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Hospital accreditation standards in sterile products

Hospital accreditation standards in this area will be explained.
The following section we provide the structures and details in Recommended Accreditation Standards. This recommendation was from a government-grant project and was completed in 2014. The project was sponsored by Taiwan Food and Drug Administration,
implemented by Taiwan Society of Health-System Pharmacists. Hopefully, the recommendation could added into official hospital accreditation criteria.
It is a consensus document
and its contents cover 3 areas: including Total Parenteral Nutrition, Parenteral Chemotherapy Agents, and Patient Controlled Analgesia.
Following are the recommendation for Total Parenteral Nutrition. It recommended the role of a pharmacist should include participating the patient evaluation in a multidisciplinary team, preparing standard formula and prescriptions and should be a member of the nutrition committee.
The primary and secondary engineer controll for Dispensing require the establishment of clean room, Horizontal Laminar Air Hood, and anteroom.
The Testing frequency for HEPA filter and Horizontal Laminar Air Hood and dispensing machine is at least once a year.
Cleaning and disinfection should be done every day and using 70% alcohol.
Check list should be established to monitor whole dispensing processes.
Double check mechanism could be done either by human or by weight
Training and evaluation should be done as two types, that are Initial education and training when the personnel is about to start and continuous education and regular training for those who have been working for years.
The followings are for Chemotherapy preparation.
Primary engineer controls are required, especially the appropriate types of biological safety cabinet for hazardous and sterile products are Biological Safety Cabinet type II B and Type III.
The Secondary Engineer Control for sterile and hazardous preparation require the establishment of clean room, anteroom, and transfer box
Pharmacists are required to perform tasks in dispensing of chemotherapy agents, including prescription verification, preparation procedure, double-check mechanisms, and labeling.
It is also important that the receiving processes and storing drug product in nursing area are monitored by pharmacists.
Before the dispensing of chemotherapy agents, the appropriate personal protective equipments need to be worn, including hair cover, surgical mask, gown, 2 pairs of sterile powderless chemotherapy gloves, and shoes cover.
Spill management requires the hospital to have appropriate number of spill kits at those places with high risk of spills and regular training and drill.
Waste management requires the labeling of all container with a sign of genotoxin and training provided to the cleaning personnel.
Quality Assurance is important to check on the quality of prescribing and dispensing. The Quality Assurance plan could also cover the Primary and Secondary engineer controls.
Training and its evaluation on Chemotherapy also requires two types, one is the initial education and training before a person entering into the chemotherapy dispensing program
and continuous education and regular training for every pharmacist who is involved in preparation.
The recommendations also require regular health checkup: Initial and Periodical, and the regular items and those items for extensive exposure to hazardous drugs, for example the large scale of spill.
Recommendations for preparing Patient Controlled Analgesia are as following: The requirement for Primary engineer controls is the same as preparing parenteral nutrition, in terms of the type and the maintenance
The recommendations on Secondary engineer control require same level of establishment of Clean room and Ante room. Regular maintenance is also required.
Patient Controlled Analgesia usually use pump for drug delivering,
therefore the recommendations also require Periodical maintenance: in terms of frequency and contents are clearly indicated.
Due to the medication used for Patient Controlled Analgesia is usually opioids, the dispensing process would involve the special steps in signing off for the opioids by pharmacists. Also, prescription of special form proposed by Drug Enforcement Administration need to be used by the hospital.
Storage, delivery, and record keeping needs to be done according to the requirement of DEA
Due to opioids’ status of high-alert and controlled medication,
the recommendations of Administration for Patient Controlled Analgesia as follow:
Pump needs to be set by two nursing staff and Record keeping on the use of controlled drug by every shift of nursing staff.
Discharge home with Patient Controlled Analgesia needs a comprehensive evaluation.
Training and evaluation to the health care professionals
could be two types: one is to provide initial education and training before the start of work,
the other is continuous education and training.
The quality of sterile product preparation is critically related to patient safety. There are consensus standards on TPN, chemotherapy, and PCA dispensing available. Finally, the hospital accreditation standards need to be updated to reflect the speed of emerging innovative therapies and new concept. Thank you for your attention.

There are various accreditation standards for hospitals. One of the most important missions of these standards is to enhance patient safety. In this video, Deputy Chiang will introduce 3 main standards related to sterile medications. These standards are implemented in Taiwan as a result of a government project in 2014.

  • Total parenteral nutrition(TPN)
  • Parenteral chemotherapy
  • Patient controlled analgesia
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