Allergy & Asthma Of South Jersey

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to maintain a NJCLL for 2023. The Program Manager for the Clinical Laboratory Improvement Services (CLIS) confirmed on 12/18/23, prior to the recertification survey, that the laboratory did not have a NJCLL license for 2023 or any prior years. The Laboratory Director confirmed on 12/19/23 at 11:30 am that the laboratory did not maintain a NJCLL for 2023 or any prior years. 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 surveyor review of Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy and reliability of nasal mucosal, conjunctival mucosal and sputum allergic cell testing twice annually from 4/22/21 to the date of the survey. The findings include: 1. The BA for nasal mucosal, conjunctival mucosal and sputum allergic cell testing in 2021, 2022 and 2023 was performed by the LD rereading previously read slides instead of 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 -- sending slides to a reference laboratory for split sample testing. 3. The LD confirmed on 12/19/23 at 11:00 am that the laboratory did not perform BA twice annually for nasal mucosal, conjunctival mucosal and sputum allergic cell testing as stated above. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from 6/16/16 to the date of survey. The LD confirmed on 6/20/18 at 10:00 am that a BA procedure was not established. 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)