O'Hare Clinical Labs

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 review of the laboratory's testing menu; procedures manual; laboratory records; and interview with the laboratory director (LD) the laboratory failed to be enrolled in HHS approved Proficiency Testing (PT) Program. Findings: 1. Review of the laboratory's testing menu revealed that the laboratory performs Real - Time (PCR) COVID- 19 Testing. 2. Review of the laboratory's procedure manual revealed that the laboratory had a policy titled, "Proficiency Testing Policy." it states, "a. The Laboratory will participate in Proficiency Testing (PT) Program available through a CMS approved provider. b. Each year and on introduction of new test, the Laboratory Director (LD) will review laboratory test menu to make sure that the laboratory is enrolled in a PT program that cover all in-house tests." 3. On December 30, 2020 at 12:00 PM, the surveyor requested PT records. The laboratory director told the surveyor that they had not enrolled in PT yet. 4. On December 30, 2020 at 12:15 PM, the LD confirmed the surveyor's findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of manufacturer's instrucitons, patients' test records, and interview with the Technical Supervisor (TS is the lab owner), the laboratory failed to report COVID-19 (SARS-CoV-2) test results to the Secretary during the Public Health Emergency. Findings: 1. Review of the Manufacturers 2. On December 30, 2020, at 2: 00 PM, the surveyor selected a total of 93 patients' test reports for COVID - 19 tests performed between December 2, 2020 through December 29, 2020, Five of 93 patients' tests reports were Positive for COVID -19 and 88 of 93 patients test reports were Negative for COVID-19. 3. On December 30, 2020 at 2:15 PM, the surveyor asked the Technical Supervisor to show her how results get reported to Public Health. The Technical Supervisor told the surveyor he gives the results to the " accountant" (lab adminstrator) to enter into a portal. The surveyor was told that this was not done at this location. 4. There was no documenation to show that COVID tests results were reported to Public Health for 93 of 93 test reports reviewed. 5. On December 30, 2020 at 2:20 PM, the TS confirmed the surveyor's findings. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the Laboratory Director (LD), safety procedures were not established and observed to ensure protection form physical chemical, biochemical, and electrical hazards, and biohazardous materials. Findings: 1. On December 30, 2020 at 1:00 AM, the surveyor was given a tour of the lab. The surveyor observed that that testing personnel entered the lab through an open doorway from a kitchen (clean area) or break area. The 1st area through the kitchen door is where extraction of patients' specimens is performed. There is a huge open window and another door leaving the extraction area that leads to the area where PCR amplification is performed. The surveyor observed that each phase of testing was performed in open areas with no doors. 2. On December 30, 2020 at 11:00 AM, the surveyor observed testing personnel wearing their masks, gloves, and lab coats in the kitchen of the laboratory. They would go back and forth from the lab to the kitchen and back again without removing their gloves, lab coats, and/or masks. 3. On December 30, 2020n at 11:15 AM, the LD confirmed the surveyor's findings. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 -- 2 of 11 -- If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedures manual; verification records; quality control (QC) records; patients' test reports, and interview with the laboratory director (LD), the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299 for the subspecialty of General Immunology for its COVID-19 Real- Time PCR tests. Findings: 1. Review of the laboratory's procedure manual revealed, the laboratory lacked a comprehensive procedure manual that is approved by the current LD. See tags D5403 and D5407 2. There was a lack of documentation to show that the laboratory verified its Real - Time PCR test methods for the presence of COVID-19 prior to testing patients' specimens. See tag D5421 3. There was a lack of QC records. On December 30, 2020 at 2:30 PM, the surveyor requested that the lab show her just 10 QC records for patients tested from December 2, 2020 to December 29, 2020. Neither the LD nor the Technical Supervisor knew how to access QC records. See tag D5455 4. Review of 93 patients' test reports show that the incorrect address of the laboratory is recorded on 93 of 93 reports reviewed. See tag D5805. 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 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 review of the laboratory's testing menu; procedures manual; laboratory records; and interview with the laboratory director (LD) the laboratory failed to be enrolled in HHS approved Proficiency Testing (PT) Program. Findings: 1. Review of the laboratory's testing menu revealed that the laboratory performs Real - Time (PCR) COVID- 19 Testing. 2. Review of the laboratory's procedure manual revealed that the laboratory had a policy titled, "Proficiency Testing Policy." it states, "a. The Laboratory will participate in Proficiency Testing (PT) Program available through a CMS approved provider. b. Each year and on introduction of new test, the Laboratory Director (LD) will review laboratory test menu to make sure that the laboratory is enrolled in a PT program that cover all in-house tests." 3. On December 30, 2020 at 12:00 PM, the surveyor requested PT records. The laboratory director told the surveyor that they had not enrolled in PT yet. 4. On December 30, 2020 at 12:15 PM, the LD confirmed the surveyor's findings. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of manufacturer's instrucitons, patients' test records, and interview with the Technical Supervisor (TS is the lab owner), the laboratory failed to report COVID-19 (SARS-CoV-2) test results to the Secretary during the Public Health Emergency. Findings: 1. Review of the Manufacturers 2. On December 30, 2020, at 2: 00 PM, the surveyor selected a total of 93 patients' test reports for COVID - 19 tests performed between December 2, 2020 through December 29, 2020, Five of 93 patients' tests reports were Positive for COVID -19 and 88 of 93 patients test reports were Negative for COVID-19. 3. On December 30, 2020 at 2:15 PM, the surveyor asked the Technical Supervisor to show her how results get reported to Public Health. The Technical Supervisor told the surveyor he gives the results to the " accountant" (lab adminstrator) to enter into a portal. The surveyor was told that this was not done at this location. 4. There was no documenation to show that COVID tests results were reported to Public Health for 93 of 93 test reports reviewed. 5. On December 30, 2020 at 2:20 PM, the TS confirmed the surveyor's findings. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the Laboratory Director (LD), safety procedures were not established and observed to ensure protection form physical chemical, biochemical, and electrical hazards, and biohazardous materials. Findings: 1. On December 30, 2020 at 1:00 AM, the surveyor was given a tour of the lab. The surveyor observed that that testing personnel entered the lab through an open doorway from a kitchen (clean area) or break area. The 1st area through the kitchen door is where extraction of patients' specimens is performed. There is a huge open window and another door leaving the extraction area that leads to the area where PCR amplification is performed. The surveyor observed that each phase of testing was performed in open areas with no doors. 2. On December 30, 2020 at 11:00 AM, the surveyor observed testing personnel wearing their masks, gloves, and lab coats in the kitchen of the laboratory. They would go back and forth from the lab to the kitchen and back again without removing their gloves, lab coats, and/or masks. 3. On December 30, 2020n at 11:15 AM, the LD confirmed the surveyor's findings. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 -- 2 of 11 -- If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedures manual; verification records; quality control (QC) records; patients' test reports, and interview with the laboratory director (LD), the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299 for the subspecialty of General Immunology for its COVID-19 Real- Time PCR tests. Findings: 1. Review of the laboratory's procedure manual revealed, the laboratory lacked a comprehensive procedure manual that is approved by the current LD. See tags D5403 and D5407 2. There was a lack of documentation to show that the laboratory verified its Real - Time PCR test methods for the presence of COVID-19 prior to testing patients' specimens. See tag D5421 3. There was a lack of QC records. On December 30, 2020 at 2:30 PM, the surveyor requested that the lab show her just 10 QC records for patients tested from December 2, 2020 to December 29, 2020. Neither the LD nor the Technical Supervisor knew how to access QC records. See tag D5455 4. Review of 93 patients' test reports show that the incorrect address of the laboratory is recorded on 93 of 93 reports reviewed. See tag D5805. 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 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)