Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #2, the laboratory failed to establish and implement policies and procedures to assess the competency for the non-testing positions and their federal regulatory responsibilities for the Laboratory Director, Clinical Consultant, and Technical Consultants listed on the CMS-209 form for 2 (December 2019 to December 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's competency records revealed a lack of competency documentation for the non-testing personnel positions listed on the CMS-209 for 2 (December 2019 to December 2021) of 2 years for the following personnel: a. Laboratory Director b. Clinical Consultant c. Technical Consultant #1 d. Technical Consultant #2 2. An interview on 12/13/2021 at 10:18 am, TC2 confirmed the laboratory did not establish and implement policies and procedures for the assessment of the above named laboratory position responsibilities. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Technical Consultant (TC) #2, the laboratory failed to follow their procedure for the annual review of the policy and procedure manual for 2 (December 2019 to December 2021) of 2 years reviewed. Findings include: 1. Record review of the "Laboratory Policy /Procedure Annual Review Sheet" states "Annually the Laboratory Site Coordinator, the Laboratory Director, and all applicable laboratory personnel are required to review each procedure that he/she performs and signs the annual review sheet." 2. Review of the "Laboratory Policy/Procedure Annual Review Sheet" revealed a lack of documentation for 2 of 2 years as follows: a. Laboratory Director - no signature in 2020 and 2021 b. Site Coordinator - no signature in 2020 c. Personnel - no signatures in 2020 3. An interview on 12/13/2021 at 9:45 am, TC2 confirmed the above findings. 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 with Technical Consultant (TC) #2, the laboratory failed to perform quality control testing each day of patient testing for 7 days (February 23 to April 13, 2021) of 2 years of documentation reviewed. Findings include: 1. A review of the "Wet Mount Log" revealed for 7 days of 2 years reviewed, the following days no quality control was performed prior to patient testing as follows: a. 2/23/2021 - 1 patient tested b. 3/02/2021 - 2 patients tested c. 3/09/2021 - 1 patient tested d. 3/16/2021 - 1 patient tested e. 3/23/2021 - 4 patients tested f. 4/06 /2021 - 1 patient tested g. 4/13/2021 - 2 patients tested 2. A review of the "Quality Control" section of the "Quality Assessment" procedure states "QC must be acceptable before testing and/or reporting of results is permitted. Any results obtained when QC is unacceptable or not performed are invalid and must be repeated. There are no exceptions." 3. An interview on 12/13/2021 at 9:50 am, TC2 confirmed the laboratory did not have quality control documentation available for the dates listed above. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #2, the laboratory failed to ensure the potassium hydroxide (KOH) results were manually transcribed from the "Wet Mount Log" into the laboratory information system (LIS) for 1 (62416571) of 13 patient results reviewed. Findings include: 1. Record review for 1 (62416571) of 13 patient results reviewed revealed the results from the "Wet Mount Log" (positive whiff test) did not match the results entered into the LIS system (negative whiff test). 2. An interview on 12/13/2021 at 10:52 am, TC2 confirmed the results in the LIS system did no match those recorded on the "Wet Mount Log." -- 3 of 3 --