Summary:
Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to verify the accuracy of the SARS-CoV-2 molecular test twice annually in the the subspecialty of Virology. Findings include: 1. Record review on 3/8/2022 of the laboratory's 'Molecular Diagnostic Test for SARS-CoV-2 in Cellular Components of Nasopharyngeal Swab Rinses by Nested RT-PCR followed by Sanger Sequencing for variant diagnosis' revealed in Section 17: "CAP SARS-CoV-2 proficiency test materials not compatible with Sanger sequencing assay .... Due to the synthetic RNA fragments used as proficiency test materials, which were designed to endorse the commercial RT-qPCR tests for SAR-CoV-2, and the results generated by RT-qPCR tests under EUA cannot be used as the reference materials or comparators for evaluation of the results achieved by Sanger sequencing". 2. Record review on 3/8 /2022 of the College of American Pathologists SARS-CoV-2 Molecular COV2 participant evaluation reports for 2021 revealed: a. Three samples each were evaluated for both COV2-A and COV2-B events. b. Laboratory results received for 6 of 6 samples were resulted as indeterminate with grades of acceptable. c. Both evaluation reports were signed by the laboratory director with the following handwritten comment "The CAP materials are not compatible with Sanger sequencing methodology." 3. Staff interview on 3/8/2022 at 1:00 PM confirmed that the CAP survey material is not compatible with Sanger sequencing and that the laboratory did not verify the accuracy of their molecular SARS-CoV-2 assay by an alternate process. 4. The laboratory performs five tests annually in the subspecialty of Virology. D5301 TEST REQUEST Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure an authorized provider for SARS- CoV- 2 testing was mandated on the laboratory requisition in the subspecialty of Virology. Findings include: 1. Record review on 3/8 /2022 of the laboratory's web address, http://dnalymetest.com/ revealed: a. Online requisition for 'Routine Partial N Gene Sanger Sequencing for SARS-CoV-2 Detection and Reflex Target S gene Sanger Sequencing for Determination of Variants of Concern and Interest' listed 'healthcare provider (optional)'. 2. Staff interview on 3/8 /2022 at 11:00 AM with the laboratory director (LD) confirmed the above. The LD was unaware that all test request must be from an authorized person. 3. The laboratory performs five tests annually in the subspecialty of Virology. 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 record review and staff interview, the laboratory failed to ensure the date and time of collection and specimen type appear on the specimen requisition. Findings include: 1. Record review on 3/8/2022 of the laboratory's SARS-CoV-2 requisition form revealed the date and time of collection and the specimen type were not solicited. 2. Staff interview with the laboratory director on 3/8/2022 at 11:00 AM confirmed the above findings. 3. The laboratory performs five tests annually in the subspecialty of Virology. 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 -- 2 of 6 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure specimens received follow the established storage requirements during transportation for the SARS-CoV-2 specimens. Findings include: 1. Record review on 3/8/2022 of the laboratory's ''Molecular Diagnostics Test for SARS-CoV-2 in Cellular Components of Nasopharyngeal Swab Rinses by Nested RT-PCR Followed By Sanger Sequencing for Variant Diagnosis' procedure revealed: a. " Store specimens at 2-8 degree Celsius and ship overnight delivery to the lab on ice pack. If a specimen is frozen at minus 70 degrees Celsius, ship overnight to the lab on dry ice." 2. Record review on 3/8/2022 of the laboratory's web address, http://dnalymetest.com/ revealed: a. "Ship the sample on the same day via FEDEX next morning delivery on a working day (not on Holidays or weekends) to Milford Molecular Diagnostics Laboratory" b. A link to the FEDEX web address, https://www.fedex.com/en-us/shipping/how-to-ship-clinical-samples. html. 3. Record review on 3/8/2022 of the FEDEX link from 2b above revealed the lack of storage or transport temperature requirements for SARS-CoV-2 clinical specimens. 4. The laboratory performs five tests annually in the subspecialty of Virology. 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)