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PART 6: HISTOCOMPATIBILITY TESTING

PART 6, SECTION A: HISTOCOMPATIBILITY TESTING ARRANGEMENTS
1.

Will you engage one or more laboratories to serve your histocompatibility testing needs that are either:
a)
b)

2.

members of the OPTN (or currently applying for membership); or
controlled by another clinical transplant center that is an OPTN member (or is currently applying for
membership)?
Yes: _______
No: ______

If Yes, give name and address of each such histocompatibility laboratory, the contact person, and the functions
performed by each laboratory.
•
Include a copy of the agreement with your Histocompatibility Laboratory.
Do not complete Section B & C unless your own laboratory performs one or more histocompatibility testing
functions.
Laboratory Name (1)

Address

Contact Person
Functions Performed

Laboratory Name (2)

Address

Contact Person
Functions Performed

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PART 6: SECTION B –
APPLICATION FOR HOSPITAL BASED HISTOCOMPATIBILITY LABORATORY
Complete this Section if the answer to Question 1 in Part 5, Section A, is No.
Name of Applicant Laboratory: ________________________________________________
1.

In order to qualify for OPTN Institutional Membership as a Clinical Transplant Center, each transplant
program of the transplant center must utilize one or more histocompatibility laboratories that meet the
applicable OPTN standards. All histocompatibility laboratories must be accredited in Solid Organ
transplantation: Deceased Donor. If your transplant center performs living donor organ transplants, the
laboratory must be accredited for Solid Organ Transplantation: Living Donor. Does your transplant center
perform living donor organ transplants?
Yes___ No ___

2.

Upon receipt your application will be forwarded to the 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.
By completion of this application 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

3.

Yes

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

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No

Hospital Based Lab - 3

4.

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

List the personnel who are/or 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.

b) List any regional, national, or international transplant registries to which you are now submitting data.
Also, list any registry to which you had previously submitted data, given the years of such
submission.

c)

Describe the methods to be used to collect, verify, and submit data on a timely basis. Identify the
current status of local data collection and compilation by hard copy and computer. Identify the
hardware and software used for any computer files.

5.

List the name and address of other transplant centers for which you will provide histocompatibility testing
services. Attach a copy of your agreement(s).

6.

If your histocompatibility laboratory is not presently accredited by ASHI or CAP, do you wish to apply for
ASHI or CAP accreditation?
ASHI:
Yes ____ No ____
CAP:
Yes ____ No ____

If your histocompatibility laboratory is currently accredited or is in the process of being accredited by ASHI or
CAP; please stop here.
Attach a copy of the ASHI/CAP application. When available, proof of certification must be provided.

Hospital Based Lab - 4

PART 6, SECTION C (1)
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

Hospital Based Lab - 5

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

Hospital Based Lab - 6

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 24hour 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.

Hospital Based Lab - 8

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.
(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

Hospital Based Lab - 9

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.
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

Hospital Based Lab - 10

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

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.

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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.
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.

Establish specification requirements for test performance

Hospital Based Lab - 12

2.
3.
4.

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:

I.

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.

6.

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.

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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.

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.

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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, pre-TX 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.

Hospital Based Lab - 16

4.

CHECKLIST OF REQUESTED DOCUMENTS
‰

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

‰

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

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Hospital Based Lab - 17

CLIA #__________________
OPTN # ___________________
Date ___________________

PART6, SECTION C(2)
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:

Hospital Based Lab - 18

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

Estimated Time Commitment (hours/week)

Hospital Based Lab - 19

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

Hospital Based Lab - 20

Description of Duties

Hospital Based Lab - 21

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

Hospital Based Lab - 22

# 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.

Hospital Based Lab - 23

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.

Hospital Based Lab - 24

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.

Hospital Based Lab - 25

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

Hospital Based Lab - 26

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

Hospital Based Lab - 27

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

Hospital Based Lab - 28

CLIA #__________________
OPTN # ___________________
Date ___________________
E.

PERSONNEL LIST
Start
Date
M/YY

Name

Position

Degrees

Certifications

Hospital Based Lab - 29

Yrs
HHT

% FTE
Clinical
HHT

Oncall

Total CE
Hours

CLIA #__________________
OPTN # ___________________
Date ___________________

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

Name

Position

Degrees

Hospital Based Lab - 30

Certifications

Yrs
HHT

% FTE
Clinical
HHT

Oncall

Total
CE
Hours

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

Name

Position

Degrees

Hospital Based Lab - 31

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)

Name
Position
Brief job description

Period (12) month period
preceding the application
date)

Name
Position
Brief job description

Period (12) month period
preceding the application
date)

Name
Position
Brief job description

Period (12) month period
preceding the application
date)

Hospital Based Lab - 32

Summary of contact hours by
type:

Hours

Lecturer
Presenter
Participant
Attendant
Total

Hospital Based Lab - 33

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

Hospital Based Lab - 34

Others

Hospital Based Lab - 35

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

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
B Cell AHG
B Cell Flow

No. of specimens with errors

No. specimens tested

Concordance(%)

Successful

Unsuccessful

Ab Screen Survey

Technology
Class I CDC
Class I AHG
Class I ELISA
Class I Flow
Class II CDC
Class II AHG
Class II ELISA
Class II Flow

No. of specimens with errors

No. specimens tested

Concordance(%)

Successful

Unsuccessful

Include corrective action documentation for each error

Hospital Based Lab - 36