Dermatologists Of Southwest Ohio

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: ITEM 1 Based on record review and an interview with Testing Personnel (TP)#2, the laboratory failed to establish and follow written policies and procedures for specimen acceptability and rejection of tissue specimens collected for testing. This deficient practice had the potential to affect 3,022 out of 3,022 patients tested under the subspecialty of Histopathology from 03/09/2023 through 05/06/2025. Findings Include: 1. Review of the laboratory's policy and procedure manual titled "Grove City Mohs Manual & Competency Evaluations", approved via signature and date by the Laboratory Director on 02/24/2025, did not find any mention of policies and procedures for specimen acceptability and rejection of tissue specimens. 2. The inspector requested policies and procedures for specimen acceptability and rejection of tissue specimens collected for testing from TP#2. TP#2 confirmed the laboratory did not have written policies and procedures for specimen acceptability and rejection of tissue specimens and was unable to provide the requested information. The interview occurred on 05/07/2025 at 9:50 AM. ITEM 2 Based on record review and an interview with Testing Personnel (TP)#2, the laboratory failed to establish and follow written policies and procedures for the conditions of tissue specimen transportation. This deficient practice had the potential to affect 3,022 out of 3,022 patients tested under the subspecialty of Histopathology from 03/09/2023 through 05 /06/2025. Findings Include: 1. Review of the laboratory's policy and procedure 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 -- manual titled "Grove City Mohs Manual & Competency Evaluations", approved via signature and date by the Laboratory Director on 02/24/2025, did not find any mention of policies and procedures for tissue specimen transportation. 2. The inspector requested policies and procedures for specimen transportation from TP#2. TP#2 confirmed the laboratory did not have written policies and procedures for tissue specimen transportation and was unable to provide the requested information. The interview occurred on 05/07/2025 at 9:50 AM. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and an interview with the Office Manager, the laboratory failed to retain quality control records for at least 2 years. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of quality control records for 2017-2018 found no quality control documentation prior to January 2018. 2. An interview with the Office Manager, on 10/1/18 at 10:12 am, confirmed that quality control records prior to January 2018 could not be produced. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and an interview with the Office Manager, the laboratory failed to retain MOHs proficiency testing records for at least 2 years. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of MOHs proficiency testing records for 2017-2018 found no MOHs proficiency testing documentation prior to January 2018. 2. An interview with the Office Manager, on 10/1/18 at 10:12 am, confirmed that MOHs proficiency testing documentation prior to January 2018 could not be produced. 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 --