Northern Light

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing reports from the laboratory. The facility was found to be out of compliance with the conditions of the CLIA program. The following: CONDITION and STANDARD level deficiencies were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation proficiency testing D2118- 42 C.F.R. 493.845 Standard: Laboratories performing Moderate Complexity testing: Chemistry 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 the proficiency testing (PT) data report (Casper Report 155D) and 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 -- staff interview, the laboratory failed to successfully participate for the regulated analyte Acetaminophen Serum. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(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 Review of the CASPER Proficiency Testing (PT) data report (155), and staff interview, the laboratory failed to successfully participate in PT for the specialty of Chemistry. Findings include: 1. Record review on 8/29/2025 of the CASPER 155 report revealed scores of 60% for CAP 2025 Event 1 and 2025 Event 2, that were unsatisfactory for the regulated analyte: Acetaminophen Serum in the subspecialty: Toxicology. 2. Email correspondence from the laboratory consultant on 9/3/2025 confirmed the findings above. 3. The laboratory performs 89,180 tests annually in the specialty of Chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review and staff interview with the General Supervisor (GS), the laboratory director (LD) failed to sign the attestation sheet for the American Proficiency Institute (API) proficiency testing (PT) samples in the specialties of Chemistry and Hematology. Findings include: 1. Record review on 2/27/2025 of the laboratory's PT attestation sheets for API Chemistry and Hematology survey events 2, 3, 2023 and 1, 2, 3, 2024 revealed the LD did not sign the attestation sheet. The attestation sheet was signed by the GS who was not designated by the LD to sign. 2. Staff interview on 2/27/2025 at 10:00am with the GS confirmed the above findings. 3. The laboratory performs 74,847 tests annually in the specialty of Chemistry and 24,117 tests annually in the specialty of Hematology. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Technical Supervisor (TS), the laboratory failed to document routine maintenance and function checks on the Vitros Chemistry analyzer and annual maintenance on the Unico G380 microscope. Findings include: 1. Record review of the Vitros maintenance logs on 5/16/2023 for the time period of 2022-2023 revealed no recorded weekly maintenance for 7 of 16 months and no recorded monthly maintenance for 9 of 16 months. 2. Record review of the Unico G380 microscope maintenance logs on 5/16/2023 revealed the last maintenance performed in December 2021. 3. Record review of the Unico G380 Microscope manual on 5/16/2023 revealed the following statement: "To keep your microscope in top condition for years, have it professionally serviced once a year." 4. Interview with (TS) on 5/16/2023 at 10:15 AM, confirmed the above findings. 5. The laboratory performs 89,180 tests under the specialty of Chemistry and 26,194 test under Hematology per year. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 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 record review and staff interview, the laboratory failed to review the preventive maintenance records for the Vitros Chemistry analyzer. Findings include: 1. Record review on 5/16/2023 of the Vitros maintenance logs revealed no review signatures or dates for monthly maintenance records from 2022-2023. 2. Staff interview with the Technical Supervisor on 5/16/2023 at 10:30AM confirmed the above findings. 3. . The laboratory performs 89,180 tests under the specialty of Chemistry. -- 2 of 2 --