Duly Health And Care - Glen Ellyn Lab

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider, the laboratory was found to be out of compliance with the 42 C.F.R. Part 493 CLIA requirements for the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in the API PT program for the hematology analyte Hematocrit for two of three consecutive PT events in 2025 and 2026 (Event 3 of 2025 and Event 2 of 2026) resulting in the initial unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the hematology analyte Hematocrit for two of three consecutive PT events in 2025 and 2026 (Event 3 of 2025 and Event 2 of 2026) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 10/02/2026, the laboratory received the following unsatisfactory scores for the hematology analyte Hematocrit. Hematocrit Event 3, 2025 - 60% Unsatisfactory Event 2, 2026 - 0% Unsatisfactory 2. Review of API PR evaluation reports (Hematology/Coagulation) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the hematology analyte Hematocrit. 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for hematology analyte Hematocrit for two of three consecutive PT events in 2025 and 2026 (Event 3 of 2025 and Event 2 of 2026) resulting in the laboratory's initial unsuccessful PT performance. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for hematology analyte Hematocrit for two of three consecutive PT events in 2025 and 2026 (Event 3 of 2025 and Event 2 of 2026) resulting in the laboratory's initial unsuccessful PT performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies 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 D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure's manuals and verification records, the laboratory director failed to ensure that verification procedures used are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method used to determine cortisol levels. Findings: 1. There were no procedures that described the processes used to determine performance characteristics for cortisol testing. 2. Review of verification records revealed that there was no documentation that identifies which records were used for the following performance characteristics: a. Accuracy b. Precision c. Reportable Range d. Reference intervals 3. There was no documentation to show that the laboratory director reviewed and approved the results of the verification studies. 4. In an interview at 1:30 PM on February 26, 2020, the Technical Supervisor told the surveyor that the laboratory went live with Cortisol testing on January 22, 2019. 5. Review of patients' test results revealed cortisol results were reported on March 27, 2109. 6. At 2:30 PM on February 26, 2020, the Technical Supervisor confirmed the surveyor's findings D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain 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 -- their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report (FORM CMS 209) and personnel records and interview with the technical supervisor, the technical supervisor failed to be responsible for evaluating the competency of all testing personnel to ensure that they maintained their competency to perform test procedures and report test results promptly, accurately and proficiently. Findings: 1. There were a total of 14 testing personnel listed on FORM CMS 209. One of the 14 testing personnel was the Technical Supervisor. 2. Review of personnel records revealed that the Technical Supervisor failed to perform the competency assessments of 13 of 14 testing personnel from March 1, 2018 through February 26, 2020. 3. At 11:30 AM, on February 26, 2020, the Technical Supervisor confirmed the surveyor's findings. -- 2 of 2 --