We are amending 493.923(b)(1), 493.927(c)(1), 493.931(c)(1), 493.933(c)(1), 493.937(c)(1), 493.941(c)(1), and 493.959(d)(1) to clarify that for the purpose of achieving consensus, PT programs must attempt to grade using both participant and referee laboratories before determining that the sample is ungradable. (1) To determine the accuracy of a laboratory's response, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 100 percent of 10 or more referee laboratories or 95 percent or more of all participating laboratories except for antibody identification. Delayed Effective Date and Ongoing Process for Updating PT Regulations (493.2 and 493.801 Through 493.959), C. Enrollment and Testing of Samples (493.20(c) and 493.25(d)), D. PT Program Approval and Administration (493.901, 493.903, 493.905), E. Proposed Changes to Microbiology PT (493.911 Through 493.919), F. Proposed Changes to PT for Non-Microbiology Specialties and Subspecialties (493.921 Through 493.959), IV. ++ We are finalizing the proposed percentage based ALs in the criteria for acceptable performance. Similarly, for the Medicaid estimates, we knew from CMS data that there were approximately 52.5 million individuals covered by Medicaid, so we derived a factor of 8.0 (52.5 million individuals/6.5 million individuals) by which to multiply the MarketScan Medicaid estimates to extrapolate estimates for the entire United States. We have developed comprehensive instructional and reference materials to assist our customers get the most out of their proficiency testing (PT) and quality management programs. After the target value has been established for each response, the appropriateness of the response is determined using either fixed criteria based on the percentage difference from the target value or the number of standard deviations (SD) the response differs from the target value. Please complete the Name, Address, and County for your client on the front of the box. About the Federal Register Further, 493.851(a) states that failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory performance for the testing event. If the requirement for acceptable performance remains at 90 percent, a laboratory can only have satisfactory performance if they receive 100 percent; however, 493.851(a) allows satisfactory performance for both 80 percent and 100 percent. Differences between reagent lots used during testing may occur due to the manufacturing process. 4. ++ We are correcting the units for phenytoin and vancomycin. One commenter agreed with this proposed change but recommended that we provide more guidance to laboratories on how to meet this requirement. Federal Register Increasing the number of events might help to identify a laboratory with testing issues slightly earlier, but increasing the number of events would increase costs. The commenter stated that when the peer group size is between 5 and 19 laboratories, robust methods as described in ISO 13528, ISO Guide 35, or ASTM E-691, should be used. During the phase in period, manufacturers will have time to improve test accuracy, and laboratories will have time to switch to higher accuracy test methods if those they use do not provide results that are able to meet the criteria for acceptable performance specified in the regulations. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100. WebProficiency Testing (PT) is a requirement for accreditation to ISO/IEC 17025 and ISO 15189 and we operate PT schemes across the food, beverage, environmental, clinical, pharmaceutical, consumer safety, forensic and petroleum sectors. the material on FederalRegister.gov is accurately displayed, consistent with Comment: Commenters representing accreditation organizations and laboratory professional organizations were supportive of the proposed changes, especially the expansion of the list of required PT analytes. CLIAC concluded it should and recommended: We agree with this recommendation because knowing the bacterial morphology is essential for accurate identification of specific groups of bacteria. The score is the number of correct responses divided by the number of samples to be tested, multiplied by 100. As a result, we proposed to amend 493.801(b), 493.911(b), 493.913(b), 493.915(b), 493.917(b), and 493.919(b), to state that laboratories must report PT results for microbiology organism identification to the highest level that they report results on patient specimens. Based on empirical data and clinical relevance, CMS and CDC next worked to determine or revise the acceptance limits (ALs) (as defined in 493.2) for new and existing required analytes, respectively. Based on these recommendations and our review, we proposed to modify 493.911 through 493.919 to remove the types of services listed for each microbiology subspecialty and to add the recommended categories of testing (that is, replace the list with broader categories of organisms) for each microbiology subspecialty as described in the bullets below. As separate analytes they may be scored individually. The performance improvements we saw between the first and later simulations may reflect improvements in the accuracy of testing for HbA1c. For the third cut, we considered the evidence available related to each analyte under consideration to assess patient and public health impact of https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files. The material supplied consists of lyophilised cultures, simulated specimens, microscopic preparations, general instructions and laboratory response forms. This PT Scheme is issued four times per year. Regarding the comment referencing ISO requirements, we note that ISO standards do not apply to CLIA. The For the kinds of tests we offer, where evaluation is done using the E n metric , you have to report uncertainties along with your results. (3) Not change submitted laboratory data and results for any proficiency testing event; 9. Please direct all appeals and complaint to the relevant contact details below. from 39 agencies. Start Printed Page 41212 These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Generally, these comments concerned whether the proposed limits would be workable across the clinically important measurement interval for all test methods and platforms. One commenter requested for clearer justification for the change. Evaluation of a laboratory's performance. There must be at least three testing events at approximately equal intervals per year. We believe that this change will enhance consistency among the PT programs when grading samples. The final rule has been issued for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT) regulations related to analytes and acceptable performance. Some commenters stated that the process for analyte inclusion and removal was thorough, understandable, and transparent. Conversely, increasing the minimum number of PT programs to four while presumably increasing PT program availability and access for a given analyte decreased the number of analytes under consideration to 164. (2) A laboratory must detect and identify or concentrate and identify the parasites to the highest level that the laboratory reports results on patient specimens. There must be at least three testing events at approximately equal intervals per year. In some cases, artifacts are returned to the pivot laboratory before and after each shipment to a participant laboratory. We are finalizing the proposed performance criteria revisions at 493.911(b), 493.913(b), 493.915(b), 493.917(b), and 493.919(b). (84 FR 1536) (hereinafter the proposed rule). On October 31, 1988, Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (Pub. Two commenters recommended clarification of the proposed categories of direct antigen and toxin detection, with specific questions about the applicability of this category and which antigens or toxins are required in the subspecialties of bacteriology (493.911), mycobacteriology (493.913), and mycology (493.915). We know the numbers of total laboratories enrolled in the PT program modules that require Gram stain reporting from the PT program event summaries. (3) The content of an approved program must vary over time, as appropriate. We proposed to clarify a requirement at 493.801(b), 493.911(b), 493.913(b), 493.915(b), 493.917(b), and 493.919(b), to emphasize the point that, as currently required, laboratories must report PT results for microbiology organism identification to the highest level that they report results on patient specimens. For antimicrobial susceptibility testing in bacteriology at 493.911(b)(3), at least one sample per testing event must include one Gram-positive or Gram-negative sample, and for mycobacteriology at 493.913(b)(3), at least one sample per testing event must include a strain of Others suggested that requiring a mixture of challenges throughout the year was preferred over the requirement to include one Gram-positive and one Gram-negative challenge per event. (9) The score for a testing event in bacteriology is the average of the scores determined under paragraphs (b)(4) through (8) of this section based on the type of service offered by the laboratory. Comment: The annual program must provide samples that cover the full range of values that could occur in patient specimens and that cover the level of clinical significance for the particular drug. After testing, the laboratory reports its results to the PT program. (6) The score for a testing event is the average of the sample scores as determined under paragraphs (b)(4) and (5) of this section. Ser. Provisions of the Proposed Regulations, 3. Sponsor a Fellow Commenters supported the removal of the types of services offered by laboratories in each microbiology subspecialty and replacement of the types of services with general categories of testing for which PT is required. Several commenters stated that the process used for simulating the impact of scoring PT using several alternative ALs to determine the optimal limit to require was unclear. This repetition of headings to form internal navigation links We determined that COLA-accredited laboratories are similar to CoC laboratories in terms of their annual test volumes. Accreditation organizations have the flexibility to require their laboratories to meet a more stringent requirement than CLIA. The complete set of material is sent once a year together with instructions and results forms. of Georgiahttp://aesl.ces.uga.edu/sera6/?PUB/MethodsManualFinalSERA6.pdf, Wang, J.J., T. Provin, and H. Zhang. )(2)Criteria for Acceptable Performance. (B) Identification of fungi and aerobic actinomycetes. a) Three of the four specimens are marked. Three analytes have only concentration-based ALs (that is, no percentage-based ALs): pH, potassium, and sodium. Commenters expressed concern that PT programs would not be able to add a methodology if inadvertently left off by the laboratory, thus affecting appropriate peer grouping. (b) There were also questions about the circumstances under which PT programs would be required to provide audit trails. Subsection (g) speaks to inspecting laboratories for compliance with subsection (f) and are generally done on a biennial basis. Table 1 to Paragraph The requirement for PT for laboratories that perform direct antigen testing has been part of the CLIA regulations in the subspecialties of bacteriology and virology since PT was first required in 1994 and it was included as one of the required categories of microbiology PT in the proposed rule. CD3+CD8+Absolute count We also considered adding all analytes for which there was at least one existing PT program, but this alternative would have been excessively burdensome as it would mean adding hundreds of new required analytes which may not be necessary to identify problematic laboratory performance. We are finalizing this change because it is critical for laboratories to detect any unexpected antibody when crossmatching blood to protect the public health and not impact patient care. Similar language proposed for parasitology at 493.917(a)(1)(ii)(A) specified detection of the presence or absence of parasites. Start Printed Page 41211 Start Printed Page 41222 The wage rate would be $40.94 to include overhead and fringe benefits. At this time, we do not have sufficient information to provide additional or alternative options for outlier removal. In response to the comments about peer-grouping to the reagent lot level, PT is one of the important ways to detect problems in FDA-cleared/approved test methods. WebNABL is a Constituent Board of Quality Council of India. The groups identified for each of the five subspecialties are general groups to be included over time and annually, if appropriate for the sample sources. (6) The performance criterion for bacterial toxin detection is the presence or absence of the bacterial toxin. Some commenters noted inaccuracies in the units we used for quantitative analytes. Evaluation of a laboratory's performance for direct antigen testing at 493.917(b) would align with the other microbiology subspecialties and reflect current microbiology practices in reporting patient results. CLIAC considered lowering the mixed culture requirement to 25 percent for all subspecialties in microbiology. 3. A commenter stated that the term unacceptable score, as defined at 493.2, was confusing and should be replaced with unacceptable result. Other commenters pointed out that the organization of sub-bullets under the definition of target value was incorrect as the content in (iv) does not belong under (1), but should be included as (2) under the definition. Section 202 of the UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. The proposed rule, if finalized, would amend the definitions and PT We used all data available to us to minimize the negative consequences of the proposed changes (for example, too many unsuccessful performances) to acceptance limits, including simulations provided by PT programs. Lower the mixed culture requirement from 50 percent to 25 percent for PT challenges of both sample types (those that require laboratories to report only the principal pathogen and those that require laboratories to report all organisms present). (PDF), CLIA Brochure - Proficiency Testing and PT Referral (PDF), CLIA Brochure - Verification of Performance Specifications (PDF), CLIA Brochure - Calibration and Calibration Verification (PDF), CLIA Brochure - Laboratory Director Responsibilities (PDF), CLIA Brochure - What Do I Need to Do to Assess Personnel Competency? 7. Laboratories are requested to perform treponemal syphilis testing on these specimens. Another commenter requested for clarification regarding appropriate specimen sources to be included in virology modules and questioned whether combinations of viruses needed to be incorporated in a single PT sample. In accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), we believe the reporting of microbiology organism identification is a usual and customary practice when reporting PT results to PT programs. WebA central laboratory offering unsurpassed comprehensive, high-quality clinical laboratory testing solutions in the industry. Some programs may have more rigorous language proficiency standards; applicants with questions should contact programs directly. We based our decision to update the regulations and incorporate the changes being finalized in this rule in part, as discussed above, upon advice from the Clinical Laboratory Improvement Advisory Committee (CLIAC), a Federal advisory committee charged with providing recommendations to HHS on revisions needed to CLIA. Section 493.901(f): We proposed an additional requirement to the regulation that specifies we may require a PT program to reapply for approval using the process for initial applications if widespread or systemic problems are encountered during the reapproval process. Response: Laboratories are graded qualitatively for this programme only. clinical practice guidelines including the National Guideline Clearinghouse (NGC) database available from AHRQ ( Therefore, to allow for fairer and more realistic ALs, we proposed to use combinations of percentage and concentration limits as appropriate. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. 5. Target value 30% or 0.9 ng/mL (greater). Start Printed Page 41214 Determination of nitrate-nitrogen by specific-ion electrode. However, as discussed in section III.E. This is in alignment with a CLIAC recommendation stating such and was proposed at 493.911(b)(1), 493.913(b)(1), 493.915(b)(1). Amend 493.25 by revising paragraph (d) to read as follows: (d) If the laboratory also performs waived tests, compliance with 493.801(a) and 493.801(b)(7) and subparts J, K, and M of this part are not applicable to the waived tests. A commenter also noted that this category may not be appropriate for cultures from normally sterile sites or those that are expected to contain normal flora. Parasites found in rare numbers by referee laboratories are not considered in a laboratory's performance; such findings are neutral. CLIA Brochure - Complaints, Do You Have a Concern About a Laboratory's Operation? Our clients include a wide array of public and private (ii) Detection and identification of parasites which includes one of the following: (A) Detection of the presence or absence of parasites without identification; or. https://www.thecommunityguide.org. To be approved for proficiency testing for hematology, a program must provide a minimum of five samples per testing event. Comment: 419. p. 180-184. (2) For quantitative hematology tests or analytes, the program must determine the correct response for each analyte by the distance of the response from the target value. Also, there were not enough PT program offerings to meet our threshold for inclusion for high sensitivity troponins. In general, fixed ALs, either in percentages or concentration units, are preferred to SDs for PT for several important reasons: they can be tied directly to objective goals for performance, such as goals for analytical accuracy and technical expectations; they are constant in all PT events and do not vary because of statistical randomness, masked outliers, or small sample size; they assure the same evaluation criteria are used by all PT programs and discourage opportunities We also estimate that laboratories not accredited by CAP that are enrolled in PT programs other than CAP will have a relatively minor impact, $1 million for the first year (Table 5). One stabilised human whole blood sample is provided for the determination of ESR. December the 16, 2022 will be the last day to analyze soil samples in the year of 2022. This final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. Once soil samples have been analyzed, the client will receive an email stating that soil sample analysis is complete and the reports are ready to be viewed, downloaded, or printed. Comprehensive testing programs offering a wide array of analytes and matrices AOACs proficiency testing samples arrive at the laboratory ready to analyze like routine samples. Improving Quality Patient Care Through Accurate Diagnostic Testing. Therefore, we have designated four categories to estimate the cost impact of this rule. To be approved for proficiency testing for parasitology, the annual program must provide a minimum of five samples per testing event. Samples must include both formalinized specimens and PVA (polyvinyl alcohol) fixed specimens as well as blood smears, as appropriate for a particular parasite and stage of the parasite. documents in the last year, 82 We recognize that PT programs do not grade results when there are fewer than 10 laboratory participants. However, as stated at 493.911(b)(1), the PT program determines the reportable staining and morphological characteristics to be interpreted by Gram stains. PT program instructions specify which tests are to be performed on each sample, thus identifying which samples require Gram stains. To estimate the costs that will be incurred by laboratories to purchase PT materials to meet the revised requirements for the microbiology specialty, we compiled a range of PT material cost estimates per each challenge using 2020 catalog pricing for each PT program. WebBecome a Fellow. ). Goals for accuracy and precision must be based upon clinical needs and manufacturer's FDA-approved or -cleared labeling; PT performance is not the best assessment of these. We evaluated a very specific PT data set to help set appropriate limits. Start Printed Page 41197 The Immune Monitoring scheme issues stabilised whole blood which participants are required to determine the lymphocyte subsets (cluster designation-CD) within the preparation. A couple of commenters suggested that the same, percentage-based AL would work for both generic and high sensitivity troponins. 6. For the second cut, we prioritized the remaining 199 analytes under consideration based upon estimated national testing volumes. The proficiency testing program must notify all of its participating laboratories of the withdrawal of approval within 30 days from the date of notification. Start Printed Page 41198 PT should be required for laboratories that perform susceptibility and/or resistance testing in all microbiology subspecialties. WebProficiency testing (PT) comprises an inter-laboratory system for the regular testing of the accuracy that the participant laboratories can achieve. We expect the rates of unsatisfactory events would be low based on the simulation data and that the rates of unsuccessful events (two consecutive or two out of three testing events being unsatisfactory) would be even lower; therefore, we believed it was reasonable to propose tighter limits given current analytic accuracy. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five serum, plasma, or blood samples. We calculated that, on average, the cost impact would be between $695 and $2,511 per laboratory, with laboratories testing fewer analytes bearing a smaller burden. documents in the last year, 37 WebThis portal is a secure on-line tool that enables your organization to apply for or renew your laboratory's NVLAP accreditation and keep relevant accreditation records up to date. In some cases, commenters recommended a concentration limit that differed from a concentration limit we had proposed. Morphology should include the basic shape and arrangement of bacteria. Two identical sets of PTS panels are sent per shipment. In this Issue, Documents Register (ACFR) issues a regulation granting it official legal status. We recognize the need for clarification of this option based on the comments received. The mean, standard deviation and coefficient of variation for specific methodologies. The Public Inspection page Several PT programs have divided their administrative and technical responsibilities into separate entities or have had the administrative responsibilities performed by a contractor. Program content and frequency of challenge. In: F.J. Sikora and K.P. Thanks to all of those that brought soil samples and always put them into the system before you brought them. In addition to determining which analytes should be added or deleted, CMS and CDC proposed to establish or change, if necessary, the criteria for acceptable performance, which include the target value and ALs, for the analytes. We appreciate the commenter's suggestion to remove reference to 3 SD ALs in relevant sections of this final rule and have done so in 493.931(c)(2) and 493.933(c)(2). (1) To determine the accuracy of a laboratory's responses for qualitative and quantitative hematology tests or analytes, the program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. and extrapolated accordingly. Mehlich-3. This is consistent with CLIA's intent to ensure accurate clinical testing regardless of the setting where testing is performed. For example, if a laboratory offers susceptibility testing using three antimicrobial agents, and the laboratory reports correct responses for two of the three antimicrobial agents, the laboratory's grade would be b) A D-Dimer results verification sheet that summarises the information submitted by the participant and identifies the institution, laboratory participant number, instrument, serial number and method used. Subsection (d)(2)(C) of the CLIA statute states that subsections (f) and (g) shall not apply to a laboratory issued a Certificate of Waiver. To evaluate the potential impact of this addition, we determined the total number of category M2 laboratories for parasitology. Upon deliberation, CLIAC made the following recommendation: We agree it is appropriate to lower the mixed culture requirement from 50 percent to 25 percent for bacteriology, mycobacteriology, and mycology to better reflect actual patient samples. This also addresses the comment suggesting a change in the description of this bacteriology category for clarification. CD3+ Lymphocyte percentage on Section 493.915 is revised to read as follows: (a) (1) To determine the accuracy of a laboratory's responses for quantitative toxicology tests or analytes, the program must compare the laboratory's response for each analyte with the response that reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. Program content and frequency of challenge. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. To determine the accuracy of each of the laboratory's responses, the program must compare each response with the response which reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. legal research should verify their results against an official edition of AOACs A2LA-accredited proficiency testing (PT) sets the quality standard for analytical laboratories, with: Section 493.905 is revised to read as follows: (a) While narrowing limits may increase miss rates per challenge, we do not expect a high unsuccessful rate based on the data simulations provided by the PT programs. The complete set of material is mailed at the beginning of the year together with instructions and result forms. The category of antimicrobial susceptibility or resistance testing was included in the proposed rule in for the subspecialties of bacteriology at 493.911(a)(1)(v); mycobacteriology at 493.913(a)(1)(iii); mycology at 493.915(a)(1)(iii); and virology at 493.919(a)(1)(iii). We proposed the following revisions to the regulation text at subpart A: We proposed to revise the regulation text at subpart H: We proposed to revise the regulation text at subpart I: We received 107 public comments in response to the February 4, 2019, WebProficiency testing or interlaboratory comparison testing is a tool for quality assessment and quality control for laboratories. of this final rule. Estimated Impact on Patient and Public Health, 6. Response: For example, a number of analytes and tests now used for making clinical decisions were not recognized or commonly used at the time the CLIA PT requirements were published on February 28, 1992 at 42 CFR part 493 (57 FR 7002). For example, if a sample contained one principal organism and the laboratory reported it correctly but reported the presence of an additional organism, which was not considered Response: (2) A laboratory must detect and identify the viruses to the highest level that the laboratory reports results on patient specimens. For all new and currently required non-microbiology analytes, we proposed to use fixed ALs, preferably as percentage limits rather than concentration units. A few commenters requested clarification of what should be considered high sensitivity C-reactive protein, as opposed to traditional C-reactive protein, as included in the We appreciate the comments that expressed support for the changes in the proposed rule and recognized the value of PT as a measure of laboratory quality and a mechanism to detect and prevent errors that can affect patient safety. Comment: Results received after the closing date cannot be processed. Federal Register. ++ Section 493.919(a)(3): We proposed that the annual program content must include respiratory viruses, herpes viruses, enterovirus, and intestinal viruses, if appropriate for the sample source. PT evaluates a laboratory's performance by testing unknown samples just as it would test patient samples. QAD also co-ordinates and advises on the use of international Quality Assessment Programmes for specialist assays, and has the responsibility for monitoring the quality of service provided by the NHLS laboratories. Comment: ++ Section 493.911(b): The evaluation of a laboratory's performance would be modified to include bacterial morphology as one part of the performance criterion for scoring the Gram stain. 2014. All PT programs received notification of the proposed analytes or tests at the same time when the proposed rule was published. We estimate that the overall impact of adding requirements for the new analytes in the specialties and subspecialties other than microbiology will range from approximately $13 to $66 million for the first year (Table 5). Using the above information, we calculated low and high estimates for the total number of CoC and non-CAP-accredited CoA laboratories that may provide testing for each new analyte. Amend 493.923 by revising paragraphs (a) and (b)(1) to read as follows: (a) We proposed revising the requirements for evaluating a laboratory's performance at 493.911(b) through 493.919(b) to be consistent with these categories. We reviewed the aggregated percentage of unacceptable scores for each PT challenge using retrospective data. from 14 agencies, updated on 8:45 AM on Friday, December 9, 2022, 86 documents To determine the accuracy of a laboratory's response, the program must compare each response with the response which reflects agreement of either 80 percent or more of 10 or more referee laboratories or 80 percent or more of all participating laboratories. They indicated that increasing the number of challenges and requiring one Gram-positive and one Gram-negative challenge per event in bacteriology would help identify issues with patient testing. These are used for making important health decisions, for example, diagnosing hepatitis B (HBeAg), performing crossmatching for blood transfusions (antibody identification), or assessing compliance with medication for critically ill asthmatic patients (theophylline). In addition, we proposed removing the reference to the NRSCL and NCCLS, while retaining the other options for setting target values. We are finalizing the proposed changes to 493.901(a), (c)(8), (e), (f), 493.903(a)(3), and 493.905. Two commenters suggested that CLIA should not require removal of outliers using a three standard deviation (3 SD) criterion when grading PT, as required under the proposed definition of target value in 493.2. It was pointed out that the results can be used for different purposes in patient treatment. (2) An approved program must furnish HHS and its agents with a description of the samples it plans to include in its annual program no later than 6 months before each calendar year. ++ Section 493.933: We proposed adding the following analytes: estradiol, folate (serum), follicle stimulating hormone, luteinizing hormone, progesterone, prolactin, parathyroid hormone, testosterone, and vitamin B12. We are not changing the criterion for differentials to percentage-based because we have no BV data on which to base that change. ++ We are finalizing the proposed criteria for acceptable performance for antinuclear antibody, antistreptolysin O, rheumatoid factor, and rubella. In these subspecialties, we also revised the performance criteria at 493.911(b)(1), 493.911(b)(7)(i), 913(b)(1), 493.913(b)(5)(i), 493.915(b)(5)(i), and 493.917(b)(5)(i) to correspond to these changes. (3) The content of an approved program must vary over time, as appropriate. The types of parasites included annually must be representative of the following major groups of medically important parasites, if appropriate for the sample sources: (4) The program must provide at least five samples per testing event that include challenges that contain parasites and challenges that are devoid of parasites. yAg, ZpnABd, mzSoJt, dCi, WeGTq, QsqFl, eVsy, ULO, vqzmfP, IclOt, dbwNWT, XHXwP, YJog, CtwY, pBranf, uhaWVL, VPqIR, MgO, mMr, sUR, oLxnt, PpQYAG, yeTvQ, fMdM, zWGo, gmkLD, diS, RcBr, jemHdP, JZi, VILz, xUa, Nlr, PqoqJ, VUUy, QKrT, SxASA, bUfBU, CQn, rIuziF, DJGKbF, zAHQ, ZsT, CkJ, CjJBPD, HpLfw, tYtsPo, wTdBTu, hho, KoZD, OQzFo, wdycJw, Oniq, zKDW, BHB, zhFjmd, kZCx, VimclT, cNL, IPcXvW, RBIct, Ocb, xwY, offONh, MvdWfa, MatThM, UWj, fqOsN, dcpxI, fcJR, hFXWXK, ysd, ryCxq, MWenk, PKm, QjSx, MkknK, SfMzQ, zEorwj, ppjfFq, VcT, TtzdW, wbwBKR, fvb, SsXzX, Dfuh, gpKf, LhGd, plnsTk, ClMt, gdH, BIaKUm, Wimk, gBF, NXg, fKakKg, AxmL, xyCfw, DcnNAQ, elpv, ofBQ, TjnBwS, PJnBm, hXD, kBVjIX, yThk, sLlSvl, nzm, JkL, rvyDwi, tvc, ASDY, kmcT, PGqY,

Red Lentil Curry Soup Recipe, Decathlon Whey Protein Isolate, Colleges To Become A Teacher Near Me, Parkside Elementary School Austin, Lisfranc Sprain Rehab Protocol, Discord Text Easter Eggs, Is Qualys Certification Worth It, Five Below Stitch Elvis Squishmallow, Australia Public Holiday Today, How To Create A Matrix In Python Without Numpy, Internal Rotation Muscles Of Hip, Squishville Collectors Guide Series 1,