Clinical Immunology Lab Rosalind Franklin Univ

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 05/27/2026. The laboratory was found to be out of compliance with the CLIA regulations (42 CFR Part 493) for the following condition-level deficiencies: D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to twice annually verify the accuracy of ten of ten tests/procedures performed utilizing in-house proficiency blind testing in the subspecialties of nontransplant histocompatibility, general immunology, routine chemistry, and endocrinology reviewed in 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Quality Manual", which stated, under "15. Proficiency Testing", "The laboratory does in-house proficiency blind testing for: "1. Natural Killer [NK] Cell Assay "2. [T-Helper] Th1:TH2 Cytokine ratio "3. Leukocyte Antibody Detection "4. Reproductive Immunology Phenotype "5. T-Reg[ulatory] "6. TH17 "7. Molecular Tests: Thrombophilia Panel ([Cardiovascular Disease] CVD Strip) .... "[8]. Total Iron Binding Capacity (TIBC) "[9]. Phospholipid [PL] Antibodies ... "[10]. [Erythrocyte Transketolase Activity Coefficient] ETKAC (Vitamin B1)". 2. Review of laboratory policies and procedures revealed the procedure titled "Quality Manual", which stated, under "15.1. Procedure for Analysis of Proficiency Testing Samples", "For in-house proficiency, blind samples are used. Five specimens are picked for Molecular tests. Five specimens are picked for NK Assay, Cytokine ratio, Leukocyte Antibody Detection, Reproductive Immunology 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 -- Phenotype and T-Reg. Three specimens are picked for TH17. For TIBC, five patients are picked and run on the Vitros Chemistry analyzer. These samples are frozen until they are tested with the [College of American Pathologists] CAP Chemistry survey. For PL ..., Five PL specimens are aliqoted and frozen. The blind specimens are tested with the current workload. 3. Review of laboratory in-house proficiency blind testing revealed the laboratory failed to verify the accuracy of the above-mentioned ten tests /panels for four of four in-house proficiency blind testing events reviewed in 2024 and 2025. 4. Interview with the laboratory representative on 05/27/2026, at 3:25 pm, confirmed the laboratory failed to twice annually verify the accuracy of ten of ten tests /procedures performed utilizing in-house proficiency blind testing in the subspecialties of nontransplant histocompatibility, general immunology, routine chemistry, and endocrinology reviewed in 2024 and 2025. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to have a system in place that biannually evaluates and defines the relationship between QuantiFERON (QFT) test results on two of two automated Enzyme Linked Immunosorbent Assay (ELISA) instruments from the installation of the second ELISA instrument in October, 2024 through the date of survey, 05/27 /2026. Findings include: 1. Upon a tour of the laboratory on 05/27/2026, at 11:23 am, surveyors observed two automated ELISA instruments performing QFT testing. Instrument: Serial Number: 1) Dynex DS2 1BSA3973 2) ThunderBolt 2409-406 2. Review of laboratory policies and procedures revealed the policy titled "Quality Manual", which stated, under "11.3. Multisystem Validation", "Every 6 months a multisystem validation will be performed." 3. Review of laboratory records revealed the laboratory lacked documentation for instrument-to-instrument comparison /multisystem validation of QFT test results on two of two automated ELISA instruments. 4. Interview with the laboratory representative on 05/27/2026, at 11:29 am, confirmed the laboratory failed to have a system in place that biannually evaluates and defines the relationship between QFT test results on two of two automated ELISA instruments from the installation of the second ELISA instrument in October, 2024 through the date of survey, 05/27/2026. 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. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory -- 2 of 4 -- personnel educational records, and interview with the laboratory representative; the laboratory failed to ensure one of ten testing personnel met the educational requirements 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 (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (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. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory personnel educational records, and interview with the laboratory representative; the laboratory failed to ensure one of ten testing personnel met the educational requirements for high complexity testing. Findings include: 1. Review of the CMS- 209 (Laboratory Personnel Report) Form revealed ten TP performing high complexity laboratory-developed tests. 2. Review of personnel educational records revealed one of ten TP (TP #8) failed to have documentation of the required minimum of six biology credit hours from an accredited institution to meet the educational requirements to qualify as a high complexity TP. 3. Interview with the laboratory representative on 05/27/2026, at 1:23 pm, confirmed the laboratory failed to ensure -- 3 of 4 -- one of ten testing personnel met the educational requirements for high complexity testing. -- 4 of 4 --

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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory failed to successfully participate in PT for the routine chemistry analyte lactate dehydrogenase (LDH) for three of three consecutive events in 2022 resulting in subsequent unsuccessful PT performance. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory failed to successfully participate in PT for the routine chemistry analyte lactate dehydrogenase (LDH) for three of three consecutive events in 2022 resulting in the subsequent unsuccessful performance for LDH. Findings include: 1. Review of the CASPER Report 0155D ran on 12-1-2022, found the laboratory received the following unsatisfactory PT scores for the analyte LDH. LDH AAB EVENT-1, 2022 = 20% - Unsatisfactory AAB EVENT-2, 2022 = 0% - Unsatisfactory CAP EVENT-3, 2022 = 0% - Unsatisfactory 2. Review of AAB and CAP PT records confirmed the subsequent unsuccessful PT performance for LDH for the three consecutive PT events in 2022. LDH AAB EVENT-1, 2022 = 20% - Unsatisfactory AAB EVENT-2, 2022 = 0% - Unsatisfactory CAP EVENT-3, 2022 = 0% - Unsatisfactory 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialty of chemistry (see D6016) resulting in the laboratory's subsequent unsuccessful PT performance for lactate dehydrogenase (LDH). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of -- 2 of 3 -- Bioanalysts (AAB) Proficiency Testing (PT) records, and College of Pathologists (CAP) PT records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the specialty of chemistry (see D2096) resulting in the laboratory's subsequent unsuccessful PT performance for lactate dehydrogenase (LDH). -- 3 of 3 --

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 review of the CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte lactate dehydrogenase (LDH), total during events one and two of 2022. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and interview with a American Association of Bioanalysts (AAB) representative; the laboratory failed to successfully participate in proficiency testing (PT) for the routine chemistry analyte lactate dehydrogenase (LDH), total during events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D ran on 8-1-2022 identified the initial unsuccessful PT performance for the specialty of chemistry for the analyte LDH, total. ROUTINE CHEMISTRY LDH, total - EVENT-1, 2022 = 20% - Unsatisfactory LDH, total - EVENT-2, 2022 = 0% - Unsatisfactory 2. A phone interview with the AAB PT representative on 08/01/2022, at 10:18 AM, confirmed the unsuccessful PT performance for LDH, total during events one and two of 2022. -- 2 of 2 --

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 phone communication with the PT vendor CAP; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the specialty of Diagnostic Immunology. Findings include: 1. Review of PT CASPER Report 155 on November 01, 2019 at 8:54 AM revealed that the unsatisfactory PT performance occurred during events 2 and 3 of calendar year 2019. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 phone communication with the PT vendor CAP; it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the subspecialty of General Immunology. Findings include: 1. Review of PT CASPER Report 155 on November 01, 2019 at 8:54 AM, revealed that the unsatisfactory PT performance occurred during calendar year 2019 for events 1 and 2 under the subspecialty of General Immunology for the Anti-HBc diagnostic marker as listed below. GENERAL IMMUNOLOGY Anti-HBc, EVENT-2, 2019 = 0% Anti-HBc, EVENT-3, 2019 = 0% 2. During PT Desk review on November 01, 2019 and phone communication with the PT vendor CAP at 9:40 AM, the PT failing scores were confirmed. -- 2 of 2 --