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 the lack of cytology proficiency testing (PT) enrollment records and interview it was determined that the laboratory failed to enroll in an approved PT program for gynecologic examination (refer to D2001). D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interview it was determined that the laboratory failed to enroll in an HHS-approved cytology PT program for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- gynecologic examination for 2019 and 2020. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in an approved cytology PT program for 2019 and 2020. 2. During an interview on October 4, 2021 at 3:30 PM, these findings were confirmed with the Laboratory Director, Technical Supervisor A, Cytology Supervisor, Anatomic Pathology Administrative Director and the Quality Coordinator. 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 the lack of a policy and procedure manual and interviews it was determined that a written procedure manual for all cytology tests and examinations performed by the laboratory was not available to laboratory personnel. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written procedure manual for all cytology tests and examinations performed at the laboratory. a. The laboratory provided the following procedures that belonged to Facility B (CLIA 17D0448802) and were used by this laboratory. Procedures include: -POLICY FOR EDUCATION NOTES TO PROVIDERS -COMPUTER DOWNTIME AND RECOVERY PROCEDURES -EVALUATION OF LIPID LADEN MACROPHAGES PROCEDURE -SECURITY PROCEDURES FOR THE CYTOPATHOLOGY LIS COMPUTER SYSTEM -EQUIPMENT MAINTENANCE PROCEDURE -ACCESSIONING PROCEDURE FOR OUTSIDE SLIDES - ORGANIZATION OF THE CYTOLOGY LABORATORY -CHECKLIST FOR TEST MANAGEMENT POLICIES, TECHNICAL PROCEDURES, RECORDS AND LABORATORY SYSTEMS -OUTSIDE SLIDE RETURN PROCEDURE - CONTINUATION OF CARE REQUEST -POLICY FOR SLIDE STORAGE, RETRIEVAL, HANDLING, AND LOANS -ADDENDUM REPORT PROCEDURE IN CO-PATH -LABORATORY RECORD MANAGEMENT AND RETENTION 2. During an interview on October 4, 2021 at 2:40 PM, the Quality Coordinator stated that the laboratory used Facility B's procedures. 3. During an interview on October 4, 2021 at 3:30 PM, these findings were confirmed with the Laboratory Director, Technical Supervisor A, Cytology Supervisor, Anatomic Pathology Administrative Director and the Quality Coordinator. 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 -- 2 of 10 -- 493.1253. (7) Control procedures. (8)