Nosky Pa

Summary Statement of Deficiencies D0000 A recertification survey was conducted on June 22, 2023. Nosky PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 interviews and review of the procedure manual and the monthly Quality Assurance (QA) checklist, the laboratory failed to follow their procedures for monitoring, assessing and correcting identified problems from July 1, 2021 to June 22 2023. Findings: Review of the laboratory's procedure titled, Quality Management System - General Quality Assurance Plan noted, "The monthly quality assurance report will be reviewed with the appropriate personnel and maintained for 2 years with all other QC (Quality Control)/QA documentation." Review of the Monthly Quality Assurance Checklists showed the last time the form was filled out and signed by the Laboratory Director was 06/30/2021. On 06/22/2023 at 12:10 PM, the Practice Manager acknowledged the laboratory had not documented their QA. 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 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 -- 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)

Summary Statement of Deficiencies D0000 A recertification survey was conducted July 21, 2021. Nosky PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually in 2020. Findings: The laboratory used peer review to verify the accuracy of the readings and interpretation of H&E stains. Review of the laboratory's records showed that peer review for the Laboratory Director was not done in 2020. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the acting Laboratory Director on 02 /20/2021, the laboratory's annual estimated histopathology test volume was 1,100 tests. On 07/21/2021 at 11:15 AM, Testing Personnel A stated it peer review for patient slides in 2020 was not performed until 2021. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding 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 2 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, patient test reports failed to provide all required information for laboratory test reports for 5 of 5 patients, (#1, #2, #3, #4, #5). Findings: Review of the patients' test reports showed the name on the report was the DBA (doing business as) name and not the name of the laboratory. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed and dated by the acting Laboratory Director on 02/20/2021, the laboratory's annual estimated histopathology test volume was 1,100 tests. On 07/21/2021 at 12:30 PM, the Laboratory Director stated the name on the patient test reports was the DBA name. -- 2 of 2 --