Ambulatory And Occupational Medicine Clinic

Summary Statement of Deficiencies D0000 During a recertification survey performed on 11/26/2024, the laboratory was found out of compliance with the following conditions: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 observation of the laboratory, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory procedures, laboratory personnel records, final patient test reports, and staff interviews, the laboratory failed to follow its policy for testing personnel (TP) training and competency for five of five TP that performed complete blood count (CBC), creatine kinase myocardial band (CK-MB), Troponin, and Myoglobin patient testing in 2024. This was cited on the previous survey conducted on 10/16/2023, and compliance was not maintained. The findings include: 1. Observation of the laboratory on 11/26/2024 at 9:15 am revealed a Sysmex pocH-100i (serial number G4769) instrument used for patient CBC testing and the Triage MeterPro (serial number 00074960) used for CK-MB, Troponin, and Myoglobin patient testing. 2. A review of Form CMS-209 revealed five TP who performed CBC, CK-MB, Troponin, and Myoglobin patient testing. The form listed the Laboratory Director as the Technical Consultant. 3. A review of the laboratory policy titled "Laboratory Quality Assessment & Improvement Plan" section "E" titled "Personnel" revealed: "Initial training with evaluation, a 6 (six) month evaluation, and an annual evaluation yearly thereafter will be conducted with the Laboratory Director and/or Technical Consultant reviewing the performance of each employee working 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 4 -- the laboratory to ensure employee competency". The following elements would be evaluated: (1) Direct observation of routine patient test performance, (2) Monitoring the recording and reporting of test results, (3) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records, (4) Direct observation of the performance of instrument maintenance and function checks, (5) Assessment of test performance through previously analyzed specimens, internal blind testing, or external proficiency testing samples, and (6) Evaluation of problem solving skills. 4. A review of the laboratory personnel records revealed the following: TP One (hired 03/22/2024): The laboratory director did not sign or date the training forms for the Sysmex pocH-100i or the Triage Meter. The laboratory director did not sign or date the form titled "Review of Competency for Moderately Complexity Testing" for the initial competency assessment, and the level of competency was not documented for either the Sysmex pocH-100i or the Triage Meter. On the survey date (11/26/2024), a six-month competency assessment for the Sysmex pocH-100i or the Triage Meter that was due 09 /22/2024 was not available. TP Two (hired 09/03/2024): The laboratory director did not sign or date the training forms for the Sysmex pocH-100i or the Triage Meter. The laboratory director did not sign or date the form titled "Review of Competency for Moderately Complexity Testing" for the initial competency assessment, and the level of competency was not documented for either the Sysmex pocH-100i or the Triage Meter. For the Sysmex pocH-100i, The sections on Routine patient test performance (Direct Observation) and Performance of instrument maintenance and function checks (Direct Observation) were incomplete. The sections on Monitoring the recording and reporting of test results, Assessment of Test Performance, and Evaluation of problem- solving skills were not addressed. For the Triage Meter, The sections on Routine patient test performance (Direct Observation), Monitoring the recording and reporting of test results, and Performance of instrument maintenance and function checks (Direct Observation) were incomplete. The sections on Review of intermediate test results and Assessment of test performance were not addressed. TP three (hired 08/14 /2024): The laboratory director did not sign or date the training forms for the Sysmex pocH-100i or the Triage Meter. The laboratory director did not sign or date the form titled "Review of Competency for Moderately Complexity Testing" for the initial competency assessment, and the level of competency was not documented for either the Sysmex pocH-100i or the Triage Meter. For the Sysmex pocH-100i, Performance of instrument maintenance and function checks (Direct Observation) was incomplete. For the Triage Meter, The sections on Routine patient test performance (Direct Observation) and Performance of instrument maintenance and function checks (Direct Observation) sections were incomplete. The sections on Review of intermediate test results, Performance of instrument maintenance and function checks (Direct Observation), and Assessment of test performance were not addressed. TP four (hired 10/07/2024) The laboratory director did not sign or date the training forms for the Sysmex pocH-100i or the Triage Meter. The forms had incomplete sections. The laboratory director did not sign or date the form titled "Review of Competency for Moderately Complexity Testing" for the initial competency assessment, and the level of competency was not documented for either the Sysmex pocH-100i or the Triage Meter. For the Sysmex pocH-100i, The sections on Review of intermediate test results, Performance of instrument maintenance and function checks (Direct Observation), and Evaluating problem-solving skills were incomplete. The sections on the Performance of instrument maintenance and function checks (Direct Observation) and Assessment of test performance were not addressed. For the Triage Meter, Assessment of test performance was not completed. Routine patient test performance (Direct Observation), Monitoring the recording and reporting of test results, review of intermediate test results, and performance of instrument maintenance and function -- 2 of 4 -- checks (Direct Observation) sections were incomplete. TP five (hired 06/05/2024) The laboratory director did not sign or date the training forms for the Sysmex pocH- 100i or the Triage Meter. The forms had incomplete sections. The laboratory director did not sign or date the form titled "Review of Competency for Moderately Complexity Testing" for the initial competency assessment, and the level of competency was not documented for either the Sysmex pocH-100i or the Triage Meter. For the Sysmex pocH-100i, The Monitoring, recording, and reporting of test results, Review of intermediate test results, Performance of instrument maintenance and function checks, Assessment of test performance, and Evaluation of problem- solving skills were not addressed. For the Triage Meter, The sections on Routine patient test performance, Review of intermediate test results, Performance of instrument maintenance, and function checks were incomplete. The sections on Monitoring the recording and reporting of test results and Assessment of test performance were not addressed. 5. A review of final patient test reports revealed the following: Patient 109596215 CBC reported 10/10/2024 performed by TP two Patient 89500038 CBC reported 10/14/2024 performed by TP three and TP five Patient 50167 CBC reported 10/26/2024 performed by TP three Patient 82888 CBC reported 11/12 /2024 performed by TP four 6. An interview with the Director of Operations and TP one on 11/26/2024 at 1:00 pm confirmed the survey findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory job descriptions, personnel records, and staff interviews, the laboratory director failed to provide overall management and direction of the laboratory. (Refer to D6029) 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 observation of the laboratory, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory job descriptions, personnel records, and staff interviews, the laboratory director failed to ensure five of five TP had -- 3 of 4 -- documented training and competency before performing CBC, CK-MB, Troponin, and Myoglobin patient testing in 2024. This was cited at the previous survey (10/16 /2023), and compliance was not maintained. (Refer to D5209) The findings include: 1. Observation of the laboratory on 11/26/2024 at 9:15 am revealed a Sysmex pocH-100i (Serial GG4769) instrument used for patient CBC testing and the Triage MeterPro (Serial 00074960) used for CK-MB, Troponin, and Myoglobin patient testing. 2. A review of Form CMS-209 revealed five TP who performed CBC, Troponin, CK-MB, and Myoglobin patient testing. The Laboratory Director fulfilled the Technical Consultant position. 3. A review of the policy titled "Laboratory Director Responsibilities" revealed that the laboratory director was responsible for monitoring the laboratory personnel who performed patient test procedures. 4. A review of the laboratory personnel records revealed the following: The laboratory director failed to document training (ten of ten reviewed) for the five TP that performed moderately complex testing. The laboratory director failed to document initial competency (five of five reviewed) for the five TP that performed moderately complex testing. The laboratory director failed to perform the six-month competency evaluation for TP one, which was due in September 2024. 5. During an interview with the Director of Operations and TP one on 11/26/2024 at 1:00 p.m., TP one stated that training was provided by personnel no longer employed at the laboratory. This confirmed the survey findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 During a recertification survey performed on 10/16/23, the laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples 493.1205 Condition: Virology 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor 493. 1487 Condition: Laboratories performing high complexity testing; testing personnel D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of manufacturer instructions for use, staff interview, review of patient test reports, review of proficiency testing records, and staff interview, the laboratory used the Quidel Sophia Respiratory Syncytial Virus (RSV) as a non-waived test in 2022 and 2023 and was not enrolled in proficiency testing, with a total of nine patients tested and reported during the two year period. The findings include: 1. Observation of the laboratory on 10/16/23 at 9:30 am revealed the Quidel Sophia in use for patient testing for RSV. 2. Review of the manufacturer instructions for use revealed the test was moderately complexity for pediatric patients from the age of seven to less than nineteen. The package insert Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- further stated "The Sophia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients." 3. An interview with the lead testing person on 10/16/23 at 1 pm revealed the laboratory tests patients of all ages. 4. Review of patient test reports revealed performance and reporting of RSV on patients over the age of six in 2022 and 2023 (patient #s 72754 on 11/12/22, 104331958 on 11/13/22, 78916911 on 11/13/22, 104331959 on 11/13/22, 103553564 on 11/20/22, 104619929 on 12/22/22, 104811496 on 01/18/23, 104891105 on 01/23/23, 101773733 on 07/30/23). 5. Review of the laboratory's proficiency testing records revealed there was no enrollment or participation in proficiency testing for the RSV direct antigen in 2022 or 2023. 6. Interview with the laboratory lead on 10/16/23 at 2 pm confirmed the laboratory used the RSV as a non-waived test in 2022 and 2023 and was not enrolled in proficiency testing. 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 observation of the laboratory, review of the Centers for Medicare and Medicaid Services Casper Report 0155D (CMS 155), the laboratory's proficiency testing records, the laboratory's quality control (QC) records, patient test records and interview with the lead testing person, the laboratory failed to ensure participation in proficiency testing for 2023 event one for chemistry with patient testing being performed. The findings include: 1. Observation of the laboratory on 10/16/23 at 9:30 am revealed the Quidel Triage instrument in use for performing patient testing for Myoglobin, Creatine Kinase Myocardial Band (CK-MB) and Troponin I. 2. Review of the CMS 155 revealed a score of 0% for the chemistry specialty and the CK-MB analyte for 2023 event one. 3. Review of the laboratory's proficiency testing records revealed the following: 0% for failure to participate. Ship date was 01/09/23; Event due date was 02/01/23. 4. Review of the laboratory's January 2023 Triage meter QC records revealed the performance of daily QC for the Triage meter during the time when the PT results were due. 5. Review of the laboratory's accession logs and patient test reports revealed reporting of patient results for Myoglobin, CK-MB and Troponin I on 01/21/23 for patient medical record #82488353, during the period when the PT results were due. 6. Interview with the laboratory lead on 10/16/23 at 11:30 am confirmed the laboratory failed to participate in proficiency testing for 2023 event one chemistry with patient testing being performed. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) -- 2 of 13 -- 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's proficiency testing records and interview with the laboratory lead, the laboratory failed to maintain three of thirteen proficiency testing performance evaluation reports for a period of two years. The findings include: 1. Review of the laboratory's proficiency testing records revealed the performance evaluation reports for hematology were not maintained for two years for 2021 event three, 2022 event one, and 2022 event three. 2. Interview with the laboratory lead on 10/16/23 at 2 pm confirmed the laboratory failed to maintain all proficiency testing records for a period of two years for three of thirteen PT events reviewed from 2021, 2022, and 2023. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of manufacturer instructions for use, patient test reports, lack of records and staff interview, the laboratory failed to verify the performance specifications for use of the Quidel RSV as a moderately complex test (Refer to D5421) and failed to establish performance specifications when it modified and used the Quidel Sophia RSV test outside the manufacturer's stated patient age groups in 2022 and 2023 (Refer to D5423). 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 observation of the laboratory, review of the laboratory procedure manual, testing personnel competency assessments, and staff interview, the laboratory failed to ensure it's testing personnel competency assessment policy and documentation was in compliance with the requirements in Subpart M when it did not include all six required elements in the policy, did not include all required elements in the competency assessment documentation, and did not ensure testing personnel had been evaluated by the laboratory director who functions as the technical consultant prior to patient testing in 2020, 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 10/16/23 at 9:30 am revealed the following non-waived test systems in use for patient testing: Sysmex PocH-100i Complete Blood Count (CBC) instrument Quidel Triage in use for performing cardiac marker testing (Myoglobin, Troponin, CK-MB) Quidel RSV being used as a non-waived test 2. Review of the laboratory 's policy titled "LABORATORY QUALITY ASSESSMENT & IMPROVEMENT PLAN" revealed the following under section V. Personnel -- 3 of 13 -- Assessment: Problem solving was not included as part of competency assessment. Direct observations were not required to be performed by the lab director or technical consultant. Direct observations were not specified, i.e. patient testing or maintenance. Record review of quality control records, preventative maintenance records, proficiency testing records was not included as part of competency assessment requirements. Monitoring the recording and report of results was not included. Reassessment of competency when test methods or instruments change was not included as a requirement. 3. Review of the laboratory's testing personnel competency assessment records revealed the following: The forms used for assessing competency in 2020, 2021, 2022, and 2023 did not separately address the required elements for each non-waived test system. RSV was not included no any of the competency assessments performed for any of the four testing personnel in 2020, 2021, 2022, or 2023. Testing person #1-annual competency done on 08/19/20 did not address CBC and cardiac marker separately, review of maintenance records was not included in the competency assessment; annual competency done on 08/15/21 did not address CBC and cardiac marker separately for the required elements, review of maintenance records was not included in the competency assessment, annual competency done on 08/25/22 did not address CBC and cardiac markers separately, review of maintenance records was not included in the competency assessment; direct observations was not addressed; annual competency done on 09/12/23- CBC and cardiac markers were not addressed separately, review of maintenance records was not included, direct observations was not included in the competency assessment. Testing person #2: initial training done on 03/10/22 for CBC and 05/20/22 for cardiac markers. Not approved by the lab director who functions as the technical consultant until 10/04/22; 6-month competency assessment done 07/30/22-proficiency testing was not included in the evaluation, CBC and cardiac markers were not addressed separately for each required element, review of maintenance records was not included in the competency assessment; annual competency done 10/09/23-Direct observations was not included in the competency assessment. Testing person #3 initial training done on 02/25/20 for CBC and 03/25/20 for cardiac markers, not approved by the lab director who functions as the technical consultant until 11/11/20; six-month competency assessment done on 08/04/20 did not address CBC and cardiac markers separately for the required elements, and did not include review of maintenance records, annual competency dated 02/04/21 did not address CBC and cardiac markers separately for the required elements, and did not include review of maintenance records, annual competency performed on 02/04/22 did not include assessment for proficiency testing, did not include review of maintenance records, the problem-solving test did not include anything for CBC, the competency assessment performed on 10/09/23 did not address CBC and cardiac markers separately for the required elements. Testing person #4-Initial training form with a date of hire of 08/03/23 with documented training for CBC that had not been signed off or approved by the lab director who functions as the technical consultant. 4. Interview with the laboratory lead on 10/16/23 at 2:00 pm confirmed the laboratory's policy for testing personnel competency assessment was not in compliance with the requirements in subpart M when it did not include all six elements in the competency assessment policy and competency assessment documentation for each non-waived test system, and did not include reassessment of competency if test methods or instrument changes. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance -- 4 of 13 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the laboratory lead, the laboratory failed to evaluate two of two proficiency testing samples with non-graded scores in 2023. The findings include: 1. Review of the laboratory's proficiency testing evaluation report for 2023 event two cardiac markers revealed non-graded scores for sample CM-06 and CM-09 for Troponin I. There was no documented evaluation of the scores to determine the laboratory's accuracy. 2. Interview with the lab lead on 10/16/23 at 2 pm confirmed the laboratory did not evaluate non-graded proficiency testing scores for Troponin I performed on samples CM-06 and CM 09 for 2023 event two - cardiac marker survey. 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)