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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Field Laboratory Equipment Requests

Subject:
Field Laboratory Equipment Requests
Area:
Operations Management
Date Revised:
September, 20 1995

 

 

PURPOSE

To define responsibilities and procedures in the ORA organization and provide an orderly process of identifying, prioritizing and purchasing laboratory equipment which cannot be purchased from Regional, District Laboratory or Research Center funds. This program encompasses all laboratory equipment and instrumentation, including computer-controlled devices or data management but specifically excluding stand-alone ADP resources to support a general office automation environment. The process grants approval to acquire laboratory equipment, including associated installation and/or training costs, with Headquarters-managed funds. These procedures do not substitute for, nor replace the requirements for, review and approval of actual procurement documents by Administrative, ADP and/or Property Management personnel.

BACKGROUND

The FDA is challenged to provide consumer protection and maintain the public health with respect to a full range of products. To carry out this mission, ORA's scientists must be equipped and trained with adequate instrumentation representing the best available proven technology.

ORA field scientists should also strive to improve their effectiveness through automation and computerization of instrumentation. These advances will foster improved accuracy and precision in analytical data reporting, enhance efficiency and provide access to real-time FDA data generated in any District Office in the United States. Both long and short term planning should occur within the Regions to set priorities for instrument and equipment procurement consistent with field laboratory specialization and laboratory capacity to fulfill ORA workplan program responsibilities.

EQUIPMENT PROCUREMENT PROCESS

Equipment procurement should occur as early in the fiscal year as possible. The following calendar of events describes the cycle for laboratory equipment procurement.

1ST QUARTER

1. Call to Centers by ORO (ORO;DFS, HFC-140) for input (October-November).

2. ORO priority setting: i.e. Agency Programs, replacement of equipment, state of the art; ORO will articulate Agency priorities to the field (November-December).

3. Call to Regions for preparation of prioritized equipment requests (ORO;DFS); guidance package distributed (including current FY software documentation) (December)

2ND QUARTER

4. DFS receives Region/District requests (January-February) and compiles equipment request list.

5. Committee reviews and prioritizes equipment list based on previously determined priorities (February).

6. ORO/DFS receives dollar mark for equipment from ORM (February).

7. DFS submits prioritized equipment list to ORO for approval (March).

3RD QUARTER

8. Approved equipment listing sent to Field (April). Funds are earmarked solely for laboratory equipment. Only equipment identified in the approved list is authorized. All changes (different items, modifications to items, different manufacturers) must be approved by DFS. Every effort must be made to obligate equipment purchase(s) by the end of the 3rd quarter.

4TH QUARTER

9. Additional or supplemental funding. Equipment items from the overall priority list will be identified.

[Note: Emergency requests, which were received after the committee deliberations, may be added by DFS to the approved prioritized list.] Generally, only items under GSA Contract will be selected. All changes (different items, modifications to items, different manufacturers) to the items/equipment listed must be approved by DFS. (June-September).

RESPONSIBILITIES

A. Office of Regional Operations

Each District's EPS and barcode data base must be maintained to reflect current inventory and repair history, since each district's EPS and barcode data, FY workplan, and current staffing will be used in equipment request reviews. At the beginning of the fiscal year, ORO will solicit input from the Centers concerning scientific instrumentation and equipment that will be necessary to meet program needs, new initiatives, emerging issues, and state-of-the-art technology. ORO then sets priorities based on factors such as: laboratory specialization, Agency Programs, replacement of equipment (EPS and barcode data), or best available technology. By the end of the first quarter, ORO will articulate Agency priorities to the field.

This process is expected to provide each District with the guidance to develop a comprehensive equipment procurement plan through the use of EPS and barcode inventory data, Center input, Workplan assignments, laboratory specialization, ORA priorities, and District expertise. This process should allow Districts to plan from a multi-year perspective and to minimize the need for emergency requests.

Throughout the planning process, participants must bear in mind that this program does not provide for the acquisition of stand-alone ADP equipment. However, computers, requested as part of an instrument package as controllers equipped with specialized hardware and/or software, and whose principal use will be instrument control and/or data acquisition and storage will be included in this process along with the associated scientific instrumentation.

B. Regional Food & Drug Directors

1. Internal Procedures

Each RFDD should establish procedures within the region for submission, clearance and development of regional priorities of equipment requests based on the priority criteria provided by ORO. Form FD-2814, Field Equipment Request (Exhibit A), should be utilized for each request. Established procedures should be in place, reflecting guidance below, to generate a FY Regional priority listing that describes only those equipment requests that are needed for Field laboratories and Research Centers to perform their Program and Research responsibilities for the next FY.

2. Annual Requests

Annual requests for the acquisition of scientific instruments or equipment for ORA field laboratories will be reviewed and approved by a committee comprised of a Science representative from each Region and DFS staff. The committee will review the prioritized list of laboratory equipment from each Region. Equipment requests should clearly identify the piece or integral related pieces of equipment. Include cost (all equipment greater than or equal to $5,000), manufacturer, GSA schedule number, reason for request (absolute program or research need, replacement, efficiency, new technology, as defined below) and justification. The justification should clearly state the compliance program(s), research project(s), the laboratory's assignment to the program work through the regional laboratory specialization, or other basis for the equipment request. The cost of building and/or room modification or alteration (MAR) to provide space and environmental conditions, installation, user training, and estimates of the cost of maintenance, or of a service agreement should be included. Each completed request should stand on its own merit.

DFS will request the prioritized regional list of laboratory equipment requests, with a completed FD-2814 for each unique item and all associated documentation, be submitted by the first week of February.

EQUIPMENT COMMITTEE PROCESS

PHASE I.

Committee teams will review Regional packages, i.e. packages from different regions than reviewers, and assess Justification, Category and Program Priority using criteria below.

Criteria: Evaluate equipment request and justification in context of laboratory workload (Workplan), available instrumentation as per EPS and barcode inventory, and laboratory specialization to assign the appropriate Category. All program and research scientific instrument and equipment requests will be assigned to one of four Categories.

Category 1.     Absolute Program or Research Needs

This equipment is required to conduct analytical or other scientific sections of new or ongoing programs or research for which suitable equipment is not now available. Instrumentation or equipment requested to meet absolute program or research needs will normally correspond to the best available proven technology.

Category 2. Replacement

This equipment will replace equipment already in the District's EPS and barcode inventory that is required for ongoing regulatory or research programs and is operating poorly or, because of its age, is of questionable accuracy or reliability. Excessive maintenance costs, down time, or the lack of service, parts or supplies may indicate that instruments or equipment should be replaced. Replacement instrumentation or equipment will normally correspond to the best available proven technology.

Category 3. Efficiency

This equipment will (1) improve sample throughput, or (2) improve the sensitivity, selectivity, or reproducibility of regulatory analyses, or (3) otherwise enhance the quality of ongoing regulatory or research programs through instrument modernization, safety, computerization or automation. Instrumentation or equipment requested to improve laboratory efficiency will normally correspond to the best available proven technology.

Category 4. New Technology

This equipment will enable the FDA to apply new technologies to ongoing regulatory and research programs or to initiate research and regulatory programs in technologically demanding areas of regulatory concern. Instrumentation or equipment representing new technology will normally correspond to the best available technology for a particular application. This technology should have the potential for a particular regulatory application, but need not have a proven record of performance.

When equipment could be classified in either of two categories, absolute program/research need and replacement, for example, it will be assigned to the Category that will give it the higher priority absolute program/research need, in this example. Within each Category, the committee will rate and rank the requests with respect to individual program areas.

PHASE II. Verification.

A second Committee team will review and verify Category, Program Priority and justification assignment(s) of the first team. Both teams must concur on Priorities assigned.

PHASE III.

Committee teams will prioritize each Category's equipment by Fiscal Year program priorities. Note: Each FDA compliance program is assigned a priority each year by ORO/DFS. As Agency programs evolve, DFS will correspondingly update the Program Priority listing. Currently 11 identified compliance programs requiring scientific support: food microbiology, medical devices, animal drugs/tissue residues, seafood/aquaculture, nutrition, elemental analysis, pesticides/industrial chemicals, drugs/biologics, food additives, natural toxins, filth/decomposition, and general purpose.

PHASE IV.

Entire Committee develops list of equipment by Category. List includes all appropriate equipment requests from highest to lowest priority. Committee discusses and reviews list and may adjust list following discussions. Committee agrees on final equipment request list.

PHASE V.

DFS generates final equipment list via computer printout(s) and presents the Committee recommendations to the ORO for consideration.

PHASE VI.

ORO approval of equipment. Approved List and Committee deliberations shared with RFDDs. Equipment procurement begins.

D. Emergency Requests

When the need for equipment is precipitated by circumstances that cannot be anticipated and when the urgency calls for immediate action, the Regions may resort to an emergency request if the cost of such equipment exceeds $5,000 or if it cannot be purchased from local funds. The emergency equipment requests should not be used to purchase equipment outside the priority setting process except for true emergencies (where the FDA's mission or employee safety would be compromised). Such situations may develop when, for example, an unforeseen accident occurs, or a failure takes place and the cost of repair outweighs the cost of replacement, and program activities cannot be continued.

Under these circumstances the Regional procedure, established by the RFDD for justifying and forwarding emergency requests to headquarters, should be followed. RFDD's should forward the approved request to Director, Division of Field Science HFC-140. All submissions must include a completed FD-2814 with a written justification. Justification must include:

1) specific program/activity need:

2) equipment is appropriate within regional/workplan laboratory specialization:

3) support is unavailable from other labs (regional or national) to accomplish sample activity; and

4) funds are not available from District or Region to support this activity.

E. Instructions for FD-2814

Attached is a copy of the revised FD-2814 Field Laboratory Equipment Request that must be completed for each requested item.

1. REQUESTED ITEM(S)

List general type of equipment with detailed individual items, part numbers, etc. on the reverse side under item 12.

2. TOTAL COST

Total price should include installation, training, all items to complete the equipment request.

3. EQUIPMENT ESSENTIAL FOR

Select Category. See explanation of four categories Section IV 2.2.

4. PROGRAM PRIORITY

Select program(s) which equipment will support.

5. BUILDING MODIFICATION

Explain if room modifications are necessary for installation.

6. JUSTIFICATION and BACKGROUND DETAILS

List purpose, program, justification of need, also show workplan or specialization. Justification must support Category and Program Priority selected.

7. LABORATORY ENDORSEMENT/PRIORITY

Indicate person initiating request and priority.

8. DISTRICT DIRECTOR ENDORSEMENT/DISTRICT PRIORITY

Signature and priority.

9. REGIONAL DIRECTOR ENDORSEMENT/REGIONAL PRIORITY

Signature and priority.

10. MANUFACTURER/ADDRESS

List mailing address for Purchase Order.

11. QUOTATION/CONTACT/TELEPHONE

Detail listing and prices of the equipment or material required and the technical contacts at the suggested source of supply.

12. GSA CONTRACT

Indicate Contract Number with associated list of items and cost.

{Note: DFS is upgrading the rating and ranking PC-based FMD81 data entry to a network-based program for utilization by Districts and Regional staff. This program revision follows the guidelines set forth in this document and further streamlines the process for approval and ranking. The network-based program will also allow data to be electronically transferred amount Districts, and Regions and ORA Headquarters. The new network program and instructions will be distributed electronically to ORA field laboratories and Regional staff in FY96.}


DISTRIBUTION:             Regional Food and Drug Directors and District Directors; FDA Headquarters Offices

ISSUED BY:                  ORA/ORO/Division of Field Science (HFC-140)

AUTHORITY:                 ORA

PUBLICATION DATE:  8/96