Erik Pasin, Md Inc

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation and interviews the laboratory failed to retain all cytology slide preparations for at least five years (refer to D3043). D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Based on observation and interviews the laboratory failed to retain all cytology slide preparations from 75 of 75 patient cases from October 2023 through May 2024 for at least five years. Findings include: 1. During a review of cytology slide preparations and the corresponding final test reports, the laboratory failed to locate and provide cytology slide preparations from 75 of 75 patient cases from October 2023 through May 2024. Slides include: -EP23-00426 -EP24-00024 -EP23-00427 -EP24-00025 - EP23-00428 -EP24-00027 -EP23-00429 -EP24-00029 -EP23-00430 -EP24-00030 - EP23-00431 -EP24-00031 -EP23-00432 -EP24-00032 -EP23-00435 -EP24-00033 - EP23-00437 -EP24-00034 -EP23-00439 -EP24-00035 -EP23-00440 -EP24-00036 - EP23-00463 -EP24-00037 -EP23-00464 -EP24-00039 -EP23-00466 -EP24-00040 - EP23-00470 -EP24-00041 -EP23-00471 -EP24-00043 -EP23-00472 -EP24-00044 - EP23-00473 -EP24-00046 -EP23-00474 -EP24-00047 -EP23-00476 -EP24-00048 - EP23-00477 -EP24-00049 -EP23-00478 -EP24-00053 -EP23-00479 -EP24-00079 - EP23-00480 -EP24-00080 -EP23-00481 -EP24-00081 -EP23-00482 -EP24-00082 - EP23-00483 -EP24-00083 -EP23-00484 -EP24-00084 -EP23-00487 -EP24-00085 - EP23-00488 -EP24-00086 -EP23-00489 -EP24-00090 -EP23-00490 -EP24-00091 - EP23-00491 -EP24-00092 -EP23-00492 -EP24-00094 -EP23-00493 -EP24-00095 - EP23-00494 -EP23-00495 -EP23-00496 -EP23-00501 -EP23-00503 2. During an interview on October 21, 2024 at 11:20 AM, the Office Manager and Staff A stated Facility B (CLIA 31D1026901) sent prepared cytology slide preparations to the Laboratory Director/Technical Supervisor's home residence for evaluation and reporting. The Laboratory Director/Technical Supervisor would "sporadically drop off" cytology slide preparations to the laboratory being surveyed for filing. 3. During an interview on October 22, 2024 at 11:55 AM, the Office Manager stated the Laboratory Director/Technical Supervisor reported that the Laboratory Director /Technical Supervisor did not have possession of any cytology slide preparations located outside of the laboratory. The Office Manager further stated the cytology slide preparations could not be located. 4. During an interview on October 22, 2024 at 2:00 PM, these findings were confirmed with the Office Manager, Laboratory Owner and Staff A. 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 the laboratory failed to ensure written policies and procedures were followed to assess the competency of the Technical Supervisor (refer to D5209); failed to follow two written policies and procedures (refer to D5401); failed to establish written policies and procedures for one laboratory test process (refer to D5403); failed to establish and follow written policies and procedures for an annual statistical evaluation of the required laboratory statistics (refer to D5629); failed to follow written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish and follow written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of -- 2 of 12 -- hours spent examining slides per 24-hour period (refer to D5645); failed to establish written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish and follow written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results (refer to D5657); failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the analytic cytology systems (refer to D5791); and failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic cytology systems (refer to D5891). 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 competency assessment records and interview the laboratory failed to ensure written policies and procedures were followed to assess the competency of the Technical Supervisor. The laboratory failed to assess the competency of one of one Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The laboratory failed to follow the procedure JOB DESCRIPTION, which stated: "Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation." 2. The Survey Team requested and the laboratory failed to provide competency assessment records for one of one Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisor includes: -Laboratory Director/Technical Supervisor 3. During an interview on October 22, 2024 at 2:00 PM, these findings were confirmed with the Office Manager, Laboratory Owner and Staff A. 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 review of 17 laboratory policies and procedures, lack of laboratory records and interviews the laboratory failed to follow two written policies and procedures. Findings include: 1. The laboratory failed to follow the procedure URINE CYTOLOGY THINPREP CONTROL SLIDES FOR THE EVALUATION OF QUALITY OF STAINING AND SPECIMEN PREPARATION - TC/PC CLIENTS, -- 3 of 12 -- which stated: "It is the responsibility of the pathology director at the TC/PC site receiving the ThinPrep urine cytology control slide and the patient Thinprep urine cytology slides to document the quality of the staining and slide preparation on the Technical Quality Assurance and Slide Log form received with the ThinPrep slides and requisitions." a. The Survey Team requested and the laboratory failed to provide records titled TECHNICAL QUALITY ASSURANCE AND SLIDE LOG for 2022, 2023 and January 1, 2024 to the date of the survey in 2024. 2. The laboratory failed to follow the procedure MICROSCOPE PREVENTATIVE MAINTENANCE, which stated: "Services of a certified company will be utilized for preventative maintenance on an annual basis." a. The Survey Team requested and the laboratory failed to provide microscope maintenance records for 2022, 2023 and January 1, 2024 to the date of the survey in 2024. b. During an interview on October 21, 2024 at 11:20 AM, the Office Manager stated the Laboratory Director/Technical Supervisor microscopically examined slides at a remote location (Laboratory Director/Technical Supervisor's home residence). c. During an interview on October 22, 2024 at 1:20 PM, the Office Manager stated the laboratory did not have any microscope maintenance records. 3. During an interview on October 22, 2024 at 2:00 PM, these findings were confirmed with the Office Manager, Laboratory Owner and Staff A. 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)