Scott County Health Department

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observations made during the survey, review of the laboratory's Gram Stain procedure and Hardy Diagnostics Gram Stain Instructions for Use and interview with laboratory personnel identifier #1 (refer to the Laboratory Personnel Report); the laboratory failed to follow manufacturer's instructions for performing gram stains as specified in D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of the laboratory's Gram Stain procedure and Hardy Diagnostics Gram Stain Instructions for Use, and interview with laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:45 am on 9/5/2024 the laboratory failed to perform gram stain testing following the manufacturer's instructions for two out of two years from 9/5 /2022 - 9/5/2024. The findings include: 1. On 9/5/2024 a tour of the laboratory 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 -- revealed that the laboratory used the Hardy Diagnostics gram stain kit (lot number A4331, expiration date 5/31/2025). 2. The Hardy Diagnostics Gram Stain Instructions For Use state: *Methanol fix slide by flooding with absolute methanol (95%) 1 - 2 minutes, then tilt the slide to drain off methanol and allow to air dry. DO NOT USE HEAT FIXATION. *Cover slide with Crystal Violet Reagent for one minute. *Rinse slide with deionized or tap water. *Cover slide with iodine reagent for one minute. *Gently rise the slide with deionized or tap water and allow to drain. *Tilt the slide and flood with a few drops of Decolorizer until no violet color runs off. This will usually take 10 seconds or less depending on the thickness of the specimen. Do not over decolorize. *Rinse slide gently with deionized or tap water. *Cover slide with Safranin, Advanced Counterstain, or Basic Fuchsin counterstain for one minute. *Rinse slide gently with deionized or tap water. The rinse water in this step should be slightly pink. Do not wash excessively. *Allow slide to drain and air dry or gently dry with a paper towel. 2. The laboratory's gram stain procedure stated the following steps: *Lab team member will determine whether to air dry smears on a flat surface, or place them on a 60 degree Celectric slide warmer until dry, depending on the amount of specimen. *Flood slide with crystal violet and let sit for 20 - 30 seconds. Rinse with a gentle stream of cool tap water. Gently shake off excess water. *Flood slide with iodine and let sit for 20 - 30 seconds. *Rinse with a gentle stream of cool tap water. Gently shake off excess water. *Flood slide with decolorizing solution until purple no longer runs from the thinnest part of the smear. *Rinse with a gentle stream of cool tap water. Gently shake off excess water. *Flood slide with Safranin and let sit for 20 - 30 seconds. *Rinse with a gentle stream of cool tap water. Gently shake off excess water. *Dry smear by blotting gently on a clean paper towel. 3. The laboratory had discrepancies from the Hardy Diagnostics Gram Stain Instructions For Use that included the smear fixation technique and staining times. 4. Laboratory personnel identifier #1 confirmed that the laboratory either heat fixed gram stain smears or did not fix the smears prior to gram staining. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of patient test reports, the Laboratory Test List & Annual Volume form, and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 10/29/2019, the laboratory failed to indicate the name and address of the testing facility for four out of four patient test reports (patient identifiers A, B, C, and D). The findings include: 1. Patient identifier A had a gram stain performed on 04/12/2019. Patient A also had the following testing performed on 04/17/2019: Reagin antibody, Treponema pallidum antibody, Neisseria gonorrhoeae rRNA (urine), and Chlamydia trachomatis rRNA (urine). 2. Patient identifier B had a gram stain performed on 04/09/2019. Patient B also had the following testing performed on 04/15/2019: Neisseria gonorrhoeae rRNA (throat), Chlamydia trachomatis rRNA (throat), Neisseria gonorrhoeae rRNA (urine), and Chlamydia trachomatis rRNA (urine). 3. Patient identifier C had a wet prep examination performed on 04/12/2019. Patient C also had the following testing performed on 04/17/2019: Neisseria gonorrhoeae rRNA (cervix) and Chlamydia trachomatis rRNA (cervix). 4. Patient identifier D had a wet prep examination performed on 04/30/2019. Patient D also had the following testing performed on 05/06 /2019: Neisseria gonorrhoeae rRNA (throat), Chlamydia trachomatis rRNA (throat), 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 -- Neisseria gonorrhoeae rRNA (cervix), and Chlamydia trachomatis rRNA (cervix). 5. The Laboratory Test List & Annual Volume form indicated the laboratory performed the following non-waived testing: gram stain, potassium hydroxide (KOH) preparation, and wet prep examination. 6. Personnel identifier #5 confirmed that the laboratory sent additional testing to a reference laboratory. 7. Test reports for Patients A, B, C, and D did not include the name and address of the laboratory or the reference laboratory. In addition, the test reports did not identify which tests the laboratory performed and which tests the reference laboratory performed. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's chart audit policy, review of chart audit documentation, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 10/29/2019, the laboratory director failed to ensure that the laboratory maintained the quality assessment program for seven out of seven time periods from 01/01/2018- 09/30 /2019. The findings include: 1. The laboratory's "Practice Fusion Chart Audit Procedure" policy stated, "Chart audits shall be conducted each fiscal year for the following time periods: July 1- September 30; October 1- December 31; January 1- March 31; April 1- June 30." The policy also stated, "Ten percent of the total number of clients seen each quarter shall be audited." 2. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not perform chart audits from 01/01 /2018- 09/30/2019. -- 2 of 2 --