Cornerstone Care Ped Ctr Of Washington

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on lack of competency assessment (CA) records and interview with the Medical Assistant (MA), the Technical Consultant (TC) failed to assess the competency of 2 of 3 Testing Personnel (TP) who performed throat culture examinations in 2020. Finding Include: 1. On the day of survey, 2/16/2022 at 11:46 a. m., The MA could not provide CA records for 2 of 3 (CMS 209 Personnel #2 and #3) who performed throat culture examinations from 1/1/2020 to 12/31/2020 2. The laboratory performed 47 throat cultures annually. 3. The MA confirmed the findings above on 2/16/2022 at 02:00 p.m. 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 --

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: Based on review of the competency records and personnel interview of the Testing Personnel #1 and the Practice Manager, on (08/15/2019), the Technical Consultant failed to document Testing Personnel competency at least annually for one of two years, (04/26/2018 through 08/15/2019). Findings include: 1. The Testing Personnel competency was last documented 04/25/2018. 2. 6 of 6 Testing Personnel competency assessments were not found for 2019. 3. During the survey (14:10 08/15/2019) the Practice Manager confirmed the above findings. 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 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of the quality control records and personnel interview with the Practice Manager and Testing Person 1, the laboratory failed to check each batch or shipment of Selective Strep Agar media, for inhibition of non streptococcus organisms, before or concurrent with initial use.. Findings: 1. Ability to inhibit growth of non streptococcus organisms was not documented for Strep Selective Agar, from February 2017 through (02/13/2018). 2. During the survey, Testing Person 1 confirmed, ability to inhibit non streptococcus growth, was not performed for the Strep Selective Agar media. 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 --