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 proficiency testing (PT) enrollment records and interview it was determined that the laboratory failed to enroll in an approved cytology 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 lack of cytology PT enrollment records and interview it was determined that the laboratory failed to enroll in a 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 7 -- 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 at 9:00 AM on September 7, 2021, Laboratory Director/Technical Supervisor #1 confirmed these findings. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews it was determined the laboratory failed to establish written policies and procedures for the transportation of gynecologic cytology slides (refer to D5311); failed to establish written policies and procedures for laboratory test process (refer to D5403); failed to ensure that three laboratory procedures were signed as approved by the Laboratory Director prior to use (refer to D5407); failed to establish written policies and procedures to compare gynecologic cytology cases with a diagnosis of HSIL or malignancy with the histopathology diagnosis (refer to D5623); failed to establish written policies and procedures for the search and review of prior negative gynecologic specimens received within the previous five years for each patient with a current HSIL or malignancy (refer to D5625); failed to establish written policies and procedures for an annual statistical evaluation of six of six required laboratory statistics, and failed to ensure the laboratory documented the six required annual statistics (refer to D5629); and failed to establish written policies and procedures to ensure unsatisfactory cytology slide preparations were identified and reported as unsatisfactory (refer to D5655). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures it was determined that the laboratory failed to establish written policies and procedures for the transportation of cytology slides from Facility B (CLIA #37D0469942) to Facility A (CLIA #37D1025073). Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the documentation of the conditions required for the transportation of cytology slides from Facility B to Facility A. D5403 PROCEDURE MANUAL -- 2 of 7 -- 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)