New England Newborn Screening Program

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 Laboratory Director (LD) and General Supervisor #1 (GS1) the laboratory did not have a written policy to evaluate the Clinical Consultants (CC), Technical Supervisors (TS), and GS based on their CLIA responsibilities. Findings Include: 1. Record review on 7/10 /2025 of the laboratory's CMS form 209, 'Laboratory Personnel Report', revealed the laboratory employs, two CC's, four TS's, and six GS's. 2. Record review on 7/10/2025 of the laboratory's 2023, 2024 and 2025 to date personnel competency records revealed the laboratory did not have documented competency evaluation for the two CC's, four TS's and six GS's based on their CLIA responsibilities. 3. Record review on 7/10/2025 of the laboratory's, electronic Policy and Procedures revealed the laboratory did not have a policy or procedure to assess the CC's, GS's, or TS's noted in #2 above based on their CLIA responsibilities. 4. During staff interview on 7/10/2025 at 2:30 PM with the LD and GS1, GS1 and the LD confirmed the laboratory does not have documented competency assessment for the CC's, GS's and TS's noted in #2 above based on their CLIA responsibilities and does not have a policy in placy to assess them. GS1 also stated, a. "We have monthly Quality Assurance meetings, attended by supervisory personnel and we go over many of the responsibilities there. We just don't have it organized on a single document." b. "We were using the CMS Competency Workbook and misunderstood the part that addresses CC, GS and TS competency. We thought it meant they had to be assessed with the same criteria as testing personnel. I 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 -- see what you mean now." 5. The laboratory performs 106,171 tests annually in the specialty of Diagnostic Immunology and 5,245,661 tests annually in the specialty of Chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Newborn Screening Program laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to: 1) establish performance specifications for newly implemented test procedures; and, 2) failed to perform adequate validation studies to validate all aspects of test performance as evidenced by the following: SMN2 gene copy number - Precision and Sensitivity : a) In May of 2023 the laboratory put into place a new test for the SMN2 gene copy number used in detecting spinal muscular atrophy (SMA)disease. A review of the validation study for the SMN2 gene copy test revealed that the laboratory failed to: 1) establish performance specifications for precision and sensitivity; and, 2) perform precision and sensitivity studies prior to implementing the test for patient sample testing and reporting. b) The technical supervisor confirmed in an interview on 7/12 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 -- /23 at 10:53 am that the laboratory had not included precision and sensitivity as part of the validation for the test. c) The laboratory has performed a total of one (1) patient sample annually. -- 2 of 2 --