Pshmg - Lime Spring

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: A. Based on review of the laboratory competency assessment records and interview with the Technical Consultant #1 (TC1), the laboratory failed to establish a complete procedure to assess the competency assessment of 2 of 5 testing personnel (TP) (on the CMS 209 form, listed as personnel #3 and #5) who analyzed urine cultures and throat cultures from 01/01/2020 to 12/31/2020. Findings include: 1. On the day of survey 04/29/2021 at 09:08 a.m., the TC1 could not provide a complete competency assessment policy to assess 2 of 5 TP for the six points of CLIA from 06/27/2019 to the day of survey. 2. Review of the competency assessment records for 2 of 5 TP revealed the laboratory did not document proficiency testing or blind sampling for urine cultures and throat cultures from 01/01/2020 to 12/31/2020. 3. The TC1 confirmed the findings above on 04/30/2021 at 13:15 B. Based on review of laboratory procedure manuals and interview with the Technical Consultant (TC) #1, the laboratory failed to establish a complete competency assessment procedure to assess the competency of 2 of 2 Technical consultants for their regulatory responsibilities from 06/27/2019 to the date of survey. Findings Include: 1. On the day of survey 04/29/2021 at 09:30 a.m., the laboratory could not provide a written procedure to assess the competency assessment of 2 of 2 TC for their regulatory responsibilities from 06/27/2019 to the day of survey. 2. The TC1 confirmed the finding above on 04/29/2021 at 09:35 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 2019 media quality control records and personnel interview with the Laboratory Manager, Clinic Manager, and Clinic Site Administrator, the laboratory failed to check each batch or shipment of BBL Selective Strep Agar media, for inhibition of non streptococcus organisms, before or concurrent with initial use, from 01/02/2019 through 06/27/2019. . Findings: 1. The laboratory media quality control records revealed only Streptococcus group A and Streptococcus non group A, were used for BBL Selective Strep Agar media quality control, from 01/02/2019 through 06/27/2019. 2. The laboratory failed to document the ability to inhibit growth of non streptococcus organisms, BBL Strep Selective Agar, from from 01/02/2019 06 /27/2019. 3. 223 patients had throat cultures performed from from 02 January through 27 June 2019. 4. During the time of the survey (13:00 06/27/2017), the Laboratory Manager 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 --