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Quality Assurance/Quality Control Activities
DCAS’ Quality Assurance (QA) program involves all of the planned and systematic activities incorporated within the DCAS organizational structure, procedures, processes, and resources needed to implement the Act/EEOICPA. DCAS has integrated Quality Control into all aspects of the NIOSH dose reconstruction program. Quality Control involves operational activities aimed at systems and processes developed to ensure the quality of our dose reconstructions.
QA/QC in the Dose Reconstruction Process
The QA/QC process begins as soon as DCAS receives a cancer claim from the Department of Labor (DOL) for dose reconstruction and continues until a claim is returned to DOL for a compensation decision.
Claim Received from the Department of Labor (DOL)
When DCAS receives a claim from DOL, the hard copy file is reviewed to ensure legibility, that the information pertains to the correct energy employee, and that there are no other issues (e.g., missing pages). The data is then scanned and uploaded into the NIOSH DCAS Claims Tracking System (NOCTS) and assigned a unique NIOSH Tracking Number. NOCTS is an electronic database that tracks claimant data and documents. The system is a central repository for all information related to each claim.
Information such as the energy employee’s name, social security number, ethnicity and smoking status (if required), date of birth, employment history, and cancer information are manually entered into NOCTS. The database has a built in validation tool that checks this data to ensure that it is entered properly (e.g., SSN pattern matches 999-99-999 or 99999999 format).
An electronic quality report is generated within NOCTS to identify any data discrepancies that may have been missed by the manual review. Any discrepancies discovered from this report are also evaluated and resolved internally or referred to DOL for resolution, if necessary.
The data is then manually reviewed. The hard copy file received from DOL is compared against the data entered into NOCTS using a QC case checklist. The checklist requires a review of data such as the cancer description, diagnosis date, claimant address, and energy employee employment history. Any discrepancies discovered from this manual review are evaluated and resolved internally or referred to DOL for resolution, if necessary.
Data Requested from the Department of Energy (DOE)
After the data has been entered and reviewed in NOCTS, DCAS submits a request to DOE for the energy employee’s exposure monitoring information. Information that may be obtained from DOE includes work site locations, radiological monitoring data, medical and x-ray data, and incident reports or investigations. This information is used to support the development of the dose reconstruction.
Energy Employee Data Reviewed
After DCAS receives the energy employee’s exposure monitoring data from DOE, the hard copy data is reviewed to ensure legibility, that the information pertains to the correct energy employee, and that there are no other issues (e.g., missing pages). The data is then scanned and uploaded into the NOCTS database.
Before a dose reconstruction can begin for the case, the data must be reviewed to determine if a DOE response has been received from all sites requiring a response, all data were received that the site indicated they sent, and if there are any anomalies associated with the data. Any additional data and/or clarifications are requested from DOE as needed.
Claimant Telephone Phone Call Conducted
Claimants have an opportunity to participate in a voluntary phone call before the dose reconstruction is started for their case. During the call, claimants can provide DCAS with additional information on the energy employee’s work activities which may have contributed to his or her radiation exposures but may not have been described in the radiation exposure information that DCAS received from DOE and DOL.
A phone call summary report is generated based upon the call and sent to the claimant for review. The claimant’s review helps DCAS ensure the information accurately reflects what he or she stated during the phone call. This information is later reviewed by the dose reconstructionist and information significant to the development of the dose reconstruction is extracted.
Draft Dose Reconstruction Report Completed by our Contractor
The draft dose reconstruction report is completed by our contractor. The personnel assigned to complete the dose reconstruction (the Health Physicist) must be trained per program requirements. This training includes three to four days of formal classroom training, required reading (with certificates of completion), and short-duration topical classroom training.
Dose reconstructions are completed per the guidance of approved documents such as implementation guidelines; technical documents such as Site Profiles, Technical Basis Documents, and Technical Information Bulletins; and other written procedures.
The initial QC review of the draft dose reconstruction report checks spelling; ensures that the name, social security number, NIOSH ID, employment information, and cancer designation on the cover sheet and in the draft dose reconstruction report match the NOCTS database; and confirms that inputs and summary file information used in NIOSH-IREP is consistent with and attached to the draft dose reconstruction report.
Draft Dose Reconstruction Report Peer Reviewed by our Contractor
After the draft dose reconstruction report is completed, it undergoes an internal peer review by our contractor. This peer review addresses (as applicable) the consistency, accuracy, and appropriateness of the demographic and dosimetry information in NOCTS; NIOSH-IREP input and summary files; accuracy of the draft dose reconstruction report; and inclusion of information gained during the phone call with the claimant.
The draft dose reconstruction report then undergoes technical editing to ensure that there are no format, reference, spelling, or grammar issues. A final QC check is performed similar to that of the initial QC review, but more detailed. Any identified issues discovered during the QC process are directed back to the individual responsible for the development of the draft dose reconstruction report for correction.
Draft Dose Reconstruction Report Reviewed by DCAS
After technical review and editing of the draft dose reconstruction report, it is placed on DCAS peer review. Each dose reconstruction is reviewed by an DCAS Health Physicist. The review ensures that the approach is technically valid, the probability of causation is sound, the DR is completed according to the guidance contained in approved procedures, and that the dose calculations are correct as compared to the input calculations. Draft dose reconstruction reports that are not approved are returned to our contractor with written comments describing any deficiencies that need to be addressed.
In addition to the reviews completed above, five percent of all of the draft dose reconstructions reviewed are randomly selected and undergo another review using a dose reconstruction review checklist. This checklist includes nineteen questions relative to the quality of the dose reconstruction. The dose reconstruction reports are compiled and evaluated quarterly to determine if any adverse trends are present. Formal assessment reports are generated and forwarded to our contractor so that any necessary corrective actions can be taken.
Draft Dose Reconstruction Report Approved by DCAS
An DCAS Health Physicist approves the draft dose reconstruction report. The draft is reviewed to ensure that the tracking number appears consistently on each page, all pages are accounted for, an DCAS Health Physicist approval signature is present, and the energy employee’s name and social security number are correct. This review is conducted prior to sending the draft dose reconstruction report to the claimant.
Each dose reconstruction goes through a final technical review to ensure that the general approach is sound and that there are no obvious errors.
Draft Dose Reconstruction Report Reviewed by Claimant
All claimants may take part in a phone call once we complete the dose reconstruction. During this call, the claimant has the opportunity to review and comment on the draft dose reconstruction report before it is forwarded to DOL for a compensation decision. Once the claimant’s comments have been addressed, the claimant signs and returns an attached form to DCAS (OCAS-1 form). The claimant’s signature on the form is not an indication that he or she agrees with the findings of the dose reconstruction report.
The claimant’s signature on the OCAS-1 form certifies that he or she agrees with the following statements:
- The claimant is not aware of any additional information that may be relevant to the dose reconstruction.
- The claimant has reviewed the draft dose reconstruction report and agrees that it identifies all of the relevant information he or she provided to NIOSH regarding the dose reconstruction.
- The dose reconstruction report is ready to be forwarded to DOL for a determination regarding the case.
Final Dose Reconstruction Report Forwarded to DOL for Compensation Decision
Once DCAS receives the signed OCAS-1 Form from the claimant, a final electronic quality report is generated in the NOCTS database to identify any data discrepancies. Any discrepancies discovered from this report are evaluated and resolved internally or referred to DOL for resolution, if necessary. The final dose reconstruction report is forwarded to the claimant and to DOL. DOL will use the information in the final report to assist with determining whether or not the claim qualifies for compensation.
QA/QC in the Technical Document Development and Approval Process
If the energy employee’s personal radiation information is incomplete, DCAS will use other sources to estimate the radiation to complete the dose reconstruction. This may involve using technical documents called Site Profiles, Technical Basis Documents, and Technical Information Bulletins.
Draft Technical Document Developed by our Contractor
Prior to submitting draft technical documents to internal review, the document is formally edited by the contractor by copy editing – checking the document for internal consistencies and for errors in spelling, grammar, punctuation, format, and style, and verifying references, and text citations.
Individuals assigned as document owners are responsible for ensuring that contributing authors do not introduce potential bias into the document in accordance with the NIOSH Policy on Conflict or Bias.
Draft Technical Document Peer Reviewed by our Contractor
After the draft technical document has undergone editing, the document is then peer reviewed by our contractor. Comments are reviewed and resolved between our contractor’s peer reviewer and Health Physicist who is responsible for the development of the technical document. Once our contractor approves the draft technical document, it is then forwarded to DCAS for a formal review.
Draft Technical Document Reviewed by DCAS
After DCAS reviews the draft technical document, it is distributed to selected DCAS reviewers based on expertise and applicable conflict of interest restrictions. Any DCAS comments generated are forwarded to the contractor and are reviewed and resolved.
Draft Technical Document Approved by DCAS
Once the contractor has addressed comments identified by DCAS, the technical document is sent back to DCAS for final approval. Approved technical documents are reviewed periodically to ensure appropriate maintenance, revision, or cancellation as needed; when policy, organizational structure, and regulatory requirement changes require revisions; and to improve the effectiveness or efficiency of the document.
QA/QC in the Program Oversight Process
Internal and External Assessments are performed by DCAS per approved procedures. These procedures detail how to perform and document assessments. Many of these assessments result in findings requiring changes in our contractor and DCAS’ programs. Findings identified in assessments require formal documented corrective action plans. DCAS must approve the corrective action plans and scheduled completion dates. After scheduled corrective actions have been completed, DCAS evaluates the actions to determine if they have been completed and if the corrective actions taken are effective.
Examples of subjects of completed assessments include:
- Assessment of Administrative Record
- Review of Contractor Dose Reconstruction Status Report
- Review of Contractor Dose Reconstruction Process
- Assessment of Dose Reconstruction Review Record
- Periodic Contractor Performance Evaluations
- Efficiency of the Dose Reconstruction Process
- Oversight of the Dose Reconstruction Process
- Quarterly Evaluation of DR Review Checklists
- Verification of Completion of Corrective Actions
- Dose Reconstruction Production
- Assessment of Potential Conflict of Interest