Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to have five of five policies and procedures reviewed, approved, signed, and dated by the current LD (as noted on the CMS-209 Laboratory Personnel Form). Findings include: 1. Review of five of five laboratory policies and procedures reviewed revealed no LD approval, including signature and date, by the current LD on the following laboratory policies and procedures: a. "A.025 Protocol for Proficiency Testing", b. "H.037 Sysmex XN- 9100 Automated Hematology System Procedure", c. "D.062 ICT (NA/K/CL) On The Abbott Alinity System", d. "QA.004 Critical Result Validation and Notification", and e. "D.114 Clinical Chemistry Calibration and Calibration Verification" 2. Interview with the LD on 04/15/2025, at 10:49 am, confirmed the laboratory failed to have five of five policies and procedures reviewed, approved, signed, and dated by the current LD. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on review of policies and procedures, laboratory records, lack of 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 -- documentation, and interviews with testing personnel (TP) #1 and technical supervisor (TS) #2; the laboratory director (LD) failed to ensure the laboratory was enrolled in an approved proficiency testing program for all regulated analytes performed in the specialties of chemistry and hematology from the beginning of patient testing in October 2024, through the date of survey, 04/15/2025. Findings include: 1. Review of policies and procedures revealed the policy titled, "A.025 Protocol for Proficiency Testing", which stated, "Rush Medical Laboratories ... participates in the College of American Pathologists (CAP) Proficiency Testing (PT) Program for all tests for which such PT is available." 2. Upon a tour of the laboratory on 04/15/2025, at 08:41 am, interview with TP #1 confirmed that testing in the specialties of chemistry and hematology began in October of 2024. 3. Review of laboratory records revealed the laboratory performing the following regulated chemistry and hematology analytes: Specialty: Analyte: Chemistry Alanine aminotransferase [255] Chemistry Albumin [265] Chemistry Alkaline phosphatase [275] Chemistry Aspartate aminotransferase [295] Chemistry Bilirubin, total [305] Chemistry Calcium, total [345] Chemistry Carbon dioxide [351] Chemistry Chloride [355] Chemistry Creatinine [405] Chemistry Glucose [415] Chemistry Immunoglobulin G [185] Chemistry Lactate dehydrogenase, total [435] Chemistry Magnesium [455] Chemistry Phosphorus [460] Chemistry Potassium [465] Chemistry Sodium [475] Chemistry Total protein [485] Chemistry Urea nitrogen [505] Chemistry Uric acid [515] Hematology Hematocrit [785] Hematology Hemoglobin [795] Hematology Platelet count [815] Hematology Red blood cell count [775] Hematology White blood cell (WBC) count [805] Hematology Blood cell identification [765] Hematology WBC differential [770] 4. Review of laboratory records revealed the laboratory enrolled in CAP PT on 04/11/2025 for the above- mentioned regulated chemistry and hematology analytes. 5. Interview with TS #2 on 04/15/2025, at 10:13 am, confirmed the laboratory director (LD) failed to ensure the laboratory was enrolled in an approved PT program for all regulated analytes performed in the specialties of chemistry and hematology from the beginning of patient testing in October 2024, through the date of survey, 04/15/2025. -- 2 of 2 --