Biosafety

Table of Contents

1. Laboratory Safety
2. Quality Assurance
3. Records
4. Inventory Management

Helpful Hints:

Scattered throughout this text are the following symbols to help you focus on what is really important.

♣  This is a routine feature of the subject being discussed. We've tried to narrow them down.

♠  This is an important feature. You should remember this.

♥  Something serious will happen if you do not remember this.

1. Laboratory Safety

♣  It is the responsibility of every employer to provide a safe work environment for employees. This may be accomplished by developing and implementing a safety plan for the workplace. The goal of the safety plan should be to protect employees from situations that may compromise their health and well being. Although the development of the safety plan may be a tedious task, it is well worth the effort. The following is a general discussion for development of a safety plan. In addition, federal, state, and local guidelines should be consulted and followed.

♣  The safety plan should include a fire plan, accident plan, chemical plan, and maintenance of Material Safety Data Sheets (MSDS.) Other plans and policies should be added according to activities performed at the workplace. The safety plan should encompass all hazards found at the workplace.

♣  The fire plan should include a policy of what is expected of the employee in the case of a fire, including emergency telephone number(s). This policy should explain if the employee should fight the fire and at what point employee and patient evacuation is necessary. It is a good idea to assign employees to assemble at a specific area outside the work area so that employees may be accounted for. Employees should be trained in all areas of fire safety including location and use of fire extinguishers.

♣  The accident plan should include policies and procedures regarding on the job accidents. Minor and extremely serious accidents can occur on the job and every accident should be reported to the employer within 24 hours of its occurrence. An accident report form may be helpful in documentation of accidents and necessary follow-up. It may be beneficial to specify in the accident plan the name and phone number of the physician with whom the injured employee should consult, if necessary.

♣  A chemical plan should include a list of all hazardous chemicals found in the workplace. The chemical plan should include a policy for secondary labels. Secondary labels are placed on containers of chemicals that have been removed from their original or primary containers. For example, if isopropyl alcohol is poured from it’s original container into another container, it should be labeled with a secondary label. The secondary label should contain the product name, the preparation date or transfer date, and any necessary hazard information, such as "Eye Irritant."

♣  In conjunction with the chemical plan, Material Safety Data Sheets (MSDS) should be maintained for all chemicals listed on the chemical inventory. These sheets are supplied by the manufacturer, and are generally shipped with a product that is considered hazardous. For some household items, the manufacturer may need to be contacted in order to obtain the MSDS. The MSDS contain helpful information including but not limited to hazardous ingredients, physical and chemical information, fire and explosion data, health hazard data and precautions for handling. This information contained in the MSDS is useful in case of accidental spills, splashes, or inadvertent injection or ingestion.

♣  Other issues that necessitate safety policies and procedures include disposal of hazardous material, sharps and biohazards. A separate policy may be needed for each of these items. It may be beneficial to include in the biohazard policy exactly how expired blood components should be disposed of.

♣  The employer may want to supply a stocked first aid cabinet for employees. An Eye Wash Station should be available in case of inadvertent splashes in the eye. Protective clothing and equipment should be furnished by the employer and a policy regarding its’ use. A policy on handwashing may also be beneficial.

♣  Ergonomic workstations and furniture may help prevent employee back problems. There are multitudes of manufacturers available for consultation.

♣  Once the appropriate safety policies and procedures are formulated and documented, it is important to provide safety training for each employee. There should be a form or worksheet to document this training. This training should be continual and ongoing as products used and work assignments change.

2. Quality Assurance

What is Quality Assurance?

♣  Quality assurance is a philosophy of the workplace that provides an organization with information to examine and regulate the quality of patient care. Examining issues related to quality assurance may assist the organization in setting high standards of patient care through constant improvement of service. This may be accomplished by setting goals regarding quality assurance. All aspects of patient care may be analyzed and monitored; the challenge is to regulate variables therein.

♣  For a Blood Bank or Transfusion Service, the main goal of a quality assurance program should be to provide a safe transfusion for every patient.

How is this Best Accomplished?

♣  First, it is advantageous to establish a committee of staff members to serve on a quality assurance team. The team should define and set goals related to quality assurance. While the quality assurance team may examine quality issues of an entire organization, this discussion will be limited to issues related to the Blood Bank or Transfusion Service. As previously discussed, the organization should have safety policies and procedures in place. In addition, practical and concise policy and procedure manuals should be available for every task performed in the Transfusion Service. These procedure manuals should provide employees with a detailed outline for performance of a given task.

♣  The main purpose of a quality assurance team may be to identify and monitor quality indicators. Quality indicators can be devised to analyze work tasks that may be measured or monitored in some manner. Obtaining or improving the task measurement may improve the service.

For example, one of the quality indicators for the Blood Bank may be to monitor the length of time it takes to draw one 450-ml unit of blood. The American Association of Blood Banks specifies a target time of 4 - 10 minutes for a 450-ml phlebotomy. The quality assurance team may include this time specification in the phlebotomy procedure. The staff who perform the canine phlebotomies can use this as a benchmark for optimal draw time.

♣  Other quality indicators may include one or more of the following:

• Check donors for bruising around the phlebotomy site. Excessive bruising may indicate the need for variation phlebotomy technique.
• Survey donor owners as to their satisfaction in regard to the blood donor program. Owners who are satisfied with the care given to their animals are more likely to continue in the blood donor program and recommend the program to their friends.
• Periodic review of product labels for component type, phlebotomy date, expiration date, and donor identification.
• Periodic review of product inventory and use.
• Quality control on blood components. Products near or beyond expiration date may be used to monitor preparation techniques. For example, the hematocrit of expired Red Cells may be examined to verify that the designated final packed cell volume has been reached. Variation may indicate a problem in component preparation.
• Performing blood cultures on expired Red Cells may verify that aseptic phlebotomy and component preparation has occurred.
• Cryoprecipitate may be analyzed for Factor VIII and fibrinogen activity periodically to ensure that component preparation is optimal.
• Review of all transfusion reactions. Is there any common occurrence with transfusions that result in adverse reactions?
• Review of accidents related to products such as broken blood bags or contaminated ports.
• Review of equipment checks and temperature checks of refrigerators, freezers, water baths and blood warmers.
• Other quality indicators may be formulated as needed.

3. Records

♣  Records provide a method of communicating with others regarding documentation of information including observations and opinions. This chapter will discuss several different types of records that may be used in a veterinary Blood Bank or Transfusion Service. Guidelines for documentation, maintenance and storage of these records will be discussed. Additionally, federal, state and local guidelines should be consulted and followed.

What Attributes are Needed to Produce a Record of Good Quality?

♣  A record should be legible and accurate.

♣  It should include the transcription date and identity of the author.

♣  The record should make sense, be complete and as detailed as necessary to convey meaning.

♣  The record should also be indelible.

For a Blood Bank or Transfusion Service, records are typically inscribed by paper or computer. While the attributes listed above pertain to both paper and computer records, there are a few additional items regarding computer records that deserve mentioning:

• Computer records should be validated for accuracy.
• The system and data should be backed up regularly.
• Data should be protected from unauthorized access and inadvertent changes.

Specific Records Related to the Blood Bank

♣  A Blood Bank or Transfusion Service should maintain certain records pertaining to blood donors and blood recipients.

♥  Failure to maintain these records on blood donors could endanger the blood supply, since valuable information regarding donor health status at the time of donation could be forgotten or lost.

♣  Guidelines for the maintenance of these records follow.

Donor Records

Donor records should be composed of:

• Initial screening including physical exam findings, laboratory results, vaccination status, heartworm medication
• Consent form signed by the owner
• Physical Exam prior to each blood donation
• Annual Recheck including physical exam findings, laboratory results, vaccination status, heartworm medication
• Documentation of any follow up, if necessary

Records Related to the Blood Bank Laboratory

The Blood Bank may perform laboratory testing in addition to donor testing. Items pertinent to the Blood Bank laboratory that should be retained are:

• Blood storage refrigerator and freezer temperature charts
• Equipment maintenance records
• Reagent vendors
• Quality Control of reagents
• Quality Control of donor units
• Blood typing and crossmatching results
• Transfusion records:

In regard to blood and blood components, a donor log composed of the date the unit of blood was collected, the unit identification, final volume, expiration date, identification of the preparer and the final disposition of the unit of blood should be maintained.

If blood products are acquired from an outside source, the log should include these units. Pertinent information includes who the products were purchased from, the date they were received, the name and identification of the component and expiration date.

Record Storage: How Long?

♣  Remember: Records are stored over a period of time for investigative and legal purposes. Federal, state and local guidelines should be consulted and followed. If there are no guidelines, it may be helpful to store laboratory records for at least 2 years and medical records indefinitely.

4. Inventory Management

♣  Blood product inventory management is difficult since use of blood products can be unpredictable and erratic. Blood products are a valuable commodity and every effort should be made to utilize this product efficiently. It is beneficial to devise a plan for the management of blood products so that this valuable resource is used in a timely and efficient manner.

♣  First, the optimal number of stored units of blood components should be established. Each stored product should be analyzed to determine the desired inventory level for that product. If specific blood groups of a particular product are needed, each blood group should be analyzed separately.

• For a 6-month period, collect data of product usage.
• Disregard any unusually high values of use.
• Total the number of units.
• Divide by the total number of weeks the data are collected.
• The value generated from this analysis is the optimum stock level of product per week.

♣  Other factors should also be considered when determining optimal stock levels of blood product.

• The number of patients serviced by the veterinary practice. A high number of patients potentially need a high number of products. Endemic disease and accident rates should be considered.
• The size of the area serviced by the hospital. A large service area could result in a large number of patients who may need transfusions.
• The average weight of the recipient. What size dogs are popular within the service area? Large dogs may use more product than small dogs.
• The expiration date of the product. Which anticoagulantpreservative-additive system is used? If product is received from a supplier, what is the average expiration date?
• Services offered at the veterinary practice. An emergency clinic will use more blood products than a clinic that offers only routine services.

♣  It may also be useful to institute internal policies in regard to blood products to assist in inventory management. These policies should be communicated every staff member who may transfuse blood products.

• Use the oldest unit first. Arrange the refrigerator and so that the oldest unit will be pulled first. This will make using the oldest unit convenient.
• Institute ordering guidelines. Make sure each clinician knows that once the order is given to transfuse, the component will be warmed and the product must be used.
• Institute guidelines for issuing blood components. Specify how many units may be prepared for one patient at a given time. It may be appropriate to warm only one unit for one patient at a time, depending on the clinical situation.

♣  What if products are not stocked, such as the case of feline whole blood?

• The number of blood donors needed should be calculated.
• Use the formula for calculating optimal stock level above.
• In addition to the list of "Other Factors," consider the frequency that blood may be obtained from a particular blood donor.
• The resulting value will provide an estimate of the approximate number of feline blood donors needed for the blood donor program.