Genesis Medical Laboratory

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency at Genesis Medical Laboratory on 5/13/2026. The laboratory was found to be out of compliance with the following condition: 493.1250 Condition: Analytic systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to meet the applicable analytic systems requirements in 493.1254 to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 humidity monitor used to record room humidity (RH) in the laboratory when hematology, chemistry and immunology testing was performed from 6/25/2024 to 5/13/2026. Refer to D5429 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: 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 -- Based on observation of the laboratory, lack of documentation, and interview with Technical Supervisor (TS) #1, the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 humidity monitor used to record room humidity (RH) in the laboratory when hematology, chemistry and immunology testing was performed from 6/25/2024 to 5/13/2026. Findings Include: 1. On the day of the survey, 5/13/2026 at 1:45 pm, observation of the laboratory revealed 1 of 1 ACURITE humidity monitor with no expiration date, serial number or identifying label on the instrument. 2. The laboratory could not provide maintenance /function check records for the 1 of 1 ACURITE humidity monitor used to record RH in the laboratory when hematology, chemistry and immunology testing was performed from 6/25/2024 to 5/13/2026. 3. TS #1 (CMS 209 personnel #2, dated 4/20/26) confirmed the above findings on 5/13/2026 at 2:15 pm. *REPEAT DEFICIENCY D5781

Summary Statement of Deficiencies D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 review of the competency records and policy & interview with the Laboratory Director, Technical Supervisor, and General Supervisor, the Technical Supervisor failed to establish written policies and procedures to assess competency for 1 of 1 Technical Consultants, 2 of 2 Technical Supervisors, and 1of 1 General Supervisor from (05/08/2018) through the date of the survey (07/14/2020). Findings: 1. At the time of the survey, the Laboratory could not provide written policies and procedures to assess Technical Consultant, Technical Supervisor, & General Supervisor competency. 2. A review of the competency assessment records revealed there was no documentation of supervisor competency assessment from (05/08/2018) through the date of the survey (07/14/2020). 3. From (05/08/2018) through the date of the survey (07/14/2020), 40927 toxicology specimens were run. 4. During the survey at (15:30 07/14/2020), the Technical Supervisor #1 confirmed, the above findings. 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)