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Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, test requisition, instrument print out, final report and interview with the laboratory technical supervisor on April 24, 2024, at 12 pm, the laboratory failed to follow its procedure for sputum specimen acceptability and rejection for 1 patient out of 4 patients, reviewed. The findings include: 1. The laboratory's procedure stated that if sputum sample storage is required for the BioFire Pneumonia Panel FilmArray test, specimen can be held at 2-8 degree centigrade for up to 1 day after collection. However, the laboratory tested and reported the sample # 23111621 that was stored at 2-8 degree centigrade for more than 1 day. The test requisition showed that the sample, # 23111621, was collected on 11/15/2023. The laboratory received the sample, # 23111621, on 11/16/2023 and ran on BioFire instrument on 11/17/2023. The laboratory tested the sample about 2 days after the collection which exceeded the storage limit. The laboratory should have rejected the sample since it had exceeded the storage time limit and should not have been tested and reported the results. The test results showed that almost all the analytes tested in the panel were negative which could have been due to the compromised sample integrity. Therefore, the accuracy of the laboratory test results cannot be assured and may have potential to harm patients. 2. The laboratory technical supervisor on April 24, 2024, at 12 pm, affirmed that the sample, # 23111621, was stored longer time than the procedure instructed before 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 -- testing. 3. The laboratory's testing declaration form signed by the laboratory director on 4/24/2024, stated that the laboratory performed approximately 80,304 molecular tests on BioFire instrument, annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's test report and interview with the laboratory technical supervisor on April 24, 2024, at 12 pm, the laboratory failed to indicate the test report date on its report. The findings include: 1. The laboratory's BioFire Pneumonia Panel FilmArray test report did not have the test report date. It contained draw and received dates, only. The test report date should be the date when the result was generated or any later date. This will ensure the sequence of testing orders and quality of the test. 2. The laboratory technical supervisor on April 24, 2024, at 12 pm, affirmed that the laboratory's test report lacked the report date. 3. The laboratory's testing declaration form signed by the laboratory director on 4/24/2024, stated that the laboratory performed approximately 80,304 molecular tests on BioFire instrument, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, test requisition, instrument print out, final test report and interview with the laboratory technical supervisor on April 24, 2024, at 12 pm, the laboratory director failed to assure laboratory's compliance with the applicable regulations and potentially harmed patients. The findings include: See D5311, D5805 and D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, test requisition, instrument print out, final report and interview with the laboratory technical supervisor on April 24, 2024, at 12 pm, the laboratory director failed to ensure that the laboratory personnel are performing the test methods as required for accurate and reliable results. The findings include: The laboratory personnel used a compromised sample to test and reported the test results, and potentially harmed patients. See D5311. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on reviews of the third quarter (Q3-2018), first quarter (Q1-2019) of the American Association of Bioanalysts (AAB) proficiency testing records, and interview with the technical consultant, it was determined that; the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. The findings included: a. AAB reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year: BUN 40% Q3-2018 Sodium 20% Q1-2019 b. For eight (8) out of nine (9) random patient test results reviewed covering period from 7/12 /2019 to 7/29/2019, eight (8) patients had Comprehensive Metabolic Panel ordered and analyzed by the laboratory during approximately the time that proficiency testing had failed which results could not be assured. c. The technical consultant and laboratory director confirmed (7/30/2019, 11:20), that the laboratory received the above unsatisfactory proficiency testing scores. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: 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 -- Based on reviews of test requisitions, final test reports, and interview with the technical consultant and laboratory director, it was determined that; the laboratory failed to transcribe or enter test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. The findings included: a. For one (1) out of nine (9) random patient test results reviewed covering period from 7/12/2019 to 7/29/2019, one (1) patient had a result for Basic Metabolic Panel without an order request from an authorized person. b. The technical consultant and laboratory director confirmed (7 /30/2019, 11:20) that the laboratory failed to follow test request as ordered. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on reviews of test requisitions, final test reports, and interview with the technical consultant and laboratory director, it was determined that; the laboratory failed to transcribe or enter test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. See D 5309. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of two (2) out of nine (9) random patient test results, instrument's printout, and an interview with the technical consult and , it was determined that; the laboratory failed to ensure that the results were accurately entered onto the patient's report (final test report) . The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. The findings included: a. Review of the laboratory's test records (testing requisition, instrument's print out, and final test reports); for patient number 1 test ordered on 7/18/2019 and patient number 2 test ordered on 7/23/2019, the Sodium test results from the instrument's print outs were different from the test results on the final reports. b. The technical consultant and laboratory director confirmed (7/30/2019, 11:20) that the laboratory failed to adequately entered manual or electronic system(s) to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry -- 2 of 3 -- (whether interfaced or entered manually) to final report destination, in a timely manner. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on interview with the technical consultant and laboratory director, review of patients reports, and instrument's print out, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the postanalytic systems. See D 5801 -- 3 of 3 --