Poseidon Diagnostics Corp

Summary Statement of Deficiencies D0000 A complaint survey #2021016603 was conducted on 12/09/2021 to 12/10/2021 at Poseidon Diagnostic Corp. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The laboratory failed to establish all test performance specifications (to include specimen, storage, and transportation conditions of the specimen ) since they were using Fastplex Triplex 1-step COVID-19 detection kit (Reverse Transcription polymerase chain reaction (RT-PCR), Ribonucleic Acid (RNA) extraction Free that did not have a (FDA) Food and Drug Administration (EUA) Emergency Use Authorization. The Laboratory failed to follow their policy for specimen collection, specimen storage and transportation of Coronavirus Disease 2019 (COVID-19) patient specimens from May 2021 to December 9, 2021. (D5300). The laboratory failed to validate a control method for testing for unvalidated COVID-19 PCR specimen with Fastplex Triplex 1-step COVID-19 detection kit (Reverse Transcription polymerase chain reaction (RT-PCR), Ribonucleic Acid (RNA) extraction Free before patient testing since 4/21/2021. ( See D5423) The following Conditions were not met: D5300 - Preanalytic Systems 493.1240 D5400 - Analytic Systems 493.1250 D6076 - Laboratory Director 493.1441 D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to ensure uni- directional sample preparation, Reagent prep and amplification of Coronavirus Disease 2019 Polymerase Chain Reaction (COVID-19 PCR) testing since 04/21/2021. The Findings Included: An observation of the Molecular area on 12/09/2021 at 2:00 PM revealed 3 tables set up at 90 degree angles from each other. The first table had a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- hood on the left end of the table, the second table had a hood on the right end of the table, and the third table had the Biorad CFX 96 Real-time System on the left end of the table. Samples arrived right next to the hood on the first table and there were materials used for reagent preparation. Sample tubes were also on the second table on the right hand side. Reagents were located in the refrigerator located on the side of the room directly across from the Biorad CFX 96 Real-time System and in the freezers located off the right end on the third table. The pipettors were shared between the 3 tables. Review of Fastplex Triplex 1-step COVID-19 detection kit (Reverse Transcription polymerase chain reaction (RT-PCR), Ribonucleic Acid (RNA) extraction Free manufacturer instructions stated, "Separate laboratory areas, dedicated to performing predefined procedures of the assay, are required. a) 1st Area: Preparation Area-Prepare testing reagent: b) 2nd Area: Sample processing-Process the specimen and controls: c) 3rd Area: Amplification Area-PCR conducted. All materials used in one area should remain in that area and should not be moved or used in other areas. After the assay procedures, the workbench and lab supplies should be cleaned and disinfected immediately. To avoid contamination, the positive control needs to be prepared in an area separate from the amplification and extraction area." During an interview with the technologist on 12/10/2021 at 3:00 PM, he stated that 18,000 patients were tested for Covid-19 PCR 4/21/2021 to present. During an interview with technologist on 12/10/2021 at 4:19 PM, he confirmed the laboratory did not ensure a uni-directional flow system for COVID-19 PCR testing since starting patient testing on 4/21/2021. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the preanalytic system and correct identified problems. The Findings Included: Cross Reference D5311. Based on record review, observations, and interview the Laboratory failed to establish all test performance specifications to include the type of specimen and the storage and transport condition of the specimen since the Fastplex Triplex 1-step COVID-19 detection kit (Reverse Transcription polymerase chain reaction (RT-PCR), Ribonucleic Acid (RNA) extraction Free does not have an (FDA) Food and Drug Administration (EUA) Emergency Use Authorization and failed to follow their policy for specimen collection, specimen storage and transportation of Coronavirus Disease 2019 (COVID-19) patient specimens from May 2021 to December 9, 2021. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. -- 2 of 12 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a written or electronic test request from an authorized person for 9 out of 9 Patient test reports reviewed. The Findings Included: Review of 5 Patients (#1 - #5) pulled from a rack on the counter and 4 Patients (#6-#9) from the Severe Acute Respiratory Syndrome (SARS) worklist revealed no test requisitions. Interview on 12/09/2021 at 2:20 PM the Owner confirmed that the laboratory did not have any electronic or written test requisitions signed by an authorized person. 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: Based on record review, observations, and interview, the laboratory failed to accurately enter the date of the Patient test collected for 1 (#8) out of 9 Patient reports pulled. The Findings Included: Review of the Severe Acute Respiratory Syndrome (SARS) worklist revealed that Patient #8 was ran on 12/06/2021. The final report for Patient #8 stated that the test was ran on 12/02/2021. Observations of the saved specimens on 12/09/2021 at 4:30 PM revealed, that Patient #8 had a specimen collection on 12/02/2021 and 12/06/2021 per the bags the specimens were grouped in. The label on both specimens stated it was collected on 12/02/2021 with the same accession number. Interview on 12/09/2021 at 4:30 PM, the Director of Operations of the sister facility stated that the accessioner must have printed a label with the first collection date instead of the correct collection date of 12/06/2021. He confirmed that the final report with the date of 12/02/2021 was not correct and should read that it was collected and ran on 12/06/2021. 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 review of the manufacturers Instruction for Use (IFU), record review, observations, and interview, the laboratory failed to establish specimen storage and transportation requirements, and follow the manufacturers IFU guidelines and their policy for specimen collection, specimen storage and transportation of Coronavirus Disease 2019 (COVID-19) patient specimens from May 2021 to December 9, 2021. Findings Included: The Laboratory is using the FastPlex 1-step COVID-19 Detection Kit (Reverse Transcription Polymerase Chain Reaction (RT-PCR), Ribonucleic Acid (RNA) extraction Free). The FastPlex 1-step COVID-19 Detection Kit (RT-PCR, -- 3 of 12 -- RNA extraction Free does not have an approved Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). Laboratory tests without the approval of the FDA are considered a Laboratory Developed Test (LDT). Laboratories that perform a LDT may use the manufactures IFU for guidance, however they must establish specimen storage and transportation requirements by performing stability studies to ensure specimen integrity. Review of the IFU for the FastPlex 1-step COVID-19 Detection Kit (RT-PCR, RNA extraction Free) noted, "Specimen Transport: Specimens must be packaged, shipped, and transported at dry ice overnight. Specimen Storage: Upon receipt, specimens can be immediately processed or stored at 2-8 degrees Celsius (C) for up to 2 hours after collection. For longer term storage, store specimens at -70 degrees C or lower." The IFU also states, "False positive and false negative results can be caused by poor specimen quality, improper sample collection, improper transportation, improper laboratory processing, or a limitation of the testing technology." Review of the laboratory's policy titled, "Specimen Collection" states, "Store at room temperature and it is going picked up after 2hrs, store at 4 degree Celsius." (as seen) On 12/09/2021 at 11:04 AM, four racks with approximately 80 patient samples were observed sitting on the table un- refrigerated. On 12/09/2021 at 11:08 AM, patient samples stored in red bags were observed in the freezer at a temperature of -26 degrees Celsius (C). The laboratory performs COVID-19 testing on specimens collected at its sister laboratory. On 12/10 /2021 at 1:50 PM during a tour of the sister facility located next door to the laboratory, specimens were observed stored un-refrigerated. Three patient samples were examined. Patient #1's specimen was collected on 12/09/2021 at 12:31 PM. Patient #2's specimen was collected on 12/09/2021 at 9:23 PM. Patient #3's specimen was collected on 12/09/2021 at 8:32 PM. On 12/10/2021 at 2:10 PM, bags of patient specimens were observed on the counter of the laboratory un-refrigerated. Review of the "Daily Specimen Transport Log" found in a bag containing the un-refrigerated patient specimens showed the log was date 12/09/2021, time of pickup was 9:45 AM. and contained 11 patient specimens from West Palm Beach. Five patient specimens were examined. Patient #1's specimen was collected on 12/08/2021 at 4:50 PM. Patient #2's specimen was collected on 12/08/2021 at 4:22 PM. Patient #3's specimen was collected on 12/08/2021 at 4:08 PM. Patient #4's specimen was collected on 12/08 /2021 at 3:55 PM. Patient #5's specimen was collected on 12/08/2021 at 4:51 PM. On 12/09/2021 at 1:45pm, the Director of Operations from the sister laboratory stated the patient specimens are not stored or transported on ice and are not refrigerated per the IFU. On 12/10/2021 at 4:00PM, the Laboratory Director confirmed the laboratory had not completed the validation for the FastPlex Triplex 1-step COVID-19 Detection Kit (RT-PCR,RNA extraction Free) before performing patient testing. 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 record review, observation, and interview, the laboratory failed to validate the Fastplex Triplex 1-step Coronavirus 2019 (COVID-19) detection kit (Reverse -- 4 of 12 -- Transcription polymerase chain reaction (RT-PCR), Ribonucleic Acid (RNA) extraction Free) for Covid-19 PCR use before patient testing since 4/21/2021. (See D5423) The findings included: Based on record review, observation, and interview, the laboratory failed to validate a control method for testing for unvalidated COVID- 19 PCR specimen with Fastplex Triplex 1-step COVID-19 detection kit (RT-PCR, RNA extraction free) before patient testing since 4/21/2021. (See D5423) 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a pooling policy for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing since pooling started on 11/29/2021. Findings Included: Review of Polymerase chain reaction (PCR) plate maps revealed that specimen pooling was being performed on 12 /06/2021. There was no pooling policy to be reviewed. There was no documentation that the kits and instruments being used for SARS-CoV-2 had an Emergency Use Authorization (EUA) that allowed specimen pooling. Interview on 12/10/2021 at 12: 51 PM the Laboratory Director confirmed that there were no policies on pooling specimens. She could not provide documentation if the test kit and instruments being used were authorized by (EUA) for patient pooling. 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)