Bellevue Health & Emergency Clinic Inc

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 off-site desk review of the Proficiency Testing (PT) data report (CASPER Report 155) and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte ABO/D(Rho). Refer to D2163. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Proficiency Testing (PT) data report (CASPER Report 155) and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in ABO/D(Rho), in two out of three testing events. Findings are: 1. API 2021 Event 3 for ABO/D(Rho) the score was 80%. 2. API 2022 Event 2 for ABO/D(Rho) the score was 0%. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, lack of documentation and staff interview at 9:50 AM on 3/7/2018, the laboratory failed to monitor room temperature for Rh testing performed. Findings are: 1. Review of the manufacturer's instructions for the Rh typing reagents used by the laboratory revealed mixing the test slide for approximately 30 seconds, then incubate for 5 minutes at 20 to 24 degrees C with occasional mixing prior to reading the results. 2. No documentation of room temperature recordings could be presented at the time of survey for the 2 to 3 days per week of testing performed from January 1 to March 7 2018. 3. The staff person interviewed stated the warming block thermometer had broken in December and the laboratory had switched at that time to a room temperature incubation but failed to monitored the room temperature on testing days. 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 --