Ar Anatomic Pathology Laboratory/Doctors'

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon review of personnel files for Technical Supervisor (TS) listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, the laboratory director failed to authorize five of five TS to perform testing without direct supervision. Survey findings include: A) Review of personnel files for five TS listed on form CMS-209 (TS 's 1, 2, 3, 4, 5) revealed no written authorization from the laboratory director to perform high complex testing without direct supervision was not present. B) In an interview, at 12:50 a.m. on 12/17/25 laboratory Operations Supervisor confirmed the lack of written authorization to test for TS 's 1, 2, 3, 4, and 5 on form CMS 209. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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). The cumulative effect of this systemic problem resulted in the laboratory's failure to meet certification requirements to accurately and reliably evaluate patients' gynecologic cytology specimen slides for 2020 and 2021. 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; 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 -- 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 CMS-approved cytology PT program for gynecologic examination for 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in an approved cytology PT program for 2020 and 2021. 2. During an interview with the Survey Team on April 20, 2021 at 1:15 PM, Laboratory Director/Technical Supervisor A confirmed these findings. 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. This STANDARD is not met as evidenced by: Based on lack of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of six of six Technical Supervisors in 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the diagnostic competency of six of six Technical Supervisors. Technical Supervisors include: - Laboratory Director/Technical Supervisor A - Technical Supervisor B - Technical Supervisor C - Technical Supervisor D - Technical Supervisor E - Technical Supervisor F 2. During an interview with the Survey Team on April 20, 2021 at 1:30 PM, Laboratory Director/Technical Supervisor A confirmed these findings. 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 policies and procedures and interview the laboratory failed to have written procedures available to laboratory personnel for 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written procedures manual. 2. During an interview with the Survey Team on April 20, 2021 at 1:15 PM, Laboratory Director/Technical Supervisor A confirmed these findings. 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 -- 2 of 10 -- 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)