Shenandoah Medical Center

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, the Laboratory Test List & Annual Volume form, observations made during the survey, and confirmed by interview with General Supervisor identifier #1 (GS #1) at 8:24 am on 5/8/2025, the laboratory failed to enroll in an HHS approved proficiency testing program for the analyte, c-reactive protein for two out of two years from 1/1/2024 - 5/8/2025. The findings include: 1. The Laboratory Test List & Annual Volume form stated the laboratory performed c- reactive protein testing using the Vitros 7600 chemistry analyzer. 2. A tour of the laboratory confirmed reagent for performing c-reactive protein testing. 3. At the time of the survey, GS #1 confirmed the laboratory did not enroll in proficiency testing for the analyte, c-reactive protein in 2024 and 2025. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on review of the BioFire Torch blood culture identification panel (BCID2) quality control records, the BioFire Torch BCID 2 procedure and confirmed by interview with testing personnel identifier #2 (TP #2), at 12:00 pm on 5/8/2025, the laboratory failed to follow the quality control procedure for one out of two lot numbers of BCID2 panel from 2/4/2025 - 3/31/2025. The findings include: 1. The BioFire Torch BCID 2 procedure states, "The External Quality Control material utilized Microbiologist Blood Culture Identification Control Panel with 43 targets. The control panel contains a Positive-1 control, Positive-2 control, and Negative vile. Run all three vials of QC monthly and with new lot and shipment of panels." 2. On 2/4 /2025 for BCID2 panel lot number 3CB224, the laboratory performed the Negative control and Positive-2 control. They did not perform the Positive-1 control. 3. TP#2 confirmed that the laboratory did not follow the BioFire Torch BCID 2 procedure for performing quality control. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #8 (refer to the Laboratory Personnel Report) at approximately 10: 30 am on 05/11/2023, the laboratory failed to perform a self evaluation when the laboratory received eight ungraded PT scores from three out of seven PT testing events from 01/01/2021- 05/11/2023. The findings include: 1. For 2021 testing event 3, the laboratory received ungraded PT test scores for the following: *Q3 Chemistry 2021: Urine chemistry total protein (specimen 11) and stool leukocytes (specimen 11) 2. For 2022 testing event 2, the laboratory received ungraded PT test scores for the following: *Q2 Chemistry 2022: Urine chemistry amylase (specimens 6 and 7); urine chemistry sodium (specimen 6); urine chemistry total protein (specimen 6); and urine chemistry urea nitrogen (specimen 6). 3. For 2022 testing event 3, the laboratory received ungraded PT test scores for the following: *Q3 Non-Chemistry 2022: Erythrocyte sedimentation rate, rapid (specimen 11) 4. At the time of the survey, the laboratory did not have additional documentation or

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 records and reports, the laboratory fails to successfully participate in a proficiency testing program for the subspecialty, virology, for two consecutive proficiency testing events: 2021 event 3 and 2022 event 1 (refer to D2064). D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for 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 fails to achieve an overall testing event score of satisfactory performance for two consecutive testing events for the subspecialty, virology. The laboratory received unsatisfactory performance scores of 20% for 2021 event 3 and zero for 2022 event 1 for the subspecialty, virology. -- 2 of 2 --