Women's Care Of Alaska

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) (c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of procedures and policies and interview with testing personnel one (TP1), the laboratory failed to provide instructions for laboratory specific specimen handling, processing, and reporting for BD Affirm VPIII, Fern testing, and Wet Mounts. The findings include: 1. Review of testing procedures revealed the laboratory is using the manufacturer instructions or other microscopy procedures approved by the laboratory director. a. Review of the BD Affirm VPIII procedure revealed a lack of instructions for specimen labeling and handling, performing controls,

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of competency assessment records and an interview with Testing Person 1 (TP1), the laboratory failed to assess the competency of eight of eight testing persons who perform wet mounts in 2021 and 2022. Findings include: 1. A request was made to review documentation of wet mount competency assessments and documentation could not be provided. 2. An interview conducted on September 11, 2023 at 11:30 AM with TP1, confirmed that the laboratory did not have written documentation of wet mount competency assessments. 3. The laboratory reports performing approximately fifty wet mounts annually. 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 D0000 The laboratory is in substantial compliance with CLIA regulation (42 CFR, Part 493, effective April 24, 2003). No deficiencies were cited. 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 --