Peterson Laboratory Services Pa

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 and interviews the laboratory failed to ensure procedures were approved, signed and dated by the current Laboratory Director (refer to D5407); failed to assess the stain quality of the Diff Quick stain each day of use (D5473); failed to follow written policies and procedures to determine the causes of discrepancies between the cytology and histopathology diagnosis (refer to D5623); failed to establish and follow written procedures for the annual evaluation and comparison of two of six gynecologic cytology statistics, and failed to document two of six required annual statistics (refer to D5629); and failed to indicated the basis of correction for four of five corrected cytology reports (refer to D5659). 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. This STANDARD is not met as evidenced by: Based on review of 51 laboratory policies and procedures and interview the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- failed to follow one written policy. Findings include: 1. The laboratory failed to follow the policy PREFACE which stated: "1. b) If there is a change in laboratory directorship, the new medical director must re-approve, sign, and date each individual procedure." 2. The Survey Team reviewed CYTOLOGY LABORATORY MANUAL. Laboratory Director A failed to approve, sign and date 51 of 51 cytology procedures from January 1, 2024 through July 31, 2024. (Refer to D5407) 3. The Survey Team reviewed CYTOLOGY LABORATORY MANUAL. Laboratory Director B failed to approve, sign and date 41 of 51 cytology procedures from August 1, 2024 through January 6, 2025. (Refer to D5407) 4. During an interview on January 28, 2025 at 8:43 AM these findings were confirmed by Laboratory Consultant. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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, observation and interviews it was determined the laboratory failed to provide written policies and procedures to describe the laboratory's process for sending gynecologic cytology tests to an outside laboratory for testing (refer to D5403); failed to ensure three of three Technical Supervisors received the appropriate training to evaluate gynecologic cytology specimens using the Hologic ThinPrep Pap Test (refer to D5411); failed to provide written policies and procedures for identifying nongynecologic specimens with a high potential for cross-contamination and staining them separately from other nongynecologic specimens (refer to D5619); failed to establish written policies and procedures to ensure cases in the 10% quality control review would be randomly selected (refer to D5621); failed to establish written policies and procedures to ensure individual workload limits were established, reassessed, pro-rated and documented for three of three Technical Supervisors (refer to D5633, D5637, D5641, D5647); and failed to maintain records of the total number of slides examined and the total number of hours spent examining slides (refer to D5645). 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of three of three Technical Supervisors in 2019, 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 three of three Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for three of three Technical Supervisors who performed microscopic evaluations in 2019, 2020 and to the date of the survey in 2021. Technical Supervisors include: - Technical Supervisor A - Technical Supervisor B - Technical Supervisor C 3. The Laboratory Director confirmed these findings on 04 /28/21 at 10:15 AM. 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)