Washington Surgi-Clinic,The

Summary Statement of Deficiencies D0000 The following deficiencies are the result of a desk review of proficiency testing scores obtained from the national database, verified with the proficiency testing company. The facility was found to be out of compliance with the CLIA program's conditions. The following condition level deficiencies were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]. D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. An onsite survey conducted on July 28, 2026 revealed the laboratory was not operational and the survey was not performed. As of 08/05/2026 the laboratory's CLIA certificate was terminated. 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. 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 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the American Proficiency Institute (API) 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three testing events (2025 Events 2 and 3) for ABO/ RHO and D (RHO) type. Refer to D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the American Proficiency Institute (API) 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three testing events (2025 Events 2 and 3) for ABO/ RHO and D (RHO) type). Findings: 1. A review of the CASPER 0155 report revealed the following results: a. API 2025 - 2nd Event - 60% for ABO/ RHO and 60% for D (RHO) type. b. API 2025 - 3rd Event - 0% for ABO/ RHO and 0% for D (RHO) type. 2. A review of API proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the American Proficiency Institute (API) 2026 proficiency testing records, the laboratory failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, the American Proficiency Institute (API) 2025 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory's services. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to: 2162 -- 2 of 2 --

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 --