Healthcare Shelf-Life Testing

HEALTHCARE SHELF-LIFE TESTING REQUEST AND AUTHORIZATION

Requester Facility Name:   Contact Person:

REQUESTER INFORMATION

PRODUCT / SAMPLE INFORMATION

Lot / Batch Number:   Units Submitted:

Date of Manufacture:   Expiry Date on Label:

TESTING REQUESTED

Select requested analyses (check all that apply):

Real-time stability testing

Accelerated stability testing (elevated temp/humidity)

Potency / assay (quantitative)

Sterility testing

Endotoxin (LAL) testing

Microbial limits / bioburden

Container closure / integrity

Visual inspection / particulate assessment

TESTING PARAMETERS AND ACCEPTANCE CRITERIA

CHAIN OF CUSTODY & SAMPLE HANDLING

Collected by:   Collection date:

Courier / Shipper:   Tracking / Waybill #:

BILLING & TURNAROUND

Requested turnaround time:   Charge estimate approval:

CONFIDENTIALITY, LIABILITY, AUTHORIZATION

By submitting this request, the requester certifies that they are authorized to provide samples and to request testing on behalf of the facility identified above. The requester warrants that samples submitted are representative of the lot or production batch described and that all information provided is true and complete to the best of their knowledge.

The laboratory's obligation is limited to performing the analyses expressly requested herein in accordance with its standard methods and documented deviations. Results are issued only for the samples received and within the scope of testing authorized. The laboratory shall not be liable for consequential, incidental, or special damages, and total liability for any claim arising from testing shall not exceed the fees paid for the testing services. Requester agrees to indemnify and hold harmless the laboratory from claims arising out of sample origin, labeling, or use of results.

Confidential testing data will be treated as proprietary and disclosed only as required by law or as authorized in writing by requester. Requester authorizes the laboratory to dispose of remaining sample material 90 days after issuance of final report unless alternate instructions are provided below.

Authorization expiration date:    I confirm I am authorized to request testing and accept the terms above.

HIPAA / PRIVACY (IF SAMPLES CONTAIN PHI)

If the samples submitted contain individually identifiable patient information or protected health information (PHI), requester must obtain patient authorization for disclosure to the laboratory. Check below to acknowledge that required authorizations are in place for any PHI submitted.

PHI authorization attached / PHI authorization on file

Patient date of birth:   Relationship to requester (if guardian):

SPECIAL INSTRUCTIONS / COMMENTS

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