Food and Drug Administration:

Laboratory Analysis of Product Samples Needs To Be More Timely

HRD-86-102: Published: Sep 30, 1986. Publicly Released: Sep 30, 1986.

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GAO reviewed the Food and Drug Administration's (FDA) field laboratories, focusing on: (1) their timeliness in processing product samples to determine if they were violative; and (2) measures FDA could implement to improve this process.

FDA district office investigators collect and ship samples to laboratories for analysis and classification as: (1) compliance samples, which FDA believes are possibly violative; or (2) surveillance samples, collected to obtain safety and other data. To achieve its consumer protection responsibilities, FDA must quickly identify and remove known or suspected violative products from the market. GAO found that FDA: (1) has not given its laboratories sufficient guidance on how quickly they should process such products; (2) does not monitor or evaluate field performance in meeting processing-time guidelines; and (3) has not given the laboratories guidance on managing the flow of samples into inventory or adequately controlling inventory size. Since laboratory documentation requirements add to sample processing time, FDA has allowed abbreviated reports of sample test results in some cases. However, many field laboratories have not used the abbreviated report. GAO previously proposed that Congress consider giving FDA broader detention authority to help keep violative products off the market, FDA believes that the detention period should be the 30 days after sample collection, which would require a shortening of the laboratory processing time to allow time for the necessary legal actions to seize the violative products.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA incorporated PMRS elements and standards in district-level staff performance plans to ensure coordination between investigations and laboratory branches.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require district offices' investigations and laboratory branches to coordinate and schedule the collection of surveillance samples.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: FDA emphasized increased coordination between investigations and laboratory branches in a November 1986 district manager's conference and will incorporate coordination in district PMRS.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require the investigations branch to collect surveillance samples in accordance with the collection schedule developed with the laboratory branch, unless an emergency should arise.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: FDA instructed its district directors to monitor and manage the flow of surveillance samples from other districts and prepare work schedules to determine when samples may be accepted. Action was accomplished at a district managers' conference. Follow-up over time is needed to ensure that oral instructions are sufficient to accomplish the purpose of this recommendation.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require laboratory directors to continue to prepare schedules for receipt of surveillance samples tested for other districts, and require these districts to follow the prepared schedules, unless agreements on deviations from the schedules are reached with the laboratory.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: District directors were directed to implement this recommendation. Additional work is needed to determine whether such a directive is effective.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish procedures that require laboratory directors to determine an approximate inventory size that will permit the processing of samples within the time-frame guidelines established by FDA.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: FDA action consisted of oral instructions at a November 1986 district managers' conference. Further follow-up over time is needed to ensure that oral instructions are sufficient to accomplish the purpose of this recommendation.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish a policy that prohibits the dumping of product samples into the laboratory's inventory.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: After assessing the different practices, FDA selected one to be used by all field laboratories. FDA issued a directive on use of the single simplified practice.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to assess the simplified analytical documentation practices used by various FDA laboratories, including eliminating detailed step-by-step descriptions of the analyses performed on nonviolative samples, and determine their applicability to all FDA laboratories.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: After assessing the different practices at various laboratories, FDA issued directives which define the universe of samples that may use abbreviated reporting.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to define the universe of samples that should be covered by abbreviated reporting.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Implemented

    Comments: After assessing the different practices at various laboratories, FDA issued a directive which includes the appropriate forms all laboratories should use with analytical processes.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to develop a standardized abbreviated form and implement its use as FDA policy on a laboratorywide basis.

    Agency Affected: Department of Health and Human Services

  9. Status: Closed - Implemented

    Comments: The laboratory management system was modified to accept and track the sample processing time frames. Software was designed to permit better management of samples and monitoring of schedules.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to change the laboratory management system sample priority classifications to those used by the laboratories in setting processing priorities to: (1) enable laboratory managers to better schedule the testing of samples; and (2) give laboratory managers greater monitoring capability over laboratory performance.

    Agency Affected: Department of Health and Human Services

  10. Status: Closed - Implemented

    Comments: A draft sample processing time-frame guideline was circulated to FDA Regional Food and Drug Directors for their review and comment. On March 9, 1987, the sample processing time frames were finalized and sent to all of the district offices for implementation.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to establish time-frame guidelines for field laboratories' processing of all samples, consistent with the four sample processing priority designators used by the laboratories.

    Agency Affected: Department of Health and Human Services

  11. Status: Closed - Implemented

    Comments: FDA modified its laboratory management system to provide better analysis capabilities. Implementation was completed in December 1987.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to evaluate field laboratory performance in meeting the time-frame guidelines.

    Agency Affected: Department of Health and Human Services

 

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