La Farge Clinic - Vmh

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on survey review of a patient's Basic Metabolic Panel (BMP) test report and laboratory procedures and interview with the technical consultant, the reference ranges shown on the patient report was not the same as the approved reference ranges for six of nine chemistry analytes reviewed. Findings include: 1. Review of the reference range of the BMP test report from April 3, 2023, in the electronic medical record (EMR) for patient 1 (an adult female) showed the following expected ranges: Analyte/Reference range Blood Urea Nitrogen/8-26 milligrams/deciliter (mg/dL) Creatinine/0.6-1.3 mg/dL Glucose/70-105 mg/dL Potassium/3.5-4.9 milli moles/Liter (mmol/L) Sodium/138-146 mmol/L Carbon Dioxide-Total/24-29 mmol/L Ionized Calcium/1.12-1.32 mmol/L Anion Gap/6-16 mmol/L Chloride/98-109 mmol/L 2. Review of the "Chemistry Testing using the i-STAT Chem8+ Cartridge type" procedures showed the approved reference ranges for an adult female are: Analyte /Reference range Blood Urea Nitrogen/8-26 milligrams/deciliter (mg/dL) Creatinine/0. 6-1.1 mg/dL Glucose/70-99 mg/dL Potassium/3.4-5.0 milli moles/Liter (mmol/L) Sodium/135-146 mmol/L Carbon Dioxide-Total/22-29 mmol/L Ionized Calcium/1.12- 1.32 mmol/L Anion Gap/6-16 mmol/L Chloride/96-108 mmol/L Further review showed the creatinine, glucose, potassium, sodium, carbon dioxide-total, and chloride reference ranges in the procedure did not match the patient's test report. 3. Interview with the technical consultant on August 2, 2023, at 11:35 AM confirmed the reference ranges in the EMR were not consistent with the approved reference ranges in the procedures. 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance logs for the Sysmex KX21N hematology analyzer from October 2020 through August 2021, and interview with testing personnel and the technical consultant, the laboratory did not perform cleaning of the sample rotor value quarterly during two of three quarters. Findings include: 1. Review of hematology maintenance logs for the Sysmex KX21N from October 2020 through August 2021 showed cleaning of the sample rotor valve is required quarterly. The cleaning was only documented on May 5, 2021 during this time period. 2. Interview with testing personnel (staff C) on September 8, 2021 at 1:30 PM revealed the cleaning was performed when the analyzer prompted the operator. Further interview revealed the prompt is based on test runs rather than the quarterly requirement. 3. Interview with the technical consultant on September 8, 2021 at 1:30 PM confirmed the cleaning was not performed quarterly as required. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 2 -- Based on surveyor review of performance evaluation records for five of seven testing personnel and interview with the technical consultant, the technical consultant did not document the 2019 annual evaluation of two of the five testing personnel reviewed. Findings include: 1. Review of annual performance evaluation records for five testing personnel revealed no evidence of documented evaluation for staff A and staff B at this laboratory in 2019. 2. Interview with the technical consultant on September 8, 2021 at 11:30 AM confirmed competency evaluations for staff A and B were not completed in 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of test records and interview with the technical consultant, the laboratory did not document the identity of the provider who performed microscopic testing of vaginal wet prep samples for four of four records reviewed. Findings include: 1. Review of four out of four test records for vaginal wet preps performed by providers in September of 2018 showed the test records did not identify the person who performed the test. 2. Interview with the technical consultant on July 18, 2019 at 1:00 PM confirmed the laboratory did not document the identity of the personnel performing vaginal wet prep tests. 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 --