Scylex Inc Dba Scylexlab

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on procedure and record review and interview with the technical supervisor (TS), the laboratory failed to establish procedures that ensured accurate positive patient identification from specimen receipt through results reporting. Findings: 1. The laboratory performed a molecular pharmacogenetic assay that included logging in the patient information, assigning a patient identification number (sample ID), transferring the specimen to a microcentrifuge tube, then to a 96 well plate for extraction and processing, and then to a BeadChip for analysis. 2. The procedure titled "Quality Control- SOP" (QC SOP) stated to "Log receipt of the sample and documentation into the tracking system (Patient Information Excel Sheet and Lims)." 3. The QC SOP also stated to record the extraction QC results "into the DNA Extraction Log Sheet" which included columns for the date of collection, the date of extraction, the sample ID, the barcode ID, the BeadChip ID, and the extraction QC values. 4. The TS stated that the sample ID number was the last 4 digits of the barcode ID 5. The procedures did not include instructions for assigning patients to wells in the 96 well plate or positions on the BeadChip. 6. Patient number 5915 was randomly selected to review from specimen receipt to results reporting. Testing was performed for patient 5915 and their parent. 7. There were two Excel worksheets containing patient information. The first was the original worksheet in use and the 2nd was just recently transcribed from the original worksheet. 8. The original Excel worksheet included patient 5915's name, but the entry for the sample ID number, 5915, was blank. Sample ID 5915 was assigned to the patient's parent. 9. The 2nd Excel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- worksheet had the parent's correct sample ID number, but listed sample ID 5913 for the selected patient instead of 5915. 10. The extraction log only contained the sample ID which was written in the barcode ID column. All other columns were left blank. 11. All patient information and QC values were correctly entered into a laboratory notebook that was not mentioned in any of the procedures. 12. During the exit interview on 12/06/2024 at 3:00 PM, the TS confirmed that sample ID 5915 was misidentified on the Excel worksheets, that the extraction log was not completed, and that there was no procedure for assigning patients to wells in the 96 well plate or position on the BeadChip to ensure positive patient identification from specimen receipt through results reporting. 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 procedure manuals and interview with the technical supervisor consultant (TS) and laboratory director (LD), the laboratory failed to establish written policies and procedures for assessing the testing personnel as defined in subpart M- CFR 493.1451(b)(8) through (9) for high complexity testing. Findings: 1. The laboratory's approved written procedure manual did not include all the required elements for evaluating the competency of the testing personnel and assuring that they maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to: direct observations 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 and function checks; assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills; and evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 2. During the survey on 12/06/2024 at 3:00 PM, the TS and LD confirmed that the approved policy and procedure manual did not include written training and competency programs to follow when training the testing personnel who perform high complexity testing. 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 review of the policies and procedures and interview with the technical supervisor (TS) and laboratory director (LD), the laboratory failed to have a written -- 2 of 7 -- policy describing the system used for verifying the accuracy and reliability of the analysis of the patient's deoxyribonucleic acid (DNA) to identify genetic variants to help inform medication efficacy, safety, and dosing for which proficiency samples are not available. Findings: 1. The policy and procedure manual did not have a written policy for evaluating the proficiency of the DNA testing at least twice a year. 2. During the survey on 12/06/2024 at 3:00 PM the TS and LD confirmed that the procedure did not have a written policy for evaluating the DNA testing system at least twice a year. The procedure should include, but is not limited to: the details of whom the samples will be exchanged with; how often samples will be exchanged; what the acceptable limits of the comparison and remedial actions to be taken when the results are not within acceptable limits. D5303 TEST REQUEST CFR(s): 493.1241(b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: Based on review of the requisitions, policy and procedure manuals, and interview with the technical supervisor (TS), the laboratory failed to establish written procedures for ensuring that verbal orders are followed up with written or electronic authorization within 30 days of the verbal request. Findings: 1. Review of 9 test requisitions showed that all 9 were missing the authorization signature for ordering the test. 2. The TS confirmed that the laboratory does not have a written procedure instructing the staff to contact the client to procure a written or electronic authorization to perform the test. 3. During the exit survey on 12/06/2024 at 3:00 PM, the TS confirmed that there was no written procedure for obtaining the written authorization signature for the 9 requisitions that were missing the authorization signature. 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 the requisitions and interview with the technical supervisor (TS), the laboratory failed to ensure that the collection date was recorded on the requisition -- 3 of 7 -- form. Findings: 1. Review of 9 test requisitions showed that all 9 failed to have the collection date recorded as required on the requisition form. 2. During the exit survey on 12/06/2024 at 3:00 PM, the TS confirmed that the laboratory staff failed to follow up with the client to get the collection date to ensure accurate turnaround time for the specimens tested. 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 procedure and patient test record review and interview with the technical supervisor (TS), laboratory personnel failed to follow procedures when patient consent and testing request forms were received incomplete. Findings. 1. The procedure titled "DNA Sample Collection using Oracollect-DX - OCD-100" stated to "Fill out the Informed Consent: Pharmacogenetic Testing and Pharmacogenetic Testing Request Form" and that the staff receiving the sample should "Ensure all required documentation is included." 2. The procedure titled "Quality Control- SOP" (QC SOP) stated to "Verify that the following required forms are submitted with the sample" and listed "Informed Consent: Pharmacogenetic Testing" and "Pharmacogenetic Testing Request Form." 3. The QC SOP then stated that "If a sample fails the quality check due to incomplete documentation or a damaged/leaky container" the laboratory should 1) "Document the issue in the tracking system", 2) "Notify the submitting entity or individual immediately", and 3) "Follow laboratory policy for sample rejection or request for resubmission." 4. Patient number 5915 was randomly selected to review from specimen receipt to results reporting (see tag D5203 for additional details). 5. Records showed that the Informed Consent form was not signed and that the Testing Request Form only contained the patient's name, date of birth, sex, and address. The provider information, testing information, and provider authorization were missing from the Testing Request Form. 6. There was no documentation that the submitting entity was notified and a request for the resubmission of completed paperwork was made as stated in the QC SOP. 7. During the exit interview on 12/06/2024 at 3:00 PM, the TS confirmed that the Informed Consent and Testing Request forms for patient 5915 were incomplete and there was no documentation that the submitting entity was notified. 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 -- 4 of 7 -- 493.1253. (7) Control procedures. (8)