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In preparation for the release of the 2010 CAP Checklist Edition in June of this year, CAP is notifying all accredited anatomic pathology laboratories of a revised checklist requirement that may have an impact on your laboratory's staffing.
The revisions will require that all non-pathologist individuals who perform macroscopic tissue examinations meet the personnel requirements for high complexity testing in accordance with CLIA. This interpretation of the CLIA requirement was recently provided to CAP from CMS. As a service to CAP Accredited laboratories, the CAP offers compliance alerts to help your laboratory maintain continuous compliance.
Previously, the Anatomic Pathology checklist differentiated two levels of macroscopic examination, "processing" and "grossing." In this context, "processing" means macroscopic examination of small specimens not requiring knowledge of anatomy, which are entirely submitted for microscopic examination, while "grossing" means macroscopic examination of more complex specimens. Unlike individuals who performed grossing, individuals who performed "processing" were not required to be qualified as high complexity testing personnel. In the 2010 checklist edition, the concept of macroscopic tissue "processing" will no longer be recognized. All macroscopic tissue examinations will be considered to be "grossing."
Therefore, any individual who performs macroscopic tissue examinations must be a pathologist, pathology resident, or an individual qualified to perform high complexity testing under the supervision of a pathologist (refer to ANP.11610, below).
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ANP.11610 Phase II
If individuals other than a pathologist or pathology resident assist in gross examinations, do such individuals qualify as high complexity testing personnel under CLIA regulations?
NOTE: The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high complexity testing personnel under CLIA regulations. The minimum training/experience required of such personnel is:
1. An earned associate degree in a laboratory science or medical laboratory technology, obtained from an accredited institution, OR
2. Education/training equivalent to the above that includes at least 60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that includes 6 semester hours of chemistry, 6 semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination. In addition, the individual must have laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLA, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), OR at least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing.
The CLIA regulations on high complexity testing personnel may be found at HC Testing Personnel (http://wwwn.cdc.gov/clia/regs/subpart_m.aspx).
In addition, the CLIA regulations include exceptions for grandfathered individuals; these regulations (42CFR493.1489 and 1491) may be found at the above Web address and at Grandfathered Exceptions (http://wwwn.cdc.gov/clia/regs/subpart_m.aspx).
It is the responsibility of the laboratory director to determine whether an individual's education, training and experience satisfies the requirements of this checklist question.
This checklist question applies only to laboratories subject to U.S. regulations.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1070-1071 [42CFR493.1489], 1071-1072 [42CFR493.1491]
2) http://www.naacls.org/news/naacls-news/archives.asp?article_id=599
The revisions will require that all non-pathologist individuals who perform macroscopic tissue examinations meet the personnel requirements for high complexity testing in accordance with CLIA. This interpretation of the CLIA requirement was recently provided to CAP from CMS. As a service to CAP Accredited laboratories, the CAP offers compliance alerts to help your laboratory maintain continuous compliance.
Previously, the Anatomic Pathology checklist differentiated two levels of macroscopic examination, "processing" and "grossing." In this context, "processing" means macroscopic examination of small specimens not requiring knowledge of anatomy, which are entirely submitted for microscopic examination, while "grossing" means macroscopic examination of more complex specimens. Unlike individuals who performed grossing, individuals who performed "processing" were not required to be qualified as high complexity testing personnel. In the 2010 checklist edition, the concept of macroscopic tissue "processing" will no longer be recognized. All macroscopic tissue examinations will be considered to be "grossing."
Therefore, any individual who performs macroscopic tissue examinations must be a pathologist, pathology resident, or an individual qualified to perform high complexity testing under the supervision of a pathologist (refer to ANP.11610, below).
-----
ANP.11610 Phase II
If individuals other than a pathologist or pathology resident assist in gross examinations, do such individuals qualify as high complexity testing personnel under CLIA regulations?
NOTE: The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high complexity testing personnel under CLIA regulations. The minimum training/experience required of such personnel is:
1. An earned associate degree in a laboratory science or medical laboratory technology, obtained from an accredited institution, OR
2. Education/training equivalent to the above that includes at least 60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that includes 6 semester hours of chemistry, 6 semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination. In addition, the individual must have laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLA, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), OR at least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing.
The CLIA regulations on high complexity testing personnel may be found at HC Testing Personnel (http://wwwn.cdc.gov/clia/regs/subpart_m.aspx).
In addition, the CLIA regulations include exceptions for grandfathered individuals; these regulations (42CFR493.1489 and 1491) may be found at the above Web address and at Grandfathered Exceptions (http://wwwn.cdc.gov/clia/regs/subpart_m.aspx).
It is the responsibility of the laboratory director to determine whether an individual's education, training and experience satisfies the requirements of this checklist question.
This checklist question applies only to laboratories subject to U.S. regulations.
REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1070-1071 [42CFR493.1489], 1071-1072 [42CFR493.1491]
2) http://www.naacls.org/news/naacls-news/archives.asp?article_id=599
