Indiana State Department Of Health Laboratories

Summary Statement of Deficiencies D0000 A recertification survey was conducted 11/19/2024 through 11/20/2024 and standard level deficiencies were cited. 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 the manufacturer's instructions, procedures, submitters instructions, direct observation, and interview with staff, the laboratory failed to ensure patient Aptima swabs integrity from the time of collection through receipt when transported via mail for 18 of 18 patient specimens. Findings included: 1. Review of Aptima Combo 2 manufacturer's instructions on page 7 and 8 stated, "Specimen Transport and Storage Before Testing ...Urogenital Swab Specimens a. After collection, transport and store the swab in the swab specimen transport tube at 2C to 30C until tested. Specimens must be assayed with the AC2 assay within 60 days of collection. If longer storage is needed, freeze urogenital specimens in the swab specimen transport tube within 7 days of collection at -20C to -70C to allow testing up to 12 months after collection." For "Extragenital Swab Specimens (throat and rectal) a. After collection, transport and store the swab in the swab specimen transport tube between 4C and 30C, or -20C and -70C until tested. Specimens must be assayed with the AC2 assay within 60 days of collection." For "Urine Specimens a. Maintain urine specimen at 2C to 30C after collection and transfer to the Aptima urine specimen transport tube within 24 hours of collection. Transport to the lab in the primary collection container or the transport tube at 2C to 30C. Store at 2C to 30C and test the processed urine specimens with the AC2 assay within 30 days of collection. b. If longer storage is needed, freeze urine Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- specimens in the Aptima urine specimen transport tube within 7 days of collection at -20C to -70C to allow testing up to 12 months after collection." 2. Review of the laboratory's Aptima Combo 2 Assay procedure (IDOH-MOL-62) stated on page 7, "Specimen Handling Requirements A. Swab and urine specimens must be transported to the laboratory at 2-30C in Aptima urine or unisex swab collection kits." 3. Review of the laboratory's instructions for submitters stated, "Urine and swab specimen must be kept at 2-30C ..." and for Shipping Instructions to place the specimen in a cannister and then into an outer shipping cannister and mail to the laboratory. The "Specimen Transport Guide" for CT/GC for temperature conditions stated, "Ambient or Refrigerated, Category B." Ambient and Refrigerated temperatures were not defined. 4. During a tour of Central Accessioning (first floor) on 11/20/2024 at 10:07 am, a drop-off from United Parcel Service (UPS) was observed (9 packages). On the "CT /GC & Serology Log" was documented 4 packages from UPS at "Room Temperature" with a log-in time of 10:14 am and 3 packages from UPS at "Room Temperature" with a log-in time of 10:15 am. Room temperature had not been defined. On 11/20 /2024 at 10:34 am, a serology testing person was observed picking up the CT/GC UPS packages and taking them to the second floor (serology department) for processing. 5. During an observation of the Serology department on 11/20/2024 at 10:34 am, the testing person opened UPS packages, and they included cannisters of Aptima swabs (total of 18) within biohazard bags and manifests. The laboratory did not have a system in place to ensure Aptima swab specimens maintained the required temperature of 2C to 30C (urogenital and urine) and 4C and 30C (for extragenital swabs) during transport. The laboratory did not ensure Aptima swab specimen integrity. 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 observation, review of laboratory procedures, review of the laboratory online test menu and interview with staff, the laboratory failed to provide transport temperature and timeframe requirements to clients for specimens for Tuberculosis /Mycobacteriology Specimen Testing. Findings included: 1. During observation of the Accessioning area on 11/20/2024 at approximately 10am, the laboratory received a United Parcel Service (UPS) shipment of several specimens for Tuberculosis testing in a plastic UPS bag. The temperature of the specimens was not taken in the accessioning area. The accessioning staff placed the plastic bag in a red bin in a temperature monitored refrigerator (serial number 174661) located in the accessioning area. At approximately 10:20am, staff from the Tuberculosis (TB) laboratory removed the plastic bag from the refrigerator in the accessioning area and carried the bag to the TB laboratory, Room 225A. The bag was opened, and a screw top can containing specimens was removed. 2. Review of the laboratory's procedure named "ISDH-TB- 05 (Mycobacteriology Culture)" found transport conditions for specimens were not addressed. 3. Review of the laboratory's online test menu (https://www.in.gov/health /laboratories/testing/available-tests/ ) revealed the following for test type "Tuberculosis -- 2 of 6 -- /Mycobacteriology Specimen Testing": under "Procedural Notes" ... If a delay in shipping is anticipated, be sure to keep the specimens refrigerated at 4 C prior to shipping to minimize the growth of contaminants."; under "Shipping Instructions" no information was provided to the client regarding the temperature or timeframe for shipping specimens to the laboratory. 4. During interview on 11/20/2024 at approximately 9:10am, the Quality Assurance Director confirmed specimen transport conditions were not defined in the online test menu. 43232 II. Based on review of the laboratory's procedure, direct observation, and a final test report, the laboratory failed to follow their own written procedure for storing one of one specimens for human immunodeficiency virus (HIV) testing in a -20C or colder freezer. Findings included: 1. Review of the laboratory's procedure for Geenius HIV 1/2 Assay (IDOH-SER-32) on page 7 stated, "8.0 Specimen Handling Requirements For long-term storage, the serum should be frozen (at -20C or colder)." 2. During a tour of the laboratory on 11 /20/2024 at 1:15 pm, patient #C24060133 specimen was observed stored in a freezer with a temperature reading of -18C. The specimen was positive for HIV Ag/Ab (antigen/antibody) and awaiting confirmatory testing with the Geenius. 3. Review of patient #C24060133 final test report included a report date of 11/21/2024 for HIV Ag /Ab and Geenius HIV 1/2 tests. The laboratory failed to store HIV specimens awaiting additional testing in a -20C or colder freezer. 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: Based on review of the laboratory's client services manual and interview with technical supervisor - 8 (TS-8), the laboratory failed to define storage and transport temperatures in their client services manual for 7 of 7 tests (random sampling). Findings included: 1. Review of the laboratory's online instructions for their submitters (client services manual) included the following (random sampling): Arbovirus Testing - Specimen Requirements - "2. Specimens may be stored at refrigerated or frozen temperature." Hepatitis B - Specimen Requirements - "2. Specimens may be stored at refrigerated, frozen or room temperature. 3. Specimens must arrive at the lab within 24 hours of collection if stored at room temperature." Hepatitis C - Specimen Requirements - "2. Specimens may be stored at refrigerated, frozen or room temperature." HIV Testing - Specimen Requirements - "2. Specimens may be stored at refrigerated, frozen or room temperature." Syphilis Testing - Specimen Requirements - "2. Specimens may be stored at refrigerated, frozen or room temperature." The laboratory had not defined "refrigerated," "frozen," or "room" temperatures to ensure optimum integrity of specimens. 2. Review of the laboratory's "Indiana Courier System: Specimen Transport Guide" for their submitters included the following (random sampling): Blood Lead - Temperature Conditions - for whole blood "Ambient, Category B" and for whole blood filter paper "Ambient." Arbovirus - Temperature Conditions - "Refrigerated, Category B**." Chlamydia/Gonorrhea - Temperature Conditions - "Ambient or Refrigerated, Category B." Hepatitis B - Temperature Conditions - "Refrigerated, Category B**." Hepatitis C (Serology) - Temperature Conditions - "Ambient or Refrigerated, Category B**." HIV - Temperature Conditions - "Ambient, Category B**." Syphilis - Temperature Conditions - "Ambient, Category B**." The laboratory had not defined "refrigerated," -- 3 of 6 -- or "ambient" temperatures to ensure optimum integrity of specimens. 3. During an interview on 11/20/2024 at 3:44 pm, TS- 8 stated their courier system has continuous temperature monitoring and room temperature was defined as 15C to 30C. TS-8 stated this is the temperature everyone had agreed on. A source for this temperature was not provided. The laboratory had not defined "refrigerated," "frozen," "ambient" or "room" temperatures in their written instructions for specimen handling. 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 determined under 493.1253. This STANDARD is not met as evidenced by: I. Based on direct observation, review of manufacturer's instructions, and the Hologic instrument report, the laboratory failed to follow manufacturer's instructions for ensuring 18 of 18 observed Aptima patient specimen containers did not contact one another. Findings included: 1. During a tour of the serology department on 11/20/2024 at 10:34 am, the following was observed being received: UPS (United Parcel Service) packages included cannisters - five Aptima patient specimen containers in one biohazard bag, four Aptima patient specimen containers in one biohazard bag, three Aptima patient specimen containers in one biohazard bag, three Aptima patient specimen containers in one biohazard bag, three Aptima patient specimen containers in one biohazard bag. Specimens were touching one another in the biohazard bags. 2. Review of Hologic Aptima Combo 2 Assay manufacturer's instructions stated (page 5), "O. Avoid cross-contamination during the specimen handling steps. Specimens can contain extremely high level of organisms. Ensure that specimen containers do not contact one another, and discard used materials without passing over open containers." 3. The following was a sampling of the observed Aptima patient specimens touching one another during transport and analyzed on the Hologic Panther for Chlamydia trachomatis and Neisseria gonorrhea on 11/20/2024: C24060514 (collected 11/15/24) C24060515 (collected 11/15/24) C24060516 (collected 11/15/24) C24060517 (collected 11/18/24) C24060610 (collected 11/19/24) C24060611 (collected 11/19/24) C24060612 (collected 11/19/24) C24060613 (collected 11/18/24) C24060614 (collected 11/18/24) The laboratory failed to ensure Aptima patient specimens did not touch one another during transportation. II. Based on review of manufacturer's instructions, direct observation, written procedures, and interview with staff and the manufacturer, the laboratory failed to ensure the manufacturer's dropping bottle and dispensing needle were used for rapid plasma regain (RPR) testing for 22 of 22 patient specimens. Findings included: 1. Review of Sure-Vue RPR manufacturer's instructions stated, "1. In order to obtain reliable and consistent results, the instructions in the package insert must be strictly followed." The material provided by Sure-Vue included: "3 ml Dropping bottle" and "20-ga Dispensing Needle (60 drops /ml)" used to dispense the Carbon Antigen. 2. During a tour of the laboratory on 11/20 /2024 at 12:46 pm, a bottle of Sure-Vue RPR Carbon Ag (Lot 4C2OR9, expiration date 12-31-25) was observed stored on the on the counter with the rest of the RPR testing supplies. An RPR Carbon Antigen dropping bottle, and a dispensing needle was not observed with the RPR supplies. Twenty-two patient specimens were observed in a rack on the counter that had been RPR tested. 3. During an interview on 11/20/2024 at 3:00 pm, the general supervisor for serology was asked whether the -- 4 of 6 -- dropping bottle and dispensing needle were used for RPR carbon antigen. She stated no, a pipette was used. 4. Review of the laboratory's written procedure for RPR testing (IDOH-SER-7) stated on pages 9,10, and 12, "Attach the syringe to the repeating pipettor. Draw up a sufficient volume of carbon antigen into the syringe. Prime the pipettor a few times by dispensing several drops of carbon antigen back into the vial. Dispense one drop (17ul) of carbon antigen into each well on the card." Review of Sure-Vue RPR manufacturer's instructions stated, "Attach the needle to the dropping bottle. Mix the CARBON ANTIGEN suspension well. Squeeze the dropping bottle and draw a sufficient volume of the antigen suspension into the bottle. Dispense several drops into the dropping bottle cap to sure the needle passage is clear ... Dispense one free-falling drop of antigen suspension onto each sample while holding the bottle in a vertical position ..." 5. During a telephone interview on 11/21/2024 at 2: 06 pm with the Arlington Scientific Executive Vice President of Operations and Compliance, he was asked about using a repeating pipettor for dispensing carbon antigen versus the dropping bottle and dispensing needle that comes with the RPR kit. He stated the dropping bottle, and dispensing needle must be used to dispense carbon antigen and not a repeating pipettor. 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: I. Based on direct observation, review of temperature logs and review of the instrument operator's manual, the laboratory failed to ensure room temperature was within manufacturer's specifications for the Bruker MALDI Biotyper sample preparation area. Findings included: 1. One Bruker MALDI Biotyper CA analyzer and one MALDI Bruker Biotyper CA sirius analyzer were observed in the sample preparation area during a tour of room 225A at approximately 1:15pm on 11/19/2024. 2. Review of the room temperature logs for room 225A indicated an acceptable room temperature of 17C - 27C. 3. The operator manual for the Bruker MALDI Biotyper CA sirius analyzer stated the following: "2.4 Environmental Requirements - Sample Preparation ...Test organism samples intended to be analyzed in the MALDI Biotyper Sirius CA System must be prepared under the following conditions. +20C/+68F to +25C/+77F ...For best results, preparation of all solutions, Standard Solvent, and the entire sample preparation process including drying steps must be performed under controlled room temperature." II. Based on observation, review of temperature logs, review of manufacturer's instructions and interview with staff, the laboratory failed to ensure the humidly level was within manufacturer's specifications for the BD BACTEC MGIT 960 analyzer. Findings included: 1. One BD BACTEC MGIT 960 analyzer was observed during a tour of room 225A at approximately 1:06pm on 11/19 /2024. 2. Review of the room temperature logs for room 225A indicated documentation of daily temperature, but no documentation of daily humidity. 3. The operator manual for the BD BACTEC MGIT 950 system states the following: "2.3 Instrument Specification ... Environmental Requirements ...MGIT 960 ...Operating -- 5 of 6 -- Conditions ...Humidity 30% - 80% RH, non-condensing" 4, During interview on 11/19 /2024 at approximately 1:06pm, the Technical Supervisor for the Mycobacteriology section confirmed the above findings. III. Based on observation of media/reagents stored in refrigerator and review of the laboratory's temperature monitoring system (ViewPoint) the laboratory failed to ensure manufacturer temperature requirements for storage of media/reagents. 1. During tour of Mycobacteriology Room 225 on 11/19 /2024 at approximately 2pm, the following items were observed stored: a. Refrigerator with serial number 11200 contained two boxes of BD BACTEC MGIT 960 Sire Kits, Lot #3324473, Expiration 2025-02-22, store 2C - 8C; and nine boxes of BD BBL Lowenstein-Jensen Medium Gruff, Lot #57802722, Expiration 2025-08-22, store at 2C - 8C. b. Refrigerator with serial number 09716 contained three boxes of QuantiFERON TB-Gold Plus kits, Lot #57802722, Expiration 2027-01-03, store at 2C - 8C. c. Review of ViewPoint temperature logs for refrigerator serial number 11200 for 11/19/2024 found the temperature alerts were set for a lower limit of -3C and an upper limit of 10C. Review of ViewPoint temperature logs for refrigerator serial number 09716 for 11/19/2023 thru 11/19/2024 found the temperature alerts were set for a lower limit of -3C and an upper limit of 10C. IV. Based on direct observation and review of temperature logs, the laboratory failed to ensure temperatures in the laboratory met manufacturer temperature requirements. 1. During tour of Virology Room 235 on 11/20/2024 at approximately 2pm, the following was observed stored on the counters: a. One box of Biofire Respiratory Panel 2.1 kit, Lot #0275724, Expiration 2025-08-04, store at 15C - 25C. b. Two boxes of QIAamp Viral RNA Mini Kit, Lot #175042786, Expiration 2025-01-05, store at 15C - 25C. c. One box of QIAamp DSP DNA Blood Mini Kit, Lot #178014958, Expiration 2025-05-19, store at 15C - 25C. 2. Review of the" Equipment Temperature Log" for Virology Room 235 for the months of July, August and September of 2024 revealed an acceptable temperature range of "15 to 30C". D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation and interview with testing personnel, the laboratory failed to label 3 of 3 secondary containers of bovine blood with identity, storage requirements and expiration dates. Findings included: 1. During a tour of the blood lead department on 11/19/2024 at 12:00 pm, the following three plastic conical tubes with blue tops were observed stored under a hood labeled with: "Blood BLK", "BLK", and "Blood Pb Blk" The tubes were used as secondary containers for bovine blood and not labeled with identity, storage requirements and expiration dates. The blood was used for blood lead calibration curves. 2. During an interview on 11/20/2024 at 1: 30 pm, testing persons 6 and 7 (as listed on CMS-209 form) confirmed the above secondary tubes were bovine blood and not labeled with the requirements. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The Indiana State Department of Health Laboratories were surveyed under 42 CFR part 493 CLIA regulations. The following deficiencies were found during the announced routine CLIA recertification survey performed from August 9, 2022 to August 10, 2022: 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 a review of laboratory personnel competency assessment records and an interview with a quality assurance (QA) specialist, the laboratory failed to establish written policies and procedures to assess technical supervisors (TS) and general supervisors (GS) for competency in 2021 and 2022. Findings Include: 1. The personnel form CMS-209 filled out by the laboratory at the time of the survey listed 6 TS, and 20 GS for the laboratory. 2. Review of the Quality Manual (ISDH-QM-1), section 6.2.12 competencies of technical personnel, revealed, that the laboratory did not establish a TS or GS competency assessment policy. 3. Interviews with QA specialist on 8/10/2022 at 9:45 am confirmed the laboratory did not establish a written policy to assess TS and GS for competency. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory Standard Operating Procedures (SOP) and an interview with the Quality Assurance (QA) specialist, the laboratory failed to follow its policy to review 21 of 28 clinical SOPs at least biennially from the last review dates. Findings Include: 1. Review of the Quality Manual (ISDH-QM-1), section 8.3.2 stated the following "Clinical SOPs are reviewed at least biennially and revised as needed by the lab supervisor. The QMs and all other SOPs are reviewed at least annually and revised as needed by the QAC." 2. On the day of survey, 08/10/2021, review of the bacteriology documents within MediaLab, the electronic document control system, revealed that 21 of 28 documents were not reviewed biennially from the last review date. 3. Interview with the QA specialist on 8/10/2022 at 3:00 pm confirmed the laboratory did not follow established written policy ISDH-QM-1 Quality Manual regarding document review. 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 record review and an interview with the serology technical supervisor (TS), the laboratory failed to update procedures to reflect the change of storage time based on Abbott Alinity human immunodeficiency virus (HIV), and HCV (hepatitis C virus) transit extension validation. Findings Include: 1. Review of the verification addendum Abbott Alinity HIV HCV transit extension validation, approved by the lab director on 07/27/2021, revealed, in "purpose and principal" that the laboratory performed this validation to the objective of this stability study is to extend the FDA approved Abbott Alinity transit time of human serum specimens sent to IDOHL for Anti-HCV and HIV Ag/Ab Combo testing, from three (3) days at ambient temperatures to nine (9) days at ambient temperatures while providing quality results. "In summary", IDH-SER-36 Standard Operating Procedure (SOP) will be modified to reflect the changes validated in this document. 2. Review of the IDOH-SER-36 Abbott Alinity i SOP, version 1, effective date 5/10/2021, revealed, in Table 1. Assay and Specimen Transit & Freeze /Thaw Requirements, Transit Time by Storage Temp (from time of collection) is 3 days at room temp. 3. Interviews with Serology TS on 8/10/2022 at 11:30 am confirmed the laboratory did not update the SOP IDH-SER-36 to reflect the changes in storage time with the validation study for transit extension. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of records, observation of the laboratory, and interview with the quality assurance (QA) director, the laboratory failed to ensure bacteriology materials had been stored as required for 17 of 17 months from 2021 and 2022. Findings include: 1. On August 9, 2022 at 09:15 am, the quality assurance director stated the MALDI Biotyper was used to perform Bacterial Identification. 2. On August 10, 2022 at 01:30 pm, seven boxes (two boxes of lot# 6030421008 and five boxes of lot# 6030422002) of In Vitro Diagnostic (IVD) and Bacterial Test Standard (BTS) were observed in the laboratory freezer with a manufacturer's storage requirement of -18 degrees Celsius or below. 3. On August 10, 2022 , a review of the policy titled, "ISDH-MOL-45 ID of Bacteria via MALDI-TOF Mass Spectrometry" revealed the IVD BTS was used in the MALDI Biotyper system quality control process to ensure reliable and accurate identification of microorganisms. 4. A review of the temperature records for 17 months (February 2021 through July 2022) revealed freezer temperatures were not documented. 5. On August 10, 2022 at 01:45 pm, the QA director confirmed freezer temperatures had not been documented until August 5, 2022. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on review of the FilmArray policies, lack of the BioFire FilmArray 2.0 System maintenance records and interview with the Quality Assurance (QA) director and technical supervisor (TS) #1, the laboratory failed to document maintenance for the BioFire FilmArray 2.0 System from January 2021 to August 2022 (19 of 19 months). Findings Include: 1. The ISDH-MOL-40, 13.0, B. states, "All documentation of maintenance and calibration is stored in the binder near the instrument". 2. The ISDH-ENT-19 and ISDH-MOL-40, 11.0, A. states, "The FilmArray pouch loading station, all work areas and racks should be cleaned with 10% bleach solution. Record cleaning on benched log". 3. On the day(s) of survey (08/09/2022 and 08/10/2022), review of the BioFire FilmArray 2.0 System records and lack of maintenance records revealed, the laboratory did not document maintenance for the BioFire FilmArray 2.0 System used for the Respiratory 2.1 (RP2.1) Panels and the Gastrointestinal (GI) Panels from January 2021 to August 2022 (19 of 19 months). 4. The QA director confirmed on 08/10/2022 around 12:00 PM, that maintenance has not been performed documented for the BioFire FilmArray 2.0 System. B. Based on review of the SCIEX 6500 analyzer manufacturer's instructions, lack of documentation and interview with the quality assurance (QA) specialist, the laboratory failed to follow the manufacturer's instructions for performing and documenting maintenance procedures from February 2021 through July 2022 (17 of 17 months). Findings Include: 1. On 08 /09/2022 at 02:00 pm, the quality assurance director stated, "Chemical threat testing (Cyanide, Volatile Organic Chemicals, Nerve Agents, Abrine and Ricine, and Tetramine) was performed using two SCIEX 6500 analyzers ("Scarlatti" serial number DY20691808 and "Vivaldi" serial number DY20101802)". 2. On 08/09/2022, a review of the manufacturer's maintenance instructions required the following daily -- 3 of 5 -- procedures: - Inspect system for leaks. - Clean curtain plate. - Clean orifice plate (front). 3. On 08/10/2022, a review of the maintenance records for 17 months revealed, daily maintenance had been performed from February 2021 through July 2022. 4. On 08/10/2022 at 9:12 am, the QA specialists confirmed the maintenance had been performed but not documented. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of maintenance records and interview with the quality assurance (QA) director, the laboratory failed to follow their centrifuge function checks protocols for three of four centrifuges used for the MALDI Biotyper from February 2021 to July 2022 (17 of 17 months). Findings include: 1. On 08/09/2022 at 09:15 am, the QA director stated the MALDI Biotyper was used to perform Bacterial Identification. 2. The ISDH-MOL-45 ID of Bacteria via MALDI-TOF Mass Spectrometry policy stated, "the laboratory used a benchtop centrifuge (at 13,000 rpm for 2 minutes) in the process for routine yeast and bacterial isolate". 3. The ISDH-QA- 13 (version 2.0) Equipment Maintenance policy under the section titled, "11.2.2 Centrifuge" stated, "Centrifuges must be calibrated to the proper set rotations per minute (RPM) semi-annually". 4. On 08/10/2022, a review of centrifuge checks revealed, the laboratory could not provide documentation of centrifuges checks performed semi-annually for 17 of 17 months (February 2021 through July 2022). 5. On 08/10/2022 at 03:00 pm, the QA specialists confirmed, there were no documents to prove the centrifuge had been checked as indicated above. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the BioFire FilmArray 2.0 System quality control (QC) records and interview with the Quality Assurance (QA) director and technical supervisor (TS) #1, the laboratory failed to perform a negative and positive control materials each day of patient testing for each pathogen tested on the Respiratory 2.1 (RP2.1) Panels and the Gastrointestinal (GI) Panels used on the the BioFire FilmArray 2.0 System from January 2021 to August 2022. Findings Include: 1. On the first day of survey, August -- 4 of 5 -- 9, 2022 review of BioFire FilmArray 2.0 System RP2.1 panel QC records revealed, each day of patient testing, the laboratory did not perform positive and negative QC for each pathogen on the RP2.1 panel from October 2021 to March 2022 (5 of 5 months). 2. On the second day of survey, August 10, 2022, review of BioFire FilmArray 2.0 System GI panel QC records revealed, each day of patient testing, the laboratory did not perform positive and negative QC for each pathogen on the GI panel from January 21, 2021 to August 10, 2022 (19 of 19 months). 3. From October 2021 to March 2022 - 46 patient RP2.1 panels were analyzed on the BioFire FilmArray 2.0 System. 4. From January 21, 2021 to August 10, 2022 - 15 patient GI panels were analyzed on the BioFire FilmArray 2.0 System. 5. The laboratory confirmed on 08/10/2022 around 4:00 PM, that negative and positive control materials were not performed each day of patient testing for each pathogen tested on the RP2.1 and GI Panels used on the the BioFire FilmArray 2.0 System. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: A. Based on a review of chemical threat testing records, lack of documentation and interview with the quality assurance (QA) director and testing personnel (TP) #7, the laboratory failed to evaluate and defined the relationship between test results using 2 of 2 Agilent analyzers and 2 of 2 SCIEX 6500 analyzers used to perform chemical threat testing twice a year from 2021 to 2022. Findings include: 1. On August 9, 2022 at 01:55 pm, TP #7 stated: "Chemical threat testing (lead, urine metals, and blood metals) was performed using two Agilent analyzers ("Lahaina" serial number SG19485075 and "Maia" serial number SP18071056)" and at 02:00 pm, the QAdirector stated: "Chemical threat testing (Cyanide, Volatile Organic Chemicals, Nerve Agents, Abrine and Ricine, and Tetramine) was performed using two SCIEX 6500 analyzers ("Scarlatti" serial number DY20691808 and "Vivaldi" serial number DY20101802)". 2. On August 9, 2022, the laboratory was unable to provide documentation evaluating the relationship between 2 of 2 Agilent analyzers and 2 of 2 SCIEX 6500 analyzers used to perform chemical threat testing twice a year from 2021 to 2022. 3. The QA director confirmed the findings above on August 9, 2022 at 02:15 pm. 42173 B. Based on observation, lack of documentation, and interview with the Biothreat lab technical supervisor (TS), the laboratory failed to perform and document comparison of test results for two of two 7500 Fast DX Real-time PCR polymerase chain reaction instruments used in the Biothreat laboratory twice a year. Findings include: 1. A tour of the Biothreat laboratory on August 10, 2022, at 10:30 am, revealed there were two 7500 Fast DX Real-time PCR instruments used in the laboratory. 2. There were no documents available for comparison of test results between two 7500 Fast DX Real-time PCR instruments used in the Biothreat laboratory for 2021 and 2022. 3. During the interview on August 10, 2022, at 10:35 am, the Biothreat lab TS confirmed that the laboratory didn't perform a comparison of test results between the two instruments. -- 5 of 5 --

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: A. Based on record review and interview, the laboratory failed to follow their procedure for quality control (QC) for four out of ten patients reviewed for optochin and bile solubility testing. 1. Procedure "ISDH-GMICRO_28 Streptococcus pneumonia ID and Serotyping" stated the following under section 12.0 "QC Requirements and Frequency of QC" "QC for Bile Solubility test: A. QC is performed on newly received lot or shipment of reagent with a known positive control organism and sterile saline, which serves as the negative control. B. QC is also performed with each day of testing." and "QC for Optochin (P disc): A. QC is performed on newly received lot, batch, or shipment of discs with known sensitive and resistant control organisms to disc AND QC is performed as frequently as the manufacturer requires." 2. The package insert for BD BBL (Trademark)Taxo (Trademark) P Discs states "User Quality Control: At the time of use, check performance with pure cultures of stable control organisms producing known desired reactions." 3. Review of four of seven patient records (C20000XXX, C2000XXXX, C2000XXXX, and C2000XXXX) revealed optochin and bile solubility were performed on the following dates: 01/14 /2020, 01/28/2020, 01/29/2020, and 02/17/2020. 4. Review of quality control records revealed no quality control recorded for bile solubility and optochin testing on the above dates. 5. The technical supervisor (TS) #1 confirmed that bile solubility and optochin QC were not performed each day of patient testing on 11/30/2020 at approximately 2:00 P.M. B. Based on record review and interview, the laboratory failed to follow their procedure for quality control for one out of one patients 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 -- reviewed for Legionella antisera testing. 1. Procedure "ISDH-GMICRO-48 Legionella Culture for Identification/Confirmation" stated in section "12.0 QC Requirements and Frequency of QC" under "QC for Antiserum (if available):" the following "B. QC is performed on each lot, shipment or batch of reagents with known positive and negative antigen control organisms. In addition, QC is performed at each time of use when patient testing." 2. Review of one of one patient record (20REF00XX) revealed that the specimen was tested with Legionella antisera Group 1 on 06/17/2020. 3. Review of quality control records for Legionella Pneumophilia Antiserum Group-1 revealed no quality control recorded for the above date. The last date of quality control testing was 09/10/2019. 4. The TS#1 confirmed the above findings on 11/30 /2020 at approximately 3:30 P.M. C. Based on record review and interview, the laboratory failed to follow their procedure for setup and culture examination for four of seven patients reviewed for yeast identification and confirmation. 1. Procedure "ISDH-GMICRO-54 Yeast Identification and Confirmation" stated in section "15.2 Setup and Culture Examination of Yeast Isolates" under "A. Initial Setup" the following "1. Label a PDA plate, a SAB plate, and a Columbia SBA plate with the isolate lab number, inoculation date, and the initials of the individual setting up the isolate." and "5. Examine the plates after overnight incubation or at the next available work day". Under section "20.0 Reporting of Results" the procedure states "A. Record observations of the appropriate spots on the lab worksheet, lab book, and electronic lab record." 2. Review of the Mycology Worksheet revealed on page 2 a place to record the media set up, the result, the date read, and the initials of the testing personnel. 3. Review of four of seven patient's (20MYC000X, 20MYC00XX, 20MYC00XX, 20MYC00XX ) lab worksheets revealed no documentation of the media used to subbed the specimen, the date the specimen was plated, or the date the media was checked for growth. 4. The TS#1 confirmed the above findings on 12/01 /2020 at approximately 08:50 A.M. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to rotate gram stain and catalase quality control among all operators for two of two years reviewed. 1. Review of C200XXXXX Listeria Worksheet revealed gram stain and catalase testing were performed by testing personnel #1 (TP#1) . 2. In interview on January 20, 2021 at approximately 09:15 A.M., TP#1 indicated that reagents from another department were used for gram stain and catalase testing. Quality control for gram stain and catalase testing was performed by staff assigned to a different testing area within the laboratory. 3. Review of the gram stain and catalase quality control logs for 2019 and 2020 revealed that quality control had not been performed by TP #1 for two of two years reviewed. 4. In interview on January 20, 2021 at approximately 09:25 A.M., technical supervisor #2 confirmed that staff does not rotate gram stain and catalase quality control among all operators. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) -- 2 of 3 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to test each batch, lot, and shipment of catalase, oxidase, and/or indole reagents for positive and negative reactivity for two of three patients reviewed in the biological threat (BT) department. 1. Review of two patient (C190XXXXX and C20XXXXXX) records indicated oxidase, catalase, and/or indole testing was performed. 2. Review of BT procedure, LRN-1074 , indicated under the quality control section to "Perform quality control of media and reagents according to package inserts, NCCLS document M22-A2, and CLIA standards, using positive and negative controls appropriate for each media and reagent. Document all quality control results according to standard laboratory practices." 3. Review of BT procedure, LRN-1047, indicated under quality control section "Clinical Laboratory Improvement Amendments (CLIA) policies and guidelines should be enforced when examining human specimens." 4. During interview on January 20, 2021 at approximately 11:20 A.M., technical supervisor #3 indicated that quality control had not been performed or documented for catalase, oxidase, or indole reagents in the BT department. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to ensure expired rubella wash reagent was not available for use for one of one patients with rubella testing reviewed. Findings include: 1. Observation on 05/15/18 at approximately 10:30 AM, showed rubella wash reagent in the refrigerator available for use with the expiration date of 07/01/2017. 2. Review of results, for one of one patients with rubella testing reviewed, revealed rubella testing was performed on 05/11 /18. 3. During interview on 05/15/18 at approximately 10:30 AM, general supervisor (GS) #1 confirmed the rubella wash reagent was expired and patient testing was performed after the expiration date. 4. During interview on 05/15/18 at approximately 10:45 AM, GS#1 stated that the expired rubella wash reagent was not used for patient testing performed on 05/11/18. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on record review and interview, the laboratory failed to follow the manufacturer's specification for quality control for optochin, Neisseria meningitidis serotyping, and Haemophilus influenzae serotyping testing for one of one patients reviewed for each of the tests. Findings include: Optochin testing 1. Review of "Streptococcus pneumoniae Testing Worksheet", for one of one patients reviewed, revealed optochin testing was set up on 03/14/18 and read on 03/15/18. 2. Review of the manufacturer's package insert for "BD BBL Taxo P Discs for Differentiation of Pneumococci" under "User Quality Control" revealed "At time of use, check performance with pure cultures of stable control organisms producing known desired reactions." 3. Review of the optochin disk quality control log revealed no documentation of quality control performance on either 03/14/18 or 03/15/18. 4. During interview on 05/17/18 between approximately 10:30 and 11:30 AM, technical supervisor (TS) #1 and general supervisor (GS) #2 confirmed that optochin quality control was not performed at time of use per manufacturer's specifications but with each new lot, shipment, and at least once every six months thereafter. Neisseria meningitidis serotyping 1. Review of "Neisseria meningitidis Testing Worksheet", for one of one patients reviewed, revealed serotyping was performed on 05/03/18. 2. Review of the manufacturer's package insert for "BD Difco Neisseria Meningitidis Antisera" under "User Quality Control" revealed "At time of use, test both positive and negative control cultures to check performance of the antisera, techniques and methodology." 3. Review of the Neisseria meningitidis antisera group A, B, C, Y and W135 quality control logs revealed no documentation of quality control performance on 05/03/18. 4. During interview on 05/17/18 between approximately 10:30 and 11:30 AM, TS#1 and GS#2 confirmed that Neisseria meningitidis serotyping quality control was not performed at time of use per manufacturer's specifications but with each new lot, shipment, and at least once every six months thereafter. Haemophilus influenzae serotyping 1. Review of "Haemophilus influenzae Testing Worksheet", for one of one patients reviewed, revealed serotyping was performed on 01/31/18. 2. Review of the manufacturer's package insert for "BD Difco Haemophilus Influenzae Antisera" under "User Quality Control" revealed "At time of use, test both positive and negative control cultures to check performance of the antisera, techniques and methodology." 3. Review of the Haemophilus influenzae antisera group a, b, c, d, e, and f quality control logs revealed no documentation of quality control performance on 01/31/18. 4. During interview on 05/17/18 between approximately 10:30 and 11:30 AM, TS#1 and GS#2 confirmed that Haemophilus influenzae serotyping quality control was not performed at time of use per manufacturer's specifications but with each new lot, shipment, and at least once every six months thereafter. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, one (testing personnel #8) out of sixteen testing personnel reviewed failed to meet qualifications of high complexity testing personnel. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) -- 2 of 4 -- (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview, one (testing personnel #8) out of sixteen testing personnel reviewed did not meet the qualifications to perform high complexity testing. Findings include: 1. Review of testing personnel (TP) #8 education credentials showed that the documentation was from a foreign (non-US) education institution and there was no foreign equivalency documentation available to show how TP#8 met the CLIA education requirements for high complexity testing. 2. During interview at approximately 1530 on 05/17/18, the quality assurance director confirmed that foreign equivalency documentation was not available for TP#8. -- 4 of 4 --