Summary:
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 lack of annual gynecologic cytology proficiency testing (PT) enrollment records and interview with the Laboratory Director/Technical Supervisor A, the laboratory failed to enroll in an annual CMS-approved PT program for gynecologic cytology examination in 2019, 2020 and 2021. Findings Include: 1) The survey team requested and the laboratory failed to provide gynecologic cytology proficiency testing enrollment records for 2019, 2020, and 2021. 2) The Laboratory Director /Technical Supervisor A confirmed on May 24, 2022 at 4:05 PM the laboratory performed gynecologic cytology testing in 2019, 2020, and 2021 and did not enroll in an approved proficiency testing program for any years. 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of laboratory policies and procedures and interview, the laboratory failed to establish written policies and procedures to assess the competency of three of threeTechnical Supervisors in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisors. 2. During a telephone interview on May 24, 2022 at 4: 05 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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 lack of a policy and procedures manual and interview, the laboratory failed to have a written procedures manual for all cytology test processes performed by the laboratory available to laboratory personnel. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written procedures manual for all cytology test processes performed at the laboratory. 2. During a telephone interview on May 24, 2022 at 4:05 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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)