Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391

Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 01D0300241 (X3) Date Survey Completed 09/20/2018
Name of Provider or Supplier Bbh P & Scn Forestdale Street Address, City, State 1480 Forestdale Boulevard, Birmingham, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies
D6023 LABORATORY DIRECTOR RESPONSIBILITIES
CFR(s): 493.1407(e)(6)

The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system;


This STANDARD is not met as evidenced by:
Based on a review of the CMS Casper reports (#153, #155), a review of API (American Proficiency Institute) performance evaluations and an interview with the Technical Consultant (TC), the surveyor determined the Laboratory Director failed to ensure the analytical systems were maintained to assure acceptable analytical performance and quality of laboratory services. The laboratory failed RBC proficiency testing (Red Blood Cell Count, Hematology) for three consecutive testing events, resulting in non-initial, unsuccessful proficiency testing participation for the laboratory. The findings include: 1. Refer to D6000. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor