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
D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR
CFR(s): 493.1403

The laboratory must have a director who meets the qualification requirements of §493.1405 of this subpart and provides overall management and direction in accordance with §493.1407 of this subpart.


This CONDITION 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. A review of the Casper reports #153/#155 revealed the laboratory failed to successfully participate in proficiency testing for RBC for three consecutive testing events, as noted below: a) The laboratory scored 20 % RBC for Event #3, 2017 b) The laboratory scored 20 % RBC for Event #1, 2018 c) The laboratory scored 60 % RBC for Event #2, 2018 2. A review of the API performance evaluations for the laboratory confirmed the 20 % RBC scores for Event #3, 2017 and Event #1, 2018, and the 60 % score for Event #2, 2018. 3. The TC left a voice mail message for the State Agency on 9/11/18 at 11:09 AM, inquiring about the failures. The surveyor returned the call on 9/14/18, and the TC confirmed the laboratory failed the RBC testing as described in the above paragraphs.