Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on interview with the Laboratory Director and testing personnel (TP) #4 as listed on the Centers For Medicaid & Medicare Services (CMS) 209 form on 10/13/22 at 11:00 a.m., review of one Complete Blood Count (CBC) final report along with the corresponding patient purple top tube, and the laboratory labeling policy, the laboratory failed to follow their policy to ensure positive identification of the patient specimen from the time of collection through testing and reporting for CBC results. Findings include: 1. The laboratory's labeling policy states specimens will be labeled with the patient name, social security number, DOB (date of birth) or chart number, and date and time of collection. The medical record number (EMR) is the unique ID of choice. 2. Interview with TP #4 indicated that the name only is written on the purple top tube after collection. She also confirmed the chart number is entered into the Sysmex XP-300 hematology analyzer for CBC testing. The CBC report is then scanned in the patient's chart. 3. Observation of 1 of 1 patient CBC report on the day of survey revealed that the chart number only was printed on the CBC report from the instrument. The CBC report (with chart number and no patient name or identifying information) was scanned into the clinic EMR. 4. Surveyor on 10/13/2022 observed a patient sample (EMR #245165) being tested on the Sysmex. a. The chart number 245165 was entered into the instrument and the patient sample run. b. The sample had to be repeated 3 times to get a valid result. c. The Chart number was not re-entered for each repeat. d. The Sysmex XP-300 automatically counts up from the previous number if a new number is not entered. e. The same sample had 4 different "chart 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 -- numbers" for the four runs (245165, 245166, 245167, 245168). f. The fourth run (with a chart number of 245168) was placed on the patient 245165 chart with no name or other identifying information to prevent errors. 5. This process does not ensure positive identification of a patient's specimen from the time of collection through reporting of results. 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: Based on an interview with the LD (laboratory director) and laboratory staff, observation of the Sysmex XP 300 hematology quality controls (QC) in use by the laboratory on 10/13/2022 at 11:30 a.m., and review of the manufacturer's instructions for the controls, the laboratory failed to follow the manufacturer's instructions for open vial stability of the QC material. Findings include: 1, Manufacturer's instructions for the Sysmex XP 300 hematology controls state that the controls are stable for 14 days after opening when stored refrigerated. Observation of three open vials of hematology controls (lot# 21930710-low, lot# 21930711-normal, lot# 21930712-high) in use on the day of survey revealed there was no open date on the vials to ensure the controls were not used past the stability date. 2. The LD and laboratory staff in an interview at 11:30 a.m. on 10/13/2022 could not confirm when the three vials of controls were opened and put into use. -- 2 of 2 --