Summary:
Summary Statement of Deficiencies D0000 The Lakeview 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 validation survey performed on December 28, 2023. The following condition-level deficiencies were cited: 493.1250 Analytic Systems The following standard-level deficiencies were cited: 493.801 Enrollment and testing of samples (Proficiency testing) 493.1236 Evaluation of proficiency testing performance 493.1251 Procedure Manual 493.1254 Maintenance and function checks 493.1289 Analytic systems quality assessment 493.1407 Laboratory director responsibilities 493.1413 Technical consultant responsibilities . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload 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 Director (LD) failed to attest to the integration of proficiency testing samples into the routine patient workload on ten of ten occasions in 2021, 2022, and 2023. In addition, Testing Personnel (TP) failed to do the same on two of ten occasions in the same time period. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology, Chemistry, and Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:15 a.m. on 12/28/23. 2. The Laboratory performed proficiency testing using the American Academy of Family Practitioners (AAFP) proficiency testing provider in 2021 and 2021 and the American Proficiency Institute (API) in 2023. 3. The LD's signature and the TP's signature were required on the attestation statements for all PT events as indicated in the Proficiency Testing Policy found in the Policy and Procedure Manual. 4. The Laboratory Director Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- failed to sign the attestation statement for ten of ten PT events reviewed from 2021, 2022, and 2023. See below. AAFP events 2021-C 2022-A 2022-B 2022-C API events 2023 Hematology - 1 2023 Microbiology - 1 2023 Hematology - 2 2023 Microbiology - 2 2023 Hematology -3 2023 Microbiology 3 5. The TP failed to sign the attestation statement for two of ten PT events reviewed from 2021, 2022, and 2023. See below. AAFP event 2021-C API event 2023 Microbiology - 1 5. In an interview at 1:08 p.m. on 12/28/23, the TC confirmed the above finding. . 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 document review of proficiency testing (PT) results for nine of ten PT events completed in 2021, 2022, and 2023. In addition, the laboratory failed to evaluate four unacceptable PT results in the same time period. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology, Chemistry, and Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:15 a.m. on 12/28/23. 2. The Laboratory performed proficiency testing using the American Academy of Family Practitioners (AAFP) proficiency testing provider in 2021 and 2021 and the American Proficiency Institute (API) in 2023. 3. The results from the following AAFP and API events did not include documented review: AAFP events 2021-C 2022-A 2022-B 2022-C API events 2023 Hematology - 1 2023 Microbiology - 1 2023 Hematology - 2 2023 Microbiology - 2 2023 Microbiology 3 4. The following unacceptable results were not evaluated by the laboratory: AAFP events Sample Test 2021-C TC-11 Throat culture 2022-B CM-15 Vaginal wet preparation API event Sample Test 2023 Hematology-1 HEM-01 Granulocytes 2023 Hematology-2 HEM-06 Monocytes 5. In an interview at 1:08 p.m. on 12/28/23, the TC confirmed the above finding. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on review of laboratory policies and procedures, patient testing and quality control logs, direct observation, and interview with laboratory personnel, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. Findings are as follows: 1. The laboratory failed to follow a Microbiology written procedure. See D5401 2. The laboratory failed to ensure one of four testing procedures included all required elements. See D5403 3. The laboratory director failed to approve three of four testing procedures prior to use. See D5407 4. -- 2 of 8 -- The laboratory failed to establish a thermometer maintenance protocol and perform and document thermometer function check activities. See D5433 . 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 observation, document review, and interview with laboratory personnel, the laboratory failed to follow a Microbiology written procedure in 2021, 2022, and 2023. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:15 a.m. on 12/28/23. 2. Media plates and a Boekel incubator were observed as present and in use during the tour. The laboratory performed Throat Cultures testing using these items. 3. Throat cultures were read after 18 hours and results were reported after 20 hours as established in the ID of Group A Beta- hemolytic Streptococcus by Culture procedure found in the Policy and Procedure manual. 4. Upon inquiry by surveyor, the TC indicated throat cultures set up on Friday were not read until the following Monday. The clinic was not open on Saturday or Sunday. 5. The laboratory performed approximately 409 Microbiology tests annually as indicated on the Form CMS-116 provided by the laboratory on date of survey. 6. In an interview at 1:38 p.m. on 12/28/23, 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)