guidelines by 27tqZL


									April 29, 2003

Judy Yost, M.A., MT(ASCP)
Director, Division of Laboratory Services
Centers of Medicare and Medicaid Services
7500 Security Boulevard
M.S. S2-12-25
Baltimore, MD 21244

Dear Ms. Yost:

The American Association for Clinical Chemistry (AACC) appreciates the opportunity to
comment on the interpretive guidelines drafted by the Centers for Medicare and Medicaid
Services, which spell out how the agency plans to implement its revised CLIA Quality
Systems regulations. In general, we believe the document is well written, appropriate and
sufficiently detailed that it will provide much assistance to both inspectors and clinical
laboratories alike. Our comments for improving the guidance follow.

General Comments

Calibration Verification
AACC agrees with the guidance and flexibility provided laboratories in sections
493.1253(b)(3) and 493.1256(d). However, we are concerned that the calibration
verification guidance provided in 493.1255(b) lacks the same flexibility. Whereas CMS
is proposing significant changes to the calibration sections, it leaves 1255(b), the
calibration verification section, essentially untouched. We believe that laboratories
should be given responsibility, and latitude, for adapting calibration verification in the
same way that calibration is handled – depending on the strength and extent of the
internal and/or procedural controls, and the documented performance of the device.

“Autoverification,” “Autofiling” or “Autovalidation”
 “Autoverification,” “Autofiling,” or “Autovalidation” are terms that refer to allowing
test results, produced by an automated, interfaced analyzer, to pass sight unseen to the
host computer, and to be printed or electronically transferred to the ordering physician.
Typically, there are automated checks, such as acceptable QC, analytical flags, and the
reportable range, etc., to monitor this process. This process is mentioned in 493.1299 in
limited circumstances. We recommend that CMS address this issue more directly,
requiring that a laboratory have written policies for this process, and monitor its
performance. We suggest adding the following language to 493.1291(2) (and other
appropriate locations):

“If the laboratory allows transmission of completed test results without review, the
laboratory must have written policies available to ensure that all such results are
accurate and correctly transmitted.”
April 29, 2003
Page Two

Date on the Test Report
The January 24, 2003 final rule responded to a number of comments regarding computer
reporting by stating [p. 3652, last bullet at the bottom of the third column]:

“[We will require] . . .at 493.1291(c) that the date of the test report be identified on the
report. This date must be maintained as the date testing results were generated as a final
report and must not change on copies reported at a later date.”

Although this requirement is appropriate for single test results, such as cytology and
surgical pathology, it is unworkable with cumulative reporting, when the report contains
many different results completed at many different times. We are concerned that many
laboratories, if they seek to comply with this directive, may have more dates than results
on a laboratory report. We suggest that CMS address this issue in later iterations of the
interpretive guidelines. See our specific suggestions below under Tag #D3240 -

Personnel Competency
In the General Laboratory – Preanalytic section, CMS makes a number of references to
assessing personnel competency. AACC strongly agrees that laboratories should
appropriately train, and periodically confirm, the competency of its personnel. We
believe that CMS should recognize individuals certified by approved accrediting bodies
(to be determined by CMS) as meeting this requirement. Thus, the laboratories need only
to provide documentation of that certification to comply with this requirement.

Specific Comments

Tag #D3240 - 493.1105(a)(6)
Since most clinical laboratories report the results of laboratory tests in a format generally
described as “cumulative reporting” (see definition below), this process should be
defined, and the requirements applicable to single test reports (commonly used in surgical
pathology, cytology, electron microscopy, cytogenetics, etc.) limited to clinical pathology
reports. The inclusion of the date a test is first reported, for example, is not necessary for
each chemistry and hematology test result that is included in a cumulative report.
Following the "partial report" definition, we recommend that you modify this section as
shown below

“A „cumulative report‟ (typically used for inpatients, whose laboratory results extend
over several days) is a series of reports which contain all results on a patient as of the
time the report is printed. Each successive cumulative report contains previously
reported results, along with results added since the last previous report.”
April 29, 2003
Page Three

At the end of the next two-sentence paragraph, ending “ . . . computer-generated reports,”
add an additional sentence as follows:

“When results contained in one or more partial reports are included in a final report in a
series of cumulative reports, it is not necessary to retain each partial report, so long as
all results are contained in the final report, which is retained.”

Tag# D5209 - 493.1235 Standard: Personnel competency assessment policies;
There is a typographical error in the second sentence, which should read: “Cite
deficiencies at this location when the laboratory has not developed personnel competency
procedures for technical consultants, technical supervisors, other consultants, and other
staff.” The word not is missing from the sentence.

Tag# D5301 - 493.1241(a) Standard: Test Request; Guidelines
AACC suggests that CMS add the following sentences, right after the first sentence,
which ends “. . . or both.” We believe that adding these two sentences will eliminate the
considerable confusion that exists within the laboratory community regarding how often
standing orders should be reconfirmed.

“Standing orders should be clearly defined in written policy, describing which tests
may be covered by standing orders, and at what interval standing orders must be
confirmed. The duration for which a standing order is valid should be determined on
a test by test basis, and in no case should exceed one year.”

(Note: This recommendation is consistent with the annual confirmation requirement for
ESRD patients stated in the OIG’s Compliance Program Guidance for Clinical

Tag# D5301 - 493.1241(a) Standard: Test Request; Probes
We suggest that CMS change the third and last sentence, which begins “How does the
laboratory . . . ” to read:

“Does the laboratory specify how long a standing order may be valid, and does the
laboratory periodically update existing standing orders in accordance with its policy?”

Tag# D5421 - 493.1253(b)(1) Standard: Establishment and verification of
performance specifications; Guidelines
We recommend adding a second sentence to the second paragraph ending “ …
performing patient testing.” Our rationale is that when a piece of equipment fails and the
laboratory gets a loaner, it is impractical to completely verify performance specifications.
Usually minimal verification is adequate.
April 29, 2003
Page Four

“When a temporary replacement (loaner) instrument is received which is identical to
the instrument which is being replaced, the laboratory must verify comparable
performance by comparing, at a minimum, results of two or more controls and either
previously tested proficiency specimens or previously tested patient specimens.”

Tag# D5423 - 493.1253(b)(2) Standard: Establishment and Verification of
performance specifications; Guidelines
The guidelines, following the regulatory language, group two significantly different
situations together: modification of an FDA cleared or approved test system, and
introduction of a test system not subject to FDA clearance and approval. We believe
that CMS should address these two situations separately in the Guidelines, as the
former may involve a dangerous off label use of the test system. In addition, the
Guidelines should distinguish between minor modifications, such as use of a different
anticoagulant or alteration of a reference range or cutoff, from major modifications,
such as change in analytical specifications.

Tag# D5795 - 493.1299 Standard: Postanalytic systems assessment; Guidelines
In paragraph five, there is an error in the example regarding the cutoff for high risk
HDL cholesterol. NCEP has changed the cutoff level from 35 mg/dL to 40 mg/dL.

Paragraph seven states a requirement pertaining to Analyte Specific Reagents, but this
issue is confused by references to “research use only” and “investigational use only”
reagents. Although there may be exceptions when reagents produced by non-U.S.
manufacturers are used as histopathology reagents, this sentence seems to condone much
wider use of “Research Use Only” and “Investigational Use Only” reagents for patient
testing. We recommend deleting all reference to “Research Use Only” and
“Investigational Use Only” reagents, and leaving the ASR requirement intact.

In paragraph eight, there is a one-sentence paragraph that says that results of tumor
antigens (e.g., PSA, CEA) requires the methodology to be reported in the test report.
Although CMS qualifies this by stating a laboratory only needs to include the
methodology, “if applicable.” We think this requirement is outdated and should be
removed. If a report states the reference range, it should be adequate.

By way of background, AACC is the principal association of professional laboratory
scientists--including MDs, PhDs and medical technologists. AACC’s members develop
and use chemical concepts, procedures, techniques and instrumentation in health-related
investigations and work in hospitals, independent laboratories and the diagnostics
April 29, 2003
Page Five

industry nationwide. The AACC provides national leadership in advancing the practice
and profession of clinical laboratory science and its application to health care. If you
have any questions or we may be of any assistance, please call me at (408) 395-0807 or
Vince Stine, Director, Government Affairs, at (202) 835-8721.


Susan Evans, PhD

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