Sharon Mitchell Medical Clinic Llc

Summary Statement of Deficiencies 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 American Proficiency Institute (API) and interview, the laboratory failed to evaluate its unacceptable proficiency testing results for three of six testing events in 2022. Findings: The following samples were scored unacceptable by API. No documentation of the laboratory's evaluation was provided at the time of survey. 1. 2022 Chemistry-Core 2nd Event-Free Thyroxine, sample CH-07. 2. 2022 Chemistry-Core 3rd Event- CK- MB and Troponin, sample CM-12 3. 2022 Hematology/Coagulation 3rd Event- Hematocrit, Lymphocytes %, MCH, MCV, and Platelet, sample HEM-15. 4. Interview with the Laboratory Director on 5/16/23 at 10:25 a.m. confirmed, the laboratory failed to evaluate its unacceptable proficiency testing results for three of six testing events in 2022. 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 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 -- 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 the CMS116 non-waived test list, documentation for six month calibration verification, and interview the laboratory failed to perform calibration verification on the Horiba ABX-Micro 60 hematology analyzer at least every 6 months. Findings: 1. Review of the CMS116 lists the Horiba ABX-Micro 60 as the laboratory hematology analyzer for complete blood counts. 2. Review of the 6 month calibration documents revealed calibrations were performed 7/20/21, 6/8/22 and 9/4/22. Calibration verification should have been performed in January 22 and March 23. No other calibration documentation was provided at the time of survey. 3. Interview with the laboratory director on 5/16/23 at 11:05 a.m. confirmed, the laboratory failed to perform calibration verification on the Horiba ABX-Micro 60 hematology analyzer at least every 6 months. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 and centrifuge function check records or certificates of accuracy, protocols for thermometer and centrifuge function checks and interview with the laboratory director (LD), the laboratory failed to define and perform a function check protocol for three of three thermometers and one of one centrifuge. Findings: 1. No documentation was available for function checks on three of three thermometers and one of one centrifuge at the time of survey. 2. No documentation was available for the certification of accuracy (NIST traceable) on three of three thermometers at the time of survey. 3. Protocols for the function checks of thermometers and centrifuge were not made available at the time of survey. 4. Interview with the LD on October 13, 2021 at 8:55 a..m. confirmed, the laboratory failed to define and perform a function check protocol for three of three thermometers and one of one centrifuge. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of lab policies and procedures, proficiency testing (PT) records during calendar years 2017 and 2018 through the PT provider, American Proficiency Institute (API) and staff interview, the laboratory failed to document each step in the testing and reporting of results for all proficiency test samples. Findings were: 1. A review of the laboratory's proficiency API records showed the Laboratory Director and Testing Person's failed to sign the Attestation Statement for the following testing events: Hematology/Coagulation - 2018: 1st and 2nd events Chemistry Core - 2018: 1st and 3rd events; 2017: 1st event Microbiology - 2018: 1st, 2nd, and 3rd events; 2017: 1st event Immunology/Immunohematology - 2018: 1st and 2nd events: 2017: 3rd event 2. This was confirmed with interview with testing personnel #2 (refer to Testing Personnel Report (CMS-209)) at 4:14 PM on October 8, 2018. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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 -- 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 be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's analyzer maintenance records and interview with staff, the laboratory failed to perform maintenance and function checks for the Frend analyzer, Horiba analyzer, rotator, microscope, and centrifuges as defined by the manufacturer and with at least the frequency specified by the manufacturer. Findings Include: 1. Review of Frend preventative maintenance (PM) records found at the time of the survey, the last documented maintenance occurred November 2016 with no documented maintenance in 2017 or 2018. 2. Review of the Horiba PM records found at the time of the survey, only cleaning had been documented and no other maintenance for 2017 or 2018. 3. Review of rotator PM records, used for the rheumatoid factor test, found no function checks or maintenance records for 2017 or 2018. 4. Review of PM records at the time of the survey, found no procedure or documentation of maintenance for the microscope for 2017 and 2018. 5. Review of PM records at the time of the survey, found no procedure or documentation of maintenance / tachometer checks for centrifuges for 2017 or 2018. 6. The above findings were verified by interview with the testing personnel (refer to Testing Personnel Report (CMS-209)) at 4:17 pm and 5:09 pm on October 8, 2018 in the laboratory. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of package inserts, 2017 and 2018 quality control records, and interview with staff, the laboratory failed to perform the quality control required by the manufacturer and per laboratory policy. Findings were: 1. Review of package insert for Sure-Vue RF (Rheumatoid Factor) states "Before performing a set of determinations it is advisable to check the latex reagent with each of the controls, positive and negative, included in the kit." 2. Review of the laboratory's procedure for RF states "run quality control prior to any testing of patient sample." 3. Review of RF quality control log has documented QC performed only once per month for 2017 and 2018. 4. The above findings were confirmed by interview with testing personnel #2 (refer to Testing Personnel Report (CMS-209)) at 4:52 pm on October 8, 2018. -- 2 of 2 --