Saints Metro Medical Associates

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/13/2022. The laboratory was found out of compliance with the following CLIA Condition of Participation: 493.1421; D6063: Testing Personnel The findings were reviewed with the directive administrator and radiology/lab technician at the conclusion of the survey. 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 records and interview with the radiology/lab technician, the laboratory failed to ensure an attestation statement had been signed by the analyst(s) for one of four events. Findings include: (1) A review of the first, second, and third 2021; and first 2022 Hematology proficiency testing events revealed the following: (a) First 2021 Event - The attestation statement had not been signed by the analyst(s) who tested samples HEM 03, HEM 04, and HEM 05. (2) The records were reviewed with the radiology/lab technician who stated on 07/14/2022 at 11:30 am, the attestation had not been signed by all analyst(s) performing the testing event. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 records and interview with the radiology/lab technician, the laboratory failed to review and evaluate proficiency testing results for one of four events. Findings include: (1) A review of 2021 and 2022 proficiency testing records revealed the following failures: (a) First 2022 Hematology Event (i) Hemoglobin - The laboratory failed the result for one of five samples (HEM-01) resulting in a score of 80%; (ii) MCH (Mean Corpuscular Hemoglobin) - The laboratory failed the result for one of five samples (HEM-01) resulting in a score of 80%; (iii) MCHC (Mean Corpuscular Hemoglobin Concentration) - The laboratory failed the result for one of five samples (HEM-01) resulting in a score of 80%. (2) A review of the records revealed no evidence proving

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/06/2020. The laboratory was found out of compliance with the following CLIA regulations: 493.1421; D6063: Testing Personnel The findings were reviewed with testing person #1 at the conclusion of the survey. 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 a review of policies and procedures, and interview with testing person #1, the laboratory failed to have written policies and procedures for assessing employee competency. Findings include: (1) During the survey, the surveyor reviewed the laboratory's policies and procedures. A policy that explained how employees were assessed for competency could not be located; (2) The surveyor asked testing person #1 if a competency policy was available for review. Testing person #1 stated to the surveyor on 10/06/2020 at 10:45 am, a policy had not been written. NOTE: For non- waived testing, the regulations require initial training, a semiannual evaluation during the first year, and an annual evaluation thereafter for each testing person for ensuring competency. The policy/procedure for evaluating competency must include, but is not limited to: *Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing *Monitoring the recording and reporting of test results *Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records *Direct observation of performance of instrument maintenance 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 -- and function checks *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples *Assessment of problem solving skills 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 a review of records and interview with the laboratory manager, the laboratory failed to verify the accuracy of Wet Prep, KOH, and Urine Microscopic testing at least twice annually. Findings include: (1) At the beginning of the survey, testing person #1 stated to the following to the surveyor: (a) Wet Prep, KOH (Potassium Hydroxide) Prep, and Urine Microscopic testing were performed in the laboratory by 2 of the 5 testing persons (testing person #1 and testing person #3); (b) The procedure for verifying the accuracy of the testing twice annually consisted of the laboratory director reading a slide after the testing person, and documenting the findings to ensure they correlate. (2) The surveyor reviewed 2019 and 2020 records which showed the following: (a) Wet Prep - There was no documentation the laboratory director performed a second review for 2 of 3 dates when accuracy verification had been documented as performed: (i) 03/12/2019 - One slide had been reviewed, with the results documented by testing person #1, and one slide had been reviewed, with the results documented by testing person #2. There was no documentation the laboratory director reviewed the slides; (ii) 07/15/2019 - One slide had been reviewed, with the results documented by testing person #1, and one slide had been reviewed, with the results documented by testing person #2. There was no documentation the laboratory director reviewed the slides. (b) KOH Prep - There was no documentation the laboratory director performed a second review for 2 of 2 dates when accuracy verification had been documented as performed in 2019. In addition, there was no documentation the testing had been verified for accuracy after 07/24 /2019 and to date in 2020: (i) 03/26/2019 - One slide had been reviewed, with the results documented by testing person #1, and one slide had been reviewed, with the results documented by testing person #2. There was no documentation the laboratory director reviewed the slides; (ii) 07/24/2019 - One slide had been reviewed, with the results documented by testing person #1, and one slide had been reviewed, with the results documented by testing person #2. There was no documentation the laboratory director reviewed the slides. (c) Urine Microscopic Testing - There was no documentation the testing had been verified for accuracy in 2019 and to date in 2020. (3) The surveyor reviewed the findings with testing person #1, who stated on 10/06 /2020 at 11:20 am, there was no documentation to prove the testing had been verified for accuracy at least twice annually as stated above. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of written policies and procedures, and interview with testing person #1, the laboratory failed to have written procedures for Wet Prep, KOH Prep, and Urine Microscopic testing. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor Wet Prep, KOH (Potassium Hydroxide) Prep, and Urine Microscopic testing were performed in the laboratory; (2) The surveyor reviewed the manual titled, "Policy and Procedure Manual" and was unable to locate written procedures for the above testing; (3) The surveyor reviewed the procedure manual with testing person #1, who stated on 10/06/2020 at 11:00 am, procedures had not been written for Wet Prep, KOH Prep and Urine Microscopic testing. 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 a review of records and interview with testing person #1, the technical consultant failed to ensure that evaluations included the review of test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records for 5 of 5 testing persons. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor CBC (Complete Blood Count) testing was performed on the Beckman Coulter AcT Diff2 analyzer; (2) The surveyor reviewed personnel records for 5 persons performing CBC testing, who had evaluations performed in 2020. For 5 of 5 persons, there was no evidence that the review of test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records had been included as part of the evaluations. The specific findings were: (a) Testing Person #1 - The evaluation form was completed on 01/21/2020; (b) Testing Person #2 - The evaluation form was completed on 02/06/2020; (c) Testing Person #3 - The evaluation form was completed on 02/06/2020; (d) Testing Person #4 - The evaluation form was completed on 07/29 /2020; (e) Testing Person #5 - The evaluation form was completed on 07/29/2020. (3) The findings were discussed with testing person #1 who stated on 10/06/2020 at 10:55 am, there was no documentation to prove the evaluations above included the review of test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory -- 3 of 4 -- failed to ensure individuals who performed moderate complexity testing met the educational qualifications. Findings include: (1) The laboratory failed to ensure a testing person met the educational qualifications. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1 and testing person #5, the laboratory failed to ensure testing persons met the required educational qualifications to perform moderate complexity testing for 1 of 5 testing persons. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor CBC (Complete Blood Count) testing was performed on the Beckman Coulter AcT Diff2 analyzer by 5 testing persons (testing person #1, testing person #2, testing person #3, testing person #4, and testing person #5); (2) The surveyor reviewed personnel records for the above testing persons, with the following identified for testing person #5: (a) The testing person had been hired to perform moderate complexity testing on 07/26/2019; (b) The testing person had earned a Bachelor of Science in Nursing Degree from the Philippines; (c) There was no documentation to prove an evaluation of the person's credentials had been performed, by a nationally recognized organization, to determine the equivalency of their education compared to an education obtained in the United States, as stated at 493.2 (d). (3) The surveyor reviewed the findings with testing person #1 and testing person #5. Both stated an evaluation of the degree to determine the equivalency in the United States had not been performed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The findings were reviewed with testing person #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033 Technical Consultant 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 records and interview with testing person #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2016, 2017, and 2018 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) First 2018 Hematology Event (i) MCHC (Mean Corpuscular Hemoglobin Concentration) - 4 of 5 results exhibited a positive bias (aa) HEM - 01 - SDI 2.4 (bb) HEM - 02 - SDI 2.3 (cc) HEM - 03 - SDI 2.1 (dd) HEM - 05 - SDI 2.4 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The surveyor reviewed the above findings with testing person #1 who stated the biases had not been addressed. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. 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 -- This STANDARD is not met as evidenced by: Based on a review of records, and interview with testing person #1, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor CBC (Complete Blood Count) testing was performed using the Beckman Coulter AcT Diff 2 analyzer; (2) Later during the survey, the surveyor reviewed two patient CBC reports - the first report was for an adult male patient with the testing performed on 06/07/18 at 10:55 am; the second report was for an adult female patient with the testing performed on 06/07/18 at 07:27 am. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit, which were: (a) RBC - 4.00 - 6.00 10^6/L (b) Hemoglobin - 11.0 - 18.0 g/dL (c) Hematocrit - 35 - 60% (3) The surveyor viewed the findings with testing person #1 who stated the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with testing person #1, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated -- 2 of 3 -- specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Findings include: (1) At the beginning of the survey, the surveyor reviewed records for 4 persons performing moderate complexity testing in 2016 and 2017. The records verified the evaluations for 4 of 4 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 (i) The 07/28/16 evaluation had been performed by testing person #1 (this person had earned an associate degree); (ii) The 12/07/17 evaluation had been performed by testing person #1. (b) Testing Person #3 (i) The 12/07/16 evaluation had been performed by testing person #1; (ii) The 12/07/17 evaluation had been performed by testing person #1. (c) Testing Person #4 (i) The 12/07/16 evaluation had been performed by testing person #1; (ii) The 12/07/17 evaluation had been performed by testing person #1. (d) Testing Person #5 (i) The 12/07/16 evaluation had been performed by testing person #1; (ii) The 12/07/17 evaluation had been performed by testing person #1. (2) The surveyor explained to testing person #1 that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non- waived testing, in the designated specialty or subspecialty areas of service). -- 3 of 3 --