Summary:
Summary Statement of Deficiencies D0000 The Neighborhood Health Source North Metro laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the initial certification survey performed on February 27, 2026. The following standard-level deficiency was cited: 493.1413 Technical consultant responsibilities . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure one of one testing personnel (TP) was evaluated for microscopic examination competency prior to testing patient specimens in 2026. Findings are as follows: 1. The laboratory performed vaginal wet preparation (VWP) microscopic examination testing as confirmed by the TC during a tour of the laboratory at 10:05 a.m. on 02/27/26. 2. An LW Scientific Revelation III microscope was observed as present and available for use during the tour. The laboratory implemented VWP testing using this microscope on 02/24/26. 3. TP competency evaluation was required in all testing areas at time of hire, after 6 months of work, and annually thereafter as established in the Competency - Test Personnel, Moderately Complex Laboratory procedure found in the NMC Lab Manual. 4. VWP microscopic examination competency assessment documentation was not found in the NMC Employee File manual on date of survey for TP1. The laboratory was unable to provide the missing documentation upon request. 5. Two patients received VWP test results from date of implementation, 02/24/26, to date of survey, 02/27/26 as stated by 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 -- the TC during the laboratory tour. 6. In an interview at 10:15 a.m. on 02/27/26, the TC confirmed the above finding. -- 2 of 2 --