DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

changed and their initials had been forged in the changed documents.” The report indicates one employee stated “He was afraid of losing his job and he knew if he brought a complaint up to the top, he would have been found out and then set up to be fired.”



4. ARC uses a system known as the “Hotline” as another means in which an employee can report concerns or problems related to the manufacturing of blood products, donor and patient safety as well as human resource matters. The following “hotline” records describe reports from ARC employees of allegations of significant record keeping irregularities:
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate one employee was “terminated for falsification of records on 5/31/02” and a second employee was forced to resign due to “falsification of records – backdated records.”
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate the employee reported that a cooler was allowed to go 12 degrees above temperature but it was never documented. “The cooler was re-cooled and then reported at the proper temperature.”
   
   ARC [REDACTED]: The records of investigation provided by ARC indicate the issues investigated were: “caller states nurses are using out of date test tubes and falsifying documents;” “caller suggests falsification of documents should be ground for termination;” and “caller states acting supervisor instructs employees to falsify documents in order to hide mistakes.”
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate the caller stated the team manager “completed a donors Blood Donation Record (BDR)” by placing the confidential unit exclusion form on the BDR for the donor.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee was instructed “to alter the donors history to indicate the initial pulse rate to be 98 beats per minute instead of 104 beats per minute.” The records also state “it was determined that you instructed other staff members on the blood drive to keep this to themselves and not allow this deviation to surface.”
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee reported that management at an apheresis center has the employees continue with the collections even though the machine alarms indicate a donor’s platelet count is too low to continue or complete the donation. It was also reported that employees are told not to document this alarm type in the alarm log.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate a supervisor changed the information on training records because he failed to properly release a new employee to perform Anti-HBc testing at an NTL. The record also states “caller stated … falsified documentation in the red book and the trainee roster which he/she stated is a violation of FDA regulations.”
   
   

The observations of objectional conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."