4m Healthcare, Llc

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted March 14 to 25, 2024. It was determined that Immediate Jeopardy existed for the following condition level deficiencies: 42 C.F.R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1290 Condition: Postanalytic Systems 42 C.F.R. 493.1409 Condition: Laboratories Performing Moderate Complexity Testing: Technical Consultant 42 C.F.R. 493.1341 Condition: Laboratories Performing High Complexity Testing: Laboratory Director 42 C.F.R. 493.1361 Condition: Laboratories Performing High Complexity Testing: Technical Supervisor On March 15, 2024, the laboratory ceased testing; therefore, Immediate Jeopardy was removed. D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on the review of the CMS Casper report 96, Form CMS-116 application test lists, and interview with the Director of Quality Assurance (DQA), the laboratory failed to authorize the College of American Pathologists (CAP) proficiency testing (PT) program to release to HHS all data required to determine the laboratory's compliance for PT testing and evaluation. Findings: 1. The review of the CMS Casper report 96 for this laboratory revealed no data was available for PT scores. 2. Interview with the DQA on 3/14/24 confirmed, the laboratory failed to authorize the CAP PT program to release to HHS all data required to determine the laboratory's compliance for PT testing and evaluation. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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 the review of the Form CMS-209, lack of documentation, and interview with the Director of Quality Assurance (DQA), the laboratory failed to assess the competency of the clinical consultant (CC) for 2022, 2023, and to date 2024. Findings: 1. Review of the Form CMS-209 revealed one person designated as the CC. 2. The surveyor requested a competency assessment for the CC. No competency documentation for the CC was available at the time of survey for 2022, 2023, and to date 2024. 3. Interview with DQA 3/22/24 at 12:35 p.m. confirmed, the laboratory failed to assess the competency for the position of CC for 2022, 2023, and to date 2024. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the College of American Pathologists (CAP), lack of evaluation documentation, and interview with the Director of Quality Assurance (DQA), the laboratory failed to evaluate unacceptable proficiency testing results for one of three Hematology testing events from 9/18/23 to 3/6/24. Findings: 1. Review of FH 13-C 2023 Hematology Auto Differentials revealed six test samples received a grade of unacceptable. Evaluation and

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the CMS 116 form test lists, procedure manual, lack of approved IQCP, quality control (QC) records, patient test reports and interview, the laboratory failed to perform a positive and negative control material each day of patient testing on the BioFire Respiratory Panel 2.0. Findings: 1. Review of the CMS116 CLIA non-waived testing list revealed the BioFire Respiratory Panel 2.0 is performed on the BioFire Torch instrument. This panel is FDA approved and classified as moderate complexity. 2. Review of the procedure "MOL-28 Biofire Respiratory Panel 2.0 and 2.1," approved for use by the laboratory director on 9/3/21, page 9, item 9.4.1 contained "External QC will be evaluated once per month, or for each new kit lot received." 3. No IQCP had been authorized by the laboratory director on the BioFire Respiratory Panel 2.0 for the reduced QC frequency. 4. Review of QC records revealed QC was performed on 3 of 91 patient testing dates. 5. Review of patient test reports revealed 355 of 371 patient results were reported from 2/4/22 -6/14 /22 without daily QC testing. 6. Interview with the Technical Supervisor on 6/14/22 at 3 p.m. confirmed, the laboratory failed to perform a positive and negative control material each day of patient testing on the BioFire Respiratory Panel 2.0. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 the review of Proficiency Testing (PT) attestation pages, CMS-209 personnel report and interview, the laboratory failed to include personnel who routinely perform the regualar patient testing in the testing of proficiency samples. Findings: 1 Review of all 2019 and 2020 to date of survey PT attestation pages from CAP revealed all testing been performed by General Supervisor (GS)#1 and GS#2. 2. Review of the CMS 209 reveals both GS#1 and GS#2 are also testing personnel (TP) and are designated as TP#11 and TP#1 respectively. There are a total of of 11 testing personnel on the CMS-209. Only 2 of 11 TP performed PT sample testsing. 3. Interveiw with GS#1 September 22,2020 at 4:30 p.m. confirmed, the laboratory failed to include personnel who routinely perform the regualar patient testing in the testing of proficiency samples. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must 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 -- be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on an absence of thermometer function check records or certificates of accuracy and interview, the laboratory failed to perform a function check protocol for the thermometers. Findings include: 1. No documentation was available for function checks on 5 of 9 thermometers for a 17 month period. 2. No documentation was available for the certification of accuracy (NIST traceble) on 5 of 9 thermometers for a 17 month period. 2. Interview with GS#1 on September 22, 2020 at 4:00 p.m. confirmed, the laboratory failed to perform a function check protocol for the thermometers. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. This STANDARD is not met as evidenced by: Based on a review of competency assessment records, and interview, the laboratory failed to ensure that all six required elements for competency assessment are performed for Testing Personnel. Findings: 1. Competency assessments for TP #1, 2,3,4,5, 8 and 11 did not contain the following required elements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; b. Monitoring the recording and reporting of test results; c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records; d. Direct observation of performance of instrument maintenance and function checks; e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and f. Assessment of problem solving skills. 2. Interview with GS#1 on September 22, 2020 at 1:00 p.m. confirmed, the laboratory failed to ensure that all six required elements for competency assessment are performed for Testing Personnel. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) and interview with the general supervisor on October 5, 2018 at 10:30 AM the laboratory failed to twice annually verify the accuracy of urine pH, creatinine, specific gravity and oxidant. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 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 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 -- 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 Olympus AU400e calibration and interview with the general supervisor on October 5, 2018 at 11:00 AM the laboratory failed to perform calibration verification of urine pH, creatinine, specific gravity and oxidant including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of range to verify the laboratory's reportable range once every six months in 2018. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require