Optional Form 380 (OF 380): Medical Material Complaints/Quality Improvement Report

Optional Form 380 (OF 380), Reporting and Processing Medical Material Complaints/Quality Improvement Report, is a two-page report about a medical material item. The footer reads OPTIONAL FORM 380 (REV. 5/2002), and the form says it is authorized for local reproduction. The form names no issuing agency. GSA hosts a copy in its forms library.

The front records the date and report number, who it goes to and comes from, the type of complaint (quality, new item or similar item, plus Type I, II or III boxes for DoD use), the item, its manufacturer and contractor, lot, serial and model numbers, dates and quantities. Items on patients, reactions and hospitalization are marked for DoD Type I complaints only. Item 27 explains the cause of the complaint, and the initiator and supply officer close the front. The back holds recommendations, the action taken and who took it.

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Top of page 1 of Optional Form 380 (OF 380): Medical Material Complaints/Quality Improvement Report, as printed by GSA

What's on OF 380

Items 1 to 5: report and complaint type

Date, report number, TO and FROM, and the complaint type: quality, new item or similar item, plus Type I, II or III for DoD use.

Items 6 to 11: item, maker and contract

Manufacturer stock number, item description, manufacturer name and address, contractor (if other than the manufacturer), contract or purchase order number and lot number.

Items 12 to 20: identifiers, dates and stock

Control number, manufacturer's serial number, model number, date manufactured, date packed, expiration date, source (direct or distributor), quantity on hand and quantity suspended.

Items 21 to 26: patient reactions

Total patients involved, total reactions, severe or unusual reactions, reactions requiring hospitalization, length of hospitalization and a vaccine block (initial, booster, interval).

Items 27 to 29: cause, initiator and supply officer

An explanation of the unsatisfactory condition, deficiency or reaction, then the initiator's and supply officer's details.

Items 30 and 31: back page

Recommendations and/or additional remarks, action taken, and the name, title, organization and date for the action taken.

The form has 31 numbered items over two pages.

How to complete OF 380

1
Date, number and route
Enter the date and report number in items 1 and 2, and the TO and FROM offices in items 3 and 4.
2
Mark the complaint type
Check quality, new item or similar item in item 5a. Item 5b is for DoD use.
3
Identify the item
Fill in the stock number, description, manufacturer, contractor, contract number, lot, serial and model numbers, dates and quantities in items 6 to 20.
4
Add reaction details where they apply
The form says to complete items 20-25 for DoD Type I complaints only.
5
Explain the cause
Item 27 asks for an explanation of the unsatisfactory condition, deficiency, or a description of the reaction. The form says to complete it for ALL complaints.
6
Sign and record action
The initiator and supply officer complete items 28 and 29. Items 30 and 31 on the back record recommendations, the action taken and who took it.

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Where it goes and what the form says

Where it goes

The PDF gives no filing address. Item 3 (TO) names the recipient and item 4 (FROM) the sender.

Reproduction

The form says it is authorized for local reproduction.

Privacy and burden

The PDF prints no Privacy Act statement, OMB number or burden estimate.

Who uses OF 380?

The initiator
Item 28 holds the initiator's name (for Type I MC/DC/NC) and DSN and commercial telephone numbers.
The supply officer
Item 29 holds the supply officer's signature, date, name and DSN and commercial telephone numbers.
The sending and receiving offices
Item 3 (TO) names where the report goes and item 4 (FROM) names where it comes from.
Whoever takes action
Item 30 on the back records recommendations and the action taken, and item 31 gives the name, title, organization and date of the person who took it.
DoD reporters
Item 5b is for DoD use, with Type I, II and III boxes, and the form says to complete items 20-25 for DoD Type I complaints only.

The form prints no instructions on who completes it. These are the roles its blocks name.

Official sources and the blank

Official GSA form page
The agency’s own page for Form OF380.
Blank PDF
The official blank form, to print or fill by hand.

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Questions about Form OF380

Who issues OF 380?

The form names no issuing agency. Its footer reads OPTIONAL FORM 380 (REV. 5/2002). GSA hosts a copy in its forms library.

What complaint types does OF 380 list?

Item 5a lists quality, new item and similar item. Item 5b, for DoD use, has Type I, II and III boxes.

Which items are only for DoD Type I complaints?

The form says to complete items 20-25 for DoD Type I complaints only. Those items cover patients involved, reactions and hospitalization.

Is item 27 needed for every complaint?

Yes. Item 27, the cause of complaint, says to complete it for ALL complaints.

Who signs OF 380?

The supply officer signs and dates item 29. The initiator gives a name and phone numbers in item 28, and item 31 names who took action.

Optional Form 380 (OF 380): Medical Material Complaints/Quality Improvement Report