Every finding on record at American Nursing Home Health Care, Inc

A Medicare recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs from 1/24/23 through 1/27/23 at: American Nursing Home Health Care 6049 19 MILE RD STERLING HEIGHTS, MI 48314 At the survey's conclusion, the agency was found to be out of compliance with standard level deficiencies for the conditions of participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to include an individual Emergency Preparedness (EP) plan for each patient as part of the comprehensive assessment for 2 of 7 records (MR# 3, 4) reviewed, resulting in the potential lack of patient care and appropriate response during an emergency. Findings include: MR #3: The start of care (SOC) was dated 3/2/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered that the patient's individualized EP plan had the patient's name and what level triage they were. The contact names, phone numbers and additional information areas were all blank. It is unclear how the limited information on the EP plan would help in an emergency situation. MR #4: The SOC was dated 10/21/2022. The POC identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. PT was ordered for a frequency of 2w4. During record review on 1/26/2023, it was discovered that the patient's individualized EP plan had the patient's name and what level triage they were. The contact names, phone numbers and additional information areas were all blank. It is unclear how the limited information on the EP plan would help in an emergency situation. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to provide initial training in emergency preparedness policies and procedures, including contract employees, and failed to maintain documentation of training, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 1/27/2023, 7 random employee files were reviewed. During the review it was discovered that 4 of the 7 employees (All contracted staff) had no emergency preparedness initial or ongoing training documented in their files. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

A Medicare recertification survey was conducted on 1/24/2023 to 1/27/2023 by the department of Licensing and Regulatory Affairs at: American Nursing Home Health Care 6049 19 Mile Road Sterling Heights, MI 48314 At the time of the survey, the agency did not operate any branch offices. For this survey, two active records were reviewed with one home visit and five discharge records were reviewed for a total of seven records reviewed. The agency had two active patients at the time of the survey. The agency was determined to not be in compliance with the Covid-19 Vaccine requirement for Home Health Agencies. Condition level deficiencies were noted at: 42 CFR§484.58 Discharge Planning 42 CFR§484.60 Care Planning, Coordination, Quality of Care 42 CFR§484.70 Infection Prevention and Control 42 CFR§484.105 Organization and administration of services 42 CFR§484.110 Clinical Records As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a home health aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80 (f)(3).

Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This ELEMENT is not met as evidenced by: Based on documents reviewed, policy review, and interview, the agency failed to ensure patient complaints were documented, investigated, and included actions and resolutions. Findings included: **Agency Policy: "Client Grievance", no date. The policy states, "The Privacy Officer will be responsible for documenting all client complaints and the disposition of the complaints. This documentation must be kept for a period of at least six years. On 1/24/2023 at 1:00 p.m., the Administrator was asked to provide a copy of the agency's complaint policy and Logged Complaints received by the agency. Upon review of the agency's complaint log, it was noted the notebook contained 3 "Patient Satisfaction Surveys", and 6 "Complaint Log Sheets" for Quarters 3 and 4 of 2020, and Quarters 1,2,3, and 4 of 2021. There were no Complaint Log Sheets in the notebook for the year 2022. All of the sheets were blank except for "NONE" or "NO COMPLAINTS THIS QUARTER" handwritten across the blank log sheets. It was noted the 3 Patient Satisfaction Surveys found in the Complaint Log Notebook were for different patients, but the handwriting was the same on each sheet. The policy states "all documentation of complaints must be kept for 6 years", yet the complaint logs only included the years 2020 and 2021. There were no further complaints logged for years 2022, and no complaint logs for 2018 or 2019. The agency failed to maintain complaint logs that documented complaints and their resolutions and failed to maintain the complaint logs for 6 years as required per agency policy. These findings were reviewed and acknowledged by the Administrator (ADM-A) and Director of Nursing (DON-B) during an interview on 1/27/2023 at 3:00 p.m.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to allow the patient to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to any changes in the care to be furnished in 1 of 7 records (MR# 3) reviewed. Findings included: MR #3: The start of care (SOC) was dated 3/2/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered that the patient's consent to treat form had a very clear patient signature. However, the consent was too blurry to read. There is no possibility the patient was able to tell what they were signing. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings and said they did not understand why a clinician would have had the patient sign the unreadable document. MR#1: The Start of Care (SOC) was dated 11/18/2022. the Plan of Care (POC) for the certification period of 11/18/2022 to 1/16/2023 identified diagnoses of Diabetes Type 2 (DM2), Hypertensive Heart Disease, Osteoarthritis, and low back pain. Upon review of the record, it was noted a signed document titled, "Patient Transfer Request." The document was signed by the patient and dated 11-18-2022, the date of admission. The language on the Transfer Request was as follows: "I__________ am having Home Health services provided by American Nursing Home Health Care, and requesting a Transfer of Provider effective______. I understand that my decision to transfer to American Nursing Home Health Care, Inc., means that my first home health care agency will no longer provide services to me and after the date of my transfer request that my first home health care Agency will no long receive payment from Medicare on my behalf for any services provided after the transfer date. Furthermore, I give my permission to release this information to any party requesting it. ____________(Patient Signature)." (sic). During an interview with the Administrator on 1/24/2023 at 3:00 p.m., the Administrator was asked to explain the purpose of this form and why this form is signed on the date the patient was admitted to the agency? The Administrator's response was, "We use it when the patient wants to be transferred to our agency." The Administrator was queried if this home-made form developed by this agency is provided to all the patients upon admission? The response was, "yes." ADM-A was further queried if it would be more legally appropriate to have the form signed and dated on the day the patient is actually requesting a transfer to the agency? There was no response to this question. The agency failed to allow the patient to participate, be informed to consent or refuse care with respect to any changes in the care to be furnished.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to provide information to the patient of the amount the patient may need to pay for services in 1 of 5 (MR#2) discharged records reviewed. Findings included: MR#1: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. Upon review of the record, the Home Care Consent and Admission Service Agreement was reviewed. The section titled "Assignment of Benefits" failed to indicate the amount the patient may be responsible to pay for services provided by the agency. That area of the document was blank; thus, the patient was not informed in advance of the amount the patient may need to pay for home health care services. This finding was reviewed and acknowledged during an interview with the Administrator (ADM-A) and Director of Nursing (DON-B) on 1/27/23 at 3:00 p.m.

Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This ELEMENT is not met as evidenced by: Based on record review and interview, the Skilled Nurse failed to determine eligibility for the Medicare home health benefit, including home bound status in 2 of 7 (MR#2, 3) records reviewed, resulting in patients receiving unqualified home health benefits as required by Medicare. Findings included: MR #3: The start of care (SOC) was dated 3/2/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered upon review of the POC dated 3/3/22, under "Category Item 99: Homebound", the following, "Patient is not homebound" was documented. In addition, a review of the Comprehensive Assessment dated 3/2/2022 under the Category of "Home Bound Reason/Homebound Status, the Registered Nurse (RN#J) documented, "Patient is not homebound." During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings. MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. Upon review of the POC, it was noted under "Category Item 99: Homebound", the following documentation, "Patient is not homebound." In addition, a review of the Comprehensive Assessment dated 3/2/2022 under the Category of "Home Bound Reason/Homebound Status, the Registered Nurse (RN#J) documented, "Patient is not homebound." This finding was reviewed and acknowledged by the Administrator (ADM-A) and Director of Nursing (DON-B) during an interview at 3:00 p.m. on 1/27/23.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status including base line data and measurements, the patient's past medical history that included dates of onset, treatments and outcomes, history of events leading to the need for current home care services and the referral date in 2 of 7 records reviewed (MR#s 1 and 2), resulting in incomplete clinical information to aid in determining the needs of the patient, and to aid in creating individualized patient specific goals to address the patient's individualized needs. Findings included: MR#1: The Start of Care (SOC) was dated 11/18/2022. The Plan of Care identified diagnoses of Diabetes Type 2 (DM2), Hypertensive Heart Disease, Primary Osteoarthritis of right and left side, and Low Back Pain. The patient was receiving nursing services 1 times a week for 3 weeks. Upon review of the comprehensive assessment, dated 11/18/2022, it was noted there were no normal ranges for the patient's diabetes on the Comprehensive Assessment to use as a baseline measurement for future assessments to determine blood sugar ranges outside the patient's normal ranges. MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. This patient was admitted to the agency after a hospitalization for gall stone surgery. Upon review of the record, it was noted at the SOC assessment dated 3/2/2022 identified a surgical wound located on the lower abdomen. However, there was no measurement of the wound, or description of the wound to determine if the wound was healing or without infection. These findings were reviewed and acknowledged with the Administrator (ADM-A) and Clinical Manager (CM-B) during an interview on 1/27/23 at 3:00 p.m.

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 record review and interview, the agency failed to ensure a registered nurse performed a comprehensive drug review in 5 of 7 (MR# 3, 4, 5, 6 & 7) sample records reviewed in which therapy only cases were ordered, resulting in the potential for undetected harmful medication side effects or interactions. Findings include: Agency policy titled “Medication Reconciliation Policy Medication Administration”, Number: 9.4.1, Effective Date: 10/10/2018 was reviewed on 1/25/23. On page 3 under letter E. “Assessment for Contraindications – Nursing Responsibilities” it stated: “2. A Medication Record and history completed by a therapist will be reviewed by a Registered Nurse… 3. Assessment will include… b. Possible drug interactions or drug incompatibility and reporting these to the physician.” MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (deterioration in spine with pain); low back pain and high blood pressure. The clinical record was reviewed on 1/25/23. The Start of Care (SOC) was completed on 10/12/22 by the physical therapist (PT) and documentation under Medications, section M2001-Drug Regimen Review, indicated that there were issues found during review with a comment of “Drug Interactions”. There was no documentation of what drugs were found to have interaction or the severity/type of the interactions found. The patient's 5 prescribed medications were entered in "Drugs.com" (online pharmaceutical encyclopedia used to provide drug information to healthcare professionals) for comparison and revealed one moderate drug interaction. There was no further documentation in the clinical record indicating that a Registered Nurse (RN) reviewed, became aware of, or reported the drug interaction. MR 6: This 83-year-old patient was admitted to the agency on 12/20/22 with diagnoses which included primary osteoarthritis (deterioration of cartilage that protects bone); peripheral neuropathy (weakness and pain in extremities due to nerve damage); and difficulty walking. The clinical record was reviewed on 1/24/23. The SOC was completed by the PT on 12/20/22 and documentation under Medications, section M2001-Drug Regimen Review, indicated that there were no issues found during drug review. The patient's 9 prescribed medications were entered in "Drugs.com" and revealed 4 moderate and 1 minor drug interactions. There was no further documentation in the clinical record indicating that an RN reviewed, became aware of, or reported any drug interactions. MR 7: This 75-year-old patient was admitted to the agency on 12/20/22 with diagnoses which included poly-osteoarthritis (arthritis of many joints); type 2 diabetes; and peripheral vascular disease (condition affecting blood vessels of extremities). The clinical record was reviewed on 1/24/23. The SOC was completed by the PT on 12/20/22 and documentation under Medications, section M2001-Drug Regimen Review, indicated that there were no issues found during drug review. The patient's 10 prescribed medications were entered in "Drugs.com" and revealed 5 moderate and 1 minor drug interactions. There was no further documentation in the clinical record indicating that an RN reviewed, became aware of, or reported any drug interactions. The above findings were reviewed and acknowledged by the Administrator (Admin A) and the Clinical Manager (DON B) during interview on 1/27/23 at 9:30 a.m. MR #3: The start of care (SOC) was dated 3/2/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered that the medication reconciliation had interactions found and no documentation in the record that the physician was notified. MR #4: The SOC was dated 10/21/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. Physical therapy (PT) was ordered for a frequency of 2w4. During record review on 1/26/2023, it was discovered that no medication reconciliation was documented in the record. A review through Drugs.com found 1 major, 11 moderate, 2 minor, 5 food interactions and 3 duplicate medications. There was no documented evidence that a medication reconciliation was sent to the physician for review. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the agency failed to develop and implement an effective discharge planning process (SEE G-562); and failed to ensure all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences were sent to the health care practitioner (SEE-G564), resulting in the potential for unidentified continuing health care concerns and unmet patient care needs. Findings include: The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.58: Discharge Planning.

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 record review and interview, it was determined the agency failed to develop and implement an effective discharge planning process, effecting 3 of 5 (MR# 3, 4, and 5) discharged records, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet patient care needs. Findings include: MR #3: The start of care (SOC) was dated 3/2/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered that the SN discharge summary dated 4/5/2022, was blank. Nine months after the patient was discharged from the agency the discharge summary was still not completed in the record. MR #4: The SOC was dated 10/21/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. Physical therapy (PT) was ordered for a frequency of 2w4. During record review on 1/26/2023, it was discovered that the PT discharge summary dated 12/9/2022 was blank. A month and a half after the patient was discharged from the agency the discharge summary was still not completed in the record. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings. Agency policy titled “Discharge Planning, Discharge Summary and Discharge Oasis/AWP/10-31-2018” was reviewed on 1/26/23 and stated: “The professional staff is responsible for providing a written summary report for each client… A written discharge summary will be prepared by the case manager… Discharge OASIS will be conducted with 48 hours of (or knowledge of) discharge to the community or death at home.” (sic) MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (deterioration in spine with pain); low back pain and high blood pressure. The clinical record was reviewed on 1/25/23 at 2:40 p.m. The start of care was completed on 10/12/22 by the physical therapist (PT). The plan of care dated 10/12/22 indicated the certification period was for 10/12/22 through 12/10/22. During review, it was noted that a PT Discharge Summary was opened under PT Notes in the electronic clinical record on 12/02/22 but it did not contain any documented information. There were no other visits entered after 12/02/22. It was also noted that there was no comprehensive discharge Outcome and Assessment Information Set (OASIS) entered in the clinical record (54 days after discharge). These findings were reviewed and acknowledged by the Administrator (Admin A) and the Director of Nursing (DON B) on 1/27/23 at 9:30 a.m.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences were sent to the health care practitioner in 4 of 5 (MR#s 2, 3, 4 and 5) sample transfer and discharge records from a total of 7 records reviewed, resulting in potentially unsafe and ineffective transition of care. Findings included: MR #3: The start of care (SOC) was dated 3/2/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered that nine months after the patient was discharged from the agency there was no evidence documented in the record that a discharge summary was sent to the physician. MR #4: The SOC was dated 10/21/2022. The POC identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. PT was ordered for a frequency of 2w4. During record review on 1/26/2023, it was discovered that a month and a half after the patient was discharged from the agency there was no evidence documented in the record that a discharge summary was sent to the physician. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings. MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. The patient was receiving Skilled Nursing Visits at the following frequency: 1xweekx1week, 2xweekx1week, 1xweekx2weeks. Upon review of the record, a Discharge Physician Order and Summary of Care Document dated 3/5/2022 was reviewed. It was noted that the document was blank of needed medical and treatment information the receiving organization would need in providing services. The missing information included: the reason for the TX/DC, patient's weight, height, functional mobility, patient recall ability, safety compliance, current pain status, patient current wound status with measurements, current medications, and patient support systems. The agency identified the patient's discharge Status as "Discharge/Transfer, inpatient short-term hospital", without any documentation of why the patient needed to be discharged to the hospital, or the name of the hospital to which the patient was discharged. In addition, there was no indication the agency had notified and updated the physician of the patient's transfer/discharge status, nor was a Discharge Summary or Discharge OASIS found in the patient's record. These findings were reviewed and acknowledged by the Administrator (ADM-A) and Clinical Manager (DON-B) during an interview on 1/27/23 at 3:00 p.m. MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (spine condition that can be painful); low back pain; and high blood pressure. The clinical record was reviewed on 1/25/23. The start of care was completed on 10/12/22 by the physical therapist (PT). The plan of care dated 10/12/22 indicated that the certification period was 10/12/22 through 12/10/22. The PT entered a PT Discharge Summary note on 12/02/22 but there was no information documented in the note. There was no evidence in the clinical record that a discharge summary was sent to the physician. This finding was reviewed and acknowledged during interview on 1/27/23 at 9:30 a.m. with the Administrator (Admin A) and Clinical Manager (DON B).

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 the plan of care (POC) included safety measures/precautions (SEE G-572), failed to ensure the POC included measurable goals (SEE G-574), and failed to ensure verbal orders were authenticated and dated by the physician in accordance with the home health agency’s policies (see G-584), resulting in the potential for patient injury and the potential for the agency to not meet the patient's needs. Findings include: The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.

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 an individualized plan of care (POC) was signed by a doctor in 4 of 7 (MR #s 2, 3, 4 and 5) sample records reviewed potentially resulting in the lack of patient care needs being met and lack of physician oversight. Findings include: MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. The patient was receiving Skilled Nursing Visits at the following frequency: 1xweekx1week, 2xweekx1week, 1xweekx2weeks. This patient was transferred and discharged to a hospital on 3/5/2022. Upon review of the record, there was no evidence the POC had been reviewed and signed by the physician. This finding was reviewed and acknowledged by the Administrator (ADM-A) and Clinical Manager (CM-B) during an interview on 1/27/2023. MR #3: The start of care (SOC) was dated 3/2/2022. The POC identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/2023, it was discovered that the POC dated 3/2/2022 was not signed by the physician, nine months after the patient was discharged from the agency. MR #4: The SOC was dated 10/21/2022. The POC identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. Physical therapy (PT) was ordered for a frequency of 2w4. During record review on 1/26/2023, it was discovered that the POC dated 10/21/2022 was not signed by the physician, a month and a half after the patient was discharged from the agency. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings. Agency policy titled “Physician’s Plan of Care Policy, Number: 8.2, Effective Date: 10/10/18” was reviewed on 1/26/23 and stated: “The physician’s Plan of Care will be sent to the physician within 10 days for signature.” MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (deterioration in spine with pain); low back pain and high blood pressure. The clinical record was reviewed on 1/25/23. The start of care was completed on 10/12/22 by the physical therapist (PT). The Plan of Care dated 10/12/22 indicated that the certification period was for 10/12/22 through 12/10/22. The discharge was dated 12/02/22. It was noted that the plan of care was not signed by the physician. There was no documented evidence in the clinical record that the plan of care had been sent to the physician for signature. This finding was reviewed and acknowledged by the Administrator (Admin A) and Clinical Manager (DON B) during interview on 1/27/23 at 9:30 a.m.

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 ensure the plan of care included safety measures and individualized, patient-specific, measurable outcomes and goals in 6 of 7 (MR#s 1, 2, 3, 4, 5, and 6) sample records reviewed, and failed to include medications prescribed to the patient on the plan of care in 1 of 7 (MR# 5) sample records reviewed. resulting in the potential for patient injury, a lack of patient inclusion in care planning, unmet patient care needs, and the inability to measure the patient's progress towards achieving goals. Findings include: MR#1: The Start of Care (SOC) was dated 11/18/2022. the Plan of Care (POC) for the certification period of 11/18/2022 to 1/16/2023 identified diagnoses of Diabetes Type 2 (DM2), Hypertensive Heart Disease, Osteoarthritis, and low back pain. Upon review of the goals on the POC it was noted the goals were not objectively measurable. Exampled included: "Discharge when optimal function attained with: Family Assist for 3 weeks; Discharge when independent with Physician follow up in 3 weeks' Discharge when all goals have been met." Essentially this patient had no identifiable goals that were measurable, the goals on the plan of care were for discharge planning. MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. The patient was receiving Skilled Nursing Visit at the following frequency: 1xweekx1week, 2xweekx1week, 1xweekx2weeks. Upon review of the Goals on the Plan of Care, it was noted the goals were not objectively measurable to determine the patient's progress towards achieving the goals. Examples included: "Patient/Caregiver (Pt/Cg) reports patient's pain within comfort level by 3/26/22; Patient/Caregiver will be knowledgeable in signs/symptoms of infection; Pt/Cg assumes responsibility for personal care needs by (AIDE) 3/26/22; Pt/Cg will demonstrate knowledge of medication and diet by 3/26/22; Pt/Cg demonstrates correct use of medication by 3/26/22." These goals are not objectively measurable to determine the patient's progress towards achieving the goals. MR #3: The start of care (SOC) was dated 3/2/22. The plan of care (POC) identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/23, it was discovered that the SN and PT goals on the POC were not measurable. One goal stated, "Pt/Cg will be knowledgeable in s/s of infection by 4/2/22." Another stated, "Pt/Cg will verbalize measures to protect skin integrity by 4/2/22. There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR #4: The SOC was dated 10/21/22. The plan of care (POC) identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. During record review on 1/26/23, it was discovered that the POC dated 10/21/22, failed to include diabetic precautions for a patient with a diagnosis of diabetes mellitus, and failed to include bleeding/anticoagulant precautions for a patient on Clopidogrel (Antiplatelet). During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings. MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (deterioration in spine with pain); low back pain and high blood pressure. The clinical record was reviewed on 1/25/23. During review of the physical therapy (PT) goals in the plan of care (POC) dated 10/12/22, it was noted that the goals were not objectively measurable. Examples included: Patient will meet maximum rehab potential within 7 weeks; Demonstrate effective pain management within 7 weeks; Return to pre-injury/illness level of function within 7 weeks; Patient will be independent with safety issues in 7 weeks. It was unclear how these goals would be measured in terms that would enable PT staff to accurately perform an objective evaluation of the patient’s progress toward these goals. Additionally, in section 10 of the POC, (Medications: Dose/Frequency/Route), none of the 5 medications that the patient was prescribed were listed, and this section was left blank. MR 6: This 83-year-old patient was admitted to the agency on 12/20/22 with diagnoses which included primary osteoarthritis (deterioration of cartilage that protects bone); peripheral neuropathy (weakness and pain in extremities due to nerve damage); and difficulty walking. The clinical record was reviewed on 1/24/23. During review of the PT goals in the POC dated 12/20/22, it was noted that the goals were not objectively measurable. Examples included: Patient will meet maximum rehab potential within 8 weeks; Return to optimal and safe functionality within 6 weeks; Demonstrate effective pain management within 5 weeks. It was unclear how these goals would be measured in terms that would enable PT staff to accurately perform an objective evaluation of the patient’s progress toward these goals. These findings were reviewed and acknowledged by the Administrator (Admin A) and Clinical Manager (DON B) during interview on 1/27/23 at 9:30 a.m.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure verbal orders were authenticated and dated by the physician in accordance with the home health agency’s internal policies in 1 of 5 (MR# 5) sample discharge records reviewed potentially resulting in the lack of physician oversight. Findings include: Agency policy titled “Medical Policies and Physician’s Orders, Number: 8.1, Effective Date: 10/10/2018” was reviewed on 1/26/23 and stated: “… all orders must be… sent to the physician within 10-14 days of written order… Verbal orders must be sent for confirmation and countersignature by the physician within 10-14 days.” MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (deterioration in spine with pain); low back pain and high blood pressure. The clinical record was reviewed on 1/25/23. The start of care was completed on 10/12/22 by the physical therapist (PT). On 11/08/22, the PT entered a physician’s order into the clinical record to extend PT services for 3 additional weeks. This order did not have signature from the physician. There was no evidence in the clinical record that the order was sent to the physician within 10-14 days for confirmation and countersignature. This finding was reviewed and acknowledged by the Administrator (Admin A) and Clinical Manager (DON B) during interview on 1/27/23 at 9:30 a.m.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on document review and interview, the governing board failed to approve a Performance Improvement Project (PIP) for the agency's Quality Assessment and Performance Improvement Program (QAPI) for the years 2022 and 2023. Findings included: Based on documents reviewed and interview, the Governing Body failed to approve a Performance Improvement Program for the years 2022 and 2023. Findings included: On 1/25/2023 at 11:00 a.m., the Director of Nursing (DON-B) was asked to provide a copy of the agency's QAPI Programs for 2022 and 2023, along with Governing Board Meeting Minutes for the years 2022 and 2023. Upon review of the documents, it was noted that the Governing Board Meeting Minutes failed to have language defining and approving the agency's 2022 or 2023 Performance Improvement Projects. During review of the documents, there was data collected for infection control and patient visits, however there was no explanation of the project for which the data was being collected. During an interview with DON-B on 1/25/2023 at 12:00 noon, DON-B was asked to provide the documents for the 2023 Performance Improvement Project. The response was, "I already provided that to you." DON-B was asked to define the Performance Improvement Project for which this data was being collected as the approval had not been found in the Governing Board Meeting minutes. DON-B explained that QA-C and QA-D were in charge of the QAPI program and were not available to come into the office at this time. DO-B was asked to explain the Performance Improvement Plan approved by the Governing Body to be performed for the year 2023. The response was, "it's there, I gave it to you, I have nothing more to give to you." The documents provided included data collection only and no language that defined why the data was being collected. The agency failed to have a Performance Improvement Project approved by the Governing Body for the years 2022 and 2023.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to coordinate an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of their Quality Assessment Performance Improvement (QAPI) program in 2022, resulting in the potential development and spread of infections between staff and the 124 patients admitted to the agency in the past 12 months (See 684); failed to provide initial training in infection control policies and procedures, including contract employees, and failed to maintain documentation of ongoing training, resulting in the potential for patient and employee infections (See 686); failed to develop and implement policy and procedure to ensure all staff were vaccinated for COVID 19, and failed to document and track the COVID-19 vaccination completion, exemption, or temporary delay status for staff that provide patient care, treatment, or other services for the agency which has the potential to negatively affect the health and well-being of the agency's 2 current patients (See 687). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the condition of participation 42 CFR 484.70: Infection prevention and control.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to coordinate an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of their Quality Assessment Performance Improvement (QAPI) program in 2022, resulting in the potential development and spread of infections between staff and the 124 patients admitted to the agency in the past 12 months. Findings include: On 1/26/23 at 11:00 a.m., the agency provided a binder for review titled “Infection Control”. The documentation consisted of infection control monitoring activities for the years of 2020 and 2021. There was no documented evidence of the agency’s efforts in 2022 to coordinate an agency wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as part of their QAPI program. During interview on 1/27/23 at 9:30 a.m., the Administrator (Admin A) and Clinical Manager (DON B) reviewed and acknowledged the findings.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to provide initial training in infection control policies and procedures, including contract employees, and failed to maintain documentation of ongoing training, resulting in the potential for patient and employee infections. Findings include: On 1/27/2023, 7 random employee files were reviewed. During the review it was discovered that 5 of the 7 employees (All contracted staff) had no infection control initial or ongoing training documented in their files. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

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 record review and interview, the agency failed to develop and implement policy and procedure to ensure all staff were vaccinated for COVID 19, and failed to document and track the COVID-19 vaccination completion, exemption, or temporary delay status for staff that provide patient care, treatment, or other services for the agency. This has the potential to negatively affect the health and well-being of the agency's 2 current patients. Findings include: On 1/26/23, request was made to the Clinical Manager (DON B) to provide agency COVID-19 vaccination policies and procedures, and a list of names of agency employees including their vaccination status as of 1/26/23. DON B brought one vaccination card but stated that they (the agency) did not have COVID-19 vaccination documentation for other staff members available. A binder was provided that included COVID-19 policies and procedures but did not contain COVID-19 vaccination policies. During interview on 1/27/23 at 10:45 a.m. with Admin A and DON B, Admin A stated that there had not been policy and procedure to track and document COVID-19 vaccination status for direct or contracted staff providing patient care or other services for the agency and acknowledged the findings.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinicians followed the visit frequency ordered by the physician as indicated in the patient plan of care in 2 of 7 (MR# 3 and 5) sample records reviewed resulting in potential for physical decline and unmet patient care needs. Findings include: MR #3: The SOC was dated 3/2/22. The POC identified the diagnoses of diabetes mellitus, hypertension, pain and chronic kidney disease. Skilled nursing (SN) services were ordered at a visit frequency of 1W1, 2W3 and 1W5. Physical therapy (PT) had orders for 2w4. During record review on 1/24/23, it was discovered that SN had a missed patient visit for week 3. There was no documented missed visit note in the record. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B)) acknowledged the above findings. MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (deterioration in spine with pain); low back pain and high blood pressure. The clinical record was reviewed on 1/25/23. The Plan of Care had orders for physical therapy (PT) services to see the patient 2 times weekly for 4 weeks, and then 1 time a week for 3 weeks (a total of 7 weeks). On week 3, PT only made one visit on 10/25/22. There was no documentation entered stating why a second visit was not made in week 3, and no indication that the physician had been informed of the missed visit. On 11/08/22 (week 5), the PT entered a physician’s order into the clinical record to extend PT services for 3 additional weeks. One visit was made on 11/16/22 (week 6). No visits were made in week 7. There was no documentation stating why no visits were made in week 7, and no indication that the physician was made aware that the patient was not seen for that week. On 12/02/22 (16 days after the last visit), the discharge visit was made. This finding was reviewed and acknowledged by the Administrator (Admin A) and the Clinical Manager (DON B) during interview on 1/27/23 at 9:30 a.m.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to maintain a Clinical Laboratory Improvement Amendment (CLIA) laboratory waiver, resulting in the potential for the Agency to be performing unauthorized laboratory tests on patients. Findings include: During the entrance conference on 1/24/2023 10:30 a.m., the administrator was asked for a copy of the agency's CLIA waiver. The administrator said he had a waiver. The administrator then presented a form that is used to renew a CLIA waiver. The form was never submitted for a renewal of the CLIA waiver. Upon calling Licensing and Regulatory Affairs (LARA) in Lansing to verify the Agency had a CLIA waiver, LARA confirmed the Agency did not have a valid CLIA waiver since 11/15/2015. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

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 agency failed to ensure the Administrator was responsible for all day-to-day operations (SEE G948); failed to ensure the Administrator or pre-designated person was available during all operating hours (SEE G-956); and failed to ensure at least one qualifying service was provided directly by agency employees (SEE 982). The systemic effects of the above deficiencies had the potential to affect all patients admitted in the past 12 months, resulting in the provision of substandard care, patients not receiving needed services and the potential for poor patient outcomes.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation and interview, it was determined the Agency failed to ensure the Administrator was responsible for all day-to-day operations, resulting in the potential for patient needs to go unmet. Findings include: During an interview on 1/24/23 at 10:30 a.m., the administrator was asked about getting access to the agency's electronic medical record (EMR) system and setting up home visits. He said he was not too sure about how that works because his alternate administrator (QA-C) basically runs the agency. The Administrator attempted to contact QA-C numerous times throughout the day on 1/24/23 and was finally able to contact QA-C on 1/25/23 at 9:30 a.m. QA-C was not available for all of 1/24/23 due to working another job. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

Available during all operating hours CFR(s): 484.105(b)(3) The administrator or a pre-designated person is available during all operating hours. This ELEMENT is not met as evidenced by: Based on observation and interview, it was determined the agency failed to ensure the administrator or pre-designated person was available during all operating hours, resulting in the potential for patients needs to be unaddressed. Findings include: Upon arrival to the agency at 9:00 a.m. on 1/24/2023, it was observed that the agency office was dark with no lights on. The information posted on the door of the agency stated hours of operation are 9:00 a.m. to 5:00 p.m. At 9:02 a.m. a call was placed to the phone number posted on the door. The return message was that the voicemail for the number was full and could not take any messages at this time. The same number was listed in the iQIES data base for government information related to this agency, and the same number was listed on the agency's website. There was no way for a patient to contact the agency or leave a message, in case of a need or concern. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for interruption in continuity of care and unmet care needs. Findings include: During interview on 1/24/23 at 10:30 a.m., the Administrator (Admin A) stated the agency provided the following services: Skilled Nursing; Physical Therapy; Occupational Therapy; Medical Social Work; Home Health Aide; and Registered Dietician. Admin A stated that the agency did contract some services. When queried regarding which one service was provided directly by agency employees, Admin A stated "nursing". At 1:20 p.m., staff lists including both direct and contracted staff were provided for review. Both staff lists included registered nurses (RN’s). Additionally, an admission list printed on 1/24/23 for review included clinical disciplines who started care for each of the 27 patient listed and included names of contracted RN's. At the time of discovery, Admin A was asked if they used contracted RN’s and responded, “yes”. The agency failed to ensure at least one service was provided directly by agency employees. This finding was reviewed and acknowledged during interview with Admin A and Clinical Manager (DON B) on 1/27/23 at 10:30 a.m.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the agency failed to define the meaning of abbreviations used in clinical notes to ensure understanding of the care provided to the patients admitted to the agency in 1 of 7 (MR#2) records reviewed (See 1010); failed to ensure the clinical record included physician referrals in 3 of 7 (MR# 5, 6, & 7) sample records reviewed, signed patient consents in 3 of 7 (MR# 4, 6 and 7) sample records reviewed, and failed to include complete clinician visit notes in 1 of 7 (MR# 5) sample records reviewed resulting in inadequate documentation supporting the need and agreement for services and unknown progress toward goals (See 1012); failed to authenticate a discharge/transfer order with a date and signature in 1 of 5 (MR#2) discharged records reviewed (See 1024); and failed to ensure that clinical records were safeguarded against loss or unauthorized use, resulting in the potential compromise of protected health information (See 1028). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.110: Clinical records.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to define the meaning of abbreviations used in clinical notes to ensure understanding of the care provided to the patients admitted to the agency in 1 of 7 (MR#2) records reviewed. Findings included: MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period 3/2/2022 to 4/30/2022 identified a diagnosis of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, and Unsteadiness on feet. Upon review of the record, it was noted under the category of M1340: Surgical Wounds, that the SN documented the following abbreviation: (C/D/I) under ordered instructions for wound care/suture line care. However, there was no definition in the record regarding the meaning of "C/D/I." During an interview with the Administrator (ADM-A) in 1/27/23, the Administrator was queried as to the meaning of C/D/I? The response was, "I don't know, I am not a medical person, I am a businessman." This finding was reviewed and acknowledged by the Administrator (ADM-A) and Clinical Manager (CM-B) during an interview on 1/27/2023 at 3:00 p.m.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review, and interview, the agency failed to ensure the clinical record included physician referrals in 3 of 7 (MR# 5, 6, & 7) sample records reviewed, signed patient consents in 3 of 7 (MR# 4, 6 and 7) sample records reviewed, and failed to include complete clinician visit notes in 1 of 7 (MR# 5) sample records reviewed resulting in inadequate documentation supporting the need and agreement for services and unknown progress toward goals. Findings include: MR #4: The SOC was dated 10/21/2022. The plan of care (POC) identified the diagnoses of diabetes mellitus, Poly osteoarthritis and gout. Physical therapy (PT) was ordered for a frequency of 2w4. During record review on 1/26/2023, it was discovered that no consent for home care services was documented in the record. Over 3 months without a signed patient consent in the record. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings and said the clinician probably still has it and has not submitted it to us yet. MR 5: This 83-year-old patient was admitted to the agency on 10/12/22 with diagnoses which included spondylosis with radiculopathy to lumbar region (spine condition that can be painful); low back pain; and high blood pressure. The clinical record was reviewed on 1/25/23. A physician’s referral for home care was not found in the electronic or physical clinical record. It was also noted that a physical therapy (PT) 30 Day Functional Re-Assessment note was opened on 11/08/22 but did not contain any documentation other than an effective date (11/09/22). The Clinical Manager (DON B) was queried on 1/25/23 at 2:45 p.m. regarding the missing referral and replied "I will look for it". On 1/26/23 at 10:40 a.m., DON B stated that the Administrator (Admin A) had called the physicians office after query regarding the referral on 1/25/23 to obtain one. A physician referral for home care was not in the clinical record during review, over 3 months after date of admission. MR 6: This 83-year-old patient was admitted to the agency on 12/20/22 with diagnoses which included primary osteoarthritis (deterioration of cartilage that protects bone); peripheral neuropathy (weakness and pain in extremities due to nerve damage); and difficulty walking. The clinical record was reviewed on 1/24/23. A physician’s referral for home care and patient signed consents for home care were not found in the electronic or physical clinical record. A query was made to DON B on 1/24/23 at 3:00 p.m. regarding the missing documents. DON B stated that the face-to-face physician visit note dated 10/27/22 was used as the referral. No home care start date or home care agency name was noted on the face-to-face physician visit note dated 10/27/22. DON B and Admin A were queried on 1/24/23 at 3:30 p.m. to whether they had another document from the physician requesting a start of care (SOC) date to be 12/20/22 (54 days later). No other explanation or documentation was provided regarding the referral. The consents were not provided during the chart review. MR 7: This 75-year-old patient was admitted to the agency on 12/20/22 with diagnoses which included poly-osteoarthritis (arthritis of many joints); type 2 diabetes; and peripheral vascular disease (condition affecting blood vessels of extremities). The clinical record was reviewed on 1/24/23. A physician’s referral for home care and patient signed consents for home care were not found in the electronic or physical clinical chart. A query was made to DON B on 1/24/23 at 3:15 p.m. regarding the missing documents. DON B stated that the face-to-face physician visit note dated 10/27/22 was used as the referral. No home care start date or home care agency name was noted on the face-to-face physician visit note and no other documents with a physician referral for a start date of 12/20/22 (54 days later) was provided. The consents were not provided during the chart review. The above findings were reviewed and acknowledged during interview with Admin A and DON B on 1/27/23 at 10:30 a.m.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to authenticate a discharge/transfer order with a date and signature in 1 of 5 (MR#2) discharged records reviewed. Findings included: MR#2: The Start of Care (SOC) was dated 3/2/2022. The Plan of Care (POC) for the certification period of 3/2/2022 to 4/30/2022 identified diagnoses of Calculus of gallbladder, Encounter for surgical after care, Hypertensive Heart Disease, Unsteadiness on feet. The patient was receiving Skilled Nursing Visits at the following frequency: 1xweekx1week, 2xweekx1week, 1xweekx2weeks. Upon review of the record, it was noted a Discharge Physician Order and Summary of Care Document dated 3/5/2022. It was noted that the document was blank of the required physician name, physician signature, and date. This finding was reviewed and acknowledged with the Administrator (ADM-A) and Director of Nursing (DON-B) during an interview on 1/27/23 at 3:00 p.m.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation and interview, the agency failed to ensure that clinical records were safeguarded against loss or unauthorized use, resulting in the potential compromise of protected health information. Findings include: At 10:00 a.m. on 1/24/2023, more than 10 patient charts were observed stacked on top of a filing cabinet out in the open and unsecured in the agency's breakroom. Anyone entering the office could potentially have access to these unsecured records. During an interview on 1/27/23 at 1:30 p.m., the administrator (Admin-A) and clinical manager (DON-B) acknowledged the above findings.