Centers For Disease Control And Prevention I

Summary Statement of Deficiencies D0000 An unannounced complaint survey was conducted at the Centers for Disease Control and Prevention I Lab on 8/03/2021. Based on the survey findings, the laboratory failed to meet the following CLIA conditions: D5300 493.1240 Condition: Preanalytic Systems D5400 493.1250 Condition: Analytic Systems 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 direct observations, review of laboratory procedures, test directory, stability data, test requisitions (50.34 forms), stability data summary, and in interview with staff, the laboratory failed to meet the preanalytic system requirements, as evidenced by: 1. The laboratory failed to ensure written policies and procedures included all preanalytic requirements (defined specimen storage, rejection criteria, conditions for transportation) for 1 of 1 assay observed (Fungal Identification) on 08/03/2021. Refer to D5311, I. 2. The laboratory did not have supporting documentation to ensure shipping methods used by outside submitters to the laboratory maintained transport conditions and specimen integrity for 2 of 2 test procedures (Fungal Identification and Respiratory Virus Molecular Detection) in 2021. Refer to D5311, II. 3. The laboratory failed to have a system in place to ensure specimens received in the STAT room included documentation of their disposition (specimen vial conditions) for 1 of 1 specimen observed on 08/03/2021. Refer to D5311, III. 4. The laboratory failed to 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 -- ensure the test directory (client services manual) included all preanalytic requirements (defined specimen storage, preservation, stability and indicate conditions for transport) for their submitters sending specimen for 1 of 1 test reviewed. Refer to D5317, I. 5. The laboratory failed to ensure all Preanalytic requirements were included in the test directory for submitters for test procedures missing conditions for transportation information for 2 of 2 test (Enteric Isolation -Primary Specimen and Fungal identification). Refer to D5317, II. 6. The laboratory failed to ensure their test directory (client services manual) included all preanalytic requirements (defined specimen storage, rejection, and conditions for transportation) for their submitters sending specimens for 1 of 1 assay reviewed (Fungal Identification). Refer to D5317, III. 16410 7. The laboratory failed to have consistent policy that included specific instructions for Preanalytic specimen storage, transportation and stability studies for testing branches. refer to D5391 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: I. Based on direct observations, review of laboratory procedures, test directory, stability data, test requisitions (50.34 forms), and in interview with staff, the laboratory failed to ensure written policies and procedures included all preanalytical requirements (defined specimen storage, rejection criteria, conditions for transportation) for 1 of 1 assay (Fungal Identification) observed on 08/03/2021. Findings included: 1. Review of Fungal Identification (ID) (test code: 10179) procedures, "Procedure for MALDI-ToF-based Identification of Yeast" (Doc.No. RES-400-P09) and "DNA-Based Identification of Molds and Yeasts, Test Procedure fpr [sic] BSL2 lab" (Doc. No. FL-0017) did not include the following preanalytical requirements: specimen storage (defined temperature); conditions for specimen transportation (defined temperature); and specimen rejection. 2. Review of the test directory (client services manual) for Fungal ID stated, "Isolates can be refrigerated or kept at an ambient temperature" for "collection, storage, and preservation of specimen prior to shipping" and "shipping instructions" were not provided. The test directory did not define "refrigerated" and "ambient" temperatures for storage; conditions for specimen transportation; and specimen rejection. Preanalytic requirements had not been established and defined in the laboratory's procedures to ensure submitters sent specimens within acceptable conditions. 3. Review of "Specimen Stability Summary" for "Fungal Identification, Yeasts" did not include defined temperature of "ambient" for storage of isolates. The study also included "4C" for storage but was not included in the laboratory's procedures and test directory; and a temperature range was not included. 4. During a tour of the STAT room on 08/03/2021 at 10:20 am, Package ID 2021007750 was observed being received and accessioned. It was an isolate on a Sabouraud Dextrose Agar (SDA) slant (specimen 3002863528 collected 07/21/21, no collection time) in a biohazard bag in a SAFTPAK box in a FedEx bag. The Team Lead documented "RT" (room temperature) on the 50.34 form for specimen container. Room temperature was not defined in the laboratory's policies. 5. Review of the -- 2 of 9 -- testing laboratory's 2020 annual test volume for "Fungal ID, Yeasts" was 108. 6. During an interview on 08/03/2021 at 11:50 am in the STAT room, the STAT team and laboratory director were asked what is the definition of "Room Temperature" (temperature range/gradient), as observed documented on the 50.34 forms; they were unable to provide a definition. 7. During a telephone interview on 08/23/2021 at 3:22 pm, the laboratory director confirmed the above findings. Word Key: MALDI-ToF - Matrix-Assisted Laser Desorption-Ionisation-Time of Flight (Mass Spectrometry) DNA - deoxyribonucleic acid BSL - biosafety level C- degree Celsius II. Based on direct observations, test directory, laboratory procedures, stability data summary, and in interview with staff, the laboratory did not have supporting documentation to ensure shipping methods used by outside submitters to the laboratory maintained transport conditions and specimen integrity for 2 of 2 test procedures (Fungal Identification and Respiratory Virus Molecular Detection) in 2021. Findings included: 1. During a tour of the STAT room on 08/03/2021 at 10:20 am, observations of processes included the following packages with specimens received from outside submitters: Package ID 2021007750 from Pennsylvania included an isolate on a SDA slant (specimen 3002863528 collected 07/21/21, no collection time) in a biohazard bag in a SAFTPAK box in a FedEx bag for Fungal ID. The Team Lead documented "RT" (room temperature) on the 50.34 form for specimen container. Results were reported 08/10/2021. Note: on 08/03/2021, one sample/test procedure was observed for this CLIA number. The above test was 1 sampling of 90 offered by the testing laboratories (units). 2. The test directory for Fungal ID did not include all preanalytical requirements to ensure submitters shipped specimens within acceptable conditions. Refer to D5317. The laboratory policies and procedures for Fungal ID did not include the following preanalytical requirements: defined specimen storage and preservation and conditions for specimen transportation to ensure specimen integrity. Refer to D5311, I. 3. The laboratory was unable to provide supporting documentation /studies to demonstrate the shipping methods observed above did not affect specimen integrity/results and maintained specimen transportation conditions, as follows: a) "room temperature" (not defined) per documentation on the 50.34 forms; b) "ambient temperature" (not defined) per the test directory and stability summary; and c) "4C" per their stability summary (a range was not provided) 4. Further review of the test directory for Respiratory Virus Molecular Detection (Non-Influenza) (test code: 10401) stated, "Collection, Storage, and Preservation of Specimen Prior to Shipping: Refrigerate all specimens promptly after collection. If specimens can be shipped to CDC within 72 hours of collection, they should be kept refrigerated at 4C and shipped on gel ice-packs. Freezing should be avoided if possible, as this will reduce virus infectivity. Specimens for virus culture should not be frozen at -20 C. If specimens must be held for >72 hours, they should be promptly frozen at -70 C and shipped on dry ice ...Shipping Instructions which Include Specimen Handling Requirements: Frozen specimen should be shipped on dry ice. Refrigerated specimen should be shipped on cold packs." The test directory included conflicting information for freezing specimens, "Freezing should be avoided if possible, as this will reduce virus infectivity" and later stated, "If specimens must be held for >72 hours, they should be promptly frozen at -70 C and shipped on dry ice." In addition, it could not be determined how the laboratory ensured shipping methods maintained a "4C" temperature, a temperature range was not provided. The laboratory was unable to provide supporting documentation/studies to demonstrate the shipping instructions above did not affect specimen integrity/results and maintained the transport conditions of "-70C" or "4C." 5. During the exit conference via phone call on 09/09/2021 at 2:00 pm, the laboratory director confirmed the above findings. III. Based on observations, review of the laboratory's procedures, test requisitions (50.34 forms), and in interview with staff, the laboratory failed to have a system in place to ensure specimens received -- 3 of 9 -- in the STAT room included documentation of their disposition (specimen vial condition) for 1 of 1 specimen observed on 08/03/2021. Findings included: 1. Review of the STAT room's "Specimen Processing" (SOP#: D10-200-004-04) procedure (page 4) stated, "Cold pack or room temperature shipments: ...8.11 record the following information on the CDC Form 50.34 in the CDC USE ONLY box located on the lower left corner of page 1 ...8.11.5 Outer package condition at STAT; 8.11.6 Specimen container at STAT; 8.11.7 Specimen (Vial condition) at STAT." The procedure did not list the options for documenting conditions on the 50.34 forms. Review of 50.34 forms included documentation of "RT" (room temperature), "CP" (cold pack), or "FR" (frozen) for "Specimen Container" on the first page (container was the shipping container). The forms for 1 specimen (Fungal ID) received in the STAT room did not include documentation for "Specimen (Vial condition)." Refer to the findings below. Note: room temperature, "cold pack", and "frozen" were not defined in laboratory procedures (temperature gradient). 2. During the tour of the STAT room on 08/03/2021 at 10:20am, the following specimen was observed being received and accessioned without documentation of the "Specimen (Vial condition) at STAT" on page 1 on the 50.34 forms: Specimen 3002863528 (Fungal ID) - isolate collected 07/21/2021 on an SDA slant, packaged in a biohazard bag in a SAFTPAK box in a FedEx bag. The Team Lead documented "G" (good) for the "Outer Package" (condition) and "RT" (room temperature) for the "Specimen Container" but did not document anything for "Specimen" (vial condition). 3. In an email on 08/25/2021 at 7: 30 am, the laboratory director sent the STAT team responses for questions asked by the surveyor, as follows: the surveyor asked, "On the 50.34 form, what does 'G' mean for 'Outer Package' and what is supposed to be documented for 'Specimen'?" and the laboratory responded, "G stands for good. Meaning the outer shipping container was intact and not damaged or wet. We only document under specimen on the 50.34 if something is wrong with the specimen such as mislabeled or leaking. If that is left blank 'good' is documented in ELIMS." The process for documenting "G" was not outlined in the laboratory's procedure. Specimen vial conditions were not documented as the specimen container conditions were documented on the 50.34 forms upon receipt ("RT," "CP," "FR"). The laboratory did not have a system in place to ensure specimens conditions/dispositions were documented upon receipt in the STAT room. The laboratory did not have a system in place to ensure specimen conditions were documented upon receipt in the STAT room. Word Key: ELIMS - enterprise laboratory information management system 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 paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: I. Based on record review, interview with laboratory director and policies and procedures, the laboratory failed to ensure the test directory (client services manual) included all preanalytic requirements (defined specimen storage, preservation, stability and indicate conditons for transport) for their submitters sending specimen for 1 of 1 test reviewed. Findings include: 1. Review of (test code: 10181) Procedure for Fungal Study, test directory found the "Collection, Storage, and Preservation of Specimen prior to Shipping and Transport Medium," states, "To be determined". Review of procedure for "Antifungal Susceptibility Testing for Yeasts following M27- -- 4 of 9 -- A4 guidance (Doc. No. FRL-100-PO9, Rev No.: 01, Effective Date: 5/9/19), does not include specimen shipping information. Review of the procedure for "Basic Procedures and Guidelines for Identification of Yeast Cultures" in 10.12 "Sample Information/Processing," provides information for specimens, which states "Store original samples in the refrigerator (2-8C) until start of testing. Review of the "Specimen Stability Data Summary," stated "Our laboratory receives yeast isolates at ambient temperature on agar slants. The laboratory failed to include defined specimen shipping information for their Fungal Study. 2. During the exit conference via conference call on 9/9/2021 at 2:00pm, the laboratory director confirmed the above findings. II. Based on record review and interview with laboratory director, the laboratory failed to ensure all Preanalytic requirements were included in the test directory for submitters for test procedures missing conditons for transportation information for 2 of 2 test (Enteric Isolation -Primary Specimen and Fungal identification). Findings include: 1. Review of the laboratory test directory found the (test code:10106) - Enteric Isolation-Primary Specimen instructs the submitter to contact the CDC Consultant. Review of the laboratory procedure for FilmArray Gastrointestinal Panel, (Doc. No. PROS.TE.C.065, Ver. No. 04, Effective Date:7/22 /2019) revealed the laboratory failed to include instructions on how the condition of laboratory transport to the submitter. 2. Review of the (test code:10179) Fungal Identification, the test directory section for "Collection, Storage and Preservation" states " Isolates can be refrigerated or kept at an ambient temperature". The "Shipping Instructions" states "Specimen should be shipped at ambient temperature". Review of the Procedure for Isolation and identification of Candida auris (Doc. No. FRL-100- P04, Rev. No. 02, Effective Date:8/1/2018), section 9.1(a) states "Eswab collection and transportation...After the specimen is collected the swab should be placed into tube containing modified liquid Amies medium and stored at 4-25C, and shipped with an ice pack to the laboratory for processing within 96 hours of specimen collection. The test directory failed to include the 96-hour shipment timeline as documented in the laboratory procedure. The Test Directory did not define refrigerated or ambient temperature and Eswab collection requirement. 3. During the exit conference via conference call on 9/9/2021 at 2:00pm, the laboratory director confirmed the above findings. 43232 III. Based on direct observations, review of test requisitions (50.34 forms), final test reports, test directory, laboratory policies and procedures, stability summary, and interview with staff, the laboratory failed to ensure their test directory (client services manual) included all preanalytic requirements (defined specimen storage, rejection, and conditions for transportation) for their submitters sending specimens for 1 of 1 assay reviewed (Fungal Identification). Findings included: 1. During a tour of the STAT room on 08/03/2021 at 10:20 am, observations of processes included the following package with a specimen received from an outside submitter: Package ID 2021007750 from Pennsylvania included an isolate on a Sabouraud Dextrose Agar (SDA) slant (specimen 3002863528 collected 07/21/21, no collection time) in a biohazard bag in a SAFTPAK box in a FedEx bag for Fungal ID. The Team Lead documented "RT" on the 50.34 form for specimen container. Results were reported 08/10/2021. 2. Review of the test directory (client services manual) for Fungal ID stated, "Isolates can be refrigerated or kept at an ambient temperature" for "collection, storage, and preservation of specimen prior to shipping" and "shipping instructions" were not included. The test directory did not define "refrigerated" and "ambient" temperatures for storage; conditions for specimen transportation; and specimen rejection. Review of Fungal Identification (ID) (test code: 10179) procedures, "Procedure for MALDI-ToF-based Identification of Yeast" (Doc.No. RES-400-P09) and "DNA-Based Identification of Molds and Yeasts, Test Procedure fpr [sic] BSL2 lab" (Doc. No. FL-0017) did not include the following preanalytic requirements: specimen storage (defined temperature); conditions for specimen -- 5 of 9 -- transportation (defined temperature); and specimen rejection. Preanalytic requirements had not been established and defined in the laboratory's procedures to ensure submitters sent specimens within acceptable conditions. 3. Review of the "Specimen Stability Summary" for "Fungal Identification, Yeasts" did not include a defined temperature of "ambient" for storage of isolates. The study also included "4C" for storage, but was not included in the the above laboratory procedures and test directory. The test directory did not include instructions to ensure shipping conditions maintained "ambient", "refrigerated" or "4C." 4. During the exit conference via phone call on 09/09/2021 at 2:00 pm, the laboratory director confirmed the above findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory Quality Assessment (QA) policies and staff interview, the laboratory's QA program was not effective to identify their laboratory's failure to establish specimen storage, preservation, and transport criteria for 90 Laboratory Developed Tests (LDTs). Findings include: 1. Review of the CLIA Consolidated Laboratory Compliance Manual, (Doc. No. CCP.060, Rev 01, Effective 3/10/2020, found the laboratory's did not address establishing specimen storage, preservation and transportation requirements to ensure specimen integrity, in "Section - 15. Analytic - Test Procedure". 2. Review of the Poxvirus and Rabies Branch (PRB) Quality Manual (Doc No. CDC-007-0024), section 5.3.2 General, found the procedure did not address establishing specimen storage, and transportation to ensure specimen integrity. 3. Review of the Enteric Diseases Laboratory Branch (EDLB) - Quality Assurance Plan (Doc. No. EDLB.AS.A.001) found the procedure did not address establishing specimen storage, and transportation to ensure specimen integrity. 4. Review of Clinical and Environmental Microbiology Branch (CEMB) - CEMB Quality Assurance and Assessment Plan (Doc. No. CEM.QMA.A.001) found the procedure did not address establishing specimen storage, and transportation to ensure specimen integrity. 5. During the exit conference via conference call on 9/9/2021 at 2:00pm, the laboratory director confirmed the above findings D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, test directory, specimen stability data summary report, and interview with staff, the laboratory failed to establish conditions for specimen storage and transport for their laboratory developed tests. 1. The -- 6 of 9 -- laboratory failed to include specimen specimen storage and transportation policies and procedures reviewed on 09/09/21. Refer to D5403 2. The laboratory failed to complete specimen stability studies for 73 of 90 laboratory developed tests reviewed on 09/09/2021. Refer to D5423 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)