Introduction

The ICCS Advocacy Committee requests your participation in a Workload Survey for clinical flow cytometry laboratories. Changes since the publication of a prior workload survey (Wolniak et. al., Cytometry B Clin Cytom 2017;92:525 PMID 27363814) include new requirements from regulatory bodies, increased data dimensionality, higher test complexity, labor shortages, and reduced reimbursement.

The objectives of the current survey are to

- compare current workload volumes and staffing between laboratories

- assess the impact of increasing high complexity assays

- assess the capacity of laboratories to implement high complexity assays

- assess the capacity of laboratories to meet applicable regulatory requirements

Confidentiality

The intention is to publish an analysis of the results. The identity of the laboratories will be kept confidential and not be shared outside of the primary team of ICCS members conducting the data analysis.

Important Definitions

Medical Laboratory Technologist: (synonyms: laboratory technologist, medical laboratory scientist): all laboratory personnel qualified to perform high complexity testing in a flow cytometry laboratory, including running the cytometer, gating, and resulting of some assays, such as CD4 counts.
Laboratory Assistant / Support Staff: Laboratory personnel who do not work on flow cytometers. They help the technologists with certain laboratory duties that do not involve staining or running the samples on the cytometer. It can include accessioning, sample preparation, etc.
Supervisor / Manager / Coordinator: Laboratory personnel primarily responsible for directly supervising, training, hiring and mentoring laboratory staff, supervising the laboratory operations, competency assessments, and continuing education.
Technical Development Specialists / Scientists: Laboratory personnel whose primary role in the flow laboratory is to develop and validate new flow cytometry assays.
Flow Cytometric Testing: All assays that require the specimen to be run on a flow cytometer
Non-flow Cytometric Testing (in a Flow Cytometry Laboratory): Any testing or duties performed by the same laboratory staff who performs flow cytometric testing, but does not require the specimen to be run on a flow cytometer. Examples are: Rotational coverage in other laboratories, such as Hematology or HLA, case accessioning, cytochemistry, aspirate smear and cytospin preparation, and iron staining of aspirate smears.
Automated Sample Preparation: Any instrument/device that automates partial or all the steps involved in the preparation of a specimen before it is run on a cytometer.

Questions

1. Laboratory Name: *

2. Country: *

3. Type of clinical flow cytometry laboratory. Choose the single best answer. *

a. Academic health center (directly affiliated to a university where pathologists have academic appointments)

b. Non-academic public health system (state or government funded)

c. Reference laboratory (for profit)

d. Community based (for profit)

e. Private industry (i.e., pharmaceutical development)

f. Government / Accreditation Agency / Military

g. Other g. Other

4. What is the current composition of full time equivalents (FTEs) in your flow cytometry laboratory? Enter the number for each category listed below.

See Important Definitions above.

Please do not include MDs or PhDs who provide interpretations/sign out/report cases or who serve as medical directors. *

	Enter the Number
4a. Medical Laboratory Technologists	Enter the Number
4b. Laboratory Assistants and / or Support Staff	Enter the Number
4c. Laboratory Managers / Supervisor / Coordinators	Enter the Number
4d. Technical Development Specialists / Scientists	Enter the Number
4e. Unfilled positions	Enter the Number

5. For your medical laboratory technologists, what is the overall approximate percentage of time spent performing non-flow cytometry-based duties?

Please see Important Definitions above.

6. For the two FTE categories below, estimate the percentage of time that is spent performing duties that are not typically considered their primary duties.

a. Laboratory Managers / Supervisor / Coordinators

b. Technical Development Specialists / Scientists
(If you answer is NA, please enter 0)

7. Does your flow cytometry laboratory currently employ any FTEs with a specific flow cytometry certification (i.e., ASCP Specialist Certification in Cytometry [SCYM] or equivalent)?

Yes

8. What is the number of professional staff who interprets/sign outs/reports flow cytometry cases?
Enter the number for the categories below:

8a. MD/DO

8b. PhD/Masters

9. How many flow cytometers does your flow cytometry laboratory have?

10. Thinking of the last time your laboratory replaced flow cytometers with newer units, what was the interval between the time the older ones were installed until the newer ones were purchased or leased?

11. From the time your most recently acquired flow cytometers were installed, how many months did it take your laboratory to validate and go-live with most assays as intended such that the laboratory was able to retire older instruments? *

12. What is the maximum number of fluorochromes/colors your flow laboratory uses per tube? Select the single best answer. *

13. Please provide approximate number of all flow cytometry testing performed per year for each category listed below. Enter “N/A” or “not sure” if most appropriate. *

	Type Your Answer
13a. Lymphocyte subset enumeration, including CD4 counts and/or B, T, and NK cell counts	Type Your Answer
13b. Absolute CD34 stem cell counts	Type Your Answer
13c. Complex immunodeficiency panels including lymphocyte subsets for memory B cells and T cells and/or functional assays	Type Your Answer
13d. Leukemia / Lymphoma panels, excluding MRD assays	Type Your Answer
13e. Paroxysmal nocturnal hemoglobinuria (PNH)	Type Your Answer
13f. Minimal residual disease for myeloid leukemias	Type Your Answer
13g. Minimal residual disease for plasma cell neoplasms	Type Your Answer
13h. Other minimal residual disease (lymphoblastic leukemias, chronic lymphocytic leukemia, mature B or T-cell lymphoma, etc.)	Type Your Answer
13i. Other (please list other tests and numbers per year)	Type Your Answer

15. What types of antibody application processes are used for staining in your laboratory? *

	Most Commonly	Occasionally	Rarely/Never
15a. Single antibody pipetting	Most Commonly	Occasionally	Rarely/Never
15b. Liquid cocktail pipetting (prepared in-house)	Most Commonly	Occasionally	Rarely/Never
15c. Liquid cocktail pipetting (purchased from vendor)	Most Commonly	Occasionally	Rarely/Never
15d. Use of dried-down antibody tubes	Most Commonly	Occasionally	Rarely/Never

16. What is the estimated breakdown of flow cytometric duties covered by medical laboratory technologists in the following four areas?

Enter percentages for the categories below. If the total percentage for the first four items does not add up to 100%, please enter the difference as "none of the above".

	16a. Clinical testing
	16b. Quality control and assurance
	16c. New assay development
	16d. Quality improvement (other than assay development)
	16e. None of the above

0/100 points

17. How often are “ad hoc” customized flow cytometry panels performed in your laboratory to accommodate special requests or troubleshoot issues? Select single best answer:

18. Among the professional staff (MD, DO, PhD), does your laboratory’s approach include a specific person or subset of people dedicated for interpretation/sign-out/reporting of more complex flow cytometry assays (e.g. minimal residual disease)?

Yes

18b. If YES, select one from the following option:

a. A single staff person

b. A group of staff

19. What are perceived barriers/constraints for timely new assay development in your flow cytometry laboratory? *

	Major	Moderate	Minor
19a. Financial resources	Major	Moderate	Minor
19b. Staff number	Major	Moderate	Minor
19c. Level of experience among staff	Major	Moderate	Minor
19d. Lack of staff and/or time dedicated or protected for such work	Major	Moderate	Minor
19e. Specimen type and numbers for validation assays	Major	Moderate	Minor
19f. Add other barriers/constraints (specify below)	Major	Moderate	Minor

19f. Other barriers/constraints

20. Please provide information about the flow cytometry laboratory hours of operation.

Note: each answer should not reflect more than 24 hours.

20a. Monday to Friday (enter number of regular working hours of operation)

20b. Saturday (enter number of regular working hours of operation or "closed")

20c. Sunday (enter number of regular working hours of operation or "closed")

20d. Are technologists/laboratory staff on-call on non-holiday Saturdays?

Yes

20e. Are technologists/laboratory staff on-call on non-holiday Sundays?

Yes

20f. Are technologists/laboratory staff on-call to accommodate for holidays?

Yes

21. In your flow laboratory, what are indications for a specimen to be tested outside regular hours of operation? Select all that apply.

a. Suspected new acute leukemia in an adult

b. Suspected new acute leukemia in a child

c. Suspected acute promyelocytic leukemia

d. Patient in poor medical condition

e. The provider says so

f. Approved by pathologist on call

g. Suspected lymphoma

h. No work is done outside of regular hours

i. Other (use comment section) i. Other (use comment section)

22. Please estimate how long it typically takes to introduce (design, validate, and implement) a new flow cytometry assay for your laboratory? *

	Number of Months or N/A
22a. Lymphoma/leukemia assay	Number of Months or N/A	Number of Months or N/A
22b. Minimal residual disease assay	Number of Months or N/A	Number of Months or N/A
22c. Enumeration assays (e.g. absolute CD34 counts, lymphocyte subsets)	Number of Months or N/A	Number of Months or N/A

23. What are the approaches in your laboratory for selecting panels for flow cytometry leukemia/lymphoma evaluations? Select all that apply.

a. Morphologic review is performed

b. Clinical history and medical indication are reviewed

c. An initial flow cytometry screening tube(s) is performed for most cases without a prior history of a hematolymphoid neoplasm

d. Reflex panels are performed based on abnormalities detected on initial screening tube(s)

e. The same flow cytometry panel is performed for all cases. No triage done.

24. Other than duplicate orders, do orders for flow cytometry get cancelled to avoid inappropriate testing?

Yes - Decisions to cancel may be made without consulting the ordering clinician

Yes – Decisions to cancel are only made after consultation with the ordering clinician

25. What are the most significant changes implemented over the last 5 years that have helped your laboratory adapt to the increasingly high complexity testing? You may select up to three choices. *

a. Increased hours of operation

b. Usage of automated sample preparation

c. Acquisition of more or new type of flow cytometers

d. Increased staffing

e. Creation of positions designated for quality control and assurance, assay development, and/or quality improvement

f. Other (use comment section) f. Other (use comment section)

26. Do you have any other comments pertaining to this Workload Survey?