Current Good Manufacturing Practices for Transfusion Services

At what MINIMUM frequency should quality control testing be performed on each lot of anti-human globulin to be in compliance with the FDA's current good manufacturing practices requirements?

. Each day of use Feedback The correct answer is B. 21 CFR 606.65 requires that a sample from the lot in use be tested on each day of use. More frequent testing may be required by the facility, such as at the beginning of each work shift or by each new user, but the FDA minimum requirement is each day of use. While testing may be required when a reagent is received, it does not substitute for testing on the day of use. If the reactions with known specimens are used for quality control evaluation, both a positive and negative specimen must be used.

Which term listed below refers to the procedures that must be followed by a transfusion service when notification is received that a donor of a unit sent to the service now tests positive for an infectious disease?

. Lookback Feedback The correct answer is A. Recipients of any products identified in the lookback process must be notified when a donor of a unit that they received now tests positive for an infectious disease. Donor notification includes regulations for notification of donors that they currently test positive for an infectious disease. Retrospective review refers to a review of any previous records.

Which of the following statements is true regarding adverse event reporting to the FDA (Director, Office of Compliance and Biologics Quality, CBER)?

. The initial notification to the FDA of a transfusion-related death must be made as soon as possible after the death is confirmed to be associated with the transfusion. Feedback The correct answer is C. According to 21 CFR 606.170, when a complication of blood collection or transfusion is confirmed to be fatal, the FDA (Director, Office of Compliance and Biologics Quality, CBER) must be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible. A written report of the investigation must be submitted to the Director, Office of Compliance and Biologics Quality, CBER within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction. If it is confirmed that the transfusion is not the cause of death, it does not need to be reported to the FDA. Not all adverse reactions that arise as a result of blood collection or transfusion need to be reported to the FDA. If the reaction did not result in the patient's death, it does not need to be reported to the FDA; however, a thorough investigation must be made and a written report of the investigation, including conclusions and followup, must be prepared and maintained as part of the record for that lot or unit of final product by the collecting or transfusing facility. If it is determined that the product was at fault in causing a transfusion reaction, copies of all such written reports must be forwarded to and maintained by the manufacturer or collecting facility.

If an allogenic blood component is shipped from the donor center with infectious disease testing incomplete, the units must be labeled with:

. The phrase "For Emergency Use Only By ____(specific patient)" Feedback The correct answer is B. A label or tie tag with the message "For Emergency Use Only By_(specific patient)" is required. In addition, the unit labeling must include the incomplete tests and those tests that are negative. The color of the label is not specified in the regulation.

A laboratory employee who is performing an internal audit of routine ABO and Rh typing procedures notes that a technologist places two drops of Anti-D in a tube, centrifuges the tube for 20 seconds, and reads the reaction using a magnifying mirror. When questioned about the procedure, the technologist indicates that most staff use two drops of Anti-D reagent because the reactions are stronger with two drops. In addition to reviewing the facility procedure manual, what should be done to ensure regulatory compliance?

A. Review the anti-D manufacturer's current instructions for use. Feedback 21 CFR 606.65 states, "Supplies and reagents shall be used in a manner consistent with instructions provided by the manufacturer." The correct answer is A. The reagents must be used according to the manufacturer's instructions for use. If the instructions say one or two drops may be used and the facility procedures also allow one or two drops, then there is no problem with the staff members choosing to use two drops. While equipment must be calibrated, it does not generally influence the number of drops used. Staff members often ask co-workers and colleagues from other facilities how to perform tasks, but it is the manufacturer's instructions for the operation of equipment and the use of reagents that must be followed.

Which of the conditions listed below must be met before a unit of Red Blood Cells that has been issued and returned can be reissued?

B. The container has a tamper-proof seal and the seal remains unbroken. Feedback The correct answer is B. There must be a tamper proof seal and the seal cannot be broken. Regarding the reissue of blood, 21CFR640.2 states: Blood that has been removed from storage controlled by a licensed establishment shall not be reissued by a licensed establishment unless the following conditions are observed: The container has a tamper-proof seal when originally issued and this seal remains unbroken. A segment is properly attached and has not been removed, except that blood lacking a properly attached segment may be reissued in an emergency provided it is accompanied by instructions for sampling and for use within 6 hours after entering the container for sampling. The blood has been stored continuously at 1 to 6° C and shipped between 1 and 10° C. The blood is held for observation until a significant inspection* can be made. While the temperature of the unit during storage should be between 1 and 6° C, it is not a requirement that a temperature monitoring device is attached to the unit. There must be a segment attached to the unit that could be used for crossmatching unless it is an emergency situation and there are special instructions sent with the unit. *If the color or physical appearance is abnormal or there is any indication or suspicion of microbial contamination the unit must not be issued for transfusion.

A staff technologist is receiving a shipment of reagents. The technologist logs the date received and the number of vials in the shipment. Two of the vials are contaminated. The manufacturer wants the vials back. Which of the following must be done to comply with the 606.160 Records section of the Code of Federal Regulations (CFR)?

B. The final disposition of the unsuitable reagents must be recorded.

Which of the following is NOT required to be in a machine-readable format on a blood component label? A. ABO & Rh of the donor B. Product code C. Collection facility D. Outdate

D. Outdate Feedback The correct answer is D. The outdate may be handwritten. 21 CFR 606.121 requires this information be machine-readable: A unique collection facility identifier Lot number relating to the donor Product code ABO and Rh of the donor`

A chart recorder must be compared to a thermometer at what frequency?

Daily Feedback 21 CFR 606.60 The correct answer is A. A chart recorder must be compared to a thermometer daily.`

An error was made in a handwritten blood bank record. Which of the following methods is acceptable for correcting the error to remain in compliance with current good manufacturing practices requirements?

Draw a single line through the error so that it can still be read. Feedback The correct answer is B. 21 CFR 600.12 requires records to be legible and indelible. Records cannot be covered up with correction fluid or tape, or be obliterated. Corrections to a record should be made in a manner that allows the error to still be read so that it can be reviewed. The correction should also include the date the correction was made and the person who made the correction.

For transfusion services in the United States, which of the following incidents must be reported to the Food and Drug Administration (FDA) because of a biological product deviation?

Incident C: The wrong specimen was used to crossmatch a unit and the unit was issued. According to 21 CFR 606.171, an event is reportable if it occurred while the product was under the control of the transfusion service, is a deviation of standard practice that affects the safety, purity or potency of the product, and if the unit was issued. Incident C is reportable to the FDA because of a biological product deviation. In this case, an error was made in the blood bank and the unit was issued. It is reportable regardless of the harm to the patient.

Which of the following procedures should be followed when storing supplies or reagents that do not have a manufacturer-assigned expiration date?

Which of the following procedures should be followed when storing supplies or reagents that do not have a manufacturer-assigned expiration date? Feedback The correct answer is C. According to 21 CFR 606.65, supplies and reagents that do not bear an expiration date should be stored in a manner that ensures the oldest is used first. It would then logically follow that newer supplies/reagents are stored behind older supplies/reagents. The regulations for good manufacturing practices do not require that each bottle of supplies or reagents be dated when they are received; however, it may be useful to label with a date received to ensure the oldest supplies are used first, particularly if the storage order of supplies is disrupted.