Illinois Department Of Public Health- Springfield

Summary Statement of Deficiencies 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 review of manufacturer's instructions, laboratory online test instructions, direct observation, patient test records, and confirmed in staff interview, the laboratory failed to have a system in place to ensure specimen integrity was maintained (transport temperature conditions) per their own specifications for two of two patient specimens for Legionella testing. Findings included: 1. The manufacturer's instructions for the BinaxNOW Legionella Urinary Antigen Card (IN852050 Rev. 12 2021/01) stated, " ...Specimen Collection Urine ...Specimens may be stored at 2-8C for up to 14 days or at -10C to -20C for longer periods before testing ...When necessary, urine specimens should be shipped in leakproof containers at 2-8C or frozen ..." 2. The laboratory's online test instructions titled, "Laboratory Manual of Services" stated, "Collect in a sterile specimen container. Specimens must be shipped refrigerated or frozen" for the Legionella Urinary Antigen. The instructions failed to define a temperature range for refrigerated specimens. 3. On 11/21/2024 at 09:45 am, delivery of specimens was observed. Boxed specimens were delivered by the FedEx delivery service. Boxes were transported by laboratory personnel to the designated areas of testing. In the microbiology testing area, Testing Person #9 (as listed on the submitted CMS-209 form) opened each box. No specimen temperatures were taken. 4. Review of patient test records (02/07/2024 through 05/13/2024) for the Legionella Urinary Antigen Card test revealed the laboratory tested two patients: Patient LEG-01- 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 -- 2024; tested 02/23/2024 Patient LEG-03-2024; tested 03/22/2024 5. In an interview on 11/21/2024 at 09:50 am, Testing Person #9 was asked if specimen receipt temperatures were monitored or documented. She stated the laboratory did not take specimen temperature upon receipt. 47517 II. Based on review of laboratory procedure, laboratory online test instructions, direct observation, patient test records, and confirmed in staff interview, the laboratory failed to have a system in place to ensure specimen integrity was maintained (transport temperature conditions) per their own specifications for ten of ten patient specimens for Influenza SARS-COV-2 Multiplex rRT-PCR testing. Findings included: 1. The laboratory's standard operating procedures titled, "Detection of Influenza A, Influenza B, and Sars-Cov-2 by Multiplex Real-Time RT-PCR (CDC Influenza SARS-CoV-2 Multiplex rRT-PCR) section 3.6.1 stated, specimens must be received cold (2-8C)." 2. The laboratory's online test instructions titled, "Laboratory Manual of Services Instructions for Influenza Virus Specimen Submission" stated, "Specimens must be maintained at 2C - 8C at all times following collection and during shipment." 3. On 11/21/2024 at 09:43 am, delivery of specimens was observed. Boxed specimens were delivered by the FedEx delivery service. Boxes were transported by laboratory personnel to the designated areas of testing. In the molecular testing area, Testing Person #8 (as listed on the submitted CMS-209 form) opened each box. No specimen temperatures were taken. 4. Review of patient test records on for the Influenza SARS-COV-2 Multiplex rRT-PCR testing test revealed the laboratory tested 10 patients and did not take specimen temperature upon receipt (11/21/2024): Accession #: S240057791 S240057242 S240057788 S240057146 S240057798 S240057786 S240057145 S240057796 S240057782 S240057144 5. In an interview on 11/21/2024 at 09:50 am, Technical Supervisor #2 was asked if specimen receipt temperatures were monitored or documented. He stated the laboratory did not take specimen temperature upon receipt. 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 laboratory procedure, laboratory temperature logs, and confirmed in staff interview, the laboratory failed to follow its own laboratory procedure for ten of ten months reviewed. 1. The laboratory's standard operating procedures titled "Real- Time Polymerase Chain Reaction (RT-PCR) for Plasmodium species, stated the following: " ...3.5.1 All blood specimens are stored at 4C for four months ...4.3.1 DNA samples should be stored at 4C until testing ...4.3.2 Primers and probes ...The reagents are aliquoted in small volumes at the molarities shown in Appendix 1.7 and stored at -20C and discarded after the log expiration date is exceeded." 2. Review of laboratory temperature logs from January 2024 to October 2024 logs revealed: a. Specimen storage refrigerator acceptable range 2-8C. Location 3550-B b. Freezer specimen and primers and probes -20C +/-5C. Location 3550-B Thermometers 230631023 and 230631018. 3. In an interview on 11/20/2024 at 2:55 pm, Technical Supervisor #2 confirmed that the laboratory procedure did not align with laboratory temperature logs. -- 2 of 4 -- 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: Based on direct observation, review of manufacturer's instructions, laboratory procedure, gram stain records, and confirmed in staff interview, the laboratory failed to follow manufacturer's instructions for gram stains for 15 of 15 testing events. Findings included: 1. During a tour of the Clinical Microbiology area (Room 3650) on 11/20/2024 at 02:40 pm, Remel Gram Crystal Violet, Remel Gram Iodine, Remel Decolorizer, and Remel Gram Safranin reagent stains were observed to be in use for gram stain testing. 2. The manufacturer's instructions for each stain stated, " ...10. Procedure ...10.2 Place the slide on a staining rack and overlay with Gram Crystal Violet for 1 minute. 10.3 Wash thoroughly with water and overlay with Gram Iodine mordant for 1 minute. 10.4 Flood with Gram Decolorizer until the solvent flows colorless from the slide (10-30 seconds). 10.5 Rinse with water and overlay with Gram Safranin for 30 seconds ..." 3. The laboratory procedure titled, "Standard Operating Procedure for the Isolation and Identification of Vibrio and Yersinia species Causing Gastroenteritis" stated, " ...6.3.3.2.1.5 Flood smear with Gram Crystal Violet, let stand for 1 minute. Wash smear thoroughly with tap water and drain off excess water. 6.3.3.2.1.6 Flood smear with Gram's Iodine, let stand 1 minute. Wash smear thoroughly with tap water and drain off excess water. 6.3.3.1.7 Decolorize until solvent running from slide is colorless (no more than 5 seconds). Be careful not to over-decolorize or under-decolorize the slide. 6.3.3.2.1.8 Wash the slide with cold tap water. 6.3.3.2.1.9 Flood smear with Gram Safranin, let stand 20 seconds. Wash thoroughly with tap water ..." The laboratory procedure stated to wash smear with tap water after Gram iodine step. This does not follow manufacturer's instructions. The laboratory procedure stated to decolorize for no more than 5 seconds. This does not follow manufacturer's instructions (10-30 seconds). The laboratory procedure stated to flood smear with Gram Safranin and let stand for 20 seconds. This does not follow manufacturer's instructions (30 seconds). 4. Review of the laboratory's gram stain records (09/08/2023 through 09/04/2024) revealed the following fifteen testing events: 09/08/2023; 10/24/2023; 12/14/2023; 01/03/2024; 01/30/2024; 02/06/2024; 02 /08/2024; 03/06/2024; 05/09/2024; 05/15/2024; 05/20/2024; 05/22/2024; 06/06/2024; 07/03/2024; 09/24/2024 5. In an interview on 11/20/2024 at 03:34 pm in the conference room, Technical Supervisor #1 (as listed on the submitted CMS-209 form) confirmed the laboratory's procedure did not follow manufacturer's instructions. Technical Supervisor #1 was asked to provide studies to support the change in procedure. No documentation was provided. 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. -- 3 of 4 -- (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 observations, review of reagent manufacturer's instructions, laboratory environmental logs, and staff interview, the laboratory failed to ensure room temperature ranges met manufacturer's specifications for 10 of 10 months in 2024. Findings included: 1. During a tour of the Clinical Microbiology area (Room 3650) on 11/20/2024 at 02:40 pm, the following reagents were observed in use: One bottle Remel Gram Crystal Violet; Lot number 137768; Expiration Date 07/03/2025 One bottle Remel Gram Iodine; Lot number 138413; Expiration Date 07/26/2025 One bottle Remel Decolorizer; Lot number 138494; Expiration Date 07/27/2025 One bottle Remel Gram Safranin; Lot number 137771; Expiration Date 07/11/2025 Two boxes Remel RapID Inoculation Fluid; Lot number 810428; Expiration Date 03/02 /2026 One box Remel RapID Inoculation Fluid; Lot number 100268; Expiration Date 03/17/206 One box Remel Tryptic Soy Broth; Lot number 181020; Expiration Date 09 /30/2025 One box Remel Tryptic Soy Broth; Lot number 105652; Expiration Date 04 /01/2025 One box Remel Tryptic Soy Broth; Lot number 135213; Expiration Date 06 /13/2025 2. Review of the manufacturer's instructions, indicated on each reagent's label, revealed the following room temperature storage requirements: Remel Gram Crystal Violet; 20-25C Remel Gram Iodine; 20-25C Remel Decolorizer; 20-25C Remel Gram Safranin; 20-25C Remel RapID Inoculation Fluid; 20-25C Remel Tryptic Soy Broth; 2-25C 3. Review of the laboratory's environmental record titled, "Room Temperature/Relative Humidity Log" for Room 3650 from January 2024 through October 2024 revealed an acceptable room temperature range of 16-30C. This range exceed the reagents manufacturer's upper room temperature specification of 25C. 4. In an interview on 11/20/2024 at 2:50 pm, the laboratory manager, after review of the manufacturer's specifications, confirmed the finding. 47517 II. Based on direct observations, review of reagent manufacturer's instructions, laboratory environmental logs, and staff interview, the laboratory failed to ensure room temperature ranges met manufacturer's specifications for 4 of 4 months reviewed in 2024. Findings included: 1. During a tour of the Molecular testing area on 11/20/2024 at 02:45 pm, the following reagents were observed in use: Four boxes QIAamp DNA Blood Mini Kit; lot number 61904; expiration date 06/01/2025 One bottle inventrogen 1M Tris pH 8.0; Lot 00945491; expiration date N/A Two boxes QIAamp Viral RNA Mini Kit Catalog Number 52906; expiration date N/A One MagMAX Viral/Pathogen Elution Buffer; lot number 2967902; expiration date 04-30-2026 2. Review of the manufacturer's instructions, indicated on each reagent's label, revealed the following room temperature storage requirements: QIAamp DNA Blood Mini Kit; 15-25C Inventrogen 1M Tris pH 8.0; 15-25C QIAamp Viral RNA Mini Kit Catalog Number 52906; 15-25C MagMAX Viral/Pathogen Elution Buffer; 15-25C 3. Review of the laboratory's environmental record titled, "Room Temperature/Relative Humidity Log" for Molecular Room number 3538 from July 2024 through October 2024 revealed an acceptable room temperature range of 15-30C. This range exceeds the reagents manufacturer's upper room temperature specification of 25C. 4. In an interview on 11 /20/2024 at 2:55 pm, Technical Supervisor #2 confirmed the finding. -- 4 of 4 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of laboratory records and e-mail communication, the laboratory failed to perform a negative and positive control material at least once each day patient specimens are assayed for legionalla urine antigen testing for one of one patient test reports reviewed. Findings include: 1) Patient test report XXXXX-2019 shows a patient test result of : Legionella Urine Antigen- Presumptive Negative with a date reported of 10/17/2019. 2) Review of appendix 13.1 shows that external positive control and external negative control swabs were were tested on September, 10, 2020, October 8, 2019 and April 14, 2020. 3) In an electronic mail communication on December 15, 2020 at 11: 21 AM, GS #1 provided the following information:"We perform external QC with each new shipment, new lot number, or every 6 months. Daily external QC is not performed with each test. IQCP has not been performed." 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. 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 -- 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 ten high complexity testing personnel did not meet the education requirements to perform high complexity testing: Findings include: 1) Review of the Form CMS-209 (Laboratory Personnel Report), signed by the laboratory director on 11/25/20, shows TP #12 is performing high complexity testing. 2) Review of education records for TP # 12 shows a matriculated bachelors degree in chemical engineering which does not meet the education requirements 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) (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 -- 2 of 3 -- 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 ten high complexity testing personnel failed to meet the education requirements to perform high complexity testing. Finding include: 1) Refer to D6168 -- 3 of 3 --

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 proficiency testing 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. The laboratory's packing slip for the LRN Proficiency Testing Samples for Pox Viruses was stamped June 25, 2019 10:59 AM. 4. Review of an email appointment sent by TP#1 revealed a teleconference to discuss the LRN Orthopox PT was set for June 25, 2019 with required attendees from three laboratories (14D0691828, 14D0647002, 14D0647032) including the laboratory director and clinical consultant. The laboratory director and clinical consultant are the same for all three laboratories. 5. Interview with TP#1 on August 14, 2019 at 1410 confirmed that the teleconference took place and there was a discussion regarding the LRN Orthopox PT with staff from all three laboratories present. 6. Review of an email sent on June 26, 2019 by TP#2 to staff from all three laboratories stated "So as a brief summary to yesterday's meeting, here's what we're going to essentially do for each sample. Please correct me if I'm wrong." The email then listed a chart of 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 TP#2 on June 27, 2019 to testing personnel at CLIA# 14D0647032 and 14D0647032 revealed an attachment with the rash algorithm risk assessment submitted to Centers of Disease Control for CLIA# 14D0647002. 9. Interview with TP#2 on August 14, 2019 at 3:15 P.M. confirmed that the attachment contained the risk criteria and what testing should be performed on each proficiency testing sample. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to report a lead result of 26.3 ug/dl to the IDPH Childhood Lead Program within 48 hours of confirming the test result as required by Illinois State law. The findings include: 1. For all children under 16 years of age all leads results greater than 10 ug/dl must be reported to the State Childhood Lead Program within 48 hours of confirmation of the test lead level. 2. Staff confirmed on July 17, 2018 around 2:00 PM that there was no evidence to demonstrate that this reporting requirement had been met. 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 record review and staff interview, the laboratory failed to follow its policy for reporting blood lead levels 35 ug/dl or higher. The findings include: 1. The blood lead level on patient 9971101 was 45 ug/dl. There was no evidence presented to the 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 -- inspector that demonstrated this result had been called to IDPH Childhood Lead Program per the policy. 2. On July 17, 2018 around 2:00 PM, staff verified that this result (45 ug/dl) was not on the call tracking log to the Lead program. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to perform and establish its own Individualize Quality Control Plan (IQCP) for Legionella testing prior to reporting patient test results. The findings include: 1. The Legionella IQCP in use was performed by Alere (the manufacturer). The IQCP must be performed in house by the laboratory's own testing personnel. 2. Around 1:00 PM on July 17, 2018 staff confirmed the IQCP in use was performed by the manufacturer's representative. -- 2 of 2 --