Osu - Clinical Laboratory

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/24/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and testing person #1 during an exit conference performed at the conclusion of the survey. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency testing program for two of three MGEN (Mycoplasma genitalium, Molecular) events reviewed in 2022 and 2023. Findings include: (1) On 10/24/2023 a review of MGEN proficiency testing records for 2022 and 2023 identified the following for two of three events: (a) First 2022 Event (MGEN-A 2022) -Three of three results had not been graded by the proficiency testing program (samples MGEN- 01, MGEN-02, and MGEN-03). There was no documentation to prove the laboratory performed a self-evaluation of the non-graded results; (b) Second 2022 Event (MGEN- B 2022) -Three of three results had not been graded by the proficiency testing program (samples MGEN-04, MGEN-5 and MGEN-06). There was no documentation to prove the laboratory performed a self-evaluation of the non-graded results. (2) The records were reviewed with the laboratory director who stated on 10/24/2023 at 01:30 pm, the laboratory had not performed a self-evaluation to evaluate the results that were not graded by the 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 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/07/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory directory, lead laboratory technologist, and testing person #3 at the conclusion of the survey. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the lead laboratory technologist, the laboratory failed to follow their written protocol for ensuring the centrifuge was functioning properly for 3 of 3 years. Findings include: (1) On 10/07 /2021 at 09:50 am, the lead laboratory technologist stated the following to the surveyor: (a) HIV (Human Immunodeficiency Virus) testing was performed using the Hologic Panther analyzer; (b) Patient specimens were processed in the Fisher Scientific Accuspin 24C centrifuge at a speed of 4500 rpm (revolutions per minute) for 10 minutes. (2) The surveyor reviewed the policy titled, "Centrifuge Calibration SOP" which stated, "Evaluate and document the performance of the centrifuge annually"; (3) The surveyor reviewed the centrifuge records from 2019 through 2021. The records showed that, although the centrifuge speed and timer checks had been performed on 07/25/2019, 07/01/2020, and 06/29/2021; the results for the speed and 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 -- timer checks had not been documented to ensure the centrifuge was processing specimens at the appropriate speed and time; (4) The surveyor reviewed the findings with the lead laboratory technologist who stated on 10/07/2021 at 12:00 pm, the results for the centrifuge speed and timer checks had not been documented as stated above. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead laboratory technologist, the technical consultant failed to ensure that persons performing moderate complexity testing had been evaluated semiannually during the first year of testing for two of two persons hired after the previous recertification survey. Findings include: (1) The surveyor reviewed personnel records. The following was identified: (a) Testing Person #1 - The initial training for this person was completed on 10/05/2020. There was no evidence that a semiannual evaluation had been performed (the next competency evaluation had been performed on 10/01/2021); (b) Testing Person #3 - The initial training for this person was completed on 10/07/2019. There was no evidence that a semiannual evaluation had been performed (the next competency evaluation had been performed on 10/05/2020). (2) The surveyor reviewed the records with the lead laboratory technologist, who stated on 10/07/2021 at 10:40 am, there were no records to prove the above persons had been evaluated semiannually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed 07/18/19. The findings were reviewed with technical supervisor/general supervisor and the testing person during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1453; D6134 : Clinical Consultant - High Complexity 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 technical supervisor/general supervisor and the testing person, the laboratory failed to ensure attestation statements had been signed by the laboratory director. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018 and 2019 proficiency testing records. The attestation statement for the 2018 Third Chlamydia/Neisseria Gonorrhoeae Event (HCG-C) had not been not signed by the laboratory director; (2) The surveyor reviewed the findings with the technical supervisor/general supervisor and the testing person, and explained that attestation statements must be signed by a qualified laboratory director. 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 -- D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures and interview with the testing person, the laboratory failed to define a function check protocol to ensure the centrifuge was functioning properly. Findings include: (1) At the beginning of the survey, the testing person stated to the surveyor HIV (Human Immodeficiency Virus) viral load was performed in the laboratory. The specimens were processed in the Fisher Scientific accuSpin 24C centrifuge at a speed of 4500 rpm (revolutions per minute) for 10 minutes; (2) The surveyor reviewed the policy and procedure manual and could not locate a function check protocol that defined how often function check (speed and timer check) were to be performed on the centrifuges; (3) The surveyor asked the testing person if the laboratory had a function check protocol for the centrifuge. The general supervisor/testing person #1stated to the surveyor the laboratory did not have a policy to check the speed and timer of the centrifuges. D6134 CLINICAL CONSULTANT CFR(s): 493.1453 The laboratory must have a clinical consultant who meets the requirements of 493. 1455 of this subpart and provides clinical consultation in accordance with 493.1457 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the technical supervisor/general supervisor and the testing person, the laboratory failed to have a clinical consultant who meets the qualification requirements of 493.1457 of this subpart. Findings include: (1) The laboratory did not have a qualified clinical consultant for high complexity testing. Refer to D6135. D6135 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1455 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1443(b)(1), (2), or (3)(i) or, for the subspecialty of oral pathology, 493.1443(b)(6); or (b) Be a doctor of medicine, doctor of osteopathy, doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical supervisor/general supervisor and the testing person, the laboratory failed to have a qualified clinical consultant for high complexity testing. Findings include: (1) At the beginning of the survey, the technical supervisor/general supervisor and the testing person stated the laboratory performed high complexity testing (i.e. Trichomonas vaginalis, HIV (Human Immunodeficiency Virus) Viral Load, Chlamydia trachomatis and Neisseria gonorrhea testing) using the Panther System; (2) The surveyor reviewed Form CMS- 209 (Laboratory Personnel Report) that had been completed prior to the survey by laboratory personnel; (3) The surveyor requested proof (state medical license) that the clinical consultant qualified to consult a laboratory performing high complexity testing. Proof could not be provided by the end of the survey; (4) The surveyor corresponded with the laboratory following the survey to provide evidence of qualifications and the laboratory failed to obtain documentation. NOTE: The regulations for clinical consultant for high complexity are as follows: *Be qualified as a laboratory director under 493.1443(b)(1), (2), or (3)(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. -- 3 of 3 --