Oak Park Laboratory, Llc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with the Technical Consultant (TC); the laboratory failed to ensure attestation statements were completed for eight of eight PT events for testing in the specialties of chemistry and hematology in 2025 and 2026. Findings include: 1. Review of API PT records for 2025 and 2026 revealed a lack of attestation statements for eight of eight events in the specialties of chemistry and hematology in 2025 and 2026. Specialty: Year: Hem** 2025 - Event 2 Hem** 2025 - Event 3 Chem* 2025 - Event 3 Hem** 2026 - Event 1 Hem** 2026 - Event 2 Chem* 2026 - Event 1 Chem* 2026 - Event 2 Chem* 2026 - Event 3 *Routine Chemistry, Endocrinology; **Hematology; Urinalysis 2. Interview with the TC on 09/08/2026, at 10:47 am, confirmed the laboratory failed to ensure attestation statements were completed for eight of eight PT events testing in the specialties of chemistry and hematology in 2025 and 2026. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing 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 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Proficiency Institute (API) Proficiency testing (PT) records, lack of documentation and interviews with Technical Consultant (TC); the laboratory failed to evaluate non-graded PT scores in three of eight PT Events reviewed from 2025 to the date of survey, 09/08/2026. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled " Quality Control " which stated on page ten under " Proficiency Testing Assessment " , " Where applicable. Samples (unacceptable, Unsatisfactory, or unsuccessful proficiency testing result(s) will be re-evaluated by the laboratory staff. ... A PT Deviancy report will be filled with all supporting documentation." 2. Review of API PT comparative evaluation summaries identified not graded performances for the following five analytes: Specialty: Hematology PT Event: Analyte: Sample: 2025 E3 Monocyte ABT-11 2025 E3 Monocyte ABT-15 Specialty: Chemistry PT Event: Analyte: Sample: 2025 E3 Total Bilirubin CH-11 2025 E3 Total Bilirubin CH-15 2026 E1 Total Bilirubin CH-05 *E = Event 3. Review of laboratory records revealed lack of documented review or self-grade of the five not graded PT samples in hematology 2025 Event 3, chemistry 2025 Event 3 and 2026 Event 1. 4. Interview with TC on 09/08/2026, at 11:30 AM, confirmed the laboratory failed to evaluate non- graded PT scores in three of eight PT Events reviewed from 2025 to the date of survey, 09/08/2026. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Proficiency Institute (API) records, direct observation, and interview with the laboratory director (LD); the laboratory failed to ensure confidentiality of patient information throughout all phases of the total testing process on 5 of 14 API proficiency testing (PT) self-assessments in the specialty of hematology. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "General Policy", which stated, under "Test Report", "Patient confidentiality, including restricted computer access codes and other information which is accessed only on a need-to-know basis, will be maintained throughout the testing process." 2. Upon review of the API PT records on 06/23/2025, at 11:22 am, surveyors observed 5 of 14 API PT self-assessment hematology result forms printed on paper which included past patients' names, ages, sex, specimen numbers, names of the test ordered, and test result. 3. Interview with the LD on 06/23 /2025, at 2:37 pm, the LD confirmed the laboratory failed to ensure confidentiality of patient information throughout all phases of the total testing process that were under the laboratory's control. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. 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 CONDITION is not met as evidenced by: Based on review of personnel records, lack of documentation, the CMS-209 (Laboratory Personnel Report), and interview with testing personnel (TP) #3; the laboratory failed to have qualifying academic documentation/records for one of three TP to meet the qualification requirement for moderate complexity testing in the specialties of chemistry and hematology (see D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records, lack of documentation, the CMS-209 (Laboratory Personnel Report), and interview with testing personnel (TP) #3; the laboratory failed to have qualifying academic documentation/records for one of three TP to meet the qualification requirement for moderate complexity testing in the specialties of chemistry and hematology. Findings include: 1. Review of personnel records found no foreign equivalency documentation were available to qualify moderate complexity TP #3 listed on the CMS-209 form dated 06/20/2025. 2. Interview with TP #3 on 06/23/2025, at 12:40 pm, confirmed the laboratory failed to have qualifying academic documentation/records for one of three TP to meet the qualification requirement for moderate complexity testing in the specialties of chemistry and hematology. -- 2 of 2 --