Public Health-Dayton & Montgomery

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review, direct observation and an interview with the Laboratory Director (LD), the laboratory failed to ensure reagents utilized for the processing of moderate complexity Gram stains were not used when they had exceeded their expiration dates. This deficient practice had the potential to affect 207 out of 207 Gram stain test procedures performed in the subspecialty of Bacteriology between 04 /17/2024 through 07/10/2024. Findings Include: 1. Review of the laboratory's policy and procedure "MEDICAL AND HAZARDOUS WASTE DISPOSAL" approved by the Laboratory Director via signature and date on 01/02/2024 and provided on the date of inspection did not find any instructions to not utilize reagents when they had exceeded their expiration dates. 2. Direct observation of the laboratory's flammable cabinet found three StatLab brand, 1-gallon plastic containers of acetone with the expiration date of 01/31/2024. 3. The LD confirmed the above listed reagents were expired and continued to be utilized for patient Gram stain tests when they had exceeded their expiration dates. The interview occurred on 06/25/2024 at 12:15 p.m. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. 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 the Laboratory Director (LD), the laboratory failed to check and document the positive and negative reactivity of control organisms using gram stains each week of use. This deficient practice had the potential to affect 207 out of 207 Gram stain test procedures performed in the subspecialty of Bacteriology between 04/17/2024 through 07/10/2024. Findings: 1. Review of the policy and procedure "GRAM STAIN" approved by the LD via signature and date on 01/02/2024 did not find any mention of checking and documenting the positive and negative reactivity of control organisms using gram stains each week of use. 2. Review of the "STAT LAB EXTERNAL CONTROL QC LOG-REIBOLD, GRAM STAIN TEST" Gram stain QC log sheet from 04/17/2024 through 06/10/2024 found the following quality control information: "Date QC Code 04/17/2024 New Lot 06/10/2024 Invalid Patient Test" 3. Review of the "Lab Results Analysis Report" log for Gram stains from 04/17/2024 through 07/10/2024 found 207 patients tested. 4. The inspector requested documentation of the positive and negative reactivity of control organisms using gram stains for each week of testing from the LD. The LD confirmed the laboratory failed to check and document the positive and negative reactivity of control organisms using gram stains each week of use and could not provide the requested information. The interview occurred on 06/25/2024 at 11:45 a.m. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of the ongoing mechanism to monitor, assess, and correct problems identified in the postanalytic systems. Findings Include: 1. Review of the laboratory's "Dayton & Montgomery County Policy and Procedures" manual provided on the date of inspection found no mention of general laboratory post analytic quality assessment. 2. The Surveyor requested the laboratory's post analytic quality assessment policy and procedure to include the general laboratory systems and 2016, 2017 and 2018 post analytic general laboratory systems quality assessment documentation from TP#2. TP#2 confirmed the laboratory did not have any post analytic quality assessment policy and procedures established, did not document any post analytic quality assessment activities, and was unable to provide the requested documentation. The interview occurred on 04/09/2018 at 12:00 PM. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's standard operating guidelines, competency assessment documentation, and an interview with the Technical Consultant (TC), the TC failed to evaluate and document the competency, and assure Testing Personnel (TP) maintained their competency to perform moderately complex testing procedures and report test results promptly, accurately, and proficiently. Findings Include: 1. Review of the laboratories standard operating guidelines titled "Public Health-Dayton & Montgomery County "Multiple Divisions" Standard Operating Guidelines for PHDMC Laboratory Competency Assessment" revealed the following statement: "Procedure: 2. Testing is to be performed under the following circumstances: D. Annually for all testing staff 3. The Technical Consultant will be responsible for directly observing Competency Assessment of personnel who perform moderate complexity testing." 2. Review of the laboratory's competency assessment documentation for TP#2 and TP#3, found no 2016 records for TP#2 and TP#3 and no 2017 records for TP#3 as required. 3. The TC confirmed that the laboratory did not assess the competency of TP#2 and TP#3, as required, and was unable to provide the requested documentation on the date of the inspection. The interviews occurred on 04 /09/2018 at 11:06 AM. -- 2 of 2 --