Every finding on record at Pacific Rim Home Health, Inc

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by:

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by:

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by:

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by:

Continuing need for home care CFR(s): 484.55(c)(3) The patient's continuing need for home care; This ELEMENT is not met as evidenced by:

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:

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:

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:

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by:

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by:

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by:

The following reflects the findings of the Department of Public Health during a Complaint Investigation survey. Complaint number: CA00755163 Representing the California Department of Public Health: Surveyor #25046, Health Facilities Evaluator Nurse Surveyor #22303, Health Facilities Evaluator Nurse Active Patients: 36 Sample Size: 7 Patients Home Visit: 4

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for the Reporting of OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health to plan care) by failing to ensure that the existing urostomy (a surgical opening in the abdominal wall through which urine passes) for one of seven patients, Patient 4, was documented in the recertification OASIS assessment. (Refer to G 374) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) staff failed to reflect an existing urostomy (a surgical opening in the abdominal wall through which urine passes) in the recertification OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health to plan care) assessment form for one of seven patients, (Patient 4). This deficient practice placed the patient at risks for infections and other complications when care and interventions are not provided. Findings: On 10/4/2021 at 10:30 a.m., a home visit was conducted at Patient 4's residence with License Vocational Nurse 1 (LVN 1). Patient 4 was observed sitting on the wheelchair in the living room. Patient 4 was observed with a urostomy connected to a pouch on her left upper abdomen. A review of Patient 4's Patient Information, indicated a start of care (SOC) date of 2/16/2021, with diagnosis that included diabetes mellitus (high blood sugar). During a review of Patient 4's plan of care (POC) for the re-certification period from 8/15/2021 to 10/13/2021, an order was written for a skilled nurse (SN) to visit of once a week for 9 weeks. SN to continue to instruct patient/ patient caregiver on disease processes, causes, signs and symptoms, complications, preventive measures, urostomy care, daily blood pressure monitoring. performing a comprehensive assessment and observations of all body system. During a review of Patient 4's recertification OASIS assessment form dated 8/13/21, the assessment did not indicate that Patient 4 had an existing urostomy. On 10/5/21 at 12 p.m. during an interview with the Director of Nursing Services (DPCS), DPCS stated the patient's OASIS assessment form information was not accurate, and the staff nurse should have included the patient's urostomy under the elimination section.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients by failing to: 1. Assess one of seven patients', (Patient 4) urostomy (a surgically opening in the abdominal wall through which urine passes) during a nurse's home visit. (Refer to G 526) 2. Assess the continuing need for skilled nursing services for five of seven patients (Patients 1, 2, 3,6 and 7). (Refer to G 532) 3. Ensure that patient medications are added in the medication profile for two of seven patients (Patients 4 and 5). (Refer to G 536) 4. Ensure that, for one of seven patients (Patient 3), who had a numerical pain level of 8/10 (numerical pain scale from 0-10, an assessment tool that measures pain levels, which eight and above is severe pain) was assessed, provided interventions, and reassessed for the effectiveness of the interventions. (Refer to G 572) 5. Notify the physician for one of seven patients (Patient 3), who had a pain level of 9/10 (severe pain) during a nurse's home visit. (Refer to G 590) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality healthcare in a safe environment.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to assess the urostomy (a surgical opening in the abdomen to drain urine) for one of seven patients, (Patient 4) during a home visit. This deficient practice placed the patient at risk for infections and potential complications when care and interventions were not provided at the time of visit. Findings: On 10/4/2021 at 10:30 a.m., a home visit was conducted at Patient 4's residence with License Vocational Nurse 1 (LVN 1). Patient 4 was observed sitting on a wheelchair in the living room. Patient 4 had a urostomy connected to a pouch on her left upper abdomen. A review of Patient 4's record indicated a start of care (SOC) date of 2/16/2021, with diagnoses that included diabetes mellitus (high blood sugar). During a review of Patient 4's plan of care (POC), for the re-certification period from 8/15/2021 to 10/13/2021, included an order for SN to visit once a week for 9 weeks, for SN to do skilled assessment and observation of vital signs and whole body system with emphasis on urinary status; on urostomy care. A review of Patient 4's recertification OASIS (outcome and assessment information set, assessment used in Medicare home health to plan a care) assessment form dated 8/13/2021, did not indicate any documentation that Patient 4 had an existing urostomy. A review of Patient 4's nursing visit note dated 8/18/2021 to 9/30/2021, did not indicate LVN 1 had assessed Patient 4’s urostomy for urinary (bladder) status. On 10/5/2021, at 1 p.m., during an interview with LVN 1, she stated she did not document that Patient 4 had a urostomy in her nursing notes. On 10/5/2021, at 1:30 p.m., during an interview with the director of nursing services (DPCS), she stated LVN 1 should have documented Patient 4's urostomy condition and stoma (opening) assessment in the nurses notes.

Continuing need for home care CFR(s): 484.55(c)(3) The patient's continuing need for home care; This ELEMENT is not met as evidenced by: d. On 10/5/2021, at 1:10 p.m., during a home visit at Patient 6's residence with Licensed Vocational Nurse 1 (LVN 1), Patient 6 was observed sitting on a chair, was alert and oriented, while PCG 6 was sitted next to the patient. During an interview with Patient 6 (with translation by LVN 1), she stated she had received care from the agency more than a year ago for six months due to open wound on the foot and was discharged. Patient 6 also stated that Caregiver 5 helps her to go to see the doctor and that she could walk using cane and walker by herself. A review of the physician's order dated 8/25/2021 indicated an order to recertify Patient 6 to continue with home health services from 8/28/2021 to 10/26/2021. It indicated Patient 6's cardiovascular status was unstable and BP was fluctuating and needed close monitoring especially with BP in order to prevent further deterioration of cardiovascular status. A review of Patient 6's vital signs graph record from 6/30/2021 to 9/29/2021, indicated BP readings ranged between 104/62 mmHg to 158/93 mmHg. According to https://www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings, blood pressure numbers of less than 120/80 mmHg are considered within the normal range. A review of Patient 6's clinical record indicated a start of care date of 3/1/2021, with diagnoses of hypertensive heart disease without heart failure, atherosclerotic heart disease (a disease in which plaque builds up inside the arteries), gastro-esophageal reflux disease (GERD, heartburn), and hyperlipidemia (high cholesterol). A review of the Patient 6's plan of care (POC) from 6/29/2021 to 8/27/2021 indicated an order for the skilled nurse to visit once a week for nine weeks to perform assessment and observation of vital signs and body systems. A review of the 60-day summary for the recertification period from 6/29/2021 to 8/27/2021 indicated the reason for recertification was that the patient had functional or mental deficit impacting ability to leave home due to anxiety, confusion, depression, forgetfulness, impaired vision, shortness of breath with moderate exertion, bladder and bowel incontinence, and limited functional mobility caused by pain. The patient required transportation or assistance of another person to leave home and required use of a device to leave home (walker). During an interview with the Director of Patient Care Services (DPCS) on 10/5/2021, at 11:50 a.m., she stated the BP readings ranged between 104/62 mmHg and 158/93 mmHg was within acceptable range for Patient 6. The DPCS stated she could not find the documented evidence Patient 6's BP was unstable and fluctuated as described in the physician's order dated 8/25/2021 and could not find the documented need of recertification for benefit period from 8/28/2021 to 10/26/2021. Physician 1 was called and left messages for interview on 10/5/2021, at 4:53 p.m., and 10/7/2021 at 12:10 p.m., but no response was received. e. A review of Patient 7's clinical record indicated a start of care date of 4/8/2021, with diagnoses that included hypertension, Type 2 diabetes mellitus (high blood sugar) without complications, and hyperlipidemia (high levels of fats). A review of Patient 7's plan of care (POC) from 8/6/2021 to 10/4/2021 indicated an order for the skilled nurse to visit once a week for eight weeks to perform assessment and observation of vital signs and body systems. A review of Patient 7's 60-day summary for the recertification period from 6/7/2021 to 8/5/2021 indicated the reason for recertification was the patient had functional or mental deficit impacting ability to leave home due to anxiety, confusion, depression, forgetfulness, impaired vision, impaired hearing, and shortness of breath with moderate exertion. Patient 7 required transportation or assistance of another person to leave home and requires use of a device to leave home (cane). A review of Patient 7's physician's order dated 8/5/2021, indicated to recertify Patient 7 for the benefit period from 8/6/2021 to 10/4/2021, to continue performing a comprehensive assessment and observation of all body systems. The SN was to continue education and instructing on disease processes, management and care, medication regimen, diet, nutrition, infection control, safety and fall precautions. A review of Patient 7's vital signs graph record from 6/7/2021 to 8/5/2021, indicated BP readings ranged between 108/60 mmHg to 123/63 mmHg, pulse rate ranged from 60 beats per minute to 76 beats per minute, and fasting blood sugar was 125 mg/dl to 159 mg/dl. During an interview with the DPCS on 10/5/2021, at 3:55 p.m., she stated the patient's vital signs including blood sugar was within normal range, no new diagnoses were added, and the patient did not have fall, or hospitalization. The DPCS stated she was not able to provide the documented evidence Patient 7 needed to be recertified for the benefit period from 8/6/2021 to 10/4/2021. Physician 1 was called and left messages for interview on 10/5/2021, at 4:53 p.m., and 10/7/2021 at 12:10 p.m., but no response was obtained. Upon request of the policy of Recertification criteria, the agency provided the policy of "Reassessment/Recertification" revised on January 2018. A review of the agency's policy of "Reassessment/Recertification” revised on January 2018, did not address for recertification for the continued need for home health service. Based on observation, interview and record review, the Home Health Agency (HHA) failed to assess the patient's continuing need for skilled nursing services (services provided by licensed health professionals like nurses, rehabilitation professionals that are ordered by a doctor) for five of seven sample patients, (Patients 1, 2, 3, 6 and 7). These patients were being re-certified for over six months without any medical needs. This deficient practice resulted in providing unnecessary continuous home health care services. Findings: a. On 9/8/2021, at 10 a.m., a home visit was conducted at Patient 1's residence with LVN 1. Patient 1 was observed sitting in her chair looking well groomed. There was a walker placed next to the chair. On 9/8/2021, at 10:15 a.m., during an interview, Caregiver 1 (family member) stated that the reason why Patient 1 was receiving home health services, was that Patient 1was legally blind and she wanted the home health nurse to continue visiting the patient. Caregiver 1 stated that she takes the patient's blood pressure reading, prepares her medications and takes her to her medical appointment every month with Physician 1. However, Caregiver 1 did not mention any skilled needs and services for Patient 1. On 9/8/2021, at 10:30 a.m., during an interview with LVN 1, she stated the reason the patient was re-certified was because the patient was old and was legally blind. LVN 1 did not mention any skilled needs and services for Pateint 1. On 9/8/2021, at 3 p.m., during a phone interview with Physician 2, she stated the reason why Patient 2 was recertified was because she was old and legally blind so the visiting nurse can continue to monitor whatever help she needed, to make sure the patient was taking her medications. A review of Patient 1's record indicated a start of care dated 1/12/2021, with diagnosis that included hypertensive heart disease (heart problem). The patient was discharge from home health services on 9/8/2021. A review of Patient 1's plan of care (POC) from 5/12/2021 to 7/10/2021, included an order for the skilled nurse (SN) visit of once a week for 9 weeks for assessment of all body system and medication compliance. A review of Patient 1's 60 day summary report dated 7/11/2021, indicated the reason for recertification was that Patient 1 has functional or mental deficits impacting ability to leave home due to forgetfulness, confusion, depression, impaired vision, impaired hearing shortness of breath with moderate exertion, speech problem, paralysis (unable to move), bowel incontinence, chair fast status and at risk for fall. Patient 1 also requires transportation or assistance of another person to leave home, dependent upon adaptive device. A review of Patient 1's nursing visit notes from 5/14/2021 to 8/4/2021 did not indicate any need for skilled nursing services to continue. There were no new medications or skilled services for the treatment of any existing condition. A review of Patient 1's physician's order dated 7/7/2021, indicated to recertify the patient to continue a comprehensive assessment and observation of all systems, to continue to educate and instruct on disease process, management and care, medication regimen, diet and fall precautions. On 10/5/2021, at 11 a.m., during an interview with the Director of Nursing Services (DPCS), she stated the reason Patient 1 was re-certified was because Patient 1 tends to forget patient teaching on medication management and diet regimen, that she needed continuous monitoring by the nursing staff to keep her safe. She further stated that Patient 1 does not need skilled nursing visits, so she was discharged from home health services. b. On 9/8/2021, at 12 p.m., a home visit was conducted at Patient 2's residence with LVN 1. Patient 2 was observed sitting in his couch and was observed getting up and walking independently, without the use of any assistive device. On 9/8/2021, at 12:15 p.m., during an interview with Caregiver 2, Caregiver 2 stated the reason why Patient 2 was enrolled to home health services was because Patient 2 had dementia (memory impairment). Caregiver 2 also stated she accompanies Patient 2 every month to see Physician 2 at his clinic, that Patient 2 could walk and take the bus with her to get to his medical appointment. Caregiver 2 did not mention any skilled needs and services for Patient 2. On 9/8/2021, at 12:25 p.m., during an interview with LVN 1, she stated, the reason that Patient 2 was re-certified was because Patient 2 was old and had dementia. On 9/8/2021, at 3 p.m., during a phone interview with Physician 2, she stated the reason why Patient 2 was recertified was because of dementia. A review of Patient 2's admission record indicated an admission to home health agency on 1/27/2021, with diagnosis that included hypertensive heart disease. The patient was discharged from home health services on 9/20/2021. A review of Patient 2's plan of care (POC) from 5/27/2021 to 7/25/2021, indicated an order for the SN visit of once a week for 9 weeks for assessment of all body system and medication compliance. A review of Patient 2's 60 day summary report dated 7/23/2021, indicated the reason for recertification was the patient has alteration in neurological status due to dementia. A review of Patient 2's nursing visit notes from 6/9/2021 to 8/13/2021 did not indicate any need for skilled nursing services to continue. A review of Patient 2's physician's order dated 7/21/2021, indicated to recertify Patient 2 to continue with home health services. On 10/5/2021, at 11 a.m., during an interview with the DPCS, she stated the reason Patient 2 was re-certified because Patient 2 tends to forget patient teaching on medication management and diet regimen. DPCS stated that Patient 2 does not need skilled nursing visits, so he was discharged from home health services. c. On 10/4/2021, at 12 p.m., a home visit was conducted at Patient 3's residence with the DPCS. Patient 3 just finished her shower and was observed walking from the bathroom towards the living room with a steady gait and sat at the couch in the living room. On 10/4/2021, at 12:30 p.m., during an interview with Caregiver 3, she stated the reason why Patient 3 was recertified was because she wanted the home health nurse to continue visiting the patient to make sure she was safe, to monitor her blood pressure reading because patient is hypertensive and to check her medications. She also stated that she takes the patient's blood pressure reading, prepares her medications and takes her to her medical appointment every month with Physician 2. Caregiver 3 did not mention any skilled needs and services for Patient 3. A review of Patient 3's admission record indicated the patient was admitted to the home health agency on 2/22/2021, with diagnosis that included diabetes mellitus (high blood sugar). A review of Patient 3's plan of care (POC) from 6/22/2021 to 9/20/2021, included an order for the SN visit of once a week for 9 weeks for assessment of all body system and medication compliance. A review of Patient 3's 60 day summary report dated 9/20/2021, indicated the reason for recertification was the patient had functional or mental deficits impacting ability to leave home due to forgetfulness, confusion, depression, impaired vision, impaired hearing shortness of breath with moderate exertion, speech problem, paralysis, bowel incontinence, chair fast hair fast status and at risk for fall. The patient also requires transportation or assistance of another person to leave home, dependent upon adaptive device. status and at risk for fall. The patient also requires transportation or assistance of another person to leave home, dependent upon adaptive device. A review of Patient 3's nursing visit notes from 8/31/2021 to 9/10/2021 did not indicate any need for skilled nursing services to continue. There were no new medications or skilled services ordered for the treatment of any existing condition. A review of Patient 3's physician's order dated 6/21/2021, indicated to recertify the patient to continue a comprehensive assessment and observation of all systems, to continue to educate and instruct on disease process, management and care, medication regimen, diet and fall precautions. On 10/5/2021, at 11 a.m., during an interview with the DPCS, she stated the reason Patient 3 was re-certified because the patient tends to forget the provided patient teaching on medication management and diet regimen that she needed continuous monitoring by the nursing staff to keep her safe. She further stated that Patient 3 no longer needed skilled nursing visits and she will be going to be discharged from home health services this week. A review of the agency's policy "Reassessment/Recertification", indicated that each patient will be re-assessed using a comprehensive assessment tool for the review and revision of the plan of care when the patient is not responding to the care provided and if the patient's condition deteriorates.

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: b. A review of Patient 5's clinical record indicated the start of care (SOC) date was 1/27/2021, with diagnoses of hypertensive chronic kidney disease (renal failure with hypertension) with Stage I through Stage IV and anemia (low blood count) in chronic kidney disease. A review of Patient 5's plan of care (POC) for certification period dated 9/24/2021 through 11/22/2021, indicated an order for the Skilled Nurse(SN) to visit the once a week for eight weeks to perform assessment and observation of vital signs and body systems. The SN was to instruct the patient/primary caregiver (PCG) about medications and indications/actions/side effects/dosage/frequency, and importance of compliance to medications. During Patient 5's home visit at the patient's residence with the Director of Patient Care Services (DPCS) on 10/1/2021 at 11:15 a.m., Patient 5 was sitting in a chair and PCG 5 was next to Patient 5. When the current medications were reviewed comparing with the medication profile at 11: 50 a.m., following was observed: 1. Patient 5 had a bottle of Isosorbide Mononitrate 30 milligram (mg) indicated to take one tablet everyday, while the POC and the medication profile indicated the patient was to take Isosorbide Mononitrate 50 mg everyday. 2. Patient 5 had Zaditor 0.025 % e eye drop (dated 9/14/2021), but it was not included in the Medication profile. 3. Patient 5 had Econazol Nitrate 1 % cream, but it was not included in the Medication profile. 4. Patient 5 did not have Benazepril Hydrochloride 5 mg, but it was included in the Medication profile. During an interview with PCG 5 at the same time, she stated Isosorbide Mononitrate 30 mg had been administered to the patient, not 50 mg, Zaditor 0.025 % e eye drop had been added to use, Benazepril Hydrochloride 5 mg was discontinued several months ago, Econazol Nitrate 1 % cream had been used for 10 years as needed. During an interview with the DPCS, she stated the Medication profile should have been updated when there was changes, and the nursing staff should have educated the patient/PCG for the changes. A review of the agency's policy titled " Medication Profile" revised on January 2018 indicated the patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. Based on observation, interview, and record review, the home health agency (HHA) staff failed to review all the medications and made clarification with the physician regarding discrepancy of the medication administration for two of seven patients (Patients 4 and 5). This deficient practice placed the patient at risk for medication errors and adverse drug reactions. Findings: a. During a review of Patient 4's Patient Information indicated, a start of care (SOC) date of 2/16/21, with diagnoses that included diabetes mellitus. During a review of Patient 4's Plan of Care (POC), for the re-certification period from 8/15/21 to 10/13/21, included an order for skilled nurse (SN) to visit of once a week for 9 weeks, for SN (skilled nurse) to assess activities of daily living (ADLs) and home safety, knowledge on disease process and management, medication knowledge and compliance. Instruct on signs and symptoms of adverse reaction to report to medical doctor (MD). A review of Patient 4's physician's order dated 9/21//21 indicated to administer Cephalexin (antibiotic medication) 500 milligrams (mg) 1 capsule by mouth twice a day during 10 days for urinary tract infection. On 10/4/21, at 10:30 a.m., a home visit was conducted at Patient 4's residence with License Vocational Nurse 1 (LVN 1). Patient 4 was observed sitting on a wheelchair in the living room. During a review of Patient 4's medications indicated there was a bottle labeled Cephalexin 500 milligrams (mg) 1 capsule by mouth twice a day during 10 days for urinary tract infection. On 10/4/21, at 10:45 a.m., during an interview with Caregiver 4, she stated she administers Cephalexin 500 milligrams (mg) 1 capsule by mouth twice a day. A review of Patient 4's medication profile sheet indicated the Cephalexin medication was not added on the medication list. On 10/4/21, at 11 a.m., during an interview with LVN 1, she stated she forgot to call the agency to let them know the Cephalexin medication should be updated on the patient's medication profile sheet. A review of facility's Administration of Medication Policy, dated 1/22/2009, indicated when there is a discrepancy in the medications, the nurse will contact the physician by telephone as soon as possible to verify the medication regimen. The nurse will instruct the patient and family in the correct medication regimen. The nurse will document all telephone conversations and instructions given to the patient and/or family in the patient clinical record.

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 observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for care planning, coordination of services and quality of care by failing to: 1. Follow the written plan of care for two of seven sampled patients, (Patients 3 and 6). (Refer to G572) 2. Notify the physician of the significant of condition for one of seven patients, (Patient 3), who had complained of severe pain. (Refer to G590) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

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: b. A review of Patient 6's clinical record indicated a start of care date of 3/1/2021, with diagnoses that included of hypertensive heart disease (heart problem that occur because of high blood pressure present over a long time) without heart failure (failure of the heart to function properly), and pain in both hip and low back. A review of the Patient 6's plan of care (POC) from 8/28/2021 to 10/26/2021 indicated an order for the skilled nurse visit once a week for eight weeks to perform assessment and observation of vital signs and body systems. The POC indicated to notify the physician when pain level was greater than 8 (hurts a whole lot), when pain level was not acceptable to the patient, when pain medications are not effective, and/or the patient was unable to tolerate the pain medication. A review of Patient 6's physician's order included Tylenol 500 milligram (mg) one tablet every 8 hours as needed for pain and Gabapentin 100 mg one capsule 1-2 capsules daily at bed time as needed for pain. On 10/5/2021, at 1:10 p.m., during a home visit at Patient 6's residence with Licensed Vocational Nurse 1 (LVN 1), Patient 6 was sitting in a chair alert and oriented, and patient caregiver (PCG) was next to the patient. At 1:40 p.m., during an interview, Patient 6 (with translation by LVN 1), stated she had pain on both hip and bottom of feet. Patient 6 stated the pain was 6 to 7 (hurts even more) out of 10 on a pain scale (from zero to ten). Patient 6 stated the pain medication helped, but it did not make the pain go away. Patient 6 stated her orthopedic (specialize in injuries of the musculoskeletal system such as bones, joints, tendons, and muscles) doctor told her that she needed hip surgery. A review of Patient 6's comprehensive assessment dated 8/25/2021, indicated Patient 6 did not have pain. The spaces for pain assessment indicated "N/A" (not applicable) and the spaces for onset, present level of pain, worst pain, best pain, pain description were blank. A review of Patient 6's "Nursing Visit Note" dated, 8/4/2021, 8/11/21, 8/18/2021 indicated Patient 6 had leg pain with the pain level 8/10. There was no pain description, location (right or left), and the space for "Relief measures" was blank. A review of the narrative section of the "Nursing Visit Note" indicated Patient 6 denied any pain "at this time". A review of Patient 6's "Nursing Visit Note" dated 9/1/2021, 9/15/2021, 9/22/2021, indicated Patient 6 had pain in the right leg with the pain level of 8/10, and the space for "Relief measures" was blank. There was no documentation of any intervention provided for the pain level of 8/10 before or after the patient complained of pain. On 10/5/2021, at 1:50 p.m., during an interview, the Director of Patient Care Services (DPCS), stated she was not able to find the documented evidence the SN implemented relief measure and assessed the effectiveness. The DPCS stated the pain level should have been assessed before and after pain intervention. On10/5/2021, at 3:30 p.m., during a telephone interview with LVN 1, she stated the pain level 8/10 was after the pain medication was administered. LVN 1 stated Patient 6 had told LVN 1 that her pain level before pain medication was 9-10/10, but she did not document it. LVN 1 stated she did not notify the physician for Patient 6's pain level (9-10/10 - before pain medication administration) because the patient's pain level decreased to 8/10 after pain medication was administered. A review of the agency's undated policy of "Pain Management" indicated, when pain is identified, a more comprehensive pain assessment would be completed, and following information would be obtained. 1. Pain location 2. Pain character 3. Pain quality, patterns of radiation, and character 4. Pain onset, duration, variations, and patterns 5. Alleviating and aggravating factors 6. Present pain management regimen and effectiveness. 7. Pain history 8. Effects of pain. 9. The patient's pain goal Based on observation, interview and record review, the agency staff failed to follow the written plan of care for two of seven sampled patients (Patients 3 and 6) with pain. For Patients 3 and 6, the staff failed to manage the patient's pain by not assessing the pain level and effectiveness of the pain medication administered to the patient. This deficient practice placed the patient at risk for an ineffective pain relief and further bodily discomfort. Findings: a. A review of Patient 3's admission record indicated the patient was admitted to the home health agency on 2/22/21, with diagnosis that included diabetes mellitus (high blood sugar). A review of Patient 3's plan of care (POC) from 8/21/21 to 10/19/21, included an order for the skilled nurse (SN) visit of once a week for 9 weeks to assess all body system, and pain/comfort status. The POC included an intervention for the SN to assess pain level and effectiveness of the current pain management. The physician's order included in the plan of care was to administer Acetaminophen 500 milligram (mg) one tablet three times a day as needed for pain. On 10/4/21, at 12 p.m., a home visit was conducted at Patient 3's residence with the DPCS (director of nursing services). Patient 3 just finished taking a shower and was observed walking from the bathroom towards the living room with a steady gait and sat on the couch. On 10/4/21, at 12:30 p.m., during an interview with Patient 3, stated she had pain on both knees and back of head in the morning and there were some days the Acetaminophen medication does not relieve her pain after taking the medicine. A review of the Nursing Visit note dated 8/31/21, 9/7, 9/14/21, indicated the patient had pain scale level of 8 (hurts a whole lot) on the back of head and both calves (muscle on the back of the lower leg) and was given the pain medication. There was no documented evidence of a post pain assessment and pain relief measures being provided by the visiting nurse. On 10/5/21, at 11 a.m., during an interview with the DPCS (director of nursing services), she stated the visiting nurse should do a post pain assessment and provide pain relief measures when Patient 3 has pain during visits. A review of the agency's undated policy of "Pain Management (revised on 11/2018)" indicated, when the patient or the clinician identifies pain, pain assessment information will be obtained including present pain management regimen and effectiveness.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the skilled nurse (SN) failed to notify the physician of patient's significant of condition to one of seven patients (Patient 3) with pain scale level of 9 (numerical scale from 0-10, with pain level of 10 being the worst pain) out of 10. This deficient practice had the potential for Patient 3's pain would not be relieved that could affect the patient's quality of life. Findings: A review of Patient 3's admission record indicated the patient was admitted to the home health agency on 2/22/21, with diagnosis that included diabetes mellitus (high blood sugar). A review of Patient 3's plan of care (POC) from 8/21/21 to 10/19/21, included an order for the skilled nurse (SN) visit of once a week for 9 weeks for assessment of all body system and medication compliance. One of the skilled nursing interventions was to notify the physician if patient's pain level is greater than 8 and pain level not acceptable to the patient. A review of Patient 3's Nursing Visit Note dated 9/21/21 indicated the patient was assessed of having a pain scale of 9 out 10 pain on both calves. There was no documented evidence the attending physician was notified. On 10/5/21, at 2 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated she could not find any communication note on 9/21/21, the physician was notified regarding Patient 3's pain level. A review of agency's policy titled "Change of Condition (undated)," indicated the clinician is responsible for any specific treatment and would notify the attending physician of significant changes in the patient's condition.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Skilled Professional Services by failing to ensure that background checks were done for two of two employees (Employee 1 and 2), prior to being hired. (Refer to G 702) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure the criminal background checks to the two of two newly hired employees (Employee 1 and 2) were obtained as indicated in the agency's hiring policy and procedure. This deficient practice had the potential for the the patients will be provided care and services by non-authorized/unqualified employees that could jeopardize the patients quality of care, and health and safety. Findings: On 9/30/21, at 10 a.m., a complaint validation survey was conducted at the facility to investigate allegation regarding the agency hired License Vocational Nurses (Employee 1 and 2) without doing the criminal background checks. A review of Employee 1's personnel file indicated a date of hire of 3/17/17, and a termination date of 3/14/18. Employee 1 had a LVN license issued on 7/8/04. There was no background check found on the employee's personnel file. A review of Employee 2's personnel file indicated a date of hire of 3/15/17, and a termination date of 3/14/18. Employee 2 was not issued a LVN's license and there was no background check on file. On 10/5/21, at 3 p.m., during an interview with the DPCS (director of patient care services), she stated Employee 1 was hired as an office manager on 3/17/2017 and Employee 2 was hired as a medical records clerk on 3/15/2017. DPCS stated both employees were terminated on 3/14/18 because of falsifying the payroll check by adding additional hours of work. DPCS also stated both employees were reported to the Labor Bureau department and reported back to the owner indicating Employees 1 and 2 had criminal records. DPCS further stated that the agency did not do a background checks to both employees when hired. A review of the agency's undated policy "Selection/Hiring of Personnel, indicated a criminal background check will be obtained for positions required by law, regulation, or organizational policy.