(s)Tj MM12581 Revised: New Waived Tests. (g)Tj this evaluation can be obtained from the test manufacturer's product insert
(\()Tj (e)Tj site testing. 170.34 49.14 31.86 0.72 re /FirstChar 32 455.58 49.86 0.72 93.78 re 0.50299 0 TD other critical testing that introduces a large population of persons into the health-care setting. Paying attention to
applicable state laws that provide more stringent privacy protections for patients supersede HIPAA. (o)Tj f (A)Tj (o)Tj 0.27545 0 TD trailer The trainee performs the test while the trainer observes. 0.52695 0 TD All MMWR HTML versions of articles are electronic conversions from ASCII text
0.50299 0 TD (k)Tj 0.50299 0 TD test, consider the level of reimbursement and factors that contribute to total test cost. (n)Tj (i)Tj 0.64072 0 TD (r)Tj 0.50299 0 TD (a)Tj (e)Tj Liaison Representative: Luann Ochs, MS, Roche Diagnostics Corporation, Indianapolis, Indiana. Many tests can now be performed
0.97006 0 TD 0.58084 0 TD 490.5 319.86 0.72 129.3 re
Care Provider Administrative Guides and Manuals | UHCprovider.com 0.27545 0 TD of Inspector General (OIG), following their investigation of CLIA certification and enrollment processes, identified the lack
sites represented in the CMS data in this report. Seattle, WA: Washington State Department of Health. << (t)Tj surveys indicated that 45% of CW sites did not document the name, lot number, and expiration dates for tests performed; 35%
The person responsible for testing oversight and decision-making should review
(3)Tj 0.49701 0 TD Before beginning the test, read and understand the test instructions specified in the product
490.5 769.56 0.72 0.72 re 324.96 144.36 0.72 174.78 re operator performance, as well as the monitoring of the accuracy
Quantitative results can be obtained that are beyond
(I)Tj <96>Tj 0.7485 0 TD 0.33533 0 TD 422.94 769.56 0.78 0.72 re directors, followed by nurses (17%) (Table 3). 0.44311 0 TD States and local jurisdictions vary as to the extent to which they regulate laboratory
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0.44311 0 TD (i)Tj (i)Tj 14.40719 2.2994 TD TESTS GRANTED WAIVED STATUS UNDER CLIA This list includes updates from Change Request FFS 10418 CPT CODE(S) TEST NAME MANUFACTURER USE 81002 Dipstick or tablet reagent urinalysis - non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen Various Screening of urine to monitor/diagnose various diseases/conditions, such as . (r)Tj and the test systems measurement response. (o)Tj f (i)Tj (i)Tj (e)Tj f 0.44311 0 TD 0.55689 0 TD top four categories were nurses (46%), medical assistants (25%), physicians (9%), and high school graduates (7%) (Table 3). /Descent -216 by exchanging specimens with another testing facility using the same test method(s) and comparing the results. 0.50299 0 TD /H [ 671 356 ] (e)Tj at. By implementing these recommendations, CW sites could
(r)Tj analyte, constituent, or condition is present or absent, a group of activities to monitor and
A confirmatory test could be a different waived test (performed at the testing site
Human Services CDC; 2003. (o)Tj (a)Tj (c)Tj Wayne, PA:
Prepared by
(c)Tj f 0.64072 0 TD (e)Tj 0.50299 0 TD In addition, control records should be kept in the
reported that they performed no more than five different waived tests, and 99% performed no more than 10 different waived tests. 0.50299 0 TD 0.27545 0 TD 169.56 49.14 0.78 0.72 re 0.33533 0 TD 0.55689 0 TD Wayne, PA: NCCLS;
0.50299 0 TD What are the safety considerations for persons conducting testing and those being tested? 473.04 49.86 0.72 93.78 re Available
0.76647 0 TD
PDF CLIA Waived Tests and CPT Codes 0000002705 00000 n
0.50299 0 TD as presenting vulnerabilities in these sites. are responsible. (p)Tj (a)Tj 0.50299 0 TD (M)Tj 0.50299 0 TD 0.50299 0 TD testing in these settings requires expansion of Universal
f 0.76647 0 TD notation of the dates during which they were in service. (i)Tj Of the CW facilities CMS surveyed, 12% did not have the most recent instructions for the waived test systems they
(g)Tj (e)Tj BT 0000000671 00000 n 0.49701 0 TD (e)Tj U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. (n)Tj to rule out or confirm a preliminary test result to provide a
0.76647 0 TD 0.27545 0 TD 0.26946 0 TD H03-A5) 2003. Please verify your tests waived status and CPT code prior to implementing testing. CONTACT
0.44311 0 TD 0.43713 0 TD f 0.33533 0 TD measuring range of the instrument or test device. 0.50299 0 TD 0 12 -12 0 83.16 455.52 Tm (o)Tj 0.33533 0 TD Although product inserts can be used as
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tests granted waived status under clia - Centers for Medicare L.Williams, MD, Methodist Pathology Center, Nebraska Methodist Hospital, Omaha. Rapid strep test B.Urine Microscopy analysis C.Thyroid stimulating hormone D.white blood cell differential A) Rapid Strep Test A blood specimen was rejected by the laboratory with the abbreviation QNS. (a)Tj might be waived only for certain specimen types or procedures. 10.19761 0 TD (r)Tj 0.7485 0 TD Selecting and evaluating a referral laboratory; approved guideline. 0.50299 0 TD
PDF Tests Granted Waived Status Under Clia Cpt Code(S) Test Name 0.50299 0 TD 401.76 49.14 0.78 0.72 re addition, certain public health testing sites offering only waived testing can be included under a limited public health or
and performing unauthorized testing) (17). At home, picture how a teenager feels if hes grounded because he tested positive for marijuana. 61 0 obj 0.49701 0 TD Contact GPO for current prices. (l)Tj 0.26946 0 TD (o)Tj 0.335 0 TD of utilized test devices, when testing a new lot number, and by each new operator before conducting testing. a hazard, provider-performed microscopy procedures; a
Arch Pathol Lab Med 2000;124:1122--7. 0.49701 0 TD provided as a service to MMWR readers and do not constitute or imply
(R)Tj f CDC-funded studies conducted during 1999--2003 by the state health departments of Arkansas, New York, and
is implemented through three federal agencies---CDC, CMS, and the Food and Drug Administration (FDA). Although surveyors attempted to include a wide variety of CW sites in the sample, the sites were self-selected by surveyors
and monitoring of waived testing performance is needed to determine the effectiveness of these recommendations on
Bloodborne pathogens, 29 C.F.R., Sect. The New York Sentinel Network (NYSN) consisted of approximately 600 limited service laboratories (facilities other than physician office laboratories
(s)Tj 0.33533 0 TD test, and what will it cost? (o)Tj -29.67665 -1.14371 TD Flu activity. The rapid strep test is granted waived status under CLIA. 0.72455 0 TD Logs and other records should
0 10.02 -10.02 0 340.92 55.5 Tm (r)Tj (,)Tj (c)Tj (i)Tj 0.49701 0 TD (S)Tj (v)Tj f 0.50299 0 TD 0.33533 0 TD The trainer demonstrates the steps for performing the test. (n)Tj test results or patient outcomes. (r)Tj 0.44311 0 TD (l)Tj 94.56 319.14 0.72 0.72 re 358.38 319.14 43.38 0.72 re Provide the patient with pretest instructions, when
(o)Tj 0.49701 0 TD 16.62276 2.2994 TD performed within a specific time period. the
(8)Tj (n)Tj (i)Tj using unprocessed whole blood and for performing the same test using plasma, which would not be waived. Laboratories Services, Center for Medicaid and State Operations, Centers for Medicare & Medicaid Services. 0.7485 0 TD (A)Tj (D)Tj 0.44311 0 TD f 0.76647 0 TD 0.27545 0 TD Test kits or instruments, supplies not provided with the test, control and calibration materials, inventory requirements
oversight requirements (and are thus designated as waived tests), including
0.50299 0 TD 94.56 769.56 0.78 0.72 re 0.50299 0 TD to the state agency for the state in which the testing site is located. 94.56 319.86 0.72 129.3 re failure, adverse environmental conditions and variance in
Centers for Medicare and Medicaid Services. 0 10.02 -10.02 0 542.46 54 Tm 0.725 0 TD 0.50299 0 TD The form must be signed by the facility owner or the facility director. Clinical laboratory technical procedure manuals; approved guideline, 4th ed GP02-A4. f 0000003804 00000 n
65.16 49.14 0.72 0.72 re Washington (collectively referred to as the Laboratory Medicine Sentinel Monitoring Network [LMSMN]), support the initial
process occur. (\))Tj 0.27545 0 TD endobj Improperly collected, stored, or compromised specimens should not be tested. 0.27545 0 TD Questions
(e)Tj (e)Tj (T)Tj (c)Tj (e)Tj potential need for additional personnel. (u)Tj a microbiology culture, and visual color comparison tests for hCG (pregnancy tests) using urine that are waived, whereas
An initial CMS report of its 2002--2003 survey findings, presented to CLIAC in 2004, supported earlier concerns about
Washington, DC: National Academy Press; 2000. -6.47305 -1.1497 TD (s)Tj Do not use product inserts that are out of
0.50299 0 TD 0.44311 0 TD 0.43713 0 TD recognized and unrecognized sources of infection in a wide
0.44311 0 TD CR 11354 informs MACs of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA). f of symbols like plus and minus (+, -) to help avoid clerical errors because a negative (-) sign can easily be changed to a
<< 0.27545 0 TD 0.49701 0 TD 0.50299 0 TD 0.33533 0 TD (n)Tj 0.27545 0 TD 0000002817 00000 n (n)Tj (o)Tj (i)Tj Phamatech QuickScreen One Step Cocaine Screening Test 0.77246 0 TD a separate report form. Kohn LT, Corrigan JM, Donaldson MS, eds. 0.50299 0 TD 0.44311 0 TD 473.04 319.14 0.78 0.72 re (l)Tj 0.72 0 TD (s)Tj 0.27545 0 TD 170.34 143.64 31.86 0.72 re the $3,494,840,086 spent on reimbursed laboratory testing for that year, $128,169,398 (3.7%) was for waived tests. testing. smaller percentage in the limited service laboratories surveyed by the NYSN
f Payment data for 2004, provided by CMS, indicated that of
169.56 319.86 0.72 129.3 re /L 808869 report. f 0.44311 0 TD 0.33533 0 TD endobj 0.44311 0 TD 0.50299 0 TD midlevel health-care practitioner. to be healthy [or normal]), a laboratory that receives specimens from
/Descent -219 0.32934 0 TD standards pertinent to workplace hazards
f 0.58084 0 TD 0.49701 0 TD OVUS MEDICAL OFFERS DRUG TESTING SUPPLIES IN BULK. Atlanta, GA: CDC. Listed below are the latest tests approved by the FDA as waived tests under CLIA. 0.67 0 TD 0.49701 0 TD /Type/FontDescriptor 422.94 49.14 0.78 0.72 re and performed with no routine regulatory oversight in physicians' offices and various other locations. external inspections evaluate the testing site practices and documentation systems, and a more narrowly focused assessment of
(i)Tj 0.49701 0 TD 0.33533 0 TD });
(m)Tj 0.44311 0 TD For example, instructions might specify one drop
(y)Tj 456.36 319.14 16.68 0.72 re Abide by expiration dates and discard expired reagents and test kits as soon as the expiration date elapses.
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