Pathology Consultants Of New Mexico

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on May 15, 2025, at Pathology Consultants of New Mexico found the laboratory to be out of compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency Testing (PT) and Slide Statistics records, lack of documentation, and interview with General Supervisor 3 (GS3), the laboratory failed to at least twice annually verify the accuracy of Gram Stains and Acid Fast Bacilli (AFB) for histopathology testing during 2024. Findings include: 1. Review of the laboratory's PT records showed no records verifying at least twice annually the accuracy for Gram Stains or AFB testing for 2024. 2. A request was made for records demonstrating verification of the accuracy of Gram Stains or AFB testing for 2024, none were provided. 3. An interview on 05/15/2025 at 12:50 with GS3 confirmed the above findings. 4. A review of the laboratory's Slide Statistics records indicated the laboratory reported 18 Gram Stains and 84 AFBs during 2024. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of laboratory's "Equipment Maintenance" policy and the laboratory's temperature logs, the laboratory failed to follow its own policy by failing to maintain operational temperatures for the Histology (Histo) Fridge for 47 days between October 2024 and April 2025 and the Slide Drying Oven for 27 days between October 2024 and April 2025. Findings include: 1. Review of the laboratory's "Equipment Maintenance" policy outlined the following temperature requirements: a. Histo Fridge: 2-8C b. Slide Drying Oven 56-60C 2. Review of the laboratory's temperature logs showed operational temperatures to be out of range for the following equipment: a. Histo Fridge: 2024 October (11,14-16, 22-25, 29-30) November (1, 5, 12, 14-15, 19- 20, 27) December (2-5, 11-12, 16, 18-19, 23, 31) 2025 January (2, 6, 13-17, 20-22, 28) February (3-7, 10-14) March (4-7, 19-20, 24, 31) April 2-4, 21-25, 28-30 b. Slide Drying Oven: 2024 October (7-9, 24) December (3) 2025 January (3, 14, 16, 22, 29- 31) February (12, 21, 24-27) March (4-5, 11, 24, 27) April (2, 21-23, 29) 3. The laboratory reports 79,822 histopathology tests annually. D5785

Summary Statement of Deficiencies 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, lack of laboratory records and interviews it was determined that the laboratory failed to establish written policies and procedures to compare gynecologic cytology with a diagnosis of HSIL or malignancy with available histopathology reports (refer to D5623); failed to establish written policies and procedures to review all prior negative gynecologic specimens received within the previous five years for each patient with a current High Grade Squamous Intraepithelial Lesion (HSIL) or malignancy (refer to D5625); failed to establish written policies and procedures for an annual evaluation and comparison of six of six laboratory statistics (refer to D5629); failed to establish written policies and procedures to establish reassess and document a workload limit for five of five Technical Supervisors (refer to D5633, D5637 and D6547); failed to establish written policies and procedures to prorate the workload limit for five of five Technical Supervisors when examining slides in less than an eight hour day (refer to D5641); failed to document the total number of slides and the total number of hours spent examining slides in each 24-hour period for five of five Technical Supervisors (refer to D5645); failed to establish written policies and procedures to document the workload limit for five of five Technical Supervisors (refer to D5647); failed to establish written policies and procedures to ensure that unsatisfactory cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); and failed to establish written policies and procedures to specify on a corrected report the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- basis for correction (refer to D5659). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. 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 review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of five of five 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 five of five Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for five of five Technical Supervisors who performed microscopic evaluations in 2020 and to the date of the survey in 2021. Technical Supervisors include: - Laboratory Director/Technical Supervisor A - Technical Supervisor B - Technical Supervisor C - Technical Supervisor D - Technical Supervisor E 3. During an interview with the Survey Team on March 22, 2021 at 2:38 PM, Laboratory Director/Technical Supervisor A confirmed these findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish a quality assessment procedure and document quality assessment activities for 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 for general laboratory quality assessment. 2. The Survey Team requested and the laboratory failed to provide documentation of quality assessment activities for 2020 and to the date of the survey in 2021. 3. During an interview with the Survey Team on March 22, 2021 at 5:00 PM, the Director of Cytology 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, -- 2 of 11 -- 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)