Innovative Renal Care Greater Hazleton

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and personnel files and based on interview with the administrator (Employee #8), the facility failed to ensure a tuberculosis screening of facility staff was performed in accordance with facility policy/procedure for two (2) of two (2) hemodialysis staff members whose date of hire was after September 17, 2021. (Employees #1 and #2) Findings include: On November 20, 2024 at approximately 11:45 AM, review of facility policy RM400, titled “Associate Health Program” revealed the following: Purpose: To ensure regular monitoring of associates for infectious diseases according to current guidelines or recommendations... Guidelines: All associates...will be screened for...Tuberculosis... III...D. Two-step testing will be done on all new associates who are initially skin test negative or who have not been tested within the past year... F. The associate will be required to complete a TB Symptom Review Questionnaire upon hire... Between November 19, 2024 at approximately 10:20 AM and November 20, 2024 at approximately 9:37 AM, review of personnel files revealed the following: Employee #1: The date of hire of the patient care technician (PCT) 08/21/2024. The first step of the TB skin test (TST) was administered on 08/23/2024. There was no documentation in the personnel file which provided evidence the second step TB TST had been completed and there was no documentation which provided evidence a TB Symptom Review Questionnaire had been completed. Employee #2: The date of hire of the social worker (SW) was 09/19/2022. There was no documentation which provided evidence a TB Symptom Review Questionnaire had been completed. During interview conducted on November 20, 2024 at approximately 5:18 PM, the administrator confirmed TB screening had not been completed in accordance with facility policy and procedure for the above identified employees.”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and personnel files and observational tour, and based on interview with the administrator (Employee #8), the facility failed to ensure a hepatitis B screening of facility staff was performed after administration of the final hepatitis B vaccine dose for one (1) of one (1) hemodialysis staff members whose date of hire was after September 17, 2021. (Employee #2) Findings include: On November 20, 2024 at approximately 11:45 AM, review of facility policy RM400, titled “Associate Health Program” revealed the following: Purpose: To ensure regular monitoring of associates for infectious diseases according to current guidelines or recommendations... Guidelines: All associates...will be screened for Hepatitis B... F. IF the new associate consents to an receives the vaccine, the associate should be retested one to two months after the third dose of the vaccine series... Observational tour on November 18, 2024 at approximately 10:36 AM revealed the facility was equipped with an isolation hemodialysis treatment room. Between November 19, 2024 at approximately 10:20 AM and November 20, 2024 at approximately 9:37 AM, review of personnel files revealed the following: Employee #2: The date of hire of the social worker (SW) was 09/19/2022. Review of immunization documentation revealed the final dose of the hepatitis B vaccine was administered on 03/03/2023. There was no documentation in the personnel file which provided evidence the SW was screened for hepatitis B status (anti-HBs) within one (1) to two (2) months after the administration of the final dose of the hepatitis B vaccine. During interview conducted on November 20, 2024 at approximately 5:18 PM, the administrator confirmed employee #2 was not screened for anti-HBs within one (1) to two (2) months after the administration of the final dose of the hepatitis B vaccine.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and medical records, and based on interview with the administrator/peritoneal dialysis registered nurse (Admin/PD RN-Employee #8), the facility failed to ensure a peritoneal equilibrium test (PET) was performed per facility policy/procedure for one (1) of one (1) peritoneal dialysis patients. (Patient #1) Findings include: On November 21, 2024 at approximately 10:23 AM, review of facility policy PD17, titled “Peritoneal Equilibrium Testing (PET)” revealed the following: Revision History ...Summary of Change ....12/2022 ...Updated the time to complete the first PET from 4-6 weeks to 6-12 weeks based on new updated guidelines ... Patient #1: On November 20, 2024 at approximately 12;05 PM, review of the medical record revealed the patient completed peritoneal dialysis training in January 2024 and home treatment record documentation revealed home PD treatments were performed between 01/31/2024 and 11/01/2024. Review of PET results revealed the PET was completed on 06/19/2024 which was more than 12 weeks after the patient began home PD treatments. There was no documentation in the clinical record which provided evidence the facility attempted to complete a PET prior to 06/19/2024. During interview conducted on 11/20/2024 at approximately 1:16 PM, the Admin/PD RN reported a delayed occurred in completion of PET because the patient kept delaying completion of same. During interview conducted on November 20, 2024 at approximately 1:16 PM, the Admin/PD RN confirmed the PET had not been completed as per facility policy/procedure for the above identified patient. Deficiency was previously cited during the August 2018 and September 2021 recertification surveys.”

“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: 19122 Based on review of agency policies/procedures and medical records, and based on interview with a registered nurse (RN-Employee #7), the medical director (Employee #9) and the administrator (Employee #8), the facility failed to ensure a physician order was obtained to modify the ultrafiltration rate (UFR-rate of fluid removal during dialysis) for three (3) of three (3) in-center hemodialysis (ICHD) patients for whom the UFR was administered at a rate greater than the prescribed rate. (Patients #2, #3 and #5) Findings include: On 11/21/2024 at approximately 10:24 AM, review of facility policy G34, titled “Orders for Patient Care” revealed the following under “Policy”: 1. A physician...shall provide orders for patient care activities... Patient #2: On November 20, 2024 at approximately 12:59 PM, review of the medical record revealed hemodialysis (HD) treatment orders dated 10/16/2024 revealed the revealed the UFR is to be administered at 13 (1.3). Review of HD treatment sheet documentation revealed the UFR exceeded 13 on the following dates and times: -11/04/2024 between 5:28 AM and 6:18 AM; and -11/11/1014 between 5:30 AM and 6:17 AM. There was no documentation in the medical record which provided evidence the medical director provided a physician to administer the UFR at a rate greater than 13. Patient #3: On November 20, 2024 at approximately 2:42 PM, review of the medical record revealed hemodialysis (HD) treatment orders dated 10/07/2024 revealed the revealed the UFR is to be administered at 13. Review of HD treatment sheet documentation revealed the UFR exceeded 13 on the following dates and times: -11/04/2024 between 10:41 AM and 11:41 AM; -11/06/2024 between 10:25 AM and 11:21 AM; -11/08/2024 between 10:30 AM and 11:19 AM; -11/11/2024 between 10:29 AM and 11:20 AM; -11/13/2024 between 10:28 AM and 11:18 AM; -11/15/2024 between 10:30 AM and 11:18 AM; and -11/18/1014 between 10:33 AM and 11:21 AM. There was no documentation in the medical record which provided evidence the medical director provided a physician to administer the UFR at a rate greater than 13. Patient #5 (Discharge): On November 20, 2024 at approximately 4:25 PM, review of the medical record revealed hemodialysis (HD) treatment orders dated 10/09/2024 revealed the revealed the UFR was to be administered at 13 (1.3). Review of HD treatment sheet documentation revealed the UFR exceeded 13 on the following dates and times: -10/11/2024 between 12:07 PM and 13:15 PM; -10/23/2024 between 12:11 PM and 13:11 PM; and -10/25/1014 between 10:55 AM and 11:30 AM. There was no documentation in the medical record which provided evidence the medical director provided a physician to administer the UFR at a rate greater than 13. During interview conducted on November 20, 2024 at approximately 4:57 PM, the RN (Employee #7) confirmed a physician order is to be obtained to administer the UFR above 13. During interview conducted on November 20, 2024 at approximately 5:18 PM, the medical director and the administrator confirmed that a physician order needs to be obtained to administer the UFR at a rate greater than the prescribed rate. The administrator confirmed a physician order had not been obtained to administer the UFR at a rate greater than 13 for the above identified patients.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 19122 Based on review of agency policies/procedures, medical records and documentation and based on interview with the administrator (Employee #8), the facility failed to ensure the quality assessment/performance improvement program measured, analyzed and tracked the fluid management status of in-center hemodialysis patients for nine (9) of nine (9) months in 2024. ( January through September 2024) Findings include: On 11/21/2024 at approximately 10:25 AM, review of facility policy G09, titled “Quality Assessment & Performance Improvement” revealed the following under “Purpose”: To ensure that ...care centers: · monitor appropriate aggregate outcomes and data to optimize patient care and improve processes as applicable · provide care that promotes patient ability to meet defined individualized patient outcome goals · regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes. Patient #2: On November 20, 2024 at approximately 12:59 PM, review of the medical record revealed hemodialysis (HD) treatment orders dated 10/16/2024 revealed the revealed the UFR is to be administered at 13 (1.3). Review of HD treatment sheet documentation revealed the UFR exceeded 13 on the following dates and times: -11/04/2024 between 5:28 AM and 6:18 AM; and -11/11/1014 between 5:30 AM and 6:17 AM. Patient #3: On November 20, 2024 at approximately 2:42 PM, review of the medical record revealed hemodialysis (HD) treatment orders dated 10/07/2024 revealed the revealed the UFR is to be administered at 13. Review of HD treatment sheet documentation revealed the UFR exceeded 13 on the following dates and times: -11/04/2024 between 10:41 AM and 11:41 AM; -11/06/2024 between 10:25 AM and 11:21 AM; -11/08/2024 between 10:30 AM and 11:19 AM; -11/11/2024 between 10:29 AM and 11:20 AM; -11/13/2024 between 10:28 AM and 11:18 AM; -11/15/2024 between 10:30 AM and 11:18 AM; and -11/18/1014 between 10:33 AM and 11:21 AM. Patient #5 (Discharge): On November 20, 2024 at approximately 4:25 PM, review of the medical record revealed hemodialysis (HD) treatment orders dated 10/09/2024 revealed the revealed the UFR was to be administered at 13 (1.3). Review of HD treatment sheet documentation revealed the UFR exceeded 13 on the following dates and times: -10/11/2024 between 12:07 PM and 13:15 PM; -10/23/2024 between 12:11 PM and 13:11 PM; and -10/25/1014 between 10:55 AM and 11:30 AM. Hemodialysis treatment sheet documentation revealed the patient complained of leg cramps on 10/11/2024 at 2:38 PM and 2:50 PM and on 10/25/2024 at 1:19 PM. On 11/19/2024 at approximately 2:17 PM and 11/21/2024 at approximately 5:01 PM, review of QAPI meeting minute documentation failed to reveal the QAPI program included a review of the fluid volume status for ICHD patients between January and September 2024. During interview conducted on November 20, 2024 at approximately 5:18 PM, the administrator the QAPI program did not include a review of the fluid volume status for ICHD patients between January and September 2024.”

“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: 19122 Based on review of agency policies/procedures and medical records and based on patient interview (Patients #2 and #4) and interview with the administrator (Employee #8), the facility failed to ensure medical records were maintained in accordance with facility policy and procedure for three (3) of five (5) patients. (Patients #1, #2 and #4) Findings include: On 11/21/2024 at approximately 10:26 AM, review of facility policy G60, titled “Medical Records” revealed the following: Purpose: To ensure ...medical records: · Provide accurate, complete and consistent patient care data ... · Are maintained according to the most stringent guidelines ... On 11/21/2024 at approximately 10:27 AM, review of facility policy G10, titled “Patient Rights & Responsibilities” revealed the following: Policy: 1. Within the patient ’ s first 6 treatments at an IRC care center and whenever the patient rights and responsibilities are revised, an appropriate associate will: · ensure that the signed copy of the rights and responsibilities documents are placed in the patient ’ s medical records · ensure that the patient or his/her legal representative for healthcare is given a signed copy of the rights and responsibilities documents... Patient #1: On November 20, 2024 at approximately 12;05 PM, review of the medical record revealed the patient was to perform a total of four (4) peritoneal dialysis (PD) exchanges per day as documented on the PD treatment orders. Review of home PD logs revealed a total of three (3) PD exchanges were completed for 10 of 10 PD treatment days between 10/05/2024 and 10/14/2024. During interview conducted on November 20, 2024 at approximately 1:16 PM, the administrator/PD registered nurse (Employee #8) reported the reduction in the number of exchanges was due to a PD solution supply issue. There was no documentation in the medical record which provided evidence an order had been provided by the physician (medical director-Employee #9) to reduce the number of exchanges from four (4) to three (3) per day between 10/05/2024 and 10/14/2024. Patient #2: On November 20, 2024 at approximately 12:59 PM, review of the medical record revealed the in-center hemodialysis start of care date was 09/11/2024. There was no documentation in the medical record which provided evidence the patient received a copy of the notice of patient rights nor the facility grievance procedure. During interview conducted on 11/20/2024 at approximately 8:25 AM, the patient confirmed a copy of the notice of patient rights and the facility grievance procedure had been provided to the patient. Patient #4: On November 20, 2024 at approximately 3:41 PM, review of the medical record revealed the in-center hemodialysis start of care date was 06/242024. There was no documentation in the medical record which provided evidence the patient received a copy the notice of patient rights nor the facility grievance procedure. During interview conducted on 11/20/2024 at approximately 11:15 AM, the patient confirmed a copy of the notice of patient rights and the facility grievance procedure had been provided to the patient. During interview conducted on November 20, 2024 at approximately 5:18 PM, the administrator confirmed the medical record for the above identified patients were not maintained in accordance with facility policy/procedure.”