Osu University Health Services

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/29,30/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the facility director, associate director of clinical operations, laboratory director, and testing person #1 during an exit conference performed at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory manager and testing person #1, the laboratory failed to follow manufacturer's directions to ensure True Metrix Pro glucose test strips had not exceeded their room temperature expiration dates. Findings include: (1) On 07/29/2025 at 12:30 pm, the laboratory manager stated glucose testing was performed on the Tru Metrix Pro; (2) Observation of the laboratory on 07/29/2025 at 12:30 pm identified one open bottle (Lot #, Z65992S expiration 08/31/2026) of Tru Metrix Pro test strips stored at room temperature, without documentation of when they were put in use; (3) Review of the manufacturer's storage requirements stated the following: (a) "Write date first opened on bottle. Discard bottle after expiration date printed on the bottle". (4) Interview with the laboratory manager and testing person #1 on 07/29/2025 at 12:30 pm confirmed the bottle had been opened without a method to monitor if they exceeded the manufacturer's modified expiration date. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for three of 19 proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 07/29/2025, a review of 2024 and 2025 proficiency testing events identified attestation statements had been signed after the graded evaluations were completed by the proficiency testing program for three of 19 events reviewed: (a) First event 2024 Immunology - The graded evaluation was completed on 04/25 /2024 and the attestation statement had not been signed by the laboratory director until 05/01/2025; (b) Second event 2024 Immunology - The graded evaluation was completed on 08/29/2024 and the attestation statement had not been signed by the laboratory director until 09/06/2024; (c) First event 2024 Hematology/Coagulation - The graded evaluation was completed on 04/16/2024 and the attestation statement had not been signed by the laboratory director until 05/01/2024; (2) The records were reviewed with the laboratory director who stated on 07/29/2025 at 02:00 pm the attestation statements had not been signed timely as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/24,25,2023. The laboratory was found out of compliance with the following CLIA Conditions: 493.493.801; D2000: Enrollment and Testing of Samples 493.1409; D6034: Technical Consultant The findings were reviewed with the facility director, associate director of clinical operations, laboratory director, and testing person #1 during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the laboratory director and testing person #1, the laboratory failed to enroll in a proficiency testing program for RPR (Rapid Plasma Reagin) testing for five of five events and Qualitative Serum Pregnancy testing for four of five events reviewed. Findings include: (1) On 07/24 /2023, a review proficiency testing records for 2021 (third event), 2022 (first, second, and third events) and to date in 2023 (first event) identified no evidence the laboratory was enrolled in proficiency testing for RPR testing for five of five events and Qualitative Serum Pregnancy testing for four of five events; (2) The records were reviewed with the laboratory director and testing person #1 who stated on 07/24/2023 at 02:30 pm, the laboratory had not enrolled in proficiency testing as stated above; (3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- A review of the test volume list completed for the survey identified the laboratory performed approximately 491 RPR tests and 229 Qualitative Serum Pregnancy tests annually. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and testing person #1, the laboratory failed to ensure proficiency testing records had been maintained; and failed to ensure proficiency testing attestation statements had been signed by the laboratory director and/or testing person for four of eight events reviewed. Findings include: (1) On 07/24/2023, a review of 2022 and 2023 proficiency testing records identified the following for three of eight events: (a) 2022 Hematology/Coagulation - First Event (i) The attestation statement had not been signed by the laboratory director and testing person(s); (ii) A copy of the results submitted to the proficiency testing program had not been maintained. (b) 2022 Microbiology - First Event (i) The attestation statement had not been signed by the laboratory director and testing person(s); (ii) A copy of the results submitted to the proficiency testing program had not been maintained. (c) 2023 Microbiology - First Event (i) A copy of the results submitted to the proficiency testing program had not been maintained. (d) 2023 Hematology/Coagulation - First Event (i) A copy of the results submitted to the proficiency testing program had not been maintained. (2) The findings were reviewed with the laboratory director and testing person #1. Both stated on 07/24/2023 at 12:40 pm, the attestation statements had not been signed and records not maintained as stated above. 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 D0000 The recertification survey was performed on 12/13/2021 and 12/16/2021. The findings were reviewed with the laboratory director and testing person #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to follow the written clinical consultant competency policy based on the job responsibilities as listed in Subpart M for one of one clinical consultant. Findings include: (1) The surveyor reviewed personnel records for competency assessments performed during 2019, 2020 and 2021. There was no evidence competencies had been performed for the clinical consultant, based on job responsibilities; (2) The surveyor asked the laboratory director if a written policy to evaluate the clinical consultant, based on job responsibilities, was available and if competencies had been performed during the review period. The laboratory director stated to the surveyor on 12/13/2021 at 10:41 am, a policy to evaluate the technical consultant annually based on job responsibilities was written but had not been performed between 07/19/2019 and 12/13/2021. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the testing person #1, the laboratory failed to follow the manufacturer's instructions for test timing for a qualitative solubility testing for three of 25 test reports. Findings include: (1) On 12/13/2021 at 09:50 am, testing person #1 stated to the surveyor: (a) The laboratory performed qualitative solubility testing using the Streck Sickledex test kit. (2) On 12/16/2021, the surveyor reviewed the manufacturer's instructions under the section titled, "Allow the sample to stand at room temperature (18C to 30C) for at least 6 minutes. Observe the sample for turbidity. Read results between 6 and 60 minutes." (3) On 12/16/2021, the surveyor then reviewed patient testing records from 01/01/2021 through 03/16/2021 and identified the following for three of 25 patient test reports: (a) Patient Report #1 - The collection date and time was on 01/14/2021 at 03:09 pm and approval date and time was on 01/14/2021 at 04:56 pm (one hour and 47 minutes later); (b) Patient Report #2 - The collection date and time was on 01/19 /2021 at 02:38 pm and approval date and time was on 01/20/2021 at 10:44 am (20 hours and six minutes later); (c) Patient Report #3 - The collection date and time was on 03/16/2021 at 12:30 pm and approval date and time was on 03/16/2021 at 03:30 pm (three hours later). (4) The surveyor reviewed the findings with testing person #1. Testing person #1 stated on 12/16/2021 at 09:13 am, the laboratory could not prove the specimen was collected, tested, and read between 6 and 60 minutes as required by the manufacturer. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory director, the laboratory failed to follow the manufacturer's instructions for performing weekly maintenance procedures for the GeneXpert analyzer. Findings include: (1) On 12/13/2021 at 09:50 am, testing person #1 stated to the surveyor Chlamydia trachomatis and Neisseria gonorrhoeae testing were performed on the GeneXpert analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log. The weekly requirements were as follows: (a) Weekly (i) Power down the GeneXpert instrument and Computer (ii) Clean Fan Prefilter (3) The surveyor then reviewed maintenance records from 12/13/2019 through 11/11/2021. The weekly maintenance had not been documented as performed between: (a) 12/13/2019 and 01/29/2020 (b) 03/24/2020 and 04/17/2020 (c) 05/13/2020 and 05/29/2020 (d) 06/19/2020 and 07/01/2020 (e) 07 /10/2020 and 08/03/2020 (f) 08/11/2020 and 10/19/2020 (g) 10/19/2020 and 11/18 -- 2 of 5 -- /2020 (h) 11/30/2020 and 01/11/2021 (4) The surveyor reviewed the findings with the laboratory director. The laboratory director stated on 12/13/2021 at 03:56 pm the weekly maintenance had not been documented as performed as indicated above. 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 a review of records and interview with the laboratory director, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for six of 23 events. Findings include: (1) On 12/13/2021, the surveyor reviewed 2020 and 2021 proficiency testing events. For six of 23 events, the attestation statements had been signed approximately two to five months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Third 2020 Hematology Event - The sample testing had been completed on 11/09/2020, and the attestation statement had not been signed by the laboratory director/designee until 03/03/2021; (b) Second 2020 Microbiology Event - The sample testing had been completed on 06/23/2020, and the attestation statement had not been signed by the laboratory director/designee until 08/19/2020; (c) Third 2020 SARS- CoV-2 Event - The sample testing had been completed on 10/30/2020, and the attestation statement had not been signed by the laboratory director/designee until 03/31/2021; (d) First 2021 Chemistry Core Event - The sample testing had been completed on 01/26/2021, and the attestation statement had not been signed by the laboratory director/designee until 03/03/2021; (e) First 2021 Hematology Event - The sample testing had been completed on 03/25/2021, and the attestation statement had not been signed by the laboratory director/designee until 05/06/2021; (f) Second 2021 Immunology Event - The sample testing had been completed on 08/17/2021, and the attestation statement had not been signed by the laboratory director/designee until 10/07/2021. (2) The surveyor reviewed the findings with the laboratory director who stated on 12/13/2021 at 12:03 pm the attestations had been signed approximately two to five months after the proficiency samples had been tested. The surveyor explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: -- 3 of 5 -- Based on a review of records and interview with the laboratory director, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) 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; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for two of four competency evaluations performed. Findings include: (1) On 12/13/2021, the surveyor reviewed records for four persons performing moderate complexity testing in 2020 and to date in 2021 (12 /13/2021). The records showed the evaluations for two of four persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 - The 03/11/2020 and 11/16/2021 evaluations had been performed by a testing person no longer employed in the laboratory (this person had earned an associate degree); (b) Testing Person #4 - -- 4 of 5 -- The 11/02/2020 evaluation had been performed by a testing person no longer employed in the laboratory (this person had earned an associate degree); (2) The surveyor reviewed the records with the laboratory director and explained that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory director stated to the surveyor on 12/13/2021 at 11:20 am, the above evaluations had been performed by an individual who did not meet the educational qualifications of a technical consultant. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/28/19. The laboratory was found in compliance with the CLIA conditions with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 a review of records and interview with the laboratory director, the laboratory director and testing person failed to sign the statement attesting proficiency testing samples were analyzed in the same manner as patient specimens. Findings include: (1) At the beginning of the survey, the laboratory director stated to the surveyor the laboratory performed KOH (Potassium Hydroxide) fungal prep examinations; (2) The surveyor reviewed Microbiology proficiency testing records for the Third 2017 Event; the First, Second, and Third 2018 Events; and the First 2019 Event. From the review, the surveyor identified in 1 of the 5 events reviewed (Third 2018 Event), the attestation statement had not been signed by laboratory director and had not been signed by the testing person who performed the proficiency testing; (3) The surveyor reviewed the findings with the laboratory director, who stated to the surveyor, the laboratory director and the testing person who performed the proficiency testing, had not signed the statement attesting the proficiency samples were tested as patient testing using the laboratory's routine methods. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) 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 -- (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to maintain proficiency testing records for a minimum of two years. Findings include: (1) At the beginning of the survey, the surveyor reviewed Hematology proficiency testing records for the Third 2017 Event; the First, Second, and Third 2018 Events; and the First 2019 Event. The surveyor could not locate the analyzer printouts from 1 of the 5 events reviewed. The analyzer printouts for proficiency samples XE-11, XE-12, XE-13, XE-14, and XE-15 from the Third 2017 Event could not be located; (2) The surveyor asked the laboratory director if the printouts from the Third 2017 Event were available. The laboratory director could not locate the printouts and stated to the surveyor the laboratory failed to maintain proficiency testing records for the Third 2017 Event as required for at least 2 years. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to retain patient records for at least 2 years. Findings include: (1) At the beginning of the survey, the laboratory director stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (e.g., WBC (White Blood Count), RBC (Red Blood Count), Hemoglobin, Hematocrit, Platelet Count, etc.). In addition, the laboratory director stated the the laboratory replaced the Sysmex XS-1000i hematology analyzer on 03/08/18 with the Sysmex XN-550; (2) The surveyor requested analyzer printouts from testing performed on the Sysmex XS-1000i analyzer during 2 randomly selected months (September 2017 and January 2018) for review to verify the laboratory followed the manufacturer's instructions and laboratory policy, for patient CBC results which obtained morphologic flags (e.g., Blasts?, Left Shift?, Atypical Lymph?, etc.); (3) The laboratory director provided patient test result reports from the LIS (Laboratory Information System), but the surveyor was unable to verify that all patient results which obtained flags and messages in the months requested, had been addressed following the manufacturer's instructions; (4) The laboratory director located a thumb drive and a computer disc on which patient test results performed on the Sysmex XS-1000i analyzer had been stored, but the laboratory director could not retrieve the information without the Sysmex XS-1000i analyzer to utilize its software; (5) The surveyor explained to the laboratory director -- 2 of 3 -- the laboratory must retain quality control and patient test records, including instrument printout, and records documenting all analytic systems activities for at least 2 years. -- 3 of 3 --