Kaiser Permanente Gaithersburg Orthopedics Lab

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the testing area and interview with the testing personnel (TP) and technical consultant (TC), the laboratory did not ensure the safety of the laboratory staff while performing testing. Findings: 1. According to the TP, testing was being performed at their work desk in the office area. The work desk within 3 feet of the TP had an open coffee mug and another desk was eight feet away and had a covered drinking container with a straw. 2. The Occupational Safety and Health Act (OSHA) (www.osha.gov) regulation 29 CFR 1910.1030 Bloodborne pathogens (d)(2) (ix) states "Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure." 3. Good laboratory practices state that there should be no eating, drinking or application of cosmetics in the laboratory. Testing involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. 4. During the survey on 10/02/2024 at 10:50 AM, the TC confirmed that the testing of synovial fluid was being performed at the workdesks of the TP and not in a designated area safe from potential hazards. 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 D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on observation of the written procedures and interview with the technical consultant, the laboratory did not have a written procedure to check the accuracy of the alpha defensin test at least two times each year by performing proficiency testing or split sampling of test samples or using controls as unknown samples for staff to test and then evaluate the laboratory's performance. Findings: 1. The laboratory did not have a written procedure stating that proficiency checks would be performed at least two times each year and did not state how many unknown samples would be tested. 2. The laboratory did not have procedures for staff to test these proficiency check samples and did not have procedures to evaluate results for accuracy and provide