Department of Health and Human Services OMB No. 0915-0184
Health Resources and Services Administration Expiration Date: ______
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
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 # ______________ Print Title: ___________________________________________
1. A histocompatibility laboratory must complete this application for institutional membership. The Criteria for Institutional Membership are found in the Bylaws, which can be accessed on the OPTN website at www.optn.transplant.hrsa.gov.
2. By submitting this application to the OPTN, the applicant acknowledges that its duly authorized representatives have received and read the current Charter and BylLaws 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. Attach additional pages as necessary and reference the question and page number on each attachment. Expand rows in tables as needed to completely answer the questions.
5. Answer all questions in full and do not use both sides of the page. "See C.V." is not an acceptable answer.
6. Supporting documentation such as C.V.’s, should be included as requested to document compliance with the requirements. Documentation may be blinded in such a way as to protect patient confidentiality.
7. Application responses must be typed and complete. Do not omit pages that were not used. The Membership and Professional Standards Committee (MPSC) may not accept for review applications that are not appropriately completed and that are missing the supporting documents for the proposed primary individual(s). Applications determined to be incomplete may be returned to the institution.
8. Additional instructions are provided under Part 2.
When the application is complete and ready for submission, record the date it is being sent on the Processing Record Form.
Return the original application and one (1) complete copy. Also return a copy of the application that has been scanned to a CD in PDF format. Label the CD with the laboratory name, contact name, and date, and include a table of contents.
Express Mail: US Mail:
UNOS UNOS
700 North 4th Street PO Box 2484
Richmond, VA 23219 Richmond, VA 23218
Main 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.
PART 1
1. Full name of applicant laboratory and identification numbers.
a) Name: ___________________________________________________________________________
b) CMS #: ____________________
c) CLIA #: ____________________
2. Indentify the principal CEO, Laboratory Director and Administrator and provide contact information.
Position |
Name, Address, phone, & email address |
CEO
|
|
Laboratory Director
|
|
Administrator
|
|
3. 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. By completion of this application, the applicant hereby grants ASHI and/or CAP the authority to provide all ASHI and CAP accreditation records and information relevant to histocompatibility testing for organ transplantation.
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 |
Yes |
No |
Solid Organ Transplantation: Deceased Donor |
|
|
Solid Organ Transplantation: Living Donor |
|
|
Islet Cell Transplantation |
|
|
4. Identify the laboratory director, clinical consultant(s), technical supervisor, and general supervisor.
Position |
Name |
Primary Laboratory Director: |
|
Other Laboratory Director(s) |
|
Clinical Consultant |
|
Technical supervisor (if other than the laboratory director): |
|
General supervisor (if other than the laboratory director): |
|
(Expand rows as needed)
5. Describe the plan for coverage if the laboratory director is not full time at this laboratory or also serves as a director at another laboratory.
6. 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.
7. Is this histocompatibility laboratory insured for professional liability? Yes ____ No _____.
If Yes, name the insurer and give the policy limits per person and per occurrence and the expiration date of the current insurance coverage. If No and 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 this laboratory.
8 List the names and addresses of clinical transplant hospitals and organ procurement organizations (OPO's) this lab will be serving and the type of program(s) (i.e. kidney, heart, heart/lung, lung, liver, and pancreas) for each transplant hospital. Attach written agreements with clinical transplant hospitals and OPO's you will serve.
9. 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 this lab will serve transplant hospitals that perform living-related organ transplants, it must be accredited in the area of Solid Organ Transplantation: Living Donor. Does the transplant hospital that it will serve perform living-related organ transplants?
Yes ______ No ________.
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.
PART 2 - OPTN ACCREDITATION PROGRAM APPLICATION INSTRUCTIONS
This Application form is used for laboratories not currently accredited by ASHI or CAP.
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
GLOSSARY OF ABBREVIATIONS
ABB American Board of Bioanalysis
ABCC American Board of Clinical Chemistry
ABHI American Board of Histocompatibility and Immunogenetics
ABMLI American Board of Medical Laboratory Immunology
ABMM American Board of Medical Microbiology
ASHI American Society for Histocompatibility and Immunogenetics
Ab antibody
Ag antigen
AHG antihuman globulin
AP Accreditation Program
ARB Accreditation Review Board
CAP College of American Pathologists
CDC complement-dependent cytotoxicity
CE continuing education
CFR Code of Federal Regulation
CLIA Clinical Laboratory Improvement Act (Amendments)
DHHS Department of Health and Human Services
DNA deoxyribonucleic acid
ELISA enzyme-linked immuno-sorbent assay
FTE full time equivalent
HCFA Health Care Financing Administration
HHT human histocompatibility testing
HLA human leukocyte antigen
JC Joint Commission
MLC mixed lymphocyte culture
OPTN Organ Procurement and Transplantation Network
PCR polymerase chain reaction
PRA panel reactive antibody
SEOPF South-Eastern Organ Procurement Foundation
SSOP sequence specific oligonucleotide probe
SSP sequence specific primer
TAT turn around time
TX transplant
UNOS United Network for Organ Sharing
XM crossmatch
IMMEDIATELY UPON RECEIPT, record the date of receipt of this application on the Processing Record Form.
Before completing the application, read all instructions carefully.
All documentation must be in English and typed.
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.).
Accreditation in Deceased Donor Solid Organ Transplantation requires that the laboratory provide 24-hour on call coverage.
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.
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.
1 (relocated)
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.
Provide the names of the laboratory, director(s), department 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.
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).
If the Director/Technical Supervisor serves as the Clinical Consultant, it must be stated on this form.
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.
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
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.
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.
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.
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.
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.
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
2. Evaluate the test system to assure that it meets the specification requirements
3. Identify and establish ongoing quality control measures
4. Train personnel and take measures to evaluate and ensure their ongoing competency
Documentation for accreditation should include the following:
Protocol and example of a case file. This should include an explanation of how and when the test will be used.
Step by step procedure. Include whether this replaces previously used technologies or is an adjunct to technologies in use.
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.
Validation summary data, analysis, and conclusions.
Limitations and shortcomings, how these will be handled, general troubleshooting. This may be included in the quality control section of the procedure.
Training guidelines and documentation of testing personnel competency (for personnel currently authorized to perform this test).
I. 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:
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.
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.
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.
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.
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).
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
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.
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
CLIA #__________________
OPTN # ___________________
Date ___________________
A. COVER PAGE
Provide the names of the laboratory, director(s), department and institution, as they should appear on the accreditation certificate (+).
Position |
Name |
+Director (Primary) |
|
Other Director(s) |
|
Technical Supervisor* |
|
Clinical Consultant* |
|
General Supervisor* |
|
+Laboratory or Department Name |
|
+Institution |
|
Street Address |
|
City, State, Zip |
|
Contact Person |
|
Telephone |
|
Fax |
|
E-Mail Address |
|
Website Address |
|
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:
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 |
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Discipline(s) |
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State Licensure (provide copy of current, if applicable) |
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City Licensure (provide copy of current, if applicable) |
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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) |
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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 |
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Laboratory Name |
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Laboratory Specialty |
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Instructor Name |
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Dates |
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Specific Training |
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Hours/week |
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Institution Name |
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Laboratory Name |
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Laboratory Specialty |
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Instructor Name |
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Dates |
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Specific Training |
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Hours/week |
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Institution Name |
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Laboratory Name |
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Laboratory Specialty |
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Instructor Name |
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Dates |
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Specific Training |
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Hours/week |
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Experience in Areas of Biology Other than Human Histocompatibility Testing.
Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/week |
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Description of Duties |
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Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/week |
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Description of Duties |
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Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/week |
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Description of Duties |
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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 |
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Laboratory Name |
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Laboratory Specialty |
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Instructor Name |
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Dates |
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Specific Training |
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Hours/week |
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Institution Name |
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Laboratory Name |
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Laboratory Specialty |
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Instructor Name |
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Dates |
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Specific Training |
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Hours/week |
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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 |
# of Cases |
Renal transplantation, deceased donor typing and crossmatch |
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Renal transplantation, living donor, typing and crossmatch |
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Non-renal deceased donor typing and crossmatch |
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Islet Cell Transplantation |
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Allele level typing |
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HLA antibody screening |
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HLA antibody characterization |
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Flow cytometry crossmatch |
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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.
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.
CLIA #__________________
OPTN # ___________________
Date ___________________
C. PERSONNEL QUALIFICATIONS
CLIA #__________________
OPTN # ___________________
Date ___________________
D. PERSONNEL 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 |
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Position |
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State Licensure (provide copy of current, if applicable) |
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City Licensure (provide copy of current, if applicable) |
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Provide description of Duties in your present position
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CLIA #__________________
OPTN # ___________________
Date ___________________
Training
List all laboratory training received, beginning with the most recent.
Institution Name |
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Laboratory Name |
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Instructor Name |
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Dates |
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Specific Training |
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Institution Name |
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Laboratory Name |
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Instructor Name |
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Dates |
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Specific Training |
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Institution Name |
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Laboratory Name |
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Instructor Name |
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Dates |
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Specific Training |
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Institution Name |
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Laboratory Name |
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Instructor Name |
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Dates |
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Specific Training |
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Institution Name |
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Laboratory Name |
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Instructor Name |
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Dates |
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Specific Training |
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Institution Name |
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Laboratory Name |
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Instructor Name |
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Dates |
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Specific Training |
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CLIA #__________________
OPTN # ___________________
Date ___________________
Experience
List all laboratory working experience, beginning with the most recent prior to your present position.
Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/Week |
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Description of duties |
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Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/Week |
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Description of duties |
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Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/Week |
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Description of duties |
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Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/Week |
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Description of duties |
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Institution Name |
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Name of Director |
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Your Title |
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Dates |
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Hours/Week |
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Description of duties |
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CLIA #__________________
OPTN # ___________________
Date ___________________
Start Date M/YY |
Name |
Position |
Degrees |
Certifications |
Yrs HHT |
% FTE Clinical HHT |
On-call |
Total CE Hours |
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CLIA #__________________
OPTN # ___________________
Date ___________________
E. Personnel list (continued)
Start Date M/YY |
Name |
Position |
Degrees |
Certifications |
Yrs HHT |
% FTE Clinical HHT |
On-call |
Total CE Hours |
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CLIA #__________________
OPTN # ___________________
Date ___________________
E. Personnel list (continued)
Start Date M/YY |
Name |
Position |
Degrees |
Certifications |
Yrs HHT |
% FTE Clinical HHT |
On-call |
Total CE Hours |
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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 |
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Position |
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Brief job description
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Period (12) month period preceding the application date)
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Program |
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Participation Hours |
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Participation Level |
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Approved by ABHI? |
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Content? |
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Program |
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Participation Hours |
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Participation Level |
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Approved by ABHI? |
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Content? |
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Program |
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Participation Hours |
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Participation Level |
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Approved by ABHI? |
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Content? |
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Program |
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Participation Hours |
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Participation Level |
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Approved by ABHI? |
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Content? |
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Summary of contact hours by type:
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Hours |
Lecturer |
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Presenter |
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Participant |
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Attendant |
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Total |
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CLIA #__________________
OPTN # ___________________
Date ___________________
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 |
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Solid Organ TX: Living Donor |
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Islet Cell Transplantation |
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All Other (e.g., HSC/BMT) |
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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:
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# of Cases |
Deceased donor renal transplants |
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Deceased donors: local |
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Deceased donors: imports |
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Average number of patients on the deceased donor renal waiting list |
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Non-renal solid organ transplants |
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Living donor transplants |
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Islet Cell transplantation |
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In the past twelve (12) month period preceding the application date, indicate the number of tests performed.
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# of tests performed |
Class l serologic |
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Class l SSP |
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Class l SSOP |
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Class l sequencing |
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Class lI serologic |
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Class lI SSP |
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Class lI SSOP |
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Class lI sequencing |
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Single Ag |
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PRA-CDC |
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PRA-ELISA |
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PRA-Flow Cytometry |
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Ab-CDC |
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Ab-ELISA |
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Ab-Flow Cytometry |
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XM-CDC |
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XM-ELISA |
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XM-Flow Cytometry |
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MLC |
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Others |
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CLIA #__________________
OPTN # ___________________
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 |
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Class I DNA-Low Resolution |
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Class I DNA-High Resolution |
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Class II Serologic |
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Class II DNA-Low Resolution |
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Class II DNA-High Resolution |
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ABO/Rh Typing |
Crossmatch Survey |
Technology |
No. of specimens with errors |
No. specimens tested |
Concordance(%) |
Successful |
Unsuccessful |
T Cell CDC |
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T Cell AHG |
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T Cell Flow |
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B Cell CDC |
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B Cell AHG |
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B Cell Flow |
Ab Screen Survey |
Technology |
No. of specimens with errors |
No. specimens tested |
Concordance(%) |
Successful |
Unsuccessful |
Class I CDC |
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Class I AHG |
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Class I ELISA |
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Class I Flow |
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Class II CDC |
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Class II AHG |
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Class II ELISA |
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Class II Flow |
Include corrective action documentation for each error
12/01/2010 Version
| File Type | application/msword |
| File Modified | 2011-02-03 |
| File Created | 2011-02-03 |