Every finding on record at Saint Francis Medical Center

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 11/02/2022. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

A partial extended survey for Medicare recertification for the home health provider was completed on 11/02/2022. The agency had 56 current patients. The COVID-19 Health Care Staff Vaccination regulation was reviewed as part of the Medicare recertification survey. During the survey one standard level deficiency was identified.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This ELEMENT is not met as evidenced by: Based on review of the agency’s current patient rights information and interview, the agency failed to provide the written notice of patient rights that included the patient’s right to have a copy of the patient’s rights and responsibilities and the agency’s transfer and discharge policies provided to a patient-selected representative within four business days of the initial evaluation visit. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the admission folder, provided by the director of home health on 10/31/2022, showed the notice of patient rights, and other information given to a patient during the initial visit, failed to contain information regarding the patient’s right to have a copy of the patient’s rights and responsibilities and the agency’s transfer and discharge policies provided to a patient-selected representative within four business days of the initial evaluation visit. The above findings were reviewed with the director on 11/01/2022 at 10:00 AM. Per an interview conducted during the review, the director stated that he/she also looked through the agency’s patient rights information and could not find anything regarding this particular right.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on policy review, review of the agency’s current patient rights information, and interview, the agency failed to provide the telephone number of the Federally-funded Quality Improvement Organization that serves the area where the patient resides. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Patient / Client Bill of Rights,” dated/reviewed 04/2022, showed: - The patient has the right to be advised of the names, addresses, and telephone numbers of the following Federally-funded entity: Quality Improvement Organization (QIO); - The policy failed to contain the telephone number for the QIO; and - The policy failed to contain the correct teletypewriter (TTY) number (used by people who cannot use a regular telephone due to hearing loss or speech impairment) (correct TTY number is (888) 985-9295). Review of the admission folder, provided by the director of home health on 10/31/2022, showed the notice of patient rights, and other information given to a patient during the initial visit, failed to contain the telephone number of the QIO (Livanta LLC [limited liability company]), and failed to have the correct phone number for the TTY. The above findings were reviewed with the director on 11/01/2022 at 10:00 AM. Per an interview conducted during the review, the director stated that he/she was not sure why the QIO’s telephone number was not included in the patient rights information and he/she would have gotten the TTY number from the QIO’s website and did not know why it was incorrect.

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 policy review, record review, and interview the agency failed to ensure a registered nurse or applicable rehabilitation skilled professional conducted an initial assessment visit within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician ordered start of care date in one (Record/Patient #2) record and failed to ensure a physician order was obtained for a delay in start of care in one (Record/Patient #5) of five full records reviewed. This deficient practice has the potential to affect the immediate care needs of all patients served by the agency. Findings included: Review of the agency’s policy titled, “Comprehensive Assessment / Resumption Of Care Following Inpatient Stay,” dated/reviewed 01/2022, showed “an comprehensive patient/client assessment will be performed within forty-eight hours of referral and within 48 hours of release from an inpatient facility.” RECORD/PATIENT #2: Review of the document titled, “Neurosurgery Established Visit,” showed: - The date of the office visit with the physician was 10/18/2022; - The time of the office visit was 11:00 AM; - The visit note stated that the patient was unable to attend outpatient physical therapy (PT) due to transportation issues and was requesting home PT; and - The visit note stated an order was placed for home health, pending review. Review of the document titled, “Ambulatory Referral to Home Health,” showed: - The order was dated 10/18/2022; - The order time was 12:52 PM; - The home health referral type is listed as “New Referral;” and - Disciplines/services requested are: Physical therapy (PT), occupational therapy (OT), and skilled nursing (SN). Review of the Outcome and Assessment Information Set (OASIS), showed: - The date the assessment was completed (M0090) was 10/25/2022; - Assessment currently being completed for the following reason (M0100) was answered as: Start of care; - Date of physician ordered start of care (M0102) was answered as: No specific start of care date ordered by the physician; and - The date of the referral (M0104) was answered as: 10/18/2022. During an interview on 11/01/2022 at 11:00 AM, the director stated that they did not receive the referral on 10/18/2022. If the referring practitioner enters the referral into their software system as “outgoing” the agency may not receive if for several days. They may receive it later but it will still have the original referral date on it. Stated that they should have called the practitioner and made them aware of when they received it and asked for an updated order. RECORD/PATIENT #5: Review of the physician office visit/referral showed it was sent to the agency on the evening of 07/26/2022. Review of a note dated 07/29/2022 at 7:45 AM, showed the patient care manager contacted the physician and patient that physical therapy (PT) would not be able to see the patient until 08/10/2022. The physician and patient agreed. Review of the PT OASIS (Outcome Assessment and Information Set, a federally mandated assessment) start of care assessment showed the date of physician ordered start of care was 08/08/2022. Review of the record showed no physician order for the delay in start of care. During an interview on 11/02/2022 at 10:05 AM, the patient care manager stated that he/she did not find a physician order for the delay but would expect there to be an order.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview the agency failed to ensure a nurse documented a review of the patient’s medications at the start of care in one (Record/Patient #5) of one record reviewed that received therapy services only. This deficient practice has the potential to affect all patients that received therapy services. Findings included: Review of the agency policy titled, “Drug Regimen Review,” revised/reviewed 01/2022, showed in part: - The nurse and/or therapist will review: *A patient’s medication list, allergies, and interactions via the electronic medical record; *Clinical record contents including laboratory and diagnostics may be reviewed as well; *Physician clinical notes may be reviewed; and *Other documentation to determine if any irregularities exist. - The clinician will determine whether or not clinically significant reactions exist between any medications or allergies the patient may have. Therapists may consult RN (registered nurse) for assistance in determining clinical significance; - The documentation of the drug regimen review will be marked by clicking the interactions check button in EPIC (software company for electronic health records); and - Irregularities detected that require immediate attention based on the clinical judgment of the clinician will be related by the nurse or therapist to the physician. RECORD/PATIENT #5: Review of the patient’s physician office visit note/referral dated 07/26/2022, showed the following medication orders in part: - Warfarin (blood thinning medication) 1 milligram (mg), take two tablets once daily; and - Warfarin 5 mg, take one tablet once daily or as directed. Review of the start of care OASIS (Outcome Assessment and Information Set, a federally mandated assessment) dated 08/08/2022, completed by the physical therapist (PT), showed: - The patient received high risk drug education and demonstrated good knowledge of the side effects of the warfarin (blood thinning medication) and tramadol (pain medication); and - No issues found during the drug regimen review. Review of the plan of care (POC) dated 08/08/2022 showed the following medication orders: - Warfarin 1 mg, take 2 mg in the evening; and - Warfarin 5 mg tablet, take 2.5 mg in the evening. The patient stated that he/she took two of the 1 mg tablets then half of the 5 mg tablets (unclear if this was in addition to the order for warfarin 1 mg, take 2 mg in the evening or if the patient took 2.5 mg total in the evening). Review of the record showed no documentation that a nurse reviewed the patient’s medications or clarification regarding the patient’s warfarin dose. During an interview on 11/01/2022 at 11:30 AM, the patient care manager stated that with therapy only cases, the therapist talks with him/her or one of the nurses to discuss the medications. If there are any questions or concerns, the nurse that reviewed the medications would call the physician. If it was needed they would send a nurse to the home. During an interview on 11/01/2022, at 12:15 PM, the patient care manager stated that the PT did talk with one of the nurses in passing about the patient’s medications, but the nurse did not document a note.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview the agency failed to ensure staff documented discharge planning in, but not limited to, one (Record/Patient #5) of two discharge records reviewed. Findings included: Review of the agency’s policy titled, “Discharge/Transfer Planning,” revised/reviewed 01/2022, showed in part: - During the initial assessment, the nurse/therapist provides information regarding the patient/client discharge potential at case conferences with other team members, as appropriate; - Home care personnel assist patients/clients regarding their discharge by: *Consulting with the patient/client and family/caregiver regarding the need for discharge or transfer from the agency; *Serving as a referral source for patient/client and family/caregiver in obtaining follow-up support services; and *Documenting the above information in clinical notes. -Patients/clients will not be discharged without appropriate preparation. The patient’s/client’s continuing care needs are assessed on an ongoing basis and at discharge. Information is provided to assist the patient/client in planning his/her discharge, including referral and transfer. RECORD/PATIENT #5: Review of the start of care OASIS (Outcome Assessment and Information Set, a federally mandated assessment) dated 08/08/2022, completed by the physical therapist (PT) showed in part: - Discharge potential was fair; and - Discharge plans was to discharge the patient to the care of family and physician. Review of the PT visit notes from 08/08/2022 through 09/02/2022 failed to show documentation that discharge planning was discussed with the patient. Review of the PT OASIS discharge assessment dated 09/09/2022 showed: - Discharge reason – Goals met; and - Discharge instructions included that the patient was instructed to continue his/her exercises one to two times a day and to walk for exercise. During an interview on 11/02/2022 at 10:30 AM, the patient care manager stated that he/she did not find documentation in the notes about discharge planning. He/she stated that they do talk about discharge planning during case conferences.

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 policy review, record review, and interview, the agency failed to ensure staff developed a complete/individualized plan of care (POC) in, but not limited to, four (Records #1, #2, #4, and #5) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency RECORD/PATIENT #5: Review of the start of care OASIS (Outcome Assessment and Information Set, a federally mandated assessment) dated 08/08/2022, completed by the physical therapist (PT), showed: - The patient received high risk drug education and demonstrated good knowledge of the side effects of the warfarin (blood thinning medication) and tramadol (pain medication); - Safety measures included bleeding precautions; and - No information regarding how and who managed the patient’s warfarin. Review of the POC dated 08/08/2022, showed no information regarding how and who managed the patient’s warfarin. During an interview on 11/01/2022 at 12:15 PM, the patient care manager stated that if the agency does not manage a patient’s warfarin, they make a note of who is managing on the front of the POC. Findings included: Review of the agency’s policy titled, “Care Coordination,” revised/reviewed 11/2021, showed in part: - The purpose is to ensure the coordination of services for each patient/client; - The agency will use a case management system to provide comprehensive, coordinated health care to patients/clients served by the agency; - The staff will coordinate its care of services with other involved organizations and individuals; and - Written evidence of care coordination will be found in the plan of care and/or case conference summary forms in the patient’s clinical record. Review of the agency’s policy titled, “Physician Orders Plans of Care,” showed in part: - All orders will be written according to agency policy, law and regulation; - The contents of the orders (plan of care) will include: * A description of the treatment and/or procedure to be done including type, frequency, and duration; * Who is to perform the treatment or procedure; and * A description of any medical, physical, psycho-social or environmental precautions or limitations that affect the implementation of the plan of care. RECORD/PATIENT #1: Review of the skilled nurse (SN) visit note, dated 09/02/2022, showed a narrative note that stated the patient was to follow-up at the wound center on 09/13/2022. Review of the plan of care (POC), dated 09/05/2022 to 11/03/2022, showed, in part: - An order for wound care and dressing changes each SN visit, three times a week; and - The POC failed to contain information that the patient goes to the wound center for treatment, the frequency the patient goes to the wound center, and that the patient receives wound care orders from the wound center physicians. During an interview on 11/02/2022, at 10:15 AM, the patient care manager confirmed that the patient does go to the wound center for treatment. The home health director stated that he/she would expect the POC to contain information that the patient was also receiving treatment at the wound center. RECORD/PATIENT #2: Review of the “Outcome and Assessment Information Set” (OASIS), dated 10/25/2022, and completed by the physical therapist (PT) showed: - The patient confirmed that they had pain; - The patient rated their current pain as a 10/10 using the numerical pain scale where “0” means you have no pain and “10” is the most severe pain imaginable; - The patient answered that pain interferes with activity or movement (M1242) as: “All of the time;” - The question, “Frequency of disruptive behavior symptoms (reported or observed) - Any physical, verbal, or other disruptive/dangerous symptoms that are injurious to self or others or jeopardize personal safety” (M1745) was answered as “Several times a week;” Review of the PT home visit note, dated 10/28/2022, the physical therapy assistant (PTA) documented, in part, the following: - The patient reported a 10/10 pain in the left arm, right ankle, right leg, sciatic nerve, and mouth; - The highest pain in the past 24 hours was a 10/10; - The lowest pain in the past 24 hours was a 10/10; - The patient’s pain goal was a 0/10; - The pain affects sleep and physical activity; and - The patient has an appointment with pain management that afternoon. Review of the occupational therapy (OT) evaluation note, dated 10/26/2022, showed in part: - The patient and daughter reported that they had not been able to get into see the pain management physician; - The patient and daughter did not recall having a visit from the physical therapist the day before; and - The patient appeared easily confused and gave conflicting information at times. Review of the POC, dated 10/25/2022 to 12/23/2022, showed; - The patient had a primary diagnosis of cervicalgia, exacerbation (worsening neck pain); - The patient had a diagnosis of chronic pain (lasting longer than six months); - The patient had physical, verbal, or other disruptive/dangerous symptoms that are injurious to self or others or jeopardize personal safety several times a week; - The patient has significant memory loss so that supervision is required; - An order to assess and monitor pain and to teach interventions to mitigate pain; - An order for acetaminophen (an over the counter pain reliever for mild pain) 500 milligrams every six hours as needed for mild pain; - The POC failed to contain any interventions related to the control of severe 10/10 pain or interventions for behaviors that made the patient a danger/injury risk to himself/herself or others; and - The POC failed to show: * The patient had a history of exaggerating his/her pain using the numeric pain scale; * The patient and daughter have a history of giving inconsistent reports of the patient’s condition; * The patient had been rejected for acceptance into the pain management center due to a history of poor compliance with the prescribed pain medication frequency. Observation during a home visit on 10/31/2022 at 2:45 PM, showed the patient greeted the clinician, surveyor, patient care manager and member of the agency’s quality improvement team at the door of his/her home dressed in a Halloween costume. The patient was laughing and speaking in a normal tone of voice and did not complain of pain, nor did the patient’s outward presentation suggest the patient was in severe pain. The patient completed his/her therapy session and was conversant with this surveyor. The patient had no complaints or concerns. During an interview on 11/01/2022 at 11:00 AM, the patient care manager stated that, when the initial assessment is performed by a physical therapist, any concerns that arise from the assessment are brought to the attention of the registered nurse (RN) or the patient care manager and they discuss the findings with the clinician and make the determination whether or not to send an RN out for a courtesy visit. He/she stated they did discuss this patient earlier that morning during their case conference. Regarding the answers given during the OASIS assessment, he/she stated that this surveyor saw what she was like at the home visit the day before and he/she tends to over-exaggerate his/her symptoms. The patient is known by the therapist and the physician and this is just how the patient behaves. He/she was unsure if this was ever documented in the clinical record but would look for a note. No further documentation was produced. During an interview on 11/02/2022 at 10:37 AM, the home health director stated that he/she would expect to see more documentation regarding any behaviors the patient felt made them a danger or injurious to him/herself or others along with follow up questions about the reported behaviors and pain. This patient had been rejected by the pain clinic because he/she would not take their pain medications appropriately in the past. The director would expect more explanation that the patient had a history of exaggerating their signs and symptoms and would expect documentation that the clinician educated the patient on the numeric pain scale or attempted to use a different pain scale to get a more accurate assessment. RECORD/PATIENT #4: Review of the skilled nurse SN visit note, dated 10/14/2022, showed a narrative note that stated: - The patient was seen by the wound center on Tuesday, 10/11/2022; - Orders were received for wound care three times a week; - The patient was to follow up with the wound center weekly on Tuesdays; and - The agency will see the patient twice a week on Mondays and Fridays. Review of the POC, dated 10/06/2022 to 12/04/2022, showed in part: - An order for wound care with dressing changes three times a week; and - The POC failed to contain information that the patient goes to the wound center for treatment, the frequency the patient goes to the wound center, and that the patient receives wound care orders from the wound center physicians. During an interview on 11/02/2022 at 10:15 AM, the director of home health stated that he/she would expect the POC to contain information that the patient goes to the wound center.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on review of the patient’s home health folder during home visit observation and interview, the agency failed to include the name and contact information of the home health agency’s clinical manager in, but not limited to, three (Records/Patients #1, #2, and #4) of three home visits conducted. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of the agency provided home health folder, during a home visit observation on 10/31/2022 at 1:00 PM showed the folder failed to contain the name and contact information of the agency’s clinical manager. During an interview immediately following the home visit, the patient care manager stated that he/she looked and could not find his/her name and contact information in the patient’s folder. The folder only contained the name and contact information of the director but they will get it fixed. RECORD/PATIENT #2: Review of the agency provided home health folder, during a home visit observation on 10/31/2022 at 2:45 PM showed the folder failed to contain the name and contact information of the agency’s clinical manager. Per an interview conducted during Patient #2’s home visit, the patient care manager stated that he had spoken via telephone with the director and his/her name and contact information is on the consent for treatment that the patient signs online and, if the patient requests a copy of the consent, then the agency will print a copy for them. He/she looked through the patient’s folder and pointed out a document that had a space for the clinical manager’s name and telephone number. Both spaces were left blank. RECORD/PATIENT #4: Review of the agency provided home health folder, during a home visit observation on 11/01/2022 at 1:30 PM showed the folder failed to contain the name and contact information of the agency’s clinical manager. Per an interview conducted immediately following the home visit, the patient care manager stated they will make sure they get the missing name and contact information in the patient’s home health folders.

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 Centers for Disease Control and Prevention (CDC) recommendations, policy review, home visit observation, and interview, the agency failed to follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases in, but not limited to, one (Record/Patient #2) of three home visit observations conducted. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the CDC guideline titled, “COVID-19, Strategies for Optimizing the Supply of Disposable Medical Gloves,” updated 12/23/2020, showed: - The purpose of the document was to offer a series of strategies or options to optimize supplies of disposable medical gloves in healthcare settings when there is limited supply; - Conventional capacity strategies for caring for suspected or confirmed COVID-19 patients include continuing the use of disposable medical gloves in accordance with standard and transmission-based precautions in healthcare settings and when indicated for other exposures such as handling cleaning chemicals; - Remind healthcare personnel about indications for when gloves are needed, as well as common care situations when gloves may not be needed; - CDC’s optimization strategies for glove supply offer a continuum of options for use when glove supplies are stressed, running low, or exhausted; and - Once glove and other personal protective equipment (PPE) supplies and availability return to normal, healthcare facilities should promptly resume conventional standard practices. Review of the agency’s policy titled, “Hand Washing,” revised/reviewed 01/2022, showed: - The purpose is to cleanse the hands of germs and prevent contamination between patients/clients and home care personnel; - Personnel providing care/service in the home setting will wash their hands: * Upon arrival for work; * Before and after each contact with the patient; * Before and after gloves are used; - When using an approved hand sanitizer; * Use the solution according to instructions; * Pay special attention to the nails and between the fingers; and * A no-rinse hand sanitizer is to be used when lack of proper facilities or a situation does not allow and when hands are not visibly soiled. Observations during a home visit on 10/31/2022 at 2:45 PM showed the occupational therapist (OT): - Donned gloves and obtained the patient’s vital signs; - Used alcohol based hand rub (ABHR) on the gloves; - Wearing same gloves, worked with patient on home exercises; - Used ABHR on the gloves; - Wearing same gloves, cleaned the equipment used to obtain vital signs; - Used ABHR on the gloves; - Wearing same gloves, adjusted the patient’s clothing and applied gait belt; - Used ABHR on the gloves; - Wearing same gloves, placed cleaned equipment back into nursing bag; - Wearing same gloves, walked with patient into kitchen to finish therapy; - Wearing same gloves, walked back into living room with patient; - Ended visit with patient, removed gloves and discarded them. During an interview on 11/01/2022 at 2:55 PM, the director of home health stated that his/her first question would be why was the OT wearing gloves to begin with? It was not appropriate for the OT to use the ABHR on the gloves and would not expect to see him/her sanitizing their gloves especially since they weren’t doing anything with the patient that necessitated the use of gloves. The director stated that if the therapist would have just sanitized his/her hands, they would have been fine. He/she also stated that the agency used vinyl gloves in the clinical setting. During an interview on 11/02/2022 at 10:50 AM, the accreditation and compliance manager stated they have reached out to Medline (brand and manufacturer of the gloves used by the agency) for any studies about the use of ABHR on gloves. The agency uses nitrile, not vinyl, gloves. The infection preventionist produced a document titled, “Effect of Multiple Alcohol-based Hand Rub Applications on the Tensile Properties of Thirteen Brands of Medical Exam Nitrile and Latex Gloves,” from the Journal of Occupational and Environmental Hygiene, dated 10/07/2016. The document refers to the CDC guidance for the disinfection of gloved hands during donning and doffing of PPE to protect health care workers caring for patients infected with Ebola virus. The study tests the tensile strength and properties of the gloves after application of ABHR. 13 brands of medical exam nitrile and latex gloves were tested from five manufactures. Medline was not one of the manufacturers tested. The accreditation and compliance manager stated that they were trying to find something to support the practice of disinfecting gloves with ABHR. It was something that was started during the COVID-19 pandemic and the resultant PPE shortages. It has been difficult getting the clinicians to stop the practice.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on policy review and interview, the agency failed to develop and implement policies and procedures that include a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency’s policy titled, “COVID-19 Vaccinations,” reviewed/revision date 10/03/2022, showed: - The policy’s purpose is to provide a consistent policy on the administration of the COVID-19 vaccine across the healthcare system in compliance with the Centers for Medicare & Medicaid Services (CMS) Omnibus COVID-19 Health Care Colleagues Vaccination Interim Final Rule; and - The policy failed to include a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19. An interview was conducted with the home health director, the accreditation and compliance manager and the infection preventionist on 11/01/2022 at 12:30 PM. All stated that the agency does not have any additional precautions in place for the unvaccinated staff but they will get the policy corrected.

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 policy review, record review and interview the agency failed to ensure staff provided ongoing interdisciplinary assessments/communication in one (Record/Patient #3) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Care Coordination,” revised/reviewed 01/2022, showed in part: - The process of care coordination will facilitate communication about changes in the patient’s/client’s status between assigned clinicians; and - Written evidence of care coordination will be found in the plan of care (POC) or case conference summary forms in the patient’s clinical record. RECORD/PATIENT #3: Review of the POC dated 10/16/2022, showed: - Principal diagnosis of chronic combined systolic and diastolic congestive heart failure (a condition where the heart does not pump blood as effectively as it should); and - Physical therapy (PT) one to two visits per week for three weeks; and - No vital sign parameters for reporting to the nurse and/or physician. Review of the PT note dated 10/28/2022 showed: - An alert for a pulse rate of 42; and - No documentation the pulse rate was rechecked or reported to the nurse. During an interview on 11/01/2022 at 3:00 PM, the director of home health stated that they do not have general parameters for vital signs. The vital sign alerts are built into their computer system. If they get an alert, the therapist would contact the nurse. The PT should have reported the patient’s pulse to someone.