Waived laboratories must meet only the following ... - Infolab

NFOLAB WAIVED LABORATORY TESTING
imagine the possibilities...
Imagine the freedom in taking control of your patient testing.
• No comprehensive record keeping
• No government inspections
• No professional staff needed
• No extensive quality control
• No COLA inspections
• No passing revenue to someone else
• No making patients wait for results
Imagine becoming a waived laboratory in three easy steps.
• Complete a simple enrollment form
1
2
3
(www.cms.hhs.gov/providers/enrollment/forms)
Waived laboratories must meet only the
following requirements under CLIA:
Enroll in the CLIA program;
Pay applicable certificate fees biennially; and
Follow manufacturers' test instructions.
The number and types of tests waived under CLIA have increased from 8 tests to
approximately 40 since the inception of the program in 1992; thereby, the number of
waived laboratories has grown exponentially from 20% to 56% of the total 174,500
laboratories enrolled.

Waived Testing Available From Infolab
ALT/AST
CHO 12-778 Alanine Aminotrasferase SGPT 10T
CHO 10-959 Cholestech LDX Analyzer each
Bone Density
QUI QUS-2 Heel Bone Densitometer each
Cholesterol/HDL
ROC 911 Accu-Chek Instant Plus Strips 25/btl
ROC 976 Accu-Check Instant Plus Meter each
CHO 10-986 Cholestech Cholesterol Cassettes 10/box
CHO 10-987 Cholesterol & HDL Cassettes 10/box
CHO 10-959 Cholestech LDX Analyzer each
Coagulation
ITC L21010025 ProTime 3 Channel Cuvettes 25/Box
ITC L110101 Pro Time Instrument each
ROC 3116247 Coagucheck S Test Strips 48/Box
ROC 2138280 Coagucheck S Meter each
ESR
GLO 3469 Sedi-rate 100T
GLO 3471 Sedi-rate 1000T
PMC S-100 Sediplast w/NA Citrate 100T
PMS S-1000 Sediplast w/NA Citrate 1000T
PMC S-101 Sediplast w/o Diluent 100T
PMC S-1001 Sediplast w/o Diluent 1000T
UL H-1600 Dispette II w/Diluent 100T
UL H-1500 Dispette w/o Diluent 100T
BD 366065 ESR Seditainer 100T
Fecal Occult Blood
BEC 61130 Hemoccult II 40/box
BEC 64151 Hemoccult Sensa 100/box
BEC 60152 Hemoccult Sensa Elite 1000/box
BEC 60151 Hemoccult Single Slide 100/box
BEC 395067 Hemoccult ICT Single 20/Box
IMM HS-34 Hema Screen Triple Slide 34/box
IMM HS-100 Hema Screen Single Slide 100/box
IMM HSPP-50 Hema Screen II Patient Pack 50/box
IMM HSTAT-50 Hema Screen STAT Dev-A-Tab 50/box
IT IFOB-101 Fecal Occult Blood 20/box
Gastric Occult Blood
BEC 66040 Gastrocult Slides 40T
Glucose
BAY 3873A Elite Test Strips 50/Btl
BAY 3942A Elite Test Strips 100/Btl
BAY 3901 Elite Meter each
CHO 10-988 T. Cholesterol, Glucose 10/box
CHO 10-990 TC, HDL, Glucose 10T
CHO 10-959 Cholestech LDX Analyzer each
ROC 00913 Accuchek Instant + Glucose Strips 50/Btl
ROC 976 Accu-Check Instant Plus Meter each
ROC 00553 Accu-Check Advantange Strips 50/Btl
ROC 00966 Accu-Check Advantange Strips 100/Btl
ROC 00860 Accu-Chek Advantage Meter each
H. Pylori
B 240905 Link 2 H. pylori 15T
BEC 82020 Flexsure HP 20T
IT IHP-402 H. Pylori 20T
LS 37030 Status H.Pylori 30T
PMC HPY25 Polystat H.Pylori 25T
QUI 0W009 Quickvue 10T
QUI 0W010 Quickvue 30T
WAM 6706KAB H.Pylori 25T
HCG
WAM 6007KCV Clearview HCG II Dip 50T
AB 101 OSOM Urine Dipstick 50T
AB 102 OSOM Urine Card 25T
AB 123 Contrast II HCG (Waived Urine) 30T
BEC 4134 HCG ICON 50T
BEC 4136 HCG ICON 24T
CHE PT124 Ultra-Fast 25T
IMM IHD-25 Detector HCG 25T
IT FHC-101 Urine Dipstick 100T
IT FHC-114 Single Dip 25T
LS 35135 Status HCG 35T
LS 35235 Status Strip 35T
MER 750450 Immunocard Stat 50T
QUI 0257 HCG Rapidvue 25T
QUI 20109 Quckvue 1-Step 25T
SB 1210-425 HCG Urine Qustick 100T
SB 1220-025 HCG Qupid 25T
SB 1220-050 HCG Qupid 50T
SB 1430-050 True 20 HCG 50T
WAM 6008KCV Clearview HCG II Cassette 30T

Hematocrit (Spun)
SST CS12 Critspin each
LW LWM24 Microhematocrit Centrifuge each
LW ZIP2 Zipspin each
Hemoglobin A1c
BAY 5035 DCA HgbA1 Test Kit 10T
BAY 5031 DCA 2000 Analyzer each
CHO 12-321 GDX A1c Test Kit 12/Box
CHO 12-319 Cholestech GDX A1c Analyzer each
Hemoglobin
ITCHGBTEST Hgb Pro Test Strips 100 T
ITC HGBMETER Hgb Pro Meter each
SB 3010-100 Hemopoint H2 MicroCuvette 100/Box
SB 3010-200 Hemopoint H2 MicroCuvette 200/Box
SB G3000-001 Hemopoint H2 Photometer each
SB 901025 STAT-Site M Test Cards 100/Box
SB 900900 STAT-Site M Hgb Meter each
Influenza
BNX 415-000 NOW Flu A/B 20T
BNX 415-120 NOW Flu A/B 10T
MER 780010 NOW Flu A/B 10T
MER 780020 NOW Flu A/B 20T
QUI 0317 Flu A/B, Quickvue 25T
QUI 0324 Flu A/B, Quickvue 10T
QUI 20183 Flu A & B Dipstick-Quickvue 25T
Lipid Profile
CHO 10-989 Cholestech Lipid Profile Cassette 10T
CHO 10-959 Cholestech LDX Analyzer each
Lyme
WAM 63220 Prevue Lyme 20T
Microalbumin
BAY 2229 Micro-Bumin 20T
BAY 2083 Microalbumin with Creatinine 25T
BAY 6516 Bayer Clinitek 50 Analyzer each
ROC 417146 Chemstrip Micral 30/vl
Mono
AB 145 Mono OSOM (Whole Blood) 25T
LS 84W10 Status Mono 10T
LS 84W30 Status Mono 30T
QUI 20121 QuickVue+ 20T
WAM 6908KCV Clearview Mono 30T
Ovulation
CCT 00471 OvuQuick 1-Step 10T
PH/Amies
QUI 20146 QuickVue Advance pH/Amines 25T
RSV
MER 790010 RSV NOW Kit 12T
WAM 135060 Clearview RSV 20T
BNX 430-100 NOW RSV 10T
Strep
AB 141 Strep A Test Osom 50T
AB 147 Strep A Ultra Osom 25T
AB 149 Strep A Ultra Osom 50T
LS 34130 Status Strep A 30T
SB 6000-050 Strep A Q-Stick 50T
WAM 6210KCV Clearview Strep A Stick 30T
B 256018 Chek Strep A 25T
B 422012 Strep A Test Link 2 25T
BEC 395040 Strep A Icon 25T
IT IST-501 Strep A Dipstick 25T
PMC STR25 Polystat Strep A 25T
QUI 0343 Strep A Quickvue 25T
Urinalysis
BAY 1554 Multistix Pro 10LS w/ P:C Ratio 100/Btl
BAY 2161 Multistix 10SG 100/Btl
BAY 6516 Clinitek 50 Urine Analyzer each
ROC 3260763 Chemstrip 10MD Strips 100/Btl
ROC 1904957 Chemstrip 101 Urine Analyzer each
ROC 617548 Urisys 1100 Urine Analyzer each

Changing the Status of a Laboratory (42 CFR 493)
Subpart B - Certificate of Waiver
Section 493.39 - Notification requirements for laboratories issued a certificate of waiver.
Laboratories performing one or more waived tests and no others must notify HHS or its designee
(state agency, COLA, etc):
a. before performing and reporting results for any test or examination that is not waived, and
b. within 30 days of any change(s) in ownership, name, location or director.
Subpart C - Registration Certificate and Certificate
Section 493.51 - Notification requirements for laboratories issued a certificate
Laboratories issued a certificate must:
a. Notify HHS or its desginee (state agency) within 30 days of any change in ownership, name, location, and/or
director. High complexity laboratories must report changes in supervisors.
b. Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty
area that is not included on the laboratory's certificate
c. Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination
included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate.
Section 493.53 - Notification requirements for laboratories issued a certificate for provider-performed
microscopy (Federal Register, January 19, 1993)
Laboratories issued a PPM certificate must notify HHS or its designee:
a. Before performing and reporting results for any test or examination that is not waived or PPM.
b. Within 30 days of any change in - ownership, name, location, and/or director.
Subpart D - Certificate of Accreditation
Section 493.63
Same as in Subpart C, Section 493.51.
(http://www.aafp.org/x2249.xml?printxml)
Contact the AAFP-PT Department (1-800-274-7911)
for additional information.
COLA has two CLIA Fact sheets (#7 and # 8) on this topic;
COLA's phone number is 800-298-8044.
INFOLAB ORDERING AND CONTACT INFORMATION
Distribution Center Toll Free Ordering Number Fax Order Line
Clarksdale, MS 1-800-647-8222 1-662-627-1913
Fort Oglethorpe, GA 1-800-241-8953 1-706-866-5234
Greensboro, NC 1-800-782-9700 1-336-272-0518
Indianapolis, IN 1-866-232-7096 1-317-873-4443
Ocala, FL 1-800-734-7584 1-352-237-9733
Round Rock, TX 1-800-322-3882 1-512-255-6764