Every finding on record at A Bion Home Health Care, Inc

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey. Representing the Department of Public Health: Surveyor ID # - 40992 - RN-HFEN Surveyor ID # - 22303 - RN-HFEN Total Census=103 Total Sample - 7 Patients Home Visit - 5

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 failed to ensure the Condition of Participation for Comprehensive assessment of patients was met as follows: The agency failed to accurately assess and qualify patients to receive home health services resulting in home health funding and services given to patients who are independent, have little or no difficulty ambulating when leaving their home, and who do not require skilled nursing and other home health services for five of seven sampled patients who were not accurately assessed and seven of seven sampled patients who were recertified. The cumulative effect of these systematic practices resulted in the failure of the agency to ensure patients met the criteria for receiving skilled nursing and home health services reserved for patients who experience difficulty or a taxing effort during ambulation.

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 observation, interview, and record review, the home health agency failed to ensure five of 7 patients (Patient 3,4,5,6 and 7) met the eligibility criteria for skilled nursing and home health services. This deficient practice resulted in the agency's utilization of medicare funds and home health resources, dedicated to persons who require skilled nursing services, and experience a severe and taxing effort when leaving their homes, given to patients who did not qualify for the services, and had no orders for home health services from their primary physicians. For Patient 3 the patient and his wife/caregiver are independent in Patient 3's care and the patients primary physician was not aware the patient was receiving home health services. For Patient's 4 and 5 the patients primary physician stated, "I have been Patient 4's and 5's primary care physician since 2015". The physician was unaware the patients are receiving home health services that she did not prescribe. For Patient 6 she stated that she was referred to home health by her friends. She also stated she wanted to have a home health nurse to visit every week to check on her health status. The patient lives by herself with a part time caregiver that comes to her house daily. A home visit was conducted at Patient 6's residence and the patient was observed walking, using a walker, without distress or difficulty, and without shortness of breath, For Patient 7 the patient was observed during a home visit walking with a steady gait without using an assistive device and stated that her attending physician denied her to have home health services because she does not need it. Findings: A. On 1/12/21, at 10 a.m., a complaint validation survey was conducted at the agency. A review of Patient 3's clinical record indicated a start of care (SOC) dated 9/23/20, with a primary diagnosis of other chronic pain (persisting for long time pain). A review of Patient 3's plan of care (POC) from 9/23/20 to 11/21/20, included an order for the skilled nurse (SN) to visit twice a week for two weeks, and once a week for seven weeks, to observe/assess all body systems. The POC was written by Physician 3, who is the admitting and referring physician, and belongs to a mobile medical group. Discharge Planning indicated to discharge when patient in a safe environment with primary medical doctor follow up appointments and supervision, under family /caregiver for minimal assistance with activities of daily living and instrumental activities of daily living (ADLS/IADLS). A review of the Comprehensive Adult Nursing Assessment (An assessment that determines the need for home health services) dated 9/23/20, indicated the patient had aching right shoulder and back pain at a pain level of 7 (moderate) and aching right hip pain at a pain level of 6 (moderate) on a pain scale from 0 (no pain) to 10 (worse pain). The pain was daily but not constantly. The assessment form indicated massage, rest, repositioning, relaxation, and medication relieved the pain. The form indicated the blood sugar reading was 142 mg/dl, blood pressure reading of 148/76 mmHg, and patient required assistance with ambulation, dressing, bathing, grooming, and transferring. On 1/13/21, at 10 a.m., a home visit was conducted at Patient 3's residence with RN 1. Patient 3 was observed walking to the door, without distress or difficulty, without shortness of breath, and without the use of a walker or a cane. During an interview with Patient 3 on 1/13/21, at 11:00 a.m. he stated he lived with his wife, who is the caregiver. She takes his vitals signs (example- blood pressure readings and heart rate) and assists him with all his needs. Patient 3 further stated, "I have been taking my blood pressure and blood sugar since the 90's, now and I take all my medications, I know how to do that." Patient 3 further stated, "I was referred to home health from a friend a few years ago and I contacted them (agency) and they sent a doctor to come see me and started nurses come and check on me every week." When asked if his primary medical doctor knows he is receiving home health services, Patient 3 stated, "No, I told him I wanted home health services a while back and he didn't write for it. So I never asked him again. I just contacted the agency directly." When asked why he thinks he needs home health services, Patient 3 stated, "I like the comfort of having a nurse come check on my health once a week, I feel more comfortable, especially now with COVID." During an interview with RN 1 on 11/13/21 at 11:15 a.m., she stated, "Patient 3 was certified for home health services because the patient needed continuous monitoring with his fluctuating BP readings, and to remind the patient to take his medications, and he is also scared of leaving the house due to COVID. The patient contacted our agency since they (spouse) were interested in home health services, and got a referral from the mobile doctor and we accepted him." During an interview with Physician 4 on 1/14/21 at 1 p.m. he stated, "Yes, I am the primary care physician for Patient 3 since 2017." When asked if he knew Patient 4 has home health services, Physician 4 stated, "No, I was unaware patient 4 has home health services, I didn't write an order for that and I had a tele-visit with him on 9/22/20 and 12/24/20." When asked if Patient 3 needs home health services per his assessment, Physician 4 stated, "Per my assessment and professional opinion he does not need home health services at this time." During an interview with Nurse Practitioner 1 (NP1) on 1/20/20 at 2:30 p.m. she stated, "I work for a mobile doctor medical group and under Physician 3. We get referrals from home health agencies and we do "tele" (contacting patients without going to the patients home) visits with patients. I assessed and referred Patient 3 for his start of care and recertification period. Physician 3 never saw the patient, I sent him my assessment and the patient was signed on to home health services". When asked if Patient 3 was homebound, NP1 stated, "Yes, he told me he doesn't drive and doesn't have transportation to leave the house, he is also scared of getting COVID." b. A review of Patient 4's clinical record indicated a start of care (SOC) dated 9/12/20 with a primary diagnosis of other chronic pain. A review of Patient 4's POC dated 9/12/20 to 11/10/20, includes an order for the SN to visit once a week for one week, twice a week for two weeks, and once a week for 6 weeks, to observe/assess all body systems. The POC was written by Physician 6, who is the admitting and referring physician, and belongs to a mobile medical group. Discharge Planning indicated to discharge when patient in a safe environment with primary medical doctor follow up appointments and supervision, under family /caregiver for minimal assistance with ADLS/IADLS. A review of the Comprehensive Adult Nursing Assessment (An assessment that determines the need for home health services) dated 9/12/20, indicated the patient had aching low back and knees pain with the pain level being 7 (moderate) and aching shoulders pain with a pain level of 5 (moderate) on a pain scale from 0 (no pain) to 10 (worse pain). The pain was daily but not constantly. The assessment indicated heat, massage, rest, relaxation, and medication to relieved the pain. The blood pressure reading for the patient was 148/82 mmHg, and the patient required assistance with ambulation, dressing, bathing, grooming, and transferring. During a tele-visit (contacting the patient outside of the patients residence) on 1/14/21 at 1:15 p.m., Patient 4 was observed walking around her house without the use of a cane or a walker without distress or difficulty, and without shortness of breath. The patient also indicated that she was able to independently perform activities of daily living during the time the Home health agency signed her up for services. During an interview with Patient 4 on 1/14/21 at 1:30 p.m. she stated, "I live with my husband. We have had home health services on and off for the past year. Last time we were signed on was in September I believe. We heard about the home health agency from a friend referral, and we contacted the agency, and the agency sent out a doctor, I don't remember his name, and they signed me and my husband for home health services." When asked if her and her husband's primary care physician is aware they are both receiving home health services, she stated "I am not sure." During an interview with Physician 5 on 1/18/21 at 11:50 a.m. she stated, "I have been patient 4's and 5's primary care physician since 2015. My last two tele-visits (contacting the patient in a location other than the patients place of residence) with them were on 8/11/20 and 10/6/20. I was unaware they are receiving home health services, I didn't prescribe it, and I didn't evaluate them for home health services. I am reviewing my documentation and I don't see a request from them for home health services." During an interview with director of patient care services (DPCS) on 1/20/21 at 1:30 p.m. she stated, "Patient 4 and Patient 5 didn't want to go to their own doctor due to COVID so they needed help, so they contacted our home health agency and a mobile doctor was sent to them. Our agency was monitoring them because they don't want to go to the hospital, they rather have home health nurses monitor them and remind them to take their medications." During an interview with NP 2 on 1/20/21 at 3:30 p.m. she stated, "I work with a mobile doctor medical group under Physician 6 and did a Facetime assessment for Patient 4 and Patient 5 on 9/11/20. I then sent my report to Physician 6, and he then signed the patients up for home health services based on my assessment and recommendations. I did my assessment based on the current medications the patients were on, what the patients were complaining about to me, and if there was a previous assessment from their last home health service." When asked if NP 2 thinks Patient 4 is homebound, she stated, "Patient 4 stated she has walking difficulties, I only observed her through my Facetime visit."(seeing the patient outside of the patients place of residence on an electronic device) c. A review of Patient 5's clinical record indicated a start of care (SOC) dated 9/12/20 with a primary diagnosis of Polyosteoarthritis (related to process of aging, as water content of body cartilage increases, and the protein makeup of cartilage degenerates resulting in joint pain and swelling). A review of Patient 5's POC dated 9/12/20 to 11/10/20, includes an order for SN to visit once a week for one week, twice a week for two weeks, and once a week for 6 weeks, to observe/assess all body systems. The POC was written by Physician 6, who is the admitting and referring physician, and belongs to a mobile medical group. Discharge Planning indicated to discharge when patient in a safe environment with primary medical doctor follow up appointments and supervision, under family /caregiver for minimal assistance with ADLS/IADLS. A review of the Comprehensive Adult Nursing Assessment (to determine the need for nursing services) dated 9/12/20, indicated the patient had aching pain in the knees and legs with a pain level of 7 (moderate) and aching back pain with a level of 6 (moderate) on a pain scale from 0 (no pain) to 10 (worse pain). The pain is daily but not constantly. It indicated rest, repositioning, relaxation, and medication relieved the pain. The blood pressure reading for Patient 5 was 142/88 mmHg, and patient required assistance with ambulation, dressing, bathing, grooming, and transferring. During a tele-visit on 1/14/21 at 1:15 p.m., Patient 5's wife was seen on camera and answered all the questions for her husband. During an interview with Patient 5's wife on 1/14/21 at 1:30 p.m. she stated, "My husband isn't feeling well, he is laying down. I can answer all the questions for him since we both have the same home health services. I live with my husband. We have had home health services on and off for the past year. Last time we were signed on was in September I believe. We heard about the home health agency from a friend referral, and we contacted the agency, and the agency sent out a doctor, I don't remember his name, and they signed me and my husband for home health services." When asked if her and her husband's primary care physician is aware they are getting home health services, she stated "I am not sure." During an interview with Physician 5 on 1/18/21 at 11:50 a.m. she stated, "I have been patient 4's and 5's primary care physician since 2015. My last two tele-visits with them were on 8/11/20 and 10/6/20. I was unaware they are receiving home health services, I didn't prescribe it, and I didn't evaluate them for home health services. I am reviewing my documentation and I don't see a request from them for home health services." During an interview with director of patient care services (DPCS) on 1/20/21 at 1:30 p.m. she stated, "Patient 4 and Patient 5 didn't want to go to their own doctor due to COVID so they needed help, so they contacted our home health agency and a mobile doctor was sent to them. Our agency was monitoring them because they don't want to go to the hospital, they rather have home health nurses monitor them and remind them to take their medications." During an interview with NP 2 on 1/20/21 at 3:30 p.m. she stated, "I work with a mobile doctor medical group under Physician 6 and did a Facetime (viewing the patient on an electronic device) assessment for Patient 4 and Patient 5 on 9/11/20. I then sent my report to Physician 6, and he then signed the patients up for home health services based on my assessment and recommendations. I did my assessment based on the current medications the patients were on, what the patients were complaining about to me, and if there was a previous assessment from their last home health service." When asked if NP 2 thinks Patient 5 is homebound, she stated, "Patient 5 stated he has walking difficulties, I only observed him through my Facetime visit." d. A review of Patient 6's clinical record indicated a start of care (SOC) date of 9/4/20, with diagnosis that included hypertension (high blood pressure). A review of Patient 6's plan of care (POC) from 9/15/20 to 11/13/20, included an order for the skilled nurse (SN) to visit of once a week for one week, twice a week for two weeks, once a week for 6 weeks, for assessment of all body system and medication compliance. It was indicated that Physician 1 ( mobile physician) that belongs to a medical group was the referring and admitting physician for Patient 6. A review of the Comprehensive Adult Nursing Assessment (A patient assessment tool used to determine the need for home health services) dated 9/15/20, indicated the patients BS reading was 194 mg/dl, BP reading of 140/80 mmHg, and that patient required assistance with ambulation, grooming and bathing. On 1/14/21, at 11 a.m., a home visit was conducted at Patient 6's residence. Patient 6 was observed walking using a walker without distress or difficulty, and without shortness of breath, At 11:15 a.m., during an interview with Patient 6, she stated she lives by herself with a part time caregiver that comes to her house daily. She also stated that she was referred to home health by her friends. She also stated she wanted to have a home health nurse to visit every week to check on her health status. On 1/15/21, at 1 p.m., an attempt to call Patient 6's attending physician over the phone, talked to the office manager of the medical clinic and stated the physician was out of town and did not get a return call from him. On 1/19/21, at 2 p.m., during an interview with the office manager from Physician 1's clinic, she stated that Physician 1 no longer works for that medical group clinic. She confirmed that Physician 1 was Patient 6's referral and admitting doctor for the home health agency. On 1/20/21, at 1:20 p.m., during an interview with the director of patient care services (DPCS), she stated that Patient 6 did not have an attending physician to refer her to their home health. Therefore, the agency's protocol was to call a medical group and have one of their physicians (mobile doctor) or nurse practitioner to do a face to face encounter with the patient to determine eligibility for home health services. e. A review of Patient 7's clinical record indicated a start of care (SOC) date of 9/20/20, with diagnosis that included hypertension (high blood pressure). A review of Patient 7's plan of care (POC) from 9/20/20 to 11/18/20, included an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for 7 weeks, for assessment of all body system and medication compliance. It was indicated that Physician 2 ( mobile physician) who belongs to a medical group was the referring and admitting physician for Patient 7. A review of the Comprehensive Adult Nursing Assessment (An assessment that determines the need for home health services) dated 9/20/20, indicated the patients BP reading was 126/82, and that patient required assistance with ambulation, grooming and bathing. On 1/14/21, at 2 p.m., a home visit was conducted at Patient 7's residence. Patient 7 was observed walking with a steady gait without using an assistive device, without distress or difficulty, and without shortness of breath. The patient also indicated that she was able to independently perform activities of daily living during the time the home health agency signed her up for services. On 1/14/21, at 2:15 p.m., during an interview with Patient 7, she stated she was hypertensive since 20 years ago and she takes Carvediloland Hydrochlorothiazide medications daily to keep her BP stable. She also stated that she lives by herself and she prepares her medications and takes her BP and BS readings. She further stated that her attending physician denied her to have home health services because she does not need it. However, she likes to have a home health nurse to visit her once a week to check on her so therefore she signed up for home health through a friend's referral. On 1/15/21, at 12 p.m., during an interview with the office manager from Patient 7's attending physician's medical clinic, she stated that the attending physician told her to relay the message to the surveyor that Patient 7 did not need home health services at all and was not aware Patient 7 have home health services. On 1/19/21, at 11:48 a.m. during an interview with Physician 2, she stated that she was the admitting physician for Patient 7 but she has never seen the patient. She also stated that she sent a nurse practitioner (NP) to do a face to face encounter with the patient and she would referred the patient to home health based on their own NP's assessment. On 1/20/21, at 1:20 p.m., during an interview with the director of patient care services (DPCS), she stated that Patient 7 did not have an attending physician to refer her to their home health. Patient 7 called the agency to sign up for home health services. Therefore, the agency's protocol was to call a medical group and have one of their physicians (mobile doctor) or nurse practitioners to do a face to face encounter with the patient to determine eligibility for home health services.

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 demonstrate a continuing need for skilled nursing and home health services for seven of seven sampled patients. (Patient 1,2,3,4,5,6 and 7). This deficient practice resulted in a failure to accurately reassess patients and admit them to continuous home health services without an order from the patients primary physicians. Findings: a. A review of Patient 1's clinical record indicated a start of care (SOC) date of 9/15/20, with diagnosis that included diabetes mellitus (high blood sugar ). A review of Patient 1's plan of care (POC) from 9/15/20 to 11/13/20, included an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for 7 weeks, for assessment of all body system and medication compliance. The plan of care indicated to notify the physician if fasting blood sugar (FBS) reading less than 60 milligrams (mg) per deciliter or above 300 mg/dl, random blood sugar (RBS) less than 60 mg/dl or above 400 mg/dl; systolic blood pressure (top number) was greater than 160 millimeter mercury (mmHg) or less than 90 mmHg, diastolic(bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The goals included the patient/PCG will demonstrate independence with diabetic care with patient's BS stabilizing between 70-200 mg/dl, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when medical condition is stable and the patient no longer in need of skilled care. A review of the Comprehensive Adult Nursing Assessment (an assessment form to determine the need for home health services) dated 9/15/20, indicated the patients BS reading was 194 mg/dl, BP reading of 140/80 mmHg, and that the patient required assistance with ambulation, grooming and bathing. On 1/12/21, at 2:30 p.m., a home visit was conducted at Patient 1's residence with RN 1. Patient 1 was observed getting up from bed on her own and ambulated with the use of the walker without distress or shortness of breath, and sat on a couch in the bedroom. On 1/12/21, at 2:55 p.m., during an interview with Patient 1, she stated she was a diabetic for a long time and she takes Metformin 500 mg medication daily to keep her BS stable. She also stated that Patient 2 (son) was her caregiver and takes her BS and BP readings, assisted her with her daily ADL's like grooming and transfers and cooks for her. She further stated that her normal systolic blood pressure range falls between 140 to 150 mm/hg and if the systolic reading goes to 170 and above, she will have a headache and syncope (loss of consciousness). She also stated that her normal BS readings will run around 120 to 146 mg/dl and she likes the home health nurse to visit her once a week to monitor her condition. On 1/12/21, at 3 p.m., during an interview with RN 1, she stated Patient 1 was recertified for another 60 day period because the patient needed continuous monitoring with her fluctuating BS and BP readings, to remind patient to take her medication since she was very forgetful and if ever there is a change of condition, the visit nurse can help and assist her with her needs. A review of Patient 1's skilled nursing visit notes dated 9/19, 9/22, and 9/26/21, 10/3, 10/10, 10/17, 10/24, 10/31 and 11/7/20, indicated the BS readings were from 120 to 146 mg/dl, BP reading from 138/80 to 156/88 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, fall, no new prescribed medications or any documentation to justify need for skilled nursing services to continue. Further review of Patient 1's clinical record indicated the patient was recertified for another 60 days for monitoring purposes and the POC "Orders for Discipline and treatments for the SN contained the same information for both certification periods. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1 p.m., she stated that she re-certified Patient 1 because the patient needed continuous monitoring for safety measures, to prevent the patient to have fall episodes, that patient seem forgetful that they need to remind Patient 1 to take her medication consistently, and since there's a COVID pandemic, the patients does not want to go the hospital so they need continuously monitor the patient to keep them in stable condition. b. A review of Patient 2's clinical record indicated a start of care (SOC) date of 9/15/20, with diagnosis that included diabetes mellitus (high blood sugar ). A review of Patient 2's plan of care (POC) from 9/15/20 to 11/13/20, included an order for the skilled nurse (SN) to visit twice a week for two weeks, once a week for 7 weeks, for assessment of all body system and medication compliance. The plan of care indicated to notify the physician if the fasting blood sugar (FBS) reading was less than 60 milligrams (mg) per deciliter or above 300 mg/dl, random blood sugar (RBS) less than 60 mg/dl or above 400 mg/dl; systolic blood pressure (top number) was greater than 160 millimeter mercury (mmHg) or less than 90 mmHg, diastolic (bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The patient's BS stabilizing between 70-200 mg/dl, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when medical condition is stable and the patient no longer in need of skilled care. A review of Patient 2's Comprehensive Adult Nursing Assessment (to determine the need for nursing services) dated 9/15/20, indicated the patient BS reading was 218 mg/dl, BP reading of 130/70 mmHg, that patient required assistance with ambulation, grooming and bathing. On 1/12/21, at 2:30 p.m., a home visit was conducted at Patient 2's residence with RN 1. Patient 2 was observed opening the entrance door by himself, and was seen walking with steady gait without using an assertive device . On 1/12/21, at 2:45 p.m., during an interview with Patient 2, he stated he was a diabetic for the past 10 years and he knew how to take his own BS and BP readings. He also stated he lives with Patient 1 (mother) and being her primary caregiver, Patient 2 prepares patient 1's medications and assist Patient 1 with her activities of daily living. He further stated that his normal systolic blood pressure range falls between 140 to 150 mm/hg and if systolic reading hits 170 and above, he does not feel good. He also stated that his normal BS reading runs around 130 to 150 mm/dl and he takes Metformin 1000 mg medication to stabilize his BS level. On 1/12/21, at 3 p.m., during an interview with RN 1, she stated Patient 2 was recertified for another 60 day period because the patient needed continuous monitoring with his fluctuating BS and BP readings, to remind patient to take his medication and if ever there is a change of condition, the visit nurse can help and assist him with his needs. A review of Patient 2's skilled nursing visit notes dated 9/19, 9/22, and 9/26/21, 10/3, 10/10, 10/17, 10/24, 10/31 and 11/7/20, indicated the BS readings were from 130 to 150 mg/dl, BP reading from 130/74 to 56/88 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, fall, no new prescribed medications or any health reason to justify need for skilled nursing services to continue. A further review of Patient 2's clinical record indicated the patient was recertified for another 60 days for monitoring purposes. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1 p.m., she stated that she re-certified Patient 2 because the patient needed continuous monitoring for safety measures, to prevent the patient to have fall episodes, that patient seem forgetful that they need to remind Patient 2 to take his medication consistently, and since there's a COVID pandemic, the patients does not want to go the hospital so they need continuously monitor the patient to keep them stable. c. A review of Patient 6's clinical record indicated a start of care (SOC) date of 9/4/20, with diagnosis that included hypertension (high blood pressure). A review of Patient 6's plan of care (POC) from 9/15/20 to 11/13/20, included an order for the skilled nurse (SN) to visit of once a week for one week, twice a week for two weeks, once a week for 6 weeks, for assessment of all body system and medication compliance. The plan of care indicated to notify the physician if fasting blood sugar (FBS) reading less than 60 milligrams (mg) per deciliter or above 300 mg/dl, random blood sugar (RBS) less than 60 mg/dl or above 400 mg/dl; systolic blood pressure (top number) was greater than 160 millimeter mercury (mmHg) or less than 90 mmHg, diastolic (bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The goals included the patient/PCG will demonstrate independence with diabetic care with patient's BS stabilizing between 70-200 mg/dl, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when medical condition is stable and the patient no longer in need of skilled care. A review of the Comprehensive Adult Nursing Assessment (to determine the need for nursing services) dated 9/4/20, indicated the patient's BS reading was 185 mg/dl, BP reading of 154/86 mmHg, that patient required assistance with ambulation, grooming and bathing. On 1/14/21, at 11 a.m., a home visit was conducted at Patient 6's residence. Patient 6 was observed walking using a walker without shortness of breath and distress. On 1/14/21, at 11:15 a.m., during an interview with Patient 6, she stated she was hypertensive for a long time. She also stated that she lives by herself and she has a caregiver that comes daily for several hours a day to prepare her medications and takes her BP and BS readings. She further stated that her normal systolic blood pressure range falls between 150 to 160 mm/hg and if systolic reading goes to 180 and above, she will have headache and syncope (unconsciousness). A review of Patient 6's skilled nursing visit notes dated 9/7, 9/11, 9/14, 9/18, 9/20, and 9/27/20, 10/4, 10/11, and 10/18/20, indicated the BP readings were from 134/80 to 154/76 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, episodes of fall, no new prescribed medications or any health reason to justify need for skilled nursing services to continue. A further review of Patient 6's clinical record indicated the patient was recertified for another 60 days for monitoring purposes. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1 p.m., she stated that she re-certified Patient 6 for another 60 days because the patient needed continuous monitoring for safety measures, to prevent the patient to have fall episodes, that patient seem forgetful that they need to remind Patient 6 to take her medication consistently, and since there's a COVID pandemic, the patients does not want to go the hospital so they need continuously monitor the patient to keep them in stable condition. d. A review of Patient 7's clinical record indicated a start of care (SOC) date of 9/20/20, with diagnosis that included hypertension (high blood pressure). A review of Patient 7's plan of care (POC) from 9/20/20 to 11/18/20, included an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for 7 weeks, for assessment of all body system and medication compliance. The plan of care indicated to notify the physician if fasting blood sugar (FBS) reading less than 60 milligrams (mg) per deciliter or above 300 mg/dl, random blood sugar (RBS) less than 60 mg/dl or above 400 mg/dl; systolic blood pressure (top number) was greater than 160 millimeter mercury (mmHg) or less than 90 mmHg, diastolic (bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The goals included the patient/PCG will demonstrate independence with diabetic care with patient's BS stabilizing between 70-200 mg/dl, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when medical condition is stable and the patient no longer in need of skilled care. A review of the Comprehensive Adult Nursing Assessment (an assessment used to determine the need for nursing services) dated 9/20/20, indicated the patient BP reading was 126/82, and that patient required assistance with ambulation, grooming and bathing. On 1/14/21, at 2 p.m., a home visit was conducted at Patient 7's residence. Patient 7 was observed walking with a steady gait without using an assistive device. On 1/14/21, at 2:15 p.m., during an interview with Patient 7, she stated she was hypertensive for the past 20 years and she takes Carvedilol and Hydrochlorothiazide medications daily to keep her BP stable. She also stated that she lives by herself and she prepares her medications and takes her BP and BS readings. She further stated that her attending physician denied her to have home health services because she does not need it. However,, she likes to have a home health nurse to visit her once a week to check on her so therefore she signed up for home health by friend's referral She further stated her normal systolic BP readings are 140 to 150 but when it reaches 170, that is when she will start having dizziness and headache. A review of Patient 7's skilled nursing visit notes dated 9/24, 9/27/20, 10/1, 10/3, 10/13, 10/20, 10/27/20, 11/3, and 11/10/20 indicated the BP readings were from 128/66 to 154/76 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, episodes of fall, no new prescribed medications or any health reason to justify need for skilled nursing services to continue. A further review of Patient 7's clinical record indicated the patient was recertified for another 60 days for monitoring purposes. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1 p.m., she stated that she re-certified Patient 7 for another 60 days because the patient needed continuous monitoring for safety measures, to prevent the patient to have fall episodes, that the patient seemed forgetful and that they needed to remind Patient 7 to take her medication consistently, and since there's a COVID pandemic, the patients does not want to go the hospital so they need continuously monitor the patient to keep them in stable condition. A review of the agency's current policy titled"Discharge Criteria and Process" indicated services will be terminated when the goals of home health have been attained or are no longer attainable. e. A review of Patient 3's clinical record indicated a start of care (SOC) dated 9/23/20, with a primary diagnosis of other chronic pain (persisting long term pain). A review of Patient 3's plan of care (POC) from 9/23/20 to 11/21/20, included an order for skilled nurse (SN) to visit twice a week for two weeks, and once a week for seven weeks, to observe/assess all body systems and medication compliance. The plan of care indicated to notify the physician if there are signs and symptoms of infection, pain level is greater than 6/10 and or not relieved with pain medication, fasting blood sugar (FBS) ) reading less than 60 milligrams (mg) per deciliter or above 300 mg/dl, random blood sugar (RBS) less than 60 mg/dl or above 400 mg/dl; systolic blood pressure (top number) was greater than 160 millimeter mercury (mmHg) or less than 90 mmHg, diastolic(bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The goals included the patient/PCG will show improvement in musculoskeletal status as evidenced by pain control, mobility strength/endurance, will demonstrate independence with diabetic care with patient's BS stabilizing between 70-200 mg/dl, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when patient in a safe environment with primary medical doctor follow up appointments and supervision, under family /caregiver for minimal assistance with activities of daily living and instrumental activities of daily living ADLS/IADLS. A review of the Comprehensive Adult Nursing Assessment (an assessment that determines the need for home health services) dated 9/23/20, indicated the patient had aching right shoulder and back pain with the pain level being 7 (moderate) and aching right hip pain with a pain level of 6 (moderate) on a pain scale from 0 (no pain) to 10 (worse pain) daily but not constantly. It indicated massage, rest, repositioning, relaxation, and medication relieved the pain. The blood sugar reading was 142 mg/dl, blood pressure reading of 148/76 mmHg, and patient required assistance with ambulation, dressing, bathing, grooming, and transferring. On 1/13/21, at 10 a.m., a home visit was conducted at Patient 3's residence with RN 1. Patient 3 was observed walking to the door without the use of a walker or a cane and without difficulty. The patient then returned to sit in the living room couch with his wife present. During an interview with Patient 3 on 1/13/21, at 11:00 a.m. he stated he lived with his wife, who is the caregiver and she takes his vitals and assists him with all his needs. Patient 3 further stated, "I have been taking my blood pressure and blood sugar since the 90's, know and take all my medications, I know how to do that." Patient 3 further stated, "My blood pressure usually fluctuates but I feel okay when the higher number is 130's to 150's, when it gets to 170's then I don't feel good, as for my blood sugar, its anywhere from 140's to low 200 at times, I take Janumet (blood sugar lowering medication) XR 50/1000 mg one tablet twice a day and Pioglitazone (blood sugar lowering medication) 15 mg one tablet by mouth daily to regulate my blood sugar. As for my blood pressure, I take Valsartan 160 mg one tablet once a day, and Atenolol 50 mg one tablet twice a day and nisoldipine 34 mg one tablet once a day. For pain, I take Tylenol 1000 mg as needed and it helps bring the pain level down." When asked why he thinks he needs home health services, Patient 3 stated, "I like the comfort of having a nurse come check on my health once a week, I feel more comfortable, especially now with COVID." During an interview with RN 1 on 1/13/21 at 11:20 a.m. she stated, " Patient 3 was recertified for another 60 day period because the patient needed continuous monitoring with his fluctuating BS and BP readings, also to remind patient to take his medication and if ever there is a change of condition, the visiting nurse can help and assist him with his needs." A review of Patient 3's skilled nursing visit notes dated 9/26/20, 9/30/20, 10/3/20, 10/9/20, 10/17/20, 10/24/20, 10/30/20, 11/6/20, 11/13/20, indicated pain level ranging from 4-6 intensity, on a scale of 0 being no pain and 10 being the worst pain, which was decreased to 2-3 intensity by rest and medication. The BS readings were from 148 to 216 mg/dl, BP reading from 136/66 to 158/86 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, fall, no new prescribed medications or any health reason to justify need for skilled nursing services to continue. A further review of Patient 3's clinical record indicated the patient was recertified for another 60 days for monitoring purposes. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1:15 p.m., she stated that she re-certified Patient 3 because the patient needed continuous monitoring for safety measures, to prevent the patient from having fall episodes, patient seemed forgetful, and they need to remind Patient 3 to take his medication consistently, and since there's a COVID pandemic, the patient does not want to go the hospital so they needed to continuously monitor the patient to keep him stable. f. A review of Patient 4's clinical record indicated a start of care (SOC) dated 9/12/20 with a primary diagnosis of other chronic pain. A review of Patient 4's POC dated 9/12/20 to 11/10/20, includes an order for SN to visit once a week for one week, twice a week for two weeks, and once a week for 6 weeks, to observe/assess all body systems and medication compliance. The plan of care indicated to notify the physician if there are signs and symptoms of infection, pain level is greater than 6/10 and or not relieved with pain medication; systolic blood pressure (top number) is greater than 160 millimeters of mercury (mmHg) or less than 90 mmHg, diastolic (bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The goals included the patient/PCG will show improvement in musculoskeletal status as evidenced by pain control, mobility strength/endurance, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when patient in a safe environment with primary medical doctor follow up appointments and supervision, under family /caregiver for minimal assistance with activities of daily living and instrumental activities of daily living ADLS/IADLS. A review of the Comprehensive Adult Nursing Assessment (to determine the need for nursing services) dated 9/12/20, indicated the patient had aching low back and knee pain with the pain level being 7 (moderate) and aching shoulder pain with a pain level of 5 (moderate) on a pain scale from 0 (no pain) to 10 (worse pain), daily but not constantly. It indicated heat, massage, rest, relaxation, and medication relieved the pain. The blood pressure reading of 148/82 mmHg, and patient required assistance with ambulation, dressing, bathing, grooming, and transferring. During a tele-visit (contacting the patient without visiting them in person) on 1/14/21 at 1:15 p.m., Patient 4 was observed without difficulty walking around her house without the use of a cane or a walker. During an interview with Patient 4 on 1/14/21 at 1:30 p.m. she stated, "I live with my husband. We have had home health services on and off for the past year. Last time we were signed on was in September I believe. We heard about the home health agency from a friend referral, and we contacted the agency, and the agency sent out a doctor, I don't remember his name, and they signed me and my husband for home health services." When asked if her and her husband's primary care physician is aware they are getting home health services, she stated "I am not sure." When asked about her medical condition, Patient 4 stated, "I am able to take my own blood pressure and take all my medications. I have had pain for a long time and am used to managing it. If I must walk down the stairs or for an extended time, around two blocks, I use a walker, and now with COVID we are scared to leave the house at all. We like having home health services because nurses come once a week and check on us, and in the beginning when we had the massage therapist, it made us feel better." A review of Patient 4's skilled nursing visit notes dated 9/15/20, 9/18/20, 9/21/20, 9/25/20, 9/28/20, 10/5/20, 10/12/20, 10/19/20 and 10/26/20 , indicated the patients pain level was ranging from 4-6 intensity on a scale of 0 being no pain and 10 being the worst pain, which decreased to 2-3 intensity by rest and medication, BP reading from 134/66 to 156/84 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, fall, no new prescribed medications or any health reason to justify need for skilled nursing services to continue. A further review of Patient 4's clinical record indicated the patient was recertified for another 60 days for monitoring purposes. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1:05 p.m., she stated that she re-certified Patient 4 because the patient needed continuous monitoring for safety measures, to prevent the patient from having fall episodes, patient seemed forgetful, and is depressed, she takes a lot of medications and they need to remind Patient 4 to take her medication consistently, and since there's a COVID pandemic, the patient does not want to go the hospital so they needed to continuously monitor the patient to keep her safe and stable. g. A review of Patient 5's clinical record indicated a start of care (SOC) dated 9/12/20 with a primary diagnosis of Polyosteoarthritis (related to process of aging, as water content of body cartilage increases, and the protein makeup of cartilage degenerates resulting in joint pain and swelling). A review of patient 5's POC dated 9/12/20 to 11/10/20, includes an order for SN to visit once a week for one week, twice a week for two weeks, and once a week for 6 weeks, to observe/assess all body systems and medication compliance. . The plan of care indicated to notify the physician if there are signs and symptoms of infection, pain level is greater than 6/10 and or not relieved with pain medication; systolic blood pressure (top number) is greater than 160 millimeters of mercury (mmHg) or less than 90 mmHg, diastolic (bottom number) is greater than 100 mmHg, or less than 50 mmHg; heart rate (HR) is greater than 100 beats per minute or less than 60 beats per minute; Respiration rates are greater than 24 breath per minute or less than 14 breath per minute. Temperature is greater than 100 Fahrenheit (F) or less than 95.6 F. The goals included the patient/PCG will show improvement in musculoskeletal status as evidenced by pain control, mobility strength/endurance, blood pressure range will be within 90-140 mmHg systolic and 60-90 mmHg diastolic, patient will have no acute care hospitalizations and will demonstrate competence with self-management of disease process as evidenced by adherence to medication regime, diet regimen and activity compliance. Discharge Planning indicated to discharge when patient in a safe environment with primary medical doctor follow up appointments and supervision, under family /caregiver for minimal assistance with activities of daily living and instrumental activities of daily living ADLS/IADLS. A review of the Comprehensive Adult Nursing Assessment (to determine the need for nursing services) dated 9/12/20, indicated the patient had aching pain in the knees and legs with a pain level of 7 (moderate) and aching back pain with a level of 6 (moderate) on a pain scale from 0 (no pain) to 10 (worse pain) daily but not constantly. It indicated rest, repositioning, relaxation, and medication relieved the pain. The blood pressure reading of 142/88 mmHg, and patient required assistance with ambulation, dressing, bathing, grooming, and transferring. During a tele-visit on 1/14/21 at 1:15 p.m., Patient 5's wife was seen on camera and answered all the questions for her husband. During an interview with Patient 5's wife on 1/14/21 at 1:30 p.m. she stated, "My husband isn't feeling well, he is laying down. I can answer all the questions for him since we both have the same home health services. I live with my husband. We have had home health services on and off for the past year. Last time we were signed on was in September I believe. We heard about the home health agency from a friend referral, and we contacted the agency, and the agency sent out a doctor, I don't remember his name, and they signed me and my husband for home health services." When asked if her and her husband's primary care physician is aware they are getting home health services, she stated "I am not sure." When asked about her husband's medical condition, Patient 5's wife stated, "He is able to take his blood pressure and take all his medications. He had difficulties walking and used a walker or a cane, but the medication helps him with the pain. We don't leave the house now with COVID we are scared to leave the house at all. We like having home health services because nurses come once a week and check on us, and in the beginning when we had the massage therapist, it made us feel better." A review of Patient 5's skilled nursing visit notes dated 9/15/20, 9/18/20, 9/21/20, 9/25/20, 9/28/20, 10/5/20, 10/12/20, 10/19/20 and 10/26/20 , indicated pain level ranging from 3-6 intensity, on a scale of 0 being no pain and 10 being the worst pain, which was decreased to 1-3 intensity by rest and medication, BP reading from 130/78 to 154/86 mm/Hg. There were no admissions to the hospital, no episodes of high blood pressure, fall, no new prescribed medications or any health reason to justify need for skilled nursing services to continue. A further review of Patient 5's clinical record indicated the patient was recertified for another 60 days for monitoring purposes. During an interview with the Director of Patient Care Services (DPCS) on 1/20/21, at 1:10 p.m., she stated that she re-certified Patient 5 because the patient needed continuous monitoring for safety measures, to prevent the patient from having fall episodes, patient seemed forgetful, and has difficulties walking, the nurses need to remind Patient 5 to take her medication consistently, and since there's a COVID pandemic, the patient does not want to go the hospital so they needed to continuously monitor the patient to keep her safe and stable.

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 observation, interview, and record review, the home health agency (HHA) staff failed to review the medications of all patients and clarify with the physician regarding discrepancies of medication administration for two of seven sampled patients (Patients 1 and 3). This deficient practice had the potential to put the patients at risk for medication errors and adverse drug reactions. Findings: a. A review of Patient 1's clinical record indicated a start of care (SOC) date of 9/15/20, with diagnosis that included diabetes mellitus (high blood sugar ). A review of Patient 1's plan of care (POC) from 9/15/20 to 11/13/20, included an order for the skilled nurse (SN) to visit of twice a week for two weeks, once a week for 7 weeks, for assessment of all body system and to assess medications and provide instructions regarding medication regimen. One of the physician's order included in the plan of care dated 9/15/20 was to apply Lidoderm patch 5 percent one transdermal patch to painful areas daily for 12 hours on and 12 hours off. A review of the Comprehensive Adult Nursing Assessment (an assessment tool used to determine the need for home health services) dated 9/15/20, indicated the patient had intermittent aching back and knee pain with worse pain level of 7 and 4 as lowest pain level but being relieved by pain medication and heat compress. On 1/12/21, at 2:30 p.m., a home visit was conducted at Patient 1's residence with RN 1. Patient 1 was observed getting up from bed on her own and ambulated with the use of the walker and sat on the couch in the living room. At 2:40 p.m., during an interview with Patient 1, she stated she has back pain every day with a pain scale of 8 to 10. She also stated that her son applies one Lidoderm patch medication on her back and gets a relief from pain for few hours from a pain level of 8 out of 10 on the scale to a pain level of 6 out of 10 on the scale. At 3:10 p.m., a review of Patient 1's medications indicated a box of Lidoderm 5 percent patches (4 left in box) to apply 1 transdermal patch daily for 12 hours. This Lidoderm medication was indicated in the medication profile sheet. However, upon interview with Patient 2 (son) who was the caregiver, he stated he applies one Lidoderm patch to Patient 1's back or knees once every 3 days. At 3:20 p.m., during an interview with RN 1, she agreed the visiting nurse should be checking all actual prescribed medications and should ask the patient how, when and how many many medications the patient are taking for each visits. On 1/20/21, at 1:30 p.m., during an interview with the DPCS, she stated that the visiting nurse should be checking the patient's actual medications and should ask if the patient is still taking the medication or not. A review of agency's current policy and procedure "Medication Profile", indicated the medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. b. A review of Patient 3's clinical record indicated a start of care (SOC) dated 9/23/20, with a primary diagnosis of other chronic pain (persisting for long term pain). A review of Patient 3's plan of care (POC) from 9/23/20 to 11/21/20, included an order for skilled nurse (SN) to visit twice a week for two weeks, and once a week for seven weeks, to observe/assess all body systems and to assess medication regimen, purpose, side effects and compliance to regarding medication regimen. One of the physician's orders included in the POC dated 9/23/20 was Valsartan (blood pressure lowering medication) 160 mg 1 tablet by mouth twice daily. A review of the Comprehensive Adult Nursing Assessment (an assessment tool used to determine the need for home health services) dated 9/12/20, indicated the patient blood pressure was 148/76 mmHg (millimeters of mercury, units of measurement) at rest. On 1/13/21, at 10 a.m., a home visit was conducted at Patient 3's residence with RN 1. Patient 3 was observed walking to the door without the use of a walker or a cane, then sitting on the living room couch with wife present. During an interview with Patient 3 on 1/13/21, at 10:45 a.m. he stated, "My blood pressure is on and off most of the time I take my own blood pressure and I usually feel okay when my blood pressure is in the 130's to 150's. I start feeling bad when the higher number gets in the 170's." During an interview and a concurrent medication profile review with Patient 3 on 1/13/21, at 10:50 a.m., he stated, "I take the Valsartan 160 mg only once a day at night, that's the way I have always been taking it." During an interview with RN 1 on 1/13/20 at 11:10 a.m., she stated, "the nurse who visits Patient 3 should have caught that the patient is only taking Valsartan once a day instead of twice a day. That is part of her assessment responsibilities. I will follow up with the nurse and the doctor." During an interview with the DPCS on 1/20/21 at 1:35 p.m. she stated, "the visiting nurse should be reviewing the patient's actual medications and should ask the patient to see if they are taking the correct prescribed dose." A review of agency's current undated policy and procedure titled "Medication Profile", indicated the medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.

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 patient's medical records were stored and safeguarded against loss and or unauthorized use for 14 boxes of medical records of patients who were discharged from the agency. This deficient practice put the agency at risk for a HIPAA (Health Insurance Portability and Accountability Act of 1996) violation by placing patient's clinical records in an unlocked location where unauthorized persons have access. Findings: On 1/12/21, at 10 a.m., a complaint validation survey was conducted at the agency. During an initial tour of the agency, there were 14 boxes of discharge patient's medical records(4 boxes 2018 and 10 boxes 2019) observed stacked in a pile from the ground, upward, in one adjacent room. The entrance door knob of this room remained unlocked and there were no staff in the room. The unauthorized personnel could easily get in the room and have access to the patient's records. At 10:20 a.m., during an interview with RN 1, she agreed the door should remained locked at all times to prevent unauthorized personnel have access to patient's files. A review of agency's current policy " Protection of Records", indicated that medical records should be stored in cabinets locked if not in use.