Prn Diagnostics, Llc

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 laboratory's Quality Assurance Manual and interview with the facility personnel, the laboratory failed to follow established policies and procedures to assess employee competency. Findings include: 1. The laboratory began patient testing on 10/27/2020 in the sub-specialty of Virology, with an approximate annual test volume of 50,000. 2. The laboratory policy reviewed during the survey titled, "Quality Assurance Manual (Personnel Training and Competency)" states, "Initial analyst training and competency is considered complete after the analyst has produced initial demonstration of method capability in the specific method or areas of analysis and this competency must be evaluated by the Technical Supervisor. Competency must be checked again after 6 months of hire, at 1 year, and annually after that... Documentation of evaluation shall be retained in personnel files." 3. The laboratory failed to follow the established policy indicated above to assess employee competency. See D6127 and D6128 for specific findings. 4. The facility personnel interviewed during the survey at 11:30am on 04/05/2022 confirmed the laboratory failed to follow established personnel competency policies to assess employee competency. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Virology at least twice annually during 2021. Findings include: 1. The laboratory began patient testing on 10/27/2020, using a Lab- Developed PCR test for COVID-19 testing. The laboratory's approximate annual test volume is 50,000. 2. No documentation was presented for review during the survey to indicate the laboratory verified the accuracy of the laboratory-developed PCR COVID- 19 test at least twice annually during 2021. 3. At 11:52am on 04/05/2022, the facility personnel interviewed confirmed the laboratory failed to verify the accuracy of the PCR COVID-19 test at least twice annually during 2021. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient test requisitions for SARS-CoV-2 (COVID-19) testing performed under the sub-specialty of virology and interview with the facility personnel, two out of two test requisitions failed to include the date and time of specimen collection. Findings include: 1. The laboratory performs SARS-CoV-2 (COVID-19) testing under the sub-specialty of virology, with an approximate annual test volume of 50,000. 2. The laboratory's policy titled, Specimen Collection, Subcontracting and Rejection (BIO-Specimens) states, "Specimens must be accompanied by a paper requisition, prepared either by hand or printed from the electronic ordering system. At a minimum, test requisition requirements for each patient collection include ...Date and time of specimen collection." 3. The test requisitions presented for review during the survey for specimen# 210180074 and specimen# 211110121 failed to include the date and time of specimen collection. 4. The facility personnel interviewed at 1:10pm on 4/05/2022 confirmed the date and time of specimen collection were not documented on the test requisition referenced above. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an -- 2 of 18 -- 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 review of pre-analytic Quality Assessment (QA) policies and procedures, patient test records and interview with the facility personnel, the laboratory failed to establish QA policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory's preanalytic systems. Findings include: 1. The laboratory performs SARS-CoV-2 (COVID-19) testing under the sub-specialty of virology, with an approximate annual test volume of 50,000. It is the practice of the laboratory to manually transcribe patients' test requisition information into the electronic Laboratory Information System (LIS). 2. Review of the test requisition and test report for specimen# 220330240 revealed the hand written test requisition listed a specimen collection time of 8:53am on 2/01 /2022. The electronic test report for specimen# 220330240 indicated a collection date /time of 2/01/2022 at 11:58am. 3. The 'Quality Assurance Manual' reviewed during the survey failed to include established policies and procedures to monitor, assess, and when indicated, correct problems identified in the pre-analytic systems, including but not limited to, a system to identify and correct errors found when manually transcribing test requisition information from a paper record into an electronic system. 4. The laboratory's established QA policy (ADM-QA Manual) states, "Over the course of the year, at least four samples will be chosen randomly and traced through the entire process...The following Pre-Analytical items must be checked: Name and Address of healthcare provider ordering the test with the NPI number, Patient name or identifier, Patient gender, Date of Birth, Test(s) ordered and source of specimen, Date and time of collection, Physician's signature, Any other pertinent patient inf D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited for quality practices identified during the survey conducted on April 5, 2022, it was determined that the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283, and failed to monitor the overall quality of the analytic systems and correct problems as specified in 493.1289 for patient testing performed by the laboratory in the sub- specialty of Virology. See D5401, D5403, D5413, D5423, D5425, D5429, D5435, D5441, D5445, D5469, D5481, D5775, D5783 and D5791 for findings. 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 -- 3 of 18 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's test procedure for real-time PCR COVID-19 testing, review of patients' test records and test reports and interview with the facility personnel, the laboratory failed to follow their established test procedure specific to data analysis and test reporting. Findings include: 1. The laboratory performs COVID- 19 testing using the Lab-Developed Test (LDT), 'SARS-CoV-2 by Bioneer Exicycler'. Patient testing for this test began on 12/10/2020 and the laboratory tested 57,226 patients from 12/10/2020 through 4/05/2022 (the date of the survey). 2. The laboratory's written test procedure, 'SARS-CoV-2 by Bioneer Exicycler - Section 12.0 Data Analysis and Reporting', lists the test interpretation as "Presumptive SARS-CoV- 2" if the E gene result is negative, the SARS-CoV-2 gene (RdRp gene/N gene) result is positive and the Internal Positive Control (IPC) result is positive. The procedure states, "All specimens that have a Presumptive SARS-CoV-2 result must be re- analyzed for confirmation." 3. Analytic test records reviewed for specimen# 220330194 tested on 02/02/2022 at 12:33:34 indicated the E gene result as negative, the SARS-CoV-2 gene (RdRp gene/N gene) result as 33.82 (positive) and the IPC as valid (or positive), resulting in a final test result of negative. The analytic test record reviewed included a highlighted positive SARS-CoV-2 gene (RdRp gene/N gene) result. The highlighted result, according to laboratory personnel, is flagged and interpreted as a Presumptive SARS-CoV-2 test result. 4. Laboratory personnel failed to follow the established test procedure with regard to Data Analysis and Interpretation and re-analyze the above referenced patient specimen for confirmation. The patient's test report was issued with a negative test result, with no repeat analysis. 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)