Salt Lake County Health Department

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API), laboratory records, and an interview with the laboratory director on 12 /07/2021, the laboratory failed to test gram stain proficiency samples in the same manner as patient samples are tested. The laboratory performs approximately 340 gram stains annually. The findings include: 1. A review of PT for gram stain from API Bacteriology 2019 event one, API Bacteriology 2019 event three, and API Bacteriology 2020 event one, the laboratory personnel records identified that five out of five laboratory testing personnel performed PT prior to the due date for the PT event. 2. Laboratory procedure covering proficiency testing states PT samples are to be tested by other staff after the PT results are back. 3. An interview with the laboratory director on 12/07/2021 at approximately 11:00 AM, confirmed that the laboratory tested the sample multiple times before the due date for the PT event. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory director, the laboratory failed to have a policy or procedure to assess the competency of testing personnel who performed gram stain tests. The laboratory performed approximately 240 microscopic tests annually. Findings include: 1. A review of the laboratory procedures revealed the laboratory failed to have a procedure or policy to assess the competency for three out of three current testing personnel. 2. An interview on 12/07/2021, at 11:00 AM, with the laboratory director, confirmed the laboratory failed to have a policy or procedure to assess the competency for testing personnel. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, direct observation, and interview with testing personnel, room temperature of the laboratory was not monitored where the Accra Lab gram stains were being performed. The laboratory performs approximately 240 gram stain tests annually. Findings include: 1. Accra Lab gram stain set requires reagents to be stored at 15-30 C. KOH reagent requires to be stored at a 15-35 C. 2. Record review did not include recorded room temperature log. 3. There was no written policy for the monitoring of room temperature. 4. No thermometer was present in the rooms where reagents were stored during observation on 12/07/2021 at approximately 11:00 AM. 5. In an interview on 12/07/2021 at approximately 11:45 PM, testing personnel confirmed room temperature was not monitored in rooms where reagents were stored. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation and interview with testing personnel, reagents were not properly labeled. The laboratory performs approximately 90 microscopic potassium hydroxide and direct wet mount preparations tests annually. Finding include: 1. Direct laboratory observation 12/07/2021 at approximately 12:30 PM, found that two out of -- 2 of 3 -- two bottles of saline were not labeled with their contents, storage requirements, preparation, and expiration dates. 2. In an interview on 12/07/2021 at approximately 12:45 PM, testing personnel confirmed that the bottles of saline were not properly labeled. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory failed to check quality controls for potassium hydroxide (KOH) for each new lot number and shipment of KOH reagent. The laboratory performs approximately 90 microscopic KOH tests annually. Finding include: 1. The KOH Quality Control procedure states that each new lot of KOH should be tested with a positive and negative control. 2. Record review on 12/07/2021 at approximately 11:19 AM, revealed that positive and negative controls were not tested with each new lot of KOH. 3. In an interview on 12/07/2021 at approximately 11:30 AM, the laboratory director confirmed that quality controls were not evaluated with each new lot of KOH. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on quality assessment documentation review, lack of documentation, and interview with staff, the laboratory failed to verify potassium hydroxide (KOH) and saline wet preparations (wet prep) test accuracy at least twice annually for 1 of 2 years reviewed (2018). The laboratory performed approximately 500 tests per year. Findings include: 1. Quality assessment records failed to include KOH and wet prep accuracy verification in 2018. 2. In an interview on 01/07/2019 at approximately 5:10 P.M., the laboratory director stated the laboratory did not verify KOH and Wet Prep testing in 2018. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on reagent records review, lack of documentation, quality assessment plan review, and interview with staff, the laboratory failed to follow policy to review reagent records that document the dates reagents were no longer in use to ensure patient testing was performed with reagents that were not expired. 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 -- performed approximately 1000 Gram's Stains, potassium hydroxide, and saline wet preparations per year using 5 staining reagents for Gram's stains and 2 reagents for KOH and Wet prep tests. Findings include. 1. Reagent records review included logs for testing personnel to record the date the reagents were received, lot numbers, expiration dates, dates in use and the date the reagent was taken out of use or finished. 2. The laboratory failed to record the dates reagents were taken out of use or the dates replacement reagents were put into use to document that expired reagent were not used beyond their expiration dates for KOH lot numbers 6240 expiration date of 08/20 /2018, saline lot number 16182 expiration date 06/20/2017. 3. The laboratory quality assessment procedure review included a plan for the laboratory director to review reagent records every two weeks to ensure documentation was maintained. The laboratory reagent logs failed to include documentation the reagent records were reviewed every 2 weeks. 4. In an interview with the laboratory director on 01/07 /2019, the director confirmed the laboratory had not maintained reagent record documentation. -- 2 of 2 --