Every finding on record at Accxell Home Health Agency

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by:

Coordination of Care CFR(s): 484.60(d) Standard: Coordination of care. The HHA must: This STANDARD is not met as evidenced by:

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency failed to coordinate with the certified home health aides to ensure home visits were provided following the resumption of care, to one of four sampled patients, Patient 1. This failure had the potential that patients' activities of daily living will not be provided by the agency which can affect the patient's highest practicable mental and psychosocial well-being. On 9/17/22, a review of Patient 1's clinical record indicated the patient's original start of care (SOC) of 1/2/2022. The resumption of care date after hospitalization was 9/9/22, with diagnoses of venous insufficiency (failure of the veins to adequately circulate the blood, especially from the lower extremities), peripherial and weekness. During the resumption of care for the certification period of 8/30/2022 to 10/28/2022, the physician ordered skilled nurse SN) to visit patient, the second week, 2 times a week to provide venous status ulcer care to bilateral ankles with soap and water and antibiotic ointment and cover with 4x4 dressing. The physican ordered the home health aide (CHHA) to visit the patient 2 times a week staring the 2nd week to provide personal care. During a joint home visit on 9/17/2022, at 11;00 am., Patient 1 and his family caregiver ( FCG) stated she has not seen of heard from the CHHA or anyone from the agency since Patient 1 returned from the hospital on 9/9/2022. The FCG stated she and Patient 1 really need the CHHA in house to provide personal care. During an interview with the Administrator and Director of Patient Care Services on 9/18/22, at 12:30 p,m., They stated they were not sure if the CHHA was notified of the updated physician's order and that the CHHA will be contacted along with Patient 1 and his FCG. A review of the agency's policy and procedure on Clinical Service Manual, Patient Care Management Process, dated, 7/1/1998, indicated, " The primary care and team clinicians or alternate designee personnel licensed to take physician orders shall be responsible for obtaining initial and ongoing patient orders.

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the Department of Public Health: Surveyor ID #25046, Health Facilities Evaluator Nurse Surveyor ID #44186, Health Facilities Evaluator Nurse Number of unduplicated admissions for the past 12 months: 31 Active patients: 23 Sample Size: 7 Home Visits: 3 The following Conditions of Participation were not met: 484.55 Comprehensive Assessment of Patients 484.70 Infection Prevention and Control

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 as follows: 1. The HHA nursing staff failed to ensure patients on pain management as identified in the plan of care, completed the comprehensive assessment to control pain that includes medication, character and location of pain, pain level before intervention, and pain level after intervention for 3 of 7 sampled patients (Patients 1, 3, and 6). (Refer to G 518). 2. The HHA failed to assess the patient’s continuing need for home care for three of 7 sampled patients (Patient 1, Patient 4, and Patient 6). (Refer to G 532) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care services in a safe manner. -

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure patients on pain management as identified in the plan of care completed the comprehensive assessment to control pain that includes medication, character and location of pain, pain level before intervention, and pain level after intervention for 3 of 7 sampled patients (Patients 1, 3, and 6). This deficient practice has the potential in the delay to mitigate the pain and notify the physician promptly for unrelieved pain that could result to the patient's bodily discomfort and complications. c-1.A review of Patient 6's clinical record disclosed a start of care dated 11/3/2011, with diagnoses which included Arthropathy (disease of the joint), neuralgia (intense, intermittent pain along the course of a nerve) and neuritis (inflammation of a peripheral nerve or nerves). The Plan of Care (POC) for the certification period from 3/10/2022 through 5/8/2022, included order for the skilled nurse (SN) to visit the patient twice a week for 9 weeks for observation and assessment of vital signs and pain level/control/effectiveness. The SN was to notify the physician about the unrelieved pain (above 5 on a pain scale from 1 to 10) by the pain medications. The POC indicated following physician’s order: * Aspirin 81 milligram (mg) one tablet daily. * Diclofenac Sodium 1 % gel – apply 4 applications to the affected area(s) two times as needed for arthritis pain. * Aleve 220 mg two tablets by mouth daily as needed for arthritic pain. A review of Patient 6’s “Skilled Nursing Visit Note” from 3/10/2022 to 4/12/2022, and from 4/19/2022 to 5/12/2022 indicated Patient 6 had pain on the low back with the pain intensity of 4- 5 on a pain scale from zero to 10 (5/10). It indicated medication was applied. However, there was no documented evidence the pain level 4-5/10 was assessed before the medication was applied or after the medication was applied in order to ensure the medication was effective for pain or not. Also, there was no indication which medication was applied. During an interview with the Director of Patient Care Services (DPCS), on 5/23/2022, at 12 p.m., she stated she was not able to answer whether the above pain level was before the medication was administered or after the medication was administered, as well as which medication was administered. c-2. A review of Patient 6's “Recertification/Follow- up Assessment” dated 3/8/2022 indicated Patient 6 had pain. It indicated that any movement and ambulation makes the pain worse and the patient was receiving local anesthetics and non-steroid anti- inflammatory drugs (NSAIDs). However, the spaces for the pain location, description, onset, present pain level, worst pain level, best pain level were blank. There was no pain level assessment that the patient was able to tolerate. A review of the “Recertification/Follow- up Assessment” dated 5/7/2022 indicated the patient had pain. It indicated movement makes the pain worse, and massage and medication make the pain better. However, the spaces for the pain location, description, onset, present pain level, worst pain level, and best pain level were blank. There was no pain level assessment that the patient was able to tolerate. During an interview with the DPCS on 5/23/2022, at 2:20 p.m., she stated pain assessment should have been done completely including the location of pain, description, onset, present pain level, worst pain level, and the best pain level. c-3. A review of Patient 6’s “Skilled Nursing Visit Note” dated 3/29/2022 indicated the spaces for the pain assessment of origin, location, duration, and intensity were blank. It only indicated “meds” in the space for “other” of pain assessment section. There were no names of medications used. During an interview with the DPCS on 5/23/2022, at 2:20 p.m., she stated the SN should have performed pain assessment completely including origin, location, duration, and the medication which was administered. A review of undated “Pain Assessment” provided by the agency indicated to ask patient about the pain’s location, onset, character, and intensity. A review of the agency’s undated policy and procedure of “Pain Management Education” indicated pain assessment-documentation of pain on a scale of 1-10, pain site, SN pain management, what pain medication the patient was taking, must be documented on the skilled nurse note. It also indicated the SN must document the patients’ pain level prior to pain medication and after taking pain medication. a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 7/23/2021, with diagnoses which included hypertension (high blood pressure) and anemia (a condition in which the blood does not have enough healthy red blood cells). A review of Patient 1's Home Health Certification and Plan of Care for the certification period of 3/20/2022 to 05/18/2022, included an order for the skilled nurse (SN) to visit the patient twice a week for 9 weeks for observation and assessment of vital signs and pain level/control/effectiveness of response to medication. Patient 1's Plan of Care indicated the SN to notify the physician of pain above 5 on a pain scale (1-10) unrelieved by pain medication. A review of Patient 1's Skilled Nursing Visit notes dated 3/22/2022, 3/24/2022, 3/29/2022, 3/31/2022, 4/05/2022, 4/07/2022, 4/12/2022, 4/14/2022, 4/19/2022, 4/21/2022, 4/26/2022 and 4/28/2022, indicated that the patient pain level was not assessed and the pain intensity on the form was left blank. There was no other documentation indicating Patient 1's level of pain. During an interview with Director of Patient Care Services (DPCS) on 5/23/2022, at 11:45 a.m., the DPCS stated that a pain assessment should include the intensity (level) of the pain. The DPCS stated that Patient 1's clinical notes dated 3/22/2022 to 4/28/2022, had no pain intensity documented and that it should have been documented in the patient’s clinical record. b. A review of Patient 3's clinical record indicated a start of care (SOC) date of 6/10/2019, with diagnosis that included Parkinson's disease (disorder of the central nervous system that affects movement, often including tremors), hypertensive heart disease (refers to heart conditions caused by high blood pressure), and major depressive disorder (a mental health disorder characterized by persistently depressed mood or loss of interest in activities). A review of Patient 3's Home Health Certification and Plan of Care for the certification period of 9/27/2021 to 11/25/2021, included an order for the skilled nurse (SN) to visit the patient once a week for 9 weeks for observation and assessment of vital signs and pain level/control/effectiveness of response to medication. Patient 3's Plan of Care indicated the SN to notify the physician of pain above 5 on a pain scale (1-10) unrelieved by pain medication. A review of Patient 3's Skilled Nursing Visit notes dated 10/14/2021 and 10/22/2021, indicated that the patient pain level was not assessed and the pain intensity on the form was left blank. There was no other documentation indicating Patient 3's level of pain. During an interview with Director of Patient Care Services (DPCS) on 5/23/2022, at 11:45 a.m., the DPCS stated that a pain assessment should include the intensity (level) of the pain. The DPCS stated that Patient 3's clinical notes dated 10/14/2021 and 10/22/2021, had no pain intensity documented and that it should have been documented in the patient’s clinical record.

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: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to conduct a comprehensive assessment to clearly demonstrate continuing needs for home health services for three of 7 sampled patients. (Patients 1, 4, and 6). This deficient practice resulted in the provision of continued HH services to patients who no longer are eligible to receive the home health benefits and care services. b. On 5/20/2022, at 11:50 p.m., during Patient 4’s home visit with Licensed Vocational Nurse 1 (LVN 1) at the patient’s residence, Patient 4 was observed alert and oriented, able to walk without using any assistive device. During an interview with Patient 4, he stated he was renting that place from Caregiver 1, who had been helping him with his living such as cooking twice a week, doing laundry, providing ride to the doctor’s office and grocery shopping. Patient 4 stated if Caregiver 1 drove him to the grocery store, he could pick the food such as milk and juice. Patient 4 stated he did not have pain except slight headache, and he was able to take medications himself. A review of Patient 4's clinical record indicated a start of care date of 6/2/2015, with diagnoses of hypertension (high blood pressure), chronic obstructive pulmonary disease (COPD- a condition involving constriction of the airways and difficulty or discomfort in breathing), and diabetes mellitus (DM- A chronic condition that affects the way the body processes blood sugar). A review of Patient 4's plan of care (POC) certification period from 4/26/2022 to 6/24/2022, indicated an order for the skilled nurse (SN) to visit once a week for nine weeks, for skilled observation and assessment of all vital signs, cardiovascular status, pulmonary status, medication compliance/effectiveness, sign/symptoms of hypo/hyperglycemia, signs and symptoms of hypertension and cerebrovascular accident. The SN was to draw blood sugar level via finger stick via blood glucose monitor every visit and was to notify the physician if blood pressure is below 90 /60 millimeter of mercury (mm Hg) or above 150/90 mmHg. The Goal/Rehabilitation potential of the POC indicated “demonstrate home safety measures” and “Rehabilitation potential: Fair due to disease process”. The Discharge Plans of the POC indicated to discharge when goals were met, and that the patient remain in situation with assist from the community resources, with the physician follow up and supervision. The 60-day summary of the POC indicated there was no report of fall or hospitalization. It indicated, Patient 4’s blood pressure ranged from 180/100 to 103/50 and the blood sugar ranged from 250 milligram (mg) /deciliter (dl) to 52 mg/dl. A review of the Skilled Nursing Visit Note from 3/2/2022 to 4/28/2022, and Recertification/Follow up Assessment dated 4/21/2022 indicated there was no documented evidence the patient had pain, fall or hospitalization. Patient 4’s blood pressure ranged from130 /60 mmHg to 148/80 mmHg, and blood sugar ranged from 81 mg/dl to 260 mg/dl. There was no documented evidence Patient 4’s blood pressure ranged from 180/100 mmHg to 103/50 mmHg, and the blood sugar ranged from 250 milligram (mg) /deciliter (dl) to 52 mg/dl from 3/2/2022 to 4/28/2022. On 5/23/2022, at 11:50 a.m., during an interview with the Director of Patient Care Services (DPCS), she was not able to provide the documented evidence Patient 4’s blood pressure ranged from 180/100 to 103/50 and the blood sugar ranged from 250 milligram (mg) /deciliter (dl) to 52 mg/dl from 3/2/2022 to 4/28/2022 and not able to provide the documented justification for the next benefit period (recertification from 4/26/2022 to 6/24/2022). The DPCS stated Patient 4 should have been discharged. c. A review of Patient 6's clinical record disclosed a start of care dated 11/3/2011, with diagnoses which included Arthropathy, neuralgia and neuritis. The POC for the certification period from 3/10/2022 through 5/8/2022, included order for the skilled nurse (SN) to visit the patient twice a week for 9 weeks for observation and assessment of vital signs and pain level/control/effectiveness. The SN was to notify the physician about the unrelieved pain (above 5 on a pain scale from 1 to 10) by the pain medications. The POC indicated following physician’s order: * Aspirin 81 milligram (mg) one tablet daily. * Diclofenac Sodium 1 % gel – apply 4 applications to the affected area(s) two times as needed for arthritis pain. * Aleve 220 mg two tablets by mouth daily as needed for arthritic pain. The POC Goal/Rehabilitation potential/Discharge plans indicated the patient ambulates independently with assistive devices, and pain will be 0-2 on a pain scale from 1-10 with pain medication. The 60-day summary of the POC indicated the patient complained of arthritic joint pain with pain level 5-6 on a pain scale from 1-10. The SN was to assess pain status and pain medication effectiveness. A review of the “Recertification/Follow- up Assessment” dated 3/8/2022 indicated Patient 6 had pain, and movement and ambulation makes the pain worse. It indicated the patient was receiving local anesthetics and non-steroid anti- inflammatory drugs (NSAIDs). However, the spaces for the pain location, description, onset, present pain level, worst pain level, and best pain level were blank. Also, there was no pain level assessment that the patient was able to tolerate. A review of the “Recertification/Follow- up Assessment” dated 5/7/2022 indicated the patient had pain. It indicated the movement makes the pain worse, and massage and medication make the pain better. However, the spaces for the pain location, description, onset, present pain level, worst pain level, and best pain level were blank. There was no pain level assessment that the patient was able to tolerate. A review of Patient 6’s “Skilled Nursing Visit Note” from 3/10/2022 to 4/12/2022, and from 4/19/2022 to 5/12/2022 indicated Patient 6 had pain on the low back with the pain intensity of 4- 5 on a pain scale from zero to 10 (4-5/10). It indicated medication was applied. However, there was no documented evidence the pain level 4-5/10 was assessed before the medication was applied or after the medication was applied in order to ensure the medication was effective for pain or not. Also, there was no indication which medication was applied. A review of Patient 6’s record indicated there was no documented evidence the agency staff ensured the patient’s pain was relieved to the point that Patient 6 was comfortable. Also, there was no documented evidence the agency staff put an effort/communicated with the physician to improve Patient 6’s pain level if the pain level 4-5/10, was the pain level after pain medication (Aleve 220 mg or Diclofenac Sodium 1 % gel) was administered. During an interview with the Director of Patient Care Services (DPCS), on 5/23/2022, at 2:30 p.m., she stated she was not able to answer whether the above pain level (4-5/10) was before the medication was administered or after the medication was administered. She was also not able to answer which medication was administered. When asked what the justification was for recertifying the benefit period since 11/3/2022, for 11 years, without assessing whether the pain had been managed or not, she was not able to answer. A review of the agency’s policy and procedure titled “Discharge Planning, Discharge Criteria, Discharge, Transfer” dated 7/1/1998 indicated the discharge criteria include: *The treatment objectives are attained – or they are no longer attainable * Conditions requiring the patient transfer of services – Determination of the inappropriateness of continuing services. The policy also indicated to review the patient’s discharge potential and corresponding plan of care for necessary revisions and to determine the appropriateness or inappropriateness of the client’s continuing to receive home care services. The Home Health Care staff assists clients and families in their discharge by consulting with the patient and caregivers regarding the need for discharge from the home health care program a. A review of Patient 1's clinical record indicated a start of care date (SOC) of 7/23/2021, with diagnoses which included hypertension (high blood pressure) and anemia (a condition in which the blood does not have enough healthy red blood cells.). A review of Patient 1's Home Health Certification and Plan of Care (POC) for the certification period of 3/20/2022 to 5/18/2022, included an order for the skilled nurse (SN) visits of twice a week for 9 weeks for assessment of all vital signs, cardiovascular status, pulmonary status, medication compliance, skin integrity and pain level/control/effectiveness. The POC indicated to notify the physician if blood pressure (Bp) is below 90/60 or above 160/90, and pain above 5 on a pain scale 1-10 unrelieved by pain medications. The goal included patient and patient caregiver will demonstrates compliance with medications, maintain Bp in range of 90/60-120/80, demonstrate home safety measures, and patient will be free from injuries at home. Discharge planning indicated to discharge when goals are met, patient to remain in situation with assist from family and from community resources, and with physician follow-up and supervision. On 5/20/22, at 11:45 a.m., a home visit was made to Patient 1's residence. Patient 1 was observed alert, oriented and walking around his residence with a steady gait without using any assistive device. During an interview with Patient 1 and his caregiver (Caregiver 3) on 5/20/22, at 12:10 p.m., Patient 1 stated that he takes his own medications daily, does not take any pain medications, and goes to his physician regularly. He also stated that he does not have any body ache, headache or pain, no dizziness, no falls, and does his activities of daily living (ADLs, like bathing, toileting, dressing, eating, mobility) independently. Caregiver 3 stated she lives with the patient and does the cooking, drove Patient 1 to the market and to his doctor’s appointment. A review of Patient 1's Skilled Nursing Visit Notes from 3/20/22 to 5/10/22 indicated Patient 1’s blood pressure ranging from 126-142 systolic (top number) and 60-80 diastolic (bottom number). The rest of the patient's vital signs (temperature, pulse rate and respiratory rate) were within a normal range, bowel movements were regulated and no complaints of pain. There were no admissions to the hospital, no episodes of falls and any evidence of the need for skilled nursing services to continue. The patient was re-certified for another 60 days for continuous skilled nursing services. During an interview with the Director of Patient Care Services (DPCS) on 5/23/22, at 12:05 p.m., the DPCS stated the patient's vital signs have been stable, no change in condition of the patient, no pain, no hospitalization and should have been discharged.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure written information of the medications including the action and side effects the patients were taking were provided to the patient/caregiver for two of 7 sampled patients (Patient 4, and 5). This deficient practice has the potential for the patient or caregiver will lack knowledge of the medication regimen, its effects, and adverse actions of the medications that could lead to medication errors. a. A review of Patient 4's clinical record indicated a start of care date of 6/2/2015, with diagnoses of hypertension (high blood pressure), chronic obstructive pulmonary disease (COPD- a condition involving constriction of the airways and difficulty or discomfort in breathing), diabetes mellitus (DM- A chronic condition that affects the way the body processes blood sugar), and insomnia (problems falling and staying asleep). A review of Patient 4's plan of care (POC) certification period from 4/26/2022 to 6/24/2022, indicated for the skilled nurse (SN) to visit once a week for nine weeks. The SN was to perform skilled observation and assessment of vital signs, medication compliance/effectiveness, and to teach medication regimen. The POC indicated antidepressant medication (Sertraline HCL 100 milligram two tablets every morning – one of the side effects was difficulty falling asleep). On 5/20/2022, at 11:50 p.m., during a home visit with Licensed Vocational Nurse 1 (LVN 1) at Patient 4’s residence, Patient 4 was observed alert and oriented, able to walk without using any assistive device. During an interview with Patient 4, he stated he lives by himself with the help of caregiver, and he was able to take his medications himself. At 12:05 p.m., Patient 4’s medications were reviewed reconciling with the medication profile. A review of the medication profile indicated the spaces for the medication class and related diagnosis were blank. During an interview with the patient, he stated he knew what his medications are for, but did not know the side effects of the medications. When asked, Patient 4 stated he was not provided the written instruction about his medications including action and side effects of the medication by the agency. During an interview with LVN 1 at the same time, he stated he did not provide the written instruction including the action and side effects Patient 4’s medications. b. A review of Patient 5's clinical record indicated a start of care date of 8/12/2020, with diagnoses of hypertensive heart disease (heart conditions caused by high blood pressure), gastro esophageal reflux disease (GERD), and psychosis. A review of the Patient 5's plan of care (POC) certification period from 4/4/2022 to 6/2/2022, indicated an order for the skilled nurse (SN) to visit once a week for nine weeks. SN was to perform skilled observation and assessment of vital signs, medication compliance/effectiveness, teach medication regimen, and medication administration. The POC included antipsychotic medication (Haloperidol 15 mg every bedtime – side effects included heart burn, dizziness, drowsiness, etc.). At 12:40 p.m., Patient 5’s medications were reviewed reconciling with the medication profile. A review of the medication profile indicated the spaces for the medication class and related diagnosis were blank. During an interview with Caregiver 1 and Caregiver 2, they both stated they did not know the side effects of the medications. Caregiver I and Caregiver 2 stated they were not provided the written instruction about Patient 5’s medications including action and side effects of the medication by the agency. During an interview with LVN 1 at the same time, he stated he did not provide the written instruction including the action and side effects Patient 5’s medications. A review of the agency’s policy and procedure titled “Medication Profile” dated 7/1/1998, indicated the Medication Information Sheet should be provided to the patient at the time of distribution of the initial delivery or with each new prescription being provided to the patient. The original Medication Information Sheet will be given to the patient with instruction on use.

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 observation, interview and record review, the home health agency (HHA) failed to ensure the Conditions of Participation for Infection Prevention and Control were met as follows: 1. The Home Health agency (HHA) failed to follow accepted standards of practice to prevent the transmission of infections and communicable diseases for one of 7 sample patients (Patient 4). The HHA failed for the skilled nurse (SN), to prevent cross contamination, when used a glucometer (a portable device that checks the blood sugar) with a lancet device to make a small prick to the fingertips (finger stick), to test Patient 4's blood sugar levels. The glucometer device was used to other patients and was not disinfected before using the device to Patient 4. Refer G 682 2. The Home Health Agency (HHA) failed to develop procedure to identify the infection and risks of infection among patients, to prevent and control the transmission of infectious and communicable disease, specific to the care and services provided, to one of four sampled patients (Patient 4). Refer to G684 The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe manner. -

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the Home Health agency (HHA) failed to follow accepted standards of practice to prevent the transmission of infections and communicable diseases for one of 7 sample patients (Patient 4). The HHA failed for the skilled nurse (SN), to prevent cross contamination, when used a glucometer (a portable device that checks the blood sugar) with a lancet device to make a small prick to the finger tips (finger stick) to test Patient 4's blood sugar levels. The glucometer device was used to other patients and was not disinfected before using the device to Patient 4. This deficient practice placed the patient at high risk for cross contamination that could affect the patient's health status.. A review of Patient 4's clinical record indicated a start of care date of 6/2/2015, with diagnoses of hypertension (high blood pressure), chronic obstructive pulmonary disease (COPD- a condition involving constriction of the airways and difficulty or discomfort in breathing), and diabetes mellitus (DM- A chronic condition that affects the way the body processes blood sugar). A review of the Patient 4's plan of care (POC) certification period from 4/26/2022 to 6/24/2022, indicated an order for the skilled nurse (SN) to visit once a week for nine weeks, for skilled observation and assessment of all vital signs, cardiovascular status, pulmonary status, medication compliance/effectiveness, sign/symptoms of hypo/hyperglycemia. The SN was to draw blood sugar level via finger stick via blood glucose monitor every visit and was to notify the physician if blood sugar is below 70 milligram (mg)/deciliter (dl) or above 250 mg/dl. On 5/20/2022, at 11:50 p.m., during Patient 4’s home visit with Licensed Vocational Nurse 1 (LVN 1) at the patient’s residence, Patient 4 was observed alert and oriented, able to walk without using any assistive device. At 11:55 a.m., LVN 1 took out the glucometer and fingerstick device (Glucometer 1) from his bag. LVN 1 put a new lancet in the fingerstick device and proceeded checking Patient 4's blood sugar level. On 5/20/2022, at 12:20 p.m., during an interview with LVN 1, he stated Glucometer 1 was not Patient 4’s. LVN 1 further stated he bought it at his own expense in “beginning of May 2022”. LVN 1 had been using the glucometer and fingerstick device for Patient 4 and three patients from other agency, four times a week since “beginning of May 2022”. LVN 1 stated the agency did not provide instructions about sharing same glucometer and fingerstick device with different patients, and he did not know the glucometer and fingerstick device should not be shared with others. On 5/23/2022, at 10:45 a.m., during an interview with the Director of Patient Care Services (DPCS), she stated if the patient did not have a glucometer and fingerstick device, the nurse could use his/her glucometer and fingerstick device that was shared with others. The DPCS stated the nurse could use the same glucometer and the fingerstick device for more than one patient as long as it was cleaned in between uses. The DPCS was not aware that the glucometer and fingerstick device should not be shared with others. A review of Glucometer 1’s “User Instruction Manual” indicated the lancing device is for single patient use only and should never be shared with another person, even a family member. The lancing device should not be used for multiple patients testing by the healthcare providers or at healthcare provider sites. The manual indicated to clean the outside of the glucometer with a damp cloth only. It did not indicate how to disinfect the Glucometer 1. According to the Centers for Disease Control and Prevention indicated as follows: Risk of blood glucose testing is the opportunity for exposure to bloodborne viruses [hepatitis B virus (HBV- infection of the liver), hepatitis C virus (contagious liver disease), and human immunodeficiency virus (HIV- attacks the body's natural defense system)] through contaminated equipment and supplies if devices used for testing or insulin administration (e.g., blood glucose meters, fingerstick devices, insulin pens) are shared. Fingerstick devices should never be used for more than one person. Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer’s instructions. If manufacturer does not specify how the device should be cleaned and disinfected, then it should not be shared.

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 observation, interview and record review, the Home Health Agency (HHA) failed to develop procedure to identify the infection and risks of infection of the patients, to prevent and control the transmission of infectious and communicable disease, specific to the care and services provided, to one of four sampled patients (Patient 4). The HHA failed for the skilled nurse (SN), to disinfect the glucometer fingerstick device, before testing Patient 4’s blood sugar level, that the glucometer has been used and shared to other patients of the agency. This deficient practice has the potential to spread and transmit infectious or communicable diseases to patients provided care and services by the home health agency. A review of Patient 4's clinical record indicated a start of care date of 6/2/2015, with diagnoses of hypertension (high blood pressure), chronic obstructive pulmonary disease (COPD- a condition involving constriction of the airways and difficulty or discomfort in breathing), and diabetes mellitus (DM- A chronic condition that affects the way the body processes blood sugar). A review of the Patient 4's plan of care (POC) certification period from 4/26/2022 to 6/24/2022, indicated an order for the skilled nurse (SN) to visit once a week for nine weeks, for skilled observation and assessment of all vital signs, cardiovascular status, pulmonary status, medication compliance/effectiveness, sign/symptoms of hypo/hyperglycemia. The SN was to draw blood sugar level via finger stick via blood glucose monitor every visit and was to notify the physician if blood sugar is below 70 milligram (mg)/deciliter (dl) or above 250 mg/dl. On 5/20/2022, at 11:50 p.m., during Patient 4’s home visit with Licensed Vocational Nurse 1 (LVN 1) at the patient’s residence, Patient 4 was observed alert and oriented, able to walk without using any assistive device. At 11:55 a.m., LVN 1 took out blood glucometer and fingerstick device from his bag. LVN 1 put a new lancet in the fingerstick device and proceeded checking Patient 4's blood sugar level. On 5/20/2022, at 12:20 p.m., during an interview with LVN 1, he stated above glucometer and fingerstick device was not Patient 4’s, but it was LVN 1's. LVN 1 stated he had bought it with his own expense in “beginning of May 2022”, and he had been using above glucometer and fingerstick device for Patient 4 and three patients from other agency, four times a week since “beginning of May 2022”. LVN 1 stated the agency did not provide instruction about sharing same glucometer and fingerstick device with different patients, and he did not know the glucometer and fingerstick device should not be shared with others. On 5/23/2022, at 10:45 a.m., during an interview with the Director of Patient Care Services (DPCS), she stated if the patient did not have a glucometer and fingerstick device, the nurse could use his/her glucometer and fingerstick device that was shared with others. The DPCS stated the nurse could use the same glucometer and the fingerstick device for more than one patient as long as it was cleaned in between uses. The DPCS was not aware that the glucometer and fingerstick device should not be shared with others. On 5/23/2022, at 2:30 p.m., upon request for the agency’s policy regarding sharing the glucometer and fingerstick device, the DPCS stated the agency did not have a policy regarding sharing the glucometer and fingerstick device. The DPCS also stated the agency did not provide the education/instruction to staff about the risk of infectious disease being spread by sharing glucometer and the fingerstick device used to monitor blood sugar levels. A review of Glucometer 1’s “User Instruction Manual” indicated the lancing device is for single patient use only and should never be shared with another person, even a family member. The lancing device should not be used for multiple patients testing by the healthcare providers or at healthcare provider sites. The manual indicated to clean the outside of the glucometer with a damp cloth only. It did not indicate how to disinfect the Glucometer 1. According to the Centers for Disease Control and Prevention indicated as follows: Risk of blood glucose testing is the opportunity for exposure to bloodborne viruses [hepatitis B virus (HBV- infection of the liver), hepatitis C virus (contagious liver disease), and human immunodeficiency virus (HIV- attacks the body's natural defense system)] through contaminated equipment and supplies if devices used for testing or insulin administration (e.g., blood glucose meters, fingerstick devices, insulin pens) are shared. Fingerstick devices should never be used for more than one person. Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer’s instructions. If manufacturer does not specify how the device should be cleaned and disinfected, then it should not be shared.

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, interview, and record review, the home health agency failed to ensure the security of patient records at all times and the privacy of information contained on those records by leaving open boxes with patient medical records exposed near the agency’s entrance door. This deficient practice may cause patients at a high risk for identity theft or misuse of health information. On 5/23/2022 at 9:45 a.m., during an observation, eleven open boxes were found on the floor near the entrance door of the Home Health Agency. Inside each of these boxes were multiple folders with patient names, medical records, and the date of discharge. On 5/23/2022 at 12:45 p.m., during an interview with the Administrator (ADM), the ADM stated the boxes near the agency’s entrance door contained medical records of patients who have been discharged. The ADM admitted anybody that comes inside the agency can see patient names on the side of the folders inside those open boxes or anyone can remove those folders without them noticing it. The ADM stated patient’s medical records should always be kept confidential and be protected from unauthorized use. A review of the agency's policy and procedure titled, "Clinical Services Manual Patient Medical Record," undated, indicated only authorized Home Health Agency professionals involved or concerned with the care of patients shall be permitted access to and/or to make entries in the Patient Medical Record (PMR). The Home Health Agency shall take reasonable precautions and implement designated security measures to safeguard both the PMR and its contents against loss, defacement, tampering, and authorized disclosure or use and all records will be stored in a secure area.