Cmh Raiter Family Clinic

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 document review and interview with laboratory personnel, the laboratory performed testing on five hematology proficiency testing (PT) samples obtained from another laboratory prior to the PT event submission deadline. Refer to D2012. . D2012 TESTING OF PROFICIENCY TESTING SAMPLES (b)(4) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample(s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced 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 2 -- . Based on observation, document review, and interview with laboratory personnel, the laboratory performed testing on five hematology proficiency testing (PT) samples obtained from another laboratory prior to the PT event submission deadline in February 2025. Findings are as follows: 1. The laboratory performed hematology testing as indicated by Technical Consultant 1 (TC1) during a tour of the laboratory at 11:00 a.m. on 07/08/25. A Sysmex XP-300 hematology analyzer was observed as present and in use during the tour. 2. The laboratory performed proficiency testing using the College of American Pathologists (CAP) proficiency testing provider. 3. The laboratory prohibited inter-laboratory communication pertaining to PT testing events as established in the Proficiency Testing Process procedure located in the Laboratory Quality Manual. 4. Documents found in the 2025 CAP Proficiency Test manual indicated the laboratory ordered CAP hematology PT package FH13 for the 2025 calendar year. Upon receipt of the FH13-A 2025 event samples, Technical Consultant 2 (TC2) discovered they had ordered the incorrect package per documentation observed on the CAP FH13-A 2025 Original Evaluation form. 5. Documentation indicated the laboratory tested the FH13-A samples and submitted the results per standard and acceptable protocol. 6. Sysmex XP-300 hematology test reports and additional documentation found in the CAP Proficiency Testing manual indicated the laboratory obtained and tested five CAP hematology PT package FH9-A 2025 samples from another laboratory on 02/11/25. 7. The result submission deadline for the FH9-A PT 2025 package was 02/12/25 as indicated on the CAP FH9-A Hematology Automated Differential Survey Result Form provided by the General Supervisor from the other laboratory. 8. Testing FH9-A 2025 PT samples obtained from another laboratory prior to the submission deadline constitutes inter-laboratory communication. 9. In an interview at 12:20 p.m. on 07/08/25, TC1 and TC2 confirmed the above finding. -- 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 one of three testing personnel who routinely performed moderate complexity testing on patient samples participated in proficiency testing (PT) in 2022 and 2023. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology, Chemistry, and Hematology testing as confirmed Testing Personnel 1 during a tour of the laboratory at 9:00 a.m. on 06/08/23. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency provider. 3. Testing Personnel 3 did not participate in nine of nine API PT events completed by the laboratory in 2022 and four of four PT events completed by the laboratory in 2023 as indicated in laboratory records. 4. In an interview at 11:10 a.m. on 06/08/23, the Technical Consultant confirmed the above finding. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- failed to ensure one of one technical consultants(TC) received a competency assessment at this laboratory which included specific position responsibilities listed in Subpart M. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology, Chemistry, and Hematology testing as confirmed by Testing Personnel 1 during a tour of the laboratory on 06/08/23 at 9:00 a.m. 2. One TC was listed on the Form CMS-209 Laboratory Personnel Report (CLIA) obtained on date of survey. 3. A competency assessment procedure was not found in laboratory procedure manuals on date of survey. See D6030. 4. A TC competency assessment was not found during review of 2021 and 2022 laboratory personnel records. The laboratory was unable to provide the competency assessment upon request. 5. In an interview at 10:45 a.m. on 06/08/23, the TC confirmed the above finding. . 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. (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)