Washington County Hospital & Clinics

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 review of proficiency testing records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, partial pressure of oxygen (PO2), for two out of three consecutive proficiency testing events: 2022 event 3 and 2023 event 2 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, partial pressure of oxygen (PO2), , for two out of three consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2022 testing event 3 and 60% for 2023 testing event 2. -- 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 proficiency testing records and confirmed by laboratory personnel identifiers #5 and #6 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 01/12/2021, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty, bacteriology (methacillin resistant staphylococcus aureus [MRSA] screen by PCR) for two out of two years from 2020- 2021. The findings include: 1. The laboratory began performing MRSA screening by PCR in December 2019. 2. At the time of the survey, personnel identifiers #5 and #6 confirmed that the laboratory failed to enroll in an approved proficiency testing program for the subspecialty, bacteriology (MRSA screen by PCR) in 2020 and 2021. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different 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 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of OCD Vitros 7600 quality control (QC) records and confirmed by laboratory personnel identifiers #5 and #6 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 01/12/2021, the laboratory failed to perform two levels of QC each day of patient testing for 6 out of 30 days of patient testing in November 2020. The findings include: 1. Review of chemistry QC records revealed that the laboratory only performed one level of QC on the following dates for the specified analytes: * 11/04/2020- Urine total protein (level 1) * 11/09/2020- Glycated hemoglobin (level 2) * 11/14/2020- Thyroid stimulating hormone (level 1); ferritin (level 1) * 11/24/2020- Procalcitonin (level 2); thyroid stimulating hormone (level 1); free triiodothyonine (level 1) * 11/25/2020- Iron (level 2) * 11/26/2020- N-terminal pro B-type natriuretic peptide (level 1) 2. Personnel identifiers #5 and #6 confirmed that the laboratory did not have additional QC records for the dates and analytes listed above. -- 2 of 2 --