RE: Clia Waved Labs -- which are you doing?

July 6, 2006

I

do rapid streps, routine UA w/o micro, lipid panel, ALT & AST, A1C, PT/INR,

urine preg., H Pylori., urine microalbumin. I have a Hgb device but

rarely use that one. I have a microscope but rarely use it (no

PPM). I do a very rare KOH prep.

Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you

doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?

Or for patient convenience?

Anyone doing the PPM -- Provider

Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

·

Employ methodologies that are so simple and

accurate as to render the likelihood of erroneous results negligible; or

·

Pose no reasonable risk of harm to the patient if

the test is performed incorrectly;

·

Are cleared by the Food and Drug Administration for

home use.

The original waived test list contained eight groups

of tests. The list has now been expanded, containing some methods of rapid

strep antigen, infectious mono, H. pylori

and cholesterol testing. Less than one percent of all laboratory tests are

classified as Waived.

Laboratories performing only waived tests must follow

the manufacturer's instructions (procedures) when performing the tests. While

none of the tests on the original waived list have quality control

requirements, it is worth noting that many of the newer waived tests have

quality control requirements. Office personnel should very carefully review the

manufacturer's instructions.

Offices wanting only to perform waived tests must apply for a

Certificate of Waiver.

These

laboratories are not routinely inspected; however they may be inspected as part

of a complaint investigation or on a random basis to determine whether or not

only waived tests are being performed.

Beginning in 1998, waived laboratories are required to

pay a $150 biennial certificate fee.

Those laboratories with an inspecting agency other

than CMS/State Agencies should contact their inspecting agencies to inquire

about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently

Waived Analytes

The following is a list of analytes that are used in

laboratory test systems that have been " waived " .

Under the current process, waiver may be granted to: 1) any test listed in the

regulation, 2) any test system for which the manufacturer or producer applies

for waiver if that test meets the statutory criteria and the manufacturer

provides scientifically valid data verifying that the waiver criteria have been

met, and 3) test systems cleared by the FDA for home use. The waived analytes

below are linked to waived test systems. Simply click on an analyte of interest

to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC

ORGANISMS - VAGINAL

ALANINE

AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN,

URINARY

ALCOHOL,

SALIVA

AMINES

AMPHETAMINES

ASPARTATE

AMINOTRANSFERASE (AST) (SGOT)

B-TYPE

NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER

TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS

(THC)

CATALASE,

URINE

CHOLESTEROL

COCAINE

METABOLITES

COLLAGEN

TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE

SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3

GLUCURONIDE

ETHANOL

(ALCOHOL)

FECAL

OCCULT BLOOD

FERN

TEST, SALIVA

FOLLICLE

STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC

OCCULT BLOOD

GASTRIC

PH

GLUCOSE

MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE,

FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED

HEMOGLOBIN, TOTAL

GLYCOSYLATED

HEMOGLOBIN (HGB A1C)

HCG,

URINE

HDL

CHOLESTEROL

HELICOBACTER

PYLORI

HELICOBACTER

PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

BY COPPER SULFATE, NONAUTOMATED

HGB,

SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1

AND HIV-2 ANTIBODIES

HIV-1

ANTIBODY

INFECTIOUS

MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA

A

INFLUENZA

A/B

INFLUENZA

B

KETONE,

BLOOD

KETONE,

URINE

LACTIC

ACID (LACTATE)

LDL

CHOLESTEROL

LITHIUM

LUTEINIZING

HORMONE (LH)

LYME

DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE

(MDMA)

MICROALBUMIN

MORPHINE

NICOTINE

AND/OR METABOLITES

OPIATES

OVULATION

TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE

(PCP)

PLATELET

AGGREGATION

PROPOXYPHENE

PROTHROMBIN

TIME (PT)

RESPIRATORY

SYNCYTIAL VIRUS

SEMEN

SPUN

MICROHEMATOCRIT

STREPTOCOCCUS,

GROUP A

THYROID

STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC

ANTIDEPRESSANTS

TRIGLYCERIDE

URINE

DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE

HCG BY VISUAL COLOR COMPARISON TESTS

URINE

QUALITATIVE DIPSTICK ASCORBIC ACID

URINE

QUALITATIVE DIPSTICK BILIRUBIN

URINE

QUALITATIVE DIPSTICK BLOOD

URINE

QUALITATIVE DIPSTICK CHEMISTRIES

URINE

QUALITATIVE DIPSTICK CREATININE

URINE

QUALITATIVE DIPSTICK GLUCOSE

URINE

QUALITATIVE DIPSTICK KETONE

URINE

QUALITATIVE DIPSTICK LEUKOCYTES

URINE

QUALITATIVE DIPSTICK NITRITE

URINE

QUALITATIVE DIPSTICK PH

URINE

QUALITATIVE DIPSTICK PROTEIN

URINE

QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE

QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL

PH

July 6, 2006

I am doing only waived only- dipstick UA, urine HCG and rapid strep. Naureen

July 6, 2006

Thanks, .

Technically, if you don't have PPM...are you "breaking the law" to look at a KOH?

Seems silly considering how easy they are to do, but if a patient got made at you and reported you to the state lab board, could you get in trouble?

Just curious.

From: [mailto: ] On Behalf Of Brock DOSent: Thursday, July 06, 2006 5:56 AMTo: Subject: RE: Clia Waved Labs -- which are you doing?

I do rapid streps, routine UA w/o micro, lipid panel, ALT & AST, A1C, PT/INR, urine preg., H Pylori., urine microalbumin. I have a Hgb device but rarely use that one. I have a microscope but rarely use it (no PPM). I do a very rare KOH prep.

Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?Or for patient convenience?

Anyone doing the PPM -- Provider Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

· Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

· Pose no reasonable risk of harm to the patient if the test is performed incorrectly;

· Are cleared by the Food and Drug Administration for home use.

The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's instructions. Offices wanting only to perform waived tests must apply for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently Waived Analytes

The following is a list of analytes that are used in laboratory test systems that have been "waived". Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC ORGANISMS - VAGINAL

ALANINE AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN, URINARY

ALCOHOL, SALIVA

AMINES

AMPHETAMINES

ASPARTATE AMINOTRANSFERASE (AST) (SGOT)

B-TYPE NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS (THC)

CATALASE, URINE

CHOLESTEROL

COCAINE METABOLITES

COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3 GLUCURONIDE

ETHANOL (ALCOHOL)

FECAL OCCULT BLOOD

FERN TEST, SALIVA

FOLLICLE STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC OCCULT BLOOD

GASTRIC PH

GLUCOSE

GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED HEMOGLOBIN, TOTAL

GLYCOSYLATED HEMOGLOBIN (HGB A1C)

HCG, URINE

HDL CHOLESTEROL

HELICOBACTER PYLORI

HELICOBACTER PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED

HGB, SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1 AND HIV-2 ANTIBODIES

HIV-1 ANTIBODY

INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA A

INFLUENZA A/B

INFLUENZA B

KETONE, BLOOD

KETONE, URINE

LACTIC ACID (LACTATE)

LDL CHOLESTEROL

LITHIUM

LUTEINIZING HORMONE (LH)

LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

MICROALBUMIN

MORPHINE

NICOTINE AND/OR METABOLITES

OPIATES

OVULATION TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE (PCP)

PLATELET AGGREGATION

PROPOXYPHENE

PROTHROMBIN TIME (PT)

RESPIRATORY SYNCYTIAL VIRUS

SEMEN

SPUN MICROHEMATOCRIT

STREPTOCOCCUS, GROUP A

THYROID STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC ANTIDEPRESSANTS

TRIGLYCERIDE

URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE HCG BY VISUAL COLOR COMPARISON TESTS

URINE QUALITATIVE DIPSTICK ASCORBIC ACID

URINE QUALITATIVE DIPSTICK BILIRUBIN

URINE QUALITATIVE DIPSTICK BLOOD

URINE QUALITATIVE DIPSTICK CHEMISTRIES

URINE QUALITATIVE DIPSTICK CREATININE

URINE QUALITATIVE DIPSTICK GLUCOSE

URINE QUALITATIVE DIPSTICK KETONE

URINE QUALITATIVE DIPSTICK LEUKOCYTES

URINE QUALITATIVE DIPSTICK NITRITE

URINE QUALITATIVE DIPSTICK PH

URINE QUALITATIVE DIPSTICK PROTEIN

URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL PH

July 6, 2006

Interesting regarding the

KOH. I think I’ve actually only done one in 2 years & it was

not diagnostic or helpful even then. Still, I’ll have to look at my

CLIA certificate as I may have PPM & not know it. I do not recall the

PPM thing being brought up at all. From the PPM list the KOH is the only

thing I would have ever done anyways.

Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you

doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?

Or for patient convenience?

Anyone doing the PPM -- Provider

Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

· Employ

methodologies that are so simple and accurate as to render the likelihood of

erroneous results negligible; or

· Pose

no reasonable risk of harm to the patient if the test is performed incorrectly;

· Are

cleared by the Food and Drug Administration for home use.

The original waived test list contained eight groups

of tests. The list has now been expanded, containing some methods of rapid

strep antigen, infectious mono, H. pylori

and cholesterol testing. Less than one percent of all laboratory tests are

classified as Waived.

Laboratories performing only waived tests must follow

the manufacturer's instructions (procedures) when performing the tests. While

none of the tests on the original waived list have quality control

requirements, it is worth noting that many of the newer waived tests have

quality control requirements. Office personnel should very carefully review the

manufacturer's instructions.

Offices wanting only to perform waived tests must apply for a

Certificate of Waiver.

These

laboratories are not routinely inspected; however they may be inspected as part

of a complaint investigation or on a random basis to determine whether or not

only waived tests are being performed.

Beginning in 1998, waived laboratories are required to

pay a $150 biennial certificate fee.

Those laboratories with an inspecting agency other

than CMS/State Agencies should contact their inspecting agencies to inquire

about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently

Waived Analytes

The following is a list of analytes that are used in laboratory

test systems that have been " waived " .

Under the current process, waiver may be granted to: 1) any test listed in the

regulation, 2) any test system for which the manufacturer or producer applies

for waiver if that test meets the statutory criteria and the manufacturer

provides scientifically valid data verifying that the waiver criteria have been

met, and 3) test systems cleared by the FDA for home use. The waived analytes

below are linked to waived test systems. Simply click on an analyte of interest

to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC

ORGANISMS - VAGINAL

ALANINE

AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN,

URINARY

ALCOHOL,

SALIVA

AMINES

AMPHETAMINES

ASPARTATE

AMINOTRANSFERASE (AST) (SGOT)

B-TYPE

NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER

TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS

(THC)

CATALASE,

URINE

CHOLESTEROL

COCAINE

METABOLITES

COLLAGEN

TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE

SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3

GLUCURONIDE

ETHANOL

(ALCOHOL)

FECAL

OCCULT BLOOD

FERN

TEST, SALIVA

FOLLICLE

STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC

OCCULT BLOOD

GASTRIC

PH

GLUCOSE

MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE,

FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED

HEMOGLOBIN, TOTAL

GLYCOSYLATED

HEMOGLOBIN (HGB A1C)

HCG,

URINE

HDL

CHOLESTEROL

HELICOBACTER

PYLORI

HELICOBACTER

PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

BY COPPER SULFATE, NONAUTOMATED

HGB,

SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1

AND HIV-2 ANTIBODIES

HIV-1

ANTIBODY

INFECTIOUS

MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA

A

INFLUENZA

A/B

INFLUENZA

B

KETONE,

BLOOD

KETONE,

URINE

LACTIC

ACID (LACTATE)

LDL

CHOLESTEROL

LITHIUM

LUTEINIZING

HORMONE (LH)

LYME

DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE

(MDMA)

MICROALBUMIN

MORPHINE

NICOTINE

AND/OR METABOLITES

OPIATES

OVULATION

TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE

(PCP)

PLATELET

AGGREGATION

PROPOXYPHENE

PROTHROMBIN

TIME (PT)

RESPIRATORY

SYNCYTIAL VIRUS

SEMEN

SPUN

MICROHEMATOCRIT

STREPTOCOCCUS,

GROUP A

THYROID

STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC

ANTIDEPRESSANTS

TRIGLYCERIDE

URINE

DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE

HCG BY VISUAL COLOR COMPARISON TESTS

URINE

QUALITATIVE DIPSTICK ASCORBIC ACID

URINE

QUALITATIVE DIPSTICK BILIRUBIN

URINE

QUALITATIVE DIPSTICK BLOOD

URINE

QUALITATIVE DIPSTICK CHEMISTRIES

URINE

QUALITATIVE DIPSTICK CREATININE

URINE

QUALITATIVE DIPSTICK GLUCOSE

URINE

QUALITATIVE DIPSTICK KETONE

URINE

QUALITATIVE DIPSTICK LEUKOCYTES

URINE

QUALITATIVE DIPSTICK NITRITE

URINE

QUALITATIVE DIPSTICK PH

URINE

QUALITATIVE DIPSTICK PROTEIN

URINE

QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE

QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL

PH

July 6, 2006

Hmmm, interesting point...

my CLIA waiver is still an " unchecked box " after three months. I guess I'm

breaking some law. It's in the next set of stuff to do....

But I assumed the main issue was that I couldn't bill for the waived tests

until I notified them and got the certificate. Otherwise, what's the idea

that doing a fingerstick glucose in my office, or a urine pregnancy test,

would be illegal??? or dangerous??? The tests I do are mostly things

patients might do at home (except urine dip)... but still I need to get

that certificate.

Crazy... I can diagnose acute asthma and prescribe steroids... or give Ace

inhibitor or other med that can cause electrolyte imbalances or impair the

kidneys... but watch out if I put drops of urine on a home pregnancy test

and then " interpret " the lines that appear! ;-) It's a funny world we

live in.

Tim

> Interesting regarding the KOH. I think I've actually only done one in 2

> years & it was not diagnostic or helpful even then. Still, I'll have to

> look at my CLIA certificate as I may have PPM & not know it. I do not

> recall the PPM thing being brought up at all. From the PPM list the KOH

> is the only thing I would have ever done anyways.

>

> Clia Waved Labs -- which are you doing?

>

> What CLIA waved labs are each of you doing?

>

> http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

>

> Do you do it for revenues?

> Or for patient convenience?

>

> Anyone doing the PPM -- Provider Provided Microscopy?

>

> http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

>

> See good Waiver brochure at...

>

> http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

>

> See some more links below.

>

> Locke, MD

>

> Here are some links.

>

> Here is a big list of tests...

>

> http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

>

> http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.htm

> l

>

> Waived Tests are defined to:

>

> * Employ methodologies that are so simple and accurate as to

> render the likelihood of erroneous results negligible; or

>

> * Pose no reasonable risk of harm to the patient if the test is

> performed incorrectly;

>

> * Are cleared by the Food and Drug Administration for home use.

>

> The original waived test list contained eight groups of tests. The list

> has now been expanded, containing some methods of rapid strep antigen,

> infectious mono, H. pylori and cholesterol testing. Less than one

> percent of all laboratory tests are classified as Waived.

> Laboratories performing only waived tests must follow the

> manufacturer's instructions (procedures) when performing the tests.

> While none of the tests on the original waived list have quality control

> requirements, it is worth noting that many of the newer waived tests

> have quality control requirements. Office personnel should very

> carefully review the manufacturer's instructions.

> Offices wanting only to perform waived tests must apply for a

> Certificate of Waiver.

> These laboratories are not routinely inspected; however they may be

> inspected as part of a complaint investigation or on a random basis to

> determine whether or not only waived tests are being performed.

> Beginning in 1998, waived laboratories are required to pay a $150

> biennial certificate fee.

> Those laboratories with an inspecting agency other than CMS/State

> Agencies should contact their inspecting agencies to inquire about their

> specific requirements.

>

> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

>

> or

>

> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

>

> Currently Waived Analytes

>

> The following is a list of analytes that are used in laboratory test

> systems that have been <http://www.fda.gov/cdrh/clia/cliawaived.html>

> " waived " . Under the current process, waiver may be granted to: 1) any

> test listed in the regulation, 2) any test system for which the

> manufacturer or producer applies for waiver if that test meets the

> statutory criteria and the manufacturer provides scientifically valid

> data verifying that the waiver criteria have been met, and 3) test

> systems cleared by the FDA for home use. The waived analytes below are

> linked to waived test systems. Simply click on an analyte of interest to

> link to test systems that are waived for the analyte.

>

> Analyte Name

>

> ADENOVIRUS

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Adenovirus & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%2

> 0DESC & PAGENUM=10>

>

> AEROBIC/ANAEROBIC

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Aerobic%2FAnaerobic%20Organisms%20%2D%20Vaginal & Clia_Complexity

> =Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> ORGANISMS -

> VAGINAL

>

> ALANINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Alanine%20Aminotransferase%20%28ALT%29%20%28SGPT%29 & Clia_Comple

> xity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> AMINOTRANSFERASE (ALT) (SGPT)

>

> ALBUMIN,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Albumin%2C%20Urinary & Clia_Complexity=Waived & SortColumn=DATE%5FE

> FFECTIVE%20DESC & PAGENUM=10> URINARY

>

> ALCOHOL,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Alcohol%2C%20Saliva & Clia_Complexity=Waived & SortColumn=DATE%5FEF

> FECTIVE%20DESC & PAGENUM=10> SALIVA

>

> AMINES

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Amines & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DES

> C & PAGENUM=10>

>

> AMPHETAMINES

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Amphetamines & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10>

>

> ASPARTATE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Aspartate%20Aminotransferase%20%28AST%29%20%28SGOT%29 & Clia_Comp

> lexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> AMINOTRANSFERASE (AST) (SGOT)

>

> B-TYPE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=B%2DType%20Natriuretic%20Peptide%20%28BNP%29 & Clia_Complexity=Wa

> ived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> NATRIURETIC PEPTIDE

> (BNP)

>

> BARBITURATES

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Barbiturates & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10>

>

> BENZODIAZEPINES

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Benzodiazepines & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECT

> IVE%20DESC & PAGENUM=10>

>

> BLADDER

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Bladder%20Tumor%20Associated%20Antigen & Clia_Complexity=Waived & S

> ortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> TUMOR ASSOCIATED ANTIGEN

>

> CANNABINOIDS

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Cannabinoids%20%28THC%29 & Clia_Complexity=Waived & SortColumn=DATE

> %5FEFFECTIVE%20DESC & PAGENUM=10> (THC)

>

> CATALASE,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Catalase%2C%20Urine & Clia_Complexity=Waived & SortColumn=DATE%5FEF

> FECTIVE%20DESC & PAGENUM=10> URINE

>

> CHOLESTEROL

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Cholesterol & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%

> 20DESC & PAGENUM=10>

>

> COCAINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Cocaine%20Metabolites & Clia_Complexity=Waived & SortColumn=DATE%5F

> EFFECTIVE%20DESC & PAGENUM=10> METABOLITES

>

> COLLAGEN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=COLLAGEN%20TYPE%20I%20CROSSLINK%2C%20N%2DTELOPEPTIDES%20%28NTX%

> 29 & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

>

> CREATININE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Creatinine & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%2

> 0DESC & PAGENUM=10>

>

> ERYTHROCYTE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Erythrocyte%20Sedimentation%20Rate%2Cnonautomated%20waived & Clia

> _Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> SEDIMENTATION RATE,NONAUTOMATED WAIVED

>

> ESTRONE-3

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Estrone%2D3%20Glucuronide & Clia_Complexity=Waived & SortColumn=DAT

> E%5FEFFECTIVE%20DESC & PAGENUM=10> GLUCURONIDE

>

> ETHANOL

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Ethanol%20%28Alcohol%29 & Clia_Complexity=Waived & SortColumn=DATE%

> 5FEFFECTIVE%20DESC & PAGENUM=10> (ALCOHOL)

>

> FECAL

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Fecal%20Occult%20Blood & Clia_Complexity=Waived & SortColumn=DATE%5

> FEFFECTIVE%20DESC & PAGENUM=10> OCCULT BLOOD

>

> FERN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Fern%20Test%2C%20Saliva & Clia_Complexity=Waived & SortColumn=DATE%

> 5FEFFECTIVE%20DESC & PAGENUM=10> TEST, SALIVA

>

> FOLLICLE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Follicle%20Stimulating%20Hormone%20%28FSH%29 & Clia_Complexity=Wa

> ived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> STIMULATING HORMONE

> (FSH)

>

> FRUCTOSAMINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Fructosamine & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10>

>

> GASTRIC

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Gastric%20Occult%20Blood & Clia_Complexity=Waived & SortColumn=DATE

> %5FEFFECTIVE%20DESC & PAGENUM=10> OCCULT BLOOD

>

> GASTRIC

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Gastric%20pH & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10> PH

>

> GLUCOSE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Glucose & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DE

> SC & PAGENUM=10>

>

> GLUCOSE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Glucose%20Monitoring%20Devices%20%28FDA%20Cleared%2FHome%20Use%

> 29 & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> MONITORING DEVICES (FDA CLEARED/HOME USE)

>

> GLUCOSE,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Glucose%2C%20Fluid%20%28Approved%20By%20Fda%20For%20Prescriptio

> n%20Home%20Use%29 & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC &

> PAGENUM=10> FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

>

> GLYCATED

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Glycated%20Hemoglobin%2C%20Total & Clia_Complexity=Waived & SortCol

> umn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> HEMOGLOBIN, TOTAL

>

> GLYCOSYLATED

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Glycosylated%20Hemoglobin%20%28Hgb%20A1c%29 & Clia_Complexity=Wai

> ved & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> HEMOGLOBIN (HGB A1C)

>

> HCG,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=hCG%2C%20Urine & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTI

> VE%20DESC & PAGENUM=10> URINE

>

> HDL

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=HDL%20Cholesterol & Clia_Complexity=Waived & SortColumn=DATE%5FEFFE

> CTIVE%20DESC & PAGENUM=10> CHOLESTEROL

>

> HELICOBACTER

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Helicobacter%20Pylori & Clia_Complexity=Waived & SortColumn=DATE%5F

> EFFECTIVE%20DESC & PAGENUM=10> PYLORI

>

> HELICOBACTER

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Helicobacter%20Pylori%20Antibodies & Clia_Complexity=Waived & SortC

> olumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> PYLORI ANTIBODIES

>

> HEMATOCRIT

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Hematocrit & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%2

> 0DESC & PAGENUM=10>

>

> HEMOGLOBIN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Hemoglobin & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%2

> 0DESC & PAGENUM=10>

>

> HEMOGLOBIN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Hemoglobin%20by%20Copper%20Sulfate%2C%20nonautomated & Clia_Compl

> exity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> BY COPPER

> SULFATE, NONAUTOMATED

>

> HGB,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=HGB%2C%20SINGLE%20ANALYTE%20INST%2E%20W%2FSELF%2DCONT%2E%2E%2E &

> Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> SINGLE ANALYTE INST. W/SELF-CONT...

>

> HIV-1

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=HIV%2D1%20and%20HIV%2D2%20Antibodies & Clia_Complexity=Waived & Sor

> tColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> AND HIV-2 ANTIBODIES

>

> HIV-1

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=HIV%2D1%20Antibody & Clia_Complexity=Waived & SortColumn=DATE%5FEFF

> ECTIVE%20DESC & PAGENUM=10> ANTIBODY

>

> INFECTIOUS

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Infectious%20Mononucleosis%20Antibodies%20%28Mono%29 & Clia_Compl

> exity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> MONONUCLEOSIS ANTIBODIES (MONO)

>

> INFLUENZA

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Influenza%20A & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIV

> E%20DESC & PAGENUM=10> A

>

> INFLUENZA

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Influenza%20A%2FB & Clia_Complexity=Waived & SortColumn=DATE%5FEFFE

> CTIVE%20DESC & PAGENUM=10> A/B

>

> INFLUENZA

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Influenza%20B & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIV

> E%20DESC & PAGENUM=10> B

>

> KETONE,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Ketone%2C%20Blood & Clia_Complexity=Waived & SortColumn=DATE%5FEFFE

> CTIVE%20DESC & PAGENUM=10> BLOOD

>

> KETONE,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Ketone%2C%20Urine & Clia_Complexity=Waived & SortColumn=DATE%5FEFFE

> CTIVE%20DESC & PAGENUM=10> URINE

>

> LACTIC

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Lactic%20Acid%20%28Lactate%29 & Clia_Complexity=Waived & SortColumn

> =DATE%5FEFFECTIVE%20DESC & PAGENUM=10> ACID (LACTATE)

>

> LDL

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=LDL%20Cholesterol & Clia_Complexity=Waived & SortColumn=DATE%5FEFFE

> CTIVE%20DESC & PAGENUM=10> CHOLESTEROL

>

> LITHIUM

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Lithium & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DE

> SC & PAGENUM=10>

>

> LUTEINIZING

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Luteinizing%20Hormone%20%28LH%29 & Clia_Complexity=Waived & SortCol

> umn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> HORMONE (LH)

>

> LYME

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Lyme%20Disease%20Antibodies%20%28Borrelia%20Burgdorferi%20Abs%2

> 9 & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

>

> METHADONE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Methadone & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20

> DESC & PAGENUM=10>

>

> METHAMPHETAMINE/AMPHETAMINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Methamphetamine%2FAmphetamine & Clia_Complexity=Waived & SortColumn

> =DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

>

> METHAMPHETAMINES

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Methamphetamines & Clia_Complexity=Waived & SortColumn=DATE%5FEFFEC

> TIVE%20DESC & PAGENUM=10>

>

> METHYLENEDIOXYMETHAMPHETAMINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Methylenedioxymethamphetamine%20%28MDMA%29 & Clia_Complexity=Waiv

> ed & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> (MDMA)

>

> MICROALBUMIN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Microalbumin & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10>

>

> MORPHINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Morphine & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20D

> ESC & PAGENUM=10>

>

> NICOTINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Nicotine%20And%2FOr%20Metabolites & Clia_Complexity=Waived & SortCo

> lumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> AND/OR METABOLITES

>

> OPIATES

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Opiates & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DE

> SC & PAGENUM=10>

>

> OVULATION

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Ovulation%20Test%20%28LH%29%20By%20Visual%20Color%20Comparison &

> Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> TEST (LH) BY VISUAL COLOR COMPARISON

>

> OXYCODONE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Oxycodone & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20

> DESC & PAGENUM=10>

>

> PH

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=pH & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PA

> GENUM=10>

>

> PHENCYCLIDINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Phencyclidine%20%28PCP%29 & Clia_Complexity=Waived & SortColumn=DAT

> E%5FEFFECTIVE%20DESC & PAGENUM=10> (PCP)

>

> PLATELET

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Platelet%20Aggregation & Clia_Complexity=Waived & SortColumn=DATE%5

> FEFFECTIVE%20DESC & PAGENUM=10> AGGREGATION

>

> PROPOXYPHENE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Propoxyphene & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10>

>

> PROTHROMBIN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Prothrombin%20Time%20%28PT%29 & Clia_Complexity=Waived & SortColumn

> =DATE%5FEFFECTIVE%20DESC & PAGENUM=10> TIME (PT)

>

> RESPIRATORY

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Respiratory%20Syncytial%20Virus & Clia_Complexity=Waived & SortColu

> mn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> SYNCYTIAL VIRUS

>

> SEMEN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Semen & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC

> & PAGENUM=10>

>

> SPUN

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Spun%20Microhematocrit & Clia_Complexity=Waived & SortColumn=DATE%5

> FEFFECTIVE%20DESC & PAGENUM=10> MICROHEMATOCRIT

>

> STREPTOCOCCUS,

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

>

Analyte_Name=Streptococcus%2C%20Group%20A & Clia_Complexity=Waived & SortColumnDATE%\

5FEFFECTIVE%20DESC & PAGENUM=10>

> GROUP A

>

> THYROID

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Thyroid%20Stimulating%20Hormone%20%28TSH%29 & Clia_Complexity=Wai

> ved & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> STIMULATING HORMONE

> (TSH)

>

> TRICHOMONAS

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Trichomonas & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%

> 20DESC & PAGENUM=10>

>

> TRICYCLIC

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Tricyclic%20Antidepressants & Clia_Complexity=Waived & SortColumn=D

> ATE%5FEFFECTIVE%20DESC & PAGENUM=10> ANTIDEPRESSANTS

>

> TRIGLYCERIDE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Triglyceride & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10>

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Dipstick%20Or%20Tablet%20Analytes%2C%20Nonautomated & Cli

> a_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10>

> DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20hCG%20By%20Visual%20Color%20Comparison%20Tests & Clia_Com

> plexity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> HCG BY

> VISUAL COLOR COMPARISON TESTS

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Ascorbic%20Acid & Clia_Complexit

> y=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE

> DIPSTICK ASCORBIC ACID

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Bilirubin & Clia_Complexity=Waiv

> ed & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> BILIRUBIN

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Blood & Clia_Complexity=Waived & S

> ortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> BLOOD

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Chemistries & Clia_Complexity=Wa

> ived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE

> DIPSTICK CHEMISTRIES

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Creatinine & Clia_Complexity=Wai

> ved & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> CREATININE

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Glucose & Clia_Complexity=Waived

> & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> GLUCOSE

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Ketone & Clia_Complexity=Waived &

> SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> KETONE

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Leukocytes & Clia_Complexity=Wai

> ved & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> LEUKOCYTES

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Nitrite & Clia_Complexity=Waived

> & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> NITRITE

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20pH & Clia_Complexity=Waived & Sort

> Column=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK PH

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Protein & Clia_Complexity=Waived

> & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE DIPSTICK

> PROTEIN

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Specific%20Gravity & Clia_Comple

> xity=Waived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE

> DIPSTICK SPECIFIC GRAVITY

>

> URINE

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Urine%20Qualitative%20Dipstick%20Urobilinogen & Clia_Complexity=W

> aived & SortColumn=DATE%5FEFFECTIVE%20DESC & PAGENUM=10> QUALITATIVE

> DIPSTICK UROBILINOGEN

>

> VAGINAL

> <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/WaivedResults.cfm?

> Analyte_Name=Vaginal%20pH & Clia_Complexity=Waived & SortColumn=DATE%5FEFFECTIVE

> %20DESC & PAGENUM=10> PH

>

July 6, 2006

Dave, have you found that the equipment and test strips for th e A1c, INR, ALT, H Pylori etc are worth it ? What are the # of tests needed to run to break even?

--------- Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?Or for patient convenience?

Anyone doing the PPM -- Provider Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

· Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

· Pose no reasonable risk of harm to the patient if the test is performed incorrectly;

· Are cleared by the Food and Drug Administration for home use.

The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's instructions. Offices wanting only to perform waived tests must apply

for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently Waived Analytes

The following is a list of analytes that are used in laboratory test systems that have been "waived". Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC ORGANISMS - VAGINAL

ALANINE AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN, URINARY

ALCOHOL, SALIVA

AMINES

AMPHETAMINES

ASPARTATE AMINOTRANSFERASE (AST) (SGOT)

B-TYPE NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS (THC)

CATALASE, URINE

CHOLESTEROL

COCAINE METABOLITES

COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3 GLUCURONIDE

ETHANOL (ALCOHOL)

FECAL OCCULT BLOOD

FERN TEST, SALIVA

FOLLICLE STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC OCCULT BLOOD

GASTRIC PH

GLUCOSE

GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED HEMOGLOBIN, TOTAL

GLYCOSYLATED HEMOGLOBIN (HGB A1C)

HCG, URINE

HDL CHOLESTEROL

HELICOBACTER PYLORI

HELICOBACTER PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED

HGB, SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1 AND HIV-2 ANTIBODIES

HIV-1 ANTIBODY

INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA A

INFLUENZA A/B

INFLUENZA B

KETONE, BLOOD

KETONE, URINE

LACTIC ACID (LACTATE)

LDL CHOLESTEROL

LITHIUM

LUTEINIZING HORMONE (LH)

LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

MICROALBUMIN

MORPHINE

NICOTINE AND/OR METABOLITES

OPIATES

OVULATION TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE (PCP)

PLATELET AGGREGATION

PROPOXYPHENE

PROTHROMBIN TIME (PT)

RESPIRATORY SYNCYTIAL VIRUS

SEMEN

SPUN MICROHEMATOCRIT

STREPTOCOCCUS, GROUP A

THYROID STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC ANTIDEPRESSANTS

TRIGLYCERIDE

URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE HCG BY VISUAL COLOR COMPARISON TESTS

URINE QUALITATIVE DIPSTICK ASCORBIC ACID

URINE QUALITATIVE DIPSTICK BILIRUBIN

URINE QUALITATIVE DIPSTICK BLOOD

URINE QUALITATIVE DIPSTICK CHEMISTRIES

URINE QUALITATIVE DIPSTICK CREATININE

URINE QUALITATIVE DIPSTICK GLUCOSE

URINE QUALITATIVE DIPSTICK KETONE

URINE QUALITATIVE DIPSTICK LEUKOCYTES

URINE QUALITATIVE DIPSTICK NITRITE

URINE QUALITATIVE DIPSTICK PH

URINE QUALITATIVE DIPSTICK PROTEIN

URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL PH

July 6, 2006

Dave, have you found that the equipment and test strips for th e A1c, INR, ALT, H Pylori etc are worth it ? What are the # of tests needed to run to break even?

--------- Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?Or for patient convenience?

Anyone doing the PPM -- Provider Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

· Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

· Pose no reasonable risk of harm to the patient if the test is performed incorrectly;

· Are cleared by the Food and Drug Administration for home use.

The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's instructions. Offices wanting only to perform waived tests must apply

for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently Waived Analytes

The following is a list of analytes that are used in laboratory test systems that have been "waived". Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC ORGANISMS - VAGINAL

ALANINE AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN, URINARY

ALCOHOL, SALIVA

AMINES

AMPHETAMINES

ASPARTATE AMINOTRANSFERASE (AST) (SGOT)

B-TYPE NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS (THC)

CATALASE, URINE

CHOLESTEROL

COCAINE METABOLITES

COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3 GLUCURONIDE

ETHANOL (ALCOHOL)

FECAL OCCULT BLOOD

FERN TEST, SALIVA

FOLLICLE STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC OCCULT BLOOD

GASTRIC PH

GLUCOSE

GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED HEMOGLOBIN, TOTAL

GLYCOSYLATED HEMOGLOBIN (HGB A1C)

HCG, URINE

HDL CHOLESTEROL

HELICOBACTER PYLORI

HELICOBACTER PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED

HGB, SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1 AND HIV-2 ANTIBODIES

HIV-1 ANTIBODY

INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA A

INFLUENZA A/B

INFLUENZA B

KETONE, BLOOD

KETONE, URINE

LACTIC ACID (LACTATE)

LDL CHOLESTEROL

LITHIUM

LUTEINIZING HORMONE (LH)

LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

MICROALBUMIN

MORPHINE

NICOTINE AND/OR METABOLITES

OPIATES

OVULATION TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE (PCP)

PLATELET AGGREGATION

PROPOXYPHENE

PROTHROMBIN TIME (PT)

RESPIRATORY SYNCYTIAL VIRUS

SEMEN

SPUN MICROHEMATOCRIT

STREPTOCOCCUS, GROUP A

THYROID STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC ANTIDEPRESSANTS

TRIGLYCERIDE

URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE HCG BY VISUAL COLOR COMPARISON TESTS

URINE QUALITATIVE DIPSTICK ASCORBIC ACID

URINE QUALITATIVE DIPSTICK BILIRUBIN

URINE QUALITATIVE DIPSTICK BLOOD

URINE QUALITATIVE DIPSTICK CHEMISTRIES

URINE QUALITATIVE DIPSTICK CREATININE

URINE QUALITATIVE DIPSTICK GLUCOSE

URINE QUALITATIVE DIPSTICK KETONE

URINE QUALITATIVE DIPSTICK LEUKOCYTES

URINE QUALITATIVE DIPSTICK NITRITE

URINE QUALITATIVE DIPSTICK PH

URINE QUALITATIVE DIPSTICK PROTEIN

URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL PH

July 6, 2006

Dave, have you found that the equipment and test strips for th e A1c, INR, ALT, H Pylori etc are worth it ? What are the # of tests needed to run to break even?

--------- Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?Or for patient convenience?

Anyone doing the PPM -- Provider Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

· Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

· Pose no reasonable risk of harm to the patient if the test is performed incorrectly;

· Are cleared by the Food and Drug Administration for home use.

The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's instructions. Offices wanting only to perform waived tests must apply

for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently Waived Analytes

The following is a list of analytes that are used in laboratory test systems that have been "waived". Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC ORGANISMS - VAGINAL

ALANINE AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN, URINARY

ALCOHOL, SALIVA

AMINES

AMPHETAMINES

ASPARTATE AMINOTRANSFERASE (AST) (SGOT)

B-TYPE NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS (THC)

CATALASE, URINE

CHOLESTEROL

COCAINE METABOLITES

COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3 GLUCURONIDE

ETHANOL (ALCOHOL)

FECAL OCCULT BLOOD

FERN TEST, SALIVA

FOLLICLE STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC OCCULT BLOOD

GASTRIC PH

GLUCOSE

GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED HEMOGLOBIN, TOTAL

GLYCOSYLATED HEMOGLOBIN (HGB A1C)

HCG, URINE

HDL CHOLESTEROL

HELICOBACTER PYLORI

HELICOBACTER PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED

HGB, SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1 AND HIV-2 ANTIBODIES

HIV-1 ANTIBODY

INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA A

INFLUENZA A/B

INFLUENZA B

KETONE, BLOOD

KETONE, URINE

LACTIC ACID (LACTATE)

LDL CHOLESTEROL

LITHIUM

LUTEINIZING HORMONE (LH)

LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

MICROALBUMIN

MORPHINE

NICOTINE AND/OR METABOLITES

OPIATES

OVULATION TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE (PCP)

PLATELET AGGREGATION

PROPOXYPHENE

PROTHROMBIN TIME (PT)

RESPIRATORY SYNCYTIAL VIRUS

SEMEN

SPUN MICROHEMATOCRIT

STREPTOCOCCUS, GROUP A

THYROID STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC ANTIDEPRESSANTS

TRIGLYCERIDE

URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE HCG BY VISUAL COLOR COMPARISON TESTS

URINE QUALITATIVE DIPSTICK ASCORBIC ACID

URINE QUALITATIVE DIPSTICK BILIRUBIN

URINE QUALITATIVE DIPSTICK BLOOD

URINE QUALITATIVE DIPSTICK CHEMISTRIES

URINE QUALITATIVE DIPSTICK CREATININE

URINE QUALITATIVE DIPSTICK GLUCOSE

URINE QUALITATIVE DIPSTICK KETONE

URINE QUALITATIVE DIPSTICK LEUKOCYTES

URINE QUALITATIVE DIPSTICK NITRITE

URINE QUALITATIVE DIPSTICK PH

URINE QUALITATIVE DIPSTICK PROTEIN

URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL PH

July 6, 2006

I’m

not exactly sure what the profit margin is on these waived tests. I’m

sure it is only a few dollars but I know I’m not losing money on them

& it really helps to have the data at the point of care (more the reason I

do them). I think the UA dips are bundled sometimes but they take all of

2 minutes total. I think all others usually are paid. The rapid streps

seem to pay fairly well whereas a PT/INR only pays ~ $5. Again though, I

don’t make much on them but do not lose on them either & they really

help clinical decisions. I have found the results to be quite accurate

when compared closely in time with a similar test at the hospital lab.

Also keep in mind that I had hospital assistance with startup so I might not

have purchased all of these waived testing devices if I were paying directly

out of pocket.

RE:

Clia Waved Labs -- which are you doing?

Dave, have you found that the equipment and test

strips for th e A1c, INR, ALT, H Pylori etc are worth it ? What are the #

of tests needed to run to break even?

---------

Clia Waved Labs -- which are you doing?

What CLIA waved labs are each of you

doing?

http://www.aafp.org/online/en/home/practicemgt/pt/clia.html

Do you do it for revenues?

Or for patient convenience?

Anyone doing the PPM -- Provider

Provided Microscopy?

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

See good Waiver brochure at...

http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf

See some more links below.

Locke, MD

Here are some links.

Here is a big list of tests...

http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf

http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html

Waived Tests are defined to:

·

Employ methodologies that are so simple and accurate as to render

the likelihood of erroneous results negligible; or

·

Pose no reasonable risk of harm to the patient if the test is

performed incorrectly;

·

Are cleared by the Food and Drug Administration for home use.

The original waived test list contained eight groups

of tests. The list has now been expanded, containing some methods of rapid

strep antigen, infectious mono, H. pylori

and cholesterol testing. Less than one percent of all laboratory tests are

classified as Waived.

Laboratories performing only waived tests must follow

the manufacturer's instructions (procedures) when performing the tests. While

none of the tests on the original waived list have quality control

requirements, it is worth noting that many of the newer waived tests have

quality control requirements. Office personnel should very carefully review the

manufacturer's instructions.

Offices wanting only to perform waived tests mus! t apply for

a Certificate of Waiver.

These

laboratories are not routinely inspected; however they may be inspected as part

of a complaint investigation or on a random basis to determine whether or not

only waived tests are being performed.

Beginning in 1998, waived laboratories are required to

pay a $150 biennial certificate fee.

Those laboratories with an inspecting agency other

than CMS/State Agencies should contact their inspecting agencies to inquire

about their specific requirements.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

or

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Currently

Waived Analytes

The following is a list of analytes that are used in

laboratory test systems that have been " waived " .

Under the current process, waiver may be granted to: 1) any test listed in the

regulation, 2) any test system for which the manufacturer or producer applies

for waiver if that test meets the statutory criteria and the manufacturer

provides scientifically valid data verifying that the waiver criteria have been

met, and 3) test systems cleared by the FDA for home use. The waived analytes

below are linked to waived test systems. Simply click on an analyte of interest

to link to test systems that are waived for the analyte.

Analyte Name

ADENOVIRUS

AEROBIC/ANAEROBIC

ORGANISMS - VAGINAL

ALANINE

AMINOTRANSFERASE (ALT) (SGPT)

ALBUMIN,

URINARY

ALCOHOL,

SALIVA

AMINES

AMPHETAMINES

ASPARTATE

AMINOTRANSFERASE (AST) (SGOT)

B-TYPE

NATRIURETIC PEPTIDE (BNP)

BARBITURATES

BENZODIAZEPINES

BLADDER

TUMOR ASSOCIATED ANTIGEN

CANNABINOIDS

(THC)

CATALASE,

URINE

CHOLESTEROL

COCAINE

METABOLITES

COLLAGEN

TYPE I CROSSLINK, N-TELOPEPTIDES (NTX)

CREATININE

ERYTHROCYTE

SEDIMENTATION RATE,NONAUTOMATED WAIVED

ESTRONE-3

GLUCURONIDE

ETHANOL

(ALCOHOL)

FECAL

OCCULT BLOOD

FERN

TEST, SALIVA

FOLLICLE

STIMULATING HORMONE (FSH)

FRUCTOSAMINE

GASTRIC

OCCULT BLOOD

GASTRIC

PH

GLUCOSE

MONITORING DEVICES (FDA CLEARED/HOME USE)

GLUCOSE,

FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE)

GLYCATED

HEMOGLOBIN, TOTAL

GLYCOSYLATED

HEMOGLOBIN (HGB A1C)

HCG,

URINE

HDL

CHOLESTEROL

HELICOBACTER

PYLORI

HELICOBACTER

PYLORI ANTIBODIES

HEMATOCRIT

HEMOGLOBIN

BY COPPER SULFATE, NONAUTOMATED

HGB,

SINGLE ANALYTE INST. W/SELF-CONT...

HIV-1

AND HIV-2 ANTIBODIES

HIV-1

ANTIBODY

INFECTIOUS

MONONUCLEOSIS ANTIBODIES (MONO)

INFLUENZA

A

INFLUENZA

A/B

INFLUENZA

B

KETONE,

BLOOD

KETONE,

URINE

LACTIC

ACID (LACTATE)

LDL

CHOLESTEROL

LITHIUM

LUTEINIZING

HORMONE (LH)

LYME

DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS)

METHADONE

METHAMPHETAMINE/AMPHETAMINE

METHAMPHETAMINES

METHYLENEDIOXYMETHAMPHETAMINE

(MDMA)

MICROALBUMIN

MORPHINE

NICOTINE

AND/OR METABOLITES

OPIATES

OVULATION

TEST (LH) BY VISUAL COLOR COMPARISON

OXYCODONE

PH

PHENCYCLIDINE

(PCP)

PLATELET

AGGREGATION

PROPOXYPHENE

PROTHROMBIN

TIME (PT)

RESPIRATORY

SYNCYTIAL VIRUS

SEMEN

SPUN

MICROHEMATOCRIT

STREPTOCOCCUS,

GROUP A

THYROID

STIMULATING HORMONE (TSH)

TRICHOMONAS

TRICYCLIC

ANTIDEPRESSANTS

TRIGLYCERIDE

URINE

DIPSTICK OR TABLET ANALYTES, NONAUTOMATED

URINE

HCG BY VISUAL COLOR COMPARISON TESTS

URINE

QUALITATIVE DIPSTICK ASCORBIC ACID

URINE

QUALITATIVE DIPSTICK BILIRUBIN

URINE

QUALITATIVE DIPSTICK BLOOD

URINE

QUALITATIVE DIPSTICK CHEMISTRIES

URINE

QUALITATIVE DIPSTICK CREATININE

URINE

QUALITATIVE DIPSTICK GLUCOSE

URINE

QUALITATIVE DIPSTICK KETONE

URINE

QUALITATIVE DIPSTICK LEUKOCYTES

URINE

QUALITATIVE DIPSTICK NITRITE

URINE

QUALITATIVE DIPSTICK PH

URINE

QUALITATIVE DIPSTICK PROTEIN

URINE

QUALITATIVE DIPSTICK SPECIFIC GRAVITY

URINE

QUALITATIVE DIPSTICK UROBILINOGEN

VAGINAL

PH

July 7, 2006

Locke's and I do lipid panel, fasting glucose, AST, ALT, HgbA1c, PT/INR, UA, Strep testing. Most are for coordination of care benefit at the time of service. Our time is worth about 2/min so none are routine money makers, but wotrth more than a call back to patient and pharmacy to adjust medication later. Worth more to the patient than extra trip to the lab. PT/INR only covers cost of test strip but E/M code reimbursement justifies use. Otherwise we were doing the management for free. Not good to do too many on the same day if medicare. With each additional test the reimbursement drops. Locke's in Colorado wrote: What CLIA waved labs are each of you doing? http://www.aafp.org/online/en/home/practicemgt/pt/clia.html Do you do it for revenues?Or for patient convenience? Anyone doing the PPM -- Provider Provided Microscopy? http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf See good Waiver brochure at... http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf See some more links below. Locke, MD Here are some links. Here is a big list of tests... http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html Waived Tests are defined to: Employ

methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or Pose no reasonable risk of harm to the patient if the test is performed incorrectly; Are cleared by the Food and Drug Administration for home use. The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's

instructions. Offices wanting only to perform waived tests must apply for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm or http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm Currently Waived Analytes The following is a list of analytes that are used in laboratory test systems that have been "waived".

Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte. Analyte Name ADENOVIRUS AEROBIC/ANAEROBIC ORGANISMS - VAGINAL ALANINE AMINOTRANSFERASE (ALT) (SGPT) ALBUMIN, URINARY ALCOHOL, SALIVA AMINES AMPHETAMINES ASPARTATE AMINOTRANSFERASE (AST) (SGOT) B-TYPE NATRIURETIC PEPTIDE (BNP) BARBITURATES BENZODIAZEPINES BLADDER TUMOR ASSOCIATED ANTIGEN CANNABINOIDS (THC) CATALASE, URINE CHOLESTEROL COCAINE METABOLITES COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) CREATININE ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED ESTRONE-3 GLUCURONIDE ETHANOL (ALCOHOL) FECAL OCCULT BLOOD FERN TEST, SALIVA FOLLICLE STIMULATING HORMONE (FSH) FRUCTOSAMINE GASTRIC OCCULT BLOOD GASTRIC PH GLUCOSE GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE) GLYCATED HEMOGLOBIN, TOTAL GLYCOSYLATED HEMOGLOBIN (HGB A1C) HCG, URINE HDL CHOLESTEROL HELICOBACTER PYLORI HELICOBACTER PYLORI ANTIBODIES HEMATOCRIT HEMOGLOBIN HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED HGB, SINGLE ANALYTE INST. W/SELF-CONT... HIV-1 AND HIV-2 ANTIBODIES HIV-1 ANTIBODY INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO) INFLUENZA A INFLUENZA A/B INFLUENZA B KETONE, BLOOD KETONE, URINE LACTIC ACID (LACTATE) LDL CHOLESTEROL LITHIUM LUTEINIZING HORMONE (LH) LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) METHADONE METHAMPHETAMINE/AMPHETAMINE METHAMPHETAMINES METHYLENEDIOXYMETHAMPHETAMINE (MDMA) MICROALBUMIN MORPHINE NICOTINE AND/OR METABOLITES OPIATES OVULATION TEST (LH) BY VISUAL COLOR COMPARISON OXYCODONE PH PHENCYCLIDINE (PCP) PLATELET AGGREGATION PROPOXYPHENE PROTHROMBIN TIME (PT) RESPIRATORY SYNCYTIAL VIRUS SEMEN SPUN MICROHEMATOCRIT STREPTOCOCCUS, GROUP A THYROID STIMULATING HORMONE (TSH) TRICHOMONAS TRICYCLIC ANTIDEPRESSANTS TRIGLYCERIDE URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED URINE HCG BY VISUAL COLOR COMPARISON TESTS URINE QUALITATIVE DIPSTICK ASCORBIC ACID URINE QUALITATIVE DIPSTICK BILIRUBIN URINE QUALITATIVE DIPSTICK BLOOD URINE QUALITATIVE DIPSTICK CHEMISTRIES URINE QUALITATIVE DIPSTICK CREATININE URINE QUALITATIVE DIPSTICK GLUCOSE URINE QUALITATIVE DIPSTICK KETONE URINE QUALITATIVE DIPSTICK LEUKOCYTES URINE QUALITATIVE DIPSTICK NITRITE URINE QUALITATIVE DIPSTICK PH URINE QUALITATIVE DIPSTICK PROTEIN URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY URINE QUALITATIVE DIPSTICK UROBILINOGEN VAGINAL PH

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July 7, 2006

Locke's and I do lipid panel, fasting glucose, AST, ALT, HgbA1c, PT/INR, UA, Strep testing. Most are for coordination of care benefit at the time of service. Our time is worth about 2/min so none are routine money makers, but wotrth more than a call back to patient and pharmacy to adjust medication later. Worth more to the patient than extra trip to the lab. PT/INR only covers cost of test strip but E/M code reimbursement justifies use. Otherwise we were doing the management for free. Not good to do too many on the same day if medicare. With each additional test the reimbursement drops. Locke's in Colorado wrote: What CLIA waved labs are each of you doing? http://www.aafp.org/online/en/home/practicemgt/pt/clia.html Do you do it for revenues?Or for patient convenience? Anyone doing the PPM -- Provider Provided Microscopy? http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf See good Waiver brochure at... http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf See some more links below. Locke, MD Here are some links. Here is a big list of tests... http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html Waived Tests are defined to: Employ

methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or Pose no reasonable risk of harm to the patient if the test is performed incorrectly; Are cleared by the Food and Drug Administration for home use. The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's

instructions. Offices wanting only to perform waived tests must apply for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm or http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm Currently Waived Analytes The following is a list of analytes that are used in laboratory test systems that have been "waived".

Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte. Analyte Name ADENOVIRUS AEROBIC/ANAEROBIC ORGANISMS - VAGINAL ALANINE AMINOTRANSFERASE (ALT) (SGPT) ALBUMIN, URINARY ALCOHOL, SALIVA AMINES AMPHETAMINES ASPARTATE AMINOTRANSFERASE (AST) (SGOT) B-TYPE NATRIURETIC PEPTIDE (BNP) BARBITURATES BENZODIAZEPINES BLADDER TUMOR ASSOCIATED ANTIGEN CANNABINOIDS (THC) CATALASE, URINE CHOLESTEROL COCAINE METABOLITES COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) CREATININE ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED ESTRONE-3 GLUCURONIDE ETHANOL (ALCOHOL) FECAL OCCULT BLOOD FERN TEST, SALIVA FOLLICLE STIMULATING HORMONE (FSH) FRUCTOSAMINE GASTRIC OCCULT BLOOD GASTRIC PH GLUCOSE GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE) GLYCATED HEMOGLOBIN, TOTAL GLYCOSYLATED HEMOGLOBIN (HGB A1C) HCG, URINE HDL CHOLESTEROL HELICOBACTER PYLORI HELICOBACTER PYLORI ANTIBODIES HEMATOCRIT HEMOGLOBIN HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED HGB, SINGLE ANALYTE INST. W/SELF-CONT... HIV-1 AND HIV-2 ANTIBODIES HIV-1 ANTIBODY INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO) INFLUENZA A INFLUENZA A/B INFLUENZA B KETONE, BLOOD KETONE, URINE LACTIC ACID (LACTATE) LDL CHOLESTEROL LITHIUM LUTEINIZING HORMONE (LH) LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) METHADONE METHAMPHETAMINE/AMPHETAMINE METHAMPHETAMINES METHYLENEDIOXYMETHAMPHETAMINE (MDMA) MICROALBUMIN MORPHINE NICOTINE AND/OR METABOLITES OPIATES OVULATION TEST (LH) BY VISUAL COLOR COMPARISON OXYCODONE PH PHENCYCLIDINE (PCP) PLATELET AGGREGATION PROPOXYPHENE PROTHROMBIN TIME (PT) RESPIRATORY SYNCYTIAL VIRUS SEMEN SPUN MICROHEMATOCRIT STREPTOCOCCUS, GROUP A THYROID STIMULATING HORMONE (TSH) TRICHOMONAS TRICYCLIC ANTIDEPRESSANTS TRIGLYCERIDE URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED URINE HCG BY VISUAL COLOR COMPARISON TESTS URINE QUALITATIVE DIPSTICK ASCORBIC ACID URINE QUALITATIVE DIPSTICK BILIRUBIN URINE QUALITATIVE DIPSTICK BLOOD URINE QUALITATIVE DIPSTICK CHEMISTRIES URINE QUALITATIVE DIPSTICK CREATININE URINE QUALITATIVE DIPSTICK GLUCOSE URINE QUALITATIVE DIPSTICK KETONE URINE QUALITATIVE DIPSTICK LEUKOCYTES URINE QUALITATIVE DIPSTICK NITRITE URINE QUALITATIVE DIPSTICK PH URINE QUALITATIVE DIPSTICK PROTEIN URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY URINE QUALITATIVE DIPSTICK UROBILINOGEN VAGINAL PH

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July 7, 2006

Locke's and I do lipid panel, fasting glucose, AST, ALT, HgbA1c, PT/INR, UA, Strep testing. Most are for coordination of care benefit at the time of service. Our time is worth about 2/min so none are routine money makers, but wotrth more than a call back to patient and pharmacy to adjust medication later. Worth more to the patient than extra trip to the lab. PT/INR only covers cost of test strip but E/M code reimbursement justifies use. Otherwise we were doing the management for free. Not good to do too many on the same day if medicare. With each additional test the reimbursement drops. Locke's in Colorado wrote: What CLIA waved labs are each of you doing? http://www.aafp.org/online/en/home/practicemgt/pt/clia.html Do you do it for revenues?Or for patient convenience? Anyone doing the PPM -- Provider Provided Microscopy? http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf See good Waiver brochure at... http://www.cms.hhs.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf See some more links below. Locke, MD Here are some links. Here is a big list of tests... http://www.aafp.org/PreBuilt/PT_CLIAWaived-PPMTestsDec02.pdf http://www.aafp.org/online/en/home/practicemgt/pt/clia/cliawaiveddefined.html Waived Tests are defined to: Employ

methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or Pose no reasonable risk of harm to the patient if the test is performed incorrectly; Are cleared by the Food and Drug Administration for home use. The original waived test list contained eight groups of tests. The list has now been expanded, containing some methods of rapid strep antigen, infectious mono, H. pylori and cholesterol testing. Less than one percent of all laboratory tests are classified as Waived. Laboratories performing only waived tests must follow the manufacturer's instructions (procedures) when performing the tests. While none of the tests on the original waived list have quality control requirements, it is worth noting that many of the newer waived tests have quality control requirements. Office personnel should very carefully review the manufacturer's

instructions. Offices wanting only to perform waived tests must apply for a Certificate of Waiver. These laboratories are not routinely inspected; however they may be inspected as part of a complaint investigation or on a random basis to determine whether or not only waived tests are being performed. Beginning in 1998, waived laboratories are required to pay a $150 biennial certificate fee. Those laboratories with an inspecting agency other than CMS/State Agencies should contact their inspecting agencies to inquire about their specific requirements. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm or http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm Currently Waived Analytes The following is a list of analytes that are used in laboratory test systems that have been "waived".

Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Simply click on an analyte of interest to link to test systems that are waived for the analyte. Analyte Name ADENOVIRUS AEROBIC/ANAEROBIC ORGANISMS - VAGINAL ALANINE AMINOTRANSFERASE (ALT) (SGPT) ALBUMIN, URINARY ALCOHOL, SALIVA AMINES AMPHETAMINES ASPARTATE AMINOTRANSFERASE (AST) (SGOT) B-TYPE NATRIURETIC PEPTIDE (BNP) BARBITURATES BENZODIAZEPINES BLADDER TUMOR ASSOCIATED ANTIGEN CANNABINOIDS (THC) CATALASE, URINE CHOLESTEROL COCAINE METABOLITES COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) CREATININE ERYTHROCYTE SEDIMENTATION RATE,NONAUTOMATED WAIVED ESTRONE-3 GLUCURONIDE ETHANOL (ALCOHOL) FECAL OCCULT BLOOD FERN TEST, SALIVA FOLLICLE STIMULATING HORMONE (FSH) FRUCTOSAMINE GASTRIC OCCULT BLOOD GASTRIC PH GLUCOSE GLUCOSE MONITORING DEVICES (FDA CLEARED/HOME USE) GLUCOSE, FLUID (APPROVED BY FDA FOR PRESCRIPTION HOME USE) GLYCATED HEMOGLOBIN, TOTAL GLYCOSYLATED HEMOGLOBIN (HGB A1C) HCG, URINE HDL CHOLESTEROL HELICOBACTER PYLORI HELICOBACTER PYLORI ANTIBODIES HEMATOCRIT HEMOGLOBIN HEMOGLOBIN BY COPPER SULFATE, NONAUTOMATED HGB, SINGLE ANALYTE INST. W/SELF-CONT... HIV-1 AND HIV-2 ANTIBODIES HIV-1 ANTIBODY INFECTIOUS MONONUCLEOSIS ANTIBODIES (MONO) INFLUENZA A INFLUENZA A/B INFLUENZA B KETONE, BLOOD KETONE, URINE LACTIC ACID (LACTATE) LDL CHOLESTEROL LITHIUM LUTEINIZING HORMONE (LH) LYME DISEASE ANTIBODIES (BORRELIA BURGDORFERI ABS) METHADONE METHAMPHETAMINE/AMPHETAMINE METHAMPHETAMINES METHYLENEDIOXYMETHAMPHETAMINE (MDMA) MICROALBUMIN MORPHINE NICOTINE AND/OR METABOLITES OPIATES OVULATION TEST (LH) BY VISUAL COLOR COMPARISON OXYCODONE PH PHENCYCLIDINE (PCP) PLATELET AGGREGATION PROPOXYPHENE PROTHROMBIN TIME (PT) RESPIRATORY SYNCYTIAL VIRUS SEMEN SPUN MICROHEMATOCRIT STREPTOCOCCUS, GROUP A THYROID STIMULATING HORMONE (TSH) TRICHOMONAS TRICYCLIC ANTIDEPRESSANTS TRIGLYCERIDE URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED URINE HCG BY VISUAL COLOR COMPARISON TESTS URINE QUALITATIVE DIPSTICK ASCORBIC ACID URINE QUALITATIVE DIPSTICK BILIRUBIN URINE QUALITATIVE DIPSTICK BLOOD URINE QUALITATIVE DIPSTICK CHEMISTRIES URINE QUALITATIVE DIPSTICK CREATININE URINE QUALITATIVE DIPSTICK GLUCOSE URINE QUALITATIVE DIPSTICK KETONE URINE QUALITATIVE DIPSTICK LEUKOCYTES URINE QUALITATIVE DIPSTICK NITRITE URINE QUALITATIVE DIPSTICK PH URINE QUALITATIVE DIPSTICK PROTEIN URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY URINE QUALITATIVE DIPSTICK UROBILINOGEN VAGINAL PH

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