Quest Diagnostics Llc (Il)

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policy / procedure manuals, and interview with the General Supervisor (GS), the Technical Supervisor (TS) failed to identify and ensure five of six testing personnel (TP) had training for immunohematology testing on the Immucor Neo Iris analyzers put into use in February of 2024 prior to patient testing. Findings include: 1.Upon a tour of the laboratory on 08/08/2024, at 07:45 am, the surveyors identified three Immucor NEO Iris immunohematology analyzers (serial numbers: 100951, 100938, 100936). 2. An interview with the GS of immunohematology at 08:04 am, on 08/08/2024, confirmed the three Immucor NEO Iris immunohematology analyzers were implemented into the laboratory the last week of February 2024 for patient testing. 3. Review of the laboratory procedure, "Policy for Training Verification", stated the following in section 5.5.1: "Initial training must be performed when: A new procedure or test system is introduced in the department." 4. Review of training records found no documented training prior to patient testing for five of six TP (TP1, TP2, TP3, TP4, TP5) on the new Immucor NEO Iris immunohematology analyzers. 5. An interview, at 11:05 AM, on 08/08/2024 with the GS of immunohematology confirmed that no training was documented prior to patient testing on the Immucor Neo Iris test systems for five of six TP. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 review of laboratory records and interviews; the laboratory failed to ensure optimum integrity of patient specimens from the time of collection through completion of testing for one of four urine toxicology specimens reviewed. Findings Include: 1. Review of the laboratory procedure, "Drug Abuse Screen by Enzyme Immunoassay" (Document No. CHICDTWD805[5.0]), under section "3.2 Specimen Type & Handling" indicated the following: a. "Transport Container & Temperature Requirements" - "Plastic urine transport container, transport at room temperature". b. "Stability & Storage Requirements" - "Room Temperature: 5 Days, Refrigerated: 7 Days (1 week), Frozen: 30 Days (1 month)". 2. The following four specimens and patient test reports were reviewed: Specimen Collected Received (at 1355 Mittel Blvd, Wood Dale, IL 60191) KS442**** 6-10-21 at 10:02 AM 6-22-21 at 4:16 pm. KS293**** 6-08-21 at 12:00 AM 6-12-21 at 5:32 pm KS298**** 6-08-21 at 12:00 AM 6-12-21 at 6:07 pm KS758**** 6-23-21 7-02-21 at 3:10 pm Specimen KS442**** was held for 12 days before testing and beyond the stability and storage requirements for an ambient or refrigerated specimen based on the laboratory's procedure. 3. Interview with the shipping manager on 10-13-21 at 11:00 AM, confirmed specimen KS442**** was collected on 6-10-21 at 10:02 am, then transported to a distribution center for Quest Diagnostics in Lenexa, KS. The specimen arrived at the Lenexa, KS distribution center on 6-17-21 and was held there till 6-22-21. The shipping manager was unable to confirm how the specimen arrived at the Lenexa, KS location (ambient/room temperature/frozen) or how the specimen was 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 -- maintained at the distribution center (ambient/room temperature/frozen). The specimen designation was changed from ambient to frozen at 4:49 am on 06-22-21 prior to shipment of the specimen from the distribution center to the 1355 Mittel Blvd, Wood Dale, IL laboratory. 4. The specimen KS442**** was processed and the results were reported by the 1355 Mittel Blvd, Wood Dale, IL laboratory on 6-22-21. 5. Interview with the LD on 10-13-21 at 12:45 pm confirmed the laboratory was unable to determine how the specimen was initially shipped to the distribution center or how the specimen sample was stored at the distribution center prior to the arrival at the 1355 Mittel Blvd, Wood Dale, IL 60191 laboratory location. -- 2 of 2 --