Davita Dialysis of Central Kentucky

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, it was determined the facility failed to ensure 2 (Station #1 and Station #2) of 3 dialysis treatment stations were cleaned and disinfected as per facility policy and procedure. The findings included: A facility policy titled, “Infection Control for Dialysis Facilities,” revised 04/2023, revealed the section of the policy titled, “DISINFECTION” specified, “13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g. [exempli gratia, for example], dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system.” The policy further indicated, “b. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient.” During a concurrent observation of the cleaning of dialysis treatment Station #2 and an interview on 08/07/2024 at 10:16 AM, Patient Care Technician (PCT) #13 cleaned and disinfected Station #2 without removing the belongings (the personal bag) of the previous patient. The previous patient’s personal bag was still in the dialysis chair. The observation also revealed PCT #13 did not clean and disinfect the biohazard sharps container located in Station #2. PCT #13 confirmed the cleaning was complete. During a concurrent observation of the cleaning of dialysis treatment Station #1 and interview on 08/07/2024 at 11:07 AM, PCT #15 did not clean and disinfect the biohazard sharps container located in Station #1. PCT #15 confirmed the cleaning was complete. During interview on 08/07/2024 at 10:42 AM, the Facility Administrator (FA) stated staff were expected to clean all parts of the stations, including the biohazard sharps containers. The FA stated the biohazard sharps containers were to be cleaned from top to bottom. The FA also stated patient belongings should be removed before cleaning and disinfecting the stations. The above findings were reviewed and confirmed with the FA and Regional Director (RD) on 08/09/2024 at 2:45 PM.”

“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: 50873 Based on interview, record review, and facility policy review, the facility failed to offer and administer the Hepatitis B virus (HBV) vaccine to 2 (Patients #S14 and Patient #S15) of 6 HBV susceptible patients sampled for HBV vaccination status. The findings included: A facility policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” revised in 04/2024, indicated, “Purpose: To prevent the spread of hepatitis B infections in the dialysis setting.” The policy also indicated, “4. All patients will be routinely tested [as required by the schedule for routine surveillance testing for Hepatitis B Virus (refer to Routine Surveillance Testing table)].” The policy also indicated, “6. Documentation of the following will remain in the patient’s current active medical record: a. HBV serology results such as Hepatitis B surface antibodies (HBsAb or anti-HBs); Hepatitis B total core antibody (total anti-HBc or HBcAb) and Hepatitis B Surface antigen (HBsAg) b. If a patient has received the hepatitis vaccination series, a copy of the vaccination record.” The policy also indicated, “11. Patients who start hemodialysis may have a history of vaccination against hepatitis B. These persons should have responded to the vaccine when their immune status was normal, but if their hepatitis B surface antibody (HBs or anti-HBs) levels are less than (<) 10 mIU/mL [Million International Units per milliliter] when they begin dialysis, they should be revaccinated with a complete primary series.” The policy included a table titled, “ADMISSION SCREENING utilizing facility baseline/admit results” that indicated if a patient’s HBsAg was negative and their HBsAb was less than 10 mIU/ML, the patient’s status was “susceptible,” and the “Next steps” were to offer the vaccination series. 1. A “Vaccinations and Surveillance Report,” printed on 08/09/2024, revealed that on 07/13/2024 Patient #S14 had a documented HBV serological status of “HBV Susceptible/HBsAb < 10,” and the patient had no current Hepatitis B vaccinations documented. Patient #S14’s, “Hepatitis B Vaccine Patient Consent,” dated 09/24/2012, revealed the patient received one full series of the HBV vaccine in 2012/2013. A medical record review for Patient #S14 revealed no documentation of the patient having declined or been given the HBV vaccine related to their HBV susceptible status, documented on 07/13/2024. During an interview on 08/09/2024 at 10:56 AM, the Medical Director (MD) stated the expectation regarding the HBV vaccine was to follow the facility’s policy. During an interview on 08/09/2024 at 12:10 PM, the Facility Administrator (FA) confirmed the findings above. The FA stated the facility process was for patients to be given annual HBV education, to offer susceptible patients the vaccine, and to document the administration of the vaccine or patient refusal. 2. A “Vaccinations and Surveillance Report,” printed on 08/09/2024, revealed that on 03/15/2024 Patient #S15 had a documented HBV serological status of “HBV Susceptible/HBsAb < 10,” and the patient had no current Hepatitis B vaccinations documented. Patient #S15’s “Consent-Hepatitis B Vaccine,” dated 05/15/2023, indicated the patient was given education regarding the HBV vaccine, and the patient signed the consent form to receive the vaccine. However, there was no documented evidence that the patient had been given the HBV vaccine, and the “Administered By” portion of the consent form was blank. During an interview on 08/09/2024 at 10:56 AM, the Medical Director (MD) stated the expectation regarding the HBV vaccine was to follow the facility’s policy. During an interview on 08/09/2024 at 12:10 PM, the Facility Administrator (FA) confirmed the findings above. The FA stated the facility process was for patients to be given annual HBV education, to offer susceptible patients the vaccine, and to document the administration of the vaccine or patient refusal.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50873 Based on record review, interview, and facility policy review, the facility failed to provide the necessary care and services to manage the patient’s volume status for 4 (Patients #2, 3, 6, and 7) of 7 patients in the medical record review sample. The findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised in April 2024, indicated, “2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance is permitted by state law, a Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN). a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters.” The policy further indicated, “3. Patient identity, prescription and machine setting are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR [ultrafiltration rate, the rate of fluid removal during dialysis treatment] and Max [maximum] UFR.” The policy also specified, “Pre-Treatment Data Collection Assessment 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section in this policy).” The section addressing “Intradialytic Collection Assessment” indicated, “11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy)” and “12. The licensed nurse notifies the physician (or NPP [non-physician practitioner] if applicable) as needed of changes in patient status.” The section of the policy addressing “Abnormal Findings” indicated, “Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time” and included the following information related to abnormal blood pressure findings, “Blood pressure: Pre-dialysis: -Systolic [top number of a blood pressure reading] greater than 180 mmHg [millimeters of mercury] or less than 90 mmHg -Diastolic [bottom number of a blood pressure reading] greater than or equal to 100 mmHg or less than 50 mmHg Blood Pressure-Intradialytic: -Systolic greater than 180 mmHg or less than 90 mmHg -Diastolic greater than or equal to 100 mmHg or less than 50 mmHg.” 1. Patient #2’s “Treatment Details Report,” for treatment date 07/26/2024, revealed the patient’s “Intradialytic Vitals” included a blood pressure reading of 189/108 mmHg at 11:32 AM. The reading was documented by Patient Care Technician (PCT) #16, and there was no documented evidence the nurse was notified. During an interview on 08/07/2024 at 11:48 AM, the Facility Administrator (FA) reviewed Patient #2’s records and confirmed the above information. The FA stated that the facility’s expectation would be for the PCT to adjust the blood pressure cuff and retake the patient’s blood pressure, and if the value was still out of range, the PCT would then be expected to notify the nurse. 2. Patient #3’s “Orders” for the timeframe from 07/15/2024 through 08/08/2024, included orders started on 07/22/2024 and inactivated on 08/02/2024 that specified a Max UFR of 13 milliliters per kilogram per hour (mL/kg/hr). The Orders also included current orders started on 08/02/2024 that also specified a Max UFR of 13 mL/kg/hr. Patient #3’s “Treatment Details Report,” for treatment date 07/29/2024, revealed the machine was set to remove 4000 mL with an estimated UFR of 14.93 mL/kg/hr. The post-treatment information indicated the “Actual UFR” was documented as 13.2 mL/kg/hour. According to the report, the patient’s “Intradialytic Vitals,” including blood pressure, were assessed every 30 minutes. Per the Treatment Detail Report, the patient’s treatment started at 11:02 AM, and the patient’s initial blood pressure reading was 147/100 mmHg. At 11:33 AM, the patient’s diastolic blood pressure exceeded 100 mmHg, and remained above 100 mmHg during all but one of the subsequent assessments. There was no documented evidence the nurse or provider were notified when the patient’s diastolic blood pressure exceeded 100 mmHG. Patient #3’s “Treatment Details Report,” for treatment date 07/31/2024, revealed the machine was set to remove 3200 mL with an estimated UFR of 10.07 mL/kg/hr. The post-treatment information indicated the “Actual UFR” was documented as 13.3 mL/kg/hour. According to the report, the patient’s “Intradialytic Vitals” included a blood pressure reading of 201/137 mmHg at 1:10 PM, recorded by Patient Care Technician (PCT) #15. The note indicated PCT #15 repositioned the patient and rechecked their blood pressure. At 1:21 PM, PCT #15 documented the patient’s blood pressure was “still elevated” at 204/131 mmHg, and the RN was notified. Per the record, the RN did not assess the patient until 2:10 PM. Patient #3’s “Treatment Details Report,” for treatment date 08/05/2024, revealed the machine was set to remove 5000 mL with an estimated UFR of 16.3 mL/kg/hr. The post-treatment information indicated the “Actual UFR” was documented as 17.1 mL/kg/hour. The Treatment Detail Report indicated Patient #3’s treatment began at 12:08 PM, and their first recorded “Intradialytic” blood pressure reading was 157/109 mmHg, documented by PCT #13. The patient’s next blood pressure reading was documented as 162/109 mmHg by PCT #17 at 12:39 PM. The patient’s diastolic blood pressure remained over 100 during the remainder of the treatment with blood pressure readings recorded by PCT #15 or PCT #17 every 30 minutes. There was no documented evidence the nurse or provider were notified when the patient’s diastolic blood pressure exceeded 100 mmHG. During an interview on 08/08/2024 at 9:13 AM, the Manager of Clinical Services (MCS) reviewed Patient #3’s records. The MCS stated when the patient’s diastolic blood pressure exceeded 100 mmHg or their systolic blood pressure exceeded 180 mmHg, the PCTs were expected to notify the nurse. The MCS further stated the nurse should have followed up sooner than an hour later on 07/31/2024 when Patient #3’s blood pressure was 201/137 mm Hg, was still elevated when the PCT rechecked, and the PCT notified the nurse. The MCS said the nurse should have followed up by checking on the patient’s status and documented the findings on the treatment sheet. The MCS also confirmed Patient #3’s record reflected treatment UFRs exceeded the patient’s prescribed Max UFR. The MCS said it was the facility’s expectation that the nurse contact the provider if there was a need to run a patient at a higher UFR than was ordered, such as if a patient had fluid overload. The MCS said without orders to exceed the Max UFR, the patient should be run as prescribed. The MCS confirmed there was no documentation to indicate the provider was notified, and there were no orders to exceed the prescribed Max UFR. 3. Patient #6’s “Treatment Details Report,” for treatment date 07/15/2024, revealed the treatment was started at 6:19 AM. The patient’s initial “Intradialytic Vitals” were recorded at 6:21 AM by Patient Care Technician (PCT) #13 and included a blood pressure reading of 73/46 mmHg. There was no indication the nurse was notified the patient’s systolic blood pressure was below 90 mmHg, and their diastolic blood pressure was below 50 mmHg. At 6:51 AM, PCT #13 documented the patient’s blood pressure was 85/55 mmHg, and at 9:37 AM, PCT #13 documented the patient’s blood pressure was 151/113 mmHg. Again, there was no documented evidence the PCT notified the nurse when the patient’s systolic blood pressure was below 90 mmHg or when the patient’s diastolic blood pressure exceeded 100 mmHg. Patient #6’s “Treatment Details Report,” for treatment date 07/22/2024, revealed the patient’s “Intradialytic Vitals” included a blood pressure reading of 88/55 mmHg at 7:14 AM. The reading was documented by PCT #13, and there was no documented evidence the nurse was notified. Patient #6’s “Treatment Details Report,” for treatment date 07/31/2024, revealed the patient’s “Intradialytic Vitals” included a blood pressure reading of 88/56 mmHg at 6:45 AM. The reading was documented by PCT #13, and there was no documented evidence the nurse was notified. During an interview on 08/08/2024 at 9:13 AM, the Manager of Clinical Services (MCS) stated when a patient’s diastolic blood pressure exceeded 100 mmHg or their systolic blood pressure exceeded 180 mmHg, the PCTs were expected to notify the nurse. During an interview on 08/08/2024 at 10:47 AM, the MCS reviewed Patient #6’s records. The MCS stated the PCTs were expected to notify the nurse when a patient’s systolic blood pressure was below 90 mmHg. 4. Patient #7’s “Treatment Details Report,” for treatment date 07/20/2024, revealed the patient’s “Intradialytic Vitals” included a blood pressure reading of 172/110 mmHg at 7:50 AM. The reading was documented by Patient Care Technician (PCT) #12, and there was no documented evidence the nurse was notified. Patient #7’s “Treatment Details Report,” for treatment date 07/30/2024, revealed the patient’s “Intradialytic Vitals” included a blood pressure reading of 210/95 mmHg at 7:27 AM. The reading was documented by PCT #12, and there was no documented evidence the nurse was notified. During an interview on 08/08/2024 at 9:13 AM, the Manager of Clinical Services (MCS) stated when a patient’s diastolic blood pressure exceeded 100 mmHg or their systolic blood pressure exceeded 180 mmHg, the PCTs were expected to notify the nurse. During an interview on 08/09/2024 at 10:56 AM, the Medical Director stated he expected staff to contact the provider with any out-of-range vitals, if a patient was experiencing fluid volume overload, or if a patient was experiencing symptoms.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to follow the individualized dialysis prescription as determined by the medical provider for 2 (Patient #2 and Patient #3) of 7 patients in the medical record review sample. The findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised in April 2024, indicated, “2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance is permitted by state law, a Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN). A. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters.” The policy further indicated, “3. Patient identity, prescription and machine setting are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR [ultra filtration rate, the rate of fluid volume removal during dialysis treatment] and Max [maximum] UFR e. UF Profiling f. Blood flow rate [BFR] g. Dialysate flow rate [DFR].” The policy also indicated, “10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.” 1. Patient #2’s “Treatment Details Report,” for treatment date 07/19/2024, revealed a transcribed physician order for a treatment BFR of 350 milliliters per minute (mL/min). Per the Treatment Detail Report, the patient’s treatment BFR was documented as 300 mL/min on 07/19/2024 at 12:51 PM, 2:21 PM, 2:51 PM, and 3:17 PM. There was no documented rationale for the change and no documented notification to the nurse or provider. During an interview on 08/07/2024 at 11:48 AM, the Facility Administrator (FA) stated that any time a patient could not achieve the prescribed treatment, including the prescribed BFR, the expectation would be to notify the physician. During an interview on 08/08/2024 at 9:22 AM, the Manager of Clinical Services (MCS) stated the expectation would be for there to be notes documenting a rationale for why the treatment deviated from the prescribed BFR. During an interview on 08/09/2024 at 10:56 AM, the Medical Director stated that the facility’s expectation would be for the provider to be notified of any inability to achieve the prescribed BFR. 2. Patient #3’s “Orders” for the timeframe from 07/15/2024 through 08/08/2024, included orders started on 07/22/2024 and inactivated on 08/02/2024 that specified a BFR of 300 mL/min. Patient #3’s “Treatment Details Report,” for treatment date 07/22/2024, indicated the BFR for Patient #3’s treatment was documented as 260 mL/min at 11:48 AM and 290 mL/min at 12:18 PM, 12:48 PM, 1:18 PM, 1:48 PM, 2:18 PM, 2:48 PM, and 3:18 PM. There was no documented rationale for the change and no documented notification to the nurse or provider. During an interview on 08/07/2024 at 11:48 AM, the Facility Administrator (FA) stated that any time a patient could not achieve the prescribed treatment, including the prescribed BFR, the expectation would be to notify the physician. During an interview on 08/08/2024 at 9:22 AM, the Manager of Clinical Services (MCS) confirmed treatment sheets lacked notes regarding why changes to Patient #3’s prescribed BFR occurred and lacked documentation of notification to the provider regarding the changes. The MCS stated the expectation would be for there to be notes documenting a rationale for why the treatment deviated from the prescribed BFR. During an interview on 08/09/2024 at 10:56 AM, the Medical Director stated that the facility’s expectation would be for the provider to be notified of any inability to achieve the prescribed BFR.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to maintain complete, accurate, and accessible medical records for 1 (Patient #S8) of 7 patients in the medical record review sample. The findings included: A facility policy titled, “Medical Records Custodian and Maintenance,” revised in 10/2019, indicated, “The responsibilities of the Custodian of medical records include:” “-Verifies that medical records contain pertinent medical information and are accessible for easy retrieval.” The policy further indicated, “11. Long Term Record Storage: Medical Records will be retained for a period of seven (7) years from the date of patient’s discharge from the facility to meet HIPAA [Health Insurance Portability and Accountability Act] and CMS [Centers for Medicare and Medicaid Services] requirements.” An undated “Admit/Discharge History” indicated Patient #S8 started dialysis services with the facility on 03/17/2020 and was discharged on 10/29/2021. On 08/06/2024 at 9:40 AM, the Facility Administrator (FA) was asked to provide the complete medical record for Patient #S8. During an interview on 08/06/2024 at 1:35 PM, the FA stated the medical record for Patient #S8 had been requested from a storage facility, and she was waiting for them to respond. During an interview on 08/07/2024 at 11:41 AM, the FA stated the facility was working to expedite the request for Patient #S8’s medial record from the storage facility. The FA provided a treatment sheet for 04/26/2021 and a plan of care for Patient #S8; no other records were provided at this time. During an interview on 08/08/2024 at 10:15 AM, the FA stated she had not received any information regarding the medical record request for Patient #S8. During an interview on 08/08/2024 at 11:15 AM, the FA stated she had requested the medical record for Patient #S8 from the Information Technology (IT) department, but they had not responded back with any information as of yet. During an interview on 08/08/2024 at 11:17 AM, the FA stated she did not have an estimated time of arrival for the complete physical medical record for Patient #S8 from the storage facility. During an interview on 08/08/2024 at 3:00 PM, the FA stated she did not have additional information from the storage facility or the IT department regarding the medical record for Patient #S8. During an interview on 08/09/2024 at 9:38 AM, the FA stated the facility was unable to provide the complete medical record for Patient #S8. The FA confirmed the medical record for Patient #S8 was not available. During an interview on 08/09/2024 at 11:58 AM, the Medical Director (MD) stated medical records should be available and accessible. The MD stated the record should be retained for six years.”

“MR-CENTRALIZE ALL INFO;IDT HAS ACCESS CFR(s): 494.170(b)(2) (2) All clinical information pertaining to a patient must be centralized in the patient’s record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient’s condition and prescribed treatment. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to ensure all patient clinical information was centralized in the patients’ records for 2 (Patient #1 and Patient #6) of 7 sampled patients reviewed for complete records. The findings included: A facility policy titled, “Medical Records Custodian and Maintenance,” revised in 10/2019, indicated, “The responsibilities of the Custodian of medical records include:” “-Verifies that medical records contain pertinent medical information and are accessible for easy retrieval.” During an interview on 08/07/2024 at 3:25 PM, the Registered Dietician stated that Physician #4 rounded on patients in the clinic, but his notes did not synchronize with the clinic’s electronic health record because Physician #4 was not connected to the dialysis clinic’s system. During an interview on 08/07/2024 at 4:27 PM, the Facility Administrator (FA) stated Physician #4’s patients’ notes, which included Patient #1 and Patient #6, were not available to the rest of the care team. During an interview on 08/09/2024 at 10:56 AM, the Medical Director stated the expectation was that medical records would be available to all members of the interdisciplinary team. The Medical Director stated that he was aware that Physician #4’s notes were not available at the dialysis clinic but stated the clinic could request them.”