 Hello everyone, I'm Doris McMillan and welcome to the final CLIA Quality System Rule Overview Satellite broadcast. The goal of today's broadcast is to increase the viewer's understanding, knowledge of the new CLIA quality control requirements. Now we're going to start out with a welcome from CMS's leadership on the importance of this broadcast, then we'll move into a general overview, changes and approach to the Quality System Regulation followed by a presentation on subpart J, Facility, Administration for Non-Wave Testing, General Lab Quality Assurance, Pre-Analytics System Quality Assurance, Analytics Systems, QC Specialties Quality Assurance, Post-Analytics Systems Quality Assurance and Summary and then Next Steps. After these presentations we're going to provide you with an opportunity to ask our panel questions, they're the experts, the number for calling and faxing us with your questions will be given out a little bit later. And now that we've told you a little bit about what you can expect from today's program, let's get started by hearing a welcome by Steve Pellevitz, Director of the Survey and Certification Group. Steve? Hello, I'm Steven Pellevitz, Director of the Survey and Certification Group in the Center for Medicaid and State Operations here at CMS. The Division of Laboratory Services, which administers the CLIA program for CMS and is your host for this broadcast is part of this group. I'd like to welcome all of you to the satellite presentation, which was designed to provide state and regional office CLIA staff with an overview of the final CLIA regulations that were published on January 24th of this year and became effective on April 24th. The CLIA final regulations have been long awaited and contain several new changes. Although you may have already noticed that much of the former regulations from 1992 have not changed, you've also probably noted that the requirements have been reformatted to follow the flow of a patient's specimen through the laboratory. This intentional reorganization of standards is designed to help facilitate the identification and prevention of errors and help laboratories think in terms of systems. Quality assessment, QA for short, is a requirement which used to be called quality assurance and has been incorporated throughout all phases of the testing process to enable laboratories to include QA as a part of their daily operations rather than as a separate requirement. Again, this helps labs to think in the quality system concepts instead of individual requirements for quality. This final regulation is a series of balanced standards. While there may be slight workload increases in some areas like moderate complexity quality control, there are workload decreases in others such as automated hematology. All changes to the requirements have been supported by public comments, data, and or advisory committee recommendations. In addition to this satellite training, you'll receive on-site training at one of three different locations to be held throughout the country in August and September that should offer you additional information to assist in assessing compliance with the final CLEA regulations. At the time of your on-site training, you'll receive fully updated surveyor interpretive guidelines. These guidelines will ultimately be placed on CMS's CLEA website so that laboratories may also access and use them to help meet the requirements of the CLEA final rule. As always, CLEA will maintain its educational approach for surveys. Over time, the CLEA program has achieved much success using this approach. CMS advocates CLEA's educational efforts to ensure the quality of testing in the United States and thanks you, the surveyors, for your long-standing efforts toward this end. You all have before you a new challenge, that is to assimilate and synthesize these new requirements and subsequently use them to assess compliance and provide technical assistance to labs to facilitate their CLEA compliance. This will be our priority for the next two years until each CMS-certified non-waved laboratory has been surveyed once. Before we continue with the broadcast, I'd like to take this opportunity to personally thank each of you for your assistance and dedication in implementing this rule. On behalf of CMS, I appreciate your continuing participation in the CLEA certification process. Now on to the broadcast. Thanks, Steve. And now that we've been officially welcome to today's program, let's get started with our first presentation from Judy Yeos, Director, Division of Laboratory Services in CMSO. Judy? Welcome to the first CLEA satellite presentation. We are delighted that you could join us today and look forward to an informative and timely session with you. These are truly exciting times for all of us. We publish the final CLEA quality system regulations in January and with this publication comes the need to revamp all other facets of the program so that they are all in concert. This includes the state operations manual or surveyor guidelines, policies, forms, and training materials, and so on. I hope you can feel the excitement and energy of this. We are reinventing ourselves. Today's forum is the first in a series of three planned training sessions in various venues for the final regulations. This satellite training contains an overview of the changes in the final regulations and is expected to establish a foundation of knowledge about the regulations for the state surveyors. The second will be on-site training sessions in three locations across the country in August and September intended to reiterate the regulatory requirements but mostly to provide guidance on assessment and citation of these final regulations. That is really the practical application of these rules. Lastly, we will convene a refresher course in 2004 to follow up the initial training and then finalize our implementation process. One important message to take away with you today is that most of the requirements have not changed since 1992. They have, however, been moved, reorganized, clarified, and streamlined. You'll also see some new terms. As you know, these regulations apply to only moderate and high complexity laboratories. The first thing you'll note is that moderate and high complexity QC has become non-waved QC. Quality assurance is now called quality assessment. The requirements have not changed, but the title is new. The former QC, QA, and patient test management requirements have become the quality system in this regulation. The 1992 regulations, just to distinguish them, we call the former regulations. The 2003 regulations are the final regulations. NIDA is now SAMHSA, the Substance Abuse Mental Health Services Administration. One of the best aspects of the reformatting is that QA has been interspersed among all phases of testing. This facilitates the lab's ability to incorporate it into their daily operations. It also helps us think in terms of systems when assessing compliance rather than in individual requirements. QA was more or less an afterthought in the former regulations at the end. Another important change is rearranging the existing requirements to parallel the flow of a specimen through the laboratory, just like the path of workflow in a quality system. This is much more logical. It helps prevent errors and eases our ability to assess compliance. As you know from previous training sessions, we have been talking about quality system and how it relates to CLIA for some time. All of the quality system essentials can be directly related to CLIA's standards. For example, quality system essential 2 is personnel, and the CLIA requirements that outline qualifications and responsibilities that would be included in a lab person's position description will meet that essential. The quality system essential for process control is quality control in the laboratory, and we sure all know what that is. It's the major focus of these final regulations. In that same vein, and that's no pun, we are continuing to use the outcome-oriented survey process that has always included a systems approach. The survey process has been updated to reflect the final regulations, but it is essentially unchanged. It is an assessment of the labs, systems, and processes. You'll hear more about that at the on-site training sessions. Before proceeding, I'd like to recognize all of the state agency, regional office, and central office folks who contributed to the development and publication of the regulations, the surveyor guidelines, training, or any aspect of the implementation of this important regulation. Your tireless efforts will not go unrecognized and are very much appreciated by us all. Okay, you're asking, so why were the 1992 regulations changed? Well we had public comments from interim regulations from 1992 on. We had recommendations from CLIAC like the PhD board certification requirement that needed to be included. We wanted to incorporate basic quality system concepts into the regulation. We had new and improved technology that needed to be updated in the current regulations. Data from 10 years of CLIAC experience needed also to be assessed and included in the regulations. We needed to close out the phase ins that were also in the 1992 regulations. If you are looking for a combined regulation document, the CFR will not be available until at least October of this year, but it will include a combination of the former and final regulations. Therefore, the crosswalk that is in the 2003 final rule is very helpful right now to make the connection between the two. Also if you look on the CMS CLIA website at www.cms.hhs.gov slash CLIA under regulations you'll be able to link to CDC's website and there you will find a combined document that was compiled by the CDC CLIA folks that you can use in the interim, but be careful it's a big document because it's got lots of headers and footers. So folks, I'm going to give you a brief summary of the changes in the regulations. You'll receive a bit more detail from the subsequent speakers. So really what's new? We have eliminated FDA's role in quality control. They will no longer be asked to be looking at products for CLIA QC. We have closed the moderate complexity phase in and created non-waved QC standards that is one set of standards for moderate and high complexity QC. We have grandfathered existing PhD or doctoral degree high complexity laboratory directors. We also are requiring subsequent to February 24th board certification for PhD laboratory directors. We have reduced quality control for automated hematology and microbiology. We have also incorporated coordination with other local, state and federal laws. Even though moderate and high complexity QC are now non-waved QC, test categorization is still being done by FDA along with their 510K reviews for the marketplace. They just won't ever start reviewing products for CLIA QC. We still need these categorizations for personnel requirements and other reasons. So be aware that MD laboratory director qualifications are unaffected by the final regulations. They have not changed. The final regulation consolidates former sections J, K and P. You know that personnel and PT still exist as part of the quality system. We just didn't do anything with them this time around. So what are the two new subparts, J and K? What do they include? Subpart J is now called facility administration. It has four pieces. It includes facilities, transfusion, record retention and safety. These are mostly generally applicable requirements. Subpart K is quality system and it includes the following. Overview of quality system and quality assessment. Calibration and calibration verification. And verification of test method. Reagent storage, specialties and subs. By reformatting the requirements to follow the path of a specimen through the lab, it reflects the total testing process. Subpart K quality system has four sections. And the first is general laboratory systems. These systems also follow through the laboratory total testing process. General laboratory systems includes confidentiality, specimen identification and integrity. Excuse me. Complaint investigations, communication, personnel competency, PT performance evaluation and quality assessment. These standards apply across all phases of testing. The second part of the quality system is pre-analytic systems and it includes the test request, specimen submission and handling and referral, and quality assessment. These standards apply to all former requirements mostly in patient test management in the specimen collection and processing phase of testing. The third part of the quality system is analytic systems and it includes procedure manual, test equipment and reagents, establishment and verification of performance specifications, maintenance and function checks, calibration and calibration verification, control procedures, specialties and subs, comparison of test results, records, corrective actions, and most importantly quality assessment. You'll recognize this as the QC requirements in the former regulations. The fourth and final part of quality system is post-analytic systems and it includes test report and quality systems. This is the information that formerly resided in patient test management for result reporting. The highlight of this new and improved subpart K is the added flexibility for the laboratory to use a CMS approved equivalent QC procedure for certain tests in lieu of two levels of control materials per day of testing. We won't be covering this in great detail today, but we will be explaining these approaches extensively at the onsite trainings in Baltimore, San Antonio and San Francisco. They are included in the revised survey or guidelines you'll also receive at the training. CMS came to the conclusion of allowing QC options for robust test systems with competent testing personnel and good overall performance as part of its deliberations with outside experts and CLIAC discussions about the fact that quality control is really just one part of the laboratory's quality system. For equivalent QC, we will need to consider the lab's patient population, test system stability, environment, personnel competency and PT performance. The ultimate responsibility for quality control is on the laboratory director as always. The only equivalent QC approved by CMS will be the only ones accepted. Please be reassured that we will not be evaluating individual manufacturers quality control, but only the laboratory's approach to quality control. These ideas will be elucidated for you at the onsite training sessions. Today, there will be two Q&A sessions during the satellite, one midway through and one at the end. Please save your questions on the second part of the regulations until after those presentations have concluded. Enjoy the satellite show and we'll see you in August and September for the onsite training. And most of all, I'd like to thank you for your ongoing hard work and dedication that have so much contributed to CLIA's success. The final regulations innovative approach to quality system and the forward thinking direction in QC places us, CLIA, in the forefront of laboratory quality oversight, instead of always catching up behind. We are now in the front seat. And so now on with the show. Thanks a lot. Next, we're going to hear from Mini Christian, a health insurance specialist in the division of laboratory services. Support J in the former regulation was patient test management. In the final rule, Support J is title, facility administration for non-wave testing and includes consolidated and reorganized requirements from the former regulation in patient test management, quality control and quality assurance. This subpart includes the overall general laboratory and administrative type requirements for the facility environment as it relates to space, utilities, equipment, supplies and safety, transfusion services and record specimen retention. There are seven new or revised requirements in this subpart. Four are in the first standard facilities. To prevent cross-contamination, molecular amplification procedures that are not enclosed systems must have a unidirectional workflow. Laboratories are now required to be in compliance with all federal, state and local laboratory requirements. Safety precautions no longer have to be posted. They only have to be accessible. Records, slides, blocks and tissue must now be maintained and stored in a manner that ensures proper preservation. One is in the second standard, transfusion services. Facilities that provide transfusion services must now report transfusion reactions to laboratories and federal and state authorities. The last two are in the standard record retention. Records of test systems performance specifications that are established or verified by the laboratory must be kept for the period of time the laboratory uses the test systems but no less than two years. Laboratories that cease operation must retain all records for the specified time frames in the regulations. And thanks, Minnie. Next, we're going to see and hear a presentation on the General Laboratory Systems section by Raylene Profetto, medical technologist in the Division of Laboratory Services in CMSO. General Laboratory Systems is the first of the four laboratory systems listed in the final regulation. The General Laboratory Systems section incorporates requirements formally in patient test management and quality assurance of the former regulation. The General Laboratory Systems section of the final regulation is composed of the applicable functions of a laboratory that are not necessarily limited to any one phase of testing or specialty or subspecialty but have the potential to span across all testing phases. This includes pre-analytic, analytic and post-analytic. General Laboratory Systems now includes confidentiality of patient information, specimen identification and integrity, complaint investigations, communications, personnel competency assessment policies, evaluation of proficiency testing performance, general laboratory systems quality assessment. New to this section of the final regulation are confidentiality of patient information and evaluation of proficiency testing performance. In the former regulation, confidentiality was incorporated within the requirement of test report. Now as standard in the final rule, confidentiality of patient information is addressed as a distinct function of the laboratory testing process. With regards to proficiency testing or PT, the PT performance evaluation now requires the laboratory to verify any PT score not reflective of the laboratory's true testing performance. As we know, in order to determine an overall score, each analyte must receive a numerical score to allow the overall specialty or subspecialty to be graded. Further, a PT program may assign an analyte score that does not reflect the laboratory's true test performance. In these circumstances can occur when the laboratory receives a score of 100% by the PT provider for an analyte evaluation that does not produce at least 80% agreement among participant or referee laboratories as required by regulation, or the laboratory did not participate in the testing event and receives a 0% score, or the laboratory's PT results were received after the cutoff date for receipt and the laboratory receives a 0% for the late return of results. Due to these concerns about the former regulations, PT performance evaluation now requires the laboratory to verify the accuracy of any analyte, specialty, or subspecialty assigned a PT score that does not reflect the laboratory's true testing performance. The final component of general laboratory system is quality assessment. As we learned earlier in this presentation, the requirements of quality assurance condition are renamed quality assessment and are now included as an assessment component within each of the four laboratory systems, general laboratory, pre-analytic, analytic, and post-analytic. We believe this final regulation is organized to more clearly reflect the activities within each of the systems based on the phases of the testing process. Again, we'd like to thank Raleen for explaining the various nuances of the general laboratory systems. Before we hear from our next speaker, I'd like to give the number for the viewing audience to call or fax in their questions. The phone number to call in your questions is 1-800-953-2233. If you'd like to fax your questions in, the number 1-866-254-8030. Alright, we're going to continue now with our next presentation on pre-analytic systems by Rinalda Leno, a medical technologist in the Division of Laboratory Services in CMSO. What now composes the pre-analytic section in the final regulation were some of the sections included in patient test management and quality assurance in the former regulation. The pre-analytic section of the final regulation now includes pre-analytic systems, test requests, specimen submission, handling and referral, and pre-analytic systems quality assessment. Based on recommendations to the former regulations, the test requisition now includes the patient's gender, age, or date of birth, and the specimen's source when appropriate. We consider these updates good laboratory practices. Additionally, regarding laboratories that enter or transcribe test requisition information into a record system or laboratory information system, we are requiring laboratories to ensure that the information is transcribed or entered accurately. Thanks a lot, Rinalda. Okay, it is time for you, the viewing audience, to ask our experts questions on what you have heard thus far. To call in your question, you should dial 1-800-953-2233. If you're too shy to call, you'd like to fax. The number is 1-866-254-8030. Our panel for this live Q&A will consist of Judy Yoast, Mini-Christian, Raylene Prefecto, and Rinalda Leno. And while we're waiting for our first caller, Judy, tell us, when can states begin using the final regulations to survey laboratories? Thank you. State surveyors will be able to use the new final regulations, as well as the associated revised surveyor guidelines to survey laboratories following the onsite trainings that will take place in August and September. Okay. Let me ask Mini. Do moderate complexity laboratories need to meet the final facility regulations? All laboratories performing non-wave testing have to comply with the facility requirements. Okay. Raylene, let me direct this question to you. What happens if a laboratory receives an ungradable PT result from their PT provider? What should they do to verify accuracy? Should a laboratory receive an ungraded PT result? They will need to refer to the participant summary that accompanies the PT and compare their results to the remaining other answers of other participants that have participated in the proficiency testing. Also, it's a good practice that they review the laboratory tests that they ran during the time that the proficiency test would have been run. Take a look at the patient results during that time that were released. Just for a good laboratory practice, good comparison. Okay. Renalda, let me direct this question to you. When is it appropriate for the laboratory to collect a specimen source? It is appropriate for the laboratory to collect the specimen source for specimen handling, preservation, and preparation. For an example, it would be proper for the laboratory to know the proper test media and inoculation media for microbiology and clinical cytogenetics. Additionally, with the application of normal values for reporting test results. Alrighty. And again, this is your opportunity to call in to ask our panel of experts any questions you might have on your hearts. The number to call is 1-800-953-2233. If you'd like to fax us, dial 1-866-254-8030. Many, let me come back to you. If you would, please clarify the record retention requirements for performance specifications for tests established or verified by the laboratory. Laboratories must keep the records for the entire time that the test system is being used by the laboratory, but no less than two years. Okay. Raleen, must consultants' competency be evaluated as well? Yes. Any technical or clinical consultants utilized by the laboratory, their competency will need to be assessed. Okay. And, Rinalda, are telephone orders for tests acceptable? Yes. Telephone orders for tests are acceptable only if the laboratory solicits a written or an electronic authorization within 30 days of the oral request. Well, when should the laboratory document time of specimen collection? The laboratory should document time of specimen collection when it is relevant for the testing to be performed. For an example, the laboratory may need to document the time of collection for peaks and troughs when interpreting results for therapeutic drug assays. Well, can laboratories still use the patient's chart to record orders and results in lieu of a test requisition report form? Yes. The laboratory can use the patient's medical chart in lieu of the test authorization or requisition form. Okay. Judy, let me come to you. I've got a couple questions. Has test categorization been eliminated? No. Test categorization still exists. It is still being done by the FDA for purposes of personnel requirements specifically, but also for laboratories to understand which requirements they are applicable to them under CLEA. Okay. And are the qualifications for high complexity laboratory directors who are MDs or DOs, I mean, have they changed? No, they have not changed in the final regulations. All right. Well, we have put out the numbers. We haven't heard from you. So keep in mind we have another question and answer session coming up a little bit later in our program. We're going to move on now with the second part of our broadcast. In the next half of our program, you're going to see and hear presentations on the analytic systems, post-analytic system, and a summary and next steps. So with all that said, let's take a look at a video dramatization regarding the analytic systems. Now we finally published the regulation. What's the basic difference between the former reg and the final? Oh, Val, the final regulation is basically a rearrangement of the former requirements, patient test management, quality control, and quality assurance arranged into two new subparts, facility administration, and quality system. Well, where are the quality control requirements located now? Diana, there in the analytic section. The analytic section is a condition under the quality system and contains most of the requirements in the former general QC, the specialties and subspecialties, and some of the patient test management and quality assurance requirements. Quality assurance requirements are now called quality assessment requirements. Well, where are the requirements for moderate complexity test systems located? The analytic systems requirements are applicable to both moderate and high complexity testing. Now we have only one set of quality control requirements for both moderate and high complexity test systems. The personnel section does have separate personnel requirements for both moderate and high complexity testing. Well, are procedure manual requirements still the same in the revised reg? During the QC phase-in period, labs performing unmodified moderate complexity testing were required to have a procedure manual describing the processes for testing and reporting patient test results. The final regulations require specific items to be included. The final regulations clarify the requirement that the test procedure must include the lab system for entering results in the patient record and the reporting of patient results, including the protocol for reporting panic values. The final regulations revise the requirement for all labs so that the current director must review, approve, and sign each procedure and change in procedure prior to use for patient testing. And the final regulations require that the procedures must be retained with the date of initial use and the date of discontinuance. Are there any differences in the requirements for test systems, equipment, instruments, or agents, materials, and supplies? Well, during the QC phase-in, labs performing unmodified moderate complexity testing were required to follow manufacturer's instructions for instrument or test system operation and test performance. The final regulations require that labs performing unmodified moderate complexity testing must define, monitor, and document those conditions that are essential for the proper storage of reagents and specimens, and those criteria must be consistent with the manufacturer's instructions when available. Do laboratories have to verify the performance specifications for all the tests currently being performed? Labs performing unmodified moderate complexity testing are not required to verify performance specifications for any test system used prior to April 24, 2003. Well, Diana, what do labs have to do now for performance specifications? Well, the final regulations require that new unmodified FDA-cleared or approved test systems must have the following performance specifications verified by the laboratory in the lab's environment, also using the lab's testing personnel prior to reporting any patient results. And these are accuracy, precision, reportable range, and they must verify that the manufacturer's reference intervals or normal ranges are appropriate for the lab's patient population. Also, those labs performing unmodified moderate complexity testing are required to determine the calibration and the control procedures based upon the performance specifications they verified above. The procedures must include descriptions of the numbers, types, and concentrations of calibration and control materials, as well as performance intervals, or when they perform them. Also, labs must document all of their establishment and verification activities. This requirement was always implied, but the final regulations clarify this requirement. Well, have there been changes made to the requirements for equipment maintenance and function checks? The final regulation clarifies the requirement that function checks must be performed and documented and must be within the manufacturer's established limits, if available, before conducting patient testing. Also, those labs performing unmodified moderate complexity testing are required to establish such limits if they are not specified in the manufacturer's instructions. Well, what are the differences in the calibration and calibration verification requirements? During the QC phase-in period, labs performing unmodified moderate complexity testing were required to follow the manufacturer's instructions. The final requirements apply to all non-wave testing now. The requirement that the calibration materials must be traceable to a reference method or a reference material of known value has been removed. This was done to allow flexibility in choosing materials for the calibration verification. Now, where does the regulation explain what controls the laboratory must run? What does it require for controls? Well, the exact citation is 493-1256, and it details what laboratories must do to assure that their test systems repeatedly generate accurate results. After a laboratory has determined how many and what type of control materials it should use, as well as how often they have to run them, it must be certain that errors are detected immediately when they occur. These errors could be caused by test system failure, by extremes in the laboratory environment, and also by improper operator performance. Now, changes over time in any of these sources of air may also adversely affect the accuracy and precision of the test system. Because of this, the laboratory must also monitor the test system's control results over time, reviewing those results routinely for shifts and trends, as well as immediately at the time of testing. Now, what controls need to be run? How often and when? Well, the laboratory should have answered these questions when it determined the test system's performance characteristics that Diana just talked about. Generally, two levels of control material must be run each day of testing. That is, unless the test system manufacturer requires them to be run more often than once a day. If the test produces a quantitative result, then two control materials and different concentrations are run each day of testing. Last, if the test result is reported as a tighter or it's semi-quantitative, the controls need to include a negative and one giving a graded or tighter result. Is that for everything? I wish it were. There are some specific requirements for certain types of testing due to the nature of the procedures themselves. Let me go over those requirements that apply in more than one specialty area. There are test systems that include one or more extraction phases. The control materials for these systems must include two controls, but one must be capable of detecting errors in the extraction process. Next is TLC, thin layer chromatography. The lab must include a calibrator on each plater card that contains the substance or drug group it reports by the method. There must also be a control or on each plater card that is processed through each step of testing, just like a patient specimen is, including the extractions. Third is electrophoresis. At least one control material containing the substance is being measured and identified must be run at the same time as patient specimens. Val, what else should we be aware of when testing? That's the big question, a long one anyway. There are a number of good laboratory practices that the regulation addresses. And because of the list, and they are all important, I don't want to miss any, let me go through them for you one at a time. The first one that we come across is that when there's a complete change of reagents or a major preventive maintenance or if the critical operating parts are replaced, you must run control materials before testing patient specimens. Also need to rotate control testing among all operators of the test system. And the controls must be run the same way that you run a patient specimen. I think we're on number four by now. And that is, if you use specific calibration materials to set a test system or to establish a cutoff point, you must use a different lot number if they're to be used as controls. We need to determine acceptable ranges for the control materials. Each batch or lot number of quantitative control materials must have the mean and standard deviation defined and available. If you use an unassayed commercial control, the stated values must be for the method and instrument you use. If unassayed materials are used, you must establish their values over time by concurrently running control materials having previously determined statistical parameters. I think we're on number six by now. And that has to do with checking reagents, median supplies. A check of positive and negative reactivity as well as graded reactivity must be run with each batch of media, if it's prepared in-house, each lot number, commercially prepared, each shipment of reagents, stains, anisera, and identification systems if those ID systems use two or more substrates, two or more reagents or a combination of the two. Each day of use, stains need to be checked for intended reactivity with a positive and if needed a negative control. Then there's fluorescent and immunohistochemical stains. These need to be checked with a positive and a negative control each time they're used. We have to check also each batch of media to see if it's supposed to be sterile before or at initial use. Check that it can support growth and that it selects or inhibits specific organisms or produces the biochemical response it's supposed to produce. All this has to be documented and if there's any signs of deterioration in any of it, it has to be reported to the manufacturer. The laboratory has to remember that it is responsible for the results it gets when using these reagents, the media, supplies and it must follow the manufacturer's instructions for proper use. The laboratory may not report patient results if the control results are outside their acceptable range. Now there are some procedures that there may not be control materials available and if the laboratory is performing any of those it must have an alternative way to assure the accuracy and reliability of the testing that it's performing. Now last but certainly not least we have to document everything we do. The old adage of if it's not written down it isn't done, holds true in control procedures as well as in all aspects of laboratory work. Now, Carol, I understand that the specialties and subspecialties have some specific requirements. Yes, there are specific requirements for those areas. They supersede the requirements found in the control procedures for those areas. They are specific to a specialty or subspecialty and may require more frequent or more stringent control. In some cases the requirements are reduced. You'll notice that not all specialties and subspecialties have additional requirements. For example, syphilis serology has no more requirements than those found in the control procedures of the analytic section. I've heard that there are many changes in the specialty and subspecialty requirements. Does anyone know what are the requirements in the final regulations? The microbiology section did have some revisions. These were based on data provided by the American Society of Microbiology, the ASM, and the CLIAC, our CLIA Advisory Committee. The data showed that a number of agents had low failure rates, so less frequent control testing is required. Now the specific requirements, and we'll go through each one of the specialties or subspecialties, are. Now for bacteriology, we must run a positive and a negative control each day of testing for beta-lactamase, each week of testing for gram staining, and when a new batch, shipment, or lot number of anise here is opened or prepared, and each six months thereafter. Now in mycobacteriology, the lab needs to check fluorochrome stains, acid-fast stains, and all reagents each day of testing with a positive and a negative control. In mycology, each lot number, batch and shipment of lactophenyl-cotton blue must be checked for intended reactivity with control organisms. This is done when the region is opened or made. There are some additional requirements for parasitology, too. Labs need to maintain a reference collection to assist in the identification of parasites, use a calibrated ocular for determining size of woven parasites, and do a monthly control to check permanent stains. In virology, labs must use a cell substrate or uninoculated cells as a negative control when they isolate or identify viruses by cell culture. The only requirements in chemistry address the number, frequency, and concentration of calibration and control materials for arterial blood gas testing. The chemistry section of the old regulation had additional requirements for toxicology. These are now included under general requirements at control procedures. Now, for hematology, the requirements address the number and frequency of patients and controls for manual cell counts. The specific requirements for coagulation testing have not changed, but there are now specific requirements for the number and frequency of controls for manual and automated testing. The former requirement for two controls each eight hours of testing for automated cell counters has been removed. A laboratory using an automated cell counter is now expected to perform two levels of controls each day of testing, and this is covered under the general requirements at control procedures. Those are the ones Val talked about. The blood banking or immunohematology requirements state that for patient testing, a laboratory must follow the FDA requirements for testing, distribution, and storage of blood and blood components, retention of samples, of transfused blood, and the investigation of transfusion reactions. In histology or histopathology, a lab must use a positive and negative control each time of use for fluorescent and immunohistochemical stains, but needs to run only a positive control slide for differential and special stains. Cytology has been reorganized. The regulations still include requirements addressing the slide examination sites, staining, control procedures, workload limits, slide examination and reporting, record and slide retention. Now, due to the new technologies, there is a new requirement for the semi-automated and automated screening devices. In clinical cytogenetics, the additional requirements address the identification process including accessioning, cell preparation, photographing, or other image reproduction techniques, and the reporting and storage of results, carry types and photographs. There are requirements unique to histocompatibility, such as HLA typing, disease-associated studies, antibody screening, cross-matching and transplantation. Now, the important thing to remember about specialties and subspecialty requirements is that they are additional requirements to those found in the general section of the control procedures. The requirements may be more stringent or less stringent in numbers or frequency, or may be unique to the critical steps in the methodology. For each procedure, a lab will want to review the manufacturer's instructions, the requirements at control procedures, and the additional requirements in the specialty and subspecialty sections to know what controls they must be done. Well, do laboratories still need to do comparison of results for their instruments? Yes. The requirements under comparison of test results were lifted from the former quality assurance section. Laboratories must compare the test results between different instruments, methods, or test sites twice a year. The laboratory must also assess patient test results with patient demographics, clinical history, and other tests performed on the same patient. Well, what requirements under the old patient test management were moved to the analytics section? Oh, Val, the test records came from the former test records in patient test management, and there are no changes in the requirements. They're identical. Well, what did you do with remedial action? Remedial action, we just changed its name. We now call corrective action, a requirement to document the corrective action taken when reagents and specimens were not stored under the required conditions was added to this. This was the only change. All of these requirements now apply to both moderate and high complexity testing. Silly, you might know the answer to this question. Has the quality assurance section been removed from the revised regulation? Oh, not at all, Carolou. The last standard under the analytics section is analytic systems quality assessment. The QA requirements appear throughout the regulation to emphasize the importance of quality throughout the total testing process. This lets the laboratory incorporate QA into its day-to-day routine. The quality assessment requirements contain generic language, allowing more flexibility, and encompassing all of the analytic systems activities. I guess in summary I should say the analytic section applies to both moderate and high complexity testing, contains the general quality control requirements, the specialty and subspecialty quality control requirements, and includes quality assessment requirements. And it applies to both moderate and high complexity testing. Our cast of stars. So what do you think? We should give them an Oscar or an Emmy. Well, the stars for this video were Val Coppola and Cecilia Henkel of the Division of Laboratory Services and NSO. Diana Fairbanks from CMS's Kansas City Regional Office and Carolou Matern from CMS's Denver Regional Office. All right, what we're going to do now is we're going to move on to the post-analytic system and we're coming back to Rinalda. Rinalda now composes the post-analytic section and the final regulation, where some of the sections included in patient test management and quality assurance in the former regulation. The post-analytic section of the final regulation now includes post-analytic systems, test report, and post-analytic systems quality assessment. Based on recommendations to the former regulation regarding the test report, the test report now includes the name and identification number or unique patient identifier and identification number. Because the former regulation did not specifically require a patient's name or unique identifier as part of the test report, several comments expressed the importance of including the patient's name with an identification number on the test reports in order to ensure positive patient identification. Other items required include the test report date, the specimen source when appropriate, and the interpretation if applicable. Additionally, in reference to laboratories maintaining an exact duplicate of each test report, CLEAR requires a laboratory to maintain the information on each test report. This information can be manually written, generated by an electronic system, maintained on a microfilm, or any other means provided it contains all of the information that was on the original test report. Therefore, the reference to an exact duplicate is removed from the final regulation. Before we hear from our final speaker, Virginia Wanamaker, I'd like to give you the numbers to call to fax in your questions during the last Q&A portion of the broadcast. If you'd like to call, the number is 1-800-953-2233. If you'd like to fax, the number is 1-866-254-8030. This is our last presentation of our program, and it's going to wrap up everything that you've heard thus far, and we're going to let you know what to expect in the future. So I'm going to turn now to Virginia. Okay, we've had an excellent overview of the final CLEAR quality system rule. The members of the regulation team did a wonderful job of giving you the requirements in a nutshell. So let's just take a moment and go over some of the highlights. We now have a facility administration section, Subpart J. This section speaks to the arrangement or physical structure of the laboratory. It also includes a standard for transfusion services. That is, CLEAR compliance are accredited entities that perform non-wave testing, but are not certified in the specialty of immunohematology. They do no typing or cross-matching, but they do transfuse blood or blood products. These entities are now held responsible for their transfusion-related activities. This section also houses all of the record retention requirements. The other section of the quality system rule is Subpart K. Quality system for non-wave testing. Within Subpart K, we have a general laboratory systems section, and the standards of this section apply across all phases of testing. This quality system rule is arranged to follow the path of the specimen through the laboratory with pre-analytic, analytic, and post-analytic sections making up the remainder of the subpart. The pre-analytic and post-analytic sections are, for the most part, a rearrangement of the former patient test management requirements. The analytic section contains the quality control requirements that we all know and love. These requirements now apply to all non-wave testing. The phase in is over. Also, the references to FDA CLEARED is meeting the CLEAR requirements for quality control have been removed. Quality assessment has been dispersed throughout the regulation with general laboratory systems, pre-analytic, analytic, and post-analytic each having an assessment piece. We believe this approach assists the laboratory in developing quality assessment techniques that become a part of their entire testing process. So what's next? Well, coming soon to your neighborhood will be a week of CLEAR training to provide more information on practical application of the regulation. In fact, we will see a number of you in Columbia, Maryland next week. For the rest of you, the traveling show will be in San Antonio on September 8th and in San Francisco on September 22nd. Hopefully, everyone is signed up by now. On behalf of the regulation team and all of us at Central Office, I'd like to thank you for your time and attention today until we see you at training. Have a happy and safe remainder of summer. Thanks a lot, Virginia. Okay, that concludes the presentation portion of the broadcast, and now it's time to give you the viewing audience your final opportunity to ask our experts questions on all that you've heard today. Again, to call in, you should dial 1-800-953-2233. If you'd like to fax in your questions, 1-866-254-8030. And while we're waiting on our first caller, let me ask Virginia, what entities are now covered by transfusion services that weren't previously? Well, any laboratory that does non-wife testing, whether they're a CLIA compliance lab or whether they're an accredited lab, they could be certified in chemistry and hematology, but not immunohematology. As long as they do any type of transfusing of blood that is giving the unit to the patient, then there are certain requirements that they will have to adhere to for transfusion services now. All right, I think we have a call on the line. Caller, please go ahead. Thank you for calling. We have Mary on the line. Mary? Yes. Go ahead with your question, please. I just had a question about the DTM media for dermatophiles, and I wanted to know if the end user, which is usually the dermatologist, still going to be responsible for QC that media? Who would like to take that question? Val Coppola, you look like you should take that question. I knew you were going to say that, Doris. Have at it. Yes, they will have to adhere to any specific requirements that are in the regulation. The short answer is yes, they will have to do it. All right, thank you for calling, Mary. All right, do we have another caller? You know the number. We'd like to hear from you. This is your opportunity to take advantage of our panel of experts. Well, while we're waiting for some other calls to come in, Val, let me come back to you. I have another question. What security controls have to be in place for electronic transmission of test requests and results? Well, Doris, we don't have security controls per se, but there is one overarching, I think, requirement that would cover both the transmission of results as well as the transmission of requests, and that is patient confidentiality requirement. And the laboratory does need to ensure that all that information is maintained and certainly not exposed in any way and to maintain confidentiality. Now, that is only the information material that the laboratory has under its control. All right, we'd like to thank Dr. Bruce Krieger for that question. Cecilia, let me come to you. If a lab institutes a new test, what should they do prior to reporting the results, and then should they do anything if they only changed methods for an analyte they've already performed? Well, Doris, the answer is yes, they should do something if they only just add a new method. And if they have a new test that they've added a new test system, the laboratory is required to either establish if it is a home brew, or verify if it is a method either high or moderate complexity that is commercial or has been approved by the FDA. That means they have to verify the accuracy, the precision, the reference range, and the reportable range that the manufacturer has established. Okay. So, Rinaldo, let me come to you. What if a small laboratory identifies their patients only using the patient's name because the laboratory doesn't have test requisitions, report forms, or log sheets, and uses no ID numbers? The patient's name alone does not ensure positive patient identification, so the laboratory must use an identification number or an accession number with the patient's name. All righty. And Cecilia, let me come back to you. What if they develop a totally new test, home brew literally, in their garage? Is this different than just verifying the manufacturer's specifications? Yes, this is Doris. The laboratory must establish the performance specifications for these tests that they develop, even if it's in their garage. We pray not. So they are required to establish their performance specifications. Okay, Val, let me come back to you. Now, if I calibrate my test device every six months using three points, do I still have to do calibration verification? Oh, that's a nice short answer. No, you've taken care of the requirements. Okay. That's it? That's it. All righty then. Nothing more needed. Okay, Rinaldo, let me come back to you. If the test report date, actually the date the test was completed, the report was printed, created, or the date it was transmitted to the authorized person. The test report date is the date the test results were generated as a final report and must not change on copies that are reported at a later date. That was short sweet to the point. Cecilia, let me come back to you. If my control materials have a matrix different from the patient's specimens, is that acceptable? If so, then how does it meet the requirements to be tested in the same manner as the patient's specimens? Well, Doris, the regulation requires that one uses a sample that has the same matrix as the patient's specimen. However, there are certain tests that one would not be able to meet this requirement. That would be like for blood gases, you would not be able to have the same matrix for the control sample as you would for the patient's specimen. So in those cases, you would not be able to do this. All right, well, if the laboratory uses a saved controls, do they need to verify their stated value? Yes, they do. They can begin to use the control and as they use it, they must tighten up their statistics. Okay. Now, folks, this is your last opportunity to call or fax in a question before I take our panel of experts away, the number to call 1-800-953-2233. And again, if you'd like to fax us, the number is 1-866-254-8030. And if we don't hear from you, well, you missed out on a great opportunity. Virginia, let me come back to you. What entities are now covered by transfusion services previously? Well, actually, we talked about that a little earlier, but I'll address it again. Any entity or any laboratory that does non-wave testing, if they don't have an immunohemitology, if they aren't certified immunohemitology, but they do any kind of transfusion of a blood product, another laboratory does all of the prep work for them, but they actually transfuse the blood. As long as they have a certificate of compliance or a certificate of accreditation, then they are now held responsible to transfusion-related activities that they do in their laboratory or their facility. And then, what other transfusion changes are addressed in the regs? Actually, that's a good question. We've now included in the CLIA regulation the requirement to investigate transfusion reactions. Okay. Well, it looks like we don't have any more callers, and can I put you on the spot, ladies? If there was one thing you'd want to say to our viewing audience before we say goodbye, what would it be? Go ahead, Val. I'll offer this, please read the regulation and the guidelines before training. That was my one request. Okay. Cecilia? I would also say, besides the regulation and guidelines, the preamble explains why we did certain things. So that's very helpful if you have a question about why we changed quality assurance to quality assessment. We answered that in the preamble. There are lots of answers in the preamble. All right. Rinalda? I concur with Val and Cecilia. It's a good idea to read the preamble that it explains the rationale for the changes in the reg. All right. And Virginia? We're looking forward to training and can't wait to see you. Okay. Well, thank you all. Thanks for the couple of questions that did come in. That's going to conclude our broadcast. I hope that it has been helpful and informative. This broadcast can also be viewed in its entirety on the Internet at http://cms.internetstreaming.com up to one year from today. If you'd prefer videotape copies of this program, they can be purchased from the National Medical Information Services at 5285 Port Royal Road, Room 1008, Sills Building, Springfield, Virginia, 22161. And of course, if you'd like to call the number 703-605-6186. Again, I'd like to thank all of our panel members and you, our viewing audience, for participating in this important and informative broadcast. I'm Doris McMillan. We'll see you next time. Thank you.