Form 0

Department of Health and Human Services
Health Resources and Services Administration

OMB No. pending
Expiration Date: pending

APPLICATION FOR APPROVAL FOR INSTITUTIONAL MEMBERSHIP
AS AN INDEPENDENT TISSUE TYPING LABORATORY
IN THE ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN)
UNOS
700 North 4th Street
Richmond, VA 23219
Main Phone: 804-782-4800

Name Laboratory: ___________________________________________________________________
Address:

___________________________________________________________________

City, State, & Zip Code:

___________________________________________________________________

Contact Person and Title: ___________________________________________________________________
Phone Number:

(_______)_____________________________

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 the applicant for this collection of information is estimated to average
40 hours 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. 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 10-33, 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. By submitting this
application to the OPTN, the applicant acknowledges that its duly authorized representatives have received and read the
current Charter, By-Laws, and Policies of OPTN and the applicant agrees: (i) to be bound by the terms thereof, 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: ___________________________________________

Applicant # ______________

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Print Title: ___________________________________________

Independent Histocompatibility Laboratory

1.

A histocompatibility laboratory must complete this application for institutional membership. The Criteria for
Institutional Membership are found in the By-Laws, which can be accessed on the OPTN website at www.optn.org.

2.

By submitting this application to the OPTN, the applicant acknowledges that its duly authorized representatives have
received and read the current Charter and By-Laws of the OPTN and the applicant agrees: (i) to be bound by the terms
thereof, 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.

3.

A duly authorized representative of the applicant must review the answers and attachments to the Application, perform
sufficient investigation to determine accuracy and completeness, and sign and date the Certification on the cover page
of the Application. Failure to furnish accurate and complete information in connection with the Application and
subsequent site visits and requests for supplemental information constitutes grounds for denial or suspension of OPTN
membership.

4.

Expand table rows as needed to fully answer questions.

5.

Additional Instructions are provided under Part 3.

PART 1
1.

List the names and addresses of clinical transplant centers and organ procurement organizations (OPO's) you will be
serving and the type of program(s) (i.e. kidney, heart, heart/lung, lung, liver, and pancreas) for each transplant center.
Attach written agreements with clinical transplant centers and OPO's you will serve.

PART 2
1.

2.

Full name of organization and CMS provider number identification.
a)

Name: ___________________________________________________________________________

b)

CMS #: ____________________

Indentify the principal CEO, Laboratory Director and Administrator and provide contact information.
Position
CEO

Name, Address, phone, & email address

Laboratory Director
Administrator

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3.

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

4.

Is your histocompatibility laboratory insured for professional liability? Yes ____

No _____.

If Yes, name your insurer and give the policy limits per person and per occurrence and the expiration date of your
current insurance coverage. If No and you have 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 your laboratory.

5.

In order to qualify for OPTN Institutional Membership as a Hospital-based Histocompatibility Laboratory, the
histocompatibility laboratory must meet the applicable OPTN standards. All histocompatibility laboratories must be
accredited in the area of Solid Organ Transplantation: Deceased Donor. If you will serve transplant centers that
perform living-related organ transplants, your laboratory must be accredited in the area of Solid Organ Transplantation:
Living Donor. Does the transplant center that you will serve perform living-related organ transplants?
Yes ______

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No ________.

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6.

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

Has your laboratory been accredited by ASHI or CAP within the last three years?
ID #

Yes

No

Last Accreditation Date

ASHI Accredited
CAP Accredited
b) If the answer to item “a” above is Yes, indicate the categories for which the laboratory was accredited.
Categories
Solid Organ Transplantation: Deceased Donor
Solid Organ Transplantation: Living Donor
Islet Cell Transplantation

7.

Yes

No

Identify the laboratory director, technical supervisor, and general supervisor.
Position
Laboratory Director:
Technical supervisor (if other than the laboratory
director):
General supervisor (if other than the laboratory
director):

Name

If your histocompatibility laboratory is currently accredited or in the process of being
accredited by ASHI or CAP; please stop here.
Attach a copy of your application and certification to this document.

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PART 3 - OPTN ACCREDITATION PROGRAM APPLICATION INSTRUCTIONS
This Application is used for the following:
Laboratories not currently ASHI or CAP accredited

TABLE OF CONTENTS
Glossary of Abbreviations
General Instructions
1.

Submission of the Application
Inspection
Response to Deficiencies
Accreditation Application Sections:

2.

Cover Page
Personnel: Director/Technical Supervisor
Personnel: Clinical Consultant
Personnel: General Supervisor
Personnel List
Continuing Education
Laboratory Activities
Proficiency Test Results
Validation Requirements for Using a New Procedure or Test
Validation Requirements: Supplementary Documentation of Director/Technical Supervisor
Procedures
Antibody Screening/Antibody Characterization
Quality Assurance
Additional Documentation, For Laboratories Not Currently ASHI Accredited

3.

Test Procedures and Protocols

4.

Checklist of Requested Documents

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GLOSSARY OF ABBREVIATIONS

ABB
ABCC
ABHI
ABMLI
ABMM
ASHI
Ab
Ag
AHG
AP
ARB
CAP
CDC
CE
CFR
CLIA
DHHS
DNA
ELISA
FTE
HCFA
HHT
HLA
JC
MLC
OPTN
PCR
PRA
SEOPF
SSOP
SSP
TAT
TX
UNOS
XM

American Board of Bioanalysis
American Board of Clinical Chemistry
American Board of Histocompatibility and Immunogenetics
American Board of Medical Laboratory Immunology
American Board of Medical Microbiology
American Society for Histocompatibility and Immunogenetics
antibody
antigen
antihuman globulin
Accreditation Program
Accreditation Review Board
College of American Pathologists
complement-dependent cytotoxicity
continuing education
Code of Federal Regulation
Clinical Laboratory Improvement Act (Amendments)
Department of Health and Human Services
deoxyribonucleic acid
enzyme-linked immuno-sorbent assay
full time equivalent
Health Care Financing Administration
human histocompatibility testing
human leukocyte antigen
Joint Commission
mixed lymphocyte culture
Organ Procurement and Transplantation Network
polymerase chain reaction
panel reactive antibody
South-Eastern Organ Procurement Foundation
sequence specific oligonucleotide probe
sequence specific primer
turn around time
transplant
United Network for Organ Sharing
crossmatch

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GENERAL INSTRUCTIONS

1.

1.

IMMEDIATELY UPON RECEIPT, record the date of receipt of this application on the Processing Record Form.

2.

Before completing the application, read all instructions carefully.

3.

All documentation must be in English and typed.

4.

Your CLIA provider number, OPTN number (if applicable), and application date must be at the top of each page of
the application and at the top of all additional documents submitted (i.e. proficiency reports, etc.).

5.

Accreditation in Deceased Donor Solid Organ Transplantation requires that the laboratory provide 24-hour on call
coverage.

6.

CFR Sec. 493.51 requires that DHHS or its designee be notified within 30 days of any change in ownership, name,
location, director, or technical supervisor.

7.

The American Society for Histocompatibility and Immunogenetics and the College of American Pathologists have
been granted deemed status to carry out its inspections and accreditation process.

SUBMISSION OF THE APPLICATION

When your application is complete and ready for submission, record the date it is being sent on the Processing Record Form.
Send an original and FOUR copies (total of five), 3-hole punched, each in an accordion file, of the completed Application, and
all documentation to the following:
Membership Services
UNOS
700 North 4th Street
Richmond, VA 23219
Phone: 804-782-4800
Processing of the application will not begin if the ASHI or CAP Executive Office has not received payment of the laboratory's
accreditation fees.
Retain these instructions, an entire copy of your submission and the Inspector’s Checklist to help you prepare for the
inspection.
The Accreditation Manager will perform an initial review of the application.
Incomplete applications will not be processed further until they are complete and deadlines cannot be extended.

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INSPECTION
Inspectors are appointed on the basis of their expertise, objectivity, integrity, experience, and to minimize expenses born by the
applicant, geographical location. If you believe an appointed inspector has a conflict of interest that will interfere with his/her
objectivity, please petition in writing for a different inspector. You will have one right of refusal. The commissioner will evaluate
the situation and take appropriate action.
The inspection may take one or more days, depending upon the areas in which accreditation is sought and size of the
laboratory. To facilitate a thorough evaluation, have all records readily available and, if possible, designate at least one
individual to assist the inspector in accessing the necessary information. The manual, or a separate protocol manual, should
provide instructions for the appropriate use of each technique and specify testing for the various clinical applications.
At the end of the inspection, an exit interview will be conducted and the inspector will inform you if deficiencies were found.
The inspection is only one part of an extensive evaluation process and any comments made by the inspector must not be
construed as judgment for or against approval of the laboratory. After the inspection has been performed, complete the
inspection questionnaire form that the inspector will leave with you and return it promptly to your commissioner.

RESPONSE TO DEFICIENCIES
Following the inspection, responses to the deficiencies, cited by the inspector and any other deficiencies identified by the
commissioner, must be submitted within 30 days of the notification of the deficiency. Responses must include supporting
documentation.

2.

COVER PAGE

Provide the names of the laboratory, director(s), department and institution, as they should appear on the accreditation
certificate (+).

CFR 493 requires that the laboratory have a director (493.1441), technical specialist (493.1447), clinical consultant,
(493.1453) and general supervisor (493.1459). Provide the appropriate name(s) for each position.
**There must be a name entered for all positions listed above, if left blank, the packet will be returned.
Check all Areas of Accreditation in which you wish to be evaluated for accreditation and record “NEW” for those in which
your lab is not currently accredited.

A. PERSONNEL: DIRECTOR/TECHNICAL SUPERVISOR QUALIFICATIONS (STANDARD B1.000)
The individual identified as director/technical supervisor must complete this section. If two or more individuals share
the director/technical supervisor’s responsibilities, use a copy of the forms for each individual. Complete all sections
and submit a copy of the curriculum vitae, current certification, and current licensure if a state requirement.
A laboratory director must have sufficient training and experience in each specialty, subspeciality, analyte, test, or
procedure for which the laboratory is accredited, to provide adequate management and direction of the laboratory
personnel and activities.

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(CFR 493.1443) For lab directors, MDs must be licensed to practice medicine in the state in which the lab is
located or deemed qualified as of 2-28-92. If not an MD, they must have an earned doctoral degree (not an MD
degree) in a biological, chemical, or physical science and, by 12-31-00 be certified by ABHI, ABB, ABCC,
ABMLI, ABMM or other board approved by HHS.
The laboratory Technical Supervisor must be qualified by education, training and experience to provide technical
supervision for each speciality, subspeciality, analyte, test or procedure for which the laboratory is accredited.
(CFR 493.1449) Technical supervisors must be either an MD licensed to practice medicine in the state in which
the lab is located (no grandfather clause) or a PhD (as above) and (for either degree) have 4 years post doctoral
training and/or experience in histocompatibility or 2 years training and/or experience in the laboratory specialty of
general immunology plus 2 years training and/or experience in histocompatibility.
In most cases, one person fills both positions.
For director/technical supervisors that were previously approved, submit an abridged publication list limited to
the last two years, include any updated information on these pages (i.e. additional lab training/experience as
required with changing lab activities, change in responsibility, etc.) and a copy of current licensure if a state
requirement (required for all MDs).

B. PERSONNEL: CLINICAL CONSULTANT QUALIFICATIONS
If the clinical consultant is not the director or technical supervisor, submit a copy of the current certification and current
licensure if a state requirement. The Clinical Consultant must have sufficient training and experience in areas of the
laboratory’s accreditation to be qualified to consult with and render opinions to the laboratory’s clients concerning the
appropriateness of human immunogenetics, histocompatibility and /or transplantation immunology testing and the
interpretation of these test results in relation to diagnosis, treatment and management of patient care.
(CFR Sec. 493.1455) The clinical consultant must be qualified to consult with and render opinions to the
laboratory’s clients concerning the diagnosis, treatment and management of patient care. The clinical consultant
must (a) be qualified as a laboratory director under Sec. 493.1443(b)(1), (2), or (3)(i) or, for the subspecialty of
oral pathology, Sec. 493.1443(b)(6); or (b) be a doctor of medicine, doctor of osteopathy, doctor of podiatric
medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located.
If the Director/Technical Supervisor serves as the Clinical Consultant, it must be stated on this form.

C. PERSONNEL: GENERAL SUPERVISOR QUALIFICATIONS
This section should be completed by all personnel with authority to sign out reports and/or function as a general
supervisor. Submit curriculum vitae for each person. If the director serves as general supervisor, indicate this on the
cover page and leave the remainder of this section blank. The general supervisor must have training and experience
under the direction of the laboratory director and supervision of the technical supervisor to provide day-to-day
supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the
general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test
results.

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D.

Personnel List
List all personnel who perform work related to histocompatibility and Immunogenetics activities of the laboratory, including
the director(s), co-director(s), associate director(s), scientist(s), fellow(s), supervisor(s), technologist(s), technician(s), lab
aide(s) and assistant(s), support staff (clerical, secretarial), administrative personnel (computer, business manager, etc.).
Supply the following information either in the following format or on the Personnel List.
Start date in this laboratory
Name
Positions
Degrees
Certifications
Years of working experience in human histocompatibility testing (HHT)
%FTE in clinical HHT
Personnel on-call for deceased donor testing
For non-degreed technical personnel not previously reviewed by the ASHI Accreditation Program, indicate those qualified
to work unsupervised, whether or not they take deceased donor call and under which specific standards of CFR 493.1489
and 1491 they qualify.
Copy of the state license for each person required to hold a license.
Copy of the competency quality assurance summary for each of the technical personnel.

E. CONTINUING EDUCATION SUMMARY
For the lab director and each member of the technical staff, submit a summary of participation in continuing education
during the previous year (calendar year or fiscal year). Note programs which are HHT related ASHI approved. Briefly,
describe the program content. Include safety training, technical meetings, clinical meetings, technical competency
assessment, and review of proficiency testing, quality control and lab manuals. Note the number of hours of actual
participation and the level of participation (lecturer, presenter, participant or attendee).
The minimum hours of continuing education will be met if the individual is ABHI certified and has maintained continued
certification. For directors/technical supervisors not maintaining continued certification, a minimum of 50 hours/year is
required. For general supervisors not maintaining continued certification, a minimum of 27 hours/year is required. For
those testing personnel not maintaining continued certification, a minimum of 12 hours/year is required.
Supply the following information either in the following format or on the Continuing Education Summary Form:
Name
Position
Brief job description (i.e. supervises serologic testing and performs molecular testing)
Program
Participation hours
Participation level
Approved by ABHI
Content
Summary of contact hours by type and total

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F.

LABORATORY ACTIVITIES
In the last year (calendar or fiscal), indicate the approximate percent of the lab’s total clinical effort for each Area of
Accreditation, the number of cases for each clinical activity listed and the number of tests performed.

G. PROFICIENCY TEST RESULTS
Laboratory accreditation requires successful participation in approved external proficiency testing programs, when
available, for all clinical tests performed by the laboratory in the categories being evaluated. Laboratories may use more
than one proficiency testing survey provider. Performance of the tests must be rotated among all technologists performing
the tests and be processed and tested in the same manner as patient specimens. Satisfactory performance requires at least
an 80% success rate for each challenge (send out), of each analyte (CFR 493, subpart H). For a survey report of 5 samples
for phenotyping (analyte), a satisfactory performance would be an error of no more than 1 of the 5 phenotypes. Tabulate
the results on the Proficiency Result Summary Form, including only those results that reached consensus and submit a
copy of corrective actions for any errors in any category submitted. If proficiency testing is not available for a test your
laboratory performs, validate accuracy and reproducibility of the test at least twice each year and submit a summary of
these results.

Unsuccessful participation in a proficiency testing: failure to attain minimum satisfactory score
Unsuccessful participation in proficiency testing requires remedial action as detailed in CFR 493.1701. Failure to take
remedial action can result in CMS imposed sanctions as specified in CFR 493, subpart R.
HLA Class I and II Antigen Typing
Results submitted for any proficiency testing survey provider for each analyte must include all results for a one-year
period. Submit the full year’s results from the cells/specimens typed for the major A, B and DR antigens, from the twelve
(12) month (calendar or fiscal year) period preceding the application date.
Laboratories required to meet the OPTN Standards must be able to type for the World Health Organization (WHO)
recognized antigens for which reagents are readily available.
HLA Class I Allele Typing
Results submitted for any proficiency testing survey provider for each analyte must include all results for a one-year
period. Submit the full year’s results from the cells/specimens typed for HLA Class I alleles, from the twelve (12) month
(calendar or fiscal year) period preceding the application date.
HLA Class II Allele Typing
Results submitted for any proficiency testing survey provider for each analyte must include all results for a one-year
period. Submit the full year’s results from the cells/specimens typed for HLA Class II alleles, from the twelve (12) month
(calendar or fiscal year) period preceding the application date.
Antibody Screen Tests and Antibody Identification
Results submitted for any proficiency testing survey provider for each analyte must include all results for a one-year
period. Submit the full year’s results from the antibody screen tests from the twelve (12) month (calendar or fiscal year)
period preceding the application date.

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Crossmatch Testing by Cytotoxicity
Results submitted for any proficiency testing survey provider for each analyte must include all results for a one-year
period. Submit the full year’s results from the crossmatch testing by cytotoxicity from the twelve (12) month (calendar or
fiscal year) period preceding the application date.
Crossmatch Testing by Flow Cytometric Methods
Results submitted for any proficiency testing survey provider for each analyte must include all results for a one-year
period. Submit the full year’s results from the crossmatch testing by flow cytometric methods from the twelve (12) month
(calendar or fiscal year) period preceding the application date.

H.

VALIDATION REQUIREMENTS FOR USING A NEW PROCEDURE OR TEST
Among the most critical aspects of laboratory evaluation are the assessment of test performance and outcome. This
evaluation process includes a review of results of not only proficiency test surveys but also of tests performed during the
various situations found in the laboratory and of internal proficiency tests. These situations include the tests performed
on subjects in varying states of health and tests performed using various types of material (blood, lymph nodes, spleen,
etc.). The purpose of these guidelines is to describe the minimum data that must be submitted by all laboratories.
Prior to reporting test results of a new procedure or test, the laboratory must establish performance specifications and
demonstrate that it can obtain these performance specifications or, for FDA-approved kits, the specifications of the
manufacturer. Performance specifications include accuracy, precision, analytical sensitivity and analytical specificity to
include interfering substances, reportable range of patient test results, reference range(s) (normal values) and any other
performance characteristics required for test performance. Calibration and calibration verification procedures must be
performed and documented. Control and quality assurance procedures must be routinely performed. Personnel must be
trained, qualified and have appropriate technical supervision available. For further information, refer to CFR 493.1201b,
493.1205a, 493.1205c, 493.1213, 493.1217, 493.1218, 493.1701, 493.1705 and 493.1709.
Minimally, these sections require the lab to do the following:
1.
2.
3.
4.

Establish specification requirements for test performance
Evaluate the test system to assure that it meets the specification requirements
Identify and establish ongoing quality control measures
Train personnel and take measures to evaluate and ensure their ongoing competency

Documentation for accreditation should include the following:
1.

Protocol and example of a case file. This should include an explanation of how and when the test will be used.

2.

Step by step procedure. Include whether this replaces previously used technologies or is an adjunct to technologies
in use.

3.

Performance requirements. This may be included in the procedure or in a quality control manual. If new
equipment is employed, include documentation of validation of the new equipment.

4.

Validation summary data, analysis, and conclusions.

5.

Limitations and shortcomings, how these will be handled, general troubleshooting. This may be included in the
quality control section of the procedure.

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6.

I.

Training guidelines and documentation of testing personnel competency (for personnel currently authorized to
perform this test).

Supplementary Documentation of Director(s)/Technical Supervisor(s) Qualification
Some applicants may fulfill the training/experience requirements for a director of a histocompatibility laboratory, but
lack sufficient documentation of professional competence as delineated in Standard B1.000 (“by external measures such
as national proficiency testing, participation in national or international workshops or publications in peer-reviewed
journals.”) In such cases, the applicant is required to submit the following supplementary documentation to UNOS:
Portfolio of Case Files
The purpose of this portfolio is to provide UNOS with documentation of the applicant’s ability to review and interpret
test results obtained in various clinical situations; to provide insight into probable causes of and appropriate solutions for
test failure; to recommend additional follow-up tests as needed; and to provide appropriate commentary for use by
clinicians. The files, therefore, must include evidence of interpretive comments and review by the applicant. The
submitted case files should be consecutive. For example, an applicant wishing to qualify in another area of expertise
could visit another accredited lab for specific training and to compile the needed number of cases. The files should
include relevant, but anonymous patient information (e.g. race/ethnicity, parity, underlying disease, etc.).
These case files need to reflect the applicant’s expertise in three major areas:
Technology
The applicant must have sufficient experience with the technologies employed to know their strengths and limitations.
This is necessary in order to be able to select technologies appropriate for each situation, interpret test results, and
establish a quality assurance program.
Test Selection
The applicant must be capable of determining what tests are necessary for various clinical applications and of
developing new tests and test strategies as dictated by changes in individual patient status.
Interpretation/Consultation
The applicant must have adequate expertise to know what information is needed to evaluate individual clinical cases and
be capable of utilizing the collective body of information to assess risk level, identify possible clinical strategies, and
make scientific evaluations of the immune state of the patient. Further, the applicant should be capable of supporting
clinical studies and of using clinical data in the ongoing development of test strategies.
In this section it is referring to ASHI, CAP should be included, though the criteria for accreditation for the lab directors
under the two organizations is quite different. The ASHI Director Training Review Committee has streamlined the
process and does not necessarily require the extensive portfolio that was previously required. Following the review of
the new director’s CV, the committee decides what is needed in terms of the portfolio. I am not sure what CAP requires.
The most effective way to acquire a case portfolio is through training and experience under the guidance of an ASHI or
CAP approved director/technical supervisor. If an individual no longer has access to case files reviewed, it may be
possible to visit another laboratory and review files. In this case, the director/technical supervisor must serve as an
advisor. The advisor will be required to submit an evaluation of the applicant’s expertise in each area in which
accreditation is sought. If various test methods are used, the cases submitted should have sufficient numbers of each test
method to validate the applicant’s expertise/qualifications (e.g. CDC, ELISA and flow cytometry antibody analysis).
The case files must be submitted as described below:
1.

Fifty (50) family work-ups for living related solid organ transplantation. For renal, living related transplantation, the
files must include the recipient’s serum screen results. Full HLA phenotypes for all available family members must
be included.

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2.

Fifty (50) recipient work-ups for deceased donor renal and/or non-renal transplantation. This portfolio must include
complete HLA phenotypes and serum screens.

3.

Fifty (50) deceased donor work-ups. This portfolio must include full HLA phenotypes and other test results as
applicable (e.g. ABO if performed in the laboratory).

Continuing Education
Documentation of continuing education during the past 5 years in the areas relevant to their application must be
submitted. For non-ASHI or non-CAP approved meetings, information about the program should be submitted in order
for the committee to assess the relevance to histocompatibility and Immunogenetics.
In addition, the applicant may submit letters from ASHI or CAP accredited directors if they might help verify training,
experience or involvement in the field. In cases of collaborative research or papers, the letter should identify the exact
role of the applicant in the project; i.e. did the applicant actually perform or assist with the portions of the project
relative to histocompatibility and Immunogenetics.

J.

PROCEDURES
Submit a copy of the laboratory procedure manual.
Submit copies of reading/scoring sheets for all tests in use.
HLA Class I and II Antigen Typing
List all HLA antigens your laboratory can identify.
HLA Class I and II Allele Typing
List all HLA alleles for which your laboratory can test and can identify.
Submit a list of probes and primers in use for various tests.
For molecular testing labs, briefly describe or submit protocols for preventing pre-PCR contamination, including
description of physical layout.
CFR 493.51 requires that DHHS or the accrediting organization be notified no later than 6 months after any deletions or
changes in test methodologies for any test.

K. ANTIBODY SCREENING/ANTIBODY CHARACTERIZATION
Briefly describe or submit your serum screening protocol indicating what serum samples are screened, when, by
what technique, etc.

Submit panel phenotypes. If the panel is not the same all the time, submit the phenotypes of the first and last panel of
the previous year (calendar or fiscal).

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L. QUALITY ASSURANCE
Submit an example of training documentation for new technical personnel.
Submit training documentation for all technical personnel.
List laboratories subcontracted and evidence of their certification.

M. ADDITIONAL DOCUMENTATION, FOR LABORATORIES NOT CURRENTLY ASHI ACCREDITED
Submit a list of all reagents used in clinical tests.
Submit a brief description of quality control testing and monitoring for all reagents.
Submit a floor plan and total square footage for the laboratory.
Submit a list of all laboratory equipment used clinically.
Submit a brief description of the equipment function verification and preventative maintenance procedure.
List the records that are maintained, for how long and what format (paper, electronic). Include worksheets, reports, QC
records, etc.
Submit a brief description of the computer validation and back-up system.

3.

TEST PROCEDURES AND PROTOCOLS
For each area in which you are seeking accreditation, submit a one-page summary of the testing. Submit a complete
case file from the last month for each clinical application.
A case file consists of: A requisition of the orders and a report.
For the application of Solid Organ Transplantation: Deceased Donor, describe the testing process including the procedures
(tests) used in the initial patient work-up (typing, antibody screening, auto crossmatching, etc.), deceased donor work-up, preTX work-up, specimen selection criteria (i.e. sera used in crossmatch), requirements for specific testing (i.e. flow crossmatch
testing on regraft patients), etc.. Accreditation in this area requires that the laboratory provide 24-hour on call coverage and
meets the requirements of the OPTN Standards.
For the application of Solid Organ Transplantation: Live Donor, describe the testing process, including the procedures
(tests) used in the initial patient work-up (typing, antibody screening, auto crossmatching, etc.), initial donor work-up, all
additional pre-TX testing, specimen selection criteria (i.e. sera used in crossmatch), requirements for specific testing (i.e.
flow crossmatch testing on regraft patients), etc. Include variations for different organ types. Accreditation in this area
requires that the laboratory meet the requirements of the OPTN Standards.
For the application of Islet Cell Transplantation, describe the testing process, including the procedures (tests) used in the
initial patient work-up (typing, antibody screening, auto crossmatching, etc.), initial donor work-up, all additional pre-TX
testing, specimen selection criteria (i.e. sera used in crossmatch), requirements for specific testing (i.e. flow crossmatch
testing on regraft patients), etc.. Accreditation in this area requires that the laboratory meet the requirements of the OPTN
Standards.

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Lab- 14

4.

CHECKLIST OF REQUESTED DOCUMENTS
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Processing Record Form with date of receipt and date of submission (original)
FIVE copies, each in an accordion file (included):

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Cover page
Director/Technical Supervisor(s) Qualifications
Director/Technical Supervisor(s) CV’s
Director/Technical Supervisor(s) certification(s)
Director/Technical Supervisor(s) current state license, if applicable
Clinical Consultant(s) Qualifications
Clinical Consultant(s) current state license, if applicable
General Supervisor(s) Qualifications
General Supervisor(s) CV’s
Personnel List
Copy of state license for each of the technical personnel, if applicable
Copy of the competency quality assurance summary for each of the technical personnel
Continuing Education Summary Form for each member of the technical staff
Laboratory Activities
Proficiency testing reports
Proficiency Result Summary Form
Proficiency testing corrective actions, if applicable
Validation documentation for new procedures or tests
Protocol and example of a case file
Step by step procedure
Performance requirements
Validation summary data, analysis, and conclusions
Limitations and shortcomings, how these will be handled, general troubleshooting
Training guidelines and documentation of testing personnel competency
Supplemental documentation of director/technical supervisor qualifications
Copy of the laboratory procedure manual
Reading/scoring sheets for all test systems
List of all HLA antigens your lab can identify
List of all HLA alleles for which your lab can test and can identify
List of probes and primers in use for various tests
Protocol for preventing pre-PCR contamination
Serum screening protocol
Panel phenotypes
Copy of training documentation for all technical personnel
Performance improvement programs initiated
List of labs subcontracted and certificates
Description of testing process and a complete case file for appropriate application(s):
Solid Organ Transplantation: Deceased Donor
Solid Organ Transplantation: Live Donor
Islet Cell transplantation
List of all reagents
Description of quality control testing and monitoring for all reagents
Floor plan and total square footage of lab
List of all laboratory equipment
Description of equipment function verification and preventative maintenance procedure
List of records maintained
Description of computer validation and back-up system

Version date pending

Lab- 15

CLIA #__________________
OPTN # ___________________
Date ___________________

PART 4 - OPTN ACCREDITATION PROGRAM ACCREDITATION APPLICATION
A. COVER PAGE
Provide the names of the laboratory, director(s), department and institution, as they should appear on the accreditation
certificate (+).

Position
+Director
Technical Supervisor*
Clinical Consultant*
General Supervisor*
+Laboratory or Department Name
+Institution
Street Address
City, State, Zip
Contact Person
Telephone
Fax
E-Mail Address

Name

*As Defined in CFR 493.1441-1467
AREAS OF ACCREDITATION
Check all areas in which you wish to be evaluated for accreditation and indicate “NEW” for those in which your lab
is not currently accredited.
Areas of Accreditation

To be
Evaluated

New

Solid Organ Transplantation: Deceased Donor
Solid Organ Transplantation: Live Donor:
Islet Cell Transplantation

Other accreditation/certification held by laboratory (specify):
(Print name of director or other authorized individual) ____________________________ does hereby apply for
laboratory accreditation in the area(s) of accreditation designated above. I understand that granting of accreditation is
dependent on complete compliance with all applicable standards. I certify that all information provided is truthful and
accurate.
Signature of authorized individual:
Date:

Version date pending

Lab- 16

CLIA #__________________
OPTN # ___________________
Date ___________________
B. PERSONNEL QUALIFICATIONS
DIRECTOR/TECHNICAL SUPERVISOR QUALIFICATIONS (Standard B1.000)
The individual identified as director/technical supervisor must complete this section. If two or more individuals share
the director/technical supervisor’s responsibilities, use a copy of the forms for each individual. Complete all sections
and submit a copy of the curriculum vitae, current certification and current licensure if a state requirement.
(CFR 493.1443) For lab directors, MDs must be licensed to practice medicine in the state in which the lab is
located or deemed qualified as of 2-28-92. If not an MD, they must have an earned doctoral degree (not an
MD degree) in a biological, chemical, or physical science and, by 12-31-00 be certified by ABHI, ABB,
ABCC, ABMLI, ABMM or other board approved by HHS.
(CFR 493.1449) Technical supervisors must be either an MD licensed to practice medicine in the state in
which the lab is located (no grandfather clause) or a PhD (as above) and (for either degree) have 4 years
post doctoral training and/or experience in histocompatibility or 2 years training and/or experience in the
laboratory specialty of general immunology plus 2 years training and/or experience in histocompatibility.
In most cases, one person fills both positions.
For directors/technical supervisors that were previously approved
submit an abridged publication list limited to the last two years, include any updated information on
these pages (i.e. additional lab training/experience as required with changing lab activities, change in
responsibility, etc.) and
a copy of current licensure if a state requirement (required for all MDs).

Name
Discipline(s)
State Licensure (provide copy of current, if
applicable)
City Licensure (provide copy of current, if
applicable)

List all professional positions at any institutions (director, supervisor, consultant, teacher) held by the
director/technical supervisor(s) and estimated time commitment of each (hours/week):
Professional Position

Version date pending

Estimated Time Commitment (hours/week)

Lab- 17

CLIA #__________________
OPTN # ___________________
Date ___________________
Post-Doctoral Training in Areas of Biology Other Than Human Histocompatibility Testing
List all laboratory specialties in which post-doctoral training was received including exact dates and specific
training received for each. Submit a letter from instructor, if possible.
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
Institution Name
Laboratory Name
Laboratory Specialty
Instructor Name
Dates
Specific Training
Hours/week
Experience in Areas of Biology Other than Human Histocompatibility Testing.
Institution Name
Name of Director
Your Title
Dates
Hours/week
Description of Duties
Institution Name
Name of Director
Your Title
Dates
Hours/week
Description of Duties
Institution Name
Name of Director
Your Title
Dates
Hours/week
Description of Duties

Version date pending

Lab- 18

CLIA #__________________
OPTN # ___________________
Date ___________________

Post-Doctoral Training in Human Histocompatibility Testing
List all laboratory specialties in which post-doctoral training was received including exact dates and specific
training received for each. Submit a letter from instructor, if possible.
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

Laboratory Involvement
Is emergency consultation available during your absence?
Detail the report review process for each laboratory report including the director/technical supervisor’s role.
If the director/technical supervisor does not review all reports, include the percentage that are reviewed and
how they are selected.
Indicate the approximate number of cases up to 500 (after that just indicate >500) that you have reviewed in each of
the following categories:
Category
Renal transplantation, deceased donor typing and crossmatch
Renal transplantation, living donor, typing and crossmatch
Non-renal deceased donor typing and crossmatch
Islet Cell Transplantation
Allele level typing
HLA antibody screening
HLA antibody characterization
Flow cytometry crossmatch

Version date pending

Lab- 19

# of Cases

CLIA #__________________
OPTN # ___________________
Date ___________________
In the space below, describe your role in the laboratory, including the
extent to which you participate in the review, interpretation and reporting of test results,
development and performance or supervision of test procedures,
training and evaluation of staff and fellows, and
establishment of laboratory policy.
If there is more than one director, indicate all areas in which you are involved and, if appropriate, in which area
you have primary responsibility.

Version date pending

Lab- 20

CLIA #__________________
OPTN # ___________________
Date ___________________

Expertise (new director/technical supervisor or when director/technical supervisor add new testing)
Provide below, a description of your professional activities which provide evidence of your expertise in human
histocompatibility testing and immunogenetics. Include the following
participation in relevant national and international scientific societies,
participation in workshops in human histocompatibility testing,
formal teaching responsibilities, and
all other activities that will be helpful in evaluating your qualifications.
Note, if documentation of expertise is not available, this requirement may be met by submitting a portfolio
of cases you have analyzed. Please contact your Commissioner for further information.

Version date pending

Lab- 21

CLIA #__________________
OPTN # ___________________
Date ___________________

C. PERSONNEL QUALIFICATIONS
CLINICAL CONSULTANT QUALIFICATIONS
If the clinical consultant is not the director or technical supervisor, submit a copy of the current certification
and current licensure if a state requirement.
(CFR Sec. 493.1455) The clinical consultant must be qualified to consult with and render opinions to the
laboratory’s clients concerning the diagnosis, treatment and management of patient care. The clinical
consultant must (a) be qualified as a laboratory director under Sec. 493.1443(b)(1), (2), or (3)(i) or, for the
subspecialty of oral pathology, Sec. 493.1443(b)(6); or (b) be a doctor of medicine, doctor of osteopathy,
doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the
laboratory is located.

Version date pending

Lab- 22

CLIA #__________________
OPTN # ___________________
Date ___________________

D. PERSONNEL QUALIFICATIONS
GENERAL SUPERVISOR QUALIFICATIONS
This section should be completed by all personnel with authority to sign out reports and/or function as a general
supervisor. Submit curriculum vitae for each person. If the director serves as general supervisor, indicate this on
the cover page and leave the remainder of this section blank.

If previously submitted, submit an abridged publication list limited to the last two years and include any updated
information on these pages.

Name
Position
State Licensure (provide copy of current, if
applicable)
City Licensure (provide copy of current, if
applicable)
Provide description of Duties in your
present position

Version date pending

Lab- 23

CLIA #__________________
OPTN # ___________________
Date ___________________
Training
List all laboratory training received, beginning with the most recent.
Institution Name
Laboratory Name
Instructor Name
Dates
Specific Training
Institution Name
Laboratory Name
Instructor Name
Dates
Specific Training
Institution Name
Laboratory Name
Instructor Name
Dates
Specific Training
Institution Name
Laboratory Name
Instructor Name
Dates
Specific Training
Institution Name
Laboratory Name
Instructor Name
Dates
Specific Training
Institution Name
Laboratory Name
Instructor Name
Dates
Specific Training

Version date pending

Lab- 24

CLIA #__________________
OPTN # ___________________
Date ___________________
Experience
List all laboratory working experience, beginning with the most recent prior to your present position.

Institution Name
Name of Director
Your Title
Dates
Hours/Week
Description of duties
Institution Name
Name of Director
Your Title
Dates
Hours/Week
Description of duties
Institution Name
Name of Director
Your Title
Dates
Hours/Week
Description of duties
Institution Name
Name of Director
Your Title
Dates
Hours/Week
Description of duties
Institution Name
Name of Director
Your Title
Dates
Hours/Week
Description of duties

Version date pending

Lab- 25

CLIA #__________________
OPTN # ___________________
Date ___________________

E.

PERSONNEL LIST
Start
Date
M/YY

Version date pending

Name

Position

Lab- 26

Degrees

Certifications

Yrs
HHT

% FTE
Clinical
HHT

Oncall

Total CE
Hours

CLIA #__________________
OPTN # ___________________
Date ___________________

E. PERSONNEL LIST (continued)
Start
Date
M/YY

Version date pending

Name

Position

Lab- 27

Degrees

Certifications

Yrs
HHT

% FTE
Clinical
HHT

On-call

Total
CE
Hours

CLIA #__________________
OPTN # ___________________
Date ___________________
E. PERSONNEL LIST (continued)
Start
Date
M/YY

Version date pending

Name

Position

Lab- 28

Degrees

Certifications

Yrs
HHT

% FTE
Clinical
HHT

Oncall

Total
CE
Hours

CLIA #__________________
OPTN # ___________________
Date ___________________
F. CONTINUING EDUCATION SUMMARY FORM
The minimum hours of continuing education will be met if the individual is ABHI certified and has maintained continued
certification. For directors/technical supervisors not maintaining continued certification, a minimum of 50 hours/year is
required. For general supervisors not maintaining continued certification, a minimum of 27 hours/year is required. For those
testing personnel not maintaining continued certification, a minimum of 12 hours/year is required.
Name
Position
Brief job description

Period (12) month period
preceding the application
date)

Program
Participation Hours
Participation Level
Approved by ABHI?
Content?
Program
Participation Hours
Participation Level
Approved by ABHI?
Content?
Program
Participation Hours
Participation Level
Approved by ABHI?
Content?
Program
Participation Hours
Participation Level
Approved by ABHI?
Content?
Hours
Summary of contact hours by type:
Lecturer
Presenter
Participant
Attendant
Total

Version date pending

Lab- 29

CLIA #__________________
OPTN # ___________________
Date ___________________

G. LABORATORY ACTIVITIES
Period (twelve (12) month period preceding the application date)

to

In the past twelve (12) month period preceding the application date, indicate the approximate percent of the lab’s total clinical
effort for each Area of Accreditation:
Area of Accreditation
Solid Organ TX: Deceased Donor
Solid Organ TX: Living Donor
Islet Cell Transplantation
All Other (e.g., HSC/BMT)

%

In the past twelve (12) month period preceding the application date, complete the following indicating the number of cases for
which your laboratory provided services:
# of Cases
Deceased donor renal transplants
Deceased donors: local
Deceased donors: imports
Average number of patients on the deceased donor renal waiting list
Non-renal solid organ transplants
Living donor transplants
Islet Cell transplantation
In the past twelve (12) month period preceding the application date, indicate the number of tests performed.
# of tests performed
Class l serologic
Class l SSP
Class l SSOP
Class l sequencing
Class lI serologic
Class lI SSP
Class lI SSOP
Class lI sequencing
Single Ag
PRA-CDC
PRA-ELISA
PRA-Flow Cytometry
Ab-CDC
Ab-ELISA
Ab-Flow Cytometry
XM-CDC
XM-ELISA
XM-Flow Cytometry
MLC
Others

Version date pending

Lab- 30

CLIA #__________________
OPTN # ___________________
H.

PROFICIENCY RESULTS SUMMARY FORM

Period (twelve [12] month period preceding the application date)

Typing Survey

Technology

No. of specimens with errors

No. specimens tested

Concordance(%)

Successful

Unsuccessful

No. of specimens with errors

No. specimens tested

Concordance(%)

Successful

Unsuccessful

Class I Serologic
Class I DNA-Low Resolution
Class I DNA-High Resolution
Class II Serologic
Class II DNA-Low Resolution
Class II DNA-High Resolution
ABO/Rh Typing

Crossmatch Survey

Technology
T Cell CDC
T Cell AHG
T Cell Flow
B Cell CDC

Version date pending

Lab- 31

B Cell AHG
B Cell Flow

Ab Screen Survey

Technology

No. of specimens with errors

Class I CDC
Class I AHG
Class I ELISA
Class I Flow
Class II CDC
Class II AHG
Class II ELISA
Class II Flow
Include corrective action documentation for each error

Version date pending

Lab- 32

No. specimens tested

Concordance(%)

Successful

Unsuccessful