Northampton Integrative Medicine, Llc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor (TS) the laboratory failed to test proficiency testing (PT) samples in the same manner as patient samples. Findings include: 1. Record review on 6/10/2025 of the laboratory's 2023, 2024 and 2025 to date American Proficiency Institute PT attestation sheets revealed: a. 2 of 3 testing personnel did not participate in PT in 2023, 2024 or 2025 to date. b. The TS performed all PT testing in 2023, 2024 and 2025 to date. 2. Interview with the TS on 6/10/2025 at 10:45 AM confirmed the above findings. 3. The laboratory performs 46,373 tests annually in the specialty of subspecialty of General Immunology. 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 Supervisor (TS) the laboratory did not have an ongoing mechanism to evaluate the TS and General Supervisor (GS) based on their CLIA responsibilities. This is a repeat 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 -- deficiency cited at the 6/16/2023 survey. Findings Include: 1. Record review on 6/10 /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 TS and GS based on their CLIA responsibilities. 2. Record review on 6/10/2025 of the laboratory's, procedure manual revealed, the procedure manual did not contain a procedure for assessing testing personnel (TP), TS or GS competency. 3. Record review on 6/10/2025 of the laboratory's

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northampton Integrative Medicine, LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . 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 policy review and interview the laboratory failed to have and follow written policies and procedures to evaluate the competency of the technical supervisor as evidenced by the following: a) A review of employee competency records on 6/16/23 for two (2) laboratory personnel revealed that there was no competency assessment performed for the technical supervisor. b) The technical supervisor confirmed in an interview on 6/16/23 at 9:55 AM that a competency assessment had not been completed on him. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. 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 an interview, the laboratory director failed to ensure that documentation was maintained to verify that new laboratory personnel were appropriately trained for the type and complexity of the services offered as evidenced by the following: a) One (1) new laboratory technologist had been put into place since the last CLIA survey performed. There was no documentation maintained to verify that the technologist had received training in all aspects of the laboratory operation prior to performing specimen processing, testing, and reporting procedures. The only documentation available was training on the analytical aspects of the laboratory operation. There was no training documentation related to the pre-analytical and post-analytical aspects of the laboratory operation. b) Interview on 6/16/23 at 9:25 AM with the technical supervisor confirmed that training for the pre-analytical and post-analytical aspects of the laboratory operation was not documented. -- 2 of 2 --