Dulcimer Medical Center

Summary Statement of Deficiencies D0000 The DULCIMER MEDICAL CENTER laboratory was found to be in substantial compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on 11/4/21. No deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . This CONDITION is not met as evidenced by; Based on record review, interview and email communications, the laboratory failed to report SARS-CoV-2 negative test results for 249 of 249 days reviewed from November 20, 2020 through November 4, 2021. Findings are as follows: 1. In an interview on 11/4/2021, at 10:15 a.m., Testing Personnel 3 (TP3) indicated that the laboratory had reported only positive SARS-CoV- 2 test results, and did not report any negative test results. 2. In an email dated 11/5/21, the Technical Consultant (TC) confirmed each of the following findings: - The laboratory had performed SARS-CoV-2 testing on 249 days during the time period from November 20, 2020 through November 4, 2021. - The laboratory performed 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 -- 1171 SARS-CoV-2 tests during the period of review. - 221 positive test results were reported as required during the period of review. - 950 negative test results were not reported as required during the period of review. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 examining specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to establish a written procedure for reporting SARS-CoV-2 results to the required health authorities. Findings are as follows: 1. The laboratory performed SARS-CoV-2 testing as confirmed by the Testing Personnel 3 (TP3) during a tour of the laboratory at 10:15 a.m. on 11/04/21. 2. In an email dated 11/5/21, the Technical Consultant (TC) confirmed that the laboratory had performed SARS-CoV-2 testing on 249 days during the time period from November 20, 2020 through November 4, 2021. 3. The procedures provided by the laboratory did not include criteria for reporting SARS-CoV-2 test results to the required authorities. 4. The laboratory was unable to provide this reporting procedure upon request. 5. In an email dated 11/5/21, the TC confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed ensure 4 of 7 testing personnel (TP) in 2018 and 3 of 7 TP in 2019 who routinely performed moderately complex testing on patient samples participated in proficiency testing (PT). Findings are as follows: 1. The laboratory performed moderately complex Microbiology, Chemistry, and Hematology testing as confirmed Testing Personnel 2 (TP2) during a tour of the laboratory at 12:35 p.m. on 02/03/20. 2. The laboratory performed PT using the American Academy of Family Physicians (AAFP) proficiency provider. 3. Laboratory records indicated TP3, TP5, TP6, and TP7 did not participate in 3 of 3 AAFP PT events completed by the laboratory in 2018 and TP5, TP6, and TP7 did not participate in 3 of 3 AAFP PT events completed by the laboratory in 2019. 4. In an interview at 4:00 p.m. on 02/03/20, TP2 confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when 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 -- they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control (QC) activities as established in the a Chemistry Individualized Quality Control Plan (IQCP) in 1 of 22 months reviewed . Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 2 (TP2) during a tour of the laboratory at 12:35 p.m. on 02/03 /20. 2. A NanoEnTek FREND chemistry analyzer was observed as present and available for use during the tour of the laboratory. Prostrate-Specific Antigen (PSA) testing was performed on this analyzer. 3. PSA QC performance was required monthly as established in the laboratory's IQCP for the test. 4. Documentation on the Appendix (G): Quality Control (QC) Log for the FREND PSA test indicated the time interval between PSA QC performance exceeded that established in the IQCP on 1 occasion in the timeframe reviewed, 03/29/18 - 02/03/20, potentially affecting 6 patient test results (Pt). See below. QC date QC date Interval Pt 09/27/18 11/29/18 64 days 6 5. In an interview at 4:30 p.m. on 02/03/20, TP2 confirmed the above finding. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant failed to ensure 4 of 7 testing personnel (TP) were assessed at least annually in 2018 and 3 of 7 TP were assessed at least annually in 2019 through testing Microbiology, Chemistry,and Hematology previously analyzed specimens, blind samples, or proficiency testing samples. Findings are as follows: 1. The laboratory performed Wet Preparations (WP), Potassium Hydroxide (KOH), and Urine Sediment (US) microscopic examinations, Chemistry testing on the NanoEnTek Frend analyzer (NF) and Qualigen FastPack system (QFP), and Complete Blood Count (CBC) Hematology testing as confirmed by Testing Personnel 2 (TP2)) during a tour of the laboratory at 12:35 p.m. on 02/03/20. 2. In an interview at 1:05 p.m. on 02/03/20, TP2 indicated all testing personnel performed the Chemistry and Hematology testing while only TP1, TP2, and TP3 performed microscopic examinations. 3. The Personnel Competency procedure located in the Policy Procedure Manual and the the Job Competence Evaluation form did not include criteria for blind sample evaluations. 4. The laboratory was unable to provide documented blind sample evaluations performed in 2018 and 2019 for any TP upon request. Laboratory records indicated not all TP participated in proficiency testing for each non-waived test in 2018 and 2019 (See D2007). See below where "x" indicates proficiency testing was not performed. 2018 Testing Personnel (TP) TP3 TP5 TP6 TP7 WP x N/A N/A N/A KOH x N/A N/A N/A US x N/A N/A N/A NF x x x x QFP x x x x CBC x x x x 2018 Testing Personnel TP5 TP6 TP7 NF x x x QFP x x x CBC x x x 5. In an interview at 3: 50 p.m. on 02/03/20, TP2 confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded Urinalysis proficiency testing results. Findings are as follows: 1. The laboratory performed Urinalysis testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 3/29/18 at 11:05 a. m. 2. The laboratory performed Proficiency Testing (PT) using American Academy of Family Practice (AAFP) as the provider. 3. The laboratory received non-graded PT results from AAFP due to lack of referee consensus for the event, samples, and test listed below. Year: 2017 Survey: PT-2017 B Sample: CM-13 and CM-15 Test: Urinalysis 4. An evaluation of the non-graded PT results were not found during review of laboratory records. The laboratory was unable to provide the evaluations upon request. 5. In an interview at 12:50 p.m. on 3/29/18, the GS confirmed the above findings. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)