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 interviews the laboratory failed to enroll in a CMS-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 the lack of cytology PT enrollment records and interviews the laboratory failed to enroll in a CMS-approved cytology PT program for gynecologic examination Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- for 2022 and 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in a CMS-approved cytology PT program for 2022 and 2023. 2. During an interview on April 8, 2024 at 8:45 AM, when asked if the laboratory had enrolled or was currently enrolled in a CMS- approved cytology PT program the Laboratory Director/Technical Supervisor A and Vice President (VP) of Quality Assurance replied "no." 3. During an interview on April 8, 2024 at 11:00 AM, the VP of Quality Assurance and Cytology Supervisor inquired as to the process of enrolling the laboratory in a cytology PT program, confirmed the laboratory had not been enrolled prior to the survey, and stated they would begin the enrollment process. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interviews the laboratory failed to establish and follow safety procedures to ensure protection from physical, chemical and electrical hazards. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure protection from physical, chemical and electrical hazards. 2. During an interview on April 8, 2024 at 8:45 AM, when asked if the laboratory had written safety procedures to ensure protection from physical, chemical and electrical hazards that were specific to the laboratory being surveyed, the Laboratory Director/Technical Supervisor A and VP of Quality Assurance replied "no." 3. During an interview on April 8, 2024 at 3:45 PM, the VP of Quality Assurance confirmed the written policies and procedures in MEDIA LAB did not reflect the safety policies and procedures of the laboratory being surveyed. The VP of Quality Assurance stated that they were creating a new manual in MEDIA LAB and would include the safety policies and procedures that were specific to the location of the laboratory being surveyed. 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)