Form D D_HistoLab_New_Clean_HRSA

Department of Health and Human Services OMB No. 0915-0184

Health Resources and Services Administration Expiration Date: XX/XX/20xx

APPLICATION FOR

HISTOCOMPATIBILITY LABORATORY MEMBERSHIP

ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN)

UNOS

700 North 4^th Street

Richmond, VA 23219

Main Phone: 804-782-4800

Name of Histocompatibility Laboratory:
Laboratory Address:
City, State, & Zip Code:
Contact Person/Title:
Phone Number:	Email:

PUBLIC BURDEN STATEMENT: 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. The OMB control number for this project is 0915-0184. Public reporting burden for this collection of information is estimated to average 4 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N-39, Rockville, Maryland 20857.

CERTIFICATION

The undersigned, a duly authorized representative of the applicant, does hereby certify that the answers and attachments to this application are true, correct and complete, to the best of his or her knowledge after investigation. I understand that the intentional submission of false data to the OPTN may result in action by the Secretary of the Department of Health and Human Services, and/or civil or criminal penalties. By submitting this application to the OPTN, the applicant agrees: (i) to be bound by OPTN Obligations, including amendments thereto, if the applicant is granted membership and (ii) to be bound by the terms, thereof, including amendments thereto, in all matters relating to consideration of the application without regard to whether or not the applicant is granted membership.

Date:	Signature:
Print Name:	Title:
OPTN Member Code:

OPTN Histocompatibility Laboratory Membership Application

Part 1: Section A – General Information

1. OPTN Membership Type

	Check One
Independent Histocompatibility Laboratory*
Hospital Based Histocompatibility Laboratory
Name of member/applicant hospital if hospital based lab applicant:

* An independent laboratory is defined as having a distinct governing body separate from any transplant hospital or commonly controlled group of transplant hospitals.

2. Upon receipt of your application, these materials will be forwarded to American Society for Histocompatibility and Immunogenetics (ASHI) or the College of American Pathologists (CAP), which have been granted deemed status to perform histocompatibility laboratory inspections for the OPTN. By completion of this application, the applicant hereby grants ASHI and/or CAP the authority to provide all ASHI and CAP accreditation records and information relevant to histocompatibility testing for organ transplantation.

Indicate whether ASHI or CAP is the agency selected by the laboratory to perform this review for the OPTN.

[Insert detailed response here. Table will expand automatically]

3. Provide the names of the laboratory, director(s), department, and institution, as they should appear in the official OPTN record.

Position
Histo Lab Director (Primary)
Other Director(s)
Director-in-Training
Technical Supervisor (Primary)
Clinical Consultant (Primary)
General Supervisor (Primary)
Other General Supervisor(s)
Laboratory or Department Name
Institution/Hospital
Lab Street Address
City, State, Zip
Main Telephone
Main Fax
Website Address	http://www.
Accreditation (if applicable)
CMS ID #
CLIA ID #
ASHI ID #
CAP ID #

4. Identify the principal CEO/Administrator(s), and provide contact information (address, phone, email).

[Insert detailed response here. Table will expand automatically]

Part 1: Section B - Areas of Accreditation

1. Check all areas in which the lab is seeking accreditation:

Areas of Accreditation	To be Evaluated	Accredited by ASHI or CAP within the last 3 years? Include last certification start and end dates
		ASHI	CAP
Solid Organ Transplantation: Deceased Donor
Solid Organ Transplantation: Living Donor

Part 1: Section C - Operations

1. Describe the histocompatibility laboratory coverage plan. Plan must address in detail the elements required in the OPTN Bylaws. If there is more than one histocompatibility director, technical supervisor, clinical consultant, or general supervisor, indicate all areas in which primary personnel will be involved and, if appropriate, in which area they have primary responsibility. The coverage plan must explain the role of each additional director, technical supervisor, clinical consultant, and general supervisor, as well as the designation of responsibilities to other staff.

[Insert detailed response here or reference attachment. Table will expand automatically]

2. Describe current and anticipated procedures for complying with the data submission requirements of OPTN membership:

a) List the personnel who are/will be responsible for data collection and submission indicating their background in this area and the percentage of their time that is dedicated to data collection and submission.

Name	Background	% of Time Dedicated to Data Collection & Submission

b) Describe the methods to be used to collect, verify, and submit data on a timely basis:

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c) Describe the training/orientation for the data coordinator(s) supporting the lab. Include details regarding competencies measured as part of the training:

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3. Is this histocompatibility laboratory insured for professional liability?

Yes

No

If Yes, name the insurer and give the policy limits per person and per occurrence and the expiration date of the current insurance coverage. If No, and the lab has a funded self-insurance program, give the name of the fund administrator and the amount of the self-insurance fund and describe the coverage available to this laboratory.

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4. Describe in detail the laboratory’s quality assurance/performance improvement protocol or process and how it will review its performance. Please indicate the method, frequency of reviews, and participants (by title). Expand or duplicate table as needed.

Individuals Involved: (name & title)
Methods:
Frequency of reviews:
Metrics/Data Tracked:
Detailed response:

5. Describe the process for ensuring compliance with OPTN obligations. Include who is responsible (name and title/position) and how this process is integrated with other transplant programs and institution wide.

Name/Title:

[Insert detailed response here, table will expand automatically.]

Part 1: Section D - Written Agreements

1. Histocompatibility laboratories must have written agreements with every transplant program and organ procurement organization (OPO) the laboratory serves. List the names and addresses of all clinical transplant hospitals or OPOs this lab will be serving and the type of program(s) at each transplant hospital. Attach written agreements with each clinical transplant program(s) and OPO(s) the laboratory will serve. Written agreements must include all of the elements required in the OPTN Bylaws.

Name & Address	Type of Programs/OPO

Expand rows as needed.

2. Histocompatibility laboratories may refer testing to another laboratory in accordance with the requirements in the OPTN Bylaws. List any subcontracts this laboratory will be implementing.

Lab Name & Location	Type of Testing	Is Lab ASHI or CAP certified?

Part 2: Section A – Personnel Qualifications, Primary Histocompatibility Laboratory Director

The individual identified below as the primary histocompatibility laboratory director must complete this section. If two or more individuals share the histocompatibility laboratory director’s responsibilities, one person must be designated as the primary director.

Complete questions below and submit a copy of the following:

• Current board certification

• Current licensure if a state requirement

• Current curriculum vitae or resume

If the proposed director has not previously served in the role of primary lab director, the OPTN Bylaws require that the following documents be provided:

• Portfolio of cases

• Letter of reference from histocompatibility laboratories where training obtained

• Proof of active interactions with transplant professionals

• Letter from the applicant that describes all experience in immunology and clinical histocompatibility testing, including a summary of time spent in the laboratory, technologies used, level of responsibility, and specific tasks performed

• Documentation demonstrating participation in transplant or clinical laboratory professional conferences or publications in peer-reviewed journals

If the primary histocompatibility laboratory director will not serve as the primary clinical consultant, and primary technical supervisor, Sections 2B and 2C of this application must also be completed.

1. Provide the following information:

Name of primary laboratory director
Start date at this laboratory (MM/DD/YY)
Effective date of this appointment (MM/DD/YY)
Degree(s)
Discipline(s)
State licensure in the state/district where the lab is located (provide copy of current license, if applicable)	Yes	No	Not required
Has this individual served in the role of primary laboratory director previously?	Yes		No

2. Is this appointment for an interim period, a specific term, or not term limited?

If the appointment is interim or for a specific term, indicate term beginning and end dates (MM/DD/YY) and explain the recruitment plan, including timeline.

[Insert detailed response here. Table will expand automatically]

3. List the director’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the director has been recertified, use that date. Provide a copy of certification(s). If the director does not possess current American board certification, provide documentation that demonstrates the foreign education or training is equivalent to that obtained in the United States.

Certification Type	Certificate Effective Date (MM/DD/YY)	Certificate Valid Through Date (MM/DD/YY)	Certification Number

4. List all professional positions (director, supervisor, consultant, instructor, etc.) currently held by the director and an estimated time commitment of each (hours/week). Include projected hours for this laboratory. Expand rows as needed.

Professional Position	Institution	Location (City/State)	Estimated Time Commitment (hours/week)

5. Post-Doctoral experience in human histocompatibility testing for solid organ transplantation. List all laboratory specialties in which post-doctoral training was received. Expand rows as needed.

Laboratory Name	Title	Dates	Description of Duties

6. Doctoral training in directing or supervising clinical histocompatibility testing for solid organ transplantation.

List all laboratory specialties in which doctoral training was received, including exact dates and specific training received for each. Add additional sections below as needed.

Institution Name
Laboratory Name
Laboratory Specialty
Instructor Name
Dates
Specific Training
Hours/week

Institution Name
Laboratory Name
Laboratory Specialty
Instructor Name
Dates
Specific Training
Hours/week

7. Laboratory Involvement

a. Detail the review process for each laboratory report including the histocompatibility laboratory director’s role. If the histocompatibility laboratory director does not review all reports, include the percentage that are reviewed and how they are selected.

[Insert detailed response here. Table will expand automatically]

b. Indicate the approximate number of cases up to 500 (after that just indicate >500) that the proposed laboratory director reviewed in each of the following categories:

Category	Method	# of Cases
Kidney: Deceased donor typing
Kidney: Deceased donor crossmatch
Kidney: Living donor typing
Kidney: Living donor crossmatch
Other Organs: Deceased donor typing
Other Organs: Deceased donor crossmatch
Islet Cell transplantation
Allele level typing
HLA antibody screening
HLA antibody characterization
Flow cytometry crossmatch

Part 2: Section B – Personnel Qualifications, Primary Technical Supervisor

The individual identified below as the primary technical supervisor must complete this section if they are not named as the primary histocompatibility laboratory director in Section 2A of this application. If two or more individuals share the technical supervisor’s responsibilities, one person must be designated as the primary.

Complete questions below and submit a copy of the following:

• Current board certification

• Current licensure if a state requirement

• Current curriculum vitae or resume

If the proposed primary technical supervisor has not previously served in this role before, the OPTN Bylaws require that the following documents be provided:

• Portfolio of cases

• Letter of reference from histocompatibility laboratories where training obtained

• Proof of active interactions with transplant professionals

• Letter from the applicant that describes all experience in immunology and clinical histocompatibility testing, including a summary of time spent in the laboratory, technologies used, level of responsibility, and specific tasks performed

• Documentation demonstrating participation in transplant or clinical laboratory professional conferences or publications in peer-review journals

1. Provide the following information:

Name of primary technical supervisor
Start date at this laboratory (MM/DD/YY)
Effective date of this appointment (MM/DD/YY)
Degree(s)
Discipline(s)
State licensure in the state/district where the lab is located (provide copy of current, if applicable)	Yes	No		Not required
Has this individual served in the role of technical supervisor previously?	Yes		No
Has this individual served in the role of primary lab director previously?	Yes		No
Does the proposed technical supervisor meet the qualification defined by CLIA (42 CFR 493)?	Yes		No

2. Is this appointment for an interim period, a specific term, or not term limited?

If the appointment is interim or for a specific term, indicate term beginning and end dates (MM/DD/YY) and explain the recruitment plan, including timeline.

[Insert detailed response here. Table will expand automatically]

3. List the technical supervisor’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the technical supervisor has been recertified, use that date. Provide a copy of certification(s). If the technical supervisor does not possess current American board certification, provide documentation that demonstrates the foreign education or training is equivalent to that obtained in the United States.

Certification Type	Certificate Effective Date (MM/DD/YY)	Certificate Valid Through Date (MM/DD/YY)	Certification Number

4. List all professional positions (director, technical supervisor, clinical consultant, instructor, etc.) currently held by the technical supervisor and estimated time commitment of each (hours/week). Include projected hours for this laboratory. Expand rows as needed.

Professional Position	Institution	Location (City/State)	Estimated Time Commitment (hours/week)

5. Post-Doctoral experience in human histocompatibility testing for solid organ transplantation. List all laboratory specialties in which post-doctoral training was received. Expand rows as needed.

Laboratory Name	Title	Dates	Description of Duties

6. Doctoral Training in directing or supervising clinical histocompatibility testing for solid organ transplantation. List all laboratory specialties in which doctoral training was received, including exact dates and specific training received for each. Add additional sections below as needed.

Institution Name
Laboratory Name
Laboratory Specialty
Instructor Name
Dates
Specific Training
Hours/week

Institution Name
Laboratory Name
Laboratory Specialty
Instructor Name
Dates
Specific Training
Hours/week

7. Histocompatibility Laboratory Involvement

a. Describe the technical supervisor’s role in the report review process for this laboratory. Include the percentage of reports review and how they are selected.

[Insert detailed response here. Table will expand automatically]

b. Indicate the approximate number of cases up to 500 (after that just indicate >500) that that the proposed technical supervisor reviewed in each of the following categories:

Category	Method	# of Cases
Kidney: Deceased donor typing
Kidney: Deceased donor crossmatch
Kidney: Living donor typing
Kidney: Living donor crossmatch
Other Organs: Deceased donor typing
Other Organs: Deceased donor crossmatch
Islet Cell transplantation
Allele level typing
HLA antibody screening
HLA antibody characterization
Flow cytometry crossmatch

Part 2: Section C – Personnel Qualifications, Primary Clinical Consultant

The individual identified below as the primary clinical consultant must complete this section if they are not named as the primary histocompatibility laboratory director or technical supervisor in Section 2A or 2B of this application. If two or more individuals share the clinical consultant’s responsibilities, one person must be designated as the primary. Complete questions below and submit a copy of the following:

• Current certification

• Current licensure if a state requirement

• Current curriculum vitae or resume

If the proposed clinical consultant has not previously served in the role of primary laboratory director or clinical consultant, the following documents must be provided:

• Portfolio of cases

• Letter of reference from histocompatibility laboratories where training was obtained

• Proof of active interactions with transplant professionals

• Letter from the applicant that describes all experience in immunology and clinical histocompatibility testing, including a summary of time spent in the laboratory, technologies used, level of responsibility, and specific tasks performed

• Documentation demonstrating participation in transplant or clinical laboratory professional conferences or publications in peer-reviewed journals

1. Provide the following information:

Name of primary clinical consultant
Degree(s)
Discipline(s)
Start date at this laboratory (MM/DD/YY)
Effective date of this appointment ((MM/DD/YY)
State licensure in the state/district where the lab is located (provide copy of current license, if applicable)	Yes	No		Not required
Has this individual served in the role of clinical consultant previously?	Yes		No
Has this individual served in the role of primary lab director previously?	Yes		No
Does the proposed Clinical Consultant meet the qualifications defined by CLIA (42 CFR 493)?	Yes		No

2. Is this appointment for an interim period, a specific term, or not term limited?

If the appointment is interim or for a specific term, indicate term beginning and end dates (MM/DD/YY) and explain the recruitment plan, including timeline.

[Insert detailed response here. Table will expand automatically]

3. List the clinical consultant’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the applicant has been recertified, use that date. Provide a copy of certification(s). If the applicant does not possess current American board certification, provide documentation that demonstrates the foreign education or training is equivalent to that obtained in the United States.

Certification Type	Certificate Effective Date (MM/DD/YY)	Certificate Valid Through Date (MM/DD/YY)	Certification Number

4. List all professional positions (director, supervisor, consultant, instructor, etc.) currently held by the clinical consultant and estimated time commitment of each (hours/week). Include projected hours for this laboratory. Expand rows as needed.

Professional Position (Include Institution)	Institution	Location (City/State)	Estimated Time Commitment (hours/week)

5. Describe the clinical consultant’s responsibilities in this laboratory:

[Insert detailed response here. Table will expand automatically]

6. Describe the clinical consultant’s experience in clinical transplantation:

[Insert detailed response here. Table will expand automatically]

Part 2: Section D - Personnel Qualifications, Primary General Supervisor

This section of the application must be completed for the primary general supervisor. If the histocompatibility laboratory director serves as general supervisor, indicate this in Question 1 below and leave the remainder of this section blank.

If two or more individuals share the general supervisor responsibilities, one person must be designated as the primary. Complete questions below and submit a current curriculum vitae or resume.

1. Provide the following information:

Name of primary general supervisor
Start date at this laboratory (MM/DD/YY)
Effective date of this appointment (MM/DD/YY)
Does the general supervisor meet the qualifications defined by CLIA (42CFR. §493? (Yes/No)

2. Provide description of general supervisor’s duties in this position:

[Insert detailed response here. Table will expand automatically]

3. Describe how the general supervisor meets the qualifications for having at least 3 years of experience in human histocompatibility or transplant immunology testing under the supervision of a qualified histocompatibility director or technical supervisor:

[Insert detailed response here. Table will expand automatically]

Part 2: Section E - Personnel List

List all staff involved in histocompatibility testing in this laboratory.

Start Date M/YY	Name	Position	Degrees	Certifications	Yrs HHT	% FTE Clinical HHT	On-Call	Total CE Hours (last calendar yr)

Expand rows as needed.

Part 2: Section F - Competency Testing

1. The laboratory must have a process for annually testing its staff for competency in performing test procedures. Provide documentation of a plan for competency testing and continuing education of staff.

[Insert detailed response here. Table will expand automatically]

2. Laboratories must document that proficiency testing and competency requirements in the OPTN Bylaws have been met. Provide documentation demonstrating a successful performance in an external proficiency testing program within the last year.

Version pending