Please click the questions below to view the Physician FAQs:
What is the Specialty Antibody Donation program?
In order to complete laboratory testing to FDA standards, a quality control group is required with each test to ensure diagnostic integrity. The human sera used to create quality control groups can only be obtained from consenting adult plasma donors. Access Biologicals works directly with patients, healthcare providers and laboratories to identify individuals who have received positive diagnoses for certain acute, autoimmune and polyclonal antibody conditions. A conscious effort to identify consenting adult plasma donors with various conditions allows for a continuous supply of FDA required quality controls, preventing the possibility of backorders for various tests.
How can a healthcare provider assure HIPAA compliance?
Access Biologicals operates under the strictest FDA and HIPAA controls for patient safety and confidentiality. We won’t ever ask you to disclose personal information to us about your patients. Once you have provided our program literature to your eligible patients, they contact us directly and indicate to us their willingness to be screened for program eligibility. Occasionally we will ask for a signed Physician Consent for patients who are on certain medications or to confirm there will not be any contraindications with plasmapherisis for certain individuals.
What are the FDA guidelines regarding frequency and volume of plasma donations?
FDA approved frequency and volume guidelines for routine Source Plasma donations are as follows:
- No more than two (2) donations in any seven (7) day period with one complete day of rest between donations
- Volume of 705ml for body weights of 110-149 lbs., or volume of 846 ml for body weights of 150-174 lbs., or 903 ml for body weights of 175-350 lbs.
What monetary benefits do patients receive if they qualify and donate plasma for the Specialty Antibody program?
Patients who have completed the eligibility screening process and successfully donate for this program can receive up to $3500 per month. This enables many donors to pay for medical services rendered and to offset financial needs as a result of employment disability.
How might a healthcare practice benefit from directing eligible patients to this program?
Access Biologicals recognizes the time and effort employed in identifying eligible patients for one of our Specialty Antibody programs. Therefore, healthcare providers are eligible to receive up to $300 reimbursement per qualified participating donor in these programs. In compliance with OIG Federal Anti-Kickback Statute 64 FR63518 (Nov. 19, 1999), this reimbursement process is considered a “safe harbor”. In addition to the direct benefit to your healthcare practice, this program helps to provide the necessary materials for diagnostic testing , thus ensuring a continuous supply of high quality diagnostic controls. Furthermore, compensating participating donors for their effort allows for more financial flexibility to cover various medical fees from services provided by healthcare professionals.
What is the healthcare providers' role in screening patients for this program?
Ideally, healthcare provider involvement should be minimal. The Access Biologicals Specialty Antibody program involves passive and voluntary donor recruiting whereby patients that wish to participate should contact us directly for thorough donor screening. Healthcare providers can aid this process by notifying patients who have received positive diagnoses for certain conditions of the opportunity to contribute to further research into their condition and also receive compensation through Access Biologicals’ Specialty Antibody Donor Program. Access Biologicals will provide brief introductory pamphlets for distribution to interested patients.