Chicago Department Of Public Health

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to include the address of the location where testing in the specialties of microbiology and diagnostic immunology was performed for 17 of 17 patient test reports reviewed. Findings include: 1. Review of 17 of 17 patient test reports reviewed found the laboratory failed to indicate the address of the performing laboratory on the final test reports. MRN*: Date of testing: Location: 2404557 12/12/2023 Lakeview 2285313 12/12/2023 Lakeview 2404577 12 /13/2023 Lakeview 2405620 04/22/2024 Roseland 2405248 04/29/2024 Roseland 40071281 05/09/2024 Roseland 2406508 07/26/2024 Austin 2406615 08/06/2024 Austin 40057181 08/07/2024 Austin 2297404 01/13/2025 Lakeview 40079419 01/31 /2025 Lakeview 2409078 05/13/2025 Austin 2409180 05/28/2025 Austin 2409205 05 /28/2025 Austin 2410300 09/11/2025 Roseland 2410297 09/11/2025 Roseland 40038713 09/11/2025 Roseland *MRN = Medical Record Number 2. Interview with the LD on 11/25/2025, at 1:07 pm, confirmed the laboratory failed to include the address of the location where testing in the specialties of microbiology and diagnostic immunology was performed for 17 of 17 patient test reports reviewed. 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 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American Pathologists (CAP) Proficiency Testing (PT) records confirmed the initial unsuccessful PT performance for the subspecialty of bacteriology (See D2028) for two consecutive PT events in 2024 (events two and three). D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- (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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American Pathologists (CAP) Proficiency Testing (PT) records the laboratory failed to achieve satisfactory performance for the subspecialty of bacteriology for two consecutive PT events in 2024 (events two and three) resulting in the initial unsuccessful PT performance for the subspecialty of bacteriology. Findings include: 1. Review of the CASPER Report 0155D, generated on 02-03-2025, the laboratory received the following unsatisfactory scores for the subspecialty of bacteriology. BACTERIOLOGY EVENT 2, 2024 - 60% Unsatisfactory EVENT 3, 2024 - 60% Unsatisfactory 2. Review of CAP PT evaluation reports for the events D5-B 2024 Gram Stain and D5-C 2024 Gram Stain confirmed the initial unsuccessful performance for the subspecialty of bacteriology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American Pathologists (CAP) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the subspecialty of bacteriology resulting in the laboratory's initial unsuccessful PT performance for the subspecialty of bacteriology for two consecutive PT events (event two and three) in 2024 (see D6014). D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American Pathologists (CAP) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the subspecialty of bacteriology (see D2028) resulting in the laboratory's initial unsuccessful PT performance for the subspecialty of bacteriology for two consecutive PT events (event two and three) in 2024. -- 2 of 2 --