Access Dx Laboratory Llc

Summary Statement of Deficiencies D0000 An announced validation survey was completed on February 22, 2024, and the facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; 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 review of the laboratory's establishment studies, manufacturer instructions, policies/procedures, specimen shipment/transport log, patient test records, submitted patient test volumes and staff interview, the laboratory failed to ensure the overall quality of the preanalytic systems and correct identified problems for four of four test platforms used by the laboratory in 2023, urinary tract infections (UTI), respiratory pathogens panel (RPP), COVID, and cytogenetics testing. Findings included: 1. The laboratory failed to document monitoring of specimen transport conditions to ensure specimen stability. Refer to D5311A. 2. The laboratory failed to follow its own policy for specimen acceptability/rejection. Refer to D5311B. 3. The laboratory failed to ensure clients follow laboratory's sample packaging and shipping policies. Refer to D5311C. 4. The laboratory's quality assurance failed to identify and correct problems with specimen collection, transport and acceptability. Refer to D5393. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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: A. Based on review of the laboratory's establishment studies, manufacturer instructions, a random sampling of the laboratory's specimen shipment/transport log, submitted patient test volumes and staff interview, the laboratory failed to document monitoring of specimen transport conditions to ensure specimen stability for samples used to perform 368,697 of 368,697 tests in 2023. Findings included: 1. Review of laboratory's establishment studies for its specimen collection/transport devices/kits revealed: a. "90 Day Stability Study Validation Report" for the DNAgenotek ORAcollect.DX saliva collection kit (approved 01/13/2021) stated "The specimen is shipped at ambient conditions". There was no definition of ambient conditions /temperature range acceptability. b. "Urine Preservative Specimen Transportation" establishment study for the Becton, Dickinson (BD) Vacutainer C&S (culture and sensitivity) Preservative Urine Tubes (completed on 11/08/2022) revealed: "Conclusion ... The following environmental conditions are considered acceptable for preservative tube specimen shipping: 1. Room temperature (~20-25C [Degrees Celsius]) 2. 2-8C Refrigerator 3. 9-25C Refrigerator 4. Courier vehicle" Courier vehicle transport temperature range was not defined. c. There were no studies completed and approved prior to December 2023 for temperature range and length of sample stability once the specimen was placed in the collection system for the Precision (Changzhou) Medical Instruments PhusionGPO Disposable Virus Sampling Kits for nasal and throat samples. 2. Review of manufacturer instructions for use for the laboratory's sample collection/transport devices revealed: a. The "DNAgenotek ORAcollect.DX Product Handbook" (document PD-HB-00010 Issue 5/2023-01) stated: "Post-collection Store ORACollect.DX saliva samples at room temperature for up to 60 days." The manufacturer did not define "room temperature" for sample stability in this device. b. The "BD Vacutainer Urine Products" (document VDP40397 (02) 02/2021, available online) stated: "Intended Use of BD Vacutainer C&S Preservative Urine Tubes ...up to 48 hours at room temperature..." The manufacturer did not define "room temperature" for sample stability in this device. c. The "PhusionGPO Disposable Virus Sampling Kit Instructions for Use" (no document identification number or issue date available) stated: Samples can be preserved in Inactivated Medium (transparent color) at room temperature for 96 hours or preserved in the Non-activated Medium (red color) at 2-8C for 48 hours." The manufacturer did not define "room temperature" for sample stability in this device. 3. Review of a sampling of the laboratory's specimen shipment/transport log revealed the laboratory did not document monitoring of transport conditions of samples upon receipt. 4. Review of laboratory's submitted 2023 test volumes revealed the laboratory performed 368,697 tests annually from samples transported in the above collection /transport media/devices. 5. In an interview on 02/21/2024 at 1101 hours at the off- site sample receiving center, the laboratory's Director of Quality Assurance (as indicated on submitted Exit/Entrance Conference Document) stated that the specimen transport conditions were not monitored, confirming the findings. B. Based on review -- 2 of 9 -- of laboratory's policies/procedures, random patient test records, annual test volumes and staff interview, the laboratory failed to follow its own policy for specimen acceptability/rejection for 4 of 42 patient samples reviewed from July 2023. Findings included: 1. Review of laboratory's policy "136240.838 RECEIVING SOP" (Version 1.0, approved 01/13/2022) revealed: "All specimens have a specific stability period from when the specimen was collected. Any specimen that passes the stability period must be rejected." And, "UTI (urinary tract infection) - 48 hours" 2. Review of random patient test records for July 2023 revealed the following 4 of 42 records reviewed showed urine samples were received and tested beyond the acceptable stability period of 48 hours: Sample: 150329142 Test: UTI PROx Collected: 06/30 /2023 Received: 07/03/2023 Elapsed time: 72 hours Sample: 150329167 Test: UTI PROx Collected: 06/30/2023 Received: 07/03/2023 Elapsed time: 72 hours Sample: 151012671 Test: UTI PROx Collected: 07/14/2023 Received: 07/17/2023 Elapsed time: 72 hours Sample:150998300 Test: UTI PROx Collected: 07/21/2023 Received: 07/24/2023 Elapsed time: 72 hours 3. Review of laboratory's test volumes for 2023 revealed the laboratory performed testing on approximately 890 UTI samples annually. 4. In an interview on 02/21/2024 at 1320 hours in the office, the laboratory's General Supervisor number 2 (as indicated on submitted Form CMS 209) confirmed the findings. C. Based on surveyor's observations, review of laboratory's policies /procedures, instructions to clients, FedEx packaging and labeling instructions, patient test records and staff interview, the laboratory failed to ensure clients follow laboratory's sample packaging and shipping policies for 2 of 2 shipment envelopes observed. Findings included: 1. Surveyor's observations on 02/21/2024 at 1120 hours at the laboratory's off-site specimen receiving center revealed two FedEx Clinical Pak soft side envelopes in the trash. The envelopes were not marked for Exempt Human Specimen or Category B Infectious Substance. Surveyor was unable to determine what samples have been transported in the Clinical Pak envelopes. 2. In an interview at the time of observation, receiving personnel (see survey notes) stated that all patient samples were received in one of the three liquid collection/transport media used by the laboratory. The samples always came packed in biohazard bags which were then placed in the FedEx Clinical Pak envelope. She also stated that she did not check for proper sample category designation on the envelopes. She confirmed the laboratory receives all samples in liquid preservative/medium, but the laboratory did not receive samples in Category B packaging. 3. Review of laboratory's policy/procedure "136240.580 Packaging and Transporting Biological Substances SOP" (version 1.0, effective 05/21/2021, last reviewed 07/24/2023) revealed: "Category B infectious substances include diagnostic or clinical specimens." And, "6.3 Secondary container - leak-proof secondary packaging that the primary container is placed within, such as Ziplock bag or a Screw-cap plastic container. 6.4 Sturdy outer packaging - hard-sided outer container used for transport." And, "7.2 Pack the specimen container inside a secondary container. ... 7.4 Place the secondary container inside the outer packaging for transport. ... 7.6 The outer packaging must be marked with the appropriate label: 7.6.1 Clinical Samples - Exempt Human Specimen 7.6.2 Category B - a UN3373 Biological Substance Category B Label." 4. Review of laboratory's instructions to client for the Urinary Tract Infection, Respiratory Pathogens Panel, COVID and Flu samples revealed the instructions for shipping did not reflect the laboratory's policies for shipping of Category B samples. The instructions stated: "Shipping instructions: 1. Place the specimen collection tube into the biohazard bag. 2. Insert any supporting documentation (...) into the FedEx Clinical Pak along with the specimens. 3. Place the biohazard bag into FedEx Clinical Pak and ensure the Clinical Pak is properly sealed prior to shipping. - Please do not pack more than 30 collected samples per Clinical Pak." There was no mention of Category B labeling, or hard-sided outer container. 5. Review of FedEx instructions for use of the Clinical Pak envelopes (available online) -- 3 of 9 -- revealed: "The FedEx Clinical Pak can be used to ship dried samples when packaged according to the dried sample guidelines." And, "If the dried sample is placed in a receptacle with a liquid preservative, then follow the packaging guidelines for liquids." And, "Blood, urine, containing or suspected of containing infectious substances must be shipped according to applicable government, International Air Transport Association (IATA), and International Civil Aviation Organization (ICAO) regulations. For the purposes of this guide, clinical samples are generally defined as non-infectious human or animal materials..." And, "If you need an overpack for shipments containing Biological Substance, Category B (UN 3373) materials, use the FedEx UN 3373 Pak." 6. Review of laboratory's patient test volumes for 2023 revealed the laboratory received approximately 12,460 patient samples annually for testing of infectious agents. 7. In an interview on 02/21/2024 at 1130 hours at the off- site sample receiving center, the laboratory's Chief Operating Officer (as indicated on submitted Exit/Entrance Conference Document) confirmed the findings. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of