Lucas County Regional Health District

Summary Statement of Deficiencies D0000 A revisit was conducted on 05/07/2025 at Lucas County Regional Health Distict 36D0674771 for all previous deficiencies cited on 04/29/2025. All deficiencies have been corrected and no new noncompliance was identified. The laboratory is in compliance with the Conditions of Participation at 42 CFR Part 493, Laboratory Requirements. 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 record review and an interview with the Director of Health Services, the laboratory failed to enroll in a proficiency testing (PT) program for the wet prep test system in the subspecialties of Mycology and Parasitology. This deficient practice had the potential to affect 34 out of 34 patients tested under the subspecialties of Mycology and Parasitology from 01/01/2025 through 04/29/2025. Findings Include: 1. The laboratory failed to enroll in a PT program for wet prep test system in the subspecialties of Mycology and Parasitology. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(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 -- The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; and This STANDARD is not met as evidenced by: Based on record review and an interview with the Director of Health Services, the laboratory failed to enroll in a proficiency testing (PT) program for the wet prep test system in the subspecialties of Mycology and Parasitology. This deficient practice had the potential to affect 34 out of 34 patients tested under the subspecialties of Mycology and Parasitology from 01/01/2025 through 04/29/2025. Findings Include: 1. Review of the "Wet Prep Manual" signed and dated by the Laboratory Director on 04/15/2024, failed to find policies and procedures for enrollment in a PT program for the wet prep test system in the subspecialties of Mycology and Parasitology. 2. The inspector requested the 2025 PT records for the wet prep test system in the subspecialties of Mycology and Parasitology from the Director of Health Services. 3. The Director of Health Services confirmed the laboratory was not enrolled with an HHS approved PT provider for the wet prep test system in the subspecialties of Mycology and Parasitology and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 04/29/2025 at 1:59 PM. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interviews with the Technical Consultant (TC) and the Testing Personnel (TP), the laboratory failed to establish and verify performance specifications of the Chembio DDP HIV-Syphilis test system before reporting patient test results. This deficient practice had the potential to affect 10 patients, tested from 05/27/2021 through 06/29/21, in the sub-specialties of General Immunology and Syphilis Serology. Findings Include: 1. A virtual review of the laboratory's policies and procedures, on 07/14/2021, found the following statement: "Chembio DPP HIV - Syphilis Rapid Test Pilot Project. The Toledo Lucas County Health Department has been given an HIV-Syphilis Rapid Test Pilot Project. They are the first organization to do this testing in Ohio. We were given 20 free tests at no charge to the patient. We will decide later if we will coniue and buy the tests. This is non-waived testing." 2. A virtual review of the laboratory's policies and procedures, on 07/14/2021, found manufacturer's instructions for the Chembio DDP HIV-Syphilis test. 3. A virtual review of laboratory records, on 07/14/2021, found Quality Control (QC) performed for the Chembio DDP HIV-Syphilis test: "Chembio DDP HIV-Syphilis External Quality Control... Date HIV Syphilis 05/17/21 ( - ) ( - ) 05/17/21 ( + ) ( + ) 05/21/21 ( + ) ( + )" 3. A virtual review of the laboratory's patient reports, on 07/14/2021, found the following 10 patients tested for HIV and Syphilis using the Chembio DDP HIV- 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 -- Syphilis test: "Patient Date HIV Results Syphilis Results 1 5/27/21 NR NR 2 6/7/21 NR NR 3 6/9/21 NR NR 4 6/9/21 NR NR 5 6/11/21 NR R 6 6/18/21 NR NR 7 6/21 /21 R R 8 6/22/21 NR NR 9 6/28/21 NR NR 10 6/29/21 NR R" (NOTE: Per manufacturer's instructions: "NR" is non-reactive; "R" is reactive.) 4. A virtual review of the laboratory's records, on 07/14/2021, failed to find evidence that the laboratory established and verified the performance specifications for the Chembio DDP HIV- Syphilis test prior to reporting patient results. 5. An video phone call interview with the TC and TP, on 07/20/2021 at 10:47 AM, confirmed that the laboratory failed to establish and verify performance specifications for the Chembio DDP HIV-Syphilis test prior to reporting patient results. -- 2 of 2 --

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 Technical Consultant (TC), the laboratory failed to establish and follow a written policy and procedure to assess competency of the TC, as specified in the personnel requirements in subpart M. All patients tested at this laboratory have the potential to be affected. Findings Include: 1. Review of the laboratory's CMS-209 Personnel Report form, approved and signed by the Lab Director on 5/15/19, found 1 person serving as TC. 2. Review of the laboratory's Competency Assessment policy and procedure failed to find a policy and procedure for assessing the competency of the TC based on the regulatory responsibility of that role, at a frequency determined by the laboratory. 3. Review of the laboratory's Competency Assessment documentation, failed to find evidence that the TC was assessed for competency, based on the regulatory responsibility of that role, at a frequency determined by the laboratory. 4. An interview with the TC, on 5/20 /19 at 1:20 pm, confirmed that the lab did not have a policy, procedure, or documentation for assessing the competency based on the regulatory responsibility of those roles, at a frequency determined by the laboratory. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon a record review and an interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to specify the duties and responsibilities of the TC listed on the CMS-209. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of the CMS-209 form found 1 individual listed as performing duties of a TC. 2. Review of policies and procedures failed to find evidence that the duties and responsibilities of the TC were specified in writing by the laboratory director. 3. An interview with the TC, on 5/20/19 at 1:20 pm, confirmed that the LD failed to specify the duties and responsibilities of the TC in writing. -- 2 of 2 --