Pathology Associates Of Tyler, Pa

Summary Statement of Deficiencies D0000 An onsite survey conducted 09/07/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instruction for use, laboratory staining documents, patient final reports, and confirmed in an interview, the laboratory failed to follow the manufacturer's instructions for the staining of slides on the ThinPrep staining system for 85 of 85 patients who were processed over the stain limit for two instances reviewed from December 2022 to June 2023. The findings included: 1. Review of the "ThinPrep Stain User's Manual", section "Procedure Notes For Automated Staining" had the following statement: "Change all solutions when the number of slides equals 1 slide for every 1 mL of bath volume, or once a week, which ever comes first. (For example if your bath volume is 650 mL, then change the bath after 650 slides, or once a week, which ever comes first.)" 2. Review of the laboratory "Thin Prep Stain Maintenance" had the following instructions at the top of the sheet: "All solutions changed *(at or before 320 slides stained)" At 11:25 hours, in the laboratory, the general supervisor (GS) demonstrated that the bath volume of the stain held 320 mL. 3. Review of the laboratory "Thin Prep Stain Maintenance" for December 2022 through June 2023 had the following batch staining occurrences where the slides stained exceeded 320 without a change of stains: December 2022: 12 /6/2022: Starting Slide Count:308 Slides stained: 16 Ending Slide Count: 324 16 patient slides were stained on 12/6/2022 to include the following 5 patient accessions: 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 -- TP22-6422 TP22-6423 TP22-6425 TP22-6432 TP22-6437 June 2023: 6/28/2023: Starting Slide Count: 315 Slides stained: 31 Ending Slide Count: 346 31 patient slides were stained on 6/28/2023 to include the following 5 patient accessions: TP23-2677 TP23-2710 TP23-2730 UTP23-662 UTP23-664 6/29/2023: Starting Slide Count: 346 Slides stained: 22 Ending Slide Count: 368 22 patient slides were stained on 6/29 /2023 to include the following 5 patient accessions: TP23-2731 TP23-2736 TP23- 2740 UTP23-666 UTP23-670 6/30/2023: Starting Slide Count: 368 Slides stained: 33 Ending Slide Count: 401 33 patient slides were stained on 6/30/2023 to include the following 5 patient accessions: TP23-2736 TP23-2748 TP23-2760 TP23-2766 UTP23- 674 4. In an interview on 9/7/2023 at 10:50 hours, in the office, the GS confirmed that the stain had not been changed at or before 320 slides for the above instances, as required by the manufacturer. -- 2 of 2 --

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, laboratory records, interviews and specimen slides the laboratory failed to ensure the required maintenance for two of two Hologic ThinPrep 2000 Processors and eight of eight microscopes was performed, as specified by the manufacturer (refer to D5429); failed to follow written policies and procedures to ensure the review of prior negative gynecologic cases was documented (refer to D5625); failed to establish written policies and procedures to ensure the prorated workload limits would not be exceeded when examining slides in less than eight hours (refer to D5641); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of hours spent examining slides per 24-hour period (refer to D5645); and failed to follow written policies and procedures to identify and report two of two gynecologic tests as unsatisfactory (refer to D5655). 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: 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 review of laboratory policies and procedures, competency assessment records and interviews the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency for seven of seven Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process to assess the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for seven of seven Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Technical Supervisors include: -Laboratory Director /Technical Supervisor A -Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 3. During an interview on February 28, 2023 at 1:15 PM, these findings were confirmed with the Cytology Supervisor. 4. During an interview on March 1, 2023 at 10:45 AM, these findings were confirmed with Technical Supervisor D, Technical Supervisor G and the Cytology Supervisor. 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 60 laboratory policies and procedures, observation and interviews the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure BODY CAVITY FLUID PROCESSING PROCEDURE, which stated: "5. Add specimen to PreservCyt Solution Vial and allow to stand for 15 minutes." "6. Process Washings on ThinPrep 2000 using a blue filter on program #2." a. The Survey Team observed Staff A perform nongynecologic specimen processing on February 28, 2023 at 2:20 PM. Staff A added the specimen to a PreservCyt Solution Vial and immediately processed the vial on the Hologic ThinPrep 2000 Processor. Staff A stated that Staff A did not know the PreservCyt Solution Vial needed to stand for 15 minutes. 2. During an interview on February 28, 2023 at 3:30 PM, these findings were confirmed with the Cytology Supervisor. 3. During an interview on March 1, 2023 at 10:45 AM, these findings were confirmed with Technical Supervisor D, Technical Supervisor G and the Cytology Supervisor. 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) -- 2 of 12 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)