Cape May County Department Of Health

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing personnel (TP), the laboratory failed to have a complete procedure for Direct Wet Mount Preparation and Potassium Hydroxide testing on the date of survey. The TP confirmed on 4/12/23 at 10:00 am that the laboratory did not have the aforementioned procedure. 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) Work Records (WR), Electronic 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 -- Medical Record (EMR) and interview with the Testing Personnel (TP) the laboratory failed to ensure test results were reported accurately for Direct Wet Mount Preparation and Potassium Hydroxide testing into the EMR on 7/14/2022 and 8/16/22. The finding includes: 1. A review of eight EMR entries revealed two patient had results as follows: a) Whit Blood Cell (WBC) positive but the EMR had no result for WBC on 7 /14/23. b) Yeast Positive but the EMR had no results for Yeast on 8/16/23 c) The EMR had Hyphae: present but the WR had no result for Hyphae on 8/16/23 2. The TP confirmed on 4/12/23 at 11:30 am that the laboratory did not ensure test results were accurately recorded in the EMR. -- 2 of 2 --

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 surveyor review of the procedure manual (PM) and Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow its policies and procedures for assessing the competency of the TP in the calendar years 2018 and 2019. The findings include: 1. The laboratory failed to follow the PM and did not evaluate these elements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b. Monitoring the recording and reporting of test results. c. Direct observation of performance of instrument maintenance and function checks. d. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. e. Evaluation of problem-solving skills. 2. There was no documentation competency was met for procedures evaluated on the CA form. 3. The TP #1 confirmed on 9/5/19 at 11: 00 am that CA procedures were not followed. 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 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 -- maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a lack of a Quality Assurance (QA) plan and interview with the Testing Personnel (TP), the Laboratory Director failed to establish a QA plan from 9/26/17 to the date of the survey. The TP #1 listed on CMS form 209 confirmed 9/5/19 at 12:00 pm that a QA plan had not been established. -- 2 of 2 --