Web Changes
This is where we'll announce the most recent
additions to our web site. If you've visited us before and want to know what's
changed, take a look here first.
Training Information -![[New!]](images/smallnew.gif)
REGISTER TODAY!!
Initial and refresher training for personnel involved in Point of Care
Testing takes place in the Department of Pathology, Medical Education
Building during the months of February and March. S Please contact
(732) 743-3630 to schedule attendance.
Quality Assurance
- HIV Oraquick -
The CDC has released QA guidelines for Testing using the Oraquick®
Rapid HIV-1 Antibody Test. This document is available at:
http://www.cdc.gov/hiv/rapid_testing/materials/QA_Guidlines_OraQuick.pdf
These guidelines are being incorporated into the HIV POCT testing
program.
Stories in the News
Billing for Point of Care Glucose Testing:
Lead article in January, 2003 of CAP Today.
“We lose money on
every test—but we make up for it in volume.”
For laboratory managers, that line used to be a joke. But it’s oddly close
to the truth when it comes to billing for point-of-care glucose tests.
The role of automated instrumentation in helping document an
order, the identification of the result, the date and time. The
consequences on not billing for glucose procedures. The
POCT and the New CMS Guidelines
Appears in Clinical Laboratory News- September,
2004 Volume 30, Number 9
Lead article September, 2004 Clinical Laboratory News
"Late last
year, the Centers for Medicare and Medicaid Services (CMS) released
“Appendix C, Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services,” a 300-plus-page resource that not
only provides a general guide for implementing CLIA ’88, but also gives
clinical labs a new way to approach quality control (QC)."
See:
ALSO See:
http://www.cms.hhs.gov/clia/.
CMS Issue Final CLIA '88 Quality Control Rule
Appears in AACC Strategies Management -
[eservices@aacc.org] 1/24/03
January 24, 2003, Washington, DC
This morning, the Centers for Medicare and Medicaid Services (CMS) finally
made good on its promise to publish a final CLIA '88 quality and personnel
rule for laboratory services. According to CMS, the new QC rules are
designed to enhance patient safety while making it easier for laboratories
to understand and comply with these requirements.
"For the first time, CLIA requirements have been reorganized in a more
logical fashion to parallel the flow of a patient specimen through the
laboratory," CMS Administrator Tom Scully said in a press release. "This
reorganization should help laboratories understand and apply the
requirements more easily, and reduce laboratory errors."
The final rule reduces the frequency with which laboratories must perform
quality control (QC) in most specialty and subspecialty areas and brings
all non-waived testing under the same QC requirements. Personnel standards
will continue to be based on test complexity.
As recommended by the Clinical Laboratory Improvement Advisory Committee (CLIAC),
the rules now require laboratories to validate the accuracy of moderate as
well as high complexity tests prior to the testing of patient specimens
and the reporting of those results; however, requirements for routine QC
will be more flexible.
Lab directors should note that the final rule also "grandfathers" certain
non-board certified individuals with a doctoral degree who have served or
are currently serving as a director of a laboratory performing high
complexity testing, allowing them to continue directing high complexity
laboratories despite their lack of board certification. All new directors
of high-complexity laboratories who have a doctorate, rather than a
medical degree, will need to be board certified. The grandfathering
provision will become effective one month from now, on February 24. For
all other requirements, the effective date will be April 24, to allow time
to educate laboratories about the new rules.
To see the Federal Register notice that contains the new rule, click on
this link to access the PDF:
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/pdf/03-1230.pdf.
Please note that the Federal Register sometimes changes its links after
the day of publication, so while this link will take you to the rule
today, it may or may not work tomorrow. If you have any problems accessing
the rule, please call the Strategies editor at (800) 892-1400, ext. 722 or
e-mail us at strategies@aacc.org and we will get you there.
In the future, a copy of the regulation will reside on CMS's CLIA home
page at: http://www.cms.gov/clia/ ,
a great source of CLIA information.
CMS Issues
results of CLIA WAIVED/PPMP LABORATORY PROJECT
"WAIVED AND PROVIDER PERFORMED MICROSCOPY (PPMP) TESTS
By the CLIA law, waived laboratories perform only tests that are
determined by FDA or CDC to be so simple that there is little risk of
error. Laboratories with a PPMP certificate perform tests, using a
microscope, during the course of a patient visit on specimens that are not
easily transportable.
1999 PILOT STUDY
Due to the increases in the types of tests waived, the large number of
laboratories with no oversight, and the serious findings in complaint
investigations of these waived laboratories, the States of Colorado and
Ohio initiated on-site inspections of a random sample of CLIA waived and
PPMP laboratories. These pilots consisted of focused on-site inspections
(Ohio did 100, Colorado did 95) with prior notification and screening of
the laboratory to confirm whether the State's concerns about quality
problems were correct. Significant quality and certification problems were
identified in over 50% of these laboratories. If quality problems were
found, the inspectors provided assistance to the laboratories to achieve
accurate results. Ohio found 10 % and Colorado found 7% of the
laboratories inspected to be testing beyond their certificate. These
laboratories were performing moderate complexity tests and, if properly
enrolled in CLIA, would be subject to biennial inspections and higher
fees.
EXPANSION OF PILOT STUDY -- (OCTOBER 2000 THROUGH JANUARY 2001)
To follow-up and verify the scope and seriousness of these initial
findings, CMS expanded this pilot to include 8 additional States across
the nation. These states were Arizona, Idaho, Iowa, Massachusetts,
Mississippi, New Mexico, New York, and Pennsylvania. Using Colorado and
Ohio's pilot as a model, CMS inspected 2.5% (or 436) of waived and PPMP
laboratories in the 8 selected States. The findings of the Pilot Project
Final Report are
available. (PDF 450K)
The quality and certificate problems found under the expanded October
2000 through January 2001 survey process are listed below.
Quality Problems in Waived Laboratories
- 32 % failed to have current manufacturer's instructions;
- 32% did not perform QC as required by manufacturer or CDC;
- 16% failed to follow current manufacturer's instructions; and
- 7% did not perform calibration as required by manufacturer.
Additional Quality Problems in Waived Laboratories
- 23% had certificate issues (i.e., change of name, director or address);
- 20% cut occult blood cards and urine dipsticks;
- 19% had personnel who were neither trained nor evaluated;
- 9% did not follow manufacturer's storage and handling instructions; and
- 6% were using expired reagents/kits.
Quality Problems in PPMP Laboratories
- 38% had no PT (did not evaluate test accuracy 2 times a year);
- 36% had no microscope/centrifuge maintenance;
- 28% no director approved SOPM;
- 25% did not document personnel competency (QA); and
- 23% had certificate issues. "
