the comprehensive assessment on 12/3/2020, the director of nursing stated "No." When asked why employee L didn't complete the assessment, the director of nursing stated, "We discovered she was behind, we wanted to get it done, so we sent it to [employee N]." She also indicated employee N saw the patient on 12/15/2020, and that visit represented completion of the comprehensive assessment dated 12/3/2020. When asked if the patient's electronic clinical record evidenced education for mitigation of pressure ulcers/wounds, the clinical director stated "No, but I can get the [paper portion] chart." Employee M retrieved it. When asked if the chart evidenced education for mitigation of pressure ulcers/wounds, employee M stated "No, looks like he goes to the wound clinic and they just advise him to keep his appointments." During an interview on 12/18/2020 at 3:20 PM, when asked which nurse did which portions of the comprehensive assessment dated 12/3/2020, the administrator stated "I can only tell [employee L] visited [the patient] on the 3rd, started writing [on the assessment on] 11th, [employee N] saw the patient on the 15th, and employee M reviewed and approved the assessment document on the 17th ... [employee M] signed the plan of care." The administrator also indicated he didn't know who did the wound assessments, or when the wounds were last assessed by staff. When asked if there had been any discipline for employee L, the administrator stated, "I don't know." Review of a document received on 12/28/2020 at 12:01 PM dated 12/22/2020 titled "Follow Up Assessment (FUA) Non-Recert OASIS" stated "... A general assessment was completed due to the findings of the State ... This client uses HNS [Home Nursing Services] for a monthly catheter change ... The physician or family have not requested the assistance of this agency for his wounds ... The state feels that HNS should be involved in the wound care. The state wants total client care not just cath [catheter] care ... The client went today [12/22/2020] to the clinic and the niece declined to allow this nurse to visualize the wounds ... The niece stated that an appointment [with agency nurse] can be set up to see wounds at a further date ... His catheter bag [bag connected urine drain tube] was stuffed an opening [sic] in the side of his wheelchair. The urine in the tube was pale yellow with sediment present ... The niece changes the dressings daily to the wounds, she state [sic] the wounds look the same to her except this morning the area to the stump had changed for the worse ... Writer [registered nurse] asked [niece] if the clinic recommended about adding vitamins and supplements of Vitamin C and Zinc for wound healing. She indicated they might have. Also asked about adding protein to the diet, niece indicated she did not remember for sure, maybe." The document failed to evidence wound diagnoses, failed to evidence the nurse and patient's niece scheduled a follow up visit to assess the wounds, failed to evidence the nurse followed up with the physician regarding orders for supplemental vitamins or additional protein diet, failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, and failed to evidence education was provided to the caregiver on proper placement of the urine drainage bag below the bladder to avoid urine back up into the bladder, which would increase risk of urinary tract infection. During the morning conference with the agency on 12/28/2020 at 10:27 AM, the clinical director indicated patient #1 expired in the hospital on 12/27/2020. During an interview with the alternate clinical director (clinical director also present) on 12/28/2020 at 11:26 AM when asked which doctor she spoke with today (12/28/2020) to inform of patient's death, she indicated she spoke to the wound clinic. When asked who specifically she spoke to, she stated "The nurse. I don't know her name." When asked if she spoke with any other physicians, she stated "No ma'am." When asked who the patient's certifying physician was, she stated "I do not know off the top of my head." When asked why there was no follow up visit scheduled to assess the patient's wounds after 12/22/2020, she stated "... planned on going back after the holidays." When asked if it was appropriate to wait so long to assess wounds (as part of the comprehensive assessment), she stated "Yes ...." When asked if she spoke with the certifying physician after she saw the patient on 12/22/2020, she stated "No ma'am." When asked if she should speak with the certifying physician after completing a comprehensive assessment, she stated "If I find something that's different or out of the ordinary." When asked if it was out of the ordinary for the patient to resist/refuse assessment of vital signs and not interact with the nurse during the assessment on 12/22/2020, she indicated it was not out of the ordinary. However, all other clinical notes evidenced the patient was cooperative during skilled nursing visits. When asked if measurements from wound clinic documentation counted as part of her comprehensive assessment, she stated "No, but I was going to go back after the holiday." During this time, when asked the last time wounds were assessed by agency nurses, the clinical director stated "I don't have that information. I'd have to look." No further information was submitted. Review of a document received on 12/29/2020 at 11:30 AM, dated 12/28/2020, and titled "Transfer to Inpatient Facility (Discharged From Agency) OASIS" stated "... The niece called [12/28/2020] and stated the client passed away on Sunday 12-27-2020 ...." Review of a document titled "Care Coordination Note" dated 12/28/2020 stated "... [nurse] made a visit on Tuesday [12/22/2020] ... The client was resistive of being touched and could not hear the conversation ... The client continued to be tired and not wanting to get out of bed on Wednesday [12/23/2020] ... niece called EMS to take the client to the hospital due to him not acting right ...." Review of hospital record received 12/29/2020, dated 12/23/2020 evidenced the patient was admitted to the hospital on 12/23/2020, and stated "... critical care was necessary for dehydration, Patient does appear to be septic from a urinary tract infection related to a foley catheter ... presented to the [emergency department] with reports of increasing confusion ... this evening ... disoriented ... poorly healing wound to left stump ... date of death 12/27/2020 ...." 3. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021 evidenced a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 10/30/2020 stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... 1 ... Stage 3 ... 1 ... Stage 1 ... 1 ... Location ... left foot (all toes) ... right foot ... all toes ... left upper coccyx ... HNS [name of agency] is not responsible for wound care ... Chronic UTI ... Yes ... Supra pubic [sic] catheter which is changed every two weeks ... Bedfast, unable to transfer and is unable to turn and position self ... unable to be up in a chair ..." The document failed to identify stage of each wound, assessment or measurements, or evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, or infection control teaching related to the urinary catheter. The document evidenced the patient had diagnoses (but not limited to) of history of stroke with left sided paralysis, indwelling urinary catheter, oxygen use for chronic lung disease, incontinent of bowel. The record failed to include diagnosis for wound on coccyx or other area(s). Review of a document dated 11/11/2020 titled "Skilled Nurse Visit Note" stated "... Urinating through penis and around [catheter] ... [after catheter change] ... Draining freely dark yellow, cloudy urine ...." The document failed to evidence wounds were assessed, failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, or infection control teaching related to the urinary catheter, including (but not limited to signs and symptoms of clogged tubing or infection). Review of a wound clinic document dated 11/24/2020 (obtained by the wound clinic, not from clinical record) titled "Wound Treatment #1 (Order 262060966)" stated "... Wash wound(s) with mild soap and water, then pat dry. Place Medihoney [wound bed ointment] and cover with ABD [surgical absorbent gauze pad]. Change dressing daily ... Home Healthcare to visit for wound care 2-3 [times] weekly and PRN [as needed] wound care/dressing changes ... left lower extremity ... right lower extremity ...." The agency record failed to evidence it provided skilled nursing visits 2-3 times weekly. Review of a document dated 12/8/2020 titled "Skilled Nurse Visit Note" stated "...Location: left heel ... wound type: pressure ... date originally reported: 6/26/2020 ... Comments: wound remains to the left heel ... Location: BLE [bilateral lower extremities]; 4th toes and left heel ... Wound type: unknown ... Date originally reported: 12/8/2020 ... Purulence [thick and milky discharge from a wound, often indicates an infection and needs treatment as soon as possible] drainage and scant blood around suprapubic stoma/foley [insertion site on abdomen for direct access to bladder with urinary drainage tube] ...." The document failed to evidence wounds were assessed/measured or treated by the nurse, the physician was notified of new open area(s) and signs of infection at urinary insertion site and failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown or signs and symptoms of infection. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/29/2020 (after the IJ was called) stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... [blank] ... Stage 3 ... [blank] ... Unstageable [full thickness skin and tissue loss in which the extent of the damage within the ulcer cannot be determined due to scabbing or dead fibrous tissue; once removed to expose wound, a stage 3 or 4 would be revealed] ... Stage 1 ... 0 ... Does this patient have a stasis ulcer [ulcer caused by impaired circulation]? ... Yes ... Current number of Stasis Ulcers that are observable ... 3 ... status of most problematic ... Not Healing ... Location ... left second toe ... left third toe ... right second toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... Integument [skin] Impression: ... unstable ... in need of skilled intermittent care ... Will continue to monitor during regular visits, but not be a focus of care ... Will require a lot of attention ... Current possible UTI symptoms: Wife stated client has been sleeping more and usually a sign of UTI ...." The document also evidenced the patient was a high risk for skin breakdown. The document failed to evidence the wounds were treated by the nurse, or education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document dated 1/2/2021 titled "Care Coordination Note" evidenced the patient was admitted to the hospital 1/2/2021 for UTI (urinary tract infection) and would likely be discharged 1/4/2021 or 1/5/2021. Review of documents received from entity D (hospital) on 1/5/2021 (not part of agency clinical record) evidenced the patient was admitted 1/2/2021 for sepsis (systemic infection)/ UTI and was discharged 1/5/2021. The document also evidenced the patient had chronic wounds to both feet, inadequate protein intake related to foot wounds and diabetes, need for more protein to assist wound healing, dietician added Juven (nutritional supplement) twice daily to assist wound healing. No wounds on back/coccyx were evidenced in the documentation. The document also evidenced the patient required contact isolation (frequent handwashing and disinfection of bathroom) due to VRE (Vancomycin Resistant Enterococcus Infection) of the urine. Review of a document titled "SN ROC [resumption of care] OASIS and Comprehensive Assessment" dated 1/5/2021 evidenced the patient was a high risk for skin breakdown, stated "... Does this patient have a stasis ulcer? ... Yes ... Current number of Stasis Ulcers that are observable ... 4 ... status of most problematic ... Not Healing ... Location ... right big toe ... right second toe ... left second toe ... left third toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... wife cleanses, applies medihoney dresses every other day and will see wound clinic 1/14/20 [sic] ...." The document failed to evidence contact precautions for VRE, skilled nursing interventions to mitigate wound status or prevention of new pressure sores such as specialized diet and supplements to promote wound healing, frequent turning schedule, or padding of bony prominences, or wound care was performed by the nurse. The document evidenced the certifying physician was contacted for orders, but the clinical record failed to evidence orders dated 1/5/2021. Review of a document dated 1/8/2021 titled "Skilled Nursing Visit Note" evidenced documentation of wounds on right big toe, left 2nd toe, left heel, and back left buttock, and indicated the wife performed the wound care, applying an ointment to the wounds. The document failed to evidence the physician was notified of the new wound(s), or new orders were received. Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated she did not know the name of the ointment the spouse applied to the wound(s). Review of an email document dated 1/11/2021 at 9:49 AM from the clinical director to employee C (registered nurse), employee M, the administrator, and the alternate administrator stated "... 1-10-2021, 12:20pm. I spoke with [patient's wife], regarding his new wound on his back. She said he is fine ... Her home remedy for his back is working ... She does not need me to stop by today to help her ...." The document failed to identify the ingredient(s) of the "home remedy", or that the physician was notified the wife was applying a home remedy to his wound(s). Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated the home remedy was urine. Review of an email document dated 1/11/2021 at 10:12 AM from the clinical director to employee C, employee M, employee D (medical records coordinator), employee H (office staff), the administrator, and the alternate administrator, stated "... new wound on left lower back reported to [wound clinic] ... [wound clinic] ordered daily wound care starting today ...." The clinical record failed to evidence a wound care order with increased skilled nursing frequency dated 1/11/2021. During an interview on 1/11/2021 at 2:23 PM, when asked if the agency requested and received hospital paperwork for admission on 1/2/2021, the alternate director of nursing stated "I don't know. I don't know if she [assessing nurse on 1/5/2021] called the hospital." When asked if the agency did any coordination with the hospital to obtain the hospital paperwork, she stated "I didn't." When asked where the resumption of care orders (1/5/2021) were located, she indicated they were in the comprehensive assessment. The record failed to evidence a physician's order. When asked what kind of bed the patient had (he was bedbound with wounds, and a new wound that developed post-hospitalization, and would benefit from a specialized mattress to decrease risk of skin breakdown), the clinical and alternate clinical directors both indicated they did not know. During an interview on 1/12/2021 at 10:50 AM, the alternate clinical director stated a nurse was going to see the patient today (1/12/2021), and she still did not know what kind of mattress the patient had. Upon exit, no further information was submitted. 4. The clinical record of patient #9, start of care 9/9/2019, certification period 11/2/2020 - 12/31/2020, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 11/1/2020 "... right second toe amputation ... Non-removable dressing present. Wound managed by orthopedics ... Report any abnormal findings to VA [veterans affairs] MD ... skilled nurse ... physical assessment ... and notify MD of any abnormal findings ... had his right second toe amputated ... His 3rd right toe is black and shriveled ...." The document also evidenced the patient had diagnoses (but not limited to) atherosclerotic heart disease (hardening of the arteries causing impaired circulation), and diabetes with diabetic neuropathy (diabetes with damage to nerves in your legs and feet, causing pain and numbness in your legs and feet). The document failed to evidence the physician was notified of the change in condition of the wound. Review of a document dated 11/2/2020 titled "Skilled Nurse Visit Note" stated "... Right second toe amputation site not healing. 3rd toe black and very painful ...." The document failed to evidence the nurse measured the wounds, performed wound care, or notified the physician for the change in the patient's integumentary or pain status. Review of a document dated and signed by employee M on 11/16/2020 titled "Skilled Nurse Visit Note" stated "... "posterior foot blackening about an 1 1/2 inch on ball of right foot, 3rd toe black and shriveled, outer edge of 5th toe; see diagram" The clinical record failed to evidence a diagram of the wound, or failed to evidence the physician was notified of the declining wound status. During an interview on 1/6/2021 at 3:56 PM, when asked if the doctor should have been notified of the change in wound status on 11/16/2020, the alternate clinical director stated, "He should be, I don't know if she did call." When asked if this failure to contact the physician could have potentially led to a negative outcome for the patient, she stated "Yes." Review of a document dated and signed by employee M on 11/30/2020 titled "Skilled Nurse Visit Note" stated "...: "No fever, No cough, No complaints, Right foot, big toe starting to blacken, middle toe black and shriveled. Per wife, US [ultrasound] showed multiple blockages and patient may lose foot d/t [due to] occlusions ...." The document failed to evidence the physician was notified of the declining wound status. Review of a document dated and signed by employee M on 12/14/2020 titled "Skilled Nurse Visit Note" stated "... No cough, No fever. Client having RLE [right lower extremity] Femoral Endarterectomy [a surgical procedure to remove plaque inside the superficial femoral artery] on Friday 12/18/20. Right foot and toes continue to blacken. There is now a foul odor associated with foot. Foot is starting to get wet and drain. Pain 10/10. Taking Norco for pain. 2 weeks of meds set-up. 100% medication compliant. The document failed to evidence the physician was notified of the declining wound status or severe pain. Review of a document dated 12/23/2020 titled "Care Coordination Note" stated "Spoke with client's wife. Client went into hospital to femoral endarterectomy. Decided to move ahead with partial amputation of right foot. Client remains in hospital. Wife will call when client home." The clinical record failed to evidence the agency coordinated with the hospital to provide patient's current status or request hospital records. Review of a document titled "Skilled Nurse Visit Note" dated 12/28/2020 stated "... returned from hospital S/P [after] Right femoral endarterectomy [a surgical procedure to remove plaque inside the superficial femoral artery] and Right partial amputation of foot. Right groin incision C/D/I [clean, dry, and intact] no redness, no draining, no swelling. OTA [open to air]. Right foot dressing C/D/I with orders not to remove same until f/u [follow up] with Podiatry 1/4/21. Plavix [medication to prevent formation of blood clots and to keep blood vessels open after surgical procedures and may cause easy bleeding/bruising] ... added to medication regimine [sic] ... Client is NWB [non-weight bearing] R foot ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician and failed to evidence the physician was notified for report and resumption of care orders. Review of a document dated 12/28/2020 titled "Pain Location Assessment" evidenced the patient now had left second toe pain (which previously had not been identified), and the nurse failed to evidence further pain/physical assessment of the toe. The document also evidenced right foot (surgical) pain, and stated "... almost constantly ... sharp ... throbbing ... Intensity 5 [pain scale 0-10, with 0 being no pain, 10 being worst/most severe pain ever] ... worst pain over last 48 hours 10 ... best pan over last 48 hours 5 ... What makes pain worse? ... [box checked] Activity with affected area ... Changing position ... Comments ...." The document failed to evidence the nurse instructed on non-weight bearing status to the right foot, which could potentially have a negative outcome on the surgical healing process, failed to evidence the nurse assessed the left second toe pain, and failed to evidence the physician was notified. Review of a document dated 12/28/2020 titled "SN ROC OASIS and Comprehensive Assessment" (additional document for same nurse visit same day) stated "... had his right second toe amputated ... ambulates without devices in his home ... Has had no ... hospitalizations ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician and failed to evidence the physician was notified for report and resumption of care orders. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/28/2020 (additional document for same nurse visit same day) stated "... Pain Assessment: ... right foot. Severity (0-10), 6 ... Cardiovascular Assessment: ... blood thinners ... Plavix ... Integumentary [skin] Assessment: No issues noted ... incisions ... open to air ... right foot ... surgical dressing in place ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection, nutritional requirements for wound healing, or other indications that should be reported to the agency and/or physician and failed to evidence the physician was notified for report and recertification care orders. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 1/1/2021 - 3/1/2021 stated "... [skilled nursing orders] ... one visit ... every 2 weeks ... medication tray set-up, to monitor compliance ... physical assessment, and report any abnormal findings to MD ...." The document failed to evidence skilled nursing interventions such as wound care/treatments, patient/family education for wound care/treatment, interventions to mitigate new or worsening skin breakdown, appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, or signs and symptoms of infection, nutritional requirements for wound healing or other indications that should be reported to the agency and/or physician. Review of documents received from person E (Podiatrist) on 1/5/2021 at 2:04 PM (not part of agency clinical record) included hospital discharge paperwork (given to the patient/caregiver upon hospital discharge on 12/28/2020), which indicated (but not limited to) the patient was not to bear weight on the right foot, and post-surgical education/instructions/limitations. Also included was a document dated 1/4/2021 titled "Progress Notes", which indicated (but not limited to) the patient was to continue to remain non-weight bearing on the right foot. During an interview on 1/6/2021 at 3:56 PM, the clinical director and alternate clinical director confirmed the skilled nursing frequency remained every two weeks since hospital discharge. When asked if waiting two weeks to see this patient could lead to a potentially negative outcome, they both stated "Yes." During an interview on 1/12/2021 at 1:50 PM, regarding the skilled nursing visit on 11/16/2020, employee M indicated she did not contact the physician, he was already aware, it (the wound/blackening of toe/foot) started as just the tip, and it was an ongoing process; regarding the skilled nursing visit on 12/14/2020, she stated "I did not call the physician ...." During the entrance conference on 12/15/2020 at 11:00 AM, when asked how the agency determined when there has been a major decline or improvement in the patient's health status, the clinical director stated, "Through nursing assessment." During an interview on 12/18/2020 at 1:00 PM, when asked the purpose of the comprehensive assessment, the clinical director stated, "To develop the plan of care." When asked if it was her expectation for staff to look at entire head to toe for comprehensive assessment, the clinical director stated, "Yes."

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the registered nurse failed to ensure the comprehensive assessment was updated and revised as frequently as the patient's condition warranted due to a major decline or improvement in the patient's health status for 7 of 10 records reviewed (#1, 2, 3, 7, 8, 9, 10). Findings include: 1. Review of an undated agency policy C-155 copyright Briggs Healthcare titled "Client Reassessment/Update of Comprehensive Assessment" stated "... Comprehensive Assessment will be updated and revised as often as the client's condition warrants due to a major decline or improvement in health status ... To identify decline or improvement ... are reassessed when significant changes occur in their condition ... [or] diagnosis ...." Review of agency policy dated 6/2000 titled "Home Nursing Services Job Description: Registered Nurse" stated "... Becomes familiar with the diagnostic services available for home health care and follows the directions of the Clinical Director in utilizing these services to meet the needs of the client ... Documents fully and accurately to record a complete, total picture of the client's status and progress, and gives a complete synopsis of the care provided by the skilled registered nurse ...." 2. The clinical record of patient #1, start of care 12/10/2019, was reviewed on 12/18/2020, and again on 1/12/2021. Review of a document received on 12/28/2020 titled "SN [skilled nurse] SOC [start of care] OASIS [outcome and assessment information set] and Comprehensive Assessment" dated 12/10/2019 evidenced the patient had no wounds, and was alert and oriented to person, place, and time, without confusion or disruptive behaviors. Review of a document titled "SN Re-Cert [Recertification/Re-Assessment] OASIS and Comprehensive Assessment" dated 10/3/2020 (for certification period 10/5/2020-12/3/2020) evidenced the patient was fully oriented and able to make own decisions, normal behavior, and had a wound on his right groin area. The document stated "... Right groin ... Irtritation [sic] from brief rubbing on the area ... scabbed over area ... measurements: 1x2 ... MD to evaluate wound ... Wound care orders already in place: No ... Orders need to be obtained: Yes ... Overall, the level of function has been: Slowly deteriorating ... Does the physician-ordered plan of care include the following ... Interventions to prevent pressure ulcer (wound) ... [box checked] Yes ... now has home attendant from entity B [personal care services] ... and they are responsible for these services ... heavy smoker ... observed foul smelling wound to the groin. Area appears dark red in color with puss [sic]-like drainage present. Advised POA [power of attorney- family member] to keep all follow-up appointments with the wound clinic due to possible infection to the area ... complete depandence [sic] on nece [sic] for all care ... Any immediate concerns or issues to be resolved before next visit: No ... Next visit [skilled nurse] planned to occur: 11/3/2020 [one month later] ...." The document also evidenced a Braden scale was completed, with a score of 16 (patients with a total score of 16 or less are considered to be at risk for developing pressure ulcers; 15 or 16 = low risk, 13 or 14 = moderate risk, and 12 or less = high risk.) The assessment evidenced (but not limited to) the patient's skin was occasionally moist, requiring a linen change approximately once a day (score of 3), and evidenced the patient moved in bed and chair independently and could maintain good positioning in bed or chair (score 3). However, the assessment also evidenced the patient was incontinent of stool more often than once daily, which would require linen changes more than once daily (score 2 - skin is often, but not always moist), and he was a bilateral amputee and unable to sit unsupported, major physical limitations, was dependent for all personal care, and was unable to transfer self from bed to chair (score 1 - requires moderate to maximum assistance in moving). The adjusted score would have been 13 (moderate risk). The document also evidenced the plan of care included interventions to prevent pressure ulcers, but were not evidenced on the plan of care. The document failed to evidence wound diagnoses, failed to evidence the physician was contacted to report wound assessment findings (with possible infection), and wound treatment orders, failed to evidence entity B was contacted for care coordination regarding the wound and possible incorrect application of brief (too tight causing pressure/friction), and failed to evidence the niece (primary caregiver) was educated on signs or symptoms of infection (redness, heat, pain, foul odor, pus-like drainage, fever), wound care/treatment, or correct application of briefs, and failed to evidence a timely skilled nursing follow up visit was scheduled to re-assess the wound, ensure treatment orders were received, and the family member was competent in performing the treatment(s). No other wounds were identified during this assessment. The clinical record contained a plan of care for the certification period of 12/4/2020 - 2/1/2021 which indicated orders for skilled nursing once per month for indwelling catheter change and system assessment with vital signs. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/3/2020 stated "... Client has a pressure ulcer on the bottom of his left stump and a friction ulcer from in his right groin from where his brief rubs. These are both being treated by the [entity C- wound clinic]. At time of assessment, the wounds were covered and not able to be assessed ...." The document failed to evidence the nurse completed the updated comprehensive assessment by failing to assess the wounds. During an interview on 12/16/2020 at 2:16 PM, when asked if their clinic records evidenced communication or care coordination with Home Nursing Services, a staff member at entity C stated "I don't see any communication with home care ... not sure we even knew he had home health care." Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). During an interview on 12/17/2020 at 3:44 PM, the comprehensive assessment for patient #1 dated 12/3/2020 was completed today (12/17/2020), and the plan of care was completed today (12/17/2020) and sent to the physician. Both were reviewed and approved by employee M (registered nurse) It was verified by the clinical director and the administrator that employee L (registered nurse) initiated the comprehensive assessment on 12/3/2020 but didn't complete it, and she did not assess the wounds. When asked, the clinical director agreed the certifying physician would not be able to provide/approve orders to meet the patient's needs without complete and accurate assessment findings. During this time, the administrator asked the director of nursing if the agency obtained wound clinic follow up. The director of nursing stated "No." During an interview on 12/18/2020 at 1:00 PM, when asked who finished the comprehensive assessment dated 12/3/2020, the director of nursing stated "[employee N- registered nurse]." When asked if she was the nurse that initiated the comprehensive assessment on 12/3/2020, the director of nursing stated "No." When asked why employee L didn't complete the assessment, the director of nursing stated "We discovered she was behind, we wanted to get it done, so we sent it to [employee N]." She also indicated employee N saw the patient on 12/15/2020, and that visit represented completion of the comprehensive assessment dated 12/3/2020. When asked if the patient's electronic clinical record evidenced education for mitigation of pressure ulcers/wounds, the clinical director stated "No, but I can get the [paper portion] chart." Employee M retrieved it. When asked if the chart evidenced education for mitigation of pressure ulcers/wounds, employee M stated "No, looks like he goes to the wound clinic and they just advise him to keep his appointments." During an interview on 12/18/2020 at 3:20 PM, when asked which nurse did which portions of the comprehensive assessment dated 12/3/2020, the administrator stated "I can only tell [employee L] visited [the patient] on the 3rd, started writing [on the assessment on] 11th, [employee N] saw the patient on the 15th, and employee M reviewed and approved the assessment document on the 17th ... [employee M] signed the plan of care." The administrator also indicated he didn't know who did the wound assessments, or when the wounds were last assessed by staff. When asked if there had been any discipline for employee L, the administrator stated, "I don't know." Review of a document received on 12/28/2020 at 12:01 PM dated 12/22/2020 titled "Follow Up Assessment (FUA) Non-Recert OASIS" stated "... A general assessment was completed due to the findings of the State ... This client uses HNS [Home Nursing Services] for a monthly catheter change ... The physician or family have not requested the assistance of this agency for his wounds ... The state feels that HNS should be involved in the wound care. The state wants total client care not just cath [catheter] care ... The client went today [12/22/2020] to the clinic and the niece declined to allow this nurse to visualize the wounds ... The niece stated that an appointment [with agency nurse] can be set up to see wounds at a further date ... His catheter bag [bag connected urine drain tube] was stuffed an opening [sic] in the side of his wheelchair. The urine in the tube was pale yellow with sediment present ... The niece changes the dressings daily to the wounds, she state [sic] the wounds look the same to her except this morning the area to the stump had changed for the worse ... Writer [registered nurse] asked [niece] if the clinic recommended about adding vitamins and supplements of Vitamin C and Zinc for wound healing. She indicated they might have. Also asked about adding protein to the diet, niece indicated she did not remember for sure, maybe." The document failed to evidence wound diagnoses, failed to evidence the nurse and patient's niece scheduled a follow up visit to assess the wounds. During the morning conference with the agency on 12/28/2020 at 10:27 AM, the clinical director indicated patient #1 expired in the hospital on 12/27/2020. During an interview with the alternate clinical director (clinical director also present) on 12/28/2020 at 11:26 AM when asked which doctor she spoke with today (12/28/2020) to inform of patient's death, she indicated she spoke to the wound clinic. When asked who specifically she spoke to, she stated "The nurse. I don't know her name." When asked if she spoke with any other physicians, she stated "No ma'am." When asked who the patient's certifying physician was, she stated "I do not know off the top of my head." When asked why there was no follow up visit scheduled to assess the patient's wounds after 12/22/2020, she stated "... planned on going back after the holidays." When asked if it was appropriate to wait so long to assess wounds (as part of the comprehensive assessment), she stated "Yes ...." When asked if she spoke with the certifying physician after she saw the patient on 12/22/2020, she stated "No ma'am." When asked if she should speak with the certifying physician after completing a comprehensive assessment, she stated "If I find something that's different or out of the ordinary." When asked if it was out of the ordinary for the patient to resist/refuse assessment of vital signs and not interact with the nurse during the assessment on 12/22/2020, she indicated it was not out of the ordinary. However, all other clinical notes evidenced the patient was cooperative during skilled nursing visits. When asked if measurements from wound clinic documentation counted as part of her comprehensive assessment, she stated "No, but I was going to go back after the holiday." During this time, when asked the last time wounds were assessed by agency nurses, the clinical director stated "I don't have that information. I'd have to look." No further information was submitted. Review of a document received on 12/29/2020 at 11:30 AM, dated 12/28/2020, and titled "Transfer to Inpatient Facility (Discharged From Agency) OASIS" stated "... The niece called [12/28/2020] and stated the client passed away on Sunday 12-27-2020 ...." Review of a document titled "Care Coordination Note" dated 12/28/2020 stated "... [nurse] made a visit on Tuesday [12/22/2020] ... The client was resistive of being touched and could not hear the conversation ... The client continued to be tired and not wanting to get out of bed on Wednesday [12/23/2020] ... niece called EMS to take the client to the hospital due to him not acting right ...." Review of hospital record received 12/29/2020, dated 12/23/2020 evidenced the patient was admitted to the hospital on 12/23/2020, and stated "... critical care was necessary for dehydration, Patient does appear to be septic from a urinary tract infection related to a foley catheter ... presented to the [emergency department] with reports of increasing confusion ... this evening ... disoriented ... poorly healing wound to left stump ... date of death 12/27/2020 3. The clinical record of patient #2, start of care 9/23/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for dates 11/16/2020 - 1/14/2021. The document evidenced the patient received (but not limited to) skilled nursing services to administer a bowel program (insertion of rectal suppository to facilitate a bowel movement), and to perform wound care to a stage 4 (full thickness with tendon and/or bone exposed) pressure injury to the left buttock. The record failed to evidence any comprehensive assessments or comprehensive re-assessments were performed by a registered nurse. 4. The clinical record review of patient #3, start of care date 1/21/2003, was completed on 1/12/2021, which evidenced documents titled "Home Health Certification/Recertification Plan of Care Order" for dates 10/18//2020 - 12/16/2020, and dates 12/17/2020 - 2/14/2021. The documents evidenced the patient received skilled nursing services (but not limited to) for tracheostomy (an incision in the windpipe made to relieve an obstruction to breathing) care, g-tube (tube inserted through the wall of the abdomen directly into the stomach. It allows air and fluid to leave the stomach and can be used to give drugs and liquids, including liquid food, to the patient.), administer medications via g-tube, breathing treatments via nebulizer machine, and personal care. The record failed to evidence any comprehensive assessments or comprehensive re-assessments were performed by a registered nurse. 5. The clinical record of patient #5 was reviewed on 1/12/21, start of care date of 11/3/21. The record contained a plan of care for certification period 11/3/21-1/1/21, which indicated diagnoses of (but not limited to) congenital absence, atresia, and stenosis of small intestine (narrowing or obstruction of the small intestine). The record failed to evidence a comprehensive assessment or re-assessment was completed. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 11/3/2020 failed to evidence the registered nurse assessed the patient in sections subtitled: Skilled Observation, Neuromuscular, Cardiopulmonary, Skin/Wounds, Gastrointestinal, Genitourinary, Medication, and IV (intravenous). The sections evidenced no documentation (they were blank). 6. The clinical record of patient #6 was reviewed on 1/12/21 and indicated a start of care date of 8/8/20. The record contained a plan of care for the certification period of 12/4/21-2/1/21 which failed to evidence a comprehensive assessment or comprehensive re-assessment was completed. During an interview on 12/28/20 at 3:20 PM, while reviewing the patient's EMR (electronic medical record), employee E (administrator) agreed no comprehensive assessments on patient #6 were performed and present in the EMR for the past 3 certification periods (180 days). 7. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021. Review of a document titled "SN ROC OASIS and Comprehensive Assessment" dated 1/5/2021 (after the IJ was called) evidenced the patient received, but not limited to, skilled nursing every other week to complete a full head to toe assessment,vital signs, and change the patient's suprapubic catheter (a tube inserted into an opening in the lower abdomen directly into the bladder to drain urine), and home health aide (HHA) services for personal care "up to 60 hours". The document evidenced a wound to the left upper coccyx, but failed to evidence it was assessed by the nurse. Review of a document dated 1/8/2021 titled "Skilled Nursing Visit Note" evidenced documentation of wounds on right big toe, left 2nd toe, left heel, and back left buttock, and indicated the wife performed the wound care, applying an ointment to the wounds. The document failed to evidence the physician was notified of the new wound(s), or new orders were received. Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated she did not know the name of the ointment the spouse applied to the wound(s). Review of an email document dated 1/11/2021 at 9:49 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), the administrator, and the alternate administrator stated "... 1-10-2021, 12:20pm. I spoke with [patient's wife], regarding his new wound on his back. She said he is fine ... Her home remedy for his back is working ... She does not need me to stop by today to help her ...." The document failed to identify the ingredient(s) of the "home remedy", or that the physician was notified the wife was applying a home remedy to his wound(s). Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated the home remedy was urine. Review of an email document dated 1/11/2021 at 10:12 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), employee D (medical records coordinator), employee H (office staff), the administrator, and the alternate administrator, stated "... new wound on left lower back reported to [wound clinic] ... [wound clinic] ordered daily wound care starting today ...." The clinical record failed to evidence a wound care order with increased skilled nursing frequency dated 1/11/2021. During an interview on 1/11/2021 at 2:23 PM, when asked if the agency requested and received hospital paperwork for admission on 1/2/2021, the alternate director of nursing stated "I don't know. I don't know if she [assessing nurse on 1/5/2021] called the hospital." When asked if the agency did any coordination with the hospital to obtain the hospital paperwork, she stated "I didn't." When asked where the resumption of care orders (1/5/2021) were located, she indicated they were in the comprehensive assessment. The record failed to evidence a physician's order. When asked what kind of bed the patient had (he was bedbound with wounds, and a new wound that developed post-hospitalization, and would benefit from a specialized mattress to decrease risk of skin breakdown), the clinical and alternate clinical directors both indicated they did not know. During an interview on 1/12/2021 at 10:50 AM, the alternate clinical director stated a nurse was going to see the patient today (1/12/2021), and she still did not know what kind of mattress the patient had. Upon exit, no further information was submitted. 8. The clinical record review for patient #8 was completed on 1/11/2021. Review of a document titled "RN Re-Certification Assessment [comprehensive re-assessment]" dated 11/20/2020 evidenced the patient received HHA (home health aide) services 2 hours per day, five days per week, and RN to supervise patient to ensure needs and goals were met, and the patient had a diabetic foot ulcer [open wound commonly located on the bottom of the foot] on the outside of his right foot. The document failed to evidence the wound was assessed, or listed diabetic ulcer in patient diagnoses. 9. The clinical record of patient #9, start of care 9/9/2019, certification period 11/2/2020 - 12/31/2020, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021. Review of a document dated 12/28/2020 titled "Pain Location Assessment" evidenced the patient now had left second toe pain (which previously had not been identified), and the nurse failed to evidence further pain/physical assessment of the toe. The document also evidenced right foot (surgical) pain, and stated "... almost constantly ... sharp ... throbbing ... Intensity 5 [pain scale 0-10, with 0 being no pain, 10 being worst/most severe pain ever] ... worst pain over last 48 hours 10 ... best pan over last 48 hours 5 ... What makes pain worse? ... [box checked] Activity with affected area ... Changing position ... Comments ...." The document failed to evidence the patient's current non-weight bearing status to the right foot, which could potentially have a negative outcome on the surgical healing process, and failed to evidence the nurse assessed the left second toe pain. Review of a document titled "RN Re-Certification Assessment [comprehensive re-assessment]" dated 12/28/2020 (additional document for same nurse visit same day) stated "... Pain Assessment: ... right foot. Severity (0-10), 6 ... right foot ... surgical dressing in place ... Integumentary Assessment ... No issues noted ...." The document evidenced the patient had a post-surgical incision to his right groin, and was non-weight bearing to the right foot, but failed to evidence complete assessment including measurements of the right groin incision. The assessed pain level of 6 was inconsistent with the pain level assessed as 5 on another document titled Pain Location Assessment", same day, same nurse. Review of a document dated 12/28/2020 titled "Nursing Resumption of Care [comprehensive re-assessment]" (additional document for same nurse visit same day) stated "... had his right second toe amputated ... ambulates without devices in his home ... Has had no ... hospitalizations ...." The document failed to evidence the patient's current post-surgical status of non-weight bearing right lower foot and other physical restrictions, and assessment including measurements of the right groin incision. Review of documents received from person E (Podiatrist) on 1/5/2021 at 2:04 PM (not part of agency clinical record) included hospital discharge paperwork (given to the patient/caregiver upon hospital discharge on 12/28/2020), which indicated (but not limited to) the patient was not to bear weight on the right foot, and post-surgical education/instructions/limitations. Also included was a document dated 1/4/2021 titled "Progress Notes", which indicated (but not limited to) the patient was to continue to remain non-weight bearing on the right foot. 10. The clinical record review for patient #10 was completed on 1/6/2021 and again on 1/12/2021, start of care date 8/23/2013, which evidenced a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 11/13/2020 for certification period 11/14/2020 - 1/12/2021 stated "... Integument Assessment ... Wound Tracking ... Location ... Abdomen ... Action Taken Today ... Not Specified ... Integument Impression: Overall, this system is: abnormal/dysfunctional, and, has steadily been declining. The system appears: ... in need of skilled intermittent care. Will require a lot of attention, will be a focus of care during regular visits ...." Additionally, the assessment evidenced pain in the patient's back, stomach, and abdominal wound, which was "Progressively worsening over time", the wound was being managed by the wound clinic, and the patient took "narcotics" (controlled substance pain medication) for the wound pain. The document failed to evidence any assessment of the wound, assessment of pain such as (but not limited to) pain level, onset, duration, or description, assessment of last bowel movement, and the medication profile failed to evidence the narcotic the patient took for pain. 11. During the entrance conference on 12/15/2020 at 11:00 AM, when asked how the agency determined when there has been a major decline or improvement in the patient's health status, the clinical director stated, "Through nursing assessment." During an interview on 12/18/2020 at 1:00 PM, when asked the purpose of the comprehensive assessment, the clinical director stated, "To develop the plan of care." When asked if it was her expectation for staff to assess head to toe for comprehensive assessment, she stated "Yes."

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients' comprehensive re-assessments were completed and/or updated the last five days of every certifications period for 6 of 10 records reviewed (#1, 2, 3, 4, 5, 6) and for 28 additional agency patients (without record review) with re-assessments due between 12/1/2020 and 12/18/2020. Findings include: 1. Review of an undated agency policy C-155 copyright Briggs Healthcare titled "Client Reassessment/Update of Comprehensive Assessment" stated "... Comprehensive Assessment will be updated and revised as often as the client's condition warrants due to a major decline or improvement in health status ... To identify decline or improvement ... are reassessed when significant changes occur in their condition ... [or] diagnosis ... at least every fifty-six to sixty (56-60) days ...." 2. The clinical record of patient #1, start of care 12/10/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a document titled "SN [skilled nurse] Re-Cert [recertification] OASIS [Outcome and Assessment Information Set] and Comprehensive Assessment" dated 12/3/2020 evidenced skilled nursing monthly for (but not limited to) indwelling catheter change and physical assessment, and report any abnormal findings to MD. During an interview on 12/18/2020 at 1:00 p.m., the clinical manager indicated employee L (indicate title) didn't complete the comprehensive assessment document (for patient #1) due to the comprehensive assessment being behind and the agency wanted it done so it was sent to employee N (indicate title) for completion. The clinical manager indicated employee N was not the nurse that had initiated the comprehensive assessment but had seen the patient on 12/15/20 and this represented the completion of the comprehensive assessment which was initially conducted on 12/03/2020 (12 days after the initial comprehensive assessment). The clinical manager then indicated there were multiple incomplete assessments unfinished by employee L which were being completed / "fixed" by other clinicians who had not conducted the visits / assessments. At 1:38 p.m., a document was received from the clinical manager which evidenced 33 patients from 12/01/2020 - 12/18/2020 had incomplete assessments with no updated plan of care. 3. The clinical record of patient #2, start of care 9/23/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for dates 11/16/2020 - 1/14/2021. The document evidenced the patient received (but not limited to) skilled nursing services to administer a bowel program (insertion of rectal suppository to facilitate a bowel movement), and to perform wound care to a stage 4 (full thickness with tendon and/or bone exposed) pressure injury to the left buttock. The record failed to evidence any comprehensive assessments or comprehensive re-assessments were performed by a registered nurse. 4. The clinical record review of patient #3, start of care date 1/21/2003, was completed on 1/12/2021, which evidenced documents titled "Home Health Certification/Recertification Plan of Care Order" for dates 10/18//2020 - 12/16/2020, and dates 12/17/2020 - 2/14/2021. The documents evidenced the patient received skilled nursing services (but not limited to) for tracheostomy (an incision in the windpipe made to relieve an obstruction to breathing) care, g-tube (tube inserted through the wall of the abdomen directly into the stomach. It allows air and fluid to leave the stomach and can be used to give drugs and liquids, including liquid food, to the patient.), administer medications via g-tube, breathing treatments via nebulizer machine, and personal care. The record failed to evidence any comprehensive assessments or comprehensive re-assessments were performed by a registered nurse. 5. The clinical record review of patient #4, start of care date 8/19/2019, was completed on 1/12/2021, which evidenced a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/9/2020 for certification period 12/11/2020 - 2/8/2021 evidenced the patient received, but not limited to, skilled nursing visits 3 times weekly for wound care and physical assessment, and alert MD for any abnormal findings. This assessment was originally assigned to employee L, but was subsequently completed by employee M, with unknown actual completion date. This assessment was on the list of incomplete assessments submitted by the agency. 6. The clinical record of patient #5 was reviewed on 1/12/21 and indicated a start of care date of 11/3/21. The record contained a plan of care for the certification period of 11/3/20-1/1/21 that indicated diagnoses of, but not limited to, congenital absence, atresia, and stenosis of small intestine (narrowing or obstruction of the small intestine). The record failed to evidence a complete recertification comprehensive assessment. 7. The clinical record of patient #6 was reviewed on 1/12/21 and indicated a start of care date of 8/8/20. The record contained a plan of care for the certification period of 12/4/20-2/1/21 that indicated diagnoses of, but not limited to, achalasia of cardia (nerve damage in the esophagus causing it to become paralyzed and dilated). The record lacked a history and physical upon referral/admission, or any time during dates of care for the client. The record failed to evidence a recertification comprehensive assessment. During an interview on 12/28/20 at 3:20 PM, Employee E (Administrator) agreed that no comprehensive assessment on patient #6 had been done for the past 3 certification periods. #2 had been done for the past 3 certification periods.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients and/or caregivers received ongoing education and training regarding the needs of the patient as identified in the plans of care, and failed to evidence patient and caregiver responses and comprehension of any training provided for 9 of 10 records reviewed (#1, 2, 3, 4, 5, 7, 8, 9, 10 ) and 1 of 1 patients (without clinical record review) identified during an interview that verbalized no teaching had ever been completed (#12). Findings include: 1. Review of an undated agency policy C-400 copyright Briggs Healthcare titled "Client/Family Education" stated "... Clients and their families will be provided with information necessary to make decisions and to take responsibility for self-management activities related to their needs ... will target the clients [sic] ability to improve outcomes through promotion of healthy behavior and involvement in their care, treatment, and service decisions ... All client and/or caregiver education and instruction, as well as their perceived comprehension and demonstrated competency, as appropriate, will be documented in the client's record ...." Review of an undated agency policy C-580 copyright Briggs Healthcare titled "Plan of Care" stated "... The Plan of Care shall be completed in full to include: ... Instructions to client/caregiver, as applicable ... All of the above items must always be addressed on the plan of care ...." Review of an agency policy dated 06/2000 titled "Home Nursing Services Job Description Registered Nurse" stated "... Provides instruction to the client and the client's family on areas listed on the plan of care, documents what is taught, and lists the client and/or family's response ...." Review of an undated agency policy titled "Home Nursing Services Job Description Licensed Practical Nurse [LPN]" stated "... Will teach the client and care giver [sic] in the areas on the plan of care, document what is taught and their response ...." 2. The clinical record of patient #1, start of care 12/10/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a plan of care (POC) for certification period 12/4/2020 - 2/1/2021, with primary diagnosis Diabetes with diabetic peripheral angiopathy (blood vessel disease caused by high blood sugar levels), and other pertinent diagnoses chronic obstructive pulmonary disease, essential (primary) hypertension, hyperlipidemia (high cholesterol), peripheral vascular disease (impaired circulation), depression, neuromuscular dysfunction of bladder, urinary incontinence, anemia, chronic atrial fibrillation, nicotine dependence (cigarettes), history of falling, encounter for fitting and adjustment of urinary device, acquired absence of right leg below knee, and acquired absence of left leg below knee. The POC also evidenced a section titled "Professional Service Orders" which stated "RN [registered nurse] Orders: ... periodic planned and unplanned supervisory visits ... 1x/month for indwelling catheter change ...." The section titled "60 Day Summary" evidenced the patient had open wounds which required wound care, an indwelling urinary catheter, he was a non-compliant diabetic, he was incontinent and wore briefs, and his niece was his primary caregiver. The POC failed to evidence skilled nursing interventions for patient and caregiver education and training based on the needs identified on the POC, such as, but not limited to, teaching the caregiver proper wound treatment/dressing changes, signs or symptoms of infection, importance of following a diabetic diet, indwelling urinary catheter management, signs and symptoms of urinary tract infection (UTI), prevention of new or worsening skin breakdown, or COVID-19 precautions. The record review failed to evidence patient or caregiver training was performed, or the patient/caregiver response to the training. Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). 3. The clinical record of patient #2, start of care 9/23/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for dates 11/16/2020 - 1/14/2021 with primary diagnosis unspecified injury at C6 (6th cervical vertebrae) level of spinal cord, and other pertinent diagnoses of unspecified injury at C7 (7th cervical vertebrae) level of spinal cord, laceration (cut) without foreign body of left buttock, presence of urogenital implants, autonomic dysreflexia, hyperlipidemia, muscle spasm, iron deficiency, constipation, essential (primary) hypertension, and unspecified cataract. The POC also evidenced a section titled "Professional Service Orders" which stated "HHA [home health aide] ... 7 days a week ... SN [skilled nurse] Orders: ... 1 visit every other day ...." The POC also evidenced a section titled "60 Day Summary" which evidenced the patient had a stage 4 (full thickness with tendon and/or bone exposed) pressure injury to the left buttock, the agency performed wound care as needed, and the patient had a suprapubic catheter (a tube inserted into a hole in the lower abdomen into the bladder to drain urine). The POC failed to evidence skilled nursing interventions for patient and caregiver education and training based on the needs identified on the POC, such as, but not limited to, teaching the caregiver proper wound treatment/dressing changes, signs or symptoms of infection, indwelling urinary catheter management, signs and symptoms of urinary tract infection (UTI), prevention of new or worsening skin breakdown, or COVID-19 precautions. The record review failed to evidence patient or caregiver training was performed, or the patient/caregiver response to the training. 4. The clinical record review of patient #3, start of care date 1/21/2003, was completed on 1/12/2021, which evidenced documents titled "Home Health Certification/Recertification Plan of Care Order" for dates 12/17/2020 - 2/14/2021 with primary diagnosis of cerebral palsy, and other pertinent diagnoses of profound intellectual disabilities, hearing loss, asthma, chronic obstructive pulmonary disease, attention and concentration deficit, sleep apnea, gastro-esophageal reflux disease without esophagitis, restlessness and agitation, impulse disorder, attention-deficit hyperactivity disorder, predominantly hyperactive type, seizures, constipation, other specified nonpsychotic mental disorders, seasonal allergies, gastrostomy (tube inserted through the wall of the abdomen directly into the stomach. It allows air and fluid to leave the stomach and can be used to give drugs and liquids, including liquid food, to the patient.) status, and tracheostomy (an incision in the windpipe made to relieve an obstruction to breathing) status. The POC evidenced the patient received skilled nursing services (but not limited to) for tracheostomy care, g-tube, administer medications via g-tube, breathing treatments via nebulizer machine, and personal care. The POC failed to evidence skilled nursing interventions for patient and caregiver education and training based on the needs identified on the POC, such as, but not limited to, teaching the caregiver tracheostomy management, gastrostomy management, aspiration precautions, signs or symptoms of infection, seizure precautions, or COVID-19 precautions. The record review failed to evidence caregiver training was performed, or the caregiver response to the training. 5. The clinical record review of patient #4, start of care date 8/19/2019, was completed on 1/12/2021, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for dates 12/17/2020 - 2/14/2021 with primary diagnosis of paraplegia, and other pertinent diagnoses of essential (primary) hypertension, anxiety disorder, fusion of spine- lumbar region, and incontinence without sensory awareness. The POC evidenced the patient received skilled nursing services (but not limited to) 3 times per week for wound care. The section titled "60 Day Summary" evidenced the patient had an open wound. The POC failed to evidence skilled nursing interventions for patient and caregiver education and training based on the needs identified on the POC, such as, but not limited to, teaching the patient/caregiver signs or symptoms of wound infection, prevention of new or worsening skin breakdown, foods to avoid for patients with high blood pressure, or COVID-19 precautions. The record review failed to evidence patient/caregiver training was performed, or the patient/caregiver response to the training. 6. The clinical record of patient #5, start of care 3/14/2019, was reviewed on 1/12/21, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/3/2020 - 1/1/2021 which evidenced orders for skilled nursing monthly for to "change central line dressing and cap; blood lab draw of CBC w diff [complete blood count with differential], CMP [sic comprehensive metabolic panel], trig. [sic triglycerides], magnesium, phosphurus [sic] every week and teach caregiver on TPN [total parenteral nutrition], and g tube [gastrostomy -tube inserted through the belly that brings nutrition directly to the stomach] maintenance. Call physician with any concerns or changes. Weekly weights to be called into pharmacy ..." Review of documents titled "Skilled Nurse Visit Note" for dates 11/3/2020, 11/10/2020, 11/17/2020, 11/24/20, 12/1/2020, 12/8/2020, and 12/29/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions. 7. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification dates 12/31/2020 - 2/28/2021. The document evidenced the patient received, but not limited to, skilled nursing every other week to complete a full head to toe assessment,vital signs, and change the patient's suprapubic catheter (a tube inserted into an opening in the lower abdomen directly into the bladder to drain urine), and home health aide (HHA) services for personal care "up to 60 hours", evidenced diagnoses listed (but not limited to) unspecified stroke and unspecified convulsions; and the section for the 60 day summary indicated (but not limited to) the patient had a wound on his tailbone, the wife performed the wound care, he was incontinent of bowel and bladder, had fragile skin, had diabetes, depression, chronic lung disease and used oxygen, and had chronic pain. The document failed to evidence any skilled nursing teaching interventions such as seizure precautions, infection control precautions, COVID-19 precautions, oxygen prevention of skin breakdown, or signs and symptoms of UTI, wound infection or respiratory issues to report to the nurse or physician. Review of documents titled "Skilled Nurse Visit Note" for dates 11/11/2020, 11/27/2020, and 12/23/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions were performed. 8. The clinical record review for patient #8 was completed on 1/11/2021, and evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification dates 11/22/2020 - 1/20/2021. The document evidenced the patient received HHA (home health aide) services 2 hours per day, five days per week, RN to supervise patient to ensure needs and goals were met (no frequency evidenced), diagnoses list included (but not limited to) diabetes, moderate intellectual disability, chronic lung disease, high blood sugar, high blood pressure; and the section for the 60 day summary indicated (but not limited to) the patient resided in a group home managed by entity O, he smoked, had anxiety at times, constipation at times, blood sugars fluctuate between 74-344, had a diabetic foot ulcer on the left foot, and had a previous ulcer that resulted in a partial foot amputation. Goals included (but not limited to) safe and free from injury, unlabored respirations and oxygen saturation 90% or above, and blood sugars less than 150. The document failed to evidence any skilled nursing teaching interventions for the group home caregivers such as signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, COVID-19 precautions, prevention of new skin breakdown, or signs and symptoms of wound infection or respiratory issues to report to the nurse or physician. 9. The clinical record of patient #9, start of care 9/9/2019, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/2/2020 - 12/31/2020. The document evidenced the patient received skilled nursing services every two weeks to fill and organize medication delivery system as scheduled and when medications were changed; and the section for the 60 day summary indicated (but not limited to) the patient had a non-removable surgical dressing on his right second toe (amputation), his 3rd right toe was black and shriveled, and a goal was set to follow a diabetic diet. Listed diagnoses included (but not limited to) hardening of the arteries, high cholesterol, high blood pressure, progressive systemic sclerosis (a condition associated with thickening of the skin and tethering to subcutaneous tissues as well as smooth muscle waste and fibrosis of internal organs such as the gastrointestinal tract, lungs, heart, and kidneys), and chronic lung disease, and the patient was a moderate fall risk. Goals stated (but not limited to) "... proper, safe and effective administration of meds ... remain safe in current living situation with agency caregiver assistance ... maintained at current status of physical and medical well-being through our assistance with obtaining proper nutrients, medications, and safe activity levels." The document failed to evidence any skilled nursing teaching interventions such as teaching caregiver proper medication administration, how to fill medication box, signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, COVID-19 precautions, prevention of new skin breakdown, or signs and symptoms of wound infection or respiratory issues to report to the nurse or physician. During an interview on 1/12/2021 at 12:48 PM, When asked how she ensured goals were being met on the plan of care, employee M (registered nurse) stated "The wife makes sure he takes his vitamins and his meds, he is only standing and pivoting. I would like to get him some therapy at home. Hoping the VA will provide that." When asked what interventions were completed to address his moderate fall risk, she stated "Clear pathways, coral the dogs so he doesn't trip, bedside commode next to bed, he does not stand or transfer by himself, he has a ramp going into the house, his wife has purchased a transport wheelchair for him." When asked how are goals established if there are no interventions, she stated "I try not to set goals I cannot control. I don't have control over the healing of the incision." 10. The clinical record review for patient #10 was completed on 1/6/2021 and again on 1/12/2021, start of care date 8/23/2013, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/14/2020 - 1/12/2021. The document evidenced skilled nursing services every other week to include, but not limited to, set up medications in medication boxes, perform a system assessment, make sure needs are being addressed and goals are being met, and notify doctor of changes in condition. Listed diagnoses included (but not limited to) heart failure, kidney failure (unspecified stage), abdominal wound, high blood pressure chronic lung disease, diabetes, and cervicalgia (neck pain); and the section for the 60 day summary stated "... a history of non-compliance with taking oral meds ... Efforts are being made at education to improve her compliance ... open wound on her abdomen that is non-healing and getting progressively worse ... Will also set a pain management goal ...." The document evidenced goals including (but not limited to) pain level at 4 or less (verbal pain scale 0-10, with 0 being no pain, and 10 being worst pain ever), wound to decrease in size by 2.0 centimeters in length, and blood sugar levels at 140 or less. The document failed to evidence any skilled nursing teaching interventions such as signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, prevention of new skin breakdown, signs and symptoms of wound infection, non-medicinal methods to mitigate pain, importance of medication compliance, or signs and symptoms to immediately report to the nurse or physician. Review of documents titled "Skilled Nurse Visit Note" for dates 12/4/2020 and 12/19/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions such as signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, prevention of new skin breakdown, signs and symptoms of wound infection, non-medicinal methods to mitigate pain, importance of medication compliance, or signs and symptoms to immediately report to the nurse or physician. Review of a document titled "Skilled Nurse Visit Note" dated 1/6/2021 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The document evidenced the nurse instructed the patient when to call physician and stated "... Client weak and called wound clinic and they advised client to go to the ED [emergency department] to r/o [rule out] infection. Client states she's lost about 30 lbs [pounds] with in [sic] the past month ...." 11. During an interview with patient #12 (no record review) on 12/29/2020 at 1:19 PM, when asked what teaching the nurses have done, she indicated she didn't need any teaching, she didn't need help, and she used to be a QMA (Qualified Medication Aide). When asked what the agency nurse did for her, she indicated she took her vital signs, filled her pill box, and checked if more medications needed to be ordered. 12. During an interview on 1/6/21 at 2:45 PM when asked if they would expect to see interventions for goals established on the plans of care, the clinical director and alternate clinical director both stated "Yes." During an interview on 1/11/2021 at 3:35 PM, When asked if documentation of patient/caregiver education/teaching and correct return demonstration of a task/skill performed should be documented, the alternate clinical director stated "Correct." When asked if the agency had a policy regarding this, the clinical director and alternate clinical director both stated "No." During an interview on 1/12/21 12:48 PM, when asked if a nurse instructed a patient to take a particular medication, would she expect to see an order for the medication, employee M stated "You have to have an order before you instruct a patient to do anything." When asked if a nurse provided skilled care to a patient, would she expect to see orders for care/treatment on the plan of care, she stated "Yes."

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse (RN) clinical director failed to ensure education was provided to patients/caregivers based on interventions evidenced in the plan of care for 9 of 10 records reviewed (#1, 2, 3, 4, 5, 7, 8, 9, 10). Findings include: 1. Review of an undated agency policy C-400 copyright Briggs Healthcare titled "Client/Family Education" stated "... Clients and their families will be provided with information necessary to make decisions and to take responsibility for self-management activities related to their needs ... will target the clients [sic] ability to improve outcomes through promotion of healthy behavior and involvement in their care, treatment, and service decisions ... All client and/or caregiver education and instruction, as well as their perceived comprehension and demonstrated competency, as appropriate, will be documented in the client's record ...." Review of an agency policy dated 06/2000 titled "Home Nursing Services Job Description Registered Nurse" stated "... Provides instruction to the client and the client's family on areas listed on the plan of care, documents what is taught, and lists the client and/or family's response ...." Review of an undated agency policy titled "Home Nursing Services Job Description Licensed Practical Nurse [LPN]" stated "... Will teach the client and care giver [sic] in the areas on the plan of care, document what is taught and their response ...." 2. The clinical record of patient #1, start of care 12/10/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 12/4/2020 - 2/1/2021 evidenced skilled nursing monthly for indwelling catheter change and physical assessment, report any abnormal findings to MD, and stated "... RN will supervise patient to make sure needs are being addressed and goals are being met ...." The document also evidenced listed diagnoses of (but not limited to) diabetes, chronic lung disease, current smoker, peripheral vascular disease (impaired circulation to the lower extremities), amputations of both lower extremities, and depression; and the section for the 60 Day Summary evidenced the patient had an indwelling foley catheter (a tube inserted from the urethra into the bladder to drain urine), a wound to the right groin from pressure/friction due to wearing incontinence briefs, a wound to the left lower extremity stump, and non-compliance with diabetes. Goals included the patient would increase his protein intake by 18 grams per day, be safe and free from injury, free of UTIs (urinary tract infections), all for the certification period. The document failed to evidence any skilled nursing teaching interventions such as infection control, foley catheter management, nutrition, wound management, prevention of new skin breakdown, smoking cessation, diabetes management, and signs and symptoms of disease exacerbation to report to the nurse or physician. Review of a document received on 12/28/2020 at 12:01 PM dated 12/22/2020 titled "Follow Up Assessment (FUA) Non-Recert OASIS" stated "... A general assessment was completed due to the findings of the State ... This client uses HNS [Home Nursing Services] for a monthly catheter change ... The physician or family have not requested the assistance of this agency for his wounds ... The state feels that HNS should be involved in the wound care. The state wants total client care not just cath [catheter] care ... The client went today [12/22/2020] to the clinic and the niece declined to allow this nurse to visualize the wounds ... The niece stated that an appointment [with agency nurse] can be set up to see wounds at a further date ... His catheter bag [bag connected urine drain tube] was stuffed an opening [sic] in the side of his wheelchair. The urine in the tube was pale yellow with sediment present ... The niece changes the dressings daily to the wounds, she state [sic] the wounds look the same to her except this morning the area to the stump had changed for the worse ... Writer [registered nurse] asked [niece] if the clinic recommended about adding vitamins and supplements of Vitamin C and Zinc for wound healing. She indicated they might have. Also asked about adding protein to the diet, niece indicated she did not remember for sure, maybe." The document failed to evidence the skilled nurse provided education to the caregiver to meet the patient's needs, such as (but not limited to), education to mitigate worsening or new skin breakdown, education on proper placement of the urine drainage bag below the bladder to avoid urine back up into the bladder, which would increase risk of urinary tract infection, nutrition teaching for food sources high in protein, or wound care/management, to also include signs or symptoms of worsening wound status to report to nurse or physician. 3. The clinical record of patient #2, start of care 9/23/2019, was reviewed on 12/18/2020, and again on 1/12/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/16/2020 - 1/14/2021. The document evidenced the patient received skilled nursing services to administer a bowel program (insertion of rectal suppository to facilitate a bowel movement), and to perform wound care to a stage 4 (full thickness with tendon and/or bone exposed) pressure injury to the left buttock, and home health aide services 3 times per day for 2 hours each visit, 7 days per week for personal care, evidenced listed diagnoses of (but not limited to) C7 spinal cord injury (paralyzed from the neck down, may have limited upper extremity movement), autonomic dysreflexia (a condition in which your involuntary nervous system overreacts to external or bodily stimuli, such as an overfull urinary catheter bag, pressure on bony area(s) from not turning or re-positioning, which causes a dangerous spike in blood pressure and slow heartbeat), constipation, high blood pressure and anemia (low red blood cell count), evidenced the patient had an indwelling urinary catheter, evidenced nutritional requirements to encourage fluids and increase protein intake, and stated "... Client was having issues with autonomic dysreflexia and was put on [11/13/2020] Nitro-BID topical ointment PRN [as needed], no issues recently. He has had an increase [dose] in his Baclofen [medication for spasms] ...." The document also evidenced goals (but not limited to) for the wound to remain free of infection, patient to remain free of UTI, increase pre-albumin levels (by increasing protein intake), and free from infection. The document failed to evidence any skilled nursing teaching interventions such as infection control, foley catheter management, nutrition, wound management, prevention of new skin breakdown, prevention of autonomic dysreflexia, and signs and symptoms of disease exacerbation to report to the nurse or physician. Review of documents titled "Skilled Nurse Visit Note" for dates 11/16/2020, 11/18/2020, 11/20/2020, 11/22/2020, 11/24/2020, 11/26/2020, 11/28/2020, 11/30/2020, 12/2/2020, 12/4/2020, 12/6/2020, 12/8/2020, 12/10/2020, and 12/12/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions such as infection control, foley catheter management, nutrition, wound management, prevention of new skin breakdown, prevention of autonomic dysreflexia, and signs and symptoms of disease exacerbation to report to the nurse or physician. 4. The clinical record review of patient #3, start of care date 1/21/2003, was completed on 1/12/2021, which evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification dates 12/17/2020 - 2/14/2021. The document evidenced the patient received skilled nursing services (but not limited to) for tracheostomy (an incision in the windpipe made to relieve an obstruction to breathing) care, g-tube (a tube inserted directly into the stomach to administer nutrition, fluids and medications), administer medications via g-tube, breathing treatments via nebulizer machine, and personal care, 6 hours per day, 5 days per week, he lived in a group home managed by entity O, evidenced listed diagnoses of (but not limited to) cerebral palsy, profound intellectual disability, seizures, g-tube, tracheostomy, constipation, asthma, and chronic lung disease. Goals included (but not limited to) to remain safe in home environment by lack of hospitalizations due to injuries from falls and/or infections, maintain oxygen saturation levels of at least 95%, and no weight loss. The document also evidenced the patient was a high fall risk, and a high risk for aspiration (fluid or objects ingested directly into the lungs). The document failed to evidence any skilled nursing teaching interventions for the family/caregivers such as fall precautions, infection control precautions, aspiration precautions, or lung precautions such as avoidance of aerosol sprays, heavy perfumes/scents to avoid bronchiospasm. 5. The clinical record review of patient #4, start of care date 8/19/2019, was completed on 1/12/2021, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification dates 12/11/2020 - 2/8/2021. The document evidenced the patient received, but not limited to, skilled nursing visits 3 times weekly for wound care (2 wounds) and physical assessment, and to alert MD for any abnormal findings, evidenced diagnoses (but not limited to) paraplegia (paralysis from the waist down), high blood pressure, anxiety disorder; and the section for the 60 day summary indicated the patient self-catheterized himself (scheduled insertion of a urinary drainage tube directly into the bladder to drain urine, which is removed once bladder is empty), and he had a wound on his right heel. The document also evidenced nutritional requirements to increase fluids, he was a fall risk, and had fragile skin. Goals included (but not limited to) no new open skin areas, no infection, have social, spiritual/physical/emotional and medical needs met. The document failed to evidence any skilled nursing teaching interventions such as fall precautions, infection control precautions, prevention of skin breakdown, or signs and symptoms to report to the nurse or physician. 6. The clinical record of patient #5, start of care 3/14/2019, was reviewed on 1/12/21, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/3/2020 - 1/1/2021 which evidenced orders for skilled nursing monthly for to "change central line dressing and cap; blood lab draw of CBC w diff [complete blood count with differential], CMP [sic comprehensive metabolic panel], trig. [sic triglycerides], magnesium, phosphurus [sic] every week and teach caregiver on TPN [total parenteral nutrition], and g tube [gastrostomy -tube inserted through the belly that brings nutrition directly to the stomach] maintenance. Call physician with any concerns or changes. Weekly weights to be called into pharmacy ..." Review of documents titled "Skilled Nurse Visit Note" for dates 11/3/2020, 11/10/2020, 11/17/2020, 11/24/20, 12/1/2020, 12/8/2020, and 12/29/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions. 7. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021 evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification dates 12/31/2020 - 2/28/2021. The document evidenced the patient received, but not limited to, skilled nursing every other week to complete a full head to toe assessment,vital signs, and change the patient's suprapubic catheter (a tube inserted into an opening in the lower abdomen directly into the bladder to drain urine), and home health aide (HHA) services for personal care "up to 60 hours", evidenced diagnoses listed (but not limited to) unspecified stroke and unspecified convulsions; and the section for the 60 day summary indicated (but not limited to) the patient had a wound on his tailbone, the wife performed the wound care, he was incontinent of bowel and bladder, had fragile skin, had diabetes, depression, chronic lung disease and used oxygen, and had chronic pain. Goals included (but not limited to) remain free of infection, and maintain optimal gas exchange (no breathing issues) with oxygen saturation reading 95% or above. The document failed to evidence any skilled nursing teaching interventions such as seizure precautions, infection control precautions, oxygen prevention of skin breakdown, or signs and symptoms of UTI, wound infection or respiratory issues to report to the nurse or physician. Review of documents titled "Skilled Nurse Visit Note" for dates 11/11/2020, 11/27/2020, and 12/23/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions were performed. 8. The clinical record review for patient #8 was completed on 1/11/2021, and evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification dates 11/22/2020 - 1/20/2021. The document evidenced the patient received HHA (home health aide) services 2 hours per day, five days per week, RN to supervise patient to ensure needs and goals were met (no frequency evidenced), diagnoses list included (but not limited to) diabetes, moderate intellectual disability, chronic lung disease, high blood sugar, high blood pressure; and the section for the 60 day summary indicated (but not limited to) the patient resided in a group home managed by entity O, he smoked, had anxiety at times, constipation at times, blood sugars fluctuate between 74-344, had a diabetic foot ulcer on the left foot, and had a previous ulcer that resulted in a partial foot amputation. Goals included (but not limited to) safe and free from injury, unlabored respirations and oxygen saturation 90% or above, and blood sugars less than 150. The document failed to evidence any skilled nursing teaching interventions for the group home caregivers such as signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, prevention of new skin breakdown, or signs and symptoms of wound infection or respiratory issues to report to the nurse or physician. 9. The clinical record of patient #9, start of care 9/9/2019, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/2/2020 - 12/31/2020. The document evidenced the patient received skilled nursing services every two weeks to fill and organize medication delivery system as scheduled and when medications were changed; and the section for the 60 day summary indicated (but not limited to) the patient had a non-removable surgical dressing on his right second toe (amputation), his 3rd right toe was black and shriveled, and a goal was set to follow a diabetic diet. Listed diagnoses included (but not limited to) hardening of the arteries, high cholesterol, high blood pressure, progressive systemic sclerosis (a condition associated with thickening of the skin and tethering to subcutaneous tissues as well as smooth muscle waste and fibrosis of internal organs such as the gastrointestinal tract, lungs, heart, and kidneys), and chronic lung disease, and the patient was a moderate fall risk. Goals stated (but not limited to) "... proper, safe and effective administration of meds ... remain safe in current living situation with agency caregiver assistance ... maintained at current status of physical and medical well-being through our assistance with obtaining proper nutrients, medications, and safe activity levels." The document failed to evidence any skilled nursing teaching interventions such as teaching caregiver proper medication administration, how to fill medication box, signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, prevention of new skin breakdown, or signs and symptoms of wound infection or respiratory issues to report to the nurse or physician. During an interview on 1/12/2021 at 12:48 PM, When asked how she ensured goals were being met on the plan of care, employee M (registered nurse) stated "The wife makes sure he takes his vitamins and his meds, he is only standing and pivoting. I would like to get him some therapy at home. Hoping the VA will provide that." When asked what interventions were completed to address his moderate fall risk, she stated "Clear pathways, coral the dogs so he doesn ' t trip, bedside commode next to bed, he does not stand or transfer by himself, he has a ramp going into the house, his wife has purchased a transport wheelchair for him." When asked how are goals established if there are no interventions, she stated "I try not to set goals I cannot control. I don ' t have control over the healing of the incision." 10. The clinical record review for patient #10 was completed on 1/6/2021 and again on 1/12/2021, start of care date 8/23/2013, evidenced a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/14/2020 - 1/12/2021. The document evidenced skilled nursing services every other week to include, but not limited to, set up medications in medication boxes, perform a system assessment, make sure needs are being addressed and goals are being met, and notify doctor of changes in condition. Listed diagnoses included (but not limited to) heart failure, kidney failure (unspecified stage), abdominal wound, high blood pressure chronic lung disease, diabetes, and cervicalgia (neck pain); and the section for the 60 day summary stated "... a history of non-compliance with taking oral meds ... Efforts are being made at education to improve her compliance ... open wound on her abdomen that is non-healing and getting progressively worse ... Will also set a pain management goal ...." The document evidenced goals including (but not limited to) pain level at 4 or less (verbal pain scale 0-10, with 0 being no pain, and 10 being worst pain ever), wound to decrease in size by 2.0 centimeters in length, and blood sugar levels at 140 or less. The document failed to evidence any skilled nursing teaching interventions such as signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, prevention of new skin breakdown, signs and symptoms of wound infection, non-medicinal methods to mitigate pain, importance of medication compliance, or signs and symptoms to immediately report to the nurse or physician. Review of documents titled "Skilled Nurse Visit Note" for dates 12/4/2020 and 12/19/2020 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The section was blank for all notes, and all notes failed to evidence any skilled nursing teaching interventions such as signs and symptoms of high and low blood sugar, importance of maintaining a diabetic diet and regularly checking blood sugars, infection control, prevention of new skin breakdown, signs and symptoms of wound infection, non-medicinal methods to mitigate pain, importance of medication compliance, or signs and symptoms to immediately report to the nurse or physician. Review of a document titled "Skilled Nurse Visit Note" dated 1/6/2021 evidenced a section titled "Interventions/Instructions", which stated "... Observe/Teach: ...." The document evidenced the nurse instructed the patient when to call physician, and stated "... Client weak and called wound clinic and they advised client to go to the ED [emergency department] to r/o [rule out] infection. Client states she's lost about 30 lbs [pounds] with in [sic] the past month ...." 11. During an interview with patient #12 (no record review) on 12/29/2020 at 1:19 PM, when asked what teaching the nurses have done, she indicated she didn't need any teaching, she didn't need help, and she used to be a QMA (Qualified Medication Aide). When asked what the agency nurse did for her, she indicated she took her vital signs, filled her pill box, and checked if more medications needed to be ordered. During an interview on 1/6/21 at 2:45 PM when asked if they would expect to see interventions for goals established on the plans of care, the clinical director and alternate clinical director both stated "Yes." During an interview on 1/11/2021 at 3:35 PM, When asked if documentation of patient/caregiver education/teaching and correct return demonstration of a task/skill performed should be documented, the alternate clinical director stated "Correct." When asked if the agency had a policy regarding this, the clinical director and alternate clinical director both stated "No." During an interview on 1/12/21 12:48 PM, when asked if a nurse instructed a patient to take a particular medication, would she expect to see an order for the medication, employee M stated "You have to have an order before you instruct a patient to do anything." When asked if a nurse provided skilled care to a patient, would she expect to see orders for care/treatment on the plan of care, she stated "Yes."

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure nursing services were provided under the supervision of a registered nurse. Review of an undated copyright Briggs Healthcare policy D-220 titled "Competency Evaluation of Home Care Staff" stated, "... assessment of the person's ability to perform required activities ... assessment will verify and focus on the individual staff knowledge and skill appropriate to assigned responsibilities ... Competencies will address ... Age/type of client ... High risk procedures ... All competencies will be documented ... To assure the personnel providing services to home care clients are trained, competent and able to respond to needs of clients in safe and effective manor ... All new employees will be assessed for competency ... A Home Health Aide will not be permitted to provide ... services until evidence of adequate training and/or competency has been determined ... There must be evidence of ... competency in the delegated tasks ...." Review of an undated copyright Briggs Healthcare policy D-180 titled "Personnel Records" stated, "... personnel record may include, but not limited to: ... Competency testing for home health aides and specific competencies per job title ... competency reviews ...." During an interview on 1/11/2021 at 3:35 PM, the clinical director indicated the agency does not require competency evaluations for agency staff. During an interview on 1/11/2021 at 4:00 PM, when asked what kind of patents she saw for this agency, employee O (registered nurse) stated "From peds to elderly." When asked if she had competency evaluations when she started this job, she stated "I already had PALS [pediatric advanced life support] from past nursing jobs." When asked if she had competency evaluations for pediatric patients with this agency, she stated "No." During an interview on 1/12/2021 11:54 AM, when asked who did her last performance evaluation and when was it done, employee K (licensed practical nurse) stated "I believe that was [the clinical director], and I am not sure the last time it was done, longer than a year." When asked what kind of patents she saw for this agency, she indicated from pediatrics to adult. When asked if she had completed competency evaluations at this agency for pediatric patients, she stated "I do not with this company, but I staff primarily for a peds [pediatric] company outside of here and have been with them for 5.5 years." When asked when she started working here, shgge stated "November of 2011. When asked who did her initial competency evaluation, she stated "It would ' ve been [employee F, not a registered nurse] from HR [human resource] in Fort Wayne." During an interview on 1/12/2021 at 12:48 PM, when asked who did her last performance evaluation and when was it done, employee M (registered nurse) stated "It would be [the clinical director], and I don't remember [when it was last done]." When asked when she started working here, she stated "April, 2018."

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the Governing Body failed to periodically review and approve the agency's operational policies and review and approve updated/new policies. Findings include: Review of an undated copyright Briggs Healthcare policy B-100 titled "Governing Body" stated "... The Governing Body shall assume full legal authority and responsibility for the operation of Home Nursing Services ... The duties of the Governing Body shall include ... Adopt and periodically review and approve the administrative and personnel policies, client care policies and procedures ... as required by state licensure ...." Review of an undated copyright Briggs Healthcare policy B-210 titled "Policy Development" stated "... All policies will be incorporated into Home Nursing Services policy manual. Selected policies will be reviewed and revised at least annually ... The Governing Body makes final approval ... New or revised policies will be approved ... Policy reviews will be documented ...." Review of an agency policy excerpt (as indicated by the administrator) submitted on 1/12/2021 at 1:30 PM from the employee handbook titled "Progressive Discipline" evidenced an amended date of 10/23/2020. Review of an agency policy titled "Client Incident/Accident" evidenced an amended date of 10/23/2020. Review of agency policies titled "Dress Code", "Home Nursing Services Job Description: Home Health Aide", and "Home Nursing Services Job Description: Homemaker", all evidenced amendment date 10/23/2020. Review of a copyright Briggs Healthcare policy D-325 titled "Exposure to Coronavirus (COVID-19): Disease Response and Management" evidenced a date of 11/3/2020. Review of an agency document dated 2/28/2020 titled "Written Consent to Resolutions of the Board of Directors of Home Nursing Services, Inc." failed to evidence agency policies were reviewed and approved, Review of an agency document dated 6/5/2020 titled "Written Consent to Resolutions of the Board of Directors of Home Nursing Services, Inc." failed to evidence agency policies were reviewed and approved. During an interview on 1/6/2021 at 12:01 PM, the administrator submitted Governing Body minutes and meetings from 2/28/2020 and 6/5/2020. When asked if the submitted documents included all minutes and meetings from 2/28/2020 to present (1/6/2021), the administrator stated "Yes."

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for all day-to-day operations of the agency; failed to have systems in place to monitor ongoing staff performance to ensure comprehensive assessments were being conducted and documented; failed to ensure staff received appropriate competency evaluations prior to providing patient care; failed to ensure staff were not documenting in the electronic medical record as other nursing staff (not themselves); and failed to ensure staff did not modify clinical documentation without prior approval from the assessing clinician, all which led to employees continuation of working without discipline, appropriate competency, and training which led to new or worsening wounds, urinary tract infection, hospitalization, amputation, and/or death to 3 of 7 patients (#1, 7, and 9) who had wounds. This practice had the potential to affect all agency patients. Findings include: 1. Review of an agency employee handbook policy amended 10/23/2020 titled "Progressive Discipline" stated "... it should be understood that certain conduct will not be tolerated and will subject an employee to warning, discipline or immediate discharge, depending on the severity of the circumstance ... any employee actions which compromise the health and safety of the clients will also be cause for immediate termination." Review of an undated copyright Briggs Healthcare policy C-873 titled "Documentation of Changes to the Medical Record" stated, "... If it is necessary to make an addition to a previous entry, this must be done using an addendum to the record. The entry will be marked as an addendum and must include the date it is written and the visit date that the entry relates to ... Changes to OASIS documentation ... The clinician who completes the assessment form is responsible for making changes (corrections, revisions, or additions) to the document. The clinical supervisor or designee may enter changes based on the review of the assessment. These changes must be documented in the record identifying the reason for the changes and the communication of those changes to the authoring clinician ... Records sourced from electronic systems containing amendments, corrections or delayed entries must: Distinctly identify any amendment, correction or delayed entry ... Provide a reliable means to clearly identify the original content, the modified content, and the date and authorship of each modification of the records ... Auditors including recovery auditors shall NOT consider any entries that do not comply with these principles ...." Review of an undated copyright Briggs Healthcare policy D-220 titled "Competency Evaluation of Home Care Staff" stated, "... assessment of the person's ability to perform required activities ... assessment will verify and focus on the individual staff knowledge and skill appropriate to assigned responsibilities ... Competencies will address ... Age/type of client ... High risk procedures ... All competencies will be documented ... To assure the personnel providing services to home care clients are trained, competent and able to respond to needs of clients in safe and effective manor ... All new employees will be assessed for competency ... A Home Health Aide will not be permitted to provide ... services until evidence of adequate training and/or competency has been determined ... There must be evidence of ... competency in the delegated tasks ...." Review of an undated copyright Briggs Healthcare policy D-180 titled "Personnel Records" stated, "... personnel record may include, but not limited to: ... Competency testing for home health aides and specific competencies per job title ... competency reviews ...." 2. The clinical record of patient #1, start of care 12/10/2019, certification period 12/4/2020 - 2/1/2021, was reviewed on 12/18/2020, and again on 1/12/2021. Review of a document received on 12/28/2020 titled "SN [skilled nurse] SOC [start of care] OASIS and Comprehensive Assessment" dated 12/10/2019 evidenced the patient had no wounds, and failed to evidence a Braden scale (a comprehensive assessment for predicting pressure sore risk) was completed by the registered nurse. The assessment further evidenced the patient had (but not limited to) diabetes with peripheral angiopathy (a blood vessel disease caused by high blood sugar), amputations of both legs below the knees, and had an indwelling urinary catheter (a tube inserted into to bladder to drain urine). The patient was alert and oriented to person, place, and time, without confusion or disruptive behaviors. Upon admission on 12/10/2019, the patient had no open skin areas or wounds. Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). During the entrance conference interview on 12/15/2020 at 11:00 AM, the clinical director indicated the agency used both paper and electronic charting. When asked the process for making corrections in the clinical record, the clinical director indicated the document would be taken to the RNCM (registered nurse case manager) to discuss, then it would be a late entry, line through, corrected, then initialed. When asked the timeframe for documents to be incorporated into the patients' medical records, the clinical director stated, "Fourteen days." During an interview on 12/17/2020 at 3:44 PM, the clinical director stated the comprehensive assessment for patient #1 dated and signed by employee L on 12/3/2020 was actually completed on that date (12/17/2020), and the plan of care was also completed that date (12/17/2020) and sent to the physician. Both were reviewed and approved by employee M (registered nurse). It was verified by the clinical director and the administrator that employee L (registered nurse) initiated the comprehensive assessment on 12/3/2020 but didn't complete it, and she did not assess the wounds. When asked, the clinical director agreed the certifying physician would not be able to provide/approve orders to meet the patient's needs without complete and accurate assessment findings. During this time, the administrator asked the director of nursing if the agency obtained wound clinic follow up. The director of nursing stated "No." During an interview on 12/18/2020 at 1:00 PM, when asked who finished the comprehensive assessment for patient #1 dated 12/3/2020, the director of nursing stated "[employee N- registered nurse]." When asked if she was the nurse that initiated the comprehensive assessment on 12/3/2020, the director of nursing stated "No." When asked why employee L didn't complete the assessment, the director of nursing stated "We discovered she was behind, we wanted to get it done, so we sent it to [employee N]." She also indicated employee N saw the patient on 12/15/2020, and that visit represented completion of the comprehensive assessment dated 12/3/2020. When asked if there were other incomplete patient assessments that employee L failed to complete that someone else was finishing, the administrator stated, "I believe so." When asked when the agency noticed employee L's had incomplete/late assessments, the clinical Director stated "Monday [12/14/2020]". When asked if the agency had a list of additional patients that other nurses were "fixing or have fixed" for employee L, the clinical director stated "Yes." The administrator indicated employee H (office staff) completed billing every week, and every week she checked in the paperwork. During this interview (at 1:23 PM), the list of all patients re-assigned to other nurses to finish was requested, and was received at 1:38 PM. The list evidenced (but not limited to) 33 patients from 12/1/2020 - 12/18/2020 which had incomplete assessments. During an interview on 12/18/2020 at 3:20 PM, when asked which nurse did which portions of the comprehensive assessment dated 12/3/2020, the administrator stated "I can only tell [employee L] visited [the patient] on the 3rd, started writing [on the assessment on] 11th, [employee N] saw the patient on the 15th, and employee M reviewed and approved the assessment document on the 17th ... [employee M] signed the plan of care." The administrator also indicated he didn't know who did the wound assessments, or when the wounds were last assessed by staff. When asked if there had been any discipline for employee L, the administrator stated, "I don't know." During an interview on 12/18/2020 at 3:53 PM, the clinical director indicated employee L was going to be fired next week. When asked why she was allowed to see patients this week, the clinical director indicated employee L kept saying she was going to finish the paperwork, the clinical director further stated she was going to terminate employee L's employment this week, and stated "... but because Indiana department of health is here, it's next week". Review of employee L's employee file on 12/18/2020, hire date 6/4/2019, evidenced a pattern of poor work performance evidenced by (including but not limited to) a document dated 2/7/2020 titled "Case Conference" which stated "... During her time as a Registered Nurse Case Manager ... [employee L] has struggled to perform her duties satisfactorily ... Due to infection control concerns, she is no longer permitted to work on [entity H intravenous infusion company] cases ... She demonstrates very little initiative or urgency about her work ...." An additional email document dated 4/30/2020 evidenced the alternate clinical director was notified by person G that employee L, while in the office, referred to a pediatric patient as a "little brat ...", person G indicated she told employee L the patient was just a baby, and employee L stated "I don't care she is still a little brat ...." The file failed to evidence any disciplinary action taken. Review of an untitled agency document received on 12/15/2020 evidenced a calendar for the month of December 2020. The clinical director indicated this was the agency on-call log. The document evidenced employee L was scheduled to be on call from 12/1/2020 - 12/31/2020. During the morning conference with the agency on 12/28/2020 at 10:27 AM, the clinical director indicated patient #1 expired in the hospital on 12/27/2020. During an interview with the alternate clinical director (clinical director also present) on 12/28/2020 at 11:26 AM when asked which doctor she spoke with today (12/28/2020) to inform of patient's death, she indicated she spoke to the wound clinic. When asked who specifically she spoke to, she stated "The nurse. I don't know her name." When asked if she spoke with any other physicians, she stated "No ma'am." When asked who the patient's certifying physician was, she stated "I do not know off the top of my head." When asked why there was no follow up visit scheduled to assess the patient's wounds after 12/22/2020, she stated "... planned on going back after the holidays." When asked if it was appropriate to wait so long to assess wounds (as part of the comprehensive assessment), she stated "Yes ...." When asked if she spoke with the certifying physician after she saw the patient on 12/22/2020, she stated "No ma'am." When asked if she should speak with the certifying physician after completing a comprehensive assessment, she stated "If I find something that's different or out of the ordinary." When asked if measurements from wound clinic documentation counted as part of her comprehensive assessment, she stated "No, but I was going to go back after the holiday." During this time, when asked the last time wounds were assessed by agency nurses, the clinical director stated "I don't have that information. I'd have to look." No further information was submitted. 3. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/1/2020 - 12/30/2020 stated "... [skilled nursing orders] System assessment with each skilled nursing visit ... report any abnormal findings to [physician] ... open area on coccyx that is being treated by the wound clinic ...." the document failed to evidence current wound care orders, wounds listed on comprehensive assessment (left foot- all toes, right foot- all toes), and failed to evidence skilled nursing interventions to mitigate wound status or prevention of new pressure sores. The document also evidenced the patient had (but not limited to) a history of stroke with left sided paralysis, indwelling urinary catheter, oxygen use for chronic lung disease. He was also incontinent of bowel, and had a wound on his coccyx (tailbone). Review of a document titled "SN [skilled nurse] Re-Cert OASIS and Comprehensive Assessment" dated 10/30/2020 stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... 1 ... Stage 3 ... 1 ... Stage 1 ... 1 ... Location ... left foot (all toes) ... right foot ... all toes ... left upper coccyx ... HNS [agency name] is not responsible for wound care ... Bedfast, unable to transfer and is unable to turn and position self ... unable to be up in a chair ..." The assessment failed to identify stage of each wound, assessment or measurements, or evidence education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document dated 11/11/2020 titled "Skilled Nurse Visit Note" stated "... Urinating through penis and around [catheter] ... [after catheter change] ... Draining freely dark yellow, cloudy urine ...." The document failed to evidence wounds were assessed, failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, or infection control teaching related to the urinary catheter, including (but not limited to) signs and symptoms of clogged tubing or infection. Review of a wound clinic document dated 11/24/2020 (obtained by the wound clinic, not from clinical record) titled "Wound Treatment #1 (Order 262060966)" stated "... Wash wound(s) with mild soap and water, then pat dry. Place Medihoney [wound bed ointment] and cover with ABD [surgical absorbent gauze pad]. Change dressing daily ... Home Healthcare to visit for wound care 2-3 [times] weekly and PRN [as needed] wound care/dressing changes ... left lower extremity ... right lower extremity ...." The agency record failed to evidence it provided skilled nursing visits 2-3 times weekly. Review of a document dated 11/27/2020 titled "Skilled Nurse Visit Note" failed to evidence wounds were assessed or treated by the nurse, and failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document dated 12/8/2020 titled "Skilled Nurse Visit Note" stated "...Location: left heel ... wound type: pressure ... date originally reported: 6/26/2020 ... Comments: wound remains to the left heel ... Location: BLE [bilateral lower extremities]; 4th toes and left heel ... Wound type: unknown ... Date originally reported: 12/8/2020 ... Purulence [thick and milky discharge from a wound, often indicates an infection and needs treatment as soon as possible] drainage and scant blood around suprapubic stoma/foley [insertion site on abdomen for direct access to bladder with urinary drainage tube] ...." The document failed to evidence wounds were assessed/measured or treated by the nurse, the physician was notified of new open area(s) and signs of infection at suprapubic insertion site, and failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown or signs and symptoms of infection. Review of a document dated 12/23/2020 titled "Skilled Nurse Visit Note" failed to evidence wounds were assessed or treated by the nurse, and failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document titled "SN [skilled nurse] Re-Cert OASIS and Comprehensive Assessment" dated 12/29/2020 (after the IJ was called) stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... [blank] ... Stage 3 ... [blank] ... Unstageable [full thickness skin and tissue loss in which the extent of the damage within the ulcer cannot be determined due to scabbing or dead fibrous tissue; once removed to expose wound, a stage 3 or 4 would be revealed] ... Stage 1 ... 0 ... Does this patient have a stasis ulcer [ulcer caused by impaired circulation]? ... Yes ... Current number of Stasis Ulcers that are observable ... 3 ... status of most problematic ... Not Healing ... Location ... left second toe ... left third toe ... right second toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... Integument [skin] Impression: ... unstable ... in need of skilled intermittent care ... Will continue to monitor during regular visits, but not be a focus of care ... Will require a lot of attention ... Current possible UTI [urinary tract infection] symptoms: Wife stated client has been sleeping more and usually a sign of UTI ...." The document also evidenced the patient was a high risk for skin breakdown. The document failed to evidence the wounds were treated by the nurse, or education was provided to the caregiver to mitigate worsening or new skin breakdown, or signs and symptoms of UTI. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for the newest certification period 12/31/2020 - 2/28/2021 stated "... [skilled nursing orders] System assessment with each skilled nursing visit ... full head to toe assessment ... Teach/train in proper positioning to reduce pressure on pressure prone areas ... Assess wound for infection and healing ... [home health aide] up to 60 hr/month ... assist with ... catheter care ...." The document failed to evidence current wound care orders or treatment performed by nurse, all wounds listed on comprehensive assessment, and failed to evidence skilled nursing interventions to mitigate wound status or prevention of new pressure sores such as specialized diet and supplements to promote wound healing, frequent turning schedule, padding of bony prominences, or catheter management and signs and symptoms to report to agency and/or physician. During an interview and personnel file review on 12/30/2020 at 2:00 PM, employee F (human resource coordinator) acknowledged there was no competency evaluation for the care of a suprapubic catheter (a tube inserted directly into the bladder via a hole surgically created in the lower abdomen to drain urine) for employee J (patient #7's primary home health aide). Employee J emptied the urinary catheter drainage bag and washed around catheter insertion site every aide visit. Review of a document dated 1/2/2021 titled "Care Coordination Note" evidenced the patient was admitted to the hospital 1/2/2021 for UTI and would likely be discharged 1/4/2021 or 1/5/2021. Review of documents received from entity D (hospital) on 1/5/2021 (not part of agency clinical record) evidenced the patient was admitted 1/2/2021 for sepsis (systemic infection)/ UTI, and was discharged 1/5/2021. The document also evidenced the patient had chronic wounds to both feet, inadequate protein intake related to foot wounds and diabetes, need for more protein to assist wound healing, dietician will added Juven (nutritional supplement) twice daily to assist wound healing. No wounds on back/coccyx were evidenced in the documentation. The document also evidenced the patient required contact isolation (frequent handwashing and disinfection of bathroom) due to VRE (Vancomycin Resistant Enterococcus Infection) of the urine. Review of a document titled "SN ROC [skilled nursing resumption of care] OASIS and Comprehensive Assessment" dated 1/5/2021 evidenced the patient was a high risk for skin breakdown, stated "... Does this patient have a stasis ulcer? ... Yes ... Current number of Stasis Ulcers that are observable ... 4 ... status of most problematic ... Not Healing ... Location ... right big toe ... right second toe ... left second toe ... left third toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... wife cleanses, applies medihoney dresses every other day and will see wound clinic 1/14/20 [sic] ...." The document failed to evidence contact precautions for VRE, skilled nursing interventions to mitigate wound status or prevention of new pressure sores such as specialized diet and supplements to promote wound healing, frequent turning schedule, or padding of bony prominences, or wound care was performed by the nurse. The document evidenced the certifying physician was contacted for orders, but the clinical record failed to evidence a resumption of care order dated 1/5/2021. Review of a document dated by the clinical director on 1/8/2021 titled "Skilled Nursing Visit Note" evidenced documentation of wounds on right big toe, left 2nd toe, left heel, and back left buttock, and indicated the wife performed the wound care, and applied an ointment to the wounds. The document failed to evidence the physician was notified of the new wound(s), or new orders were received. Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated she did not know the name of the ointment the spouse applied to the wound(s). Review of an email document dated 1/11/2021 at 9:49 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), the administrator, and the alternate administrator stated "... 1-10-2021, 12:20 PM. I spoke with [patient's wife], regarding his new wound on his back. She said he is fine ... Her home remedy for his back is working ... She does not need me to stop by today to help her ...." The document failed to identify the ingredient(s) of the "home remedy", or that the physician was notified the wife was applying a home remedy to his wound(s). Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated the home remedy was urine. Review of an email document dated 1/11/2021 at 10:12 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), employee D (medical records coordinator), employee H (office staff), the administrator, and the alternate administrator, stated "... new wound on left lower back reported to [wound clinic] ... [wound clinic] ordered daily wound care starting today ...." The clinical record failed to evidence a wound care order with increased skilled nursing frequency dated 1/11/2021. During an interview on 1/11/2021 at 2:23 PM, when asked if the agency requested and received hospital paperwork for admission on 1/2/2021, the alternate director of nursing stated "I don't know. I don't know if she [assessing nurse on 1/5/2021] called the hospital." When asked if the agency did any coordination with the hospital to obtain the hospital paperwork, she stated "I didn't." When asked where the resumption of care orders (1/5/2021) were located, she indicated they were in the comprehensive assessment. The record failed to evidence a physician's order. When asked what kind of bed the patient had (he was bedbound with wounds, and a new wound that developed post-hospitalization, and would benefit from a specialized mattress to decrease risk of skin breakdown), the clinical and alternate clinical directors both indicated they did not know. During an interview on 1/12/2021 at 10:50 AM, the alternate clinical director stated a nurse was going to see the patient today (1/12/2021), and she still did not know what kind of mattress the patient had. Upon exit, no further information was submitted. 4. The clinical record of patient #9, start of care 9/9/2019, certification period 11/2/2020 - 12/31/2020, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021. Review of a document titled "SN Re-Cert [recertification] OASIS [outcome and assessment information set] and Comprehensive Assessment" dated 11/1/2020 "... right second toe amputation ... Non-removable dressing present. Wound managed by orthopedics ... Report any abnormal findings to VA [veterans affairs] MD ... skilled nurse ... physical assessment ... and notify MD of any abnormal findings ... had his right second toe amputated ... His 3rd right toe is black and shriveled ...." The document also evidenced the patient had diagnoses (but not limited to) atherosclerotic heart disease (hardening of the arteries causing impaired circulation), and diabetes with diabetic neuropathy (diabetes with damage to nerves in your legs and feet, causing pain and numbness in your legs and feet). The document failed to evidence the physician was notified of the change in condition of the wound. Review of a document dated 11/2/2020 titled "Skilled Nurse Visit Note" stated "... Right second toe amputation site not healing. 3rd toe black and very painful ...." The document failed to evidence the nurse measured the wounds, performed wound care, or notified the physician for the change in the patient's integumentary or pain status. Review of a document dated and signed by employee M on 11/16/2020 titled "Skilled Nurse Visit Note" stated "... "posterior foot blackening about 1 1/2 inch on ball of right foot, 3rd toe black and shriveled, outer edge of 5th toe; see diagram" The clinical record failed to evidence a diagram of the wound, or failed to evidence the physician was notified of the declining wound status. During an interview on 1/6/2021 at 3:56 PM, when asked if the doctor should have been notified of the change in wound status on 11/16/2020, the alternate clinical director stated "He should be, I don't know if she did call." When asked if this failure to contact the physician could have potentially led to a negative outcome for the patient, she stated "Yes". Review of a document dated and signed by employee M on 11/30/2020 titled "Skilled Nurse Visit Note" stated "... "No fever, No cough, No complaints, Right foot, big toe starting to blacken, middle toe black and shriveled. Per wife, US [ultrasound] showed multiple blockages and patient may lose foot d/t [due to] occlusions ...." The document failed to evidence the physician was notified of the declining wound status. Review of a document dated and signed by employee M on 12/14/2020 titled "Skilled Nurse Visit Note" stated "... No cough, No fever. Client having RLE [right lower extremity] Femoral Endarterectomy [a surgical procedure to remove plaque inside the superficial femoral artery] on Friday 12/18/20. Right foot and toes continue to blacken. There is now a foul odor associated with foot. Foot is starting to get wet and drain. Pain 10/10. Taking Norco for pain. 2 weeks of meds set-up. 100% medication compliant ...." The document failed to evidence the physician was notified of the declining wound status or severe pain. Review of a document dated 12/23/2020 titled "Care Coordination Note" stated "Spoke with client's wife. Client went into hospital to [sic] femoral endarterectomy. Decided to move ahead with partial amputation of right foot. Client remains in hospital. Wife will call when client home." The clinical record failed to evidence the agency coordinated with the hospital to provide patient's current status or request hospital records. Review of a document titled "Skilled Nurse Visit Note" dated 12/28/2020 stated "... returned from hospital S/P [after] Right femoral endarterectomy and Right partial amputation of foot. Right groin incision C/D/I [clean, dry, and intact] no redness, no draining, no swelling. OTA [open to air]. Right foot dressing C/D/I with orders not to remove same until f/u [follow up] with Podiatry 1/4/21. Plavix [medication to prevent formation of blood clots and to keep blood vessels open after surgical procedures, and may cause easy bleeding/bruising] ... added to medication regimine [sic] ... Client is NWB [non-weight bearing] R foot ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document dated 12/28/2021 titled "Pain Location Assessment" evidenced the patient now had left second toe pain (which previously had not been identified), and the nurse failed to evidence further pain/physical assessment of the toe. The document also evidenced right foot (surgical) pain, and stated "... almost constantly ... sharp ... throbbing ... Intensity 5 [pain scale 0-10, with 0 being no pain, 10 being worst/most severe pain ever] ... worst pain over last 48 hours 10 ... best pan over last 48 hours 5 ... What makes pain worse? ... [box checked] Activity with affected area ... Changing position ... Comments ...." The document failed to evidence the nurse instructed on non-weight bearing status to the right foot, which could potentially have a negative outcome on the surgical healing process, failed to evidence the nurse assessed the left second toe pain, and failed to evidence the physician was notified. Review of a document dated 12/28/2021 titled "SN ROC OASIS and Comprehensive Assessment" (additional document for same nurse visit same day) stated "... had his right second toe amputated ... ambulates without devices in his home ... Has had no ... hospitalizations ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/28/2021 (additional document for same nurse visit same day) stated "... Pain Assessment: ... right foot. Severity (0-10), 6 ... Cardiovascular Assessment: ... blood thinners ... Plavix ... Integumentary [skin] Assessment: No issues noted ... incisions [groin] ... open to air ... right foot ... surgical dressing in place ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection, nutritional requirements for wound healing, or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and recertification care orders. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 1/1/2021 - 3/1/2021 stated "... [skilled nursing orders] ... one visit ... every 2 weeks ... medication tray set-up, to monitor compliance ... physical assessment, and report any abnormal findings to MD ...." The document failed to evidence skilled nursing interventions such as wound care/treatments, patient/family education for wound care/treatment, interventions to mitigate new or worsening skin breakdown, appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, or signs and symptoms of infection, nutritional requirements for wound healing or other indications that should be reported to the agency and/or physician. During an interview on 1/5/2021 at 1:29 PM person F (staff at entity E-podiatrist office) indicated the patient was seen 1/4/2021 for surgical follow up. When asked if she received any communication/coordination from the agency, she stated "On 12/29 [2020] we got a call from [employee M] to request PT/OT [physical and occupational therapy] order. That's the only thing I see ...." Review of documents received from person E (Podiatrist) on 1/5/2021 at 2:04 PM (not part of agency clinical record) included hospital discharge paperwork (given to the patient/caregiver upon hospital discharge on 12/28/2021), which indicated (but not limited to) the patient was not to bear weight on the right foot, and post-surgical education/instructions/limitations. Also included was a document dated 1/4/2021 titled "Progress Notes", which indicated (but not limited to) the patient was to continue to remain non-weight bearing on the right foot. During an interview on 1/6/2021 at 3:56 PM, the clinical director and alternate clinical director confirmed the skilled nursing frequency remained every two weeks since hospital discharge. When asked if waiting two weeks to see this patient could lead to a potentially negative outcome, they both stated "Yes." During an interview on 1/12/2021 at 1:50 PM, regarding the skilled nursing visit on 11/16/2020, employee M indicated she did not contact the physician, he was already aware, it (the wound/blackening of toe/foot) started as just the tip, and it was an ongoing process; regarding the skilled nursing visit on 12/14/2020, she stated "I did not call the physician ...." 5. During an interview on 1/11/2021 at 3:35 PM, the clinical director indicated the agency does not require competency evaluations for agency staff.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical director failed to ensure all agency patients received effective coordination of care. Findings include: Review of an undated copyright Briggs Healthcare policy C-360 titled "Coordination of Client Services" stated "... Each staff Registered Nurse shall meet with the Clinical Director/Designee weekly or as necessary to review all areas of client needs ...." During an interview on 12/17/2020 at 2:34 PM, employee M (registered nurse) submitted a list which evidenced (but not limited to) 10 patients with wounds. Employee M indicated all were managed by wound clinics, the agency did not coordinate with the wound clinics, and there we no wound clinic notes in any of the patients' charts. During an interview on 12/17/2020 at 2:34 PM, when asked which wound clinic managed patient #8's wound, the clinical director indicated she did not know. During an interview on 12/17/2020 at 3:44 PM, when asked who performed patient #8's wound care, the clinical director indicated staff at entity O (group home) did the wound care. When asked if the staff were clinicians, she stated "No, they do have a nurse that floats to the different houses. I'm not sure she's involved." When asked at what point do you get involved, she stated "When they need a skilled nurse to take over." During this interview, the administrator asked the clinical director "Do we receive wound clinic follow up?", she stated "No." During an interview on 12/28/2020 at 11:26 AM, when asked if the agency contacted a hospital to coordinate care and obtain hospital paperwork to relay information to the certifying physician, the clinical director stated "We usually don't, because they usually come home with papers." When asked how the hospital would know the patient was getting home care services, she stated "Through the client or the client's family." During an interview on 1/11/2021 at 10:50 AM, the alternate clinical director indicated they received wound clinic coordination/notes for all but one patient requested, and coordination of care with other entities involved with agency patients was not complete, and would be completed by 1/22/2021.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical director failed to ensure the registered nurse (RN) continually assessed and accurately described the patient's status, which led to new or worsening wounds, urinary tract infection, hospitalization, amputation, and/or death for 3 of 7 patients' records reviewed with wounds (#1, 7, and 9). This practice had the potential to affect all 11 patients identified with wounds. Findings include: 1. Review of an undated agency policy C-155 copyright Briggs Healthcare titled "Client Reassessment/Update of Comprehensive Assessment" stated "... Comprehensive Assessment will be updated and revised as often as the client's condition warrants due to a major decline or improvement in health status ... To identify decline or improvement ... are reassessed when significant changes occur in their condition ... [or] diagnosis ... [and] at least every fifty six to sixty (56-60) days ...." Review of agency policy dated 6/2000 titled "Home Nursing Services Job Description: Registered Nurse" stated "... Becomes familiar with the diagnostic services available for home health care and follows the directions of the Clinical Director in utilizing these services to meet the needs of the client ... Documents fully and accurately to record a complete, total picure of the client's status and progress, and gives a complete synopsis of the care provided by the skilled registered nurse ...." 2. The clinical record of patient #1, start of care 12/10/2019, was reviewed on 12/18/2020, and again on 1/12/2021. Review of a document received on 12/28/2020 titled "SN [skilled nurse] SOC [start of care] OASIS and Comprehensive Assessment" dated 12/10/2019 evidenced the patient had no wounds, and was alert and oriented to person, place, and time, without confusion or disruptive behaviors. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 10/3/2020 (for certification period 10/5/2020-12/3/2020) evidenced the patient was fully oriented and able to make own decisions, normal behavior, and had a wound on his right groin area. The document stated "... Right groin ... Irtritation [sic] from brief rubbing on the area ... scabbed over area ... measurements: 1x2 ... Overall, the level of function has been: Slowly deteriorating ... Does the physician-ordered plan of care include the following ... Interventions to prevent pressure ulcer (wound) ... [box checked] Yes ... now has home attendant from entity B [personal care services] ... and they are responsible for these services ... heavy smoker ... observed foul smelling wound to the groin. Area appears dark red in color with puss [sic]-like drainage present. Advised POA [power of attorney- family member] to keep all follow-up appointments with the wound clinic due to possible infection to the area ... complete depandence [sic] on nece [sic] for all care ... Any immediate concerns or issues to be resolved before next visit: No ... Next visit [skilled nurse] planned to occur: 11/3/2020 [one month later] ...." The document also evidenced a Braden scale was completed, with a score of 16 (patients with a total score of 16 or less are considered to be at risk for developing pressure ulcers; 15 or 16 = low risk, 13 or 14 = moderate risk, and 12 or less = high risk.) The assessment evidenced (but not limited to) the patient's skin was occasionally moist, requiring a linen change approximately once a day (score of 3), and evidenced the patient moved in bed and chair independently and could maintain good positioning in bed or chair (score 3). However, the assessment also evidenced the patient was incontinent of stool more often than once daily, which would require linen changes more than once daily (score 2 - skin is often, but not always moist), and he was a bilateral amputee and unable to sit unsupported, major physical limitations, was dependent for all personal care, and was unable to transfer self from bed to chair (score 1 - requires moderate to maximum assistance in moving). The adjusted score would have been 13 (moderate risk). The document failed to evidence wound diagnoses, failed to evidence the physician was contacted to report wound assessment findings (with possible infection), and wound treatment orders, failed to evidence entity B was contacted for care coordination regarding the wound and possible incorrect application of brief (too tight causing pressure/friction), and failed to evidence the niece (primary caregiver) was educated on signs or symptoms of infection (redness, heat, pain, foul odor, pus-like drainage, fever), wound care/treatment, or correct application of briefs, and failed to evidence a timely skilled nursing follow up visit was scheduled to re-assess the wound, ensure treatment orders were received, and the family member was competent in performing the treatment(s). No other wounds were identified during this assessment. The clinical record contained a plan of care for the certification period of 12/4/2020 - 2/1/2021 which indicated orders for skilled nursing once per month for indwelling catheter change and system assessment with vital signs. Review of a document titled "SN [skilled nurse] Re-Cert OASIS and Comprehensive Assessment" dated 12/3/2020 stated "... Client has a pressure ulcer on the bottom of his left stump and a friction ulcer from in his right groin from where his brief rubs. These are both being treated by the [entity C- wound clinic]. At time of assessment, the wounds were covered and not able to be assessed ...." The document failed to evidence wound diagnoses or assessment. During an interview on 12/16/2020 at 2:16 PM, when asked if their clinic records evidenced communication or care coordination with Home Nursing Services, a staff member at entity C stated "I don't see any communication with home care ... not sure we even knew he had home health care." Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). During an interview on 12/17/2020 at 3:44 PM, the comprehensive assessment for patient #1 dated 12/3/2020 was completed today (12/17/2020), and the plan of care was completed today (12/17/2020) and sent to the physician. Both were reviewed and approved by employee M (registered nurse) It was verified by the clinical director and the administrator that employee L (registered nurse) initiated the comprehensive assessment on 12/3/2020 but didn't complete it, and she did not assess the wounds. When asked, the clinical director agreed the certifying physician would not be able to provide/approve orders to meet the patient's needs without complete and accurate assessment findings. During this time, the administrator asked the director of nursing if the agency obtained wound clinic follow up. The director of nursing stated "No." During an interview on 12/18/2020 at 1:00 PM, when asked who finished the comprehensive assessment dated 12/3/2020, the director of nursing stated "[employee N- registered nurse]." When asked if she was the nurse that initiated the comprehensive assessment on 12/3/2020, the director of nursing stated "No." When asked why employee L didn't complete the assessment, the director of nursing stated "We discovered she was behind, we wanted to get it done, so we sent it to [employee N]." She also indicated employee N saw the patient on 12/15/2020, and that visit represented completion of the comprehensive assessment dated 12/3/2020. When asked if the patient's electronic clinical record evidenced education for mitigation of pressure ulcers/wounds, the clinical director stated "No, but I can get the [paper portion] chart." Employee M retrieved it. When asked if the chart evidenced education for mitigation of pressure ulcers/wounds, employee M stated "No, looks like he goes to the wound clinic and they just advise him to keep his appointments." During an interview on 12/18/2020 at 3:20 PM, when asked which nurse did which portions of the comprehensive assessment dated 12/3/2020, the administrator stated "I can only tell [employee L] visited [the patient] on the 3rd, started writing [on the assessment on] 11th, [employee N] saw the patient on the 15th, and employee M reviewed and approved the assessment document on the 17th ... [employee M] signed the plan of care." The administrator also indicated he didn't know who did the wound assessments, or when the wounds were last assessed by staff. When asked if there had been any discipline for employee L, the administrator stated, "I don't know." Review of a document received on 12/28/2020 at 12:01 PM dated 12/22/2020 titled "Follow Up Assessment (FUA) Non-Recert OASIS" stated "... A general assessment was completed due to the findings of the State ... This client uses HNS [Home Nursing Services] for a monthly catheter change ... The physician or family have not requested the assistance of this agency for his wounds ... The state feels that HNS should be involved in the wound care. The state wants total client care not just cath [catheter] care ... The client went today [12/22/2020] to the clinic and the niece declined to allow this nurse to visualize the wounds ... The niece stated that an appointment [with agency nurse] can be set up to see wounds at a further date ... His catheter bag [bag connected urine drain tube] was stuffed an opening [sic] in the side of his wheelchair. The urine in the tube was pale yellow with sediment present ... The niece changes the dressings daily to the wounds, she state [sic] the wounds look the same to her except this morning the area to the stump had changed for the worse ... Writer [registered nurse] asked [niece] if the clinic recommended about adding vitamins and supplements of Vitamin C and Zinc for wound healing. She indicated they might have. Also asked about adding protein to the diet, niece indicated she did not remember for sure, maybe." The document failed to evidence wound diagnoses, failed to evidence the nurse and patient's niece scheduled a follow up visit to assess the wounds, failed to evidence the nurse followed up with the physician regarding orders for supplemental vitamins or additional protein diet, failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, and failed to evidence education was provided to the caregiver on proper placement of the urine drainage bag below the bladder to avoid urine back up into the bladder, which would increase risk of urinary tract infection. During the morning conference with the agency on 12/28/2020 at 10:27 AM, the clinical director indicated patient #1 expired in the hospital on 12/27/2020. During an interview with the alternate clinical director (clinical director also present) on 12/28/2020 at 11:26 AM when asked which doctor she spoke with today (12/28/2020) to inform of patient's death, she indicated she spoke to the wound clinic. When asked who specifically she spoke to, she stated "The nurse. I don't know her name." When asked if she spoke with any other physicians, she stated "No ma'am." When asked who the patient's certifying physician was, she stated "I do not know off the top of my head." When asked why there was no follow up visit scheduled to assess the patient's wounds after 12/22/2020, she stated "... planned on going back after the holidays." When asked if it was appropriate to wait so long to assess wounds (as part of the comprehensive assessment), she stated "Yes ...." When asked if she spoke with the certifying physician after she saw the patient on 12/22/2020, she stated "No ma'am." When asked if she should speak with the certifying physician after completing a comprehensive assessment, she stated "If I find something that's different or out of the ordinary." When asked if it was out of the ordinary for the patient to resist/refuse assessment of vital signs and not interact with the nurse during the assessment on 12/22/2020, she indicated it was not out of the ordinary. However, all other clinical notes evidenced the patient was cooperative during skilled nursing visits. When asked if measurements from wound clinic documentation counted as part of her comprehensive assessment, she stated "No, but I was going to go back after the holiday." During this time, when asked the last time wounds were assessed by agency nurses, the clinical director stated "I don't have that information. I'd have to look." No further information was submitted. Review of a document received on 12/29/2020 at 11:30 AM, dated 12/28/2020, and titled "Transfer to Inpatient Facility (Discharged From Agency) OASIS" stated "... The niece called [12/28/2020] and stated the client passed away on Sunday 12-27-2020 ...." Review of a document titled "Care Coordination Note" dated 12/28/2020 stated "... [nurse] made a visit on Tuesday [12/22/2020] ... The client was resistive of being touched and could not hear the conversation ... The client continued to be tired and not wanting to get out of bed on Wednesday [12/23/2020] ... niece called EMS to take the client to the hospital due to him not acting right ...." Review of hospital record received 12/29/2020, dated 12/23/2020 evidenced the patient was admitted to the hospital on 12/23/2020, and stated "... critical care was necessary for dehydration, Patient does appear to be septic from a urinary tract infection related to a foley catheter ... presented to the [emergency department] with reports of increasing confusion ... this evening ... disoriented ... poorly healing wound to left stump ... date of death 12/27/2020 ...." 3. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021 evidenced a document titled "SN [skilled nurse] Re-Cert OASIS and Comprehensive Assessment" dated 10/30/2020 stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... 1 ... Stage 3 ... 1 ... Stage 1 ... 1 ... Location ... left foot (all toes) ... right foot ... all toes ... left upper coccyx ... HNS [name of agency] is not responsible for wound care ... Chronic UTI ... Yes ... Supra pubic [sic] catheter which is changed every two weeks ... Bedfast, unable to transfer and is unable to turn and position self ... unable to be up in a chair ..." The document failed to identify stage of each wound, assessment or measurements, or evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, or infection control teaching related to the urinary catheter. The document evidenced the patient had diagnoses (but not limited to) of history of stroke with left sided paralysis, indwelling urinary catheter, oxygen use for chronic lung disease, incontinent of bowel. The record failed to include diagnosis for wound on coccyx or other area(s). Review of a document dated 11/11/2020 titled "Skilled Nurse Visit Note" stated "... Urinating through penis and around [catheter] ... [after catheter change] ... Draining freely dark yellow, cloudy urine ...." The document failed to evidence wounds were assessed, failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown, or infection control teaching related to the urinary catheter, including (but not limited to signs and symptoms of clogged tubing or infection. Review of a wound clinic document dated 11/24/2020 (obtained by the wound clinic, not from clinical record) titled "Wound Treatment #1 (Order 262060966)" stated "... Wash wound(s) with mild soap and water, then pat dry. Place Medihoney [wound bed ointment] and cover with ABD [surgical absorbent gauze pad]. Change dressing daily ... Home Healthcare to visit for wound care 2-3 [times] weekly and PRN [as needed] wound care/dressing changes ... left lower extremity ... right lower extremity ...." The agency record failed to evidence it provided skilled nursing visits 2-3 times weekly. Review of a document dated 12/8/2020 titled "Skilled Nurse Visit Note" stated "...Location: left heel ... wound type: pressure ... date originally reported: 6/26/2020 ... Comments: wound remains to the left heel ... Location: BLE [bilateral lower extremities]; 4th toes and left heel ... Wound type: unknown ... Date originally reported: 12/8/2020 ... Purulence [thick and milky discharge from a wound, often indicates an infection and needs treatment as soon as possible] drainage and scant blood around suprapubic stoma/foley [insertion site on abdomen for direct access to bladder with urinary drainage tube] ...." The document failed to evidence wounds were assessed/measured or treated by the nurse, the physician was notified of new open area(s) and signs of infection at urinary insertion site, and failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown or signs and symptoms of infection. Review of a document titled "SN [skilled nurse] Re-Cert OASIS and Comprehensive Assessment" dated 12/29/2020 (after the IJ was called) stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... [blank] ... Stage 3 ... [blank] ... Unstageable [full thickness skin and tissue loss in which the extent of the damage within the ulcer cannot be determined due to scabbing or dead fibrous tissue; once removed to expose wound, a stage 3 or 4 would be revealed] ... Stage 1 ... 0 ... Does this patient have a stasis ulcer [ulcer caused by impaired circulation]? ... Yes ... Current number of Stasis Ulcers that are observable ... 3 ... status of most problematic ... Not Healing ... Location ... left second toe ... left third toe ... right second toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... Integument [skin] Impression: ... unstable ... in need of skilled intermittent care ... Will continue to monitor during regular visits, but not be a focus of care ... Will require a lot of attention ... Current possible UTI symptoms: Wife stated client has been sleeping more and usually a sign of UTI ...." The document also evidenced the patient was a high risk for skin breakdown. The document failed to evidence the wounds were treated by the nurse, or education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document dated 1/2/2021 titled "Care Coordination Note" evidenced the patient was admitted to the hospital 1/2/2021 for UTI (urinary tract infection) and would likely be discharged 1/4/2021 or 1/5/2021. Review of documents received from entity D (hospital) on 1/5/2021 (not part of agency clinical record) evidenced the patient was admitted 1/2/2021 for sepsis (systemic infection)/ UTI, and was discharged 1/5/2021. The document also evidenced the patient had chronic wounds to both feet, inadequate protein intake related to foot wounds and diabetes, need for more protein to assist wound healing, dietician will added Juven (nutritional supplement) twice daily to assist wound healing. No wounds on back/coccyx were evidenced in the documentation. The document also evidenced the patient required contact isolation (frequent handwashing and disinfection of bathroom) due to VRE (Vancomycin Resistant Enterococcus Infection) of the urine. Review of a document titled "SN ROC OASIS and Comprehensive Assessment" dated 1/5/2021 evidenced the patient was a high risk for skin breakdown, stated "... Does this patient have a stasis ulcer? ... Yes ... Current number of Stasis Ulcers that are observable ... 4 ... status of most problematic ... Not Healing ... Location ... right big toe ... right second toe ... left second toe ... left third toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... wife cleanses, applies medihoney dresses every other day and will see wound clinic 1/14/20 [sic] ...." The document failed to evidence contact precautions for VRE, skilled nursing interventions to mitigate wound status or prevention of new pressure sores such as specialized diet and supplements to promote wound healing, frequent turning schedule, or padding of bony prominences, or wound care was performed by the nurse. The document evidenced the certifying physician was contacted for orders, but the clinical record failed to evidence orders dated 1/5/2021. Review of a document dated 1/8/2021 titled "Skilled Nursing Visit Note" evidenced documentation of wounds on right big toe, left 2nd toe, left heel, and back left buttock, and indicated the wife performed the wound care, applying an ointment to the wounds. The document failed to evidence the physician was notified of the new wound(s), or new orders were received. Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated she did not know the name of the ointment the spouse applied to the wound(s). Review of an email document dated 1/11/2021 at 9:49 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), the administrator, and the alternate administrator stated "... 1-10-2021, 12:20pm. I spoke with [patient's wife], regarding his new wound on his back. She said he is fine ... Her home remedy for his back is working ... She does not need me to stop by today to help her ...." The document failed to identify the ingredient(s) of the "home remedy", or that the physician was notified the wife was applying a home remedy to his wound(s). Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated the home remedy was urine. Review of an email document dated 1/11/2021 at 10:12 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), employee D (medical records coordinator), employee H (office staff), the administrator, and the alternate administrator, stated "... new wound on left lower back reported to [wound clinic] ... [wound clinic] ordered daily wound care starting today ...." The clinical record failed to evidence a wound care order with increased skilled nursing frequency dated 1/11/2021. During an interview on 1/11/2021 at 2:23 PM, when asked if the agency requested and received hospital paperwork for admission on 1/2/2021, the alternate director of nursing stated "I don't know. I don't know if she [assessing nurse on 1/5/2021] called the hospital." When asked if the agency did any coordination with the hospital to obtain the hospital paperwork, she stated "I didn't." When asked where the resumption of care orders (1/5/2021) were located, she indicated they were in the comprehensive assessment. The record failed to evidence a physician's order. When asked what kind of bed the patient had (he was bedbound with wounds, and a new wound that developed post-hospitalization, and would benefit from a specialized mattress to decrease risk of skin breakdown), the clinical and alternate clinical directors both indicated they did not know. During an interview on 1/12/2021 at 10:50 AM, the alternate clinical director stated a nurse was going to see the patient today (1/12/2021), and she still did not know what kind of mattress the patient had. Upon exit, no further information was submitted. 4. The clinical record of patient #9, start of care 9/9/2019, certification period 11/2/2020 - 12/31/2020, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021. Review of a document titled "SN Re-Cert [recertification] OASIS [outcome and assessment information set] and Comprehensive Assessment" dated 11/1/2020 "... right second toe amputation ... Non-removable dressing present. Wound managed by orthopedics ... Report any abnormal findings to VA [veterans affairs] MD ... skilled nurse ... physical assessment ... and notify MD of any abnormal findings ... had his right second toe amputated ... His 3rd right toe is black and shriveled ...." The document also evidenced the patient had diagnoses (but not limited to) atherosclerotic heart disease (hardening of the arteries causing impaired circulation), and diabetes with diabetic neuropathy (diabetes with damage to nerves in your legs and feet, causing pain and numbness in your legs and feet). The document failed to evidence the physician was notified of the change in condition of the wound. Review of a document dated 11/2/2020 titled "Skilled Nurse Visit Note" stated "... Right second toe amputation site not healing. 3rd toe black and very painful ...." The document failed to evidence the nurse measured the wounds, performed wound care, or notified the physician for the change in the patient's integumentary or pain status. Review of a document dated and signed by employee M 11/16/2020 titled "Skilled Nurse Visit Note" stated "... "posterior foot blackening about an 1 1/2 inch on ball of right foot, 3rd toe black and shriveled, outer edge of 5th toe; see diagram" The clinical record failed to evidence a diagram of the wound, or failed to evidence the physician was notified of the declining wound status. During an interview on 1/6/2021 at 3:56 PM, when asked if the doctor should have been notified of the change in wound status on 11/16/2020, the alternate clinical director stated "He should be, I don't know if she did call." When asked if this failure to contact the physician could have potentially led to a negative outcome for the patient, she stated "Yes." Review of a document dated and signed by employee M on 11/30/2020 titled "Skilled Nurse Visit Note" stated "...: "No fever, No cough, No complaints, Right foot, big toe starting to blacken, middle toe black and shriveled. Per wife, US [ultrasound] showed multiple blockages and patient may lose foot d/t [due to] occlusions ...." The document failed to evidence the physician was notified of the declining wound status. Review of a document dated and signed by employee M on 12/14/2020 titled "Skilled Nurse Visit Note" stated "... No cough, No fever. Client having RLE [right lower extremity] Femoral Endarterectomy [a surgical procedure to remove plaque inside the superficial femoral artery] on Friday 12/18/20. Right foot and toes continue to blacken. There is now a foul odor associated with foot. Foot is starting to get wet and drain. Pain 10/10. Taking Norco for pain. 2 weeks of meds set-up. 100% medication compliant. The document failed to evidence the physician was notified of the declining wound status or severe pain. Review of a document dated 12/23/2020 titled "Care Coordination Note" stated "Spoke with client's wife. Client went into hospital to femoral endarterectomy. Decided to move ahead with partial amputation of right foot. Client remains in hospital. Wife will call when client home." The clinical record failed to evidence the agency coordinated with the hospital to provide patient's current status or request hospital records. Review of a document titled "Skilled Nurse Visit Note" dated 12/28/2020 stated "... returned from hospital S/P [after] Right femoral endarterectomy [a surgical procedure to remove plaque inside the superficial femoral artery] and Right partial amputation of foot. Right groin incision C/D/I [clean, dry, and intact] no redness, no draining, no swelling. OTA [open to air]. Right foot dressing C/D/I with orders not to remove same until f/u [follow up] with Podiatry 1/4/21. Plavix [medication to prevent formation of blood clots and to keep blood vessels open after surgical procedures, and may cause easy bleeding/bruising] ... added to medication regimine [sic] ... Client is NWB [non-weight bearing] R foot ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document dated 12/28/2020 titled "Pain Location Assessment" evidenced the patient now had left second toe pain (which previously had not been identified), and the nurse failed to evidence further pain/physical assessment of the toe. The document also evidenced right foot (surgical) pain, and stated "... almost constantly ... sharp ... throbbing ... Intensity 5 [pain scale 0-10, with 0 being no pain, 10 being worst/most severe pain ever] ... worst pain over last 48 hours 10 ... best pan over last 48 hours 5 ... What makes pain worse? ... [box checked] Activity with affected area ... Changing position ... Comments ...." The document failed to evidence the nurse instructed on non-weight bearing status to the right foot, which could potentially have a negative outcome on the surgical healing process, failed to evidence the nurse assessed the left second toe pain, and failed to evidence the physician was notified. Review of a document dated 12/28/2020 titled "SN ROC OASIS and Comprehensive Assessment" (additional document for same nurse visit same day) stated "... had his right second toe amputated ... ambulates without devices in his home ... Has had no ... hospitalizations ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/28/2020 (additional document for same nurse visit same day) stated "... Pain Assessment: ... right foot. Severity (0-10), 6 ... Cardiovascular Assessment: ... blood thinners ... Plavix ... Integumentary [skin] Assessment: No issues noted ... incisions ... open to air ... right foot ... surgical dressing in place ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection, nutritional requirements for wound healing, or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and recertification care orders. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 1/1/2021 - 3/1/2021 stated "... [skilled nursing orders] ... one visit ... every 2 weeks ... medication tray set-up, to monitor compliance ... physical assessment, and report any abnormal findings to MD ...." The document failed to evidence skilled nursing interventions such as wound care/treatments, patient/family education for wound care/treatment, interventions to mitigate new or worsening skin breakdown, appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, or signs and symptoms of infection, nutritional requirements for wound healing or other indications that should be reported to the agency and/or physician. Review of documents received from person E (Podiatrist) on 1/5/2021 at 2:04 PM (not part of agency clinical record) included hospital discharge paperwork (given to the patient/caregiver upon hospital discharge on 12/28/2020), which indicated (but not limited to) the patient was not to bear weight on the right foot, and post-surgical education/instructions/limitations. Also included was a document dated 1/4/2021 titled "Progress Notes", which indicated (but not limited to) the patient was to continue to remain non-weight bearing on the right foot. During an interview on 1/6/2021 at 3:56 PM, the clinical director and alternate clinical director confirmed the skilled nursing frequency remained every two weeks since hospital discharge. When asked if waiting two weeks to see this patient could lead to a potentially negative outcome, they both stated "Yes." During an interview on 1/12/2021 at 1:50 PM, regarding the skilled nursing visit on 11/16/2020, employee M indicated she did not contact the physician, he was already aware, it (the wound/blackening of toe/foot) started as just the tip, and it was an ongoing process; regarding the skilled nursing visit on 12/14/2020, she stated "I did not call the physician ...." During the entrance conference on 12/15/2020 at 11:00 AM, when asked how the agency determined when there has been a major decline or improvement in the patient's health status, the clinical director stated, "Through nursing assessment." During an interview on 12/18/2020 at 1:00 PM, when asked the purpose of the comprehensive assessment, the clinical director stated, "To develop the plan of care." When asked if it was her expectation for staff to look at entire head to toe for comprehensive assessment, the clinical director stated, "Yes."

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical director failed to ensure all patients' records identified that had wounds, or were high risk for skin breakdown, included skilled nursing interventions such as wound care/treatments, patient/family education for wound car/treatment, care coordination/orders from physicians or wound clinics, or interventions to mitigate new or worsening skin breakdown that led to new or worsening wounds, urinary tract infection, hospitalization, amputation, and/or death for 3 of 7 patients' records reviewed with wounds (#1, 7, and 9). This practice had the potential to affect all 11 patients identified with wounds. Findings include: 1. Review of an undated copyrighted Briggs Healthcare policy C-580 titled "Plan of Care" stated "... Home Nursing Services staff to develop a plan of care individualized to meet [patient] specific identified needs ... to include ... specific procedures ... medications, treatments, and procedures ... other appropriate items ... professional staff shall promptly alert the physician to any changes that suggest a need to alter the Plan of Care ...." Review of an undated copyrighted Briggs Healthcare policy C-100 titled "Services Provided" stated "... Services will be coordinated by the Registered Nurse managing the care. This will include implementing, revising, and updating the Plan of Care; physician conferencing ... conferencing with health team members to plan and evaluate client [patient] care ...." Review of an undated copyrighted Briggs Healthcare policy C-360 titled "Coordination of Client Services" stated "... to ensure appropriate, quality care is being provided to clients ... to establish effective interchange, reporting and coordination of client care does occur ... Coordination with other agencies and institutions ... alert physician to changes in client condition ...." Review of an undated agency policy C-155 copyright Briggs Healthcare titled "Skilled Nursing Services" stated "... Skilled nursing services will be provided ... In determining whether a service requires the skills of a Nurse, the inherent complexity of the service, condition of the client ... Regularly reevaluates the client needs ... Initiates the Plan of Care and necessary revisions and updates to the plan of care ... Provides services requiring specialized nursing skill and initiates appropriate preventive and rehabilitative nursing procedures ... Informs the physician and other personnel of changes in the client condition and needs ... Counsels the client and family/caregivers in meeting their needs ... Prepares clinical and progress notes ...." 2. The clinical record of patient #1, start of care 12/10/2019, certification period 12/4/2020 - 2/1/2021, was reviewed on 12/18/2020, and again on 1/12/2021. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 10/5/2020 - 12/3/2020 stated "... SN [skilled nurse] monthly for full assessment with vital signs and ... foley catheter change ... Coordination of Care: SN will report changes in condition to MD, Client has Home attendant services from [entity B] and they are responsible for these services [personal care and hygiene] ... friendly and pleasant during visit ... catheter ... draining thick, dark, gold-colored urine ... Foul smelling wound to the groin remains ... Advised POA [power of attorney] to have MD [physician] assess wound at appointment next week ...." The plan of care failed to evidence care coordination with the physician, entity B, or wound clinic, and failed to evidence skilled nursing interventions to mitigate wound status or prevention of new pressure sores or urinary tract infection. Review of a document titled "Skilled Nurse Visit Note" dated 11/5/2020 stated "... Skin/Wounds ... Turgor [skin elasticity] [box checked] Poor [clinical indication of dehydration] ... [box checked] See Wound Location Assessment ... Hydration adequate [box checked] No ...." The document failed to evidence the physician was contacted for potential dehydration or wound treatment orders. Review of a document titled "Wound Location Assessment" dated 11/5/2020 stated "... Location: left [sic] groin ... Wound type: unknown ... Date originally reported: 2/3/2020 ... Comments: Small open area to the right groin area ... Client is being treated at the wound clinic for this wound ... Location: left buttocks ... Wound type: Pressure ... Date originally reported: 4/3/2020 ... Small reddened area on the buttocks ... Area is healed ...." The document failed to evidence wound measurements, the physician was contacted for change in wound status, or education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document titled "Skilled Nurse Visit Note" dated 12/3/2020 stated "... Heart sounds ... [box checked] Regular ... Skin/Wounds ... Turgor: [box checked] Poor ... [box checked] See Wound Location Assessment ... encouraged to increase fluids ... Hydration adequate [box checked] No ...." The document failed to evidence the physician was contacted for ongoing potential dehydration, wound treatment orders, or education was provided to the caregiver to mitigate worsening or new skin breakdown or signs and symptoms of dehydration to report to agency or physician. Review of a document titled "Wound Location Assessment" dated 12/3/2020 stated "... Location: left [sic] groin ... Wound type: unknown ... Date originally reported: 2/3/2020 ... Comments: Small open area to the right groin area ... Treatments to the area continue with [entity C- a wound clinic] ... Location: left buttocks ... Wound type: Pressure ... Date originally reported: 4/3/2020 ... Small reddened area on the buttocks ... Treatments to the area continue by family at home following wound clinic orders ...." The document failed to evidence wound measurements, the physician was contacted for change in wound status, or wound treatment orders. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/3/2020 stated "... Client has a pressure ulcer on the bottom of his left stump and a friction ulcer from in his right groin from where his brief rubs. These are both being treated by the [entity C]. At time of assessment, the wounds were covered and not able to be assessed ...." The document failed to evidence care coordination with entity C or the physician for new home care orders, which included but not limited to wound care orders. During an interview on 12/16/2020 at 2:16 PM, when asked if their clinic records evidenced communication or care coordination with Home Nursing Services, a staff member at entity C stated "I don't see any communication with home care ... not sure we even knew he had home health care." Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). Review of a document received on 12/28/2020 at 12:01 PM dated 12/22/2020 titled "Follow Up Assessment (FUA) Non-Recert OASIS" stated "... A general assessment was completed due to the findings of the State ... This client uses HNS [Home Nursing Services] for a monthly catheter change ... The physician or family have not requested the assistance of this agency for his wounds ... The state feels that HNS should be involved in the wound care. The state wants total client care not just cath [catheter] care ... The client went today to the clinic and the niece declined to allow this nurse to visualize the wounds ... The niece stated that an appointment [with agency nurse] can be set up to see wounds at a further date ... The niece changes the dressings daily to the wounds, she state [sic] the wounds look the same to her except this morning the area to the stump had changed for the worse ... Writer [registered nurse] asked [niece] if the clinic recommended about adding vitamins and supplements of Vitamin C and Zinc for wound healing. She stated they might have. Also asked about adding protein to the diet, niece stated she does not remember for sure, maybe ...." The document failed to evidence the nurse and patient's niece scheduled a follow up visit to assess the wounds, failed to evidence the nurse followed up with the physician regarding orders for supplemental vitamins or additional protein diet, and failed to evidence education was provided to the caregiver to mitigate worsening or new skin breakdown. During the morning conference with the agency on 12/28/2020 at 10:27 AM, the clinical director indicated patient #1 expired in the hospital on 12/27/2020. During an interview with the alternate clinical director (clinical director also present) on 12/28/2020 at 11:26 AM when asked which doctor she spoke with today (12/28/2020) to inform of patient's death, she indicated she spoke to the wound clinic. When asked who specifically she spoke to, she stated "The nurse. I don't know her name." When asked if she spoke with any other physicians, she stated "No ma'am." When asked who the patient's certifying physician was, she stated "I do not know off the top of my head." When asked why there was no follow up visit scheduled to assess the patient's wounds after 12/22/2020, she stated "... planned on going back after the holidays." When asked if it was appropriate to wait so long to assess wounds (as part of the comprehensive assessment), she stated "Yes ...." When asked if she spoke with the certifying physician after she saw the patient on 12/22/2020, she stated "No ma'am." When asked if she should speak with the certifying physician after completing a comprehensive assessment, she stated "If I find something that's different or out of the ordinary." When asked if measurements from wound clinic documentation counted as part of her comprehensive assessment, she stated "No, but I was going to go back after the holiday." During this time, when asked the last time wounds were assessed by agency nurses, the clinical director stated "I don't have that information. I'd have to look." No further information was submitted. Review of a document received on 12/29/2020 at 11:30 AM, dated 12/28/2020, and titled "Transfer to Inpatient Facility (Discharged From Agency) OASIS" stated "... The niece called [12/28/2020] and stated the client passed away on Sunday 12-27-2020 ...." Review of hospital record received 12/29/2020, dated 12/23/2020 evidenced the patient was admitted to the hospital on 12/23/2020, and stated "... critical care was necessary for dehydration, Patient does appear to be septic from a urinary tract infection related to a foley catheter ... presented to the [emergency department] with reports of increasing confusion ... this evening ... disoriented ... poorly healing wound to left stump ... date of death 12/27/2020 ...." 3. The clinical record of patient #7, start of care 5/26/2016, certification period 11/1/2020 - 12/30/2020, was reviewed on 12/18/2020, and again on 1/11/2021. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 11/1/2020 - 12/30/2020 stated "... [skilled nursing orders] 1 visit every other week ... physical assessment ... and to change suprapubic catheter ... with each skilled nursing visit ... report any abnormal findings to [physician] ... RHHA [respite home health aide] up to 60 hr/month ... catheter care ... open area on coccyx that is being treated by the wound clinic ...." the document failed to evidence current wound care orders, wounds listed on comprehensive assessment (left foot- all toes, right foot- all toes), and failed to evidence skilled nursing interventions to mitigate wound status or prevention of new pressure sores, and failed to educate patient/caregiver on signs and symptoms of urinary tract infection, and when to notify agency/physician. Review of a document dated 11/11/2020 titled "Skilled Nurse Visit Note" failed to evidence wounds were assessed, and failed to evidence education was provided to the caregiver to mitigate worsening, signs and symptoms of infection, dehydration, urinary tract infections or new skin breakdown. Review of a wound clinic document dated 11/24/2020 (obtained by the wound clinic, not from clinical record) titled "Wound Treatment #1 (Order 262060966)" stated "... Wash wound(s) with mild soap and water, then pat dry. Place Medihoney [wound bed ointment] and cover with ABD [surgical absorbent gauze pad]. Change dressing daily ... Home Healthcare to visit for wound care 2-3 [times] weekly and PRN [as needed] wound care/dressing changes ... left lower extremity ... right lower extremity ...." The agency record failed to evidence it provided skilled nursing visits 2-3 times weekly. Review of a document dated 12/8/2020 titled "Skilled Nurse Visit Note" stated " Client had urine from penis, has yellow purulence around foley [sic- suprapubic catheter insertion site] ...Location: left heel ... wound type: pressure ... date originally reported: 6/26/2020 ... Comments: wound remains to the left heel ... Location: BLE [bilateral lower extremities]; 4th toes and left heel ... Wound type: unknown ... Date originally reported: 12/8/2020 ...." The document failed to evidence wounds were assessed/measured or treated by the nurse, the physician was notified of new open area(s), and failed to evidence education was provided to the caregiver to mitigate worsening, signs and symptoms of infection, dehydration, urinary tract infections or new skin breakdown. Review of a document titled "SN [skilled nurse] Re-Cert OASIS and Comprehensive Assessment" dated 12/29/2020 (after the IJ was called) stated "... Current Number of Unhealed Pressure Ulcers/Injuries at Each Stage ... Stage 2 ... [blank] ... Stage 3 ... [blank] ... Unstageable [full thickness skin and tissue loss in which the extent of the damage within the ulcer cannot be determined due to scabbing or dead fibrous tissue; once removed to expose wound, a stage 3 or 4 would be revealed] ... Stage 1 ... 0 ... Does this patient have a stasis ulcer [ulcer caused by impaired circulation]? ... Yes ... Current number of Stasis Ulcers that are observable ... 3 ... status of most problematic ... Not Healing ... Location ... left second toe ... left third toe ... right second toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... Integument [skin] Impression: ... unstable ... in need of skilled intermittent care ... Will continue to monitor during regular visits, but not be a focus of care ... Will require a lot of attention ... Current possible UTI symptoms: Wife stated client has been sleeping more and usually a sign of UTI ...." The document also evidenced the patient was a high risk for skin breakdown. The document failed to evidence the wounds were treated by the nurse, or education was provided to the caregiver to mitigate worsening or new skin breakdown. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 12/31/2020 - 2/28/2021 stated "... [skilled nursing orders] 1 visit every other week x 9 weeks ... System assessment with each skilled nursing visit ... full head to toe assessment ... change suprapubic catheter ... RHHA up to 60hr ... catheter care ... Teach/train in proper positioning to reduce pressure on pressure prone areas ... Assess wound for infection and healing ...." The document failed to evidence current wound care orders or treatment performed by nurse, all wounds listed on comprehensive assessment, and failed to evidence skilled nursing interventions to mitigate wound status or prevention of new pressure sores such as specialized diet and supplements to promote wound healing, frequent turning schedule, or padding of bony prominences, signs and symptoms of UTI, and catheter management. Review of a document dated 1/2/2021 titled "Care Coordination Note" evidenced the patient was admitted to the hospital 1/2/2021 for UTI (urinary tract infection) and would likely be discharged 1/4/2021 or 1/5/2021. Review of documents received from entity D (hospital) on 1/5/2021 (not part of agency clinical record) evidenced the patient was admitted 1/2/2021 for sepsis (systemic infection)/ UTI, and was discharged 1/5/2021. The document also evidenced the patient had chronic wounds to both feet, inadequate protein intake related to foot wounds and diabetes, need for more protein to assist wound healing, dietician will added Juven (nutritional supplement) twice daily to assist wound healing. No wounds on back/coccyx were evidenced in the documentation. The document also evidenced the patient required contact isolation (frequent handwashing and disinfection of bathroom) due to VRE (Vancomycin Resistant Enterococcus Infection) of the urine. Review of a document titled "SN ROC OASIS and Comprehensive Assessment" dated 1/5/2021 evidenced the patient was a high risk for skin breakdown, stated "... Does this patient have a stasis ulcer? ... Yes ... Current number of Stasis Ulcers that are observable ... 4 ... status of most problematic ... Not Healing ... Location ... right big toe ... right second toe ... left second toe ... left third toe ... left foot (all toes) ... right foot (all toes) ... left upper coccyx ... wife cleanses, applies medihoney dresses every other day and will see wound clinic 1/14/20 [sic] ...." The document failed to evidence contact precautions for VRE, skilled nursing interventions to mitigate wound status or prevention of new pressure sores such as specialized diet and supplements to promote wound healing, frequent turning schedule, or padding of bony prominences, or wound care was performed by the nurse. The document evidenced the certifying physician was contacted for orders, but the clinical record failed to evidence orders dated 1/5/2021. Review of a document dated 1/8/2021 titled "Skilled Nursing Visit Note" evidenced documentation of wounds on right big toe, left 2nd toe, left heel, and back left buttock, and indicated the wife performed the wound care, applying an ointment to the wounds. The document failed to evidence the physician was notified of the new wound(s), or new orders were received. Review of an email document dated 1/11/2021 at 9:49 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), the administrator, and the alternate administrator stated "... 1-10-2021, 12:20pm. I spoke with [patient's wife], regarding his new wound on his back. She said he is fine ... Her home remedy for his back is working ... She does not need me to stop by today to help her ...." The document failed to identify the ingredient(s) of the "home remedy", or that the physician was notified the wife was applying a home remedy to his wound(s). Additionally, during the exit interview on 1/12/2021 at 2:50 PM, the clinical director indicated the home remedy was urine. Review of an email document dated 1/11/2021 at 10:12 AM from the clinical director to employee C (registered nurse), employee M (registered nurse), employee D (medical records coordinator), employee H (office staff), the administrator, and the alternate administrator, stated "... new wound on left lower back reported to [wound clinic] ... [wound clinic] ordered daily wound care starting today ...." The clinical record failed to evidence a wound care order with increased skilled nursing frequency dated 1/11/2021. During an interview on 1/11/2021 at 2:23 PM, when asked if the agency requested and received hospital paperwork for admission on 1/2/2021, the alternate director of nursing stated "I don't know. I don't know if she [assessing nurse on 1/5/2021] called the hospital." When asked if the agency did any coordination with the hospital to obtain the hospital paperwork, she stated "I didn't." When asked where the resumption of care orders (1/5/2021) were located, she indicated they were in the comprehensive assessment. The record failed to evidence a physician's order. When asked what kind of bed the patient had (he was bedbound and would benefit from a specialized mattress to decrease risk of skin breakdown), the clinical and alternate clinical directors both indicated they did not know. During an interview on 1/12/2021 at 10:50 AM, the alternate clinical director stated a nurse was going to see the patient today (1/12/2021), and she still did not know what kind of mattress the patient had. Upon exit, no further information was submitted. 4. The clinical record of patient #9, start of care 9/9/2019, certification period 11/2/2020 - 12/31/2020, was reviewed on 12/18/2020, 1/6/2021, 1/11/2021 and 1/12/2021. Review of a document titled "SN Re-Cert [recertification] OASIS [outcome and assessment information set] and Comprehensive Assessment" dated 11/1/2020 "... right second toe amputation ... Non-removable dressing present. Wound managed by orthopedics ... Report any abnormal findings to VA [veterans affairs] MD ... skilled nurse ... physical assessment ... and notify MD of any abnormal findings ... had his right second toe amputated ... His 3rd right toe is black and shriveled ...." The document also evidenced the patient had diagnoses (but not limited to) atherosclerotic heart disease (hardening of the arteries causing impaired circulation), and diabetes with diabetic neuropathy (diabetes with damage to nerves in your legs and feet, causing pain and numbness in your legs and feet). The document failed to evidence the physician was notified of the change in condition of the wound. Review of a document dated 11/2/2020 titled "Skilled Nurse Visit Note" stated "... Right second toe amputation site not healing. 3rd toe black and very painful ...." The document failed to evidence the nurse measured the wounds, performed wound care, or notified the physician for the change in the patient's integumentary or pain status. Review of a document dated and signed by employee M 11/16/2020 titled "Skilled Nurse Visit Note" stated "... "posterior foot blackening about an 1 1/2 inch on ball of right foot, 3rd toe black and shriveled, outer edge of 5th toe; see diagram" The clinical record failed to evidence a diagram of the wound, or failed to evidence the physician was notified of the declining wound status. During an interview on 1/6/2021 at 3:56 PM, when asked if the doctor should have been notified of the change in wound status on 11/16/2020, the alternate director of nursing stated "He should be, I don't know if she did call." When asked if this failure to contact the physician could have potentially led to a negative outcome for the patient, she stated "Yes". Review of a document dated and signed by employee M on 11/30/2020 titled "Skilled Nurse Visit Note" stated "...: "No fever, No cough, No complaints, Right foot, big toe starting to blacken, middle to black and shriveled. Per wife, US [ultrasound] showed multiple blockages and patient may lose foot d/t [due to] occlusions ...." The document failed to evidence the physician was notified of the declining wound status. Review of a document dated and signed by employee M on 12/14/2020 titled "Skilled Nurse Visit Note" stated "... No cough, No fever. Client having RLE Femoral Endarterectomy on Friday 12/18/20. Right foot and toes continue to blacken. There is now a foul odor associated with foot. Foot is starting to get wet and drain. Pain 10/10. Taking Norco for pain. 2 weeks of meds set-up. 100% medication compliant. The document failed to evidence the physician was notified of the declining wound status or severe pain. Review of a document dated 12/23/2020 titled "Care Coordination Note" stated "Spoke with client's wife. Client went into hospital to femoral endarterectomy. Decided to move ahead with partial amputation of right foot. Client remains in hospital. Wife will call when client home." The clinical record failed to evidence the agency coordinated with the hospital to provide patient's current status or request hospital records. Review of a document titled "Skilled Nurse Visit Note" dated 12/28/2020 stated "... returned from hospital S/P [after] Right femoral endarterectomy [a surgical procedure to remove plaque inside the superficial femoral artery] and Right partial amputation of foot. Right groin incision C/D/I [clean, dry, and intact] no redness, no draining, no swelling. OTA [open to air]. Right foot dressing C/D/I with orders not to remove same until f/u [follow up] with Podiatry 1/4/21. Plavix [medication to prevent formation of blood clots and to keep blood vessels open after surgical procedures, and may cause easy bleeding/bruising] ... added to medication regimine [sic] ... Client is NWB [non-weight bearing] R foot ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document dated 12/28/2020 titled "Pain Location Assessment" evidenced the patient now had left second toe pain (which previously had not been identified), and the nurse failed to evidence further pain/physical assessment of the toe. The document also evidenced right foot (surgical) pain, and stated "... almost constantly ... sharp ... throbbing ... Intensity 5 [pain scale 0-10, with 0 being no pain, 10 being worst/most severe pain ever] ... worst pain over last 48 hours 10 ... best pan over last 48 hours 5 ... What makes pain worse? ... [box checked] Activity with affected area ... Changing position ... Comments ...." The document failed to evidence the nurse instructed on non-weight bearing status to the right foot, which could potentially have a negative outcome on the surgical healing process, failed to evidence the nurse assessed the left second toe pain, and failed to evidence the physician was notified. Review of a document dated 12/28/2020 titled "SN ROC OASIS and Comprehensive Assessment" (additional document for same nurse visit same day) stated "... had his right second toe amputated ... ambulates without devices in his home ... Has had no ... hospitalizations ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document titled "SN Re-Cert OASIS and Comprehensive Assessment" dated 12/28/2020 (additional document for same nurse visit same day) stated "... Pain Assessment: ... right foot. Severity (0-10), 6 ... Cardiovascular Assessment: ... blood thinners ... Plavix ... Integumentary [skin] Assessment: No issues noted ... incisions ... open to air ... right foot ... surgical dressing in place ...." The document failed to evidence the nurse educated the patient/caregiver on appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, nutritional requirements for wound healing, signs and symptoms of infection or other indications that should be reported to the agency and/or physician, and failed to evidence the physician was notified for report and resumption of care orders. Review of a document titled "Home Health Certification/Recertification Plan of Care Order" for certification period 1/1/2021 - 3/1/2021 stated "... [skilled nursing orders] ... one visit ... every 2 weeks ... medication tray set-up, to monitor compliance ... physical assessment, and report any abnormal findings to MD ...." The document failed to evidence skilled nursing interventions such as wound care/treatments, patient/family education for wound care/treatment, interventions to mitigate new or worsening skin breakdown, appropriate post-surgery instructions/precautions such as (but not limited to) non-weight bearing status and other physical restrictions, bleeding precautions, nutritional requirements for wound healing, or signs and symptoms of infection or other indications that should be reported to the agency and/or physician. During an interview on 1/5/2021 at 1:29 PM person F (staff at entity E) indicated the patient was seen 1/4/2021 for surgical follow up. When asked if she received any communication/coordination from the agency, she stated "On 12/29 [2020] we got a call from [employee M] to request PT/OT [physical and occupational therapy] order. That's the only thing I see ...." Review of documents received from person E (Podiatrist) on 1/5/2021 at 2:04 PM (not part of agency clinical record) included hospital discharge paperwork (given to the patient/caregiver upon hospital discharge on 12/28/2021), which indicated (but not limited to) the patient was not to bear weight on the right foot, and post-surgical education/instructions/limitations. Also included was a document dated 1/4/2021 titled "Progress Notes", which indicated (but not limited to) the patient was to continue to remain non-weight bearing on the right foot. During an interview on 1/6/2021 at 3:56 PM, the clinical director and alternate clinical director confirmed the skilled nursing frequency remained every two weeks since hospital discharge. When asked if waiting two weeks to see this patient could lead to a potentially negative outcome, they both stated "Yes." During an interview on 1/12/2021 at 1:50 PM, regarding the skilled nursing visit on 11/16/2020, employee M indicated she did not contact the physician, he was already aware, it (the wound/blackening of toe/foot) started as just the tip, and it was an ongoing process; regarding the skilled nursing visit on 12/14/2020, she stated "I did not call the physician ...."

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all clinical record entries were complete, and appropriately authenticated, dated, and timed for 1 of 10 records reviewed (#1). This practice had the potential to affect all agency patients. Findings include: Review of an undated copyright Briggs Healthcare policy C-873 titled "Documentation of Changes to the Medical Record" stated, "... If it is necessary to make an addition to a previous entry, this must be done using an addendum to the record. The entry will be marked as an addendum and must include the date it is written and the visit date that the entry relates to ... Changes to OASIS documentation ... The clinician who completes the assessment form is responsible for making changes (corrections, revisions, or additions) to the document. The clinical supervisor or designee may enter changes based on the review of the assessment. These changes must be documented in the record identifying the reason for the changes and the communication of those changes to the authoring clinician ... Records sourced from electronic systems containing amendments, corrections or delayed entries must: Distinctly identify any amendment, correction or delayed entry ... Provide a reliable means to clearly identify the original content, the modified content, and the date and authorship of each modification of the records ... Auditors including recovery auditors shall NOT consider any entries that do not comply with these principles ...." The clinical record of patient #1, start of care 12/10/2019, certification period 12/4/2020 - 2/1/2021, was reviewed on 12/18/2020, and again on 1/12/2021. Review of a document received on 12/28/2020 titled "SN [skilled nurse] SOC [start of care] OASIS and Comprehensive Assessment" dated 12/10/2019 evidenced the patient had no wounds and failed to evidence a Braden scale (a comprehensive assessment for predicting pressure sore risk) was completed by the registered nurse. The assessment further evidenced the patient had (but not limited to) diabetes with peripheral angiopathy (a blood vessel disease caused by high blood sugar), amputations of both legs below the knees, and had an indwelling urinary catheter (a tube inserted into to bladder to drain urine). The patient was alert and oriented to person, place, and time, without confusion or disruptive behaviors. Upon admission on 12/10/2019, the patient had no open skin areas or wounds. Review of documents received from wound clinic on 12/16/2020 at 3:23 PM (not part of agency clinical record) included (but not limited to) physician wound progress notes. Review of a document titled "[entity C] Progress Note" dated 11/10/2020 evidenced the patient had a stage 3 (full thickness through skin to fatty tissue) pressure injury to the right thigh, no pressure injury to the left [sic- should state 'right'] lower extremity stump (previous below knee amputation), and two deep wounds to the right [sic- should state 'left'] lower extremity stump "... I fear more aggressive debridment [sic] will expose bone ...." Review of another document titled "[entity C] Progress Note" dated 11/24/2020 evidenced the left lower extremity pressure ulcers were worsening stage 4 (full thickness with bone or tendon exposed), and pressure ulcer to right groin remained (stage 3). Review of the last document titled "[entity C] Progress Note" dated 12/8/2020 evidenced the right groin was worsening with deep tendon exposed (stage 4), and the left stump pressure ulcer now had sharp bone exposed (worsening stage 4). During the entrance conference interview on 12/15/2020 at 11:00 AM, the clinical director indicated the agency used both paper and electronic charting. When asked the process for making corrections in the clinical record, the clinical director indicated the document would be taken to the RNCM (registered nurse case manager) to discuss, then it would be a late entry, line through, corrected, then initialed. During an interview on 12/17/2020 at 3:44 PM, the clinical director stated the comprehensive assessment for patient #1 dated and signed by employee L on 12/3/2020 was actually completed on that date (12/17/2020), and the plan of care was also completed that date (12/17/2020) and sent to the physician. Both were reviewed and approved by employee M (registered nurse). It was verified by the clinical director and the administrator that employee L (registered nurse) initiated the comprehensive assessment on 12/3/2020 but didn't complete it, and she did not assess the wounds. When asked, the clinical director agreed the certifying physician would not be able to provide/approve orders to meet the patient's needs without complete and accurate assessment findings. During this time, the administrator asked the director of nursing if the agency obtained wound clinic follow up. The director of nursing stated "No." During an interview on 12/18/2020 at 1:00 PM, when asked who finished the comprehensive assessment for patient #1 dated 12/3/2020, the director of nursing stated "[employee N- registered nurse]." When asked if she was the nurse that initiated the comprehensive assessment on 12/3/2020, the director of nursing stated "No." When asked why employee L didn't complete the assessment, the director of nursing stated "We discovered she was behind, we wanted to get it done, so we sent it to [employee N]." She also indicated employee N saw the patient on 12/15/2020, and that visit represented completion of the comprehensive assessment dated 12/3/2020. When asked if there were other incomplete patient assessments that employee L failed to complete that someone else was finishing, the administrator stated, "I believe so." When asked when the agency noticed employee L's had incomplete/late assessments, the clinical Director stated "Monday [12/14/2020]". When asked if the agency had a list of additional patients that other nurses were "fixing or have fixed" for employee L, the clinical director stated "Yes." The administrator indicated employee H (office staff) completed billing every week, and every week she checked in the paperwork. During this interview (at 1:23 PM), the list of all patients re-assigned to other nurses to finish was requested, and was received at 1:38 PM. The list evidenced (but not limited to) 33 patients from 12/1/2020 - 12/18/2020 which had incomplete assessments. During an interview on 12/18/2020 at 3:20 PM, when asked which nurse did which portions of the comprehensive assessment dated 12/3/2020, the administrator stated "I can only tell [employee L] visited [the patient] on the 3rd, started writing [on the assessment on] 11th, [employee N] saw the patient on the 15th, and employee M reviewed and approved the assessment document on the 17th ... [employee M] signed the plan of care." The administrator also indicated he didn't know who did the wound assessments, or when the wounds were last assessed by staff. When asked if there had been any discipline for employee L, the administrator stated, "I don't know."