Illinois Department Of Public Health - Carbondale

Summary Statement of Deficiencies D0000 A recertification survey conducted April 1 through April 3, 2025. The laboratory was found in compliance with standard-level deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 direct observation, review of laboratory procedure, patient records, and interview with the laboratory manager and technical supervisor #3 (TS #3), the laboratory failed to follow written laboratory procedures for one of eight patient test reports. Findings include: 1. Direct observation on 04/01/25 at 9:35 am during a laboratory tour, revealed the laboratory performed Influenza SARS-CoV-2 Multiplex RT PCR (Reverse Transcription Polymerase Chain Reaction) using the ABI (Applied Biosystems Instrument) 7500 DX analyzer. 2. The laboratory's procedure titled, "Clinical Quality Manual" section, "6.8 Specimen Submission, Handling and Referral" stated the following: a. "6.8.2.3.2. Any packages received outside of required temperature requirements, including irretrievable specimens (See list of examples of irretrievable specimens in Section 11.):" b. "6.8.2.3.2.1. Perform the assay and include the following comment, "Specimen was received outside of recommended shipping temperature range, which may affect the final results. Please correlate clinically and re-collect if necessary." 3. A review of patient requisitions and final patient reports from 03/03/24 through 01/24/25 revealed the laboratory failed to follow the laboratory's procedure for one of eight patient reports: a. Patient (#D250005228) requisition - laboratory documented, "20.7 C Out of Range" for a specimen collected on 1/14/25 and received in the laboratory on 01/15/25. b. Patient 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 -- (#D25005228) final report - revealed no comment for specimens received outside of the recommended shipping temperature range. The laboratory failed to follow their own written procedure to include a comment when a specimen was received outside of required temperature requirements. 4. In an interview on 04/02/25 at 11:45 am, TS #3 confirmed the findings above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation, review of manufacturer's instructions, laboratory policy, laboratory environmental records, and confirmed in staff interview, the laboratory failed to ensure room temperature was within manufacturer's requirements for seven of seven boxes of Aptima Assay Fluid. Findings included: 1. During a tour of the laboratory area on 04/01/2025 at 9:08 am in the hallway, seven boxes of Aptima Assay Fluids was observed. Five boxes; Lot number 912334; expiration date 01/15 /2027 Two boxes; Lot number 904716; expiration date 09/15/2026 2. The manufacturer's instructions, indicated on the box label, stated a storage temperature of 15 - 30C for the Aptima Assay Fluids. 3. The laboratory policy titled "Clinical Quality Manual" (DCA001-26-1224) stated " ...7.3 Reagent, Standard, and Specimen Storage ...Storage of reagents and standards must be consistent with the manufacturer's instructions, if provided ..." 4. Review of the laboratory's environmental monitoring logs revealed the laboratory did not monitor and document room temperature in the hallway and failed to ensure the room temperature was within manufacturer's specifications for the Aptima Assay Fluid. 5. In an interview on 04/02/2025 at 8:30 am, the Laboratory Manager was asked to provide documentation of room temperature monitoring in the hallway. No documentation was provided. The Laboratory Manager confirmed that the hallway was not temperature monitored. 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. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory procedure, laboratory records, and interview with the laboratory manager, the laboratory failed to perform comparison studies on two different analyzers used to perform LRN (Laboratory Response Network) testing at least twice a year for one of one year (2024). Findings include: 1. -- 2 of 3 -- Direct observation on 04/01/25 at 9:45 am during a laboratory tour, revealed the laboratory performs LRN testing using two ABI (Applied Biosystems Instrument) 7500 DX PCR (Polymerase Chain Reaction) analyzers interchangeably: a. ABI 7500 DX (ABI #3) b. ABI 7500 DX (ABI #4) 2. The laboratory's written procedure titled, "Clinical Quality Manual" section, "7.11. Comparison of Test Results" stated the following: a. "7.11.1 Laboratories performing the same test using different methodologies (distinct analytical, chemical, biochemical, molecular etc. techniques or kits) or instruments must have a system that, at least every six months, evaluates and defines the relationship between test results using different methodologies or instruments." 3. Record review from January 2024 through December 2024 revealed one comparison study was performed for the ABI 7500 DX PCR instruments on 04/23 /2024. 4. In an interview on 04/01/25 at 2:50 pm, the laboratory manager confirmed the laboratory performed one comparison study between January 2024 through December 2024 on the ABI 7500 DX. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review, written policies and procedures, and interview with the laboratory quality specialist and technical supervisor #1, the laboratory failed to have written policies and procedures for assessing employee competency based on the job responsibilities as listed in Subpart M for two of two general supervisors and four or four technical supervisors for 2021 and 2022. Findings include: 1. Review of the Clinical Quality Manual (DCA001-22-0223) revealed the laboratory did not establish a GS or TS competency assessment procedure 2. Review of the CMS 209 and 2021 and 2022 competency assessment records revealed competencies was not performed for general supervisor (GS) #1, GS #2, technical supervisor (TS) #1, TS #2, TS#3, and TS#4. 3. Interviews on 3/23/23 with TS#1 at approximately 11:30 am and the Laboratory Quality Specialist at approximately 1:45 pm confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of laboratory records, one of seven high complexity testing personnel did not meet the education requirements to perform high complexity testing. Findings include: 1) Review of Form CMS-209 (Laboratory Personnel Report), signed by the laboratory director on 11/25/2020, shows TP #7 is listed a high complexity testing personnel. 2) Review of education records for TP#7 shows a matriculated bachelors degree in geology which does not meet the education requirement to perform high complexity testing. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (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) 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 -- (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. This STANDARD is not met as evidenced by: Based on review of laboratory records, one of seven high complexity testing personnel failed to meet the education requirements to perform high complexity testing. Findings include: 1) Refer to D6168. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to meet proficiency testing requirements by engaging in interlaboratory communication prior to the submission deadline with two laboratories for one proficiency testing event in 2019. (See D2011) D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory engaged in communication across site locations regarding the Laboratory Response Network (LRN) Proficiency testing (PT) event of June 2019. Staff from three different locations had several discussions about the June 2019 PT event prior to the submission deadline date.. Findings include: 1. The laboratory's procedure titled "Standard Operating Procedure for Handling, Analysis and Reporting of Proficiency Testing Samples" under section 5 "Interlaboratory Consultations" stated "5.1 The IDPH laboratories are strongly encouraged to consult with one another and provide technical expertise when there are problems with procedures or particular patient samples. However, great care must be taken to avoid even the appearance of consulting on issues specifically involving PT samples. If an issue involves only PT samples no consultation/communication may be done. If there is an issue requiring consultation which also involves patient samples the consultation should be done but there should be no specific reference to the PT samples. 5.2 When an issue involving only PT samples requires a consultation in order to report results, report as "would refer" or equivalent, if possible. 5.3 Consultations regarding issues specifically pertaining to PT samples may be made only after the samples have been graded/evaluated by the PT agency and the results of the evaluation have been received by IDPH laboratory." 2. Review of "LRN Proficiency Testing Instructions for Analysis and Results Reporting" revealed under "Testing Instructions" that "Laboratories must report their test results or referral of the samples within 3 business days of package receipt." 3. Review of the document Appendix 7.1 titled "Illinois Department of Public Health - Division of Laboratories Commercially Prepared or CMS approved Proficiency Testing Performance Report" indicated the LRN Pox virus PT arrived June 25, 2018 at 9:45 A.M. and results were submitted June 28, 2019 by TP#1. 4. Review of an email sent to testing personnel #1 (TP#1) revealed that on June 14, 2019 an invite for June 25, 2019 from 14:30 - 15:00 with "Subject: LRN Orthopox PT Discussion" was sent to laboratory personnel at the following three laboratories: CLIA #14D0691828, #14D0647002, and #14D0647032. 5. Interview with TP#1 on August 15, 2019 confirmed that the teleconference took place with staff from all three laboratories including the laboratory director and clinical consultant. The laboratory director and clinical consultant are the same for all three laboratories. 6. Review of an email sent to TP#1 revealed that on June 26, 2019 testing personnel from CLIA #14D0647002 sent a summary of the June 25, 2019 meeting to laboratory personnel at both #14D0691828 and #14D0647032. The summary included the Sample ID (PT06191 - PT06195) and the Recommended Action (risk level and testing to be performed). 7. Review of an email sent on June 27, 2019 by the laboratory director to staff from all three laboratories revealed the following statement "What I need from you and is for you to complete the details for the outcome of the collaboration. That can be shared because we collaborated and came to decisions on each of the cases. TP#2 did a summary of recommended actions (testing to perform. For each PT sample, I need you to provide this group with the remaining info that was the outcome of the collaboration that is require for entry in the report." 8. Review of an email sent by testing personnel from CLIA# 14D0647002 on June 27, 2019 to TP#1 and a testing personnel at CLIA# 14D0647032 had an attachment with the rash algorithm risk assessment submitted to Centers of Disease Control for CLIA# 14D0647002. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify twice annually the accuracy of FTA testing that is performed for identifying syphilis. The findings include: 1. No records were made available to the inspector when requested for this twice per year verification. 2. On July 19, 2018, about 10:30 AM staff confirmed no twice per year verification records were available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --