Emw Womens Surgical Center

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on staff interview and record review of proficiency testing results from the American Proficiency Institute (API) proficiency testing agency, on 02/20/2020, the laboratory failed to ensure proficiency testing samples were tested by all testing personnel who routinely perform patient testing for Complete Blood Count (CBC) analysis. The findings include: 1. There was no evidence of Testing Personnel #2, Testing Personnel #3, and Testing Personnel #4 listed on the CMS Form 209 testing proficiency samples for three (3) testing events in 2018 and three (3) testing events in 2019. 2. Testing personnel acknowledged in an interview at 10:08 AM, on 02/20 /2020, the laboratory failed to have a system to ensure proficiency testing samples were rotated among all testing personnel responsible for patient testing. 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 staff interview and record review on 02/20/2020, the Laboratory Director failed to perform and document annual competency using the six (6) mandated 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 -- competency assessment requirements for testing personal. Competency assessment was not performed using six (6) methods of assessment for four (4) out of four (4) employees from 03/07/2018 through 02/19/2020. Findings include: 1. Record review on 02/20/2020, revealed there was no documented competency assessments for Complete Blood Count (CBC) testing and Rhesus (Rh) typing from 03/07/18 through 02/19/2020, for four (4) employees that included the following: competency assessments failed to include direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results. In addition, there was not documented evidence the facility reviewed of worksheets, reviewed of quality control records, reviewed proficiency test results, reviewed maintenance records, the assessment of testing external proficiency testing samples and problem solving skills. An interview with the testing staff on 02/20/2020 at 9:30 AM revealed the facility failed to have a system in place between 03/07/18 through 02/19/2020 to ensure competency was performed using all six (6) mandated competency assessment requirements. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the American Proficiency Institute on 10/02/2018, the laboratory failed to successfully participate in the Red Blood Cell certified analyte in two consecutive testing events. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the American Proficiency Institute 10/02/2018, the laboratory failed to attain a satisfactory score of at least 80 percent on the Red Blood Cell analyte. Findings include: The laboratory scored an unsatisfactory 60 percent in the first testing event of 2018 and scored an unsatisfactory 40 percent in the second testing event of 2018. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency test results from the American Proficiency Institute on 10/02/2018, the laboratory failed to successfully achieve satisfactory performance for the Red Blood Cell certified analyte in two consecutive testing events. Findings include: The facility scored 60 percent in the first testing event of 2018 and scored 40 percent in the second testing event of 2018 for an unsuccessful performance. -- 2 of 2 --