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 interviews and review of annual gynecologic cytology proficiency test (PT) records Facility B (CLIA #34D0685109) referred gynecologic cytology PT slidesets to Facility A (CLIA #34D0238170) in 2022 and 2023. (Refer to D2013) D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency 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 -- testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on interviews and review of annual gynecologic cytology PT records the laboratory (Facility B) referred one annual gynecologic cytology Proficiency Test (PT) slideset consisting of 10 slides to Facility A in 2022. The laboratory (Facility B) referred two annual gynecologic cytology PT slidesets consisting of 10 slides each to Facility A in 2023. Findings include: 1. During interviews on October 21, 2024 these findings were confirmed by Proctor B, Cytotechnologist A and Laboratory Director /Technical Supervisor A. a. At 3:22 PM, Proctor B stated that Proctor A delivered the annual gynecologic cytology PT slidesets to Facility A in 2022 and 2023 and administered the test to three of three Technical Supervisors in their offices. Proctor B stated that the Technical Supervisors never came to Facility B to participate in the annual gynecologic cytology PT event. Proctor B also stated that Proctor A was no longer employed at Facility A or Facility B. b. At 3:31 PM, Cytotechnologist A confirmed that the annual gynecologic cytology PT slidesets were delivered to Facility A in 2022 and 2023 and that testing was administered to three of three Technical Supervisors in their offices. Cytotechnologist A stated that, beginning with the 2024 gynecologic cytology PT event due soon, the Technical Supervisors will be required to come to Facility B to take the test. c. At 4:48 PM, Laboratory Director /Technical Supervisor A confirmed during a phone interview that Technical Supervisor A, Technical Supervisor B, and Technical Supervisor C received annual gynecologic cytology PT slidesets from Facility B and completed the testing event in their offices at Facility A in 2022 and 2023. 2. The Survey Team reviewed annual gynecologic cytology PT records from 2022 for Technical Supervisor A, Technical Supervisor B and Technical Supervisor C. While the gynecologic cytology PT records stated the CLIA number for the PT event was for Facility B, three of three Technical Supervisors performed the PT testing event at Facility A in 2022. a. Technical Supervisor A tested on the 10-slide testing set #34278 on 10/17/2022. b. Technical Supervisor B tested on the 10-slide testing set #34278 on 10/17/2022. c. Technical Supervisor C tested on the 10-slide testing set #34278 on 10/17/2022. 3. The Survey Team reviewed annual gynecologic cytology PT records from 2023 for Technical Supervisor A, Technical Supervisor B and Technical Supervisor C. While the gynecologic cytology PT records stated the CLIA number for the PT event was for Facility B, three of three Technical Supervisors performed the PT testing event at Facility A in 2023. a. Technical Supervisor A tested on the 10-slide testing set #34137 on 08/21/2023. b. Technical Supervisor B tested on the 10-slide testing set #34136 on 08/21/2023. c. Technical Supervisor C tested on the 10-slide testing set #34136 on 08 /21/2023. 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 -- 2 of 7 -- 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)