Mays Medical Wellness, Llc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing event records and confirmation with Technical Consultant/Lab Director (TC/LD), the laboratory failed to retain all proficiency records to include but not limited to results, attestation statements, submitted results and analyzer printouts for four of four proficiency testing events. Findings include: 1. Review of 3rd event of 2022, 1st and 3rd events for 2023 and 1st event for 2024 proficiency testing records revealed the laboratory did not retain the following: a. Report sheets and submitted result sheets for 3rd event of 2023. (1 of 5 events report sheets not retained) b. Attestation statement for 3rd event of 2023. (1 of 5 events attestation statements not retained) c. Analyzer printouts for 3rd event of 2022. (1 of 5 events analyzer printouts not retained) d. Proficiency graded results for 3rd event of 2022, 1st and 3rd events of 2023 and 1st event of 2024. (4 of 4 graded results not retained.) 2. Interview with TC/LD on 6/12/2024 at 1:00 p.m. confirmed that the listed proficiency records were not retained after completion of each proficiency event. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory temperature records and interview with the Technical Consultant/Lab Director (TC/LD), the laboratory failed to monitor and document 22 of 22 months of the laboratory room temperature where hematology testing was performed. Findings include: 1. Beckman Coulter DxH 500 manufacturer's instructions require: a. DxH 500 rinse and diluent should be stored at temperature of 4-32 degrees Celsius(C). b. Operating specifications for the DxH 500 hematology analyzer require a room temperature of 18-32 degrees Celsius(C). c. Quality control and calibration materials for the DxH 500 must be allowed to come to room temperature before testing. 2. Review of the laboratory room temperature logs from 8/15/2022 through 6/12/2024 revealed the room temperature was not documented as monitored for 22 of 22 months. 3. The TC/LD confirmed in an interview on 6/12/2024 at 10:00 a.m., the laboratory room temperature was not documented as monitored where hematology testing was performed. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, the Centers for Medicare and Medicaid Services (CMS)database Casper report 0155D and interview with the Technical Consultant/Lab Director (TC/LD), the technical consultant failed to ensure the laboratory participated in an HHS approved proficiency testing (PT) program for (complete blood count) CBC performed on the Beckman Coulter DxH 500 for the 3rd event of 2023. The laboratory failed to participate in 1 of 6 proficiency testing events. Findings include: 1. Review of the laboratory proficiency records for 8 /10/2022 through 6/12/2024, and the CMS database Casper Report 0155D proficiency report, confirmed the laboratory did not perform or participate in proficiency testing for CBC's for the 3rd event of 2023. The laboratory did not participate in 1of 6 proficiency events. 2. The TC/LD confirmed in an interview on 6/12/2024 at 12:00 p. m. that the laboratory did not participate in the 3rd proficiency event of 2023 for hematology testing (CBC). THIS IS A REPEAT DEFICIENCY D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(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. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing records and interview with the Technical Consultant/Lab Director (TC/LD), the technical consultant (TC) failed to document review for four of four graded proficiency test events. Findings Include: 1. -- 2 of 3 -- Review of proficiency records from 2022 through 2024, revealed there was no documented review of proficiency graded test results for the 3rd event of 2022, 1st and 3rd events of 2023 or 1st event of 2024. The TC did not review for four of four graded proficiency results returned to the laboratory. 2. Interview with the TC/LD on 6 /12/2024 at 12:30 p.m. confirmed there was no documentation available on the day of survey of review of these records by the TC. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter AcT Diff 4C quality control (QC) records from 2/5/2021 until 8/10/2022, the AcT Diff ES QC manufacturer assay sheets, patient CBC (complete blood count) logs and an interview with the laboratory director /technical consultant (LD/TC) at 12:00 p.m. on 8/10/22, the laboratory failed to follow the manufacturer's instructions for the open expiration date requirement from 3/2/22 through 3/17/22. Findings include: 1. Review of the Beckman Coulter AcT Diff 4C control records from 2/5/21 through 8/10/22 revealed the following hematology controls (low normal, high) were tested 3/2/22 through 3/17/22 which exceeds the manufacturer's expiration date: Low Control lot number 069100 exp date 2/28/22 Normal lot number 079100 exp date 2/28/22 High lot number 089100 exp date 2/28 /22 2. Review of three patient CBC logs on 8/10/22 revealed approximately 121 patient samples were tested between 3/2/22 and 3/17/22 when 3 expired levels of quality control were used. 3. The LD/TC in an interview at 12:00 p.m. on 8/10/22 confirmed that 121 patient CBC samples were tested between 3/2/22 and 3/17/22 when all 3 levels of QC (low,normal,high) had exceeded the manufacturer's expiration date. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

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 review of proficiency testing (PT) records for the 1st, 2nd and 3rd events of 2019 and 2020, the (CMS) Centers for Medicare & Medicaid Services 209 personnel form and confirmation by laboratory testing personnel (TP) and technical consultant (TC) at 11:00 am on the day of survey 2/5/21, the laboratory failed to rotate proficiency testing samples among testing personnel who routinely test CBC (complete blood counts) on patient samples. Findings include: 1. Review of proficiency records since the last survey, revealed the 1st and 2nd events of 2019 were performed by TP #1 and the 3rd event of 2019 and all 3 events of 2020 were all performed by the TC. 2. The TC confirmed that CBC testing is routinely performed by TP#1 and TP#2. 3. In an interview at 11:00 a.m. on the day of survey, the TC and TP#1 confirmed that TP#1 performed both 1st and 2nd proficiency test events for 2019 and the TC performed the 3rd event of 2019 and all events in 2020. The proficiency testing events must be performed by testing personnel who routinely test patients. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (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 -- Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the AcT Diff hematology calibration records from last survey through the survey on 2/5/21 and interview with testing personnel (TP) #1 and the laboratory technical consultant (TC) listed on the CMS (Center for Medicare & Medicaid Services) form at 12:00 p.m., the laboratory failed to perform calibration on CBC (complete blood count) on the AcT Diff hematology analyzer every 6 months as required by the manufacturer. Findings include: 1. Interview with TP #1 and the TC at 12:00 p.m. on 2/5/21 confirmed AcT Diff CBC (complete blood count) calibrations were not performed every 6 months as evidenced by the calibration records available the day of survey. 2. Review of the AcT Diff calibration records from 1/3/19 through the day of survey revealed calibrations were performed on 1/3/19, and again on 2/20 /20. This exceeds the 6 month calibration requirement of the manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 12/18/19, the laboratory did not successfully participate in proficiency testing for ERYTHROCYTE COUNT and HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ERYTHROCYTE COUNT and HEMATOCRIT: PROFICIENCY TESTING PROVIDER: Medical Laboratory Evaluation ERYTHROCYTE COUNT: Year 2019 2nd Event 0% Year 2019 3rd Event 60% HEMATOCRIT: Year 2019 2nd Event 0% Year 2019 3rd Event 60% Scores less than 80% for this analyte or 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 -- parameter indicates failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 12/18/19, the laboratory did not successfully participate in proficiency testing for ERYTHROCYTE COUNT and HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ERYTHROCYTE COUNT and HEMATOCRIT: PROFICIENCY TESTING PROVIDER: Medical Laboratory Evaluation ERYTHROCYTE COUNT: Year 2019 2nd Event 0% Year 2019 3rd Event 60% HEMATOCRIT: Year 2019 2nd Event 0% Year 2019 3rd Event 60% Scores less than 80% for this analyte or parameter indicates failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 the AcT Diff analyzer records from installation, 5/2/18 through 1 /17/19 (day of survey) and confirmation with technical consultant at 10:30 am, the laboratory failed to retain the quality control (QC) assay sheets to include but not limited to acceptable ranges, storage requirements, lot numbers and standard deviations for at least 2 years. Findings include: Review of the AcT Diff QC assay sheet (in use the day of survey) and other hematology records indicated the laboratory did not retain all QC assay sheets with the change of a new lot number of hematology low, normal and high controls. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)