Medplus Urgent Clinic, Llc

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 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 -- two of two testing events (2023-Event 2, and 2023-Event 3) resulting in unsuccessful participation in Routine Chemistry for the analyte CK Isoenzyme (CK-MB). Refer to D2096. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. 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 participate in proficiency testing in Routine Chemistry for the analyte CK Isoenzyme/CK-MB 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 Routine Chemistry/CK Isoenzyme (CK-MB): Routine Chemistry/CK Isoenzyme (CK-MB): Year 2023-2nd Event 0% Year 2023-3rd Event 0% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 Routine Chemistry for the analyte CK Isoenzyme (CK-MB) 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 Routine Chemistry (CK Isoenzyme /CK-MB): Routine Chemistry (CK Isoenzyme/CK-MB): Year 2023-2nd Event 0% Year 2023-3rd Event 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory personnel records since 2/6/2022 and an interview with testing personnel #1/general supervisor (TP/GS) at 5:00 p.m. on 8/30/2023, the laboratory failed to follow written policies to assess the technical consultant (TS) and technical supervisor (TS) competency annually. The technical consultant/technical supervisor competency evaluation had not been performed by the laboratory director since 8/30/22. Findings include: 1. There was no documented competency evaluation available for review on the TC or TS. 2. Laboratory policy stated that the TC and TS would be evaluated at least annually. 3. TP #1 confirmed in an interview at 5:00 p.m. on 8/30/2023 that the laboratory failed to follow policies to assess general supervisor and technical consultant competency. 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) 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 -- 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 Medonic M Series hematology analyzer records including quality control, maintenance, and calibration records from 2/1/2022 through 8/30 /2023 and confirmation with testing personnel (TP) #1 (as listed on the Centers for Medicare and Medicaid Services 209 Personnel form) at 10:00 a.m. on 6/14/2023, the laboratory failed to calibrate the CBC (complete blood count) performed on the Medonic M Series every 6 months as required by the written laboratory procedure manual and instrument manufacturer for 1 of 3 calibrations due. Findings include: 1. Review of the Medonic M Series calibration records revealed calibration was performed on 12/6/2021, 6/1/2022, 4/12/2023 and 5/18/2023. 2. The manufacturer requires that the Medonic M series be calibrated every 6 months. 3. The time frame between the calibration on 6/1/2022 and 4/12/2023 exceeded the required 6 month calibration. 4. TP #1 confirmed in an interview at 10:00 a.m. on 8/30/2023 that CBC calibrations were not performed every 6 months for 1 of 3 calibrations required between 2/1/2022 and 8/30/2023. 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 Medonic M Series hematology analyzer calibrations from 2/1/2022 through 8/30/2023, and interview with TP#1 at 3:00 p.m. on 8/30/3023, the technical consultant (TC) failed to document review for 2 of 3 Medonic calibrations performed for the evaluation of the competency of the staff. Findings Include: 1. Review of Medonic M Series calibrations from 2/6/2022 through 8/30 /2023 revealed no documentation of review by the TC for 2 of 3 calibrations. 2. TP #1 confirmed in an interview at 3:00 p.m. on 8/30/2023 that Medonic M Series calibrations performed on 4/12/2023 and 5/18/2023 were not documented as reviewed by the TC. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory personnel records since 2/6/2022, including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and personnel competency evaluations, and interview with testing personnel (TP) #1 at 5: 00 p.m. on 8/30/2023, the technical consultant (TC) failed to evaluate and document -- 2 of 3 -- the performance of testing personnel TP #6 and TP #7 (2 of 6 new TP since 2/6/2022) at least semiannually during the first year of moderate complexity testing. Findings include: 1. Review of the laboratory personnel records indicated that TP #6 and TP#7 were initially trained on 8/31/2022 and 8/2/2022. 2. There was no 6-month competency evaluation available for review on TP #6 (due in January 2023) and for TP #7 (due in January 2023). 3. TP #1 confirmed in an interview at 5:00 p.m. on 8/30 /2023 that there were no 6-month competency evaluations documented as performed on TP #6 or TP #7 during their first year of performing moderate complexity testing. 4. The TC failed to document 6-month competency evaluations on 2 of 6 new testing personnel. -- 3 of 3 --

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 from 2019, 2020 and 2021 and confirmation with Technical Consultant/Lab Director (TC/LD) and testing personnel (TP) #1 at 5:30 p.m. on the day of survey, the laboratory failed to retain all proficiency records to include but not limited to results, attestation statements, submitted results and analyzer printouts. Findings include: 1. Review of records 3rd event of 2019, 1st, 2nd and 3rd events for 2020 and 2021 proficiency testing records revealed the laboratory did not retain the following: a. Report sheet /submitted result sheets for 3rd event of 2019, 2nd and 3rd events of 2020 and 2nd and 3rd events of 2021 for COVID SARS 2 proficiency testing. b. Attestation statement for 3rd event of 2019; 1st, 2nd, 3rd events of 2020; and 2nd, 3rd events of 2021 for COVID SARS 2 proficiency testing. c. Analyzer printouts for 1st, 2nd and 3rd events of 2020 and 2nd and 3rd events of 2021 2. Interview with TP #1 and the laboratory TC at 5:30 p.m. on 2/1/22 confirmed that the listed proficiency records were not retained after completion of each proficiency event. 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 laboratory proficiency records from 2019, 2020 and 2021 and 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 -- interview with the technical consultant/laboratory director (TC/LD) and testing personnel (TP) #1 at 5:30 p.m., on the day of survey (2/1/22), the laboratory failed to verify the accuracy of the complete respiratory panel testing at least twice annually for year 2021. Findings Include: 1. Review of the proficiency records from 2019, 2020 and 2021 revealed the QIAstat -DX Respiratory Panel had not been verified as accurate for the year 2021. The QIAstat-DX Respiratory Panel includes the following elements: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A H1, Influenza A H1N1 pdm09, Influenza A H3, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4. Respiratory Syncytial Virus A+B, Rhinovirus /Enterovirus, SARS-CoV-2, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae 2. During an interview with the TC/LD and TP #1 at 5:30 p.m. on 2/1/22, confirmed the accuracy had not been verified on the complete Respiratory Panel performed on the QIAGEN QIAstat-DX analyzer. Only the SARS-CoV-2 had been verified for accuracy by participating in proficiency testing twice in 2021. 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. This STANDARD is not met as evidenced by: Based on review of records for the Biosite Triage Meter analyzer, lack of documentation of verification of performance specifications, and interview with testing personnel (TP) #1 and the technical consultant/ laboratory director(TC/LD) at 6:00 p.m. on 2/1/22, the laboratory failed to ensure that performance specifications including comparison studies were performed prior to testing patients. The Biosite Triage Meter was put back into use on 4/10/21 after being out of operation for several years. Findings: 1. Review of the Triage Meter records for the analyzer put into use on 4/10/21 revealed no documentation of a method comparison study performed. According to surveyor notes the Triage Meter, which the laboratory uses to tests troponin, myoglobin, CKMB and D-dimer had not been used since before the last survey on 8/22/19. 2. Interview with TP #1 and the TC/LD at 6:00 p.m. on 2/1/22 revealed no method comparison had been performed for the troponin, myoglobin, CKMB and D-dimer tested on the Biosite Triage Meter before testing patients on 4/10 /21. . 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 -- 2 of 4 -- 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 the Biosite Triage Meter chemistry laboratory records, lack of documentation and interviews with testing personnel (TP) #1 and the technical consultant/laboratory director (TC/LD) at 6:30 p.m. on 2/1/22, the laboratory failed to perform initial calibration verification during the installation of the Biosite Triage Meter put in use on 4/10/21 and every 6 months for D-dimer, troponin, myoglobin and CKMB as required by the manufacturer. Findings include: 1. Review of the Biosite Triage records revealed the meter was put back into use on 4/10/21. 2. According to surveyor records the instrument had not been used since before 8/22/19. 3. There were no records of calibration verification performed for D dimer, troponin, myoglobin or CKMB. a. There was no documentation of initial calibration verification performed on the Biosite Triage meter during installation on 4/10/21. b. There was no documentation of any 6 month calibration verifications. 4. Calibration verification is required by the manufacturer initially and every 6 months on the Biosite Triage Meter for all tests performed. 5. TP #1 and the TC/LD confirmed in interview at 6:30 p.m. on 2/1/22 that there were no calibration verifications documented for D-dimer, myoglobin, troponin and CKMB. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel (TP) records available on 2/1/22, the CMS (Centers for Medicare and Medicaid Services) 209 form and interview with the technical consultant/laboratory director (TC/LD) and testing personnel (TP) #1, the laboratory director had not ensured that all testing personnel as listed on the CMS 209 personnel form had received the appropriate documented training prior to performing -- 3 of 4 -- moderate complexity testing on the QIAGEN QIAstat-DX Analyzer which is used to test respiratory panels (including SARS-CoV-2) that was installed on 2/6/21 in the laboratory. Findings Include: 1. Based on lack of training documentation available the day of survey, testing personnel had not been trained on the new QIAstat-DX analyzer prior to performing testing on patients beginning on 2/6/21. 2. An interview with the TC/LD and TP #1 at 5:30 p.m. on 2/1/22 confirmed that no initial training had been documented for all testing personnel who perform testing on the QIAGEN QIAstat- DX Respiratory analyzer prior to testing patients on 2/6/21. -- 4 of 4 --