INSTRUCTIONS FOR PERSONALIZING A NEWLABORATORYWAIVED/PPM MANUAL

Thank you for purchasing the POC Laboratory Manual. The following are pages that need to be filled out by the office lab. The manual MUST be personalized to be in compliance. No two labs are the same. If you have questions - call our office for assistance. Keep this list as a guide. If the procedures change after the manual was purchased - the new procedures must be added and the old dated when discontinued (not discarded).

Remember to copy blue paees - they are masters. Everything you need to pass an inspection is here!

Section 1 Review - it contains many of the CLIA regulations

Section 2 Quality Assessment

This is your laboratory plan from the time a test is ordered till it is acted upon. ll is important that you personalize this chapter to reflect how you operate your lab. POC can perform an annual quality assessment check ifwe come in annually.

There is a self check you can use after pg 2-35 if you want to do your own check.


Section 3


Specimen Collection

pg 3-2 If you do not have a running record of tests performed- copy and use this log.


pg 3-3

pg 3-5

pg 3-18


If you have tests that are automatically done - fill this in.

Most offices use a super bill or computer for test request - use this if you only went by verbal orders.

If you have tests that can not be performed due to a problem - list it here.


Section 4

Section 5


Quality Control

Every test - even waived tests require quality control studies. This chapter gives you logs you can pick and choose from to help document the type of test controls you are running.

If you are in proficiency testing we recommend you copy pgs. 4-12 to 4-14

and keep it with your proficiency testing records. Maintenance

This chapter has instrument problem logs, temperature logs, microscope

maintenance, timer and centrifuge maintenance. Copy ones you need and keep good documentation.


P.O.C. Consultants, LLC, 2 Russ Farm Way, Delanco, N.J. 08075 (856) 824-0800


!!! IMPORTANT !!!!

THANK YOU FOR ORDERING THE P.O.L. WAIVED/PPM LABORATORY MANUAL.

YOUR OFFICE MUST ADD THE PACKAGE INSERT THAT COMES WITH ALL WAIVER PRODUCTS TO THE SECTION TITLED "TEST PROCEDURES". A SHEET PROTECTOR IS PROVIDED FOR EACH PROCEDURE. THE PACKAGE INSERT OR CONTROL INFORMATION SHEET MUST BE ADDED TO THE WRITTEN PROCEDURE. IF THE TEST YOU PERFORM DOES NOT HAVE A PACKAGE INSERT - NOTHING MUST BE ADDED.


,

Quality concerns uncovered

at laboratories doing waived tests


A n at i o nal s u r v ey has found that serious problems exist in the quality of work performed by laboratories doing certif icate of waiver tests andprovider-performed microscopy procedures.


S

By Joan Szab o

er io us problems exist in the quality of work performed by laboratories doing cer­ tificate of waiver tests

(COW) and provider-performed mi­ croscopy procedures (PPMP), ac­ cording to results from a recent na­ tional survey by the Centers for Medicare Services (CMS), formerly known as the Health Care Financing Administration (H CFA).

Laboratory tests that receive a waiver from CLIA (Clinical Labo­ ratory Improvement Amendments of 1988) are the least regulated tests, with no routine oversight under that federal law.

CLIA regulations define waived tests as simple laboratory examina­ tions and procedures that are cleared by the federal government for home use; that employ methodologies that are so simple and accurate that er-

What the CMS survey found


roneous results would be negligible; or that pose no reasonable risk of harm to the patient if the test is per­ formed incorrectly.

CLIA lists a number of lab tests that receive waivers, including fecal occult blood tests, ovulation tests, urine pregnancy tests, and dipstick or tablet reagent urinalysis for biliru­ bin, glucose, hemoglobin, protein, and nitrite.

Approximately 52 percent of the nation's laboratories perform only waived tests, and 22 percent are lim­ ited to performing waived and/ormi­ croscopy tests. As a result, more than 74 percent of the nation's laborato­ ries fall ou tside the purview of rou­ tine government oversight, according to CMS. T he remaining laboratories, which perform moderate and/or high complexity laboratorie s tests, must follow specific requiremen ts for qua!-


ity control and assurance, personnel qualifications, proficiency testing, and routine biennial inspections.

As mor e tests are classified as waived, some in the laboratory in­ dustry say the definition of waived tests may require review. "When waived testing was established, it was designed for procedures chat were simple to perform and didn't have any mechanical element. Now what we have in many of these (waived) applications is a kit or box that is simple to operate, but is complicated internally and accomplishes very so­ phisticated testi ng ," says Mark Bire nbaum, PhD, administrator for the American Association of Bioanalysts (AAB), a national profes­ sional association whose members are directors, owners, managers, and


In its national survey, the Centers for Medciareand Medicaid Services {CMS) found the following types of quality problems existedin labs performing certificate of waiver tests:

32 percent failed to includecurrent manufacturer's instructions

32 percent didn't perform quality control as requiredby the manufacturer or CDC 20 percent cut occult blood cards and urine dipsticks

19 percent of the labs personnlewere neither trained nor evaluated

:J .pe(c n.t faiJ d !o fqlf9 u ei:it:r:uamJ.f ,ctvre_r' instruction , .- . . .

I . ,if! '-¥61wf l iftnt¥. u . tr.. twkJ;ta?gJk,aHd7H ndt{djinfoiro"rHi 06s0 •

7 percent didn't perform calibration as required by manufacturer

Source: Center for Medicare and M edicaid Serv ices


supervisors of community clinical laboratories.

To perform waived tests , labora­ tories must enroll in the CLIA pro­ gra m, become certified, pay a certifi­ cate fee, and follow the ma nu ­ fac t u r e r 's instructions for eac h waived test. Many of the laborato­ ries performing waived tests are lo­ cated in physicians' o ffices.

Because of the quality problems rece nt ly doc um c.. •·e d by che CMS


32 O c to b e r 2001 • MLO ww w.m lo-onli ne.com


W_AIVED TESTS


survey, such as waived labs not per­


Recent waived tests

Following is a list of some of the tests that have recenlty received a CUA waiver from the Food and Drug Administration:

Test System Name Decision Date


forming quality control as required by the manufacturer, industry lead­ ers worry that inaccurate testing will proliferate, causing harm to pa­ tients. The survey did not have out­ come data to show adverse effects on patient care.

Carolyn Jones, vice present for technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed) says these


Orasure Technologies QED Saliva Alcohol Test Home Diagnostic Genicare Blood Glucose System

Home Diagnostics Prestige IQ BloodGlucose System Cholestech LOX

Source: U.S. Food and Drug Administration


January 22. 2001

February 26, 2001

March 26. 2001

April 13. 2001


concerns are "i na ppro priate ." AdvaMed represents more than 1,000 manufacturers of medical de­ vices, diagnostic products and medi­ cal information systems. Further, she says, "a product that is waived has gone through an approval process. The waiver is an additional review to look at the simplicity of the in­ structions to determine if an un­ trained user can obtain the same re­ sults as a trained user."

Waived tests also have an impact on the laboratories that must com­ ply with CLIA regulations. "Waived laboratories don't have to hire trained personnel, do proficiency testing, or comply with CLIA recordkeeping and quality control requirements, which gives them an economic advantage over a regulated lab," Birenbaum says.

To address the quality problems uncovered in waived laboratories, CMS is taking steps to assure that improvements are made.

CMS survey uncovers quality problems

When CMS surveyed 270 COW labor atorie s and l 90 PPl\tlP labo­ ratories between October 2000 and January of this year, it found 48 per-

w w w .m lo -o n li n e.c o m


cent of waived arid 38 percent of PPMP labs were experiencing qual­ ity testing problems.

In the COW labs, CMS found a number of problems, including practices such as failing to follow manufacturer's instructions, using expired reagents, and testing be­ yond the scope of the complexity level for which the lab was certified. With PPMP lab s, the deficiencies ranged from not evaluating test ac­ curacy to problems with micro­ scope/centrifuge maintenance.

CMS is not alone in its findings. The Department of Health and Hu­ man Services Office of Inspector General (OIG) completed a similar survey of waived laboratories and uncovered deficiencies in both types of labs. Some of the problems the OIG found included misu nde r­ standing of CLIA requirements, un­ trained staff, and failure to identify incorrect results.

When asked about the results of the survey, Paul Fischer, MD, a pri­ mary care physician in Augusta, GA, says that "most of what has been approved for waived testing is per­ fectly appropriate, and the problems the survey found were not things that are li kely to lead to patient care


problems." Fischer is a consultant for the American Academy of Fam­ ily Physicians on laboratory issues and proficiency testing.

Education is key to improvement

As a result of the deficiencies un­ covered, CMS is calling on waived and PPMP laboratories to take a number of corrective steps.

The primary focus of the agency's recommendations is edu­ cation, says Judith Yost, the CMS official who oversees CUA for the agency. "Education is the most im­ portant and the first thing we will work on,"sheadds. The aim of such efforts is to help those in the lab to better understand how to perform the tests properly.

Because those performing waived tests often don't understand the labeling instructions, CMS also plans to work with professional as­ sociations, such as AdvaMed, to help spearhead education efforts for waived lab personn el. "We need to clarify the language as well as the instructions," Yost says.

Jones says AdvaMed strongly supports better educat io n to im­ prove the quality of work waiv ed labs perform. Manufacturers would

Comh111es 0 11 Mg c 34

MLO • O c to b e r 2001 33


WAIVEDTESTS


be " prepared to help with such an effort ," she adds.

Jones also points out that the dif­ ficulties in dealing with small labs is that they are somewhat discon­ nected from the rest of the lab com­ munity. It would help, she believes, if the rest of the lab community finds some way to make small labs more connected so the same type of information distributed to tradi­ tional clinical labs can find their way to waived labs.

The difficulties in dealing with small labs is that they are somewhat disconnected from the

rest of the lab community.

In addition to education, CMS is considering the development of a self-assessment tool for PPMP labs. Yost says the agency may continue to periodically survey both types of labs to make sure the recent prob­ lems are being addressed by lab per­ sonnel as well as physicians and nurses who are ultimately respon­ sible for the work being performed. The OIG issued a set of recom­ mendations to address quality prob­ lems it found. It suggested that rou­

tine inspections of moderate/high complexity labs include a review of any waived/PPMP testing per­ formed.

"Even though all the corrective steps that have been proposed would be beneficial, they are not really ad­ dressing the core of the problem," says AAB's Birenbaum. "The major problem cent ers on the definition of waived tests, wh ich has bee n ex ­ panded beyond what Congress origi­ nally intended."


to im p ove the quality of the work perfonped, some in the lab indus­ try are concerned about the ex­ panded role the Food and Drug Administration (FDA) now has with regard to waived testing.

Over the past year, FDA has been granting premarket approval for many new diagnostic kits that are coming to market. In addition, when the FDA approves a test for home and over- the-counte r use, that test also wins approval under law for a CLIA waiver.

The FDA has r.esponsibility to categorize lab tests, determining whether they should be considered 1waived, moderate, or high complex­ ity. This was formerly accomplished by the Centers for Disease Control and Prevention (CDC). In 1999, an interagency agreement transferred the responsibility for this job from CDC to FDA.

In this role, the FDA recently asked for comments on draft guid­ ance it proposed to medical device manufacturers and others on an al­ ternative method to obtain CLIA waived status for products. Critics claim the FDA proposal will result in the agency being less restrictive on granting waivers than was the CDC. Responding co the FDA request

for comments, AAB said it believes

" all tests granted CLIA waiver should be held to the same strin­ gent standards for accuracy and preci sion and meet the same re­ quirements for design , labeling, quality contro l, and training and monitoring of field users."

AAB's Birenbaum says that once a manufacturer gets a home test kit


waived category, the test can be sold to physician laboratories.

The Clinical Laboratory Im­ provement Advisory C ommit tee has expressed its concern over the FDA's decision to au tomatically waive home-use tests. The panel is concerned that home use approval will become a "back door" method for winning CLIA waiver approval. It pointed out that the criteria used for home-us e tests are not equal to other waiver approval criteria.

As manufacturers and physicians push to win approval for more waiv­ ers, some in the lab field worry that the industry is headed toward de­ reguIatio n. "If the government keeps expanding the category of waived testing, soon the federal rules won't apply to anything," Birenbaum says. O rganized medi ­ cin e, he says, has been trying to re­ peal CLIA for some time. "They were unsuccessful, and they see this (waiver route) as another way to achieve the same objective," hesays.

In addition, he points out that

manufacturers are following "the route of least resistance. If it is much simpler to get a test approved via the home test kit, then they will take that route."

While AdvaMed understands these concerns, Jones says the lab industry is "going to have to come to grips with the fact that trad itional clinical labs may not stand the test of time."

In the meantime, CMS ' Yost says the agency will cont in ue to mo ni­ cor waived labs and pursue efforts to brin g about better management of the program . '.-:1


FDA's role or product into the waived catego ry,


W hile CMS works o n finding a way to ed ucate waived labs on how


it has a big marketing advantage. He explai ned that once in the


Joan Szab o. a Was'1ington-based freelance

w riter, ,s the author o f " Was h,n gton Repor t." a m on thly co lum n in M LO.


34 October 2001 • MLO w ww.m lo -onli ne.com