Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director (LD), the laboratory failed to provide an eyewash station in the area where testing was performed. Findings: 1. It was observed that the area where testing was performed did not contain an eyewash station to aid in flushing out the eyes of testing personnel should they be splashed with cleaning solutions, testing reagents, or patient specimens. 2. During the exit interview on 08/19/2021 at 11:25 AM, the LD confirmed that there was no eyewash station in the laboratory testing area. 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 review of records and proficiency testing (PT) documentation, the laboratory failed to verify the accuracy of group A Streptococcus (GAS) screening cultures for vaginal and rectal specimens at least twice annually. Findings: 1. The laboratory's throat culture log was reviewed from 11/25/2020 - 08/17/2021. In this time the laboratory cultured 3 vaginal specimens and 7 rectal specimens for GAS screening which were documented on the throat culture log. 2. The laboratory's PT 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 -- records showed that the laboratory was enrolled in PT for throat cultures, but not for cultures of vaginal and rectal specimens. 3. The laboratory did not verify the accuracy of culturing vaginal and rectal specimens for GAS screening at least twice annually. 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 and interview with the laboratory director (LD), the laboratory failed to ensure that culture media was not used past their expiration date. Findings: 1. The laboratory used Selective Strep Agar (SSA) for throat culture screening and dermatophyte test medium (DTM) for dermatophyte culture screening. 2. Patient results were recorded on throat culture and fungal screening logs that included the lot number and expiration dates of the culture media that was used for each patient specimen cultured. 3. The throat culture log was reviewed from 05/2020 - 08/2021. The log showed that SSA lot number 19630 had an expiration date of 10/04 /2020, but was used to culture 9 patient specimens from 10/06/2020 - 10/22/2020 and lot number 455923 had an expiration date of 05/12/2020, but was used to culture 6 patient specimens from 05/14/2020-06/02/2020. 4. The fungal screening log was reviewed from 01/2021 - 08/2021. The log showed that DTM lot number 917802 had an expiration date of 01/06/2021, but was used to culture 17 patient specimens from 01 /15/2021-08/03/2021. 5. During the exit interview on 08/19/2021 at 11:25 AM, the LD confirmed that the throat culture and fungal screening logs recorded SSA and DTM being used past their expiration date. -- 2 of 2 --