Noam Glaser Md Pc

Summary Statement of Deficiencies D0000 An offsite revisit survey was completed on April 16, 2026, for all previous deficiencies cited on February 06, 2026. All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with all regulations. 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 review of the temperature and humidity records, the laboratory's Standard Operating Procedure (SOP) manual, as well as interview with the Testing Person (TP), the laboratory failed to follow written Quality Assessment (QA) procedure for an ongoing mechanism to monitor, assess, and, when indicated, correct problems. FINDINGS: 1. The laboratory failed to follow current, approved QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic systems annually. 2. There was no documentation of review and signature on the temperature and humidity log from 2024 through the survey date. 3. This is contrary to instructions indicated in the current, approved temperature humidity SOP. 4. The TP confirmed the findings on February 6, 2026, at approximately 10:45 A.M. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; 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 -- This STANDARD is not met as evidenced by: Based on review of the temperature and humidity records, the laboratory's SOP manual, as well as interview with the TP, the Laboratory Director (LD) failed to ensure that the established QA programs were maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Refer to D5291. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the review of laboratory's Standard Operating Procedure 3.3 Specimen Handling step f, the procedure failed to include second identifier unique to the patient. Confirmed finding on an interview with testing person on 5/12/2023 about 12:30pm. 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 review of the laboratory's standard procedure manual, lack of a written Quality Assessment (QA) procedure and an interview with the laboratory testing person, the laboratory failed to establish a written QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic systems. FINDINGS 1. The laboratory's standard operating procedure manual did not contain a written QA procedure to monitor, evaluate all phases of the laboratory's pre analytic, analytic and post analytic systems. 2. The testing person confirmed on 5/12/2023 at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- approximately 12:45 PM, that the laboratory did not have a written procedure to monitor, evaluate all phases of laboratory testing. 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)