Matthew Cohen Md Pc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on September 17, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, 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 -- laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology specialty for the White Blood Cell (WBC) Differential test analyte in 2025 resulting in unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports from 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the analyte WBC Differential. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. WBC Differential Analyte: 2025 First Event = 68% 2025 Second Event = 60% b. A review of the PT scores from API (2025) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT summary reports from 2025, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT summary reports, the LD failed to ensure successful participation in an HHS approved PT program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) PT Certification and Survey Provider Enhanced Reporting system (CASPER 0096D and 0155D) and American Proficiency Institute (API) Proficiency Testing (PT) summary records, as well as interview with the Office Manager (OM), the laboratory failed to document attestation that routine integration of PT samples into the patient workload using the laboratory's routine methods occurred. FINDINGS: 1. There was no documentation of laboratory director (LD) and testing person (TP) signature as well as date of signature for the API 2024 Hematology first event attestation form. 2. The OM confirmed the findings on June 18, 2024, at 11:00 A.M. 3. It was noted that the laboratory scored 96% for the API 2024 Hematology first event. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observations and interview with the OM, the laboratory failed to remove from inventory expired reagents in the patient specimen processing laboratory 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 -- as required by the current, approved standard operating procedures. FINDINGS: 1. The surveyor's observations in the patient specimen processing laboratory confirmed on June 11, 2024, at approximately 12:00 P.M. the following reagents and processing materials were not removed from inventory as required by the standard operating procedures: a. OC - Auto Sampling Bottle Lot#: 2X295; Expiration: April 17, 2024; Fifty vials. b. OC - Auto Sampling Bottle Lot#: 29247; Expiration: March 6, 2024; Fifty vials. c. Urine HCG Lot#: 2052060; Expiration: April 30, 2024; Thirty-three kits. d. Mononucleosis Lot#: 221158; Expiration: March 31, 2023; One box. 2. The OM confirmed on June 18, 2024, at approximately 12:00 P.M. that the respective expired reagents and processing materials were not utilized for patient specimen processing. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of Beckman Coulter DxH 500 hematology analyzer Quality Control (QC) reports, current, approved standard operating procedures, as well as interview with the OM, the LD failed to document quality control review and

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and lack of documentation, the laboratory failed to retain facility records for two years. FINDINGS: 1. There was no documentation of Annual Quality Assurance records, room temperature logs, humidity logs, staff 2021 competency logs, instrument calibration records, Coulter Act Diff II hematology analyzer validation records, laboratory standard operation procedure manual, and proficiency testing attestation records. 2. Confirmed findings by interview with the Laboratory Director (LD) on October 19, 2023, at approximately 12:00 P.M. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and lack of documentation, the laboratory failed to draft, approve, and maintain policies and procedures for on-site laboratory testing. FINDINGS: 1. There was no documentation of current laboratory policies and procedures. 2. No laboratory Safety Manual was available for review. 3. 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 -- Approximately 3000 patients were tested. 4. Confirmed findings by interview with the LD on October 19, 2023, at approximately 11:00 A.M. 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)