Adams Endocrinology Associates

Summary Statement of Deficiencies 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 a review of the Procedure manual, and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of the Fine Needle Aspirate examination in Exfoliative Cytology from 2021 to 07/05/2023 as required. Findings Include: 1) On the day of the survey 07/05/2023 at 11:30 AM, the laboratory could not provide a procedure manual for verification of the accuracy of the Fine Needle Aspirate examination performed in the laboratory. 2. At the time of the survey, the laboratory could not provide documentation of verification activities performed. 3. Laboratory performed 150 Fine Needle Aspirate testing (CMS 116 Annual Volume). 4. LD confirmed the findings above on 07/05/2023 around 12:30 PM. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. 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 a lack of laboratory's quality control (QC) records, a review of the procedure manual, and an interview with the Laboratory Director (LD), the laboratory failed to perform and document QC for Fine Needle Aspirate slide staining performed in Exfoliative Cytology from 04/13/2021 to the date of the survey. Findings include: 1. On the day of the survey, 07/05/2023 at 12:00, the laboratory failed to provide QC documentation for the Fine Needle Aspirate testing performed in Exfoliate cytology from 2021 to 2023. 2. The laboratory could not provide a QC procedure for the Fine Needle Aspirate test. 3. The laboratory performed 150 Cytology tests in 2022 (CMS 116 annual volume). 4. LD confirmed the finding above on 07/05/2023 around 01:00 PM. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review on the laboratory procedure manuals and interview with the laboratory director (LD), the laboratory failed to include the preparation of specimen collection of fine needle aspirate (FNA) samples, step-by-step performance of the FNA adequacy procedure and literature references in the FNA cytology procedure in 2019. Findings Include: 1. On the day of survey, 06/25/2019, review of the laboratory procedure manual revealed the LD did not approve the FNA procedure before patient testing began and the procedure manual did not include the follow: - Requirements for patient preparation; specimen collection, labeling, storage, preservation, processing and specimen acceptability and rejection of FNA samples. - Step-by-step performance of the FNA adequacy procedure. - Pertinent literature references. 2. The LD confirmed the findings above on 06/25/2019 around 9:45 am. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 observation of cytology reagents, review of cytology reagent safety data sheets (SDS) and Interview with Laboratory Director (LD), the laboratory failed to follow manufacturer instructions for the storage of 1 of 1 bottle of Statlab Medical Products Hema-Diff #1 Fixative and 1 of 1 bottle of Medite Cancer Diagnostics Sure Thin Preserve Cell Solution. Finding Include: 1. The Statlab Medical Products Hema- Diff #1 Fixative, Section 7: Handling and Storage, Conditions for Safe Storage, Including any Incompatibilities, states " keep in a fire proof place". 2. The Medite Cancer Diagnostics Sure Thin Preserve Cell Solution, Handling and Storage, states "store locked up". 3. On the day of survey, 06/25/2019, review of reagents in the cytology laboratory revealed the following reagents were not being stored in accordance to manufacturers instructions: - 1 of 1 bottle of Statlab Medical Products Hema-Diff #1 Fixative was stored in an wall cabinet. - 1 of 1 bottle of Medite Cancer Diagnostics Sure Thin Preserve Cell Solution was stored out on top of a work bench. 4. The LD confirmed the findings above on 06/25/2019 around 10:30 am. -- 2 of 2 --