Mrh Medical Grp-Premier Diabetes & Medical Clinic

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 six of seven proficiency testing events. Findings include: 1. Review of the 3rd event of 2022, the 2nd and 3rd events of 2023 and the 1st, 2nd and 3rd events of 2024 proficiency testing records revealed the laboratory did not retain the following: a. Report sheets and submitted result sheets for the 1st event of 2024. (1 of 6 events report sheets not retained) b. Attestation statements for the 2nd and 3rd events of 2023 and 1st, 2nd and 3rd of 2024. (5 of 6 events attestation statements not retained) c. Analyzer printouts for the 3rd event of 2022, 2nd and 3rd of 2023 and 1st and 2nd of 2024 (5 of 6 events analyzer printouts not retained) d. Proficiency graded results for the 2nd event of 2024 (1 of 6 graded results not retained.) 2. Interview with TC/LD on 11/6/2024 at 10:00 a.m. confirmed that the listed proficiency records were not retained after completion of each proficiency event. 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) 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 -- -- (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 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 Qualigen Fast Pack Endocrinology records, and confirmation with the Laboratory Director (LD)/Technical Consultant (TC) and testing personnel (TP) #1 as listed on the Centers for Medicare and Medicaid Services (CMS) 209 form, the laboratory testing personnel failed to perform the calibration verification on the Qualigen for Free T4 for four of four sixth-month calibration verification procedures due. Findings include: 1. Review of the Qualigen Fast Pack records for Free T4 from 10/11/2022 through 11/6/2024, revealed a calibration verification was not performed on Free T4 every 6 months as required by the manufacturer. Four of four sixth-month calibration verifications were not performed. 2. Interview with the LD/TC and TP #1 on 11/6/2024 at 2:00 p.m., confirmed the calibration verification on Free T4 had not been performed every 6 months as required by the manufacturer. 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) data system CASPER report 0155D and interview with the Laboratory Director (LD)/Technical Consultant (TC) and testing personnel (TP) #1, the TC failed to ensure the laboratory enrolled and participated in an HHS approved proficiency testing (PT) program for Free T4, TSH (thyroid stimulating hormone) and Testosterone performed on the Qualigen Fast Pack analyzer for the 1st event of 2023 and 2nd event of 2024. Findings include: 1. Review of the laboratory proficiency records from 2022 through 2024, and the CMS database casper report revealed: A. The laboratory did not enroll and participate in proficiency testing for the 1st event of 2023. There were no PT records available the day of survey and no PT scores in the CMS database for the 1st event of 2023. The laboratory failed to enroll and participate in 1 of 7 PT events. B. The laboratory did not participate in the 2nd PT event of 2024. On the day of survey TP #1 provided the unsubmitted endocrinology results in the API database for the 2nd event of 2024 but failed to -- 2 of 3 -- submit the results for grading. The laboratory scored 0% for nonparticipation. The laboratory failed to participate in 2 of 7 PT events. 2. The LD/TC and TP #1 confirmed in an interview on 11/6/2024 at 10:00 a.m., that the laboratory did not enroll and participate in the 1st PT event of 2023, nor did they participate in the 2nd PT event of 2024 for Endocrinology testing (Free T4, TSH and Testosterone). The laboratory is under a cease testing sanction as of the day of the survey. 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 review of laboratory testing records and interview with the Laboratory Director/Technical Consultant (LD/TC), the technical consultant (TC) failed to document the review of the Qualigen Fastpack analyzer's quality controls, maintenance and temperature logs from 10/13/2022 through 11/06/2024. Findings Include: 1. Review of laboratory records from 10/12/2022 through 11/6/2024 revealed no documented review by the TC for the following records: a. Laboratory temperature logs (room, refrigerator, freezer, humidity) from 5/1/2024 through 10/31/2024 b. Free T4 quality control (QC) from 10/10/2022 through 9/11/2024 and calibrations from 12 /29/2022 through 10/29/2024 c. Testosterone QC from 11/14/2022 through 6/24/2024 and calibrations from 12/6/2022 through 10/29/2024 and calibration verification on 7 /25/2023 c. TSH calibrations from 12/27/2022 through 10/29/2024 2. Interview with LD/TC on 11/6/2024 at 2:00 p.m. confirmed there was no available documentation of review of these records by the technical consultant during these time frames. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and interview with the Laboratory Director/Technical Consultant LD/TC, the technical consultant failed to evaluate the performance for one of two testing personnel at least annually for moderate complexity testing. Findings include: 1. The surveyor reviewed moderate testing personnel records form 10/11/2022 through 11/6/2024 including competency evaluations and the CMS 209 personnel form. 2. Testing Personnel #2 had no annual competency/evaluation for 2023 or 2024: 3. The LD/TC just assigned to this position confirmed in an interview on 11/6/2024 at 2:00 p.m., there was no annual competency evaluation documented as performed by the previous TC for TP #2 (1 of 2 TP) for the years 2023 and 2024. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/20/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 2 and 2023-Event 3) resulting in unsuccessful 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 -- participation in the subspecialty of Endocrinology for the analyte Thyroxine (T4). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 11/20/2023, the laboratory failed to achieve satisfactory performance in the subspecialty of Endocrinology for the analyte Thyroxine (T4) in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Endocrinology and Thyroxine (T4): Endocrinology: Year 2023-2nd Event 50% Year 2023-3rd Event 50% Thyroxine (T4): Year 2023-2nd Event 0% Year 2023-3rd Event 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory temperature and humidity records since 2/25/2022 and confirmation with testing personnel (TP) and technical consultant (TC) at 2:00 p.m. on 10/11/2022, the laboratory failed to monitor and document the room humidity and temperature of the laboratory room where the Qualigen analyzer was stored and testosterone, TSH and Free T4 testing performed. Findings include: 1. Observation of the laboratory where testosterone, TSH, and Free T4 testing was performed revealed no thermometer or hygrometer to monitor the room temperature or humidity for optimal performance of the IP Fast Pack Qualigen analyzer. 2. Laboratory records (room temperature and humidity) available for review were documented from monitoring the thermometer and hygrometer in another room (where phlebotomy was performed and the refrigerator was housed). 3. IP Fast Pack Qualigen manufacturer's instructions require a room temperature of 15 - 32 degrees Celsius and a relative humidity of 10 - 80%. The instructions read "Record the temperature and humidity of the lab area on a daily basis and write values in the daily environment log." 4. Interview with the TP and the TC at 2:00 p.m. on 10/11/2022 confirmed that room temperatures and humidity results recorded on the Qualigen environment log were taken from the thermometer and hygrometer in another room rather than the 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 -- laboratory room where testosterone, TSH, and Free T4 testing was performed on the Qualigen analyzer. -- 2 of 2 --

Summary Statement of Deficiencies 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) 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 Qualigen Fast Pack IP #2 calibration records from installation on 4/21/20 and interview with testing personnel (TP) #1 listed on the CMS (Center for Medicare & Medicaid Services) form at 2:00 pm on the day of survey, the laboratory failed to perform calibration on Vitamin D every 30 days and TSH (thyroid stimulating hormone) every 14 days as required by the manufacturer. Findings include: 1. Review of the Qualigen Fast Pack TSH package insert indicates that the assay must be calibrated every 14 days or with each new lot of reagent. Review of the Qualigen Fast Pack Vitamin D package insert indicates that the assay must be calibrated every 30 days or with each new lot of reagent. 2. Review of the Qualigen Fast Pack IP #2 calibration records for TSH from 4/21/20 through the day of survey revealed a calibration was performed on 4/21/2020. The next documented calibration was performed on 11/5/2020. These dates exceed the 14 day calibration requirement by the manufacturer. 3. Review of the Qualigen Fast Pack IP #2 calibration records for Vitamin D from 4/21/20 through the day of survey revealed a calibration was 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 -- performed on 4/21/2020. The next documented calibration was on 12/18/2020. Calibration was performed on 1/5/21 and again on 2/11/21. The period from 4/21 until 12/18/2020 and the period from 1/5 until 2/11/21 exceed the 30 day calibration requirement by the manufacturer. 4. Interview with TP #1 at 2:00 pm on 2/25/21 confirmed that calibration was not performed on the Qualigen Fast Pack IP analyzer #2 for Vitamin D every 30 days and TSH every 14 days as required by the manufacturer's policy. 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 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 Qualigen Fast Pack IP System records from installation on 4/21 /20 through the day of survey and confirmation with testing personnel #1 at 1:30 pm on 2/25/21, the laboratory failed to perform calibration verification on the Quality Fast Pack System #2 every 6 months for TSH (thyroid stimulating hormone) and Vitamin D. Findings include: 1. Review of the laboratory Qualigen Fast Pack IP records for TSH and Vitamin D from installation on 4/21/20 through the day of survey revealed that a calibration verification had not been performed for either assay since installation. 2. Interview with testing personnel #1 at 1:30 pm on the day of survey confirmed that calibration verification had not been performed for the TSH and Vitamin D assays since installation. This period exceeded the 6 month calibration verification requirement from the manufacturer. -- 2 of 2 --