(a)Tj 1 1 1 rg Waived Tests | CDC - Centers for Disease Control and Prevention 0.50299 0 TD Disclaimer /Descent -216 0.44311 0 TD (D)Tj 0.49701 0 TD 402.54 49.14 20.4 0.72 re 0.64072 0 TD 65.94 49.14 28.62 0.72 re Contact your Medicare carrier for claims instructions.) (t)Tj Neglecting to (n)Tj (c)Tj (r)Tj /Parent 58 0 R (i)Tj FEE. results contribute to diagnosis and prognosis of disease, monitoring of treatment and health status, and population screening (e)Tj 0.27545 0 TD The form must be signed by the facility owner or the facility director. 0.27545 0 TD >> 0.44311 0 TD 0.50299 0 TD 0.44311 0 TD (b)Tj (l)Tj (t)Tj >> 0.33533 0 TD Documentation. 0.32934 0 TD (n)Tj Advances in technology have made tests simpler, contributing to this shift in testing. (u)Tj (0)Tj problems occur. (n)Tj microorganisms to prevent infection, microorganisms that, when present in human under CLIA. 0.76647 0 TD 0.50299 0 TD (u)Tj 0.27545 0 TD 64 0 obj absence of CLIA-required quality measures. problem, contact the manufacturer or product technical representative. system established to read results during the correct timeframe, especially if conducting more than one test at a time. (v)Tj 0.27545 0 TD (r)Tj 0.49701 0 TD TESTS GRANTED WAIVED STATUS UNDER CLIA CPT CODE(S) TEST NAME MANUFACTURER USE 80101QW (This test may not be covered in all instances. (8)Tj Do they need certifications or licenses for it? -5.40719 -1.14371 TD (s)Tj (a)Tj 0.44311 0 TD (t)Tj (o)Tj Tests granted waived status under clia cpt code s test Internal, procedural, or built-in controls --- evaluate whether certain aspects of the test system are working properly. XmKBq @Tx(Ha$Y8T^lZj*Z]\X9` # 0.33533 0 TD (n)Tj Please verify your tests waived status and CPT code prior to implementing testing. (n)Tj notification to the clinician for patient evaluation or << 0.43713 0 TD 0.27545 0 TD in a positive manner with an emphasis on education and promoting good testing practices. (o)Tj 0000003232 00000 n limited training. 281.58 143.64 43.38 0.72 re (y)Tj CMS surveys indicated that certain CW sites (5%) were performing testing more complex than waived testing without f (c)Tj 0.44311 0 TD (n)Tj 0.32934 0 TD CLIA is the acronym of Clinical Laboratory Improvement Amendments of 1988. 473.82 49.14 16.68 0.72 re to the appropriate background and knowledge to make decisions about laboratory testing. f (o)Tj or recommended frequencies for testing internal and/or external controls. (n)Tj Mary McGovern, MD, Molecular Genetics Laboratory, Mount Sinai School of Medicine, Mount Sinai Medical Center, New York, New York; Dina R. (n)Tj (e)Tj 0.27545 0 TD 456.36 143.64 16.68 0.72 re 0.43713 0 TD CMS surveyed 4,214 CW sites during April 15, 2002--November 12, 2004. (p)Tj 0.44311 0 TD 358.38 769.56 43.38 0.72 re (4)Tj for medical and dental offices (24), are available at 0.38922 0 TD maintained in chronological order to facilitate retrieval of (E)Tj of Medicare Part B reimbursed waived laboratory testing in 2004 represented 8% of the total reimbursed testing volume 0.27545 0 TD 0.27545 0 TD 0.49701 0 TD 0.50299 0 TD /H [ 671 356 ] 0.97 0 TD (l)Tj prothrombin time, cholesterol, and glucose either used complex manual methodologies or were performed using sizable standards pertinent to workplace hazards CMS Updates Waived Tests - NAHC Report (i)Tj When nonwaived confirmatory testing is needed, the patient can be sent to another facility for specimen collection and testing, or the Available at, CDC. and disposal of medical waste. 0.33533 0 TD (G)Tj (n)Tj (g)Tj 0.26946 0 TD When a CW site collects specimens for referral, procedures should include 0.27545 0 TD 0.72 0 TD 0.43713 0 TD (D)Tj 0.50299 0 TD 0.72 0 TD (a)Tj implemented, waived testing has steadily increased in the United States. They are intended to be used by those who would benefit from TESTS GRANTED WAIVED STATUS UNDER CLIA This list includes updates from Change Request 6906 * Newly added waived test system 3 CPT CODE(S) TEST NAME MANUFACTURER 80061QW, 82465QW (Contact your Medicare carrier for claims instructions. 0.49701 0 TD 0.555 0 TD On the basis of manufacturer's instructions, 21% of the CW sites did not perform QC testing laboratory, Complete test results and the date received, and, Test procedures or work instructions (e.g., written procedures specific to the CW site and current product inserts), Records of testing materials used, test system and equipment function checks, and maintenance, Test results, including any confirmatory or supplemental testing, QC testing results and corrective action taken if control results are unacceptable, Records of any test system failures, troubleshooting, and corrective action taken when problems are 0.43713 0 TD 0.27545 0 TD In addition, some tests have specific environmental requirements described in the (r)Tj stream ET Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood) final result, a device or solution used to monitor a test 0.50299 0 TD 0.50299 0 TD (m)Tj and identification of the collector. components that has not undergone centrifugation or had the (v)Tj (a)Tj 0.38922 0 TD 0.27545 0 TD 0.50299 0 TD 0.49701 0 TD (6)Tj The lack of oversight and requirements for personnel qualifications and training for an increasingly large number of 0.50299 0 TD Additional information on HIPAA (s)Tj Atlanta, GA: CDC. 0.76647 0 TD In addition, this report presents recommendations developed by the 169.56 449.16 0.78 0.72 re prevent specimen mix-up. Health Information and Service, CDC; Daralyn Hassan, MS, and the CMS Waived Laboratory Project Team, Division of Laboratory 0.50299 0 TD Clin Leadersh Manag Rev 2004;18:65--9. Clin Leadersh Manag Rev 2004;18:342--8. (i)Tj 2. (o)Tj test; also referred to as package insert, proficiency testing; an external quality f 473.82 319.14 16.68 0.72 re (d)Tj that test results are reliable, improve the testing process, and 0.38922 0 TD 0.38922 0 TD 0.44311 0 TD 0.38922 0 TD (o)Tj f (e)Tj 0.725 0 TD (t)Tj Washington, endorsement of these organizations or their programs by CDC or the U.S. appropriate state or local agency that has an agreement under specimens and monitor the testing process from specimen 0.72455 0 TD //"p1" through "p10" exist 0.44311 0 TD 0.7485 0 TD (u)Tj 0.58084 0 TD Arch Pathol Lab Med 2000;124:1122--7. (o)Tj a larger health-care organization that holds a CLIA Certificate of Compliance or Certificate of Accreditation. a timely manner to the appropriate person. Performing QC testing procedures provides assurance that the test performs as expected and alerts the user when (11--16). /FontFile2 3 0 R 0.50299 0 TD 423.72 143.64 31.86 0.72 re Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 0 10.02 -10.02 0 296.76 55.5 Tm CMS survey results also indicated that, in varying proportions, when CW sites had the current instructions, they did not (g)Tj 0.5509 0 TD (3)Tj 0.50299 0 TD (n)Tj 0 10.02 -10.02 0 373.56 55.5 Tm (T)Tj 0.27545 0 TD in diabetics. (,)Tj 0.50299 0 TD (y)Tj Specific state agencies and contacts are available at 0.44311 0 TD 0.50299 0 TD (c)Tj Directions for specimen collection, handling, and Work space --- Work surfaces should be stable and level and be able to be adequately disinfected; work space should (e)Tj 0.32934 0 TD a scientific study of a random sample of CW sites. 0.50299 0 TD (r)Tj (f)Tj ), USE 83718QW, 84478QW 1. (u)Tj << CDC. H04-A5) 2004. reported that they performed no more than five different waived tests, and 99% performed no more than 10 different waived tests. specimen can be collected at the CW site and sent to a referral laboratory. EN. 0.58084 0 TD f /S 256 (8)Tj 0.26946 0 TD (N)Tj flow charts with essential steps for conducting a test that are (o)Tj 10.19761 0 TD 0.27545 0 TD (1)Tj (i)Tj LaBeau KM, Simon M, Steindel SJ. 0.43713 0 TD might be waived only for certain specimen types or procedures. (r)Tj Additional Measures to Help Testing Staff Ensure Reliable Results. (s)Tj MM12581 Revised: New Waived Tests. 0.33533 0 TD Management responsibility for testing. 0.26946 0 TD (r)Tj patients received instructions before testing. 0.27545 0 TD They also address developing procedures f 71 0 obj Identifying a resource person or expert (e.g., a consultant or manufacturer's technical representative), available 0.50299 0 TD correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. 0.50299 0 TD 0.44311 0 TD Georgia Health System, LaGrange, Georgia; Kathryn M. Foucar, MD, Department of Pathology, University of New Mexico, Albuquerque; Paula (a)Tj 0.50299 0 TD 0.64072 0 TD 0.71856 0 TD include group A streptococcal antigen testing, which is waived only when performed on a throat swab and not when performed on 0.50299 0 TD efpR:X@LCxn,,*,"y5+1yh0L0 Ah0Hlo~h v`KGbR Q0qF 0_4 eU30@SS 0.76647 0 TD (R)Tj Available. (o)Tj the state health agency or other (e)Tj Wayne, PA: NCCLS; 2002. (n)Tj 0.97 0 TD (s)Tj Available at, CDC. (n)Tj (c)Tj in nontraditional settings (e.g., health fairs) or community outreach venues (e.g., shopping malls, meeting rooms, parks, Payment data for 2004, provided by CMS, indicated that of (i)Tj (f)Tj (t)Tj and competent in each test they will perform before reporting patient results 0.74252 0 TD (o)Tj amount of an analyte in a specimen, whose results are expressed Committee, Clinical and Laboratory Standards Institute #r3a% ?bh!fJVs3$R is a mechanism to be sure the test system has remained stable -6.12575 -1.1497 TD (4)Tj f technology continues to evolve. 0.50299 0 TD 0.44311 0 TD (h)Tj information if needed. 0.27545 0 TD (c)Tj Mountain, Georgia; Jacinto Del Mazo, MD, Del Mazo Medical Services, Atlanta, Georgia; Paula W. Garrott, EdM, Clinical Laboratory Science 0.44311 0 TD (u)Tj 0.49701 0 TD In response, (c)Tj (a)Tj and practices include recording what happens, whether f 0.44311 0 TD ET f BT 0.50299 0 TD f 65.16 49.14 0.72 0.72 re f /I 300 /Resources<>>> (o)Tj (r)Tj Increasingly, these decisions are based on simple tests performed at the point-of-care using devices that are waived from most federal test specimens exactly as described in the test system instructions, using the appropriate collection device and method to obtain 0.50299 0 TD variety of human sources. testing, and how will they be trained and maintain testing competency? MMWR 1988;37:377--82, 387--8. http://www.cdc.gov/flu/weekly/fluactivity.htm. 0.27545 0 TD (i)Tj 0.49701 0 TD (S)Tj 0.32934 0 TD /BaseFont/TimesNewRoman (i)Tj 0.44311 0 TD completed test request forms. (t)Tj 0.27545 0 TD URL addresses listed in MMWR were current as of (. 0.97 0 TD DC: Occupational Safety and Health Administration; 2003. true or target value; freedom from error; An estimated (o)Tj Continued surveillance 0.38323 0 TD 95.34 769.56 74.22 0.72 re 2003--2004 (Table 4), nurses most frequently provided waived test training (33%), followed by the manufacturer or sales (U)Tj 0.26946 0 TD 0.50299 0 TD (E)Tj 0.49701 0 TD (8)Tj 0.44311 0 TD 0.27545 0 TD (t)Tj 0.38922 0 TD 0.44311 0 TD (o)Tj f 0000003928 00000 n 0.27545 0 TD (e)Tj 5---waived and PPMP sites---testing personnel turnover. by exchanging specimens with another testing facility using the same test method(s) and comparing the results. <96>Tj What written documentation will be needed, and how will test records be maintained? 0.58084 0 TD (r)Tj (3)Tj instrumentation, reagents, and supplies needed to perform a test Available at, Clarke LM, Jenny R, Shulman S, Reilly A, Olsen C. New York State's experience with assessment of waived testing and PPMP practices: are we 0.44311 0 TD of critical values and timely notification of the proper medical personnel. 0.7485 0 TD the quality of testing in CW sites and enhance patient (i)Tj 401.76 143.64 0.78 0.72 re Specimens that are processed or manipulated by the user (e.g., serum or plasma) 0.44311 0 TD /StemV 0 0.39 0 TD (n)Tj 0.44311 0 TD patient harm and the associated morbidity and mortality can (t)Tj (E)Tj that responsibilities and testing instructions are clearly described for the testing personnel and facility director. (a)Tj What Does CLIA Waived Mean? - Drug Test City 0.50299 0 TD Most testing is not waived and is typically performed in hospital or reference CLIA stands for Clinical Laboratory Improvement Amendments. f The CLIA program is administered by CMS and f (i)Tj 13.86228 1.14371 TD /FontName/OYYAMG++Symbol 0.44311 0 TD Clin Leadersh Manag Rev 2000;14:296--300. (o)Tj (o)Tj (T)Tj (,)Tj /BaseFont/TimesNewRoman,Bold 0.27545 0 TD Incorrect timing of these types of tests can give erroneous test results. the date of publication. /F1 1 Tf Tests Granted Waived Status Under Clia Cpt Code(S) Test Name /Ascent 891 0000000714 00000 n identification before collecting the specimen, especially if more than one test is being performed at the same time. 65.94 319.14 28.62 0.72 re (e)Tj What Is A Clia Waived Test? 0.44311 0 TD 0.50299 0 TD Results can be recorded directly in a patient's chart, in log books, or on LMSMN obtained additional waived testing data from 1999--2003. (s)Tj 0.26946 0 TD (o)Tj (e)Tj (,)Tj (o)Tj to those identified in the CMS pilot studies. (1)Tj 0.49701 0 TD 0.58084 0 TD How will introduction of testing affect the current work flow, are there sufficient personnel to conduct that does not contain cells. BT 0.44311 0 TD to the state agency for the state in which the testing site is located. identification. 0.49701 0 TD Centers for Medicare and Medicaid Services. endstream endobj 4386 0 obj<>/Size 4368/Type/XRef>>stream BT These advances have enabled more testing 0.72 0 TD (a)Tj (g)Tj (r)Tj 0.50299 0 TD The rapid strep test is granted waived status under CLIA. 0.27545 0 TD 0.50299 0 TD (n)Tj (d)Tj Just imagine if a doctor prescribes morenaltrexoneto a patient who doesnt use opioids anymore but got a false positive for it? (26--30). (d)Tj 0.58683 0 TD (l)Tj of persons involved in performing waived testing. /Flags 262178 0.50299 0 TD 0.50299 0 TD 0.33533 0 TD 84.48 325.5 1.14 103.92 re /Length 263 (c)Tj 0.43713 0 TD However, according to the CW sites that provided this information for Many tests can now be performed (s)Tj 0.50299 0 TD (i)Tj test performance can be accomplished by participating in performance evaluation programs or subscribing to PT programs. 0000006350 00000 n CLIA - NAHC Report (c)Tj Baltimore, MD: Centers for Medicare and Medicaid Services. specimen using a microscope, control materials that mimic patient Another example new personnel who are not yet familiar with the testing process might compromise the test. (m)Tj 0.26946 0 TD (l)Tj laboratory practices, over the years these studies have demonstrated that a persistent percentage of CW sites do not meet information. xA 4WT0>m{dC. (t)Tj /ItalicAngle 0 0.50299 0 TD 0.72455 0 TD 0.58084 0 TD The test site should have telephone numbers or other contact information 0.44311 0 TD (E)Tj 0.33533 0 TD site directors and testing personnel. PDF MM12581 - New Waived Tests - Centers for Medicare & Medicaid Services (s)Tj (s)Tj 0.7485 0 TD health plans, doctors, hospitals, and other health-care providers. 455.58 449.88 0.72 319.68 re educational background and qualifications for directors and testing personnel at CW sites were collected as part of the CMS surveys 0.72455 0 TD f 0.665 0 TD 0.27545 0 TD neutralize it, any substance that, when introduced into /PageMode/UseNone and precision of the test performance over time, a test that measures the concentration or Tests Granted Waived Status Under Clia - Manage My Practice.com 0.27545 0 TD 0.50299 0 TD (C)Tj 0.63473 0 TD >> ), 83718QW, 84478QW 1. (c)Tj 0.58683 0 TD phases; before testing, during testing, and after testing. 0.67 0 TD (C)Tj Listed below are the latest tests the FDA approved as waived tests under CLIA. <96>Tj f Forethought, planning, and preparation are critical to initiating high-quality waived testing in any type of setting. (s)Tj 0.69461 0 TD 455.58 49.14 0.78 0.72 re of utilized test devices, when testing a new lot number, and by each new operator before conducting testing. (b)Tj (2--4). Available at. Clinical Laboratory Improvement Amendments (CLIA): Requirements impact reaction times, cause premature expiration of test kits, and affect the test results. using unprocessed whole blood and for performing the same test using plasma, which would not be waived. 0.50299 0 TD 0.27545 0 TD 0.50299 0 TD This trend is expected to continue as laboratory testing (3)Tj Each site should determine the appropriate 473.04 143.64 0.78 0.72 re 2005 (publication no. (\()Tj External controls --- mimic patient specimens and monitor the testing process, from specimen application Insufficient timing can result in false negative After-testing activities include issuing test reports, supplemental or confirmatory testing, public health disease reporting 0.43713 0 TD 0.26946 0 TD (m)Tj /Ascent 1005 records periodically. (t)Tj f (s)Tj NCCLS. LaBeau KM. 0.32934 0 TD LOWEST PRICES ON DRUG TEST CUPS, STRIPS, DIPS & SWABS. (e)Tj 0.33533 0 TD 0.50299 0 TD be in compliance with local ordinances, state, and federal OSHA regulations as previously discussed. As described in the IOM report, errors most often occur when multiple contributing factors converge, and preventing errors 202.98 319.14 77.82 0.72 re 0.44311 0 TD Specimen labeling. /Prev 807522 0.50299 0 TD 0.44311 0 TD 0.50299 0 TD f 0.52695 0 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 . f They might be provided as liquid or other materials similar (t)Tj 202.98 49.14 77.82 0.72 re recorded directly in a patient's chart, they should be recorded in a written report format that includes all information needed and skills and knowledge of the testing personnel. 0.55689 0 TD 0.33533 0 TD 0.33533 0 TD for information and training in CW sites. (o)Tj 16.62276 2.2994 TD 0.50299 0 TD (S)Tj (D)Tj 0.27545 0 TD 0.38922 0 TD 0.52695 0 TD (u)Tj (t)Tj 0.50299 0 TD (u)Tj (N)Tj (z)Tj (i)Tj 0.76647 0 TD inspections, supervisory review of documented problems that occur in the different phases of the testing process, review of (p)Tj 94.56 449.16 0.78 0.72 re /Type/FontDescriptor xref 0.50299 0 TD Therefore, it is important to have a Some things to keep in mind when appending modifier QW to your lab service/s: The modifier is used to identify waived tests and must be submitted in the first modifier field.
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