Baptist Health Family Clinic Bryant

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Through review of package inserts, observation, and interview it was determined that the laboratory did not change expiration dates on control materials after opening as required by manufacturer. Finding follow: A) Review of the package insert for Boule Con-Diff Trilevel hematology controls revealed that the product expires in fourteen days after vial is opened and the expiration dates should be changed as required after opening. B) On 1/4/23 at 11:15 the surveyor observed three vials of Boule Con-Diff Trilevel hematology controls lot numbers 22210-01, 22210-02 and 22210-03 in current use without a date of when the controls were opened or amended expiration written on the vials. C.) In an interview on 1/04/2023 at 11:25 laboratory staff member ( number 3 on form CMS 209) confirmed that no dates were written on the vials when the controls were put into use and, when asked when the control material was put into use, stated that she did not know. 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 D5783

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, review of temperature records, lack of documentation, and interview it was determined that the laboratory failed to monitor the room temperature in one of two rooms in which laboratory supplies with a storage temperature requirements were stored. Findings follow: A: During a tour of the laboratory on 6/12 /18 at approximately 1300, two ea. Alere Influenza A&B Control Swab kits lot number 094931 with a storage temperature requirement of 2 degrees C. to 30 degrees C. , two ea. Alere Influenza A&B Control Swab kits lot number 985537 with a storage temperature requirement of 2 degrees C. to 30 degrees C., and two ea. Hemosure IFOB Test kits lot number A6150077 with a storage temperature requirement of 2 degrees C. to 30 degrees C. were observed in a storage room separate from the laboratory. B. Upon request, the laboratory was unable to produce a record of temperature measurement in the storage room identified above. C. In an interview on 6 /12/18 at approximately 1330, the Laboratory Director identified as number 7 on the CMS 209 form, confirmed that laboratory supplies with a storage temperature requirement were stored in the storage room and that room temperature had not been monitored in that room. 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 --