United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 1 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

1. Purpose:

To provide standard procedures to ensure that data and results retained in and reported by 

laboratories participating in the Microbiological Data Program (MDP) meet minimum data 

entry, record-keeping and reporting requirements.

2. Scope:

This Standard Operating Procedure (SOP) shall be followed by laboratories conducting 

microbiological studies for MDP, including support laboratories conducting non-routine 

activities that may impact the program. The procedures and measures required under this 

SOP must be documented and records must be kept in laboratory logbooks.

3. Outline of Procedures:

Remote Data Entry (RDE) System................. 5.1

System Administration.................................. 5.1.1 

System Access........................................... 5.1.2

Data Entry................................................. 5.1.3

Data Review Requirements............................. 5.1.4

Data Transmission....................................... 5.1.5

Pathogen Detection Results Reporting............ 5.2

Preliminary Positive Findings.......................... 5.2.1

Final Negative Results..................................... 5.2.2

Final Positive Results................................... 5.2.3

Pulsed-Field Gel Electrophoresis..................... 5.2.4

After-hours Notification................................ 5.2.5

Required Results Table................................. 5.2.6

Recordkeeping........................................ 5.3

Additional Reporting Requirements............... 5.4

4. References:

 Remote Data Entry (RDE) procedures are found in the RDE system's "On-line Help" 

function and are provided in a User Guide that was distributed to all laboratories. 

 SOP MDP-SHIP-03, Procedures for Packaging, Shipping, and Archiving Microbiological 

Cultures

 SOP MPO-ADMIN, Administrative Procedures for the Microbiological Data Program 

and Pesticide Data Program
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 2 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

5. Procedures:

5.1 Remote Data Entry (RDE) System - Results for USDA/AMS MDP samples, along 

with any associated sample set quality assurance (QA) data, shall be reported to the 

USDA/AMS Monitoring Programs Division (MP), Manassas, Virginia, following established 

Remote Data Entry (RDE) procedures.

5.1.1 System Administration

5.1.1.1 Each laboratory shall designate an individual or individuals to administer 

applicable aspects of the RDE system. MP shall create or modify the RDE 

account for the designated individual to grant laboratory system administrator 

privileges.

5.1.1.2 The laboratory system administrator shall create RDE user accounts for 

laboratory personnel using the Maintain User option on the RDE System Admin 

menu. Each user account shall be assigned one or more roles, which serve as 

defined permissions to access the different RDE options, based on position 

requirements.

5.1.1.3 The laboratory system administrator shall disable the RDE user account 

when an individual terminates employment with the organization. A user account 

will be automatically disabled if there is no log-in activity for 90 days. 

5.1.1.4 The laboratory system administrator may reset passwords and unlock 

accounts as needed using the Maintain User option in the RDE System.

 5.1.2 System Access

5.1.2.1 The RDE system requires a Web browser and an assigned user account 

and password to gain access.

5.1.2.2 Laboratory users shall access the secured RDE site by preceding the Web 

address with “https” for encrypted data communication between the central server 

and the user’s workstation.

 5.1.3 Data Entry

5.1.3.1 The laboratory shall create analytical sets, referred to as Groups in RDE, 

so that samples related to specific QA results are included under one unique 

Group identification number.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 3 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

5.1.3.2 Sample identity information shall be entered into RDE if a paper Sample 

Information Form (SIF) was submitted. A sample shall be attached to a Group in 

RDE if an electronic SIF was submitted.

5.1.3.3 Analytical data results shall be entered for each sample through the RDE 

system in the prescribed format.

5.1.3.4 Data may be entered and maintained on a Laboratory Information 

Management System (LIMS), but shall be imported into the RDE System for 

sign-off and transmission to MP.

5.1.3.5 Refer to the latest RDE System documentation for further information. 

The system documentation is the User’s Manual provided by the contractor and 

any documentation supplied by MP. System documentation is available on the 

Extranet.

 5.1.4 Data Review Requirements

5.1.4.1 The data shall go through a multi-level review and sign-off process prior 

to submission to MP. The RDE system provides for up to three reviewer signoffs for each analytical set. 

5.1.4.2 Analyst - this first-level sign-off is optional.

5.1.4.3 The Technical Program Manager or designee shall review the data for 

accuracy and completeness. This sign-off is required by the RDE system before 

the analytical set is allowed to be transmitted 

5.1.4.4 Laboratory Quality Assurance Officer (QAO) or designee shall review the 

data for integrity of the overall quality system and adherence to MDP criteria. The 

Quality Assurance Unit (QAU) shall have access to the data and supporting 

documentation. The QAO sign-off is required.

5.1.4.5 Following QAU review of a data package, data may not be changed by 

any laboratory personnel unless approved by the QAU. Corrections taken shall be 

documented.

 5.1.5 Data Transmission

5.1.5.1 Data shall be electronically transmitted to MP using the Transmit option in 

the RDE System. Analytical data on any other media shall not be submitted 

without prior authorization from MP. Data may be entered and maintained on a 
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 4 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Laboratory Information Management System (LIMS), but shall be signed off and 

transmitted through the Web-based RDE system.

5.1.5.2 Participating laboratories shall submit electronic results of routine testing

to MP via RDE within 60 calendar days of sample receipt according to 

established procedures as detailed in this SOP. If the 60 day reporting 

requirement will not be met, the laboratory shall send the MP Director or Deputy 

Director, monthly updates detailing the reason for the delay and a projected 

schedule for data delivery.

 5.2 Pathogen Detection Results Reporting

5.2.1 Preliminary POSITIVE findings are defined in the method SOP for each target 

organism listed below:

a. Salmonella

b. Non-O157 Shiga-toxin carrying Escherichia coli (STEC)

c. E. coli O157:H7

For this SOP, PRELIMINARY positive findings for the above listed target organisms are 

defined as a positive PCR result, e.g., BAX® PCR for Salmonella, BAX® real-time PCR 

for E. coli O157:H7, FDA’s real-time or quantitative PCR methods for STEC. The 

preliminary positive results report from real-time PCR for non-O157 STECs should also 

include results from real-time BAX® PCR for E. coli O157:H7. MDP laboratories must 

continue to keep MP informed of subsequent testing, isolation status or confirmation.

Laboratories shall report preliminary positive findings (see 5.2.6 table) for all target 

pathogens to the MP laboratory liaison(s) with a courtesy copy provided to the Deputy 

Director, using Results Notification Form, MDP DATA-01- Atch 1. Preliminary positive 

reports should be submitted to MP as soon as possible (MP prefers receiving report not 

later than close of next business day).

5.2.2. Final NEGATIVE results should be reported as soon as possible. In the event 

that a preliminary positive advanced to cultural (Example: PCR pool positive followed by 

a PCR individual positive, then cultural), but the target organism was not isolated, test 

results (see 5.2.6 table) should accompany the final negative report form. If other than 

target organisms are isolated and identified, e.g., Enterobactor sakazakii, this information 

shall be annotated in the comment section of the report form.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 5 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

This type of negative results reporting is important in gaining understanding of the 

limitations in procedures and technology. The final reports and/or support documentation 

shall be reviewed by the QAO or designee. The dates, identities/names of analyst(s) and 

reviewer must be annotated on all final report forms prior to transmission to MP.

5.2.3 Final POSITIVE results:

5.2.3.1 For Salmonella: Send the Final Positive report using the Results 

Notification Form, MDP-DATA-01- Atch 1 and include the required test results 

(see 5.2.6 table). Reporting to MP shall be done within 24 hours of completing 

VITEK® and poly O/H testing.

5.2.3.2 For E. coli O157:H7: Send the Final Positive report using the Results 

Notification Form, MDP-DATA-01-Atch 1, and include the required test results 

(see 5.2.6 table). Reporting to MP shall be done within 24 hours of completing the 

VITEK® test.

5.2.3.3 Once a Salmonella or E. coli O157:H7 organism is isolated, confirmed

and reported to MP, the laboratories shall insure Pulsed-field Gel Electrophoresis 

(PFGE) and/or serotyping is initiated within five business days of isolation OR

ship (3) slants of the isolate to the MDP repository so PFGE and/or serotyping, 

can be initiated within five business days of isolation.

Clearly annotate on Isolate Shipment form (Refer to MDP SHIP-03 SOP) 

that accompanies slants to MDP repository, whether PFGE and serotyping 

have been completed or if it still needs to be done.

5.2.3.4 For non-O157 STECs: Send the Final Positive report using the Results 

Notification Form, MDP-DATA-01-Atch 1 and include required test results (see 

5.2.6 table). Reporting to MP shall be done within 24 hours of completing the 

confirmatory SmartCycler® real-time PCR test on the positive isolate(s) already 

tested by cultural and VITEK®. 

5.2.3.5 When a non-O157 STEC organism is isolated and reported to MDP, the 

laboratory shall ship (3) slants of the isolate to the MDP repository within five 

business days of isolation so PFGE, serotyping, virulence characterization, 

archival and antimicrobial susceptibility testing, can be initiated as soon as 

possible.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 6 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Note: Prior to shipping isolates to the MDP Repository, provide notification via email 

to: achen@agri.ohio.gov and jbalogh@agri.ohio.gov. Attach the Results Notification 

Form, MDP-DATA-01 Attachment 1, the Isolate Information Form, MDP-DATA-01 

Attachment 4 (Form 001) and the Isolate Shipment Form, MDP-SHIP-03 Atch 4 to the 

notification email.) 

5.2.4. Pulsed-Field Gel Electrophoresis (PFGE) - The isolates of target pathogens 

listed in section 5.2.1 shall be subjected to molecular fingerprinting by PFGE within 

five business days after isolation and this data will be uploaded to Centers for Diseases 

Control and Prevention’s (CDC) PulseNet database within three days after completion 

of PFGE (refer to SOP MDP-SHIP-03, section 4.6). 

5.2.4.1 To correctly populate PFGE entries to the PulseNet database, the 

originating laboratory will insure that the fully completed Microbiological Data 

Program Isolate Information Form (MDP DATA-01 Form 001) accompanies the 

isolate to the PFGE laboratory. 

5.2.4.2. PFGE-uploading laboratories must update the isolate’s data in PulseNet 

once they receive any additional isolate information such as serotyping and/or

virulence factors. In this regard, MDP prefers that the laboratories that perform 

Salmonella PFGE and upload to PulseNet should also perform the serotyping. 

This will minimize delay in updating the data record in PulseNet. 

5.2.4.3 All PFGE and serotyping results shall be communicated to MP as soon 

as results are available.

5.2.5. After-hours notification - For immediate after-hours telephonic results 

notifications (weekends, holidays, etc.), refer to Attachment 2 of this SOP, “MP Contact 

Information”.

5.2.6 Required Results Table - The required test results to accompany reports to MP

are shown in the table below.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 7 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Organism Tests Results Required 

for Preliminary Positive

Report

Tests Results Required 

for Final Positive 

Report

Tests Results Required 

for Final Negative 

Report (refer to section 

5.2.2)

Salmonella BAX® PCR (melting 

curves, +/- display page 

and detailed BAX®

printout)

Cultural worksheets, IMS 

(when required), poly 

O/H serology, VIDAS®, 

VITEK® (≥ 95% 

confidence interval)

Cultural worksheets, 

VIDAS®; target pathogen 

not isolated or isolation of 

non-target organism

E. coli

O157:H7

FDA Real-time PCR 

(rtPCR) and BAX®

O157 rtPCR

Cultural worksheets, IMS 

(when required), O157:

H7 serology, VITEK® (≥ 

95% confidence interval)

Cultural worksheets; 

target pathogen not 

isolated or isolation of 

non-target organism

Non-O157 

STEC

FDA rtPCR and BAX®

O157 rtPCR 

Cultural worksheets, IMS 

(when required), 

VITEK® (≥ 95% 

confidence interval), 

FDA rtPCR results of 

isolate

Cultural worksheets; 

target pathogen not 

isolated or isolation of 

non-target organism

 5.3 Recordkeeping - This is a general guideline representing minimum requirements. Each 

laboratory shall develop written procedures providing specific details about how 

recordkeeping has been implemented. 

5.3.1 Data Package Contents -Each data package retained by the program participant 

(e.g., State or Federal laboratory) shall consist of laboratory records (i.e., worksheets 

and/or completed forms), USDA records of collection and analytical results reports, and 

all raw and/or derived sample data for a given set or group of samples analyzed. If raw 

data/observations are collected in a bound notebook, the notebook need not be included 

in the raw data package; however, it must be maintained by the laboratory as supporting 

documentation.

5.3.2 Supporting documentation (e.g., refrigerator/freezer logs, training records) do not 

need to be included in the data package, but must be maintained separately by the 

laboratory.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 8 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

5.3.3 Data packages shall be maintained for at least two years following electronic 

transmission (via RDE) and before applying for disposition to Federal Records Centers as 

described in ADMIN SOP. Special consideration shall be granted for early disposition 

on a case-by-case basis. Supporting documentation generated by MDP participants shall 

be maintained by the laboratory and may be transferred to a Federal Records Center as 

described in ADMIN SOP after a period of at least two years. 

5.3.4 Records shall be maintained documenting the custody of samples from collection to 

final disposition. These records shall show the storage conditions and personnel handling

the samples.

5.3.5 Records shall be kept regarding sample preparation and analyses, including sample 

description, storage condition, description of analytical methods, raw data, observations, 

calculations, and conclusions. The analyst(s) responsible for each segment of a procedure 

shall be legibly identified in the record.

5.3.6 Records regarding shipment of cultures to other laboratories shall be documented as

described in SOP MDP-SHIP-03.

5.3.7 USDA/AMS MP will provide the U.S. Food and Drug Administration (FDA) and 

Centers for Disease Control and Prevention (CDC) with appropriate information semiannually.

5.3.8 Data will be compiled on an annual basis and a summary report released by MP.

Standard USDA/AMS practices to ensure protection of confidential business information 

will be used when publishing data.

5.4 Additional Reporting Requirements:

5.4.1 Laboratories shall report all final positive results to MP first. MP will review 

final positive results and then report to the FDA’s Office of Food Safety, Produce Safety 

Staff and Laboratory Operations Branch. If a collected sample and the testing laboratory 

are from the same state, as soon as MP receives FDA’s acceptance and confirmation of 

the positive results, MP will inform the testing laboratory and also provide a Sample and 

Isolated Pathogen Information form. That testing laboratory will then have the option to 

report the positive detection results to its own State agencies or let FDA handle any 

further investigations/actions. MP will ensure rapid feedback to the testing laboratory’s 

Administrative, Quality, and Technical Program Managers regarding these reporting 

actions.
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 9 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

5.4.2 If a laboratory reports positive results to its State agencies, it is required to furnish 

MP with information on the agency/department/office notified and the person of contact 

information (name, email, phone, etc.) for that agency. 

5.4.3 For positive detections on trans-state shipped samples, MP will inform 

appropriate agencies of the State where the samples were collected. MP may also share 

positive detection isolate information with the testing laboratory and Centers for Disease 

Control and Prevention (CDC). 

Disclaimer: Reference to brand names (kits, equipment, media, reagents, etc.) does not 

constitute endorsement by this agency. 
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 10 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Mary Tijerina 22 June 2011

___________________________________________________________

Revised by: Mary Tijerina Date

Microbiologist, Microbiological Data Program

8609 Sudley Road, Suite 206, Manassas, VA 20110

(703) 330-2300 x111

Maya Achen 27 June 2011

_____________________________________________________________

Reviewed by: Maya Achen Date

Chairperson, MDP Technical Advisory Group

Ohio Department of Agriculture Consumer Analytical Laboratory

Bldg 3, 8995 E Main Street, Reynoldsburg, OH 43068

(614) 728-2790

Shanker Reddy 6 July 2011

_____________________________________________________________

Reviewed by: Shanker Reddy, PhD Date

Molecular Biologist, Microbiological Data Program

8609 Sudley Road, Suite 206, Manassas, VA 20110

(703) 330-2300 x135

Diana Haynes 7 July 2011

Approved by: Diana Haynes Date

Deputy Director, Monitoring Programs Division

8609 Sudley Road, Suite 206, Manassas, VA 20110

(703) 330-2300 x134

ELECTRONICALLY REPRODUCED SIGNATURES - ORIGINAL SIGNATURE PAGE MAINTAINED BY USDA, AMS, S&T, MONITORING PROGRAMS OFFICE
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 11 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Revision 11 May 2011 Monitoring Programs Division

 Added words “...data entry, record-keeping and...” to Section 1

 Updated Outline of Procedures, Section 3

 Updated References, Section 4

 Added words “routine” and “or Deputy Director”, Section 5.1.5.2

 Added words “a. Salmonella; b. Non-O157 Shiga-toxin carrying Escherichia coli

(STEC); c. E. coli O157:H7” after first sentence of Section 5.2.1. Added new paragraph: 

“For this SOP, PRELIMINARY positive findings for the above listed target organisms 

are defined as a positive PCR result, e.g., BAX® PCR for Salmonella, BAX® real-time 

PCR for E. coli O157:H7, FDA’s real-time or quantitative PCR methods for STEC. The 

preliminary positive results report from real-time PCR for non-O157 STECs should also 

include results from real-time BAX® PCR for E. coli O157:H7. MDP laboratories must 

continue to keep MP informed of subsequent testing, isolation status or confirmation.”

 To 2nd paragraph, Section 5.2.1, added bold-type words: “Laboratories shall report 

preliminary positive findings (see 5.2.6 table) for all target pathogens to the MP

laboratory liaison(s) with a courtesy copy provided to the Deputy Director, using

Results Notification Form, MDP DATA-01- Atch 1. Preliminary positive reports should 

be submitted to MP as soon as possible (MP prefers receiving report not later than close 

of next business day).

 After first sentence, replaced remaining old Section 5.2.2 with new paragraph

 Redefined and expanded Section 5.2.3 to separate target organisms and their reporting 

requirements by adding: “5.2.3.1, 5.2.3.2, 5.2.3.3, 5.2.3.4, 5.2.3.5”

 Added new Section 5.2.4

 Added new Section 5.2.6

 Redefined and expanded additional participant reporting requirements in old Section 5.4

by adding: “5.4.1, 5.4.2, 5.4.3”

 Revised Attachment 1, Results Notification Form: added “CT” to commodity codes; 

added stx1/stx2 in results designations
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 12 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Revision 10 September 2010 Monitoring Programs Office

 Updated References, Section 4

 Revised Section 5.4 to read “Additional Reporting Requirements – Laboratories will 

first report final positive results to MP. MP will be responsible for reporting final positive 

results to other Federal and/or State agencies/departments. MP will ensure rapid 

feedback to the testing laboratory’s Administrative, Quality, and Technical Program 

Managers regarding these reporting actions.”

 Updated Attachment 02, Contact Information

 Revised Attachment 03, PFGE Quick Reference Guide, Paragraph 2

 Updated Form 001

Revision 09 June 2010 Monitoring Programs Office

 Throughout document, removed the word “ETEC” and replaced the words “mPCR” with

Real-time BAX® O157:H7

 Throughout document, removed “OH” and/or “Ohio” replaced with “MDP repository”

 Added sentence “A user account will be automatically disabled if there is no log-in 

activity for 90 days.”, Section 5.1.1.3

 Removed Sections 5.1.2.3 and 5.1.2.4

 Added words “Ct values” to Section 5.2.1 and 5.2.2

 Added word “archival” to Section 5.2.4

 Replaced the word “secondary” with “additional”, section 5.2.6

 Updated Attachment 1, Results Notification Form

 Updated Attachment 2, MP Contact Info

Revision 08 December 2009 Monitoring Programs Office

 Added Section 3, Outline of Procedures

 Alphabetized and removed numbering from Section 4, References

 Replaced “is not” with “will not be”, Section 5.1.5.2

 Changed order of paragraphs in Section 5.2

 Removed “/presumptive” and replaced “within 24 hours of positive results or before 

close of next business day” with “as soon as possible (MP prefers receiving report not 

later than by close of next business day).”, Section 5.2.1

 Added new Sections 5.2.2 through 5.2.7
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 13 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

 Replaced the word “confirmed” with the word “final” throughout the SOP, in association 

with reporting of results

 Added “MDP DATA-01 Form 001” to SOP

Revision 07 September 2009 Monitoring Programs Office

 Updated References, Section 3

 Revised Sections 4.1 through 4.4

 Updated Attachment 1, Fillable, Positive Results Notification Form

 Added Attachment 2, MP Contact Info

 Added Attachment 3, PulseNet Quick Reference Guide

Revision 06 December 2008 Monitoring Programs Office

 Removed warning letter in subsec. 5.5.2

Revision 05 May 2008 Monitoring Programs Office

 Revised subsec. 5.6.1.1 to reflect reporting of target pathogens

 Revised subsec. 5.6 to remove Preliminary/Final Results Notification Form (data elements to 

be emailed to MP)

 Archived USDA/AMS MDP Preliminary/Final Results Notification Form

Revision 04 February 2008 Monitoring Programs Office

 Revised data reporting requirement in subsection 5.5.2

Revision 03 May 2006 Monitoring Programs Office

 Updated RDE procedures

 Revised data review requirements

 Revised data reporting to include use of LIMS

 Added CDC as data recipient

 Updated recordkeeping requirements
United States Department of Agriculture

Agricultural Marketing Service, Science & Technology

Microbiological Data Program

SOP No: MDP-DATA-01 Page 14 of 14

Title: Data Entry, Record Keeping and Results Reporting

Revision: 11 Replaces: 10/01/2010 Effective: 9/1/2011

Revision 02 November 2004 Monitoring Programs Office

 Revised to include notification of preliminary and final positive results to MP, using 

Attachment 01

 Added data review requirements and RDE review documentation procedures

 Revised to accommodate review process done in LIMS rather than RDE.

 Revised to update references to related SOPs

 Revised to extend data submission frequency to thirty days