Ridgewood Diagnostic Laboratory

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on survey review of the Procedure Manual (PM), Proficiency Testing Reports, Alternative Assessment Records and interview with the General Supervisor (GS), the laboratory failed to verify the accuracy of all analytes for Urine Confirmation Toxicology (UCT) testing from from 1/1/24 to 4/9/25. The findings include: 1. The PM states "when PT surveys are not available through a CAP and CMS approved PT provider, the laboratory must participate in an alternative assessment program for the test every 6 months/ semi-annually." "Laboratory manager documents and evaluates the new results on the original alternative assessment form." 2. The laboratory performed a method comparison for the analytes not covered by the proficiency testing provider, but there was no evaluation of the results by the laboratory. 3. The GS confirmed on 4/9/25 at 1:30 pm, the laboratory failed to verify the accuracy of all analytes for UCT. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with 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 -- General Supervisor (GS), the laboratory failed to perform and document two levels of external controls on each day of patient testing for Urine Creatinine (CREAT) and urine Potential of Hydrogen (pH) run on the AU 680 from 7/19/18 to 4/9/25. The findings include: 1. The laboratory did not select control material that correlated with the abnormal patient range. 2. The Patient Range (PR) for Urine CREAT was 20-300 mg/dL. a) The high QC mean was 26.11 mg/dL 3. The PR for pH was 5.0-8.0 a) The high QC mean was 6.11 4. The laboratory performed approximately 7000 urine pH and CREAT tests. 5. The GS confirmed on 4/9/25 at 12:20 pm that laboratory did not select control material that correlated with the abnormal patient range for the above mentioned analytes. -- 2 of 2 --

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: An unannounced complaint survey was performed on 11/30/23 to determine if Ridgewood Diagnostics Laboratory was in compliance with CLIA regulations 42 C.F. R. 493. Based on surveyor interview with the laboratory technical/general supervisor (TGS) and 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 2022 and 2023. The findings include: 1. The TGS stated that their NJCLL had been denied for 2022 and 2023 by the NJ State Clinical Laboratory Licensure Program (NJCLLP). 2. The NJCLLP Manager confirmed on 11/29/23, prior to the complaint survey, that the laboratory was denied their NJCLL license for 2022 and 2023. 3. The laboratory performed Toxicology testing on 4,480 patient specimens from 1/1/22 to 12/31/22. 4. The laboratory performed Toxicology testing on 4,259 patient specimens from 1/1/23 to 11/28/23. 5. The laboratory performed allergy testing under Diagnostic Immunology on 37 patient specimens from 1/7/22 to 12/5/22. 6. The laboratory performed allergy testing under Diagnostic Immunology on 252 patient specimens from 1/12/23 to 7/7/23. 7. The TGS confirmed on 11/30/23 at 11:00 am that the laboratory did not maintain a NJCLL for 2022 and 2023. 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 --