National B Virus

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 20, 2025. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2062 VIROLOGY CFR(s): 493.831(d) (d)(1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing events, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: A review of the 2023 - 2024 AAB Medical Laboratory Proficiency Records, confirmed that the lab failed to conduct the required

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 21, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on document review for Proficiency Testing (PT) and staff interview, the laboratory failed to perform

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 16, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel competency assessment records and interviews with the technical Supervisor and laboratory director, the laboratory failed to include the six required competency assessment criteria when evaluating competency on testing personnel for Virology and Immunology testing procedures in 2017 and 2018. The findings include: 1. Review of testing personnel competency assessment records for 2017 and 2018 on (TP # 2 and 3 CMS 209), revealed the assessment did not include the six competency assessment criteria required by CLIA. 2. Interviews with the laboratory director and Technical Supervisor in the office used by the surveyor on November 16, 2018 at approximately 1:00 PM confirmed both employees annual competency assessments did not contain the six CLIA required competency assessment criteria. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --