Wadsworth Center - Griffin Laboratory

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) CLIA federal surveyors conducted an announced CLIA recertification survey at Wadsworth Center - Griffin Laboratory on February 29, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following deficiencies were found during the announced routine CLIA recertification survey completed on February 29, 2024 around 12:00 pm. 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 record review and interview with the Quality Assurance (QA) Officer, the laboratory failed to have a written Clinical Consultant competency policy based on the job responsibilities for one of one Clinical Consultant. Findings include: 1. The Laboratory Personnel Report (Form CMS-209) signed by the Laboratory Director on 02/14/2024 lists one Clinical Consultant for the laboratory. 2. Record review on 02/29 /2024 of 2023 and 2024 personnel competency records revealed no documentation for one of one Clinical Consultant competency based on job responsibilities. 3. Review of the competency assessment policy on 02/29/2024 revealed the laboratory did not establish a written policy to assess the Clinical Consultant based on job responsibilities. 4. Interview on 2/29/24 at 09:30 am with the QA Officer confirmed the findings above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 a review of laboratory procedures, lack of received specimen documentation, and interview with laboratory staff, the laboratory failed to establish and document specimen acceptability temperatures for received rabies specimens from 2022 to 2024. 1. Review of the RAB 037 SOP Ante-Mortem Sample Receipt, Accessioning, Resulting procedure, %. Sample Requirements/shipping/labeling procedure revealed, 5.1 "All samples other than whole blood or serum should be quickly frozen after collection, stored at minimum -70 degrees Celsius and shipped on cold pack if sent by local carrier or on dry ice if sent overnight". 2. The rabies specimen, collection, storage, and shipping process states, "ship at room temperature". 3. On the day of the survey, February 29, 2024, the laboratory was unable to provide documentation of the temperatures of received rabies specimens from 2022 to 2024. 4. Laboratory staff stated that they check to see if the specimen is received with dry ice in the box, or if at room temperature, but they do not check and document the exact temperature of the specimen received. 5. Per the CMS 116 form, signed by the laboratory director on February 14, 2024, two virology specimens and 575 general immunology specimen tests have been performed annually. 6. The laboratory staff confirmed the temperature are not taken when samples specimens are received on February 29, 2024, around 11:00 am. 47272 B. Based on a review of laboratory procedures, lack of received specimen documentation, and interview with Technical Supervisor #2 (TS #2), the laboratory failed to document specimen acceptability for received Plaque Reducing Neutralization Testing (PRNT) specimens in 2023 and 2024. Findings include: 1. Review of "SOP VI-004 Plaque Reduction Neutralization Test" under "4.0 SAMPLE REQUIREMENTS" stated, "Samples are shipped by intra agency mail frozen, on cooler packs, or at ambient temperature." 2. Review of the laboratory's specimen receipt log revealed no documentation of the specimen disposition upon receipt into the laboratory. 3. Interview on 2/29/2024 with TS #2 confirmed the findings. 4. Per the CMS 116 form, signed by the Laboratory Director on 02/14/2024, two virology specimens were performed annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of laboratory humidity records and interviews with laboratory -- 2 of 3 -- staff, the laboratory failed to monitor and document humidity conditions of the rabies laboratories from 2022 to 2024. Finding Include: 1. The Rabies laboratory uses two Thermo Fisher Scientific 3500 Genetic Analyzers for Ante-mortem Rabies Virus testing. 2. The Thermo Fisher Scientific 3500 Genetic Analyzers user guide stated, Environmental requirements, operating conditions of 20% to 80% relative humidity, noncondensing. 3. On the day of survey, February 29, 2024, the laboratory could not provide documentation of humidity conditions monitored in the rabies laboratories from 2022 to 2024. 4. Laboratory staff confirmed humidity was not monitored or documented in the rabies laboratory on February 29, 2024, around 12:00 pm. D5781

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of procedure manual and staff interview the laboratory failed to provide a standard operating procedure (SOP) for the ABI 7500 PCR instrument approved and signed by the current laboratory director (LD). Findings include: 1. The surveyor requested the current in-use procedure manual used by the Rabies section of the Griffin Laboratory. 2. On 05/06/2022 at approximately 12:40PM during a review of the in-use procedure manual, the SOP for the maintenance of ABI 7500 series revealed the most up to date signature and approval occurred in 2013 by the previous laboratory director. 3. During an interview with the laboratory staff confirmed the Griffin Laboratory does not have updated , approved and signed procedures by the current LD for the ABI 7500 Series. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation, record review and staff interview the laboratory failed to document calibration verification for the ABI 7500 PCR instrument utilized in the molecular section of the Rabies laboratory. Findings include: 1.On 05/06/2022 at approximately 12:30PM during a record review of ABI 7500 PCR instrument calibration verification records revealed the laboratory failed to document the Pure Dye Calibration procedure as recommended in accordance with the Standard Operating Procedure for the ABI 7500 PCR Instrument for every 6 months. 2. The surveyor requested documentation of the calibration verification for the ABI 7500 PCR instruments for the year 2020-2022. 3. An interview with the general supervisor (GS#1) confirmed the laboratory did not perform and document calibration verification performance test on the ABI 7500 PCR instruments. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the arbovirus laboratory reagent logs, lack of media quality control (QC) records and interview with testing personnel (TP) #1, the laboratory failed perform and document each batch of 2x Eagles bic P/S +2% FBS and 2x Eagles bic P/S +10% FBS culture media for sterility and ability to support growth for the plaque reduction test from February 12, 2020 to March 31, 2022. Findings Include: 1. On the day of survey, 05/06/2022, TP #1 stated, all media is prepared from the core laboratory at 120 Scotland Avenue. 2. TP#1 stated, "a visually inspection of all received media is performed, but not documented". 3. Review of the arbovirus laboratory reagent logs and lack of media quality control (QC) records at approximately 9:30 am revealed, the following 2x Eagles bic P/S +2% FBS and 2x Eagles bic P/S +10% FBS culture media lots that were received by the laboratory from February 12, 2020 to March 31, 2022 were not QC by the laboratory: 2x Eagles bic P/S +2% FBS culture media. - 02/12/2020 - 06/15/2020 - 07/17/2020 - 08/12/2020 - 11/04/2020 - 02/09/2021 - 03/23/2021 - 04/28/2021 - 06/10/2021 - 06/24/2021 - 01 -- 2 of 3 -- /25/2022 - 03/31/2022 2x Eagles bic P/S +10% FBS culture media. - 02/12/2020 - 06 /15/2020 - 07/17/2020 - 08/12/2020 - 11/04/2020 - 02/09/2021 - 03/23/2021 - 04/28 /2021 - 06/10/2021 - 09/08/2021 - 01/25/2022 - 03/31/2022 4. From February 12, 2020 to March 31, 2022, 79 plaque reduction tests were analyzed. 5. TP#1 confirmed viral culture media was not performed or documented for the plaque reduction test on May 6, 2022 at 12:30 pm. D5781