Medical Record Abstraction

Attachment 9

Chart Abstraction Form

i. Chart Abstraction Information

i.1 This chart abstraction form is (check one):	a. a consolidated form (i.e., combined records from all sources)		b. a facility-specific form (i.e., record from one provider/facility only)
i.2 If i.1 = b, enter Provider Study ID:		If i.1 = a, enter Provider Study ID as indicated below in Tables I, II, and III

1. Patient Demographics

A.1 Study ID Number:			A.2 Month and Year of Birth: ____ /____
A.3 Hispanic or Latino origin:		Yes		No	Unknown
A.4 Race (check all that apply):	White/Caucasian	Asian		Native Hawaiian/Pacific Islander
	African American	American Indian/Alaskan Native		Other	Unknown

2. Cervical Cancer Diagnosis

5-year Review Period (registry to provide these dates)	B.1 Date 5 years prior to diagnosis (start of 5-year review period): ____ /____ /____ MM/DD/YY	B.2 Date of diagnosis (end of 5-year review period): ____ /____ /____ MM/DD/YY
B.3 Patient had tubal ligation prior to diagnosis (B.2)? Yes No
B.4 Did patient undergo a cervical procedure (e.g., LEEP or cold knife cone biopsy) prior to review period (B.1)? Yes No
B.5 Has the patient had a hysterectomy? Yes No (If B.5 = YES, complete B.6 and B.7)
B.6 Date of hysterectomy: ____ /____ /____ MM/DD/YY
B.7 Was cervical cancer found as a result of the hysterectomy? Yes No

3. Cervical Cancer Screening

C.1 Has patient had a PAP or HPV test during the 5-year review period?

 Yes  No

(If YES, please complete TABLE I for all Pap and HPV results during the review period)

Table I. Pap and HPV Testing, review period only

	C.2	C.3	C.4	C.5	C.6	C.7	C.8	C.9	C.10	C.11	C.12	C.13	C.14	C.15	C.16	C.17
					Pap Testing (if C.3 = Pap or Both)						HPV Testing (if C.3 = HPV or Both)
PAP, HPV	Date of Test(s)	Test(s) Performed	Test(s) Performed by	Provider Study ID (If i.1 = a)	Type of Pap	Lab where run? (Name)	Image-based evaluation?	Satisfactory test result?	Endocervical/ TZ component present?	Pap result (check all that apply)	Type of HPV	HPV result	HPV genotyping performed? (check all that apply)	Results of genotyping? (record result for each test in C.14)	Was patient referred to colposcopy/ treatment?	Did patient return for colposcopy/ treatment?
1	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
2	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
3	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
4	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
5	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
6	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
7	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
8	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
9	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A
10	____ /____ /____ MM/DD/YY	 Pap  HPV  Both	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 STM/ Glass slide  ThinPrep  SurePath  Not reported		 Yes  No  Not reported or Not available	 Yes  No  Not reported	 Yes  No  Not reported	 Normal  ASC-US  ASC-H  LSIL  HSIL  AGC  Squamous CA  Other (specify) _______________	 Qiagen  Cervista  Roche Cobas  Aptima  Laboratory Developed Test (LDT)  Not Specific	 Positive HR  Negative HR  Indeterminate  Not reported	 HPV 16	 Pos.  Neg.  Not Rep.  N/A	 Yes  No  Not reported	 Yes  No  Not reported
													 HPV 18	 Pos.  Neg.  Not Rep.  N/A
													 HPV 45	 Pos.  Neg.  Not Rep.  N/A
													 HPV 18/ 45	 Pos.  Neg.  Not Rep.  N/A
													 Other: __________	 Pos.  Neg.  Not Rep.  N/A

4. Cervical Cancer Diagnostic Testing

D.1 Has patient had a COLPOSCOPY (with or without CERVICAL or ENDOCERVICAL BIOPSIES) during the 5-year review period?

 Yes  No

(If YES, please complete TABLE II for all COLPOSCOPY and BIOPSY results during the review period)

Table II. Colposcopies and Biopsies, review period only

	D.2	D.3	D.4	D.5	D.6	D.7	D.8	D.9.a	D.9.b	D.9.c	D.9.d	D.10	D.11	D.12	D.13
						Cervical Biopsies (if D.6 = Cervical or Both)						ECC (if D.6 = ECC or Both)
COLPOSOPY	Date of colpo-scopy	Colposcopy performed by	Provider Study ID (If i.1 = a)	Were cervical biopsies or Endocervical Curettage (ECC) performed?	Type of Biospy/ Biopsies (choose one)	Number of cervical biopsy specimens	Number of cervical biopsy test results returned	Cervical biopsy test results: specimen 1, or all specimens if combined (check all that apply)	Cervical biopsy test results: specimen 2 (check all that apply)	Cervical biopsy test results: specimen 3 (check all that apply)	Cervical biopsy test results: specimen 4 (check all that apply)	Endocervical Curettage (ECC) test results (check all that apply)	Was patient referred to treatment/ diagnosis?	Did patient return for treatment/ diagnosis?	Comments (e.g., biopsy results for more than 4 specimens)
1	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 Yes  No (if no, skip to next colposcopy)	 Cervical  Endocervical Curettage (ECC)  Both	 1  2  3  4  > 4	 1  2  3  4  > 4	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Yes  No  Not reported	 Yes  No  Not reported
2	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 Yes  No (if no, skip to next colposcopy)	 Cervical  Endocervical Curettage (ECC)  Both	 1  2  3  4  > 4	 1  2  3  4  > 4	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Yes  No  Not reported	 Yes  No  Not reported
3	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 Yes  No (if no, skip to next colposcopy)	 Cervical  Endocervical Curettage (ECC)  Both	 1  2  3  4  > 4	 1  2  3  4  > 4	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Yes  No  Not reported	 Yes  No  Not reported
4	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ____________________		 Yes  No (if no, skip to next colposcopy)	 Cervical  Endocervical Curettage (ECC)  Both	 1  2  3  4  > 4	 1  2  3  4  > 4	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Normal  CIN1  CIN2  CIN3  CIN2/3  AIS  LSIL  HSIL  CA  Other (specify) ______________	 Yes  No  Not reported	 Yes  No  Not reported

5. Diagnosis

E.1 Was DIAGNOSIS OR TREATMENT PROCEDURE REQUIRED as a result of pap or biopsy test results during the 5-year review period?

 Yes  No

(If YES, please complete TABLE III for all DIAGNOSTIC AND EXCISIONAL PROCEDURES RECEIVED during the review period.)

Table III. Diagnostic procedures received, review period only

	E.1	E.2	E.3	E.4
PROCEDURE	Date of diagnostic procedure/treatment	Diagnostic procedure/treatment performed by	Provider Study ID (If i.1 = a)	Type of diagnostic procedure/treatment (check all that apply)
1	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ______________________		 LEEP  Cold knife cone  CO2 Laser therapy  Cryo  Other: ____________________
2	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ______________________		 LEEP  Cold knife cone  CO2 Laser therapy  Cryo  Other: ____________________
3	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ______________________		 LEEP  Cold knife cone  CO2 Laser therapy  Cryo  Other: ____________________
4	____ /____ /____ MM/DD/YY	 Family practice  Primary care physician  Gynecologist  Gyn/onc  Advanced Practice Clinician (APN, PA, NP)  Other (specify) ______________________		 LEEP  Cold knife cone  CO2 Laser therapy  Cryo  Other: ____________________

6. Other Patient History

F.1 Has patient experienced symptoms of cervical disease during the 5-year review period?

Yes No (IF F.1 = YES, complete F.2)

F.2 Check all that apply.

Abnormal bleeding Bleeding after intercourse Discharge Pain Urinary symptoms Other

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