The
mission is to promote quality practice in Histocompatibility and Immunogenetics
through the objective and consistent evaluation of compliance with
ASHI standards. The purpose of the accreditation program is
to evaluate laboratory personnel, procedures and facilities to determine
if they are in compliance with those published standards of ASHI and
with those standards of organizations by which ASHI is deemed and
which apply to the activities of that laboratory. Laboratories will
be evaluated for the technology utilized and, if applicable, the clinical
services provided.
The
goals of the accreditation program are:
-
To
perform the evaluation process in an ethical, objective and timely
fashion
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To
promote the educational aspects of the accreditation process.
-
To
provide to various committees of the Society, data obtained in the
accreditation process, which are useful for maintaining the Society's
awareness of standard and novel procedures and methodologies.
With the objective
of maintaining the highest standards of reliability and quality in
histocompatibility testing laboratories, ASHI established its accreditation
program in 1974. ASHI Accreditation was originally and still
remains voluntary. Its purpose is to evaluate laboratory personnel,
procedures, and facilities to determine if they are in compliance
with ASHI standards; to promote the educational aspects of
the accreditation process, particularly in assisting laboratories
in the correction of deficiencies; to provide expert advice and assistance
to committees of the society; and to maintain the society's awareness
of standard and novel procedures and methodologies. Categories and
techniques of accreditation include:
| HCS/BM Transplantation: Related
Donor |
| HCS/BM Transplantation: Unrelated
Donor |
| Solid Organ Transplantation:
Deceased Donor |
| Solid Organ Transplantation:
Live Donor |
| Parentage Testing |
| Histocompatibility Testing
for Other Clinical Purposes |
| Transfusion Support |
| Technologies |
Methods |
| Serology I |
CDC |
| Serology II |
CDC |
| DNA I |
SSP, SSO, SBT |
| DNA II |
SSP, SSO, SBT |
| Antibody Screening |
CDC, ELISA, Flow, Microarray |
| Antibody Identification |
CDC, ELISA, Flow, Microarray |
| Crossmatch |
CDC, Flow, Microarray, Solid phase |
| Engraftment / Fragment Analysis |
SBT, STR, VNTR |
| Cellular assays |
MLC, Immune Monitoring |
| Flow Cytometry |
Immunophenotyping,
CD34 Enumeration
|
This voluntary
program has accredited over 200 histocompatibility laboratories and
is administered through the ASHI Accreditation Review Board. The Centers for Medicare and Medicaid (CMS), National Marrow Donor Program
(NMDP), United
Network for Organ Sharing (UNOS), The American Foundation for Donation and Transplantation (AFDT, formerly SEOPF) and the states of California, Florida,
Oregon and Washington grant deemed status to ASHI accredited labs. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recognizes ASHI Accreditation with Complimentary status. Any of these organizations may do their own inspections, however, for validation purposes or complaint response.
ASHI Accreditation was
originally and still remains voluntary.
| 1974 |
Establishment
of the Accreditation Committee |
| 1976 |
Start
of Laboratory Evaluations |
| 1986 |
Upon
recognition of the increasing diversity of histocompatibility
testing and the growing number of laboratories seeking ASHI
Accreditation, the ASHI Council charged the Accreditation
Committee to revise the program to make it more specific to
the activities of the laboratory |
| 1987 |
The
reorganization program began in August 1986 and became effective
in January 1987
Accreditation was granted or denied for
specific laboratory activities
Recognizing
the need for a responsive program, which could perform a
thorough and unbiased evaluation of histocompatibility laboratories
performing testing for organ transplantation, UNOS contracted
with ASHI to perform evaluation of laboratories applying
for membership
|
| 1988 |
ADTF (formerly SEOPF)
adopted a policy of accepting ASHI Accreditation as a recognized
approval of its member laboratories |
| 1990 |
The
NMDP contracted with ASHI for laboratory evaluation services |
| 1992 |
NMDP
began requiring ASHI Accreditation for its contract and transplant
center laboratories |
| 1995 |
The
ASHI Accreditation program achieved its deemed status with
CMS (formerly HCFA) and CLIA |
| 1997 |
Deemed
status with JCAHO, State of New York, Florida, Oregon and
Washington. |
| 1998 |
New
name given, Accreditation Program. New structure, Accreditation
Board, and process defined. |
| 2004 |
ASHI
Standards, Checklists, Guidelines, Inspection Packets, and
Operations Manual updated. |
| 2005 |
CMS grants
deemed status to ASHI as an accrediting organization for a
period of 6 years, March 25, 2011 |
| 2005 |
New ASHI
Accreditation Program debuts, May 1, 2005 including a new online Interim Application and online Inspection’s Checklist |
| 2006 |
The ARB debuts the online On Site Application Packet |
|
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