Millennium Medical Management Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Millennium Medical Management LLC on April 20, 2026 to May 4, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 493.1250 Condition: Analytic Systems D6033 493.1409 Condition: Technical Consultant - Moderate Complexity D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of calibration records and interview, the laboratory failed to perform calibration verification for the Horiba Micro 60 hematology analyzer at least every six months in 2025 for the calibration records reviewed from 01/02/2024 to 04/15/2026. (See D5439) D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of allegation of compliance, calibration records, and interview, the laboratory failed to perform calibration verification for the Horiba Micro 60 hematology analyzer at least every six months in 2025 for the calibration records review from 01/02/2024 to 04/15/2026. This is a repeat deficiency from recertification survey performed on 12/27/2023. Findings: 1. Review of the allegation of compliance (signed by the Laboratory Director on ) stated "The lab consultant and Lab Director will be responsible for making sure that calibration is completed every 6 months, using the manual calendar and the Outlook email reminder. They will also use the monthly document sheet to check for calibration results if present, and if due, can investigate." 1. Review of calibration records for the hematology analyzer revealed calibrations were performed on 01/02/2024, 07/26/2024, 12/19/2024, 05/09/2025, 05 /19/2025, and 04/15/2026. 2. Review of the document titled

Summary Statement of Deficiencies D0000 Recertification survey was conducted from December 13, 2023 to December 27, 2023. Millennium Medical Management LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of proficiency testing (PT) records, proficiency testing policy, and interview, the laboratory failed to ensure the attestation form for specialty of Hematology was signed by Testing Personnel for 2 (2023 2nd and 3rd) of 6 events (2022 1st, 2nd and 3rd; 2023 1st, 2nd and 3rd). Findings: Review of the attestation for American Association of Bioanalysts (AAB) noted, "The undersigned analyst attests that samples were tested in the same manner as patient samples." Review of the laboratory's policy titled, Proficiency testing noted, "This attestation document is signed by the analyst, technical consultant and laboratory director . . . ." Review of the AAB PT records showed the attestation statements were not signed by the Testing Personnel for the specialties of specialty of Hematology for 2 2023 2nd and 3rd event. On 12/13/2023 at 2:00 PM, Testing Personnel B confirmed the attestations were not signed by the Testing Personnel. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of temperature logs, and interview, the laboratory failed to maintain documentation of the Laboratory Temperature Logs for 1 (May 2022) of 20 months (May 2022 to December 2023) reviewed. Findings: Review of the Laboratory Temperature Logs revealed the month of May 2022 was missing. On 12/13/2023 at 5: 18 PM, the Laboratory Consultant stated she did not know where the May 2022 temperature log was located. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, review of temperature logs, and interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on April 28, 2022. Millennium Medical Management LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 interview, the laboratory failed to document the initial competency assessment for one of one Technical Consultant from 12/13/2021 to 04/28 /2022. Findings: Review of the Laboratory Personnel Report dated and signed by the Laboratory Director on 04/27/2020 showed there was one Technical Consultant. Review of personnel records revealed there was no initial competency evaluations for the Technical Consultant. On 04/28/2022 at 9:40 AM, Testing Personnel A stated there was no competency evaluation for the Technical Consultant. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain documentation on the verification of performance specifications for the Complete Blood Count testing on the Horiba Micro 60 hematology analyzer from 12/13/2021 to 04/28/2022. Findings: Review of the laboratory's records for performance verification (validation) for the hematology analyzer showed the laboratory failed to maintain documentation of the accuracy, reportable range, and the manufacturer's normal ranges appropriate for their patient population. On 04/28/20/22 at 10:11 AM, Testing Personnel A explained the field technician that performed the validation did not leave a copy of all the paperwork from the validation. D5781