F C Lab Lemont

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation and interview, the laboratory failed to maintain a uni- directional workflow for the laboratory developed Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) procedures used to test more than 27,050 patient specimens. Findings Include: 1. The laboratory used a laboratory developed test (LDT) procedure for RT-PCR to detect and identify SARS-CoV-2, Streptococcus Group A (Strep A), methicillin-resistant staphylococcus aureus (MRSA), and Influenza A & B. 2. On a tour of the laboratory facility on March 3, 2022 at 1:40 PM, the surveyor observed the following: -Patient specimens collected from sites were received, labeled, and reracked in room #1; -The reracked specimens were then taken to room #2, which is adjacent to room #1. In room #2, specimens were accessioned, prepped, treated, and pipetted into test plates. -The completed test plate(s) were taken through a small hallway. -Situated in this hallway were two Real-time PCR analyzers, the Applied Biosystem (ABI) 7500 & 7900HT Fast. -Past the analyzers towards the end of the hallway to the left was room#3. In this room the reagents, master mix, nucleic acid, etc. were made and added to the plate which is now ready to run. -From room#3, the plate(s) were taken back into the hallway to the ABI 7500/7900HT station where the assay was performed. -Also, at the end of the hallway adjacent to Room#3 were the breakroom area, kitchen, and exit/entrance door for personnel. 3. Direct observation of the technical supervisor on March 3, 2022 at 2:10 PM, demonstrated PCR analysis of patients' test data and it was observed that multiple personnel were passing back and forth from room#1 and 2 through the hallway to the breakroom or exit door creating a bottleneck at the PCR analyzer station. 4. Interview Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- with the testing personnel on March 3, 2022, at 2:15 PM revealed that the laboratory had not performed any wipe tests to evaluate the contamination of the main specimen processing area since the unidirectional workflow was not maintained. 5. Interview with the laboratory director on March 3, 2022, at 2:15 AM confirmed more than 27,050 patients had been tested for SARS-CoV-2, MRSA, Strep Group A, and Influenza A&B while the laboratory failed to maintain a uni-direction workflow. 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 direct observation, record review, lack of documentation, and interview, the laboratory failed to establish written policies and procedures to assess employees performing the Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) laboratory developed tests (LDTs) for seven of seven testing personnel (TP). Findings include: 1. The competency policy and procedures, employee files, and the Laboratory Personnel Report (CMS 209) were reviewed. 2. The laboratory used laboratory developed RT-PCR tests to detect and identify SARS-CoV-2, Streptococcus Group A (Strep A), methicillin-resistant staphylococcus aureus (MRSA), and Influenza A & B. 3. The CMS 209 reviewed listed seven TP (TP1, TP2, TP3, TP4, TP5, TP6, and TP7) performing the LDT tests. 4. Review of the competency procedure and employee files showed 7 of 7 TP were assessed on the eppendorf pipetting instrument. 5. During a tour of the laboratory facility on March 3, 2022 at 1:40 PM, the surveyor observed TP1, TP2, and TP3 receive and accession specimens, perform reagent preparation, sample extractions, PCR plate preparations, and result reporting. 6. Interview with TP1 on March 3, 2022 at 2:00 PM, described their duties in the laboratory to include, resuspension of reagents, extraction of patient specimens, accessioning patients' specimens to prepare for pipetting, test plate processing (depending on LDT method), master mix preparation and addition, running assays on the Applied Biosystem (ABI) 7500 and 7900HT Fast Real-Time PCR analyzers, analyzing the test data, and reporting patients results. 7. Further review of the competency policy and procedure revealed that the laboratory failed to include these activities and processes in their competency policy and procedures. 8. The laboratory director and TP1 confirmed the above findings on March 3, 2022, at 2:45 PM. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, record review, lack of documentation, and interview, the -- 2 of 7 -- laboratory failed to establish written policies and procedures for specimen submission, handling, and referral procedures (D5311) for the laboratory developed Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) procedures used to detect and identify SARS-CoV-2, Streptococcus Group A(Strep A), methicillin-resistant staphylococcus aureus (MRSA), and Influenza A & B, affecting 27, 058 patients tested. 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: Based on direct observation, record review, lack of documentation, and interview the laboratory failed to establish written policies and procedures for specimen submission, handling, and referral for four of four laboratory developed tests (LDTs) reviewed affecting 27,058 patient tests performed. Findings include: Item 1. 1. The laboratory's policies and procedures were reviewed. 2. The laboratory used a laboratory developed Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) test (LDT) to detect and identify SARS-CoV-2, Streptococcus Group A(Strep A), methicillin-resistant staphylococcus aureus (MRSA), and Influenza A & B. 3. Direct observation of testing personnel (TP2) on March 3, 2022 at 11:50 AM, demonstrated the specimen receiving process and it was observed that the patient specimens removed from the specimen bags did not have requisitions. These specimens were placed in a test tube rack and taken to a computer designated for receiving specimens. TP2 entered the name and date of birth written on the patient's tube into the laboratory Information system (LIS) which retrieved the patient's information/order. The LIS assigned the patient a number and generated a barcode label for the patient's specimen tube. 4. Interview with the laboratory director (LD) on March 3, 2022 at 11:55 AM, the LD stated that requisitions were not required for standing orders. 5. The laboratory reported 25,523 SARS-CoV-2 test results. Item 2. 6. Direct observation on March 3, 2022 at 1:40 PM, the surveyor observed TP3 enter the laboratory from the outside with a test tube rack of patient specimens contained in a plastic bag. The specimen rack removed from the plastic bag contained 26 patient specimen tubes with the barcode label already attached and no requisitions forms. Further examination of the tubes revealed 26 of 26 had no visible written identifiers. TP3 transferred the 26 specimens to another rack and took them to room#2 for PCR processing. 7. Interview with the LD on March 3, 2022 at 1:40 PM, the LD stated these patient specimens were collected at the laboratory located on 8635 Lemont Rd, Downers Grove (14D1078862). The patient information, collection, and barcoding were done at the Downers Grove laboratory and transported to the Lemont laboratory without requisitions. 8. Review of the laboratory's policies and procedures revealed the processes described in findings #3, #5, and #6 had not been included in their manuals and the laboratory failed to establish a written preanalytic policy and procedure that included and detailed the following: (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 -- 3 of 7 -- transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. for the SARS-CoV-2, MRSA, Strep Group A, and Influenza A&B performed in the laboratory. 9. The laboratory reported 58 RSV and Influenza A&B, 29 MRSA, and 5 Strep Grp A results. 10. The LD confirmed the above findings on March 3, 2022, at 3:35 PM and stated that the laboratory does not have a requisition form but it can be created in their computer system upon request. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor review of CASPER Report 155 Proficiency Testing (PT) records and communication with the PT vendor American Association of Bioanalysts (AAB); this laboratory failed to successfully participate in the testing of Bacteriology PT samples. Findings include: 1. Review of the CASPER Report 155 on August 03, 2020 and communication with the PT provider at 09:53 AM confirmed the initial unsuccessful PT performance under the subspecialty of Bacteriology for PT event 1 and 2, of 2020. See D-2028. D2028 BACTERIOLOGY 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 -- CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of CASPER Report 155, Proficiency Testing (PT) records and communication with the PT vendor American Association of Bioanalysts (AAB); this laboratory failed to successfully participate in the testing of Bacteriology PT samples. Findings include: 1. Review of the CASPER Report 155 on August 03, 2020 revealed that the initial unsuccessful PT performance occurred under the subspecialty of Bacteriology for PT event 1 and 2, of 2020 as listed below: BACTERIOLOGY EVENT - 1, 2020 = 0% Unsatisfactory EVENT - 2, 2020 = 0% Unsatisfactory 2. During a phone communication with the PT vendor AAB on August 03, 2020 at 09:53 AM, the Bacteriology PT failing scores for events 1 and 2, of 2020 were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to meet the requirements specified in 493.1230 through 493.1256. Findings Include: 1. The laboratory failed to perform quality control procedures as outlined in the Individual Quality Control procedure for Kirby-Bauer susceptibility testing for 21 of 26 patient test reports reviewed. See D5445. 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 review of the laboratory records and interview with the laboratory director (LD); the laboratory failed to establish policies and procedures to assess employee competency. Findings Include: 1. Review of the laboratory's policy and procedure manual found no policy had been established to assess the competency of personnel listed on the CMS-209 which include the technical supervisors, general supervisors, 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 -- clinical consultants and testing personnel. 2. On survey date 01-11-2018 at 2:15 pm the LD confirmed the laboratory had failed to establish a competency assessment policy for all personnel listed on the CMS-209. 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 review of laboratory records and interview with the laboratory director (LD); the laboratory failed to perform control procedures using the number and frequency specified by the laboratory's individual quality control plan (IQCP) for antimicrobial susceptibility testing for 21 of 26 patient test reports reviewed. Findings include: 1. Review of the IQCP for Kirby-Bauer (KB) antimicrobial susceptibility testing stated the following, "Testing of appropriate QC strains on each panel type weekly." 2. Review of the laboratory policy and procedure manual under section 12, "Quality Control Procedures for Microbiology" additionally stated the following: "Sensitivity Disc: Proper reaction and zone sizes. Procedure: Use no. 2 procedures of part A above once a week. Read all zones sizes on quality control materials, dated, logged and initialed." 3. Review of patient tests results found that for 1 of 5 dates reviewed the KB sensitivity disk weekly quality control (QC) zones sizes were not performed. Patient Identification Test Date C6 11-28-2017 4. Review of the "Mueller Hinton Plates and Sensitivity Disk Quality Control" log found the November 2017 log was an exact photocopy of the December 2017 quality control log. 5. Further review of "Mueller Hinton Plates and Sensitivity Disk Quality Control" logs for KB susceptibility testing found that in addition to the November 2017 log the October 2017 log was an exact copy of the December 2017 log. 6. Review of patient testing logs identified an additional 20 patients who had results reported for KB susceptibility testing during the months of October and November of 2017 when no QC was performed/documented for KB susceptibility testing. Patient Identification Test Date C7 11-28-2017 C8 11-28-2017 C9 11-14-2017 C10 11-13-2017 C11 11-09-2017 C12 10-31-2017 C13 10-23-2017 C14 10-23-2017 C15 10-20-2017 C16 10-19-2017 C17 10-19-2017 C18 10-19-2017 C19 10-18-2017 C21 10-11-2017 C22 10-06-2017 C23 10-06-2017 C24 10-05-2017 C25 10-03-2017 C27 10-27-2017 C28 10-04-2017 7. On survey date 01-11-2018, at 2:15 pm, the LD confirmed that the quality control logs for October and November of 2017 were photocopies of the December 2017 "Mueller Hinton Plates and Sensitivity Disk Quality Control" log and no weekly quality controls were documented for KB susceptibility testing during that time frame. 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. -- 2 of 4 -- 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 and interview with the laboratory director (LD); the laboratory failed to have 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. Findings Include: 1. The laboratory failed to ensure 2 of 2 testing personnel were qualified for high complexity testing. See D6171. 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 stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality -- 3 of 4 -- 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 and interview with the laboratory director (LD); the laboratory failed to ensure 2 of 2 testing personnel were qualified for high complexity testing. Findings Include: 1. Review of educational documentation for 2 of 2 testing personnel identified on the CMS-209 failed to have foreign equivelency documentation for foreign degrees. 2. On survey date 01-11-2018, at 2:15 pm, the above findings were confirmed by the LD. -- 4 of 4 --