Medical Complications Reporting Form

ATTACHMENT 4

MEDICAL COMPLICATIONS REPORTING FORM

Form Approved

OMB No. 0920-xxxx

Exp. Date_________

Colorectal Cancer Screening Demonstration Program (CRCSDP)

Medical Complications Reporting Form

Public reporting burden of this collection of information is estimated to average one hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-XXXX).

Instructions

Please complete this Medical Complications Reporting Form for any medical complications experienced by clients who receive a sigmoidoscopy, colonoscopy, or double contrast barium enema for screening or diagnostic purposes through the CRCSDP. This form should be completed for any medical complication occurring either during the procedure or within 30 days following the procedure.

For Medical Complications Requiring Hospitalization

For clients hospitalized due to a medical complication, the following protocol should be followed:

• Within 72 hours of the hospitalization, notify your CDC technical assistance team (CDC program and scientific consultants and IMS technical consultant) by e-mail.

• Within 5 days of the hospitalization, complete and submit the Medical complications Reporting Form to your CDC technical assistance team (listed above). It may be helpful for you to obtain a copy of the endoscopy report (you do not need to send CDC the endoscopy).

• Communicate regularly by e-mail and/or your routine monthly telephone calls with your CDC technical assistance team to provide updates regarding the client’s medical status.

• Re-submit the form monthly or more frequently as the client’s status changes to your CDC technical assistance team until resolution. On the resubmission, you need to only fill out the record id, client id, date form completed, examination date and last two questions completed.

• Complete all fields of the CCDE record on this client per usual and submit when due.

For Medical Complications NOT Requiring Hospitalization

For clients experiencing a medical complication that does not require hospitalization, the following protocol should be followed:

• Complete the Medical Complications Reporting Form and submit by e-mail with any new or updated Medical Complications Reporting Forms quarterly to your CDC technical assistance team (listed above) on September 1, December 1, March 1, or June 1.

• If the medical complication was not resolved by the quarterly submission date, re-submit at subsequent quarterly submissions until resolution.

• Complete all fields of the CCDE record on this client per usual and submit when due.

Medical Complications Reporting Form

1. Today’s date:      /      /       (mm/dd/yyyy)

2. Program:

Baltimore, MD

St. Louis, MO

State of Nebraska

Stony Brook, NY

Seattle and King County, WA

3. CCDE Client Identification Number:

                                                                                         

4. CCDE Record Identification Number:                                    

5. For which examination are you reporting an medical complication?

Sigmoidoscopy

Colonoscopy

Double Contrast Barium Enema

6. What was the indication for the examination?

Screening

Surveillance after a positive colonoscopy (done outside program or during prior cycle)

Follow-up to positive FOBT in this cycle

Follow-up to positive DCBE in this cycle

Follow-up to positive sigmoidoscopy in this cycle

Unknown

7. Examination date:      /      /       (mm/dd/yyyy)

8. Results of examination (check all that apply):

Normal/negative

Diverticulosis

Hemorrhoids

Other finding not suggestive of cancer/polyp(s)

Polyp(s)/suspicious for cancer/presumed cancer

No findings/inconclusive

Pending

Unknown

9. Was the bowel preparation considered adequate by the clinician performing the examination?

Yes

No

Unknown

10. If sigmoidoscopy or colonoscopy, segment reached:

Rectum

Rectosigmoid junction

Sigmoid colon

Descending colon

Splenic flexure

Transverse colon

Hepatic flexure

Ascending colon

Cecum

Appendix

Overlapping lesions

Unknown

11. Was the examination noted to be difficult?

Yes (please describe)

No

Unknown

12. Was a biopsy/polypectomy performed?

Yes

No

Unknown

13. Were any of these procedures performed? (report all that apply)

Snare polypectomy

Hot biopsy forceps or cautery

Cold biopsy

Ablation

Submucosal injection

Control of bleeding

Unknown

Other, specify

14. a. What was the nature of the medical complication? (check all that apply and describe)

Bleeding

Cardiopulmonary events (hypotension, hypoxia, arrhythmia, etc)

Complications related to anesthesia

Possible perforation

Excessive abdominal pain

Emergency room visit

Death (please provide cause of death)

Other _________________________________________

14. b. Please describe the medical complication:

15. Client medications (prescription and OTC) if available:

Aspirin

H2 blockers

NSAIDs

Anticoagulants

Inhaled corticosteroids

Oral corticosteroids

Proton pump inhibitor

None

Other,      

16. Did this outpatient examination lead to a hospital admission?

Yes - please notify CDC within 72 hours of hospital admission

No

17. Current status of client (please include date completing form, current patient status, and length of hospitalization with admission and discharge date included):

18. Interventions to address medical complications with pertinent dates included: