Image-Assisted Cytology Workload Practices Survey--Labor

Attachment C: Image-Assisted Cytology Workload Practices Survey - Laboratory

Form Approved

OMB No. 0920-XXXX

Expiration Date (one year from date of approval)

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Image-Assisted Cytology Workload Practices Survey

Laboratory Supervision Section

See the Glossary at the end of this questionnaire for abbreviations.

1. Please select the option which best describes your laboratory.

• Non-profit hospital

• For-profit hospital

• City/County/State hospital

• University hospital/academic medical center

• Public health, non-hospital

• Veteran’s Administration hospital

• Department of Defense hospital

• Regional/local independent laboratory group practice

• National/corporate laboratory (owned by a national corporation)

2. Which accrediting body inspects your laboratory?

• College of American Pathologists

• The Joint Commission

• Centers for Medicare & Medicaid Services

3. Please provide information on the laboratory’s cytology personnel for 2012.

Personnel	Number of FTEs
Pathologists who practice gynecologic cytopathology
Pathologists who perform primary screening of GYN slides
Cytotechnologists
Cytotechnologists (Included in line above) who screen only gynecologic slides

4. What were your laboratory’s cytology test volumes for 2012?

Preparation type	Number of cases
Total
GYN ThinPrep®
GYN SurePath™
GYN Conventional
Non-GYN/FNA

5. How many cases did your laboratory screen by computer-assisted screening in 2012?

Method	Number of cases
Total
ThinPrep® Imaging
Focal Point™ GS Imaging System
GYN Focal Point™ Slide Profiler

6. What per cent of your imaged assisted GYN cytology cases required Full Manual Review (FMR) in 2012?

_________

7. For workload recording, how does your laboratory count a GYN slide? Select all that apply.

• Each slide screened for FOV is counted as one half (0.5) slide

• Each slide (either FOV or FMR) is counted as 1 slide

• Each slide that is screened for FOV and a FMR is performed, count as 1 slide

• Each slide that is screened for FOV and a FMR is performed, count as1.5 slides

• Other __________________________________________________________________ _______________________________________________________________________ _______________________________________________________________________

8. For workload recording, how does your laboratory count a Non-GYN slide? Select all that apply.

• Each case counts as 1 slide

• Each slide counts as 1 slide

• Each slide prepared by Cytospin® counts as 1 slide

• Each slide prepared by Cytospin® counts as 0.5 slide

• Each slide prepared by automated methods (other than Cytospin®) counts as 1 slide

• Each slide prepared by automated methods (other than Cytospin®) counts as 0.5 slide

• Each cell block slide counts as 1 slide

• Each cell block slide counts as 0.5 slide

• Each smear counts as 1 slide

• Each smear counts as 0.5 slide

• Other _______­­­­­­­­­­­­­­­­­­­­­­­__________________________________________________________ _______________________________________________________________________

9. Does your laboratory have a written policy that defines when a FMR is required?

• No written policy

• Yes, reasons listed in the policy include: (check all that apply)

• Reactive cells seen in the FOVs

• Abnormal cells seen in the FOVs

• Patients with a history of being high risk

• No endocervical component seen in the FOVs

• Scant cellularity seen in the FOVs

• Evidence of infection is seen in the FOVs

• Discretion of CT, Explain____________________________________________

___________________________________________________________________

10. If your laboratory includes a MINIMUM % of slides that a CT screens for FMR, how is the number determined?

• No minimum % for FMR

• Equal the % of abnormal cases in our laboratory

• Double the % of abnormal cases in our laboratory

• Depends on the ability of the CT

• Other _____

__________________________________________________________________________

11. If your laboratory includes a MAXIMUM % of slides that a CT screens for FMR, on what is the number based?

• No maximum percent for FMR

• Accuracy of CT interpretation

• Productivity of total cases interpreted

• Other _____

__________________________________________________________________________

12. What percent of ASC-US cases also test positive for high risk HPV? __________

13. What percent of the NILM slides are rescreened for quality assessment? __________

(Includes random 10% cases and patients that are high risk per laboratory defined criteria)

14. What is the number of cases in each of the following interpretation categories that your laboratory reported in 2012?

INTERPRETATION	NUMBER of CASES	Number of cases with corresponding LSIL+ or (CIN2) biopsy within 6 months of Pap
Total unsatisfactory cases
Total number of NILM cases
PRIMARY SCREENING
Number of ASC-US cases primary screening
Number of ASC-H cases primary screening
Number of LSIL cases primary screening
Number of HSIL+ cases primary screening
RESCREENING
Number of ASC-US cases rescreening
Number of ASC-H cases rescreening
Number of LSIL cases rescreening
Number of HSIL+ cases rescreening

15. Does your laboratory have a process that describes how the Technical Supervisor determines a CT’s individual workload maximum?

• No

• Yes

16. What criteria are used for INCREASING a CT’s workload maximum? Select all that apply.

• CT consistently screens their workload maximum in less than 8 hours and CT states they are able or want to screen more than their maximum

• Technical Supervisor determines that the CT is qualified to screen more, including:

  • Rescreening of at least 10% of cases interpreted as NILM

  • Comparison of CT interpretation with technical supervisor’s confirmation

• Other – Describe your criteria _______________________________________________

______________________________________________________________________________________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

17. What criteria are used for DECREASING a CT’s workload maximum? Select all that apply.

• CT consistently is unable to screen their workload maximum

• CT states they are unable to screen at their maximum

• Technical Supervisor determines that the CT should screen less

  • Review of at least 10% rescreen

  • Comparison of CT interpretation with technical supervisor’s confirmation

• Other – Describe your criteria: ______________________________________________

______________________________________________________________________________________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

18. Please provide the following information for each CT working in the laboratory.

(Each letter should correspond to one CT who screens/interprets cytological preparations. If additional letters are required, use double or multiple letters: AA, BB, CC, etc.)

Cytotechnologist Identifier Letter (to be used by CTs for completing the CT Section)	What is the Technical Supervisor assigned maximum screening rate using the FDA standard for calculating slides? *(Please indicate if per 8 hour period or per hour.)	Has the CT’s workload maximum been altered in the last 2 years?	How many years has the CT been screening Pap tests?
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
X
Y
Z

Glossary

Abbreviation Definition________________________________________________

ASC-H Atypical squamous cells – cannot exclude HSIL

ASC-US Atypical squamous cells – of undetermined significance

CIN2 Cervical intraepithelial neoplasia

CT Cytotechnologist (includes SCTs)

Cytospin® Thermo Scientific - Shandon Cytospin® non-gyn thin layer centrifuge

FMR Full manual review

FN False negative interpretation

FNA Fine needle aspiration

FOV Field-of-view

FP False positive interpretation

GYN Gynecological cytology

HPV Human papilloma virus

HSIL High-grade squamous intraepithelial lesion

LSIL Low-grade squamous intraepithelial lesion

NILM Negative for Intraepithelial Lesion or Malignancy

Non-GYN Nongynecological cytology

TP True positive interpretation

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