brenda jensen cpht, cnmt, mba · sterile compounding sops the sections in this chapter are...

Compounding Compliance: SOPs and Staff Training

Brenda Jensen CPhT, CNMT, MBA

Disclosure

The views and opinions expressed are those of the speaker and are not endorsed by or affiliated with USP.

Brenda Jensen declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

Learning Objectives

1. List SOP requirements for sterile and nonsterile compounding.

2. Describe the difference between training and competency.

3. Describe training requirements for sterile and nonsterile compounding.

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Standard Operating Procedures

Purpose

Definitions

Scope

Procedure

References

Attachments

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Document Control

SOP Index

SOP Title

SOP Number

Version Number

Date of issue or revision

Approval Signature

Page Numbers

<795> Nonsterile <797> Sterile<800> Nonsterile & Sterile HDs<1163> Quality AssuranceRelated chapters<51>, <71>, <85>, etc.

Shall or Must = RequiredShould = Recommended

Timeline associated for the proposed revisions to <795> and <797> and opportunities to engage with USP and provide input.

http://www.usp.org/compounding/updates-on-standards

Also need to include…as appropriate

Resident state law

Nonresident state law(s)

Federal law

Accreditation standards

Credentialing standards

<795> Nonsterile Compounding SOPs

All significant procedures performed in the compounding area should be covered by written standard operating procedures

(SOPs). Procedures should be developed for the facility, equipment, personnel, preparation, packaging, and storage of compounded preparations to ensure accountability, accuracy, quality, safety, and uniformity in compounding.

Implementing SOPs establishes procedural consistency and also provides a reference for orientation and training of personnel.

<1163> Quality Assurance (S & NS)

• Beyond-Use dating

• Chemical and physical stability

• Cleaning and disinfecting

• Component quality evaluation

• Compounding methods

• Dispensing

• Documentation

• Environmental quality and maintenance


• Equipment maintenance, calibration, and operation

• Formulation development

• Labeling

• Materials & final compounded preparation handling and storage

• Measuring and weighing

• Packaging and repackaging

• Patient monitoring, complaints, and adverse event reporting

• Patient or caregiver education and training


• Personnel cleanliness and garb

• Purchasing

• Quality assurance and continuous quality monitoring

• Safety

• Shipping

• Testing

• Training and retraining

<795> Nonsterile Compounding Training

Personnel are appropriately trained and are capable of performing and qualified to perform their assigned duties.

All personnel involved in the compounding, evaluation, packaging, and dispensing of compounded preparations shall be properly trained for the type of compounding conducted. It is the responsibility of the compounder to ensure that a training

program has been implemented and that it is ongoing. Compounding personnel should be evaluated at least annually.


Steps in the training procedure include the following:

• Read and be familiar with <795> & other relevant publications.

• How to read and interpret SDSs.

• Read and be familiar with each of the procedures related to compounding, including those involving the facility, equipment, personnel, actual compounding, evaluation, packaging, storage, and dispensing.


• All personnel who compound hazardous drugs shall be fully trained in the storage, handling, and disposal of these drugs. This training shall occur before preparing or handling hazardous drugs.

• The following are references for the safe handling of antineoplastic and hazardous drugs in healthcare settings:

OSHA Technical Manual

NIOSH Alert


• All training activities shall be documented. The compounder shall meet with employees to review their work and answer any questions the employees may have concerning compounding procedures.

• The compounder shall demonstrate the procedures for the employee and shall observe and guide the employee throughout the training process. The employee will then repeat the procedure without any assistance from, but under the direct supervision of, the compounder.


• When the employee has demonstrated to the compounder a verbal and functional knowledge of the procedure, then and only then will the employee be permitted to perform the procedure without direct supervision. However, the compounder should be physically present and shall approve all ingredients and their quantities and the final preparation.


• When the compounder is satisfied with the employee’s knowledge and proficiency, the compounder will sign the documentation records to show that the employee was appropriately trained.

• The compounder shall continually monitor the work of the employee and ensure that the employee's calculations and work are accurate and adequately performed.

• The compounder is solely responsible for the finished preparation.

Training does not equal competency!

• Training usually includes some sort of knowledge check (like a quiz).

• Demonstrating competency usually involves a visual assessment.

• Someone can have very good knowledge of a subject but not be competent in performing a specific task. Both is needed.

<797> Sterile Compounding SOPs

The sections in this chapter are organized to facilitate the practitioner's understanding of the fundamental accuracy and quality practices for preparing CSPs. They provide a foundation for the development and implementation of essential procedures and include (as applicable):

• Responsibility of Compounding Personnel

• CSP Microbial Contamination Risk Levels

• Personnel Training and Evaluation in Aseptic Manipulation Skills

• Immediate-Use CSPs


• Single-Dose and Multiple-Dose Containers

• Hazardous Drugs as CSPs

• Radiopharmaceuticals as CSPs

• Allergen Extracts as CSPs

• Verification of Compounding Accuracy and Sterility

• Environmental Quality and Control

• Suggested Standard Operating Procedures (SOPs)

• Elements of Quality Control


• Verification of Automated Compounding Devices (ACDs) for Parenteral Nutrition Compounding

• Finished Preparation Release Checks and Tests

• Storage and Beyond-Use Dating

• Maintaining Sterility, Purity, and Stability of Dispensed and Distributed CSPs

• Patient or Caregiver Training

• Patient Monitoring and Adverse Events Reporting

• Quality Assurance (QA) Program

<797> Sterile Compounding Training

Compounding personnel must be adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties:

• Perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces.

• Select and appropriately don protective garb.


• Maintain or achieve sterility of CSPs in ISO Class 5 PEC devices and protect personnel and compounding environments from contamination by radioactive, cytotoxic, and chemotoxic drugs.

• Identify, weigh, and measure ingredients.

• Manipulate sterile products aseptically, sterilize high-risk level CSPs, and label and quality inspect CSPs.


• Initial 3 x fingertip tests with zero cfus performed in your pharmacy. Use separate media plate for each hand.

• Media fills must mimic the most stressful conditions including: batch size, dosage forms, time of day. Media fill batch size, dosage forms, etc. that is performed is the maximum that staff members are validated to perform.


• High-risk media fill – every six months

• Low/medium-risk media fill – annually

• Perform with media fills - three page competency evaluation (from USP <797> Appendices III-V), post garb and post compound fingertip sample and post media fill surface sample.

<800> Hazardous Drug SOPs

• Receipt

• Storage

• Compounding

• Dispensing

• Administration

• Spill Management

• Disposal

• Transport


For each hazardous drug handling activity include (as applicable)

• Location

• Environmental monitoring

• Who is permitted to perform the activity.

• What training is needed and how competency will be assessed.

• PPE and hand-hygiene requirements

• HD handling procedure

• Cleaning procedure

Table 1 AntineoplasticTable 2 Non-antineoplasticTable 3 Reproductive hazardTable 5 Recommendations for Personal Protective Equipment (PPE)


Receipt

In addition to the above, also include

• Use of tiered approach, starting with visual examination of the shipping container.

• Handling of damaged packages.

• Spill kit must be accessible in the receiving area.


Storage

In addition, also include

• HDs must be stored in a manner that prevents spillage or breakage if the container falls. In areas prone to natural disasters the manner of storage must meet applicable safety precautions.

• Do not store HDs on the floor.


Compounding


• Comply with the appropriate USP standards for compounding.

• Equipment must be dedicated for use with HDs.

• Equipment use, maintenance and cleaning.


Dispensing


• Counting and repackaging equipment should be dedicated for use with HDs and should be decontaminated after every use.

• Antineoplastic HDs must not be placed in automated counting or packaging machines.

• Pneumatic tubes must not be used to transport any liquid HDs or any antineoplastic HDs because of the potential for breakage and contamination.


Administration


• Use of protective medical devices and techniques.

• Use of CSTD with antineoplastic HDs if dosage form allows.

• Use of techniques/devices that minimize risk of open systems.

• Avoid manipulating HDs (e.g. crushing tablets or opening capsules). If not possible, don appropriate PPE and use a plastic pouch to contain any dust or particles generated.


Spill Management


• Include clean-up of spills (address the size and scope), use of spill kit, location of spill kits and clean-up materials, PPE requirements, and specify who is responsible for spill management.

• Prevention of accidental exposures or spills.

• Use of Safety Data Sheets (SDS).

• Response to known or suspected HD exposure.


Disposal


• Consider all PPE worn when handling HDs to be contaminated with, at minimum, trace quantities of HDs.

• Place waste in an appropriate waste container and further disposed of per jurisdictional regulations.

• Refer to SDS Section 13 for disposal considerations that meet federal requirements. Refer to state/local law for additional requirements.


Transport


• Address appropriate shipping containers and packaging materials.

• Ensure labels include storage instructions, disposal instructions, and HD category information in a format consistent with the carrier's policies.

• Refer to SDS Section 14 for transport information.

• Address use of exposure-reducing strategies. labeling.


• Receipt

• Storage

• Compounding

• Dispensing

• Administration

• Spill Management

• Disposal

• Transport


Recommended

• Hazard communication program (required by federal law)

• Occupational safety program (required by federal law)

• Hand hygiene for each HD handling scenario.

• Washing of non-disposable clothing contaminated with HD residue

• Environmental monitoring (e.g., wipe sampling) – If performed.

• Medical surveillance – If performed.

<800> Hazardous Drug Training

• All personnel who handle HDs or who perform custodial waste removal or cleaning activities must be trained based on job functions (receipt, storage, compounding, repackaging, dispensing, administrating, and disposing of HDs).

• Training must occur before independently handling HDs.

• Personnel must be trained prior to the introduction of a new HD or new equipment and prior to a new or significant change in process or SOP.


• Effectiveness of training must be demonstrated.

• Competency must be reassessed at least annually.

• All training and competency assessments must be documented according to OSHA standards and other applicable laws and regulations.


• Overview of HDs in use and their risks

• Use of Safety Data Sheets

• Storage

• Review of SOPs related to handling of HDs

• Use of equipment and devices.

• Use of PPE including use of NIOSH-certified respirators

• Prevention of HD contamination


• Labeling

• Transport

• Disposal of HDs and trace-contaminated materials

• Spill management and use of a spill kit

• Response to known or suspected HD exposure

Learning Assessment #1

_______ is a way to assess competency.

A. Written quiz B. Answering questions correctly C. Demonstrating tasks


_______ is a way to assess competency.

A. Written quiz B. Answering questions correctlyC. Demonstrating tasks


USP <800> requires SOPs for ______.

A. Handling hazardous drugs. B. Operating a balance. C. Performing media fills.


Nonsterile compounders must be knowledgeable about USP <795>.

A. True B. False

References

American Society for Qualityasq.org

United States Pharmacopeia USP 41 - NF 36app.uspnf.com

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016

https://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf

Additional Resources

USP <800> FAQhttps://www.usp.org/frequently-asked-questions/hazardous-drugs-

handling-healthcare-settings

USP <800> HazRx Mobile Apphttps://www.usp.org/hazrx-app

The Chapter <800> Answer Book by Patricia Kienlehttps://store.ashp.org

Contact Information

Brenda Jensen CPhT, CNMT, [email protected]

605-214-1311

mailto:[email protected]

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