Ohmc, Pc Dba Columbus Mens Clinic

Summary Statement of Deficiencies 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 record review and an interview with the Senior Director of Clinical Operations in Compliance (SDCOC), the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Consultant (TC) based on the responsibilities of the position and at a frequency determined by the laboratory. This deficient practice had the potential to affect 600 patients tested under the subspecialty of Endocrinology performed from 01/13/2022 to 07/25/2023. Findings Include: 1. Review of the laboratory's Form CMS-209 on 07/25/2023, approved by the Laboratory Director on 06/21/2023, revealed one individual listed and qualified by the Laboratory Director to function as a TC. 2. Review of the laboratory's "Staff Orientation Training and Competency" policy and procedure, signed and dated by the Laboratory Director on 12/02/2022 found no mention of instructions for assessing TC competency assessment. 3. The Inspector requested a TC competency assessment policy and procedure, and TC competency assessment documentation based on the responsibilities of the position from the SDCOC. The SDCOC confirmed the laboratory did not have a TC competency assessment policy and procedure, did not perform a TC competency assessment, and was unable to provide the requested information. The interview occurred on 07/25/2023 at 1:30 PM. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Senior Director of Clinical Operations in Compliance (SDCOC), the laboratory failed to follow their Calibration /Calibration Verification policy and procedure. This deficient practice had the potential to affect 600 patients tested under the subspecialty of Endocrinology from 01 /13/2022 to 07/25/2023. Findings Include: 1. Review of the "Calibration/Calibration Verification" policy and procedure signed and dated by the Laboratory Director on 12 /02/2022 and provided on the date of the inspection, found the following statements: "Calibration Verification For analyzers and analytes that are not calibrated with a minimum of three calibrators verifying the low, midpoint and high end of the reportable range, calibration verification must be performed every six months to substantiate the continued accuracy of the monitors throughout the reportable range, after initial validation studies are performed with the setup of the analyzer." "Calibration verification is performed every six months, as stated in current CLIA and State regulations" 2. The inspector requested the calibration verification documentation for 2022 and 2023 from the SDCOC. 3. The SDCOC confirmed the laboratory did not perform any calibration verification for 2022 and 2023 as required, and was unable to provide the requested documentation. The interview occurred on 07 /25/2023 at 3:10 PM. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Clinic Manager (CM), the laboratory failed to follow their General Maintenance policy and procedure for monitoring and documenting room temperature and humidity conditions for reliable Qualigen FastPack IP testing procedures. All Qualigen FastPack IP testing procedures performed in this laboratory from 12/01/2021 to 01/13/2022 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the "FastPack IP System Product Specifications" document provided on the date of the inspection, found the following statements: "Ambient Operating Temperature: 15C (59F) to 32C (90F)" "Operating Humidity: 10% to 80% relative humidity" 2. Review of the laboratory's policy and procedure manual titled "General Laboratory Policy and Procedure Manual", signed and dated by the LD on 11/18/2021 found the following statement: "3. Read and record each day of operation the room temperature and humidity for the laboratory." 3. The Inspector requested the laboratory's temperature and humidity documentation from 12/01/2021 to 01/13/2022 from the CM. The CM confirmed the laboratory did not document laboratory temperatures and humidity conditions consistent with the manufacturer's instructions and was unable to provide the requested documentation on the date of the inspection. The interview occurred 01 /13/2022 at 10:45 AM. C; degrees Celsius F; degrees Fahrenheit D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and an interview with the Clinic Manager (CM), the laboratory failed to, each day of patient testing, perform and document quantitative testosterone quality control (QC) procedures, to include two levels of QC material of different concentrations. This deficient practice had the potential to affect two out of two patients tested under the sub-specialty of endocrinology. Findings Include: 1. Review of the laboratory's policy and procedure manual titled "General Laboratory Policy", signed and dated by the LD on 11/18/2021 found the following statement: "Quality Control Assessment Immunoassay (Qualigen FastPack) 1. Two valid levels of quality control results must be obtained by running Qualigen Control 1 & 2 control prior to running patient samples and after any daily maintenance has been performed. Because this test is FDA classified as moderately complex, two levels of control are required each day of patient testing." 2. Review of the laboratory's December 2021 "Quality Control Chart", provided on the date of the inspection, found the laboratory did not perform and document two levels of testosterone QC material on the Qualigen FastPack IP system on 12/09/2021 and 12/30/2021. 3. The Inspector requested documentation of two levels of testosterone QC material on the Qualigen FastPack IP system for 12/09/2021 and 12/30/2021 from the CM. The CM confirmed the laboratory did not test and document two levels of testosterone QC materials on the Qualigen FastPack IP system as required, and was unable to provide the requested documentation on the date of the inspection. The interview occurred 01/13/2022 at 11: 00 AM. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record reviews and an interview with the Clinic Manager (CM), the laboratory failed to include on the final test report the units of measure for patient testosterone results. This deficient practice had the potential to affect 300 out of 300 patients tested from 12/08/2021 to 01/13/2022 under the sub-specialty of endocrinology. Item 1 Findings Include: 1. Review of one out of one of the laboratory's final test reports for patient results did not find any units of measure or cutoff values. 2. The CD confirmed the laboratory did not include any units of measure for any patient testosterone test results on the final test report. The interviews -- 2 of 3 -- occurred on 01/13/2022 at 11:30 AM. Based on record reviews and an interview with the Clinic Manager (CM), the laboratory failed to include on the final test report the test result for testosterone. This deficient practice had the potential to affect 300 out of 300 patients tested from 12/08/2021 to 01/13/2022 under the sub-specialty of endocrinology. Item 2 Findings Include: 1. Review of one out of one of the laboratory's final patient test reports did not find a testosterone result for the ordered test. 2. The CM confirmed the laboratory did not include results for patient testosterone on the final test report. The interview occurred 01/13/2022 at 11:30 AM. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and an interview with the Clinic Manager (CM), the Laboratory Director (LD) failed to ensure one out of one Testing Personnel (TP) was trained and had demonstrated they could perform testing procedures reliably to provide and report accurate results prior to performing patient testing. This deficient practice had the potential to affect 300 out of 300 patients tested from 12/08/2021 to 01/13/2022 under the sub-specialty of endocrinology. Findings Include: 1. Review of the laboratory's policies and procedures, approved and signed by the LD on 11/18 /2021, and provided on the date of the inspection, found the following statement: "Initial Training Initial training on individual analyzers, equipment, test methods and kits must be documented. Document initial training competency at the completion of each training activities. Document all initial instrument orientation on the Personnel Training Checklist and the New Employee Checklist." 2. The Inspector requested the laboratory's "Personnel Training Checklist" and the "New Employee Checklist" for Testing Personnel (TP) #1 from the CM. The CM confirmed the laboratory did not document training or initial demonstration of competency in order to reliably provide and report accurate results prior to patient testing for TP #1 and was unable to provide the requested documentation on the date of the inspection. The interview occurred 01 /13/2022 at 10:24 AM. -- 3 of 3 --