Every finding on record at Maxim Healthcare Services Inc

Based on the findings of an unannounced state re-licensure and Medicare recertification survey conducted onsite 9/27/23 - 10/3/23 and completed offsite 10/10/23, Maxim Healthcare Services was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Based on the findings of an unannounced state re-licensure and Medicare recertification survey conducted onsite 9/27/23 - 10/3/23 and completed offsite on 10/10/23, Maxim Healthcare Services was found not to be in compliance with the following requirements of 42 CFR, Part 484.22, Subpart B and C, Conditions of Participation: Home Health Agencies.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on a review of clinical records (CR), agency policies and procedures, and employee interviews (EMP) the agency failed to follow the physician's ordered plan of treatment for four (4) of seven (7) clinical records reviewed (CRs 1, 4, 6, and 7). Findings included: Agency policy reviewed on 10/6/23 at approximately 9:00 am titled, " Wound Care ...Effective Date 10/10/2016 ...Revised Date 4/09/2021 " read as follows, "Purpose: ...1.1. To provide guidelines for the management of wounds in the home setting. 2. Policy: 2.1. Wound care shall be done in accordance with the ordering practitioner order ....2.3 Wound measurements shall be obtained and documented by the qualified clinician at least once each week .... Procedure: 4.1 Ordering practitioner orders for wound care shall be received and documented by the office clinical leader or clinical designee. ... 4.3. Weekly wound measurement will be completed by the qualified clinician. Documentation of wound measurement(s) will be noted and include a description of: 4.3.1 Wound size: length, width, and depth ... 4.3.6. Any development of undermining or sinus tract that may require packing ....4.4. Wound care documentation in the medical record or system of record shall include: 4.4.1. Procedure and type of dressing used ... 4.4.2 Patient ' s response to procedure ...4.4.3 Temperature and vital signs 4.4.4. Wound observations 4.4.5 Response of the wound to prescribed treatment ... " CR1, SOC 7/20/23, Certification Period Reviewed 7/20/23 - 9/17/23. CR1's Plan of Care for 7/20/23 - 9/17/23 was obtained onsite 9/27/23 and contained orders for Skilled Nursing services, "16 hours per day, 7 days per week Sunday-Saturday throughout the 60-day certification period" and "Terbinafine HCL 1% Topical cream...1 application Two Times Daily for Six Days Topical" and "Triamcinolone acetonide 0.5% topical ointment...1 application Three Times Daily for Six Days Topical." Topical medication orders did not specify site of application. CR1's Medication Administration Records (MAR) dated between 7/20/23- 9/28/23 were obtained onsite and reviewed 10/2/23. Between 7/20/23 - 7/29/23 BID scheduled Terbinafine remained undocumented from 7/20/23 until 8/6/23. A notation on MAR dated 8/6-8/12 reads "terbinafine...used in hospital D/C'd 8/8/23" CR7, Start of Care (SOC) 8/14/23, Certification Period Reviewed 8/14/23 - 10/12/23. CR7 ' s Plan of Care for 8/14/23-10/12/23 was obtained onsite 9/28/23 and contained orders for Skilled Nursing (SN) Wound Care as follows, " Left Ischium-Cleanse with Saline and pack with narrow strip of mesalt rope cover with dry dressing. change daily and PRN for soiling. ...Right Buttocks-Irrigate wound with Normal Saline, pack wound with Mesalt rope, cover wound with foam dressing daily and PRN for soilage. ... Apply Skin prep to heels Bilaterally daily and offload for pressure relief. ... " Plan of Care contained dressing orders for two wounds #1. Left Ischium, #2. Right Buttock as well as skin prep application to both heels. CR7 ' s Outcome and Assessment Information Set Home Health Patient Tracking Sheet (OASIS report) signed 8/17/23 contained a wound addendum listing three wounds: #1. Scar, Left, Posterior, Buttocks [not charted as a pressure ulcer] measuring Length " 0.02 cm " Width " 0.02 cm " #2. Pressure Ulcer, Right, Posterior, Buttocks, Stage 3, length 1.7cm x width 1.7cm and #3. Pressure Ulcer, Right Heel, Unstageable, 100% brown eschar. CR7 ' s Medication Administration Records (MAR) dated 8/20/23 - 9/9/23 were obtained onsite 10/2/23 and revealed the following scheduled orders for wound care: 1. " Skin Prep Wipes (1 application) Box Topical Two Times Daily Starting 08/14/2023 ...Order Date: 8/12/2023 ...Notes: Apply Skin Prep to Heels Bilaterally BID and off load heels to relieve pressure " 2. " Silvadene 1% topical cream (1 application) CREAM (GRAM) Topical Three Times Weekly Starting 08/14/2023 ...Order Date 8/14/2023 ...Notes: Apply M/W/F to left buttock pressure injury " 3. " Aquacel Hydrofiber Dressing 4 " X4 " (1 bandage) Bandage Topical Three Times Weekly starting 08/14/2023 ...Order Date: 8/12/2023 ...Notes: Apply Aquacel dressing after Silvadene on M/W/F " 4. "sodium chloride 0.9% (flush) injection syringe (1 application) Syringe (ML) Irrigate Every Morning Starting 08/14/2023 ...Order Date: 8/12/2023 ... Notes: Irrigate Right buttocks wound daily, Pack with Mesalt Rope dressing and cover with Foam dressing. May repeat PRN for soilage" A review of MARs Dated 8/20/23 - 8/26/23, 8/27/23 - 9/2/23, and 9/3/23 - 9/9/23 revealed physician orders for Silvadene 1% topical cream which was to be applied M/W/F to left buttock pressure injury were not documented as completed. In addition, Aquacel Hydrofiber Dressing 4 " x 4 " did not specify a site for application. A nursing note from 8/22/23 contained documentation which read: " Wound Interventions ...Time 13:00 ...Wound Care performed per physician orders: packing ribbon and optifoam used due to non-availability of silvadeen and aquacell. " Clinician wound care charting for 8/22/23 13:00 did not include corresponding updated physician orders for wound care. No updated orders permitting changes or substitutions to left buttock pressure injury wound order were provided by agency. A review of CR7 ' s Skilled Nursing Notes dated 8/14/23 to 9/15/23 did not provide weekly wound measurements as per agency policy for any wounds between the dates of 8/30/23 and 9/15/23. The right heel wound was documented as having a measurement of 1.7 cm x 1.7 cm and labeled a stage 2 pressure ulcer on 8/22/23. After the measurement on 8/22, Right heel wound measurements remained undocumented. The skilled nursing note dated 9/15/23 read " right heel dressed by another caregiver " no documentation of wound size was noted. CR6, SOC 9/9/04, Certification Period Reviewed 8/1/23 - 9/29/23. Agency policy reviewed 10/6/23 at approximately 10:30 am titled, " Intravenous Therapy and Venipuncture ...Effective date 01/11/2016 ...Revised Date 04/09/2021 " read as follows, " Purpose: ...To establish additional standards for administration of intravenous medications/solutions or performing venipuncture in the home ...5.9 All orders for IV medications and solutions include the name of the medication or solution, dosage, dilution, route, frequency of administration, rate of infusion and the volume of saline and heparin for flushes ... " CR6 ' s MARs dated 8/13/23 - 9/3/23 was obtained onsite 9/28/23 and contained orders for " Normal Saline Flush - Flush IV catheter [with] 10 ml before and after infusing each dose of medication as directed. Flush every 24 hours when not in use " and " Heparin 10 units/ml (5ml) push IV [with] 3-5 ml Heparin [after] last saline flush daily as directed. " CR6 MAR dated 8/13/23 - 8/19/23 documented, " IV Vancomycin 750mg/250ml every 12 hours via PICC line " given 8/17 at 0630 and 1830, then on 8/18 at 0630 and 1830, and 8/19 on 1830. MAR did not contain documentation of Normal Saline Flush or Heparin Flush for 8/17, 8/18, or 8/19. CR6 MAR dated 8/20/23 - 8/26/23 documented, " Vancomycin 750mg/250ml I.V. every 12 hrs via Picc line " given 8/21 630, 8/22 630, 8/23 645, 8/24 630, 8/25 630. MAR did not contain documentation of Normal Saline Flush on 8/21, 8/22, 8/23, 8/24, 8/25. CR6 MAR dated 8/27/23 - 9/2/23 documented, " Vancomycin 750mg/250ml every 12 hrs. via Picc line " given 8/28 630A, 8/29 930A, 8/30 645A, 8/31 645A, and 9/1 630A. MAR did not contain documentation of Normal Saline Flush on 8/28, 8/29, 8/30, 8/31, or 9/1. CR6 MAR dated 9/3/23 - 9/9/23 documented, " I.V. Vancomycin 750 mg/250ml every 12 hrs. via PiCC line " given 9/4 645A, 9/5 630A, 9/6 630A, 9/7 830A, 9/8 7A, 9/9 0830. MAR did not contain documentation of Normal Saline Flush between 9/4 - 9/9. Agency policy reviewed 10/6/23 at approximately 11:00 am titled, " Missed Shift/Visit ...Effective date 01/11/2016 ...Revised Date 04/09/2021 " read as follows, " Purpose: To ensure patient/client shifts are scheduled and completed according to the plan of care/plan of service. ...5.7. If at any time the services provided do not match the ordering practitioner order (or range of orders) as required by the plan of care, a Missed Shift/Visit Note and notification to the ordering practitioner is required. The medical record will include all documentation related to the missed shift including alternative care for the patient. " CR4, SOC 3/2/20, Certification Period Reviewed 8/14/23 to 10/12/23. CR4, Plan of Care for 8/14/23 - 10/12/23 listed Skilled Nursing Treatment as " Frequency and Duration Maxim Healthcare Services to provide skilled nursing services for 19 hours per day Monday through Friday and 17 hours per day Saturday and Sunday. " CR4, list of completed shifts dated 8/3/23 - 9/27/23 were reviewed and focused on the period between 8/14 - 9/14. Missed shifts were documented due to lack of caregivers on 8/18, 8/19, 8/20, 8/25, 8/26, 8/27, 9/1, and 9/2. The findings of missed visits and incomplete wound/medication documentation were discussed in a telephone exit interview with agency administrator, EMP1, on 10/10/23 at approximately 1:00 pm.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on a home visit observation (HV) the agency failed to follow accepted standards of practice to prevent the transmission of infections and communicable diseases for one (1) of three (3) home visit observations involving CR5. Observation #1. Findings included: Observation #1, CR5: Start of Care 11/28/22. Certification Period Reviewed (7/26/23 - 9/23/23). Surveyors attended a home visit for patient of CR5 conducted on 9/29/23 between approximately 10:00 to 10:30 AM accompanied by agency employees: EMP2, Clinical Manager to view skilled nursing visit performed by EMP6, LPN. During the visit the surveyor observed EMP6 performing a patient assessment with vital signs using a stethoscope. EMP6 did not clean the stethoscope prior to placement into the carrying case. Findings of the home observation visit and infection control procedures for cleaning of equipment were discussed with EMP2, clinical coordinator, after the home visit on 9/29/23 at approximately 10:30 am.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on a review of agency policy, job descriptions, clinical records (CR), and employee interviews (EMP) the agency did not provide ongoing interdisciplinary assessment of the patient for one (1) out of seven (7) clinical records reviewed. CR7. Findings include: Agency policy for Suprapubic Catheter care reviewed 10/10/23 at approximately 9:00 am noted, "Potential problems associated with suprapubic catheters...c. Bladder spasms ... d. Leakage around the catheter ...f. Bladder stone formation...Aftercare: Document in the patient's record: ...Communication with physician, as indicated..." CR7, Start of Care (SOC) 8/14/23, Certification Period Reviewed 8/14/23 - 10/12/23. CR7's Plan of care for 8/14/23-10/12/23 was obtained onsite 9/28/23 and contained orders for Skilled Nursing, "Suprapubic Catheterization Change 22 French catheter, 4-5 ml balloon, every 30 days and as needed for catheter dislodgement/dysfunction using same size or one size smaller." CR7's Skilled Nursing Notes on 9/6, 9/11, 9/12, 9/13, and 9/19, noted leakage of urine from urethra. Last date of suprapubic catheter change was noted at 9/7/23. Note from 9/13/23 under "Wound" Assessment reads, "Right Ischial [pressure wound] ... Stage 3 deteriorating...macerated...wound is hard to keep dry and dressed due to urine leakage..." Agency policy reviewed 10/10/23 at approximately 9:00am titled, "Care Coordination/Case Conference...MD-CL-018.7...Effective Date: 07/11/16...Revised Date: 10/07/2022" reads, "2. Purpose: 2.1. To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services...5. Procedure: 5.1. Direct Care Staff shall communicate changes in patient status amongst the assigned personnel and the office clinical leader or clinical designee. 5.2. Direct Care Staff will communicate changes in a timely manner via telephone, one-on-one meetings, case conferences and/or home visits. Documentation of communications will be included in the medical record on a communication note, case conference note, clinical visit note, supervisory visit note or in the system of record." Agency policy reviewed 10/10/23 at approximately 9:00 am titled, "Job Title: Registered Nurse - Homecare...Essential Duties and Responsibilities...Initiates the plan of care when directed and requests from prescriber any necessary revisions as patient status and needs change...Intervenes as applicable in response to changes in patient/client condition and reports such changes to appropriate physician or supervisor..." No noted documentation in Skilled Nursing Note dated 9/13/23 of communication to clinical supervisor or prescribing physician of wound deterioration or continued catheter dysfunction. Upon request of "case conference notes" surveyor was supplied with "Clinical Meeting" notes. Clinical meeting notes from 09/20/23 did not provide information on ongoing interdisciplinary assessment for CR7. During exit telephone interview on 10/10/23 at approximately 1:20 pm EMP1, administrator, was notified of potential finding related to CR7.

Based on the findings of an unannounced onsite complaint investigation completed on July 28, 2022, Maxim Healthcare Services, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of agency policy and procedure, job description, clinical records (CR), and interview with staff (EMP), the agency failed to follow the physician's ordered plan of care for one (1) of three (3) clinical records reviewed (CR1). Findings included: Review of Licensed Practical Nurse agency job description on 7/28/22 revealed: Job Title: Licensed Vocational Nurse (LVN).Licensed Practical nurse(LPN)…assumes responsibility and accountability for the application of the nursing process and the delivery of patient/client care…Essential Duties and Responsibilities…Notifies Director/Supervisor if applicable on the following:…physician notification to obtain necessary orders for interventions…Changes in patient/client condition…Communicates observations and significant changes in patient status to the Director of Clinical Services and/or Clinical Supervisor/case Manager or licensed designee…Documents all physician collaboration/coordination… Essential Duties and Responsibilities…Performs interventions, treatments, and medication administration, according to identified priorities, plan of care, facility policies and patient outcome standards as applicable… Review of agency policies on 7/28/22 revealed: Subject: Wound care…Procedure…Weekly wound measurement will be completed by the qualified clinician. Documentation of wound measurement will be noted and include a description of…Wound size: Length, width, and depth…Wound bed tissue…Evidence of wound healing…Drainage characteristics…symptoms of infection…development of undermining… Review of clinical records (CR) on 7/28/22 at approximately 10:00 AM revealed: CR1, start of care 1/10/17, certification period 4/14/22 to 6/12/22, revealed the following: Plan of Care (POC) “…Medications…Oxygen 1 – 6 lpm (liters per minute)…Titrate from 1 – 6 lpm to maintain oxygen saturations 92% and above…Orders for treatment Skilled Nursing (SN)…7 – 12 hours per day, 4 – 7 days per week throughout the 60 day certification period (LPN Start time schedule for period was 6:00 AM)…Vital Signs:..every shift and as needed for changes in condition. Notify physician for temperature…greater than 101F (Fahrenheit)…Pulse…greater than 120 sustained for 15 minutes, respiratory rate…greater than 32 sustained for 15 minutes…Oxygen, Report signs and symptoms of decreased saturation not resolved per interventions as ordered by physician…Maintain saturation equal or greater than 92 % percent with interventions prescribed…encourage …cough, nebulizer treatment, administer oxygen…Wound Care Sacral pressure ulcer – Wash with soap and water. Apply barrier cream to wound edges, pack with silver aquacel and cover with bordered foam dressing. Change dressing three times a week or as needed…” Nursing flow sheet visits for period reviewed revealed the following: 4/15/22, Vital Signs…9:00 AM…O2 (oxygen) saturations (level), 90%. 4/21/22, Vital Signs…5:50 AM…O2 saturations, 91%. Narrative…10:00 AM…Admin (administered) Nebulizer tx (treatment). 4/26/22, Vital Signs…5:55 AM…O2 saturations, 91%. 4/28/22, Vital Signs…5:45 AM…O2 saturations, 91%. 5/2/22, Vital Signs…6:05 AM…O2 saturations, 91%. 5/5/22, Vital Signs…6:10 AM…O2 saturations, 91%. Narrative…9:00 AM…Admin albuterol and nebulizer treatments. 5/9/22, Vital Signs…6:05 AM…O2 saturations, 91%. 5/10/22, Vital Signs…6:45 AM…O2 saturations, 91%. 5/12/22, Vital Signs…6:05 AM…O2 saturations, 90%...7:15 AM…O2 saturations 91%. 5/13/22, Vital Signs…6:05 AM…O2 saturations, 91%. 5/16/22, Vital Signs: 6:00 AM, Temperature 102.3, Pulse 134, Respirations 60, blood pressure 90/55, O2 saturations 68%...7:00 AM, Temperature 99.7, Pulse 114, Respirations 48…O2 saturations 89%, 5L (5 lpm O2)…8:00 AM, Temperature 99.1, Pulse 106, Respirations 40…O2 saturations 91%, 5L. Respiratory: (boxes checked)…Labored…Tachypneic…Rhonchi…Cough: N/A…Secretions: N/A…Oxygen: 5 L/min via…NC (nasal cannula)…Mask… Physician Notified: Yes…12:15 PM [by family member]…Orders received: Yes… There was no further documentation identified on above nursing visit flow sheets of interventions and/or additional assessments of patient O2 saturations to maintain oxygen saturation levels equal to or greater than 92% per POC physician order on above noted flow sheets from 4/15/22 to 5/13/22. There was no documentation of SN notifying physician of patient change in condition related to vital signs out of parameters per the POC during SN visit on 5/16/22 between 6:00AM (start of shift) and 12:15 PM (documented time physician notified of change in condition by family member). Nursing flow sheet wound care (sacral pressure ulcer) reviews for certification period reviewed revealed the following: Week 4/17/22 – 4/23/22: There was a wound measurement documented for “coccyx…6 x 7 cm…” on 4/18/22. Length x Width x Depth was not disseminated. Week 4/24/22 – 4/30/22: There was a wound measurement documented for “coccyx…6 x 6 cm…” on 4/24/22 and a wound measurement documented for “coccyx…7 x 5 cm…” on 4/26/22. Length x Width x Depth were not disseminated. Week of 5/1/22 – 5/7/22: There was a wound measurement documented for “coccyx…6 x 6 cm…” on 5/13/22. Length x Width x Depth was not disseminated. There were no weekly wound measurements documented on 5/3/22, 5/5/22, or 5/6/22 for the wound care treatments. Additionally, a narrative note that documented “…treated wound area…” on 5/6/22, wound care assessment treatment section did not document wound bed assessment. Week of 5/8/22 – 5/14/22: There was a wound measurement documented for “coccyx…6 x 6 cm…” on 5/13/22. Length x Width x Depth was not disseminated. SN visits wound care interventions did not include complete documentation on visit flow sheets in accordance with agency wound care policy and procedure (measurements/wound assessment) for certification period reviewed. An exit conference was conducted on 7/28/22 at approximately 2:40 PM with agency clinical manager (EMP3) and business manager (EMP7). Above findings were reviewed.

Based on the findings of an unannounced onsite complaint investigation completed on May 28, 2021, Maxim Healthcare Services, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of agency policy and procedure, clinical records (CR), and interview with staff (EMP), the agency failed to follow the physician's ordered plan of care for one (1) of two (2) clinical records reviewed (CR1). Findings included: Based on review of agency policy and procedure, clinical records (CR), and interview with staff (EMP), the agency failed to follow the physician's ordered plan of care for one (1) of two (2) clinical records reviewed (CR1). Findings included: Review on 5/28/2021 at approximately 10:00 AM of CR1 revealed the following: Start of Care 10/30/2020, Certification period 2/272021 to 4/27/2021 ...Plan of Care (POC) " Orders for Discipline and Treatments ...Skilled Nursing (SN) ...84 - 140 hours per week for 60 days ...TREATMENTS ...Change trach ties (Bands around the neck that attach to a tracheostomy tube to hold in place) daily and as needed for soiling ...Goals/Rehabilitation Potential/Discharge Plans ...Patient ' s ADL/IADL care needs will be met safely in the home by agency discharge ... " " Treatment/Order Update/Change in Condition ...Begin Date: 4/27/2021 End Date: Discharge ...Discharge client from ...services effective 4/27/2021 ...(signed by patient physician) 4/29/2021 ... " Review of SN visits (Sunday - Saturday/shifts 8am - 6pm and 10pm to 8am) " NURSING FLOW SHEETS " from 3/19/2021 to 4/27/2021 revealed the following: SN visits conducted from 3/19/2021 to 3/26/2021 and 4/1/2021 to 4/9/2021 flow sheets contained section labeled " RESPIRATORY ...Tracheostomy tie changes ... " with the word " Daily " written in the blank underlined space after the word " changes " . " NURSING FLOW SHEETS " for 8am to 6pm shift dated on 3/23/2021, 4/7/2021, and 4/9/2021 documented tracheostomy tie changes completed in the " Nursing documentation " narrative section of flow sheets. Surveyor was unable to discern that tracheostomy tie changes were completed daily for the other SN visits for periods reviewed. CR1 review of agency SN visit time records revealed that no SN visits were completed from 4/10/2021 through 4/27/2021 (date of physician ordered discharge). Agency documentation noted each missed visit from 4/10/2021 to 4/27/2021 as " ...Status: canceled ...Reason: Admission Hold ... " Agency " Care Coordination Note " dated 4/12/2021 documented " [Family member] informed on Friday [4/9/2021] evening (6:20p) that nursing services were suspended indefinitely due to issues in the home. " There was no documented evidence identified of agency providing a resolution for patient CR1 for above missed visits/shifts nor was there evidence identified that agency provided timely resolution with patient CR1 service coordination for above missed visits/shifts prior to discharge. An exit conference was conducted at approximately 2:20 PM on 5/28/2021 with agency administrator (EMP1) and agency nursing supervisor (EMP4). Above findings were reviewed.

Based on the findings of an unannounced onsite complaint investigation survey completed January 12, 2021, Maxim Healthcare Services, Inc. was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Based on the findings of an unannounced onsite complaint investigation completed on January 12, 2021, Maxim Healthcare Services, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

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 may choose to include. This ELEMENT is not met as evidenced by: Based on review of agency policy and procedure, clinical records (CR), and interview with staff (EMP), the agency failed to specify frequency of services and frequency of visits for skilled nursing services on the individualized plan of care for three (3) of three (3) clinical records reviewed (CR1, CR2, CR3). Findings included: Review of agency policies on 1/12/21 at approximately 11:00 a.m. revealed: Policy-Home Health Certification and Plans of Care, #3. Policy: 3.1.1 The Plan of Care will be individualized to include, but not limited to, all treatments, procedures, medications and services authorized to be provided by direct care staff. #5. Procedure: 5.3 The Plan of Care shall include, but not limited to: 5.3.7 Description of orders of discipline and treatments (specify the amount, frequency and duration). Policy- Confirmation of Supplemental Physician Orders, #3 Policy: 3.1.1 Revisions to the plan of care due to change in patient health status will be communicated to the patient, representative (if any), caregiver and all physicians issuing orders for the Home Health Agency plan of care. #5. Procedure: 5.2 The physician order will include, but not limited to the following: 5.2.6.1 For care, treatment and/or service: 5.2.6.1.2. The frequency and duration of the care, treatment and/or service. Review of clinical records completed on 1/12/2021 between approximately 10:00 a.m. and 11:00 a.m. revealed the following: CR1, Start of Care (SOC): 7/16/2020, certification period: 9/14/2020-11/12/2020. Primary Diagnosis: Muscular Dystrophy (a group of diseases that cause progressive weakness and loss of muscle mass). Physicians Orders: Frequency and Duration...to provide skilled nursing services (RN/LPN) authorized as follows: 33.5-56 hours per week throughout the 60 day certification period. The order failed to specify the amount, frequency and duration for nursing services to be provided. CR2, SOC: 8/31/2020, certification period: 8/31/2020-10/29/2020. Primary Diagnosis: Exomphalos (a type of abdominal wall defect). Physician orders: Frequency and Duration...to provide skilled nursing services 57-96 hours per week for 60 days. The order failed to specify the amount, frequency and duration for nursing services to be provided. CR3, SOC: 10/24/14, certification period: 7/20/2020-9/17/2020. Primary Diagnosis: Epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). Physician orders: Frequency and Duration...to provide skilled nursing services for 64-106 hours per week throughout the 60 day certification period. The order failed to specify the amount, frequency and duration for nursing services to be provided. Exit conference was conducted on 1/12/2020 at approximately 1:00 p.m. with agency Director of Business Operations (EMP1) directly and Clinical Manager (EMP2) via phone and above findings were confirmed.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician orders. This STANDARD is not met as evidenced by: Based on review of agency policy and procedure, clinical records (CR), and interview with staff (EMP), the agency failed to follow the physician's ordered plan of care for three (3) of three (3) clinical records reviewed (CR1, CR2, CR3). Findings included: Review of agency policies on 1/12/21 at approximately 11:00 a.m. revealed: Policy-Home Health Certification and Plans of Care, #3 3.1.1 The Plan of Care will be individualized to include, but not limited to, all treatments, procedures, medications and services authorized to be provided by direct care staff. Policy- Confirmation of Supplemental Physician Orders, #3 3.1.1 Revisions to the plan of car due to change in patient health status will be communicated to the patient, representative (if any), caregiver and all physicians issuing orders for the Home Health Agency plan of care. Review of clinical records completed on 1/12/2021 between approximately 10:00 a.m. and 11:00 a.m. revealed the following: CR1, Start of Care (SOC): 7/16/2020, certification period: 9/14/2020-11/12/2020. Primary Diagnosis: Muscular Dystrophy (a group of diseases that cause progressive weakness and loss of muscle mass). Physicians Orders: Oximeter -Finger Pulse Oximeter (device that measures oxygen in the blood): Obtain O2 (oxygen) saturations three times a day, AM, Noon and at 4 PM. Review of Nursing Flow Sheets revealed the following: 9/25/2020 No documentation of O2 saturations for 12:00 p.m. and 4:00 p.m. 10/2/2020 No documentation of O2 saturation for 4:00 p.m. 10/5/2020 No documentation of O2 saturations for 12:00 p.m. 10/10/2020 No documentation of O2 saturation for 12:00 p.m. 10/11/2020 No documentation of O2 saturations for 12:00 p.m. and 4:00 p.m. 10/16/2020 No documentation of O2 saturation for 12:00 p.m. 10/18/2020 No documentation of O2 saturation for 4:00 p.m. 10/19/2020 No documentation of O2 saturations for 12:00 p.m. and 4:00 p.m. 10/21/2020 No documentation of O2 saturations for 12:00 p.m. and 4:00 p.m. CR2, SOC: 8/31/2020, certification period: 8/31/2020-10/29/2020. Primary Diagnosis: Exomphalos (a type of abdominal wall defect). Physician orders: Oxygen: report signs and symptoms of decreased saturation not resolved per interventions as ordered to physician. Oximeter: obtain O2 saturation every shift and as needed for respiratory distress. CR2 no documented evidence of physician orders for parameters for O2 saturations, when to notify the physician or physician order specifying amount of oxygen. Physician orders: Chest physical therapy (PT) (airway clearance technique to drain the lungs, and may include percussion (clapping))...every morning and as needed for increased congestion. No documented evidence that Chest PT was performed 10/2/2020 and 10/3/2020. Physician orders: Enteral Feedings (nutrition taken through a tube that goes directly to the stomach or small intestine) Pediasure 22 cal: Mix 790 ml (milliliters) Pediasure with 320 ml of tap water (total 1100 ml/day). Administer feedings six times daily (9 am, 1pm, 5pm, 1am, 6am). Rate: 185 ml/hr for each feeding. Review of Nursing Flow Sheets revealed the following: 10/2-3/2020 Pediasure 1140 ml daily. 10/3-4/2020 Pediasure 1140 ml daily. 10/4-5/2020 Pediasure 1140 ml daily. CR3, SOC: 10/24/14, certification period: 7/20/2020-9/17/2020. Primary Diagnosis: Epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). Physician orders: Brace- Apply soft hand brace/splint to both hands/wrists daily and as directed by Mother and as client tolerates, during waking hours. Review of Nursing Flow Sheets revealed the following: 7/30/2020 No documented evidence that brace was applied. 8/10/2020 No documented evidence that brace was applied. 8/12/2020 No documented evidence that brace was applied. 8/17/2020 No documented evidence that brace was applied. 9/16/2020 No documented evidence that brace was applied. Exit conference was conducted on 1/12/2020 at approximately 1:00 p.m. with agency Director of Business Operations (EMP1) directly and Clinical Manager (EMP2) via phone and above findings were confirmed.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on review of agency policy and procedure, clinical records (CR), and interview with staff (EMP), the agency failed to ensure staff who provided care, directly or under arrangement were coordinating all identified patient concerns and patient progress toward the goals of the plan of care with others involved in the patient's care for one (1) of three (3) clinical records reviewed. (CR2). Findings Included: Review of agency policies on 1/12/21 at approximately 11:00 a.m. revealed: Policy-Home Health Certification and Plans of Care, #3. Policy: 3.1.1 The Plan of Care will be individualized to include, but not limited to, all treatments, procedures, medications and services authorized to be provided by direct care staff. #5. Procedure: 5.3 The Plan of Care shall include, but not limited to: 5.3.7 Description of orders of discipline and treatments (specify the amount, frequency and duration). Policy- Confirmation of Supplemental Physician Orders, #3 Policy: 3.1.1 Revisions to the plan of care due to change in patient health status will be communicated to the patient, representative (if any), caregiver and all physicians issuing orders for the Home Health Agency plan of care. #5. Procedure: 5.2 The physician order will include, but not limited to the following: 5.2.6.1 For care, treatment and/or service: 5.2.6.1.2. The frequency and duration of the care, treatment and/or service. Review of clinical records completed on 1/12/2021 between approximately 10:00 a.m. and 11:00 a.m. revealed the following: CR2, SOC: 8/31/2020, certification period: 8/31/2020-10/29/2020. Primary Diagnosis: Exomphalos (a type of abdominal wall defect). Review of agency documentation revealed a concern expressed from mother of CR2 regarding wrong ventilator (a machine that provides mechanical ventilation by moving breathable are into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe or breathing insufficiently) settings. Interviews with the Clinical Manager and the Director of Business Operations on 1/12/21 at approximately 12:45 p.m. indicated that the Durable Medical Equipment (DME) company set up the ventilator and followed the discharge instructions from the hospital. Review of CR2 revealed no documented evidence of clarification of the orders with CR2 physician and no evidence of case coordination with the care team with updates to the plan of care accordingly. Agency provides services for CR2 as well as another agency (agency #2). A nurse from agency #2 noted the ventilator settings were not correct. The DME company was contacted and returned to the home and adjusted the settings. CR2 oxygen saturations decreased and was admitted to the hospital. Exit conference was conducted on 1/12/2020 at approximately 1:00 p.m. with agency Director of Business Operations (EMP1) directly and Clinical Manager (EMP2) via phone and above findings were confirmed.