Grove City Hospital Outpatient Services

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 review of the laboratory's procedure and interview with the Technical Consultant (TC) , the laboratory failed to have a complete policy to assess the competency of 3 of 3 Testing Personnel (TP) who performed complete blood count (CBC) from 12/07/2019 to the day of survey. Findings Include: 1. On the day of survey 12/07/2021 at 09:00, The technical supervisor could not provide a complete competency assessment procedure that includes the six points of CLIA to assess 3 of 3 TP from 12/07/2019 to 12/07/2021. 2. The TC confirmed the finding above on 12/07 /2021 at 11:00 a.m. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Consultant (TC), The TC failed to evaluate the test performance of 1 of 3 testing personnel (TP) through internal blind testing samples or external PT samples for complete blood count (CBC) examinations 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 in 2020 and 2021. Findings Include: 1. On the day of survey, 12/07/2021 at 09:10 a.m., review of API PT records revealed, 1 of 3 TP (TP#1) did not perform in external PT samples for CBC examinations for 3 of 3 events in 2020 and 3 of 3 events in 2021. 2. The manager could not provide documentation of internal blind testing evaluations performed for 1 of 3 TP (TP# 1) for CBC examinations performed in 2020 and 2021. 3. The TC confirmed the findings above on 12/07/2021 at 11:00 a.m. -- 2 of 2 --

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: By review of the competency records and personnel interview of the Testing Personnel and Technical Consultant, on (07/18/2019), the Technical Consultant failed to document Testing Personnel competency at least annually for one of two years, (01 /10/2018 through 01/10/2019). Findings include: 1. The Testing Personnel competency was last documented 01/10/2018. 2. During the survey (14:00 07/18 /2019)) the Technical Consultant confirmed that no Testing Personnel competency assessment was performed in 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --