Northeast Men's Health

Summary Statement of Deficiencies D0000 Based on desk review of 2025 proficiency testing (PT), the laboratory failed to meet the following conditions, resulting in an initial unsuccessful PT participation: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition:Laboratories performing moderate complexity testing; laboratory director 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 a desk review of 2025 proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) records, the laboratory failed to successfully 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 -- participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Endocrinology for the analyte of testosterone. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and American Proficiency Institute (API) 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events in the subspecialty of Endocrinology for the analyte Testosterone. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Endorinology/Testosterone 2025 1st Event: The laboratory received an unsatisfactory score of 40% for Testosterone. Endorinology/Testosterone 2025 2nd Event: The laboratory received an unsatisfactory score of 60% for Testosterone. 2. A review of the American Proficiency Institute (API) 2025 proficiency testing records (2025 Chemistry - Core - 1st Event and 2025 Chemistry - Core - 2nd Event ) confirmed the laboratory received the above results. 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 a proficiency testing desk review of CASPER 0155 report and 2025 American Proficiency Institute records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 a proficiency testing desk review of CASPER 0155 report and 2025 American Proficiency Institute records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and confirmed through an interview with the technical consultant (TC) and testing personnel #1 (TP1), the laboratory did not have an ongoing mechanism to evaluate the TC based on their CLIA responsibilities. Findings Include: 1. Record review on 3/31/2025 of the laboratory's 2023, 2024 and 2025 to date personnel competency records revealed the laboratory did not have documented competency evaluation for the TC based on their CLIA responsibilities. 2. Record review on 3/31/2025 of the laboratory's, 'Staff Orientation, Training and Competency' procedure revealed: a. The procedure contained a form entitled, 'Competency Evaluation: Technical Consultant/Technical Supervisor.' b. The procedure did not contain any information about the above form. c. The procedure did not contain any information about TC competency based on their CLIA responsibilities. 3. During staff interview on 3/31/2025 at 9:55 AM with TP1, TP1 confirmed the laboratory does not have documented competency assessment of the TC both past and present based on their CLIA responsibilities. 4. Staff Interview by telephone on 3/31/2025 at 10:00 AM with the TC confirmed the above findings. The TC stated, "I am new to this position and I haven't been on site yet. The Old TC left on 3/25/2025." 5. The laboratory performs 4,000 tests annually in the specialty of Chemistry. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with Testing Personnel #1 (TP1) and Testing Personnel #2 (TP2) the laboratory failed to perform and document two control materials as specified in the laboratory's Individualized Quality Control Plan (IQCP). Findings Include: 1. Record review on 3/31/2025 of the laboratory's IQCP revealed 2 levels of QC material are run weekly for Prostate Specific Antigen (PSA) and Testosterone. 2. Record review on 3/31/2025 of the laboratory's QC records revealed QC was not run on the following dates: a. 8/12/2024, 10/3/2024, 11 /26/2024 (PSA) b. 9/9/2024, 9/19/2024, (Testosterone) c. 10/3/2024, 10/31/2024, 11/6 /2024 (PSA and Testosterone) 3. During staff Interview on 3/31/2025 at 9:55 AM with TP1, a. TP1 confirmed the above findings. b. TP1 stated, "We had a very hard time getting in touch with the TC when we needed them. We would frequently receive an away message. Our old TC is no longer working with our laboratory. We have a new TC that recently took over." 4. During staff interview on 3/31/2025 at 12:35 PM with TP2, a. TP2 stated, "I was the only person running controls and when I am not working, the staff does not always remember to run controls or how to troubleshoot." b. The Technical Consultant told us that