Every finding on record at Genesis Home Health Services Inc

A recertification survey entrance conference was conducted on 07/26/22 at 10:15 AM with Alternate Administrator and Office Manager. Census: LCHHS -- 1 LHHS -- 0 PAS -- 0 An exit conference was conducted on 07/29/22 at 3:30 PM with the Alternate Administrator and Office Manager. The preliminary findings were discussed. The agency was given the opportunity to provide additional information. The agency is in substantial compliance with 484.22 Condition of Participation for Home Health Agencies, Appendix Z - Emergency Preparedness Requirements.

A recertification survey entrance conference was conducted on 07/26/22 at 10:15 AM with Alternate Administrator and Office Manager. Census: LCHHS -- 1 LHHS -- 0 PAS -- 0 An exit conference was conducted on 07/29/22 at 3:30 PM with the Alternate Administrator and Office Manager. The preliminary findings were discussed. The agency was given the opportunity to provide additional information. Written instructions were provided for submitting a Plan of Correction within 10 days of the receipt of the Statement of Deficiencies. The agency was informed that Condition Level deficiencies would be cited. Abbreviations PT-Physical Therapist RN-Registered Nurse CM-Centimeters NS-Normal Saline AG-Alginate SN-Skilled Nurse WCC-Wound Care Certified ROM-Range of Motion Supervising Nurse / Clinical Manager / DON Alternate Supervising Nurse / Alternate Clinical Manager / Alternate DON DON - Director of Nursing

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview RN B failed to conduct a complete and accurate Comprehensive assessment that determined immediate needs of the patient for 1 of 7 (patient #2) records reviewed in that the RN did not conduct a complete skin assessment that included the sacral wound or the wound on the foot, did not conduct an accurate pain assessment and did not include any details about the urine collected for analysis and sensitivity. This failure resulted in the patient’s infections worsening until she required an ambulance to take her to the Emergency Room where she subsequently died. Review of Patient #2’s Plan of Care for 06/24/2021-08/22/2021 revealed diagnoses of Primary Hypertension (abnormally high blood pressure that is not the result of a medical condition), Dementia (the loss of cognitive functioning, thinking, remembering, and reasoning to such an extent that it interferes with a person's daily life and activities) and Multiple fractures (ribs, lumbar vertebrae and scapula (shoulder blade)). Review of the PT evaluation from 06/24/21 revealed that she was non-verbal, and bed bound. She was transferred from bed to recliner chair daily through use of Hoyer lift (A Hoyer lift is a mobility tool used to help patients with mobility challenges get out of bed) with 2 person assist. The PT evaluation of 06/24/22 revealed that the patient would yell when moved or repositioned during therapy ROM. Review of the start of care assessment for patient #2, initiated by RN B and signed by the Supervising Nurse, revealed that she resided in an ALF. The assessment also revealed when the patient was admitted to the ALF her urine was malodorous. RN B, who did the Start of Care assessment, documented that she obtained a urine sample for UA and sensitivity. RN B noted in the skin assessment section that the “skin was intact. No breakdown of the skin noted”. Review of the Clinical record did not reveal documentation of the results of the urine analysis or if the patient was started on an antibiotic. Further review of the clinical record documentation noted at each SN visit dated 06/28/21, 07/11/2, 07/26/21 and 08/02/2, signed by the Supervising Nurse, that the urine was odorous and had sediment. On the SN notes of 07/06/21 and 07/20/21, signed by the Supervising Nurse, there was no documentation about the Urine. In an interview with the Facility Manager of the ALF on 06/28/22 at 3:00 PM she stated that the odor that came from the patient’s room was very bad. She stated it was probably a combination of the urine and the wound smells. She stated the patient was on an antibiotic shortly after arriving at the facility in June, but the urine smell never got better. In an interview with the Supervising Nurse (who was also the case manager for patient #2) on 07/29/22 at 2:15 PM she stated that yes, she smelled the malodor of patient #2’s urine. She stated she asked the facility to notify the patient’s doctor when he came to the facility, but she didn’t know if they did. “According to medicalnewstoday.com, UTIs [urinary tract infections] are a common cause of white particles in the urine. UTIs occur when bacteria enter the urethra and make their way to the bladder, kidneys, or ureter, where they multiply and cause the infection. Less commonly, viruses, parasites, or fungi entering the urinary tract may cause a UTI. According to a 2018 review, Trusted Source, a UTI can cause discharge in both males and females and can cause white particles to appear in the urine. Other symptoms of UTIs include: pain in the abdomen or pelvis, an urgent need to urinate, pain while urinating, trouble urinating, cloudy or discolored urine, foul-smelling urine, fever or chills. Bacterial UTIs usually require antibiotics.” Further review of patient #2’s clinical record revealed that she had a stage 2 pressure ulcer on her coccyx (The coccyx is a triangular arrangement of bone that makes up the very bottom portion of the spine below the sacrum sometimes called the tailbone) that was first noted on 06/28/21 by the Supervising Nurse with measurements of 2.2 cm x 1.8 cm x .02 cm. The record contained a physician’s order dated 06/28/21 ordering wet to dry dressing (to the coccyx wound) to change daily and educate the caregiver to change dressing. On 07/12/21 the nurse documented that the wound was getting larger at 3cm x 1.5cm X 0.2cm with moderate serosanguinous drainage (thin, watery discharge that contains a small amount of blood). On 07/28/21 the nurse documented that “bedsore on coccyx is progressing in size”, but no wound measurements were noted. Review of the PT re-evaluation dated 07/31/21 the PT assessed the wound. [The PT was WCC (Wound Care Certified)]. The PT documented that the patient was referred for wound care assessment of sacral wound. Further review of the PT's wound assessment note read in part: "Sacral wound measurement 10.5cm x7.0cm x.4cm; undermining at 9-12 o’clock at 1.5 cm; linear edges; no tunneling. Wound base 80% beefy red, 20% black eschar with odor. Minimal drainage." The PT suggested a new dressing protocol on his evaluation and with a new order for PT to do the wound care. In an interview with the Facility Manager at the ALF on 07/28/21 at 3:00 pm she stated that the caregivers at the facility did their best to keep the wound clean. They changed the wet to dry dressing 1-2 times a day. She stated, “The wound smelled bad and one day when they were turning the patient the wound burst open and pus poured out of the wound.” When this happened on 08/09/21 the ALF called the ambulance and sent the patient to the hospital where, according to the ALF facility manager, she subsequently died of infection. In an interview with the Supervising Nurse (who was also the Case Manager for the patient #2) on 07/29/21 at 2:15 PM, she stated she knew the wound was worsening and that was why she asked PT#2 to see the patient as he was wound care certified. She stated she did not realize the wound was so bad, she only superficially looked at the wound because she could not turn the patient and she put the dressing on the part of the wound that she could see. She stated she knew this was a mistake on her part. Agency Policy PE.2 Patient Assessment guidelines stated in part… The comprehensive assessment must accurately reflect the patient’s status and include, at a minimum: The patient’s current health …status.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to ensure that services were provided as written in the individualized plan of care as ordered by the physician in 2 of 7 patients reviewed (Patients #1 and #6) in that the frequency of Skilled Nurse and PT visits was not followed for patient #1 and the frequency of SN visits was not followed for patient #6. This failure has the potential to increase the risk of decline in health status and condition specific to each patient. Refer to G572 Based on record review and interview the agency failed to include all treatments on the plan of care for 1 of 7 patients (#1) reviewed, in that wound care orders were not included in the Plan of Care. This failure could affect any patient with a wound as missing physician orders increases the potential for clinician error and increases the potential for failed patient safety. Refer to G574 Based on record review and interview the agency failed to alert the physician of changes in the patient’s condition or needs that suggested outcomes were not being achieved and/or the plan of care should be altered in 3 of 7 patients reviewed (patient #2, patient #3 and patient #7). Patient #2's physician was not informed of the worsening urine and wound infections, or the ineffectiveness of the medication ordered for pain Patient #3's physician was not informed that the patient fell and had skin tears Patient #7's physician was not informed of the Blood pressure reading that was outside of parameters Failure to report changes or needs in the patient's condition to the physician may result in deterioration in health status for the patient. Refer to G590

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure that services were provided as written in the individualized plan of care as ordered by the physician in 2 of 7 patients reviewed (Patients #1 and #6) in that the frequency of Skilled Nurse and PT visits was not followed for patient #1 and the frequency of SN visits was not followed for patient #6. This failure has the potential to increase the risk of decline in health status and condition specific to each patient. Findings include: Patient #1 Review of the clinical record revealed that patient #1 was admitted on 06/04/22 with diagnosis of Type 2 diabetes (impairment in the way the body regulates and uses sugar (glucose) as a fuel) with kidney complications and Stage 2 Pressure Ulcers (the sore has broken through the top layer of the skin and part of the layer below). Review of the Plan of Care for 06/04/22-08/22/22 revealed orders for SNV 2 times a week for 4 weeks and then 1 time a week for 5 weeks. For the weeks of 06/05/22-06/11/22, 06/12/22-06/18/22, 06/19-06/25/22 and 06/26/22-07/02/22 the nurse saw the patient only 1 time per week instead of the 2 times a week that was ordered. In an interview with RN A on 07/27/22 at 10:30 AM he stated that he had seen the patient 1 time per week from the start of care. He stated that he was not aware he had orders to see the patient 2 times per week for 4 weeks. In an interview with the Supervising Nurse o 07/27/22 at 11:30 AM she stated that she did not know why RN A was visiting 1 time per week. She stated that the nurse had access to the Plan of Care in the electronic documentation system. She stated she would talk to him about reviewing the Plan of Care. Review of the PT evaluation of 06/08/22 revealed the frequency of visits was ordered as 1 time a week for 6 weeks. The PT visited 1 time a week for 3 weeks and then the record revealed no further PT notes. There was no documentation that the patient had been discharged from Physical Therapy or that the physician had been consulted about this change. In an interview with the patient’s caregiver on a home visit on 07/27/22 at 10:30 AM she stated that the PT used to come but they had not seen him for some time. She was not sure why he quit coming. In an interview with the Supervising Nurse on 07/27/22 at 11:30 AM she stated that the PT seeing the patient went on vacation and they had no one else to see the patient. She stated when this happens, they usually get an order from the physician to hold the visits until the visits can resume. She stated she was not sure why they had not gotten an order this time. She stated she knew holding visits was not good practice, but they contract with 2 independent contractors for PT and sometimes they are both unavailable. Patient #6 Review of the clinical record revealed patient #6 was admitted on 07/03/20 with diagnoses of Hypertension (blood pressure that is higher than normal), Recent Acute Cholecystitis with surgery (inflammation of the gallbladder. It usually happens when a gallstone blocks the cystic duct). The Plan of Care for the certification period 07/03/20-08/31/20 ordered skilled nurse visits 1 time a week for 1 week and 2 times a week for 8 weeks. Review of the SNV notes revealed that RN A visited the patient 2 times a weeks for 2 weeks and then 1 time a week for 6 weeks; the RN missed 6 of the skilled nursing visits ordered. There was no documentation that the agency documented why the change in visit frequency occurred or that the physician was contacted / informed about this change. In an interview with the Supervising Nurse on 07/29/22 at 9:30 AM about the missed visits she stated that she did not know why RN A would change the visit schedule. She stated she guessed it was another occurrence of not reviewing the Plan of Care. Review of agency policy TX 6. titled "Plan of Care" read in part… "The physician is promptly alerted to any relevant changes in the patient’s condition or needs that suggest outcomes are not being achieved or that the plan of care should be altered....." Review of agency Policy 97 titled "Missed Visits" read in part … "1st Genesis Home Health Services will ensure that physician’s orders are followed by the nursing staff...."

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to include all treatments on the plan of care for 1 of 7 patients (#1) reviewed, in that wound care orders were not included in the Plan of Care. This failure could affect any patient with a wound as missing physician orders increases the potential for clinician error and increases the potential for failed patient safety. Findings include: Review of patient #1's clinical record revealed that patient #1 was a 92-year-old male, admitted on 06/04/22. The POC certification period for 06/04/22 to 08/02/22 revealed the following diagnoses: Type 2 diabetes (impairment in the way the body regulates and uses sugar (glucose) as a fuel) with kidney complications and Stage 2 Pressure Ulcers (the sore has broken through the top layer of the skin and part of the layer below). Review of patient #1’s clinical note dated 06/07/22 revealed the patient had a Stage 2 Pressure Ulcer on the right buttock measuring 4.5cm x 4.0cm and a Stage 2 Pressure Ulcer on the Left buttock measuring 3.4cm x 3.0 cm. The documentation read that the Skilled Nurse performed wound care as follows: Cleanse with NS. Apply AG Silver dressing and cover with Alevyn dressing (absorbent foam dressing). Further review of the Plan of Care dated 06/04/22-08/02/22 revealed no order for the wound care treatment implemented by the SN on 6/7/22. Review of the referral documentation revealed no order for the wound care provided nor was there a verbal order for wound care. In an interview with RN A on 07/27/22 at 10:15 AM during a home visit to patient #1, the nurse stated that the patient had the pressure ulcers when admitted. RN A stated he had no order for the dressing change, so he implemented the protocol that he knows the physician usually orders. RN A added he was not aware that an order was not written for the wound care or that there were no wound care orders on the Plan of Care. He stated that the dressing change was done daily and that he had educated the caregivers in the group home on the dressing change process. In an interview with the Supervising Nurse on 07/27/22 at 1:10 PM she stated that agency staff know the doctors who refer to them very well and know what they would order for wound care. She agreed that there should have been an order from the doctor for the wound care and that it should have been on the Plan of Care. She stated she would talk to RN A about this. Review of Agency policy TX6. titled "Plan of Care" read in part… "Other items included in the Plan of Care include but limited to: … (3) Interventions to prevent pressure ulcers and pressure ulcer/injury treatment based on principals of moist wound healing.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to alert the physician of changes in the patient’s condition or needs that suggested outcomes were not being achieved and/or the plan of care should be altered in 3 of 7 patients reviewed (patient #2, patient #3 and patient #7). Patient #2's physician was not informed of the worsening urine and wound infections, or the ineffectiveness of the medication ordered for pain Patient #3's physician was not informed that the patient fell and had skin tears Patient #7's physician was not informed of the Blood pressure reading that was outside of parameters Failure to report changes or needs in the patient's condition to the physician may result in deterioration in health status for the patient Findings include: Patient #2 Patient #2’s Plan of Care for 06/24/2021-08/22/2021 revealed diagnoses of Primary Hypertension (abnormally high blood pressure that is not the result of a medical condition), Dementia (the loss of cognitive functioning, thinking, remembering, and reasoning to such an extent that it interferes with a person's daily life and activities) and Multiple fractures (ribs, lumbar vertebrae and scapula (shoulder blade)). Review of the patient’s start of care assessment revealed that the patient resided in an ALF. Review of the PT evaluation from 06/24/21 revealed that she was non-verbal, and bed bound. She was transferred from bed to recliner chair daily through use of Hoyer lift (A Hoyer lift is a mobility tool used to help patients with mobility challenges get out of bed) with 2 person assist. The PT evaluation of 06/24/22 revealed that the patient would yell when moved or repositioned during therapy ROM. The start of care assessment prepared by RN B revealed that the patient indicated her pain as a 3 on a scale of 1-10. In subsequent visits by the Supervising Nurse pain was rated as 5 on 06/28/21 and a 3 on 07/06/21, 07/11/2, 07/20/21, 07/26/21 and 08/02/21. However, in an interview with the Facility Manager at the ALF on 06/27/22 at 3:00 PM she stated “She was suffering. Every time the ALF staff went to turn her or transfer her, she would start screaming”. She stated that the only medication they had for her for pain was Tylenol. When asked if they ever called the doctor about this, she said that they left calling the doctor up to the home health nurse. In a review of the medication profile for patient #2 it revealed no medication for pain. The Tylenol being given was not listed on the medication profile. There was no documentation in the record that the nurse called the physician to report the pain and request an order for pain medication. In an interview with the Supervising Nurse (who was also the Case Manager for this patient) on 07/29/22 at 2:15 PM she stated that she never called the physician about the pain. She stated “I guess I didn’t realize that the patient was not getting pain medication and that the patient was in so much pain” In further review of the Patient #2’s record it revealed that when the patient was admitted to the ALF her urine was malodorous. RN B, who did the Start of Care assessment, documented that she obtained a urine sample for UA and sensitivity. However, there was no documentation the chart of the results of the lab work or if the patient was started on an antibiotic. The documentation in the record noted on each visit (06/28/21, 07/11/2, 07/26/21 and 08/02/2) was that the urine was odorous and sediment. On the SN notes of 07/06/21 and 07/20/21 there was no documentation of Urine. In an interview with the Facility Manager of the ALF on 06/28/22 at 3:00 PM she stated that the odor coming from the patient’s room was very bad. She thought from a combination of the urine and the wound. She stated the patient was on an antibiotic shortly after arriving at the facility in June, but the urine never got better. In an interview with the Supervising Nurse (who was also the case manager for patient #2) on 07/29/22 at 2:15 PM she stated that she never called the physician about the continuing issue with the patient’s urine. She stated she asked the facility to notify the patient’s doctor when he came to the facility, but she didn’t know if they did. “According to medicalnewstoday.com, UTIs [urinary tract infections] are a common cause of white particles in the urine. UTIs occur when bacteria enter the urethra and make their way to the bladder, kidneys, or ureter, where they multiply and cause the infection. Less commonly, viruses, parasites, or fungi entering the urinary tract may cause a UTI. According to a 2018 review, Trusted Source, a UTI can cause discharge in both males and females and can cause white particles to appear in the urine. Other symptoms of UTIs include: pain in the abdomen or pelvis, an urgent need to urinate, pain while urinating, trouble urinating, cloudy or discolored urine, foul-smelling urine, fever or chills. Bacterial UTIs usually require antibiotics.” Further review of the patient #2’s record revealed that she a stage 2 pressure ulcer on her coccyx (The coccyx is a triangular arrangement of bone that makes up the very bottom portion of the spine below the sacrum sometimes called the tailbone). It was first noted on 06/28/21 with measurements of 2.2 cm x 1.8 cm x .02 cm. There was evidence of a physician’s order on 06/28/21 ordering wet to dry dressing to change daily and educate the caregiver to change dressing. On 07/12/21 the nurse documented that the wound was getting larger at 3cm x 1.5cm X 0.2cm with moderate serosanguinous drainage (thin, watery discharge that contains a small amount of blood). On 07/28/21 the nurse documented that “bedsore on coccyx is progressing in size”, but no wound measurements were noted. On 07/31/21 the PT completed a revaluation and assessed the wound. The PT was a WCC (Wound Care Certified). He documented that the patient was referred for wound care assessment of sacral wound. Further review of his note revealed documentation that read: Sacral wound measurement 10.5cm x7.0cm x.4cm; undermining at 9-12 o’clock at 1.5 cm; linear edges; no tunneling. Wound base 80% beefy red, 20% black eschar with odor. Minimal drainage. The PT suggested a new dressing protocol on his evaluation and new order for PT to do the wound care. Prior to this PT evaluation there was no documentation that the nurse contacted the physician to report the worsening wound. After the PT evaluation, there was no documentation that the nurse followed-up with the physician to verify PT orders for wound care. In an interview with the Facility Manager at the ALF on 07/28/21 at 3:00 pm she stated that the caregivers at the facility did their best to keep the wound clean. They changed the wet to dry dressing 1-2 times a day. She stated, “The wound smelled bad and one day when they were turning the patient the wound burst open and pus poured out of the wound.” When that happened on 08/09/21 the ALF called the ambulance and sent the patient to the hospital where, according to the ALF facility manager, she subsequently died of infection. In an interview with the Supervising Nurse (who was also the Case Manager for the patient #2) on 07/29/21 at 2:15 PM, she stated she knew the wound was worsening and that was why she asked PT#2 to see the patient as he was wound care certified. She stated she never called the doctor about the worsening wound because she did not realize the wound was so bad. She stated she knew this was a mistake on her part. The patient's Plan of Care for 06/24/21-08/10/21 ordered skilled nurse to see the patient 1 time every other week for 9 weeks. The nurse saw the patient every week from 06/24/21 to 08/10/22 when the patient was transferred to the hospital. There was no documentation that the agency consulted the physician about this change. In an interview with the Supervising Nurse on 07/27/22 at 12 P.M. about discrepancy in Skilled Nurse visit frequency, she stated that on admission when frequency was put on Plan of Care, she was not aware the patient had a wound. When she became aware, she changed the frequency to 1x per week. She stated she just forgot to get a physician’s order to change the frequency. Patient #3 Patient #3’s Plan of Care for 09/03/20-11/01/20 revealed a diagnosis of Acute Myeloblastic Leukemia (a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell), Neutropenia (occurs when you have too few neutrophils, a type of white blood cells) and Muscle weakness. Review of the record revealed that the patient reported to Nurse A on a home visit on 09/18/20 that he had fallen a few days before and incurred skin tears on his left elbow and anterior (near the front) left leg. The nurse assessed the skin tears and noted they were healing well with scab formation noted. The record contains no documentation that the nurse notified the physician about the fall or skin tears. In an interview with the Supervising Nurse on 07/26/22 at 1:20 PM she stated she did not know why the nurse did not notify the physician. She stated he was usually good about keeping the physician informed. She will talk to him about calling with issues like this. Patient #7 Patient #7’s Plan of Care for 10/01/20-11/29/20 revealed diagnoses of Hypertension (blood pressure that is higher than normal), Type 2 Diabetes (an impairment in the way the body regulates and uses sugar (glucose) as a fuel), Difficulty Walking, Chronic Pain and Debility (physical weakness, especially because of illness). Orders on the plan of care stated in part… Notify MD if… Systolic Blood Pressure greater than 180 and less than 90; Diastolic Blood Pressure if greater than 90 and less than 60. Review of the record revealed that on a home visit to the patient on 10/08/20 the nurse obtained a sitting Blood Pressure reading of 144/92. On a home visit on 10/28/20 the nurse obtained a sitting blood pressure reading of 156/96. Her documentation revealed that 1 hour later she took the blood pressure again with a reading of 140/80. There was no documentation that the nurse notified the physician of these elevated blood pressures as ordered on the plan of care. Interview with the Supervising Nurse on 07/29/22 at 10:00 AM she stated she did not know why the nurse did not call the doctor. She guessed it was because the blood pressure came down the second time. She stated that these parameters for vital signs were there for a reason to alert the physician if problems were occurring. She stated this nurse no longer worked for the agency, but she will inservice the others. Agency Policy 97.288 Coordination of Services read in part: "..to assure that all pateint care services are coordinated through effective interchange and reporting among healthcare professionals involved in the care of the client. Agency staff will coordinate care to assure that patient receives appropriate care.....The physican or other authorized individuals must be included in the commnication and thus in the cooordination of care and services.. Staff will contact the physican when there are significant changes in the pateint's condition......."

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview the administrator failed to ensure that the agency's Alternate Clinical Manager / Alternate Supervising Nurse was available during operating hours in that the Alternate Clinical Manager / Alternate Supervising Nurse was not available in person, by phone and was not available to see patients during the agency's operating hours. This failure may lead to safety issues and poor outcomes for agency patients Refer to G950 Based on record review and interview the Supervising Nurse / Clinical Manager failed to ensure that the patient needs were continually assessed in 1 of 7 patients reviewed (patient #2) in that the patient’s pain, urinary tract infection and wound were not correctly/ appropriately assessed throughout the certification period. This failure caused decreased patient safety, poorer health outcomes and may have contributed to her death. Refer to G966 Based on record review and interview the agency failed to provide wound care services in accordance with current clinical practice in that wet-to dry dressings were used for 1 of 2 patients reviewed (#2) with an infected wound and the wound infection worsened. This failure resulted in Patient’s #2’s wound deteriorating and likely contributed to her death. Refer to G984

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on record review and interview the administrator failed to ensure that the agency's Alternate Clinical Manager / Alternate Supervising Nurse was available during operating hours in that the Alternate Clinical Manager / Alternate Supervising Nurse was not available in person, by phone and was not available to see patients during the agency's operating hours. This failure may lead to safety issues and poor outcomes for agency patients Findings include: Review of personnel records revealed an Administrator, Alternate Administrator/ Supervising Nurse, Alternate Supervising Nurse / Alternate Clinical Manager and RN A as employees. Review of agency contracts revealed no contract for backup nursing. In an interview with the Alternate Administrator/Supervising Nurse on 07/28/22 at 2:10 PM she stated that she was not able to go out and see patients, she might go out for one visit, but she was just not physically able to see patients anymore. The Alternate Administrator/Supervising Nurse stated that the Alternate Supervising Nurse / Alternate Clinical Manager was basically just on paper only. Sometimes if she (the Alternate Administrator/Supervising Nurse) was out of town, the Alternate Supervising Nurse / Alternate Clinical Manager would take calls for her but would not make visits. When asked what her plan was for back-up to see patients, she stated she would ask RN A to help; if RN A was unavailable, she would transfer the patients to other agencies for care. In an interview with the Alternate Supervising Nurse / Alternate Clinical Manager via telephone on 07/28/22 at 3:00 PM she stated that she had not worked at the agency in years and was surprised she was listed as Alternate Supervising Nurse / Alternate Clinical Manager. She stated she had a full-time position at a wound care center. She stated as the Alternate Administrator/Supervising Nurse was a family member, she would sometimes help her out by answering calls, but she did not want the responsibility of being an Alternate Supervising Nurse / Alternate Clinical Manager. She stated she would not make patient visits or be involved with the agency. Review of the Alternate Supervising Nurse / Alternate Clinical Manager job description read in part..."The Assistant Director of Nursing assists the Director of Nursing in running, efficient nursing services and implementing agency policies and procedures. Oversees documentation, provides field supervision, functions as a resource person and field nurse when appropriate. Administers specific care to patients or emergency treatments when necessary."

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 Supervising Nurse / Clinical Manager failed to ensure that the patient needs were continually assessed in 1 of 7 patients reviewed (patient #2) in that the patient’s pain, urinary tract infection and wound were not correctly/ appropriately assessed throughout the certification period. This failure caused decreased patient safety, poorer health outcomes and may have contributed to her death. Findings include: Review of the PT evaluation dated 06/24/21 revealed that the patient was a 91-year-old female with decreased cognitive, decreased speech and decreased strength. The evaluation also revealed the patient was non-verbal and bed bound and transferred from bed to chair with a hoyer left. with 2 person assist. Review of Patient #2’s Plan of care for 06/24/2021-08/22/2021 revealed diagnoses of Essential Primary Hypertension, Dementia and Multiple fractures of ribs, fracture of shaft of clavicle and fracture of fifth lumbar vertebrae. The Plan of Care also included information that the patient resided in an ALF. Review of the admission assessment revealed it was completed on 06/24/21 by RN B. The documentation on the assessment stated the patient had no wounds and “Overall skin integrity was intact with no skin breakdown.” Review of the Skilled Visit Note (SVN) dated 6/28/21 the documentation read in part, “bedsore on coccyx is progressing in size”. The wound addendum documented a Stage 2 pressure ulcer measuring 2.2cm x 1.8 cm x.2cm. On this visit an order was obtained for wet to dry dressing daily. Review of the SVN dated 07/06/21 the nurse documented “starting a stage 1 bed sore.” There were no wound descriptions on this note. Review of the SVN dated 07/26/21 the nurse documented “Wound size is getting bigger in measurement with serosanguinous large drainage. The wound addendum documented a Stage 1 pressure ulcer 4.8cm x 3.5cm x 0.2cm. Wound bed is 100% pink with large amount of serosanguinous drainage. No tunneling and no undermining. She documented that she requested MD order for WCC PT (PT C) to assess wound for more effective wound care. Review of PT C's wound assessment on 07/31/21 read in part ” Sacral wound (The sacral region (sacrum) is at the bottom of the spine and lies between the fifth segment of the lumbar spine (L5) and the coccyx (tailbone) measurements 10.5cm x 7.0 cm x 0.4 cm undermine at 9-12 o’clock max of 1.5. Linear edges No tunneling. Wound base with 80% beefy red and 20% black eschar (Eschar is a type of necrotic tissue that is dryer than slough, adheres to the wound bed, and has a spongy or leather-like appearance) with foul odor. Black eschar source of foul odor. Minimal serosanguinous drainage, no sign of purulent drainage." A new wound care protocol was suggested by physical therapist to apply Silvercell to all wounds, cover with gauze or ABD pad secure with tape change MWF or as needed. Review of 06/24/21 PT Evaluation the PT noted in his assessment that the patient had a small pressure ulcer on her foot. On the PT evaluation on 07/31/21 the PT documented wound along left medial foot measurements 1.0 cm x 1.9 cm 100% pink granulating tissue. There was no documentation in the skilled nurses notes of this pressure ulcer. In an interview with the Supervising Nurse (who was the case manager for this patient) on 07/27/22 at 2:00 PM when questioned how she did not see the eschar on the wound she stated that she really did not see the wound. When asked how she could assess the wound, change the dressing and measure the wound if she could not see the wound, she stated she did the wound care superficially. She stated she could not roll the patient over so she only measured what she could see and changed the dressing on that part of the wound. She stated she never saw the entire wound. She stated she never assessed the legs or feet so was not aware of the pressure ulcer on the patient’s left foot. In further review of the Patient #2’s record it revealed that when the patient was admitted to the ALF her urine was malodorous. RN B, who did the Start of Care assessment, documented that she obtained a urine sample for UA and sensitivity. However, there was no documentation the chart of the results of the lab work or if the patient was started on an antibiotic. The documentation in the record noted on each visit that the urine had odor, sediment and mucus. In an interview with the Facility Manager of the ALF on 06/28/22 at 3:00 PM she stated that the odor coming from the patient’s room was very bad. She thought from a combination of the urine and the wound. She stated the patient was on an antibiotic shortly after arriving at the facility in June, but the urine never got better. In an interview with the Supervising Nurse (who was also the case manager for patient #2) on 07/29/22 at 2:15 PM she stated that she never called the physician about the continuing issue with the patient’s urine. She stated she asked the facility to notify the patient’s doctor when he came to the facility, but she didn’t know if they did. “According to medicalnewstoday.com, UTIs [urinary tract infections] are a common cause of white particles in the urine. UTIs occur when bacteria enter the urethra and make their way to the bladder, kidneys, or ureter, where they multiply and cause the infection. Less commonly, viruses, parasites, or fungi entering the urinary tract may cause a UTI. According to a 2018 review, Trusted Source, a UTI can cause discharge in both males and females and can cause white particles to appear in the urine. Other symptoms of UTIs include: pain in the abdomen or pelvis, an urgent need to urinate, pain while urinating, trouble urinating, cloudy or discolored urine, foul-smelling urine, fever or chills. Bacterial UTIs usually require antibiotics.” Review of the admission assessment completed by RN B on 06/24/21 revealed the nurse assessed the patient’s pain at 3, intermittent, tolerable, worse on movement, better on relaxation. Medication patient takes for pain OTC (Not on medication profile). Record review of skilled nurse visit notes throughout certification period revealed documentation of pain rated at 3 with movement and transfers making it worse. It was documented the patient takes OTC meds for pain management but no documentation of its effectiveness. Review of the PT reevaluation on 07/31/21 the PT documented “The patient c/o pain only with ROM she is unable to describe pain and rate pain. Pt yells during bed mobility and ROM. Pain is relieved by not moving.” In an interview with the Facility Manager at the ALF on 07/28/22 at 3:00 PM she stated that she thought the patient was suffering because of the pain and the wound. She stated that when the patient was moved in bed or transferred to the chair she would scream in pain. She stated the only thing they had to give was Tylenol for pain. She stated that she thought the agency nurse had asked the doctor for something more for pain and she wondered why he had not prescribed something. In an interview with the Supervising Nurse (who was the case manager for this patient) on 07/28/22 at 10:00 AM she stated that she assessed pain using the pain scale 0-10. When asked if the patient could answer her or understand her question, she stated that most of the time she just judged what the pain was by the patient’s expression. When asked if she talked to the ALF staff about how the patient responded to movement or the PT how the patient’s pain was during exercise, she stated she did not. Patients who have pain are often unable to self-report their pain placing them at increased risk for under-recognized and undertreated pain. Use if appropriate assessment tools such as the Nonverbal Pain Scale (NVPS), quantifies pain in patients unable to speak due to dementia, etc. and significantly enhances the likelihood of effective pain management and improved pain -related outcomes. [McGuire, Deborah B, PhD RN, Snow, Karen PhD RN; Pain Assessment in Non-Communicative Adult Palliative Care Patients. Nursing Clinics of North America Vol 51, Issue 3 September 2016, Pages 397-431] Review of Agency policy PE2. Patient Assessment read in part…, The SN and Therapist clinical progress notes will contain the following but not limited to: The history and physical exam pertinent to the day’s visit, objective measurements of physical outcomes of treatment…. The agency's policy manual did not include any policy on wound assessment or pain assessment and the Administrator / Supervising Nurse when asked if the agency had policies for Wound and Pain Assessment, stated she did not think so.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to provide wound care services in accordance with current clinical practice in that wet-to dry dressings were used for 1 of 2 patients reviewed (#2) with an infected wound and the wound infection worsened. This failure resulted in Patient’s #2’s wound deteriorating and likely contributed to her death. Findings include: Record review of Patient #2’s Plan of care for 06/24/2021-08/22/2021 revealed diagnoses of Essential Primary Hypertension, Dementia and Multiple fractures of ribs, fracture of shaft of clavicle and fracture of fifth lumbar vertebrae. The patient resided in an ALF. Review of the patient’s record revealed that she was non-verbal, and bed bound. Record review of the Skilled Nurse Visit Note dated 6/28/21 revealed documentation that read in part, “bedsore on coccyx is progressing in size”. The wound addendum documented a Stage 2 pressure ulcer measuring 2.2cm x 1.8 cm x .2cm. On this visit an order was obtained for wet to dry dressing daily. The order read: Wet to dry dressing daily. Wash with normal saline pat dry. In an interview 07/27/22 at 11:30 AM with the Supervising Nurse she stated that whenever the agency had a wound she would write an order for wet to dry dressing and send to the physician. The agency always used wet to dry unless the physician ordered another kind of dressing. When asked why she would choose wet to dry dressings over dressings that were the standard of practice and provided moist wound healing, she stated that she was most familiar with wet to dry. Record review of agency policy TX1 Standards of Practice read in part…The agency will provide patient care in accordance with the professional, acceptable standards of care and Agency’s policies and procedures. Review of agency Policy TX6 Plan of Care read in part... "Interventions to prevent pressure ulcers and pressure ulcer/injury treatment based on principals of moist wound healing." Review of the literature published in the last eight years strong support was found that advanced wound care dressing improved outcomes when compared to wet-to-dry dressings. Some of the outcomes compared were healing time, pain, infection rated and costs; several articles took it a step further stating the use of wet-to dry dressing is considered sub- standard practice. The articles provided evidence-based support for the use of moist wound healing. [Wodash, Aaron J. RN WCC Wet-to-Dry Dressings do not Provide Moist Wound Healing. Journal of American College of Clinical Wound Specialists v.4 (3) 2021 Sep.]