Stevens Community Medical Center-Starbuck Clinic

Summary Statement of Deficiencies D0000 The Starbuck Clinic laboratory was found to be out of 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 November 20, 2024. The following standard-level deficiencies were cited: 493.1413 Technical consultant responsibilities, (b)(7) and (b)(8) . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure comprehensive initial training for two of two new testing personnel (TP) was performed and documented in 2024. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology, Chemistry, and Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 12:05 p.m. on 11/20/24. 2. An Afinion 2 chemistry analyzer was observed as present and available for use during the tour. The laboratory performed Microalbumin testing using this analyzer. 3. Competency evaluation of testing personnel was required in all testing areas at time of hire, after 6 months of work, and annually thereafter as established in the 6 Month/Annual Employee Competency procedure found in the Quality Assurance and Incident Management manual. 4. TP2 received initial laboratory training and competency assessment in June 2024 and TP3 received initial laboratory training and competency assessment in May 2024 as indicated on training and Employee Competency Documentation forms reviewed on date of survey. 5. The training and competency documents did not include 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 -- Microalbumin testing on the Afinion 2 analyzer. The laboratory was unable to provide the missing training records upon request. 6. In an interview at 2:05 p.m. on 11/20/24, the LD confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure two of two tenured testing personnel (TP) were evaluated for competency in two of three microscopic examination test procedures in 2022 and 2023. Findings are as follows: 1. The laboratory performed KOH preparation (KOH) and vaginal wet preparation (VWP) microscopic examination testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 12:05 p.m. on 11/20/24. 2. An American Optical Spencer microscope was observed as present and available for use during the tour. 3. Competency evaluation of testing personnel was required in all testing areas at time of hire, after 6 months of work, and annually thereafter as established in the 6 Month/Annual Employee Competency procedure found in the Quality Assurance and Incident Management manual. 4. Competency assessments for KOH and VWP microscopic examination testing was not included in the Employee Competency Documentation forms completed for the LD and TP1 in 2022 and 2023. The laboratory was unable to provide the missing evaluations upon request. 5. In an interview at 1:07 p.m. on 11/20 /24, the LD confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate an unacceptable Chemistry proficiency testing (PT) result for 1 analyte in 2020. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 03/04/21. 2. The laboratory performed PT using the American Proficiency Institute (API) program. 3. The laboratory received an unacceptable Low- Density Lipoprotein (LDL) PT result for 1 of 15 LDL PT challenges completed in 2020. See below. API 2020 Chemistry 3rd event Sample Test Lab result API range CH-13 LDL 63 32-62 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing Procedure located in the 2021 API 3-ring binder. 5. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 12:18 p.m. on 03/04/21, the LD confirmed the above finding. 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). 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 -- 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 one 2020 proficiency testing (PT) result when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed manual microscopic analysis of urine sediment testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a. m. on 03/04/21. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One urine sediment result from the third 2020 Hematology PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte US-06 Urine Sediment 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above analyte was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. 5. Investigation of non- graded PT results was required as established in the Proficiency Testing Procedure located in the 2021 API 3-ring binder. The laboratory was unable to provide an evaluation of the non-graded result upon request. 6. In an interview at 12:18 p.m. on 03/04/21, the LD confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure reference intervals were consistent between Hematology procedures and tables, and a patient test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 05/31/19. 2. A Sysmex XN-330 hematology analyzer was observed as present and available for use during the tour. The laboratory began testing patient specimens using this analyzer on 12/12/18 as confirmed in an interview with the LD at 3:15 p.m., on 05/31/19. 3. Reference intervals included in the Hematology Sysmex XN-330 standard operating procedure (SOP) and Starbuck Clinic In-House Test List Table for 14 of 14 analytes reviewed on date of survey were not consistent with those included on the patient test report reviewed, as indicated below. Patient: MRN #82505232 - adult male tested on 05/31 /19. Analyte SOP / Table Report WBC Count * 4.23-9.07 4.5-11.0 RBC Count * 4.63- 6.08 4.60-6.20 Hemoglobin 13.7-17.5 14.0-18.0 Hematocrit 40.1-51.0 42.0-52.0 MCV * 79.0-92.2 80.0-100.0 MCH * 25.7-32.2 26.0-33.0 MCHC * 32.3-36.5 31.0- 36.0 Platelets 163-337 130-400 % Neutrophils 34.0-67.9 45.0-70.0 % Lymphocytes21. 8-53.1 28.0-55.0 % Monocytes 5.3-12.2 Not Given % Eosinophils 0.8-7.0 Not Given % Basophils 0.2-1.2 Not Given 4. In an interview at 3:15 p.m., on 05/31/19, the LD confirmed the reference interval discrepancies between the Sysmex XN-330 SOP and the patient test report. The LD stated that the reference intervals shown on the patient report were entered as part of a new Laboratory Information System (LIS), implemented on 10/1/18, and were taken from those used at a sister facility. *Note: 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 -- WBC Count White Blood Cell Count RBC Count Red Blood Cell Count MCV Mean Corpucular Volume MCH Mean Corpucular Hemoglobin MCHC Mean Corpucular Hemoglobin Concentration . -- 2 of 2 --