Washington Regional Medical Center

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted April 22-24, 2024. Based on the survey findings, Immediate Jeopardy was identified and the laboratory was notified April 24, 2024 at approximately 1:30 p.m. The following condition level deficiencies were identified during the survey: D2000 - 493.801 Enrollment and testing of samples D5016 - 493.1210 Routine chemistry D6076 - 493.1441 Laboratories performing high complexity testing: laboratory director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of 2021, 2022, and 2023 proficiency testing (PT) records, the absence of 2024 PT records, interview with general supervisor (GS) 04/22/24 and 04 /23/24, and telephone interview with an American Proficiency Institute (API) customer service representative 04/29/24, the laboratory failed to enroll in proficiency testing for 2024. Findings: Review of 2021, 2022, and 2023 PT records revealed the laboratory was enrolled with API. There were no 2024 PT records available for review during the survey. During interview 04/22/24 at approximately 1:30 p.m., the GS stated she started trying to enroll in PT for 2024 in August 2023. She stated they have not received any samples for 2024 yet because the bill has not been paid. During interview 04/23/24 at approximately 2:00 p.m., the GS stated she had been notified by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- hospital management that the bill was paid. Interview with an API customer service representative 04/29/24 at approximately 3:30 p.m. revealed API had not received payment for the laboratory's 2024 order, and the order had not been processed. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2022, 2023, and 2024 laboratory temperature and humidity logs, review of 2022, 2023, and 2024 i-STAT records, and interview with the GS 04/22/24 and 04/24/24, the laboratory failed to retain temperature and humidity logs for 6 of 28 months reviewed and failed to retain i-STAT quality control (QC) records for at least two years. Findings: 1. The laboratory failed to retain temperature and humidity logs for 6 of 28 months reviewed. Review of 2022, 2023 and 2024 laboratory temperature and humidity logs revealed the laboratory failed to retain the following logs from May of 2022 through November of 2022, a period of approximately 6 months: a. "Blood Bank Room Temperature" b. "Blood Bank Reagent Refrigerator" c. "Daily Temperature and Humidity - Side A" d. "Daily Temperature and Humidity - Side B" e. "Daily Temperature Log for Peppermint Patty" (refrigerator) f. "Daily Temperature Log for Lucy" (refrigerator) g. "Daily Temperature Log for Linus" (refrigerator) h. "Daily Temperature Log for Charlie Brown" (refrigerator) Interview with GS 04/22 /24 at approximately 3:00 p.m. confirmed the logs were not retained. The GS stated the laboratory had an electronic monitoring system, but they were unable to continue using it and were unable to retrieve the records. 2. The laboratory failed to retain i- STAT QC records for at least two years. Review of 2022, 2023, and 2024 i-STAT records revealed there were no VAS (Value Assignment Sheets) available for review during the survey to determine acceptable ranges for quality control results. During interview 04/24/24 at approximately 11:30 a.m., the GS confirmed that the laboratory had not saved the VAS for each lot number of QC material. She stated they do review their QC results using the VAS for the lot number in use, but the VAS is discarded after the lot number is used up. She stated she thought they might be saved electronically but she was unable to retrieve them. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of 2021, 2022, 2023, and 2024 laboratory records 04/22/24-04/24 /24, the laboratory failed to monitor and evaluate the ongoing and overall quality of the chemistry testing performed to identify and correct problems and ensure accurate and reliable patient test results. Findings: 1. Procedures not complete for all testing performed (see D5403). 2. Manufacturer's instructions not followed for quality control on the i-STAT (see D5411). 3. Expired reagents used for quality control and patient -- 2 of 13 -- testing on the Abbott Architect c4000 and the Abbott Architect ci4100 from April 2022 - April 2024, a period of approximately 2 years with no

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2021 API(American Proficiency Institute) proficiency testing results 12/17/21, the laboratory failed to successfully participate for FT4(Free Thyroxine) on two out of three consecutive testing events. See the deficiency cited at D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and review of 2021 API(American Proficiency Institute) proficiency testing results 12/17/21, the laboratory failed to successfully participate for FT4(free Thyroxine) in two out of three consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2021 API proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 FT4 samples, and received a score of 40% on the 2021 1st Chemistry Core test event. 2. Desk review of CMS Casper report 155D and 2021 API proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 FT4 samples, and received a score of 20% on the 2021 3rd Chemistry Core test event. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2021 API(American Proficiency Institute) proficiency testing results 12/17/21, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2021 API(American Proficiency Institute) proficiency testing results 12/17/21, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2021 API proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 FT4 samples, and received a score of 40% on the 2021 1st Chemistry Core test event. 2. Desk review of CMS Casper report 155D and 2021 API proficiency testing results revealed the laboratory provided unacceptable responses for 4 of 5 FT4 samples, and received a score of 20% on the 2021 3rd Chemistry Core test event. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of 2019 and 2020 API (American Proficiency Institute) proficiency testing records 3/16/20 and 3/17/20 and interview with the GS (general supervisor) 3 /17/20, the laboratory failed to enroll in proficiency testing for all required tests in 2019 and 2020. Review of 2019 and 2020 API proficiency testing records revealed: 1. The laboratory's 2019 API order confirmation included the Immunology Package which contained Infectious Mononucleosis and RF (rheumatoid factor). During interview 3/17/20 at approximately 10:05 a.m., the GS stated that the first event arrived while the facility was closed, so the samples were shipped back to API. When the facility reopened in May 2019, the GS stated they had to contact API to request shipment of the remaining events. She stated the Immunology Package must have been overlooked and not requested. She verified they did not test any Infectious Mononucleosis and RF proficiency samples in 2019. 2. The laboratory failed to enroll in proficiency testing for Infectious Mononucleosis and RF in 2020. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2018, 2019, and 2020 hematology calibration records, and interview with GS(general supervisor) 3/16/20, the laboratory failed to retain all calibration records for at least two years. Findings: Review of 2018, 2019, and 2020 Sysmex XS-1000i hematology records revealed the laboratory failed to retain copies of calibrator assay sheets used for calibrations for the primary hematology analyzer (Serial #68089) on 6/19/18, 12/10/18, 5/20/19, and 2/13/20 and for secondary hematology analyzer (Serial #68088) on 6/13/18, 12/3/18, 5/20/19, and 2/13/20. During interview at approximately 3:45 p.m., the GS stated the service representative told her the calibrator assay sheets did not need to be kept. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of 2019 API (American Proficiency Institute) proficiency testing records 3/16/20 and 3/17/20 and interview with the GS (general supervisor) 3/17/20, the laboratory failed to enroll in proficiency testing or establish a system to verify the accuracy of all tests not included in subpart I during 2019. Review of 2019 API proficiency testing records revealed the laboratory failed to participate in proficiency testing or establish a system to verify the accuracy of the following tests in 2019: 1. C- Reactive Protein 2. Ferritin 3. Folate 4. IBC (iron binding capacity) 5. PSA (prostate specific antigen) 6. PTH (parathyroid hormone) 7. Testosterone 8. Transferrin 9. Vitamin B12 10. Vitamin D 11. Urine drug screen (amphetamines /methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine) During interview at approximately 10:05 a.m., the GS stated that the samples for 2019 API 1st event arrived while the facility was closed and the samples were returned to API. When the facility reopened in May 2019, the GS stated they had to contact API to request shipment of the remaining events. She stated the modules that included the above analytes must have been overlooked and not requested. The GS confirmed that the laboratory did not perform any activity (split sample testing, etc.) to verify the accuracy of the tests that were not included in proficiency testing. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of 2018, 2019 and 2020 laboratory temperature and humidity logs, and interview with General Supervisor (GS) 3//17/20, the laboratory failed to perform and/or document