Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, review of laboratory client services instructions, patient results, and confirmed in interview of facility personnel found the laboratory's client services instructions failed to include instructions for specimen transportation of CBCs. The findings included: 1. Direct observation made on July 14, 2021 at 10:20 hours found one Complete Blood Count (CBC) delivered by a third party courier to the laboratory. The specimen was delivered in a cooler with one ice pack. The specimen was cool to the touch. No thermometers were available to determine the temperature of the specimen. 2. Review of the manufacturer's instructions for the Sysmex XS-1000iC analyzer under section 6.10 "Conditions for samples to be analyzed," it stated, "Sample collection conditions ..."After drawing the sample, analyze it within 4 hours. If it is not possible to analyze the sample within 4 hours, store it in a refrigerator at 2-8 degrees Celsius until it can be analyzed." 3. Review of client instructions for CBC found no instructions for the transportation of CBC specimens. 4. Review of the patient final report revealed the following: Specimen ID: 195-859-5001-0 Date Collected: 07-14-2021 Time Collected: 09:19 local time Time Received: 10:20 local time (59 minutes) 5. The laboratory's client services instructions failed to include instructions for transportation 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 -- of CBCs and therefore did not have mechanism in place to ensure samples are transported at the correct temperature. 6. Interview of the Laboratory Director conducted on July 14, 2021 at 10:25 AM found the laboratory did not monitor the temperatures of the couriered specimens transported to the laboratory by outside couriers. -- 2 of 2 --