Cancer Specialists, Llc

CLIA Laboratory Citation Details

1
Total Citation
2
Total Deficiencyies
2
Unique D-Tags
CMS Certification Number 10D2187778
Address 80 Pinnacle Dr Suite 700, Palm Coast, FL, 32164
City Palm Coast
State FL
Zip Code32164
Phone386 387-8500
Lab DirectorMARC WARMUTH

Citation History (1 survey)

Survey - February 29, 2024

Survey Type: Standard

Survey Event ID: RY2211

Deficiency Tags: D0000 D5415

Summary:

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 2/29/24. Cancer Specialists, Llc was found to be not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 observation and staff interview, the facility failed to ensure the glass jars used for the Quick III Hematology Stains for staining peripheral blood smears were labeled with the identity of the stain, preparation, and expiration date. The findings include: During the tour of the laboratory on 2/29/24 at 11:15am, three jars with no identifying labels were observed on the counter in the hematology testing area with light blue, orange, and purple colored liquids inside. The interview with the testing person on 2/29/24 at 11:20am confirmed the jars were used for making blood smears using the Quick III procedure for performance of cell differentials. . 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 --

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