Washington Surgi-Clinic,The

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the quality controls (QC), temperature logs, and interview with the testing person (TP), the lab director (LD) failed to perform quality assessment (QA) procedures for all areas of the laboratory. Findings: 1. The laboratory performs Red Cell Rh testing and syphilis testing. 2. Review of QC and temperature logs showed the logs were not reviewed by LD to maintain QA procedures. 3. The TP stated that at the time of the survey on April 27th at 1:00 PM that the LD reviews patient test logs for QA but was not aware that he needed to review QC and temperature logs. 4. The TP confirmed that QA reviews of QC and temperature logs were not performed by the LD. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory (lab) did not include the results of both serum controls for the Rh positive and Rh negative control. Findings: 1. The quality control worksheet has only one column to record the serum control results, even though both the Rh (D) positive control and the Rh (D)negative control both have a serum control test; and 2. This was confirmed with the staff during interview at approximately 2:00 p.m. on the day of survey. 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 --