Chesapeake Toxicology Resources, 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 personnel report (CMS-209), review of competency assessment records, and interview with the laboratory director (LD), the laboratory failed to establish and follow written policies and procedures to assess competency of technical consultants (TCs), technical supervisors (TSs), and general supervisors (GSs). Findings: 1. Form CMS-209 listed three TCs, five TSs, and six GSs. 2. Competency records did not contain assessments for the TCs, TSs, and GSs in their roles and responsibilities as TCs, TSs, and GSs. 3. During the survey on 11/29/2023 at 2:55 PM, the LD confirmed that there were no policies/procedures to assess competency of the TC, TS, and GS roles and responsibilities. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of the written procedure and interview, the laboratory written procedures for specimen acceptability did not include specific instructions for identifying unacceptable specimens and the resolutions for such unacceptable specimens. Findings: 1. The written procedure, CTR-Accessioning, for specimen acceptability did not state that the patient specimen container must be labeled with at least the patient name or a unique patient identifier on the container and not just the lid of the container. 2. The written procedure, CTR-Accessioning, for specimen acceptability states that the information on the requisition must match the specimen container, but does not specifically state what must be on the label attached to the specimen container, in addition to the information on the specimen label matching the requisition. 3. The written procedure, CTR-Accessioning, for specimen acceptability did not specifically identify labeling errors that require rejection and those that may be resolved by contacting the user for clarification. 4. The written procedure, CTR- Accessioning, for specimen processing did not state that accessioning staff must affix the laboratory unique specimen identification (accessioning) number to the specimen container and not just the lid of the specimen container. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the toxicology and COVID-19 proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to ensure that the PT attestation statements were being printed, signed and dated by the laboratory director and testing person. Findings: 1. The PT records for toxicology (5 events) and COVID- 19 (3 events) testing were reviewed. 2. The PT records did not include the attestation worksheet that is required to be printed and signed by the laboratory director or designee and testing person. 3. During the survey on 04/11/2022 at 4:30 PM, the TP confirmed that the attestation statements were not being printed, signed and dated as required. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the quality assurance manager (QAM), the laboratory failed to provide clients with instructions for how to collect, store and transport specimens referred for COVID-19 reverse transcription polymerase chain reaction (RT-PCR) testing. Findings: 1. The laboratory's procedure manual did not include approved instructions for clients referring specimens for COVID-19 RT-PCR testing including, from CFR 493.1242(a)(1) through (a)(7), patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, and specimen acceptability and rejection. 2. During the survey on 04/11/2022 at 4:30 PM, the QAM confirmed that the laboratory did not provide clients with instructions for how to collect, store and transport specimens referred for COVID-19 RT-PCR testing. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the quality assurance manager (QAM), the laboratory failed to record which reagent lot numbers were in use for each batch of patient specimens for COVID-19 reverse transcription polymerase chain reaction (RT-PCR) testing. Findings: 1. The laboratory maintained a list of reagents and lot numbers used for the extraction and amplification of patient specimens for COVID-19 RT-PCR testing. The laboratory also created a worksheet for each batch of patient specimens to record each step performed in the testing procedure. 2. Neither the list of reagents nor the batch worksheets indicated which lot numbers of reagents were used for each batch of patient specimens tested. 3. During the survey on 04/11/2022 at 4:30 PM, the QAM confirmed that the laboratory did not have documentation of which reagent lot number was used for each batch of patient specimens for COVID-19 RT-PCR testing. -- 2 of 2 --