Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review for Mohs testing and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2020, 2021 and 2022. Findings include: 1. No documentation was presented for review during the survey conducted on February 2, 2023 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading/diagnosis) of histopathology specimens which are read during the Mohs procedure at least twice annually during 2020, 2021 and 2022. 2. The facility personnel interviewed on February 2, 2023 at 11:45am confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2020, 2021 and 2022. 3. The laboratory's approximate annual test volume under the sub-specialty of Histopathology is 360. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 7 -- Based on lack of established Quality Assessment (QA) policies and procedures for review and interview with the facility personnel, the laboratory failed to establish QA policies and procedures for the general laboratory systems, including but not limited to, policies and procedures related to the accuracy verification process for dermatopathology testing performed by the laboratory. Findings include: 1. The laboratory performs the microscopic interpretation (reading/diagnosis) of dermatopathology specimens which are read during the Mohs procedure. 2. No documenation was presented for review during the survey to indicate the laboratory established policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 3. No documentation was presented for review during the survey to indicate the laboratory established policies and procedures related to the verification of accuracy process for Mohs testing, including but not limited to, information specific to the frequency of the review, number of cases reviewed, individual or laboratory performing the review and a remedial action plan in the event of a noted discrepancy. 4. The facilty personnel interviewed during the survey on February 2, 2023 at approximately 12:05pm confirmed that the laboratory failed establish a written policy and procedure specific to the verification of accuracy process for the microscopic interpretation of Mohs specimens and failed to establish policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 5. The laboratory began patient testing on April 1, 2020. The laboratory's annual test volume is 360. 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 the severity and number of deficiencies cited for quality control practices identified during the survey conducted on February 2, 2023, it was determined that the laboratory failed to monitor the overall quality of the analytic systems and correct problems as specified in 493.1289 for patient testing performed by the laboratory in the sub-specialty of Histopathology. See D5403, D5407, D5413, D5473 and D5791 for 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. -- 2 of 7 -- (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)