Non Hazardous Sterile Preparation Assessment Criteria

Use a NON HAZARDOUS STERILE PREPARATION ASSESSMENT CRITERIA 2021 template to make your document workflow more streamlined.

What this assessment criteria form covers

Non Hazardous Sterile Preparation Assessment Criteria is a structured record used to evaluate whether non-hazardous sterile compounding practices meet defined preparation, personnel, facility, equipment, documentation, and quality-control expectations. In the United States, the evaluator records observations, supporting evidence, findings, and corrective actions rather than relying on a simple pass-or-fail statement. The completed criteria help pharmacy or healthcare teams identify gaps, assign follow-up work, and preserve a dated review record. SignNow can convert the completed assessment into a fillable, reviewable document with signer fields and an audit trail.

Healthcare and pharmacy

Pharmacy quality teams use the criteria to review non-hazardous sterile preparation activities, document observations, assign corrective actions, and obtain accountable approvals. The workflow can include facility managers, compounding personnel, pharmacists, compliance staff, and designated reviewers while limiting access to necessary records.

Regulated operations

Healthcare organizations can use the assessment alongside internal quality programs, training reviews, and facility oversight. If the document contains protected health information, apply HIPAA controls and confirm a business associate agreement before using the workflow for PHI.

Organizations that use this criteria

The form fits healthcare operations that need a documented review of non-hazardous sterile preparation practices and accountable follow-up.

Independent compounding pharmacies can use a reusable criteria template to record facility observations, assign remediation, and collect pharmacist or owner approval without circulating paper copies.
Hospital pharmacy departments can route assessments among compounding personnel, pharmacy leadership, quality teams, and compliance reviewers while preserving role-specific responsibility for findings and corrective actions.
Multi-site healthcare organizations can standardize assessment fields across facilities, send location-specific reviews, and consolidate completed records for quality oversight, provided access and retention rules are configured by policy.

Structured criteria

Record preparation areas, personnel qualifications, equipment checks, environmental controls, documentation, and quality-assurance findings in one structured assessment.

Corrective actions

Assign each deficiency to a responsible person with a due date and supporting evidence, keeping follow-up visible after the review.

Role-based signing

Add reviewer, preparer, approver, and acknowledgement fields so every conclusion has a clear relationship to the assessment record.

Required fields

Use required fields for observations, findings, and approvals to reduce incomplete assessments before the document reaches a signer.

Audit trail

Preserve timestamps, signer identity, actions, and completion evidence in the signNow audit trail for later review.

Reusable template

Reuse an approved assessment template while updating facility-specific observations, dates, and corrective-action assignments for each review.

How the assessment workflow works

The workflow moves the criteria from preparation to review, approval, corrective-action assignment, and controlled retention without recreating the document.

Upload: Upload the approved assessment template.
Prepare: Review detected fields and add missing controls.
Route: Assign reviewers and corrective-action owners.
Archive: Complete signatures and preserve the record.

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Steps to complete and sign

Prepare the criteria, route it to the people responsible for review, and retain the completed assessment with its supporting signing evidence.

Upload document:
Upload the completed criteria document to signNow.
Check fields:
Review auto-detected fields and place missing fields.
Add recipients:
Assign reviewers, approvers, and corrective-action owners.
Send for signing:
Send the assessment for review and signatures.
Store records:
Download the completed document and audit trail.

Setting	Recommendation
Authentication method	Email verification with SMS OTP
Signature type	Electronic signature with signer intent
Audit trail	Enable document history and export
Document retention	Six years for HIPAA records
Encryption	TLS 1.2/1.3 and AES-256

Find and fill out the correct non hazardous sterile preparation assessment criteria

airSlate SignNow helps you fill in and sign documents in minutes, error-free. Choose the correct version of the editable PDF form from the list and get started filling it out.

Versions	Form popularity	Fillable & printable
Canada Ontario College of Pharmacists Community Pharmacy Assessment Criteria 2021	4.8 Satisfied (1226 Votes)
Canada Ontario College of Pharmacists Community Pharmacy Assessment Criteria 2020	4.8 Satisfied (2382 Votes)
Canada Ontario College of Pharmacists Community Pharmacy Assessment Criteria 2020	4.7 Satisfied (101 Votes)

Connect assessment records to existing systems

Named signNow integrations can move completed assessment records into the systems teams already use for operations, documentation, storage, and follow-up.

Security controls for assessment records

Data in transit:

TLS 1.2/1.3

Data at rest:

AES-256 encryption

Security controls:

SOC 2 Type II

Information security:

ISO 27001

Health information:

HIPAA with BAA

Signer verification:

Two-factor authentication

Signer authentication:

Records the reviewer’s authentication event.

Timestamp capture:

Captures when each assessment action occurred.

Document history:

Links the completed document to its signing history.

Tamper evidence:

Creates evidence of changes and completion status.

Audit details:

Lists recipients, actions, and recorded events.

Trail retrieval:

Exports completion evidence with the signed assessment.

Best practices for retaining assessments

A reliable recordkeeping process connects the assessment, supporting evidence, approvals, and audit trail without extending a retention period beyond the rule that actually applies.

Identify the assessment scope before review

Use the organization’s approved criteria version and identify the facility, assessment date, reviewer, preparation activities, and scope before recording findings. Do not replace objective observations with broad conclusions; attach supporting evidence where the workflow permits.

Document findings and corrective actions precisely

Separate observations from conclusions and describe each deficiency precisely. Record the affected preparation process, responsible owner, required correction, target date, and verification evidence so another reviewer can determine whether remediation was completed.

Export and archive the audit evidence

Export the completed assessment and its signNow audit trail together. Store them in a restricted repository with access limited to personnel responsible for pharmacy quality, compliance, operations, or authorized oversight.

Apply the governing retention rule

Apply the retention period required for the record’s actual category. If the assessment contains HIPAA-covered documentation, 45 CFR §164.530(j) requires six years from creation or the last effective date; state and organizational rules may require longer.

Retention periods for related records

Retention depends on the record’s content and legal category. Apply only the rule that actually governs this assessment and check state requirements before disposal.

Six years — HIPAA records

HIPAA-covered assessment records require six years under 45 CFR §164.530(j).

Three years — tax records

Federal tax records require three years from filing under IRC §6501(a), when that rule applies.

Six years — tax understatement

Tax records require six years when income is understated by 25% or more under IRC §6501(a).

Three years — payroll records

Payroll records require three years under 29 CFR §516.5 when the assessment is part of covered payroll documentation.

Five years — injury records

OSHA injury records require five years following the year covered under 29 CFR §1904.33.

Platform requirements for assessment work

Complete Non Hazardous Sterile Preparation Assessment Criteria through Chrome, Firefox, Safari, or Edge on Windows or macOS. SignNow also provides mobile apps for iOS and Android, while document access uses TLS 1.2/1.3 connections.

Browser support Chrome, Firefox, Safari, and Edge on Windows or macOS.
Mobile apps signNow mobile apps for iOS and Android.
Secure connection TLS 1.2/1.3 connection for document access.

For regulated deployment, use organization-managed Windows, macOS, iOS, or Android devices and apply the organization’s access policy. Teams using API, SSO, or advanced authentication should confirm the selected signNow plan and configure retention, audit-trail export, and permission controls before production use.

Troubleshooting the assessment workflow

Use these answers to resolve field, authentication, privacy, and retention questions before approving a non-hazardous sterile preparation assessment.

Upload the assessment as a PDF or document file, then review signNow’s detected fields. Add missing observation, corrective-action, date, and signature fields manually before sending.

The Business plan costs $8 per user per month with annual billing and includes templates and audit trails. Business Premium costs $15 annually billed and adds bulk send and kiosk mode.

For patient-related information, signNow lists HIPAA compliance with a BAA required. Confirm the organization’s BAA, access controls, and minimum-necessary handling before placing PHI in the assessment.

ESIGN and UETA generally recognize electronic signatures when intent, consent, attribution, and record retention are established. Consumer-facing records also require the disclosure and access procedures described in 15 U.S.C. §7001(c).

Use SMS OTP or another available signer-authentication control when the reviewer’s identity needs stronger verification. Keep the authentication setting aligned with organizational policy and the assessment’s sensitivity.

After completion, open the document history or audit-trail record and export the completion evidence with the signed assessment. Retain both together under the organization’s applicable records policy.

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