Dermatologists Of Southwest Ohio

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 Practice Manager, the laboratory failed to follow a written policy and procedure to assess competency of the Testing Personnel (TP) #8 as specified in the personnel requirements in subpart M. This deficient practice had the potential to affect all patients tested at this laboratory in the subspecialty of histopathology from 03/09/2022 to 08/31/2022. Findings Include: 1. A virtual review of the laboratory's CMS-209 Personnel Report form, approved and signed by the Lab Director on 08/30/2022, found eight individuals listed as TP. 2. A virtual review of the laboratory's "Competency Assessment Policy" found the following: "...3. During the employment with DGC/DOCS, a competency assessment will be performed: a. Initially b. 6 months c. yearly..." 3. A virtual review of the laboratory's Competency Assessment documentation, failed to find evidence of an initial competency assessment for TP #8. 4. An email with the Practice Manager, on 09 /01/2022 at 10:40 AM, confirmed that the laboratory failed to perform an initial competency assessment for TP #8 after the hire date of 03/09/2022 and prior to patient testing. 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. 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 -- This CONDITION is not met as evidenced by: Based on record reveiw and an email interview, the laboratory failed to ensure Testing Personnel (TP) #8 met the qualification requirements of 493.1489 for high complexity testing. This deficient practice had the potential to affect all patients tested in the subspecialty of histopathology from 03/09/2022 to 08/31/2022. Findings Include: 1. The laboratory failed to ensure TP #8 met the high complexity testing personnel qualification requirements. (Refer to 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 have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the -- 2 of 3 -- factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (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; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and an email interview, the laboratory failed to ensure Testing Personnel (TP) #8 met the appropriate educational requirements. This deficient practice had the potential to affect all patients tested under the subspecialty of histopathology from 03/09/2022 to 08/31/2022. Findings include: 1. Review of the CMS-209 Personnel Report Form found TP #8 listed as testing personnel under the subspeciality of histopathology. 2. Review of education documents failed to find the 60 semester equivalent credit hours to qualifiy as having an associates degree. 3. The Practice Manager confirmed via an email, sent 09/01/2022 at 10:40 AM, that the lab failed to ensure TP #8 met the educational requirements for high complexity testing. -- 3 of 3 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: REPEAT Based on a review of a test record and staff interview, the laboratory failed to ensure that the identity of testing personnel were provided on test records. Findings were as follows: 1. A review of a test record revealed that the identity of the testing person was not indicated. This person performs the grossing of tissue, to include tissue orientation, mapping and inking prior to processing of tissue for pathology examination procedure. 2. The above finding was confirmed by interview with testing person #2 on 06/25/2018 at 2:30 PM. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personal (TP), the laboratory failed to indicate the date when the test procedures were performed on the final test report. Findings include: 1. Review of one test report did not find the date when the test procedure occurred. 2. TP#2 confirmed the laboratory did not indicate the test date on the test reports. The interview occurred on 06/25/2018 2:30 PM. -- 2 of 2 --