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FDA offers CLIA test categorization database, CMS plans inspections in waived and PPMP laboratories, and ICD.9 coding is clarified. (POL adviser).

New CLIA test categorization database

The Food and Drug Administration has a searchable database of all manufacturers' categorized test systems. The site is found at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

* Manufacturer Test System Name

* Qualifier

* Analyte Name

* Document Number

* Analyte Specialty

* Effective Date

* Sort By

Enter one or a combination of the values and select Search. If a user enters just one or two variables, the database will provide all of the above listed information and additional information relating to the manufacturer's application to the FDA. Questions about the database can be sent to Clara A. Sliva, acting CLIA coordinator at: (301) 827-0496 or clia@cdrh.fda.gov.

CMS plans inspections in waived and PPMP laboratories

The Office of the Inspector General issued a report "Enrollment and Certification Processes in the Clinical Laboratory Improvement Amendments Program" in August. The report concludes with the OIG recommendations to the Centers for Medicare and Medicaid Services (formerly known as Health Care Financing Administration) regarding the noncompliance of waived and PPMP laboratories. As reported at previous Clinical Laboratory Improvement Advisory Committee meetings, a CMS pilot project enlisted 10 states to survey more than 400 waived and PPMP laboratories for CLIA compliance. The project findings indicated that more than 50 percent of the laboratories were not compliant. The most common deficiencies noted were: Laboratories did not have current manufacturer's package inserts or operator manuals; manufacturers instructions were not followed for operations and/or quality control; and tests were performed beyond the laboratory's certificate.

The OIG made the following recomendations to CMS:

* Provide educational outreach to laboratory directors of waived and provider-performed microscopy laboratories regarding CLIA requirements.

* Require laboratories applying for waived and provider-performed microscopy certificates to identify which tests they plan to conduct and which test systems they will use.

* Establish a mechanism whereby Medicare claim denials can be used to inform state laboratory surveyors about laboratories billing Medicare outside their certificate.

* Use periodic paper self-assessment tools to help ensure compliance for laboratories that are not routinely visited.

* If CMS, pilot project shows that the extent of problems in waived and provider-performed microscopy laboratories is similar to that found in the Ohio and Colorado studies, we would encourage CMS to conduct random surveys of some waived and provider performed microscopy laboratories each year.

* Review the waived and provider-performed microscopy tests conducted at moderate and high complexity laboratories during routine surveys to ensure compliance with CLIA regulations.

* Shorten the length of time allowed between application and surveys for new laboratories.

* Establish a workgroup to develop methods that can be used to identify uncertified laboratories.

The CMS concurred with the above recommendations. Included in a CMS response to the OIG recommendations, CMS stated it already had plans to conduct random on-site surveys of waived and PPMP laboratories. CMS also stated it plans to survey waived and PPMP rests performed in moderate and high complexity laboratories.

Although the CMS concurred with the recommendation to solicit lists of waived and PPMP tests performed in a laboratory, CMS noted that had been problematic when it had tried to collect similar lists in moderate and high complexity laboratories. My thought is that waived laboratories change their kits as frequently as distributor representatives grace the laboratory's doors, and therefore costly time could be spent trying to keep current with the laboratories.

Although the above OIG recommendations were agreed with, CMS pointed out that the ability to implement the recommendations may be limited due to lack of resources, program priorities, and funding.

Clarification of ICD.9 coding for diagnostic tests

On Sept. 26, CMS issued a program memorandum to carriers to clarify ICD-9-CM coding for diagnostic tests. One strong point driven home in the PM is that in the absence of a confirmed diagnosis, it is appropriate to code the signs and symptoms that lead a physician to order the diagnostic tests. It also points out the incidental findings, unrelated, and co-existing conditions and diagnoses should only be reported as secondary diagnoses.

There was a surprise clarification after one of the many examples stating it is appropriate to obtain signs, symptoms, and diagnostic information directly from the patient in the, as CMS puts it, "rare" occasion when the interpreting physician does not have diagnostic information and the referring physician is unavailable to provide such information. It goes on to say, "How ever, an attempt should be made to confirm any information obtained from the patient by contacting the referring physician." Let's think about this -- if we could confirm the information, why would the patient be asked? This situation does seem problematic, particularly if the patient says something that the ordering physician did not record in the medical record. That would create an audit nightmare. This also blurs the rules for ABNs. The PM does not state that the patient-given sign, symptom or diagnosis may be used for ABN purposes; this PM is coding submitted for billing.

The entire PM can be obtained at: http://www.hcfa.gov/pubforms/transmit/ ABO1144.pdf.

CLIAC meeting canceled

Usually this month I would report significant information from the fall meeting of the Clinical Laboratory Improvement Advisory Committee. The meeting was scheduled for Sept. 12 and 13. As you can imagine, it was canceled by 11 a.m. on Sept. 11, a day we will never forger. CLIAC is not going to reschedule any meeting for 2001 but will have at least two scheduled meetings in 2002. The 2002 meeting dates will be posted at the CDC website: http://www.phppo.cdc.gov/cliac/default.asp.

C. Anne Pontius, MBA, CMPE, CLC (AMT), MT (ASCP), a mamber of MLO's editorial advisory board, is president of Laboratory Compliance Consultants in Raleigh, NC.
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Title Annotation:Food and Drug Administration
Author:Pontius, C. Anne
Publication:Medical Laboratory Observer
Article Type:Brief Article
Geographic Code:1USA
Date:Nov 1, 2001
Words:948
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