Davita Willow Creek Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 30177 Based on observations, staff interviews, review of manufacturer directions for use (MDFU), and facility policy review, the facility failed to meet the Condition for Coverage (CfC) for Water and dialysate quality when two of three staff members (Patient Care Technician (PCT)1 and PCT2) failed to execute chlorine testing according to MDFU and facility policy. The failure to complete the test correctly posed a significant risk for patients receiving in-center hemodialysis at risk of harm by receiving water with chlorine levels greater than 0.1 parts per million (ppm). This could cause red blood cell hemolysis (destruction of red blood cells), thus causing severe anemia (deficiency of red blood cells or of hemoglobin in the blood). The facility’s non-compliance with adherence to the manufacturer’s instruction for use and the facility’s policy regarding testing of hemodialysis water for total chlorine has resulted in a significant risk of harm and injury to all 46 in-center hemodialysis patients currently receiving in-center hemodialysis treatment in this facility. Findings include: The facility failed to ensure two of three staff members (Patient Care Technician (PCT)1 and PCT2) executed chlorine testing according to MDFU and facility policy. (See the findings in V196).”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 30177 Based on staff interview, review of the facility’s documents, and a review of the facility’s policy, the facility failed to meet the Condition for Coverage (CfC) for Physical Environment when the facility did not maintain the integrity of surfaces and maintain equipment in good repair in the water treatment area, patient treatment area, and the clean supply storage area. The cumulative effects of non-compliance, multiple and pervasive deficient practices in the maintenance of the physical environment, and/or equipment created environmental concerns likely to impact the health and safety of patients and staff. Failure to meet the CfC for Physical Environment created a patient safety hazard and had the potential to negatively affect all 46 in-center hemodialysis patients receiving care in this facility. Findings include: The facility failed to maintain the integrity of surfaces and equipment in good repair, as well as in critical areas such as the water treatment area, patient treatment area, and clean supply storage area. Refer to V402.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 30177 Based on interview, “Emergency Management Plan” review, and review of the facility’s “Hazard Vulnerability Assessment,” the facility failed to implement an emergency preparedness patient orientation program based on the emergency plan and risk assessment. Failure to implement an emergency preparedness patient orientation program had the potential to hinder patients’ emergency preparedness knowledge and delay patients’ response during an emergency. This failure placed all 46 in-center hemodialysis patients at this facility at risk for possible adverse outcomes. Findings include: Review of the facility’s “Emergency Management Plan,” revised in April 2024, revealed the Facility Administrator or designee is responsible to provide training of the “Emergency Management Plan” to patients annually, including training on facility-specific emergency response procedures, and any changes and/or updates to the Emergency Management Plan or facility-specific emergency procedures.” Review of the facility’s “Hazard Vulnerability Assessment” revealed “Terrorist attack and active shooter” were identified as potential hazards requiring patient education. In an interview on 06/06/24 at 10:59 AM with the Director of Operations, he/she was asked to provide documentation showing that the patients had been trained on the “Emergency Management Plan” and facility-specific emergency response procedures (terrorist attack and active shooter). The Director of Operations revealed that the patients had not been educated on terrorist attacks and active shooters. The Director of Operations confirmed that patients should have been educated on both potential hazards.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 30177 Based on interview, personnel file review, and policy review, the facility failed to follow its policy in ensuring four of seven staff members (Registered Nurses (RN) 2, Patient Care Technician (PCT) 3, Facility Administrator, and the Biomedical Technician) were screened for hepatitis B surface antigen and hepatitis B surface antibodies within 10 days of hire. This failure to ensure staff members were screened for hepatitis B put the health and safety of both patients and staff at risk. The non-compliance has potentially exposed all susceptible staff and the 46 in-center hemodialysis patients to adverse outcomes. Findings include: Review of the untitled personnel file spreadsheet revealed that four staff members (RN2, PCT3, Facility Administrator, and the Biomedical Technician) had no documented evidence of being screened for hepatitis B surface antigen and hepatitis B surface antibodies. During an interview with the Facility Administrator on 06/07/24 at 3:00 PM, hepatitis B surface antigen and hepatitis B surface antibodies were requested for staff selected and sampled for compliance with hepatitis B documentation. The Facility Administrator revealed that he/she did not have documented evidence regarding hepatitis B screening for himself/herself, RN2, PCT 3, and the Biomedical Technician. When asked if he/she, RN2, PCT 3, and the Biomedical Technician received hepatitis B surface antigen testing every six months, he/she replied, “No.” The Facility Administrator confirmed that all staff members who did not have documented evidence of hepatitis B surface antibodies of 10 milli-international units per milliliter (mIU/ml) or greater should have been screened for hepatitis B surface antigen and antibodies. Review of the facility’s policy titled, “Teammate Hepatitis B Monitoring and Follow-Up Guidance,” revised April 2024, revealed, “New teammates who are not able to provide documentation of hepatitis B surface antibody of 10 mIU/ml or greater from anytime in the past ... will be screened for hepatitis B surface antigen and hepatitis B surface antibody within 10 days and offer the vaccination as indicated by their results. New teammates found to be hepatitis B surface antigen positive must be referred to their personal physician for evaluation. Teammates who do not have acceptable documentation of hepatitis B surface antibodies of 10 or greater on file must have hepatitis B surface antigen testing completed every six months.””

“IC-HBV-ISOLATION (NEW FACILITY) CFR(s): 494.30(a)(1)(ii) When dialysis isolation rooms as required by (a)(1)(i) are available locally that sufficiently serve the needs of patients in the geographic area, a new dialysis facility may request a waiver of such requirement. Isolation room waivers may be granted at the discretion of, and subject to, additional qualifications as may be deemed necessary by the Secretary. This Standard is not met as evidenced by: 30177 Based on the interview, document review, and observation, the facility failed to provide documented evidence of a waiver of the requirement for an Isolation Room or had a transfer agreement with a local chronic facility with the capacity for isolation stations. This failure did not ensure patients who may become hepatitis B antigen-positive have access to life-sustaining dialysis treatments and care. The failed practice had the potential to adversely affect the 46 in-center hemodialysis patients receiving care at this facility. Findings include: On 06/05/24 at 2:15 PM, observation of the dialysis treatment area did not reveal an Isolation Room. In an interview with the Facility Administrator on 06/05/24 at 3:00 PM, he/she confirmed that the facility does not have an Isolation Room or area and does not accept or treat hepatitis B antigen-positive patients. When asked if the initial Medicare certification date was 05/01/11, he/she replied, “Yes.” The Facility Administrator voiced that he/she was unsure when the facility was built but denied expansion. A request was then made for a copy of a waiver of the requirement for an isolation room or the transfer agreement with a local dialysis facility that has isolation stations and the capacity to receive patient (s) in the event of hepatitis B seroconversions. By the end of the business day on 06/05/24 at 5:30 PM, no waiver or transfer agreement concerning hepatitis B was provided to the surveyor. During an interview with the Director of Operations on 06/06/24 at 10:30 AM, a request was made for a copy of a waiver of the requirement for an isolation room or transfer agreement with a local dialysis facility that has isolation stations and the capacity to receive patient (s) in the event of hepatitis B seroconversions. By the end of the business day on 06/06/24 at 5:30 PM, no waiver or transfer agreement concerning hepatitis B was provided to the surveyor. A review of a document received on 06/07/24 at 12:15 PM, titled “Backup Dialysis Service Agreement,” with an effective date of 11/20/11, did not indicate if the “Backup Dialysis” facility accepts or treats patients who are hepatitis B antigen positive and has capacity for isolation stations. A review of an additional document titled, “Mutual AID Agreement for Provision of Dialysis Services,” revealed no indication the facility accepts or treats patients who are hepatitis B antigen positive and has the capacity for isolation stations. During a follow-up interview with the Director of Operations on 06/07/24 at 2:30 PM, he/she confirmed that the documents failed to include documentation that the accepting facility accepts or treats patients who are hepatitis B antigen positive and has the capacity for isolation stations.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 30177 Based on observations, staff interviews, review of manufacturer directions for use (MDFU), and facility policy review, it was observed that two of three staff members (Patient Care Technician (PCT)1 and PCT2) failed to execute chlorine testing according to MDFU and facility policy. The failure to complete the test correctly posed a significant risk and placed all 46 patients receiving in-center hemodialysis at risk of harm by receiving water with chlorine levels greater than 0.1 parts per million (ppm). This could cause red blood cell hemolysis (destruction of red blood cells), thus causing severe anemia (deficiency of red blood cells or of hemoglobin in the blood). Findings include: During routine observation of the chlorine testing on 06/06/24, from 8:30 to 9:30 AM, , two of the two employees (PCT1 and PCT 2) responsible for testing the hemodialysis water for total chlorine performed the water test for chlorine. On 06/06/24 at 8:30 AM PCT1 executed total chlorine testing without allowing the reverse osmosis (RO) (water purification system) to operate for at least 15 minutes before samples were drawn to guard against inadvertently sampling water that had been stagnated for an extended period. When asked before testing began if the RO was on and operational, PCT1 responded, “No.” When asked after total chlorine testing was complete, if the RO was on, he/she answered, “No.” PCT1 was then asked to determine if the RO is on and operational. PCT1 replied, “I have to move that valve...” PCT1 agreed the chlorine test had not been conducted according to MDFU and facility policy. During total chlorine testing on 06/06/24 at 9:03 AM. PCT2 filled the sample cup with 100 milliliters (ml) of water to be tested. After testing the sample, he/she failed to shake off excess water before comparing the indicator pad’s color to the color chart identified on the bottle. PCT2 agreed that he/she did not shake off excess water before comparing the indicator color indicator pad to the color chart on the bottle. PCT2 confirmed the chlorine test had not been conducted according to MDFU and facility policy. A review of the facility’s policy titled, “Daily Water System Total Chlorine Monitoring,” revised date of 04/23, revealed, “All observations and testing are done while the RO machine is actively supplying water. For both direct and indirect feed systems (holding tanks), pretreatment samples will be collected after the RO has operated for 15 minutes ... For both direct and indirect feed systems, RO samples and RO monitoring parameters should be taken while the RO is operating with stable flows, pressures, and conductivity values.” A review of the facility’s procedure titled, “Serim HiSense Ultra 0.1 Test for Total Chlorine in Feed or Rinse Water,” revised date of 10/21, revealed, “ ...Remove test strip from the test water and shake to remove excess sample ...” A review of the “HiSense Ultra 0.1 Test Strips” instructions for use, the brand of test strips used by the facility, revealed, “It is also very important that the water system be in full operation for at least 15 to 20 minutes before the water is tested. After vigorously swishing the test strip back and forth for a full 30 seconds, remove the test strip shake off excess water sample and immediately compare color of the indicator pad to the color chart on the bottle label.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 30177 Based on observation, staff interview, document review, and policy review, the facility failed to maintain the integrity of surfaces and maintain equipment in good repair in the water treatment area, patient treatment area, and the clean supply storage area. In addition, there was an excessive accumulation of rust on multiple components in the water treatment area and the clean supply storage area. Failure to maintain the integrity of surfaces allowed an accumulation of grime and rust, rendering the surfaces porous. Rust accumulation on the piping system in the water room had the potential to transfer accumulated rust into the water system, which can potentially contaminate the water and expose the patients to contaminates in the hemodialysis water. This failure created a patient safety hazard and had the potential to negatively affect all 46 incenter hemodialysis patients at this facility. Findings Include: Observation of the “Water Treatment Room,” on 06/05/24 at 4:30 PM with the Biomedical Technician (BMT) on 06/05/24 at 4:30 PM, the following observations were made and confirmed by the BMT: 1. A clear/white protective barrier covered the ceiling. The barrier has some breaches in its surface integrity, and there is a noticeable buildup of black substance throughout the ceiling. The presence of black buildup raised concerns about the potential for mold, and there was uncertainty about whether it could be confirmed. 2. The ductwork in the ceiling is not properly sealed around the pipe, which is currently exposed, revealing insulation. 3. The metal outer housing of the air duct located in the ceiling had an accumulation of rust. 4. Rust noted on the lower left and right interior door jambs. 5. Rust noted on the metal door hinges. 6. Rust noted on the metal drain cover (floor drainage system). 7.A thick black and greenish substance was found in one of three drains. 8.A cart that held the chlorine supplies had a buildup of rust and white residue. 9.Substantial and widespread rust accumulation was observed on multiple brackets and screws that held the water treatment piping. 10. Multiple metal shut-off valves throughout the water room were observed to be heavily rusted. 11.A buildup of green substance was noted on multiple copper pipes. 12. The metal piping atop the water heater and the metal pipes connected to the water heater were noted to have a thick and excessive accumulation of rust. 13. A pair of metal pliers with red rubber grips, with a significant buildup of rust, was noted stored and hanging on the piping system. 14. Five filter housings were noted to have a buildup of white powdery substance. 15. A section of the wall behind the “Reverse Osmosis (RO) Product Out” valve started to peel and is hanging loose, potentially posing a safety hazard. 16. A wall section displayed a streak of brown substance trailing from a rusty metal pipe bracket. 17. The unsealed concrete floor displayed visible signs of rust, dirt, grime, white powdery substance, and water buildup, with the porous surface allowing these elements to settle in. 18. The brine tank had spats of a white powdery substance on the exterior surface. Observation of the “Clean Supply Area,” on 06/05/24 at 5:00 PM with the Facility Administrator and Manager of Clinical Services, the following observations were made and confirmed at the time of observation: 1. The air duct extending from the ceiling displays a damaged outer surface, marred by multiple rips and tears. 2. Rust was noted on a vertical oxygen cylinder cart (cart used to store oxygen cylinders in an upright orientation) and two of two tilt-wheel vertical single oxygen Cylinder Carts. 3. A buildup of grime and rust on the metal wrench (a tool used to open a 55-gallon drum) was stored on a 55-gallon 2.0 potassium (K)/2.5 calcium (Ca) drum. It could be assured that rust did not enter the acid. 4. Significant and extensive rust was detected on the metal shelving with wheels. 5. A pallet used to store acetic acid and bicarbonate jugs had a buildup of white powdery substance. 6. The unsealed concrete floor displayed visible signs of rust, dirt, grime, and water stains, with the porous surface allowing these elements to settle in. 7. A 12-ounce bottle of liquid “Goo Gone” adhesive remover was noted on the 55-gallon 2.0 K/2.5 Ca drum. 8. An accumulation of white crystalline substance was observed to be present on the exterior surface of the drums. Observation of the “Patient Treatment Area,” on 06/05/24 at 5:30 PM with the Facility Administrator, the following observations were made and confirmed: 1. Multiple circular holes were noted in the walls. 2. The floor was noted to have a considerable accumulation of white powdery substance, dirt, and grime. 3. The countertop formica ledge had visible areas where the formica was comprised with tears or missing. 4. One of the ceiling tiles in the room had a noticeable brown water stain on its surface. 5. The wall displayed an area stained with spats of a white substance, which created a disheveled and unkempt appearance. 6. A section of the baseboard was loose, coming away from the wall, and there was damage in the wall above the baseboard. 7. The exterior surface of the back of six hemodialysis machines had an accumulation of dirt, grime, and dust. 8. The outer surface of the wall beneath the hemodialysis station’s four dialysis wall boxes was damaged by a large tear. 9. The four rolling stools displayed noticeable wear and tear, with multiple rips and tears indicating disrepair. 10. The wingback chairs in the staff area on the treatment floor had noticeable rips and tears. 11. Three non-hospital grade fabric suitcases described as the emergency preparedness kits were noted with a large accumulation of dust. 12. The wall had areas with an accumulation of a dark, brown, grimy substance. 13. The polyvinyl chloride (PVC) piping beneath the handwashing sink was noticeably coated with a substantial accumulation of dirt and grime. 14. The two carts that are used to store clean supplies showed a conspicuous accumulation of rust. Observation of the “Patient Treatment Area,” on 06/06/24 at 9:30 AM with the Patient Care Technician (PCT)1 revealed the following and confirmed at confirmed at the time of the finding: 1. The hemodialysis machine’s bloodlines were visibly tinged with a hue ranging from pink to reddish. 2. The outer protective housing that encases the diasafe filter appeared to have accumulated a significant amount of dust in six of the six hemodialysis machines. 3. The power circuit on the back of six of six hemodialysis machines had accumulated a significant amount of dust. 4. The dialysis arterial and venous Hansen connectors were observed to have a buildup of white substance. 5. The integrity of the exterior surfaces of 12 of 12 hemodialysis machines was not maintained in good repair. The outer sealant has been removed, resulting in a porous surface. 6. All 12 of the hemodialysis wall boxes were observed to have various types of stains, dirt, grime, and a white substance accumulated on them. Observation of the front entrance of the dialysis facility on 06/07/24 at 3:30 PM with the Director of Operations, a vent cover that displayed noticeable and extensive rust accumulation was observed. The Director of Operations confirmed that the vent cover indeed exhibited excessive rust. A follow-up joint interview on 06/07/24 at 4:30 PM was held with the Biomedical Technician, Director of Operations, Manager of Clinical Services, and the Facility Administrator to discuss the environmental concerns. The Biomed was asked if he/she does environmental rounds on a regular basis. He/she stated, “I do monthly rounds. When asked for a copy of the rounds for the last six months, he/she stated he does not document the findings but included a brief note in Quality Assessment and Performance Improvement (QAPI) . Review of the QAPI from June 2023 - April 2024 revealed the following: April 2024, a note indicated, “The floors could use a coat of wax.” March 2024, a note indicated, “No issues at this time.” February 2024, a note indicated, “Floor under acid barrels need to be cleaned.” January 2024, a note indicated,” The floors need a coat of wax.” December 2023, a note indicated, “The floors in the clinic could use a coat of wax.” November 2023, a note indicated, “The floor under the acid barrels needs to be cleaned. The floors in the clinic could use a coat of wax.” October 2023, a single note indicated, “The floors in the clinic could use a coat of wax.” September 2023, a note indicated, “The floors in the clinic could use a coat of wax. The floor under the acid barrels needs a good cleaning.” August 2023, a note indicated, “The floors need to be waxed. The storage room floor under the acid barrels needs to be cleaned. The water room floor continues to have a lot of bicarb residue on it.” July 2023, a note indicated, “Floors under acid barrels in back need to be cleaned.” June 2023, a single note indicated, “Back-room floor under acid barrels very sticky.” A review of a document titled “Biomed Safety Snapshot,” revised in February 2024, revealed, in your review of the facility, are areas including parking lot and lobby, in good condition and no repairs are needed? (Includes floors, walls, counters, doors, carts, ceiling tiles. Is the facility clean and uncluttered? Observe: No evidence of serious lack of environmental maintenance that has the potential to impact patient safety, e.g., large areas of water damage, presence of mold in the patient related areas, uneven/broken floor surfaces creating multiple trip hazards where patients ambulate, peeling paint, counter tops with chips/damaged laminate, missing/loose molding. In your review of the facility, are all of the chases slash wall boxes free of leaks, acid/concentrate buildup, or other debris? Are the dialysis treatment chairs in good condition with no rips, tears, or other issues? Observe: Check each chase access panel and validate no debris. Buildup, or leaks within the chases. Observe all wall boxes for debris. Buildup or other issues. Observe all treatment chairs for rips, tears, or other issues. A review of the facility’s policy titled “Physical Environment,” revised in April 2018, revealed, “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public. ... The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations. Supplies are stored to minimize deterioration, contamination or breakage.””

“PR-PRIVACY & CONFIDENTIALITY-RECORDS CFR(s): 494.70(a)(4) The patient has the right to- (4) Privacy and confidentiality in personal medical records; This Standard is not met as evidenced by: 30177 Based on observation, interview, and policy review, the facility failed to ensure hard copies of medical records were stored in a secure location & protected from casual access when not in use. This failure prohibited safeguarding patient medical records against loss, destruction, or unauthorized use. The failed practice did not ensure the medical records of the 46 patients receiving in-center hemodialysis treatments at this facility were stored in a safe manner to protect unauthorized access, privacy, and confidentiality. Findings include: Observation on 06/07/24 at 4:07 PM, accompanied by the Director of Operations, revealed the “Medical Records” room was located in the patient’s lobby. The entrance door was noted ajar, rendering the hard copies of the medical records unsecure and accessible to all staff, patients, and visitors, potentially enabling unauthorized access to the patient’s medical records. The hard copies of the medical files were stored in unlocked cabinets. During an interview on 06/07/24 at 4:15 PM, the Director of Operations confirmed that the entrance door to the medical records room was open and unsecure. When asked if all staff, patients, and visitors had access to the “Medical Records,” the Director of Operations replied, “Yes.” He/she was then asked what security measures the facility implements to guarantee the safeguarding of patients’ health information. The Director of Operations stated, “The door should be locked when no one is in the room.” Review of the facility’s policy titled, “Medical Records Custodian and Maintenance,” revision date October 2019, revealed, “The responsibilities of the custodian of medical records include ... Safeguards the confidentiality of the medical record in accordance with established policy and legal requirements ... Verifies that all medical records are stored in a safe manner to protect against loss, destruction, or unauthorized use.””