Ohio Department Of Health Laboratory

Summary Statement of Deficiencies D0000 A federal jurisdictional recertification survey was conducted on 6/10/2025 to 6/12 /2025. Standard level deficiencies were cited. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of emails, and interview with Quality Officer, the laboratory failed to have a system in place to ensure document all complaints and conduct investigation of complaints in 2024 and 2025 as evidenced by: 1. In review the laboratory's policy, "

Summary Statement of Deficiencies 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 procedure and record review and interview with the Quality Assurance supervisor, the laboratory failed to establish acceptable criteria for humidity in 2 of 2 procedures and 4 of 4 Room Temperature and Humidity Records. Findings include: 1. Review of QA procedure 51793.1130 "Laboratory Environmental Monitoring" and procedure NBS-18 SCID/SMA (TREC/SMNI), showed no established range for humidity defined. 2. Review of room temperature and humidity records, document 51793.847 for the calendar year 2022 for Section TB, Room 105B, Section Molecular Room 141, Section Microbiology Room 156, and for the calendar year 2021 for Section Molecular Room 141 showed no acceptable range for humidity defined. 3. On 7/27/2023 at 11:00 am, the Quality Assurance supervisor confirmed the above findings. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to check and document for 10 of 72 weeks, the positive and negative reactivity of control organisms using gram stains each week of use in the specialty of Bacteriology. Findings: 1. Review of the "Gram Stain" test log revealed the following statement: "QC (quality control) frequency: Each Week of Use". 2. Review of the Gram stain QC log sheets from the year of 2022 and January through July of 2023 documented the following gaps in QC dates: 02/07/2022 - 02/25/2022 = 18 days 03/14/2022 - 03/29/2022 = 15 days 09/01 /2022 - 09/12/2022 = 10 days 10/11/2022 - 10/27/2022 = 16 days 12/01/2022 - 12/16 /2022 = 15 days 12/28/2022 - 01/13/2023 = 16 days 03/06/2023 - 03/21/2023 = 15 days 04/18/2023 - 05/02/2023 = 15 days 05/17/2023 - 06/06/2023 = 19 days 06/28 /2023 - 07/10/2023 = 12 days 3. Further review of the QC documents failed to show any evidence of review by the technical/general supervisor. 4. On July 27, 2023 at 2: 35 PM, the Quality Assurance supervisor and laboratory personnel confirmed the above findings. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on the review of procedures and interviews with the new laboratory director and quality assurance supervisor, the new laboratory director failed to approve 16 of 16 laboratory procedures. Findings include: 1. Review of 16 procedures in the electronic document control system showed the new laboratory director did not approve 16 of 16 documents. These included: NBS-1,9,11,10,16,12,14, 7,8,19,17,18,20, and 21 51793.107 Appendix C-Cut off and Panic Values 51793.1130 laboratory Environmental Monitoring 2. On 7/27/2023 at 1:15 pm the Laboratory Director confirmed the documents were only reviewed and not approved. 3. On 7/27 /2023 at 10:00 am the Quality Assurance Supervisor confirmed the above findings and the laboratory director's start date as April 1, 2023. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on the review of preventative maintenance records and interviews with the quality assurance supervisor and general supervisor, the technical supervisor failed to review 6 f 6 maintenance records and 12 of 12 equipment temperature records. Findings include: 1. Review of completed preventative maintenance records showed no review by the technical supervisor or designee for the following records: a. GSP Maintenance Log, October 2022 b. Dailey Preventative Maintenance Log, Instrument ID TQD1, November 2021 c. Weekly Maintenance Log, Instrument ID TQD2, 2021 d. Instrument Quality Control and Preventive Maintenance Record, ABI #3 2022 e. -- 2 of 3 -- Instrument Quality Control and Preventive Maintenance Record, ABI #4 2022 f. Instrument Quality Control and Preventive Maintenance Record, ABI #5 2022 2. Review of 12 equipment temperature records for water baths, freezers, and refrigerators showed no review by the technical supervisor or designee for the following: a. Micro room 143 -20C freezer b. Micro room 143 VWR fridge 9558560 c. NBS Isotemp Y15D-504865 d. Micro East Hall phcbi freezer e. Micro room 143 -20 C freezer f. Micro room 143 VWR fridge 9558560 g. BT room 105 freezer h. BT/TB room 106 refrigerator i. Gen Micro room 116 waterbath j. BT/TB room 106 refrigerator k. Micro -20 freezer l. Gen Micro room 148 Revco Isotemp low freezer 3. No delegation of duties was available at the time of the survey. 4. Review of the general supervisor's annual competency form for newborn screening did not show any responsibility for the review of preventative maintenance records. 5. On 7/27/2023 at 11:00 am the Quality Assurance supervisor confirmed the above findings. 6. On 7/27 /2023 at 1:00 pm the general supervisor #1 confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of patient test records and laboratory procedure manual, laboratory personnel failed to follow the written procedure manual and performed patient testing beyond the approved symptom onset date for one of one patient test reports and one of one laboratory procedure manual reviewed. Findings include: 1) Review of the approved laboratory procedure manual titled, "Trioplex real-time RT-PCR Assay (EUA), approval date 12/19/2018, Section 3.5 states, "Specimens collected greater than 7 days after symptom onset will not be tested by PCR but forwarded to CDC for serological testing." 2) Review of the "Ohio Department of Health Microbiology Submission Form," ID # XXXXXXXX14, in Section #3 lists a symptom onset date of 12/31/2018 with a collection date of 01/13/2019, which is greater than 7 days after the onset of symptoms. 3) Review of patient test report ID # XXXXXXXX14 shows the following PCR tests were analyzed and reported on January 15, 2019, which is greater than 7 days from symptom onset: Chikungunya Virus RNA- Not Detected Dengue Virus RNA- Not Detected Zika Virus RNS- Not Detected D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as 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 -- determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer testing instructions, patient test records and TP interview, the facility failed to follow the manufacturer's instructions for Neisseria meningitidis serogroup testing for one of one patient test report and one of one manufacturer testing instructions reviewed. Findings include: 1) Review of BD Difco Neisseria menigitidis manufacturer testing instructions state, "Difco-Quality Control- at the time of use, test both negative and positive control culture to check performance of antisera." 2) Review of patient test report XXXXXXXXX4 shows that patient testing was performed for Neisseria menigitidis serotyping using the BD Difoc Neisseria menigitidis test kit on 02/21/2018 with a final patient test report of "Neisseria menigitidis group B." 3) Review of Neisseria meningitidis Serogrouping QC chart shows that there was no entry or documentation on 02/21/2018 to show that the antisera performance was tested with negative and positive control cultures at the time of use for patient test report XXXXXXXXX4. 4) TP #3 stated on 05/13/2019 at 11:15 AM, "We use Difco for Serotyping." -- 2 of 2 --