Question and Answer Session

Due to an overwhelming response to this month’s presentation, Dr. Nichols will not be able to answer each and every question that was received. However, he has kindly offered to spend some additional time with Expert Access, and we will posting more of the Q&A session later this afternoon. Thank you very much for participating in this month’s program.

Managing a POCT program seems a lot like running a corporation.
Washington, DC

James Nichols, PhD, DABCC, FACB: Managing a POCT program is indeed a lot like running a corporation. There are staff to manage, their training, competency, continuing education, and there is always concern over the quality of the product, in this case, the POCT test result. As the laboratory world becomes more concerned over medical errors, many of the techniques that we can utilize to address medical errors, like FMEA analysis, are borrowed from industry and manufacturing. If we think about the number of test results we produce in a given day, the type of quality control systems to detect errors or flawed test results, are very comparable to the systems that factory lines utilize to detect errors in their products. We now need to start thinking beyond process control and controlling each individual test (ie internal checks) to guarantee quality results.

What vendor was chosen for the neonate patient ID label? Does the barcode sit horizontal or vertical on the patient ID? Is the neonate barcode easily scannable by your meters?
San Francisco

James Nichols, PhD, DABCC, FACB: I believe the wristbands are from the same manufacturer as our adult wristbands. We utilize the interleaved 2 or 5 symbology and Compuband wristbands (Precision Dynamics Corporation, San Fernando, CA) and Zebra 4M Plus model direct thermal technology printers (Zebra Technologies, Vernon Hills, IL). The neonatal bands come equipped with a parent wristband that matches the neonate so that the baby and parent can be matched to prevent child mixups. However, the bands are bigger than the patient’s wrist, so we have the same problem that most nurseries encounter by having to attach the wristband to the crib, basinet or have a large amount of the band hanging off of the child’s body. I am not certain if there are good alternatives that allow a small enough band to be printed for the tiny neonates. Our bands print horizontally along the direction of the band, but we do encounter sporadic issues with barcode readability as the band ages, or if the band is pulled too fast from the printer while printing, or if the barcode curves around the patient’s wrist. We’ve encouraged staff to flatten the barcode with one hand while scanning with the device in the other hand. This helps the success rate of scanning

For CAP accredidation do you have to run a linearity on each ISTAT every six months or can you use a different method to show linearity?
Stafford Springs, CT

James Nichols, PhD, DABCC, FACB: For CAP accreditation, we were cited three years ago by an inspector who requested that we perform linearities (actually termed AMR/Calibration verification) on each i-stat, every 6 months for every cartridge type that we were utilizing. We were, however, able to successfully petition for an exception to this after the recent CAP checklist update, dated 3/31/04, where we specifically indicated that we treat the i-stat as a device, a reader, and the chemistry which may change, is in the cartridge. We therefore, run cal verification/AMR on each shipment of cartridges and every six months on 3 i-stats, for each cartridge type in use. With the number of shipments, our lots generally don’t last longer than 6 months, so we perform cal verification on receipt for most lots, and just those that happened to last longer than 6 months in our distribution center. **REVISED** 03/31/04 POC.08500 Phase II N/A YES NO Is verification of the analytic measurement range (AMR) performed with matrix-appropriate materials of known analyte value appropriate to the AMR of the instrument, and is the process documented? NOTE: If the materials used for calibration or for calibration verification include low, midpoint, and high values that are near the AMR, and if calibration verification data are within the laboratory's acceptance criteria, the AMR has been verified; no additional procedures are required. If the calibration and/or calibration verification materials do not include the full AMR, the AMR must be verified by assaying additional materials reasonably near the lowest and highest values of the AMR. Single-use devices are a special case in which a large number of devices may be in use at any time within an institution. In this case it may not be practical to periodically validate the AMR using a special set of specimens for each device and alternate approaches are acceptable. The AMR must be validated for each device when placed in service, and following maintenance or repair. However, subsequent biannual AMR validation may be performed on a representative subset of instruments. (If different types of instruments and different lots of reagent strips/cartridges are in use, a sample of each instrument type and each lot of strips/cartidges must be included in this subset.) For the remaining instruments, validation of the AMR may be inferred by other approaches. Examples include: 1, review of QC results to ensure acceptability; 2, comparison of POCT results with near-simultaneously collected specimens analyzed in the main laboratory. (This type of comparison is facilitated when the POCT results are downloaded to a central data management computer.) Other approaches may be satisfactory. Manufacturer’s instructions for calibration verification/AMR verification must be followed. COMMENTARY: N/A REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3702 [42CFR493.2]; 2) NCCLS. Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline-second edition C30-A2. Wayne, PA:NCCLS, 2002.

Standardisation of instrumentation and QA can be of great benefit. Adoption of a standardised accreditation program may equally be of benefit. ISO 15189 and the associated ISO/WD 22870 for POCT, increasingly are being adopted throughout the world for accreditation benchmarking. Do US Accreditation Authorities plan to adopt these Standards in the future?
Mr Chris Budgen, POCT Coordinator, Canterbury Health Labs, Christchurch, New Zealand

James Nichols, PhD, DABCC, FACB: The ISO documents are very close to many of the US accreditation agency standards with what I would consider to be minor differences. So I don’t believe that the different standards are that far apart to not be amenable to merging at some time in the future.

We have in our hospital 4 instruments (Radiometer ABL 7OO)for blood gases.One of them are in the clinical biochemistry lab, and all the other are POCT instruments. In all the instruments we perform daily QC and EQC. As part of our QC programme we suggest to performe once a day some pateints blood ( from the ICU ) in the POCT instrument, and the same samples in our lab. By using this blood samples comparison, we intend to harmonize between the instruments. Our questions: 1.What is your opinion about it? 2.What is the recommended frequencyand number of samples,for performing this comparison?
Israel, Beilinson

James Nichols, PhD, DABCC, FACB: I think it is great that you want to ensure comparability of results across your different devices (main lab against POCT and POCT against POCT), but performing daily patient correlations is very labor intensive, as well as difficult to perform given the instability of blood gas specimens (ie needing to transport specimens between the POCT site and the core lab and vice versa). By CAP and other accreditation standards, such comparisons are really only required initially (at the time that you would implement a new method or device) and periodically thereafter to ensure that there hasn’t been a drift in performance (like after major maintenance, new lot of reagents, or every six months). So daily comparison is a bit of “over-kill” in my view. I am not aware that the standards mention the exact number of specimens required for such comparisons, as this is left up to the lab director, but when we perform our comparisons we generally look to performance of the device at critical levels and select samples at those concentrations. Generally, somewhere between 3 and 10 samples depending on the reagent, the cost of the test and the availability of specimens of the required concentration is sufficient for a comfort level in our lab.

Where would be a place that we could get a template or starting place for a job description for a POCT Coordinator?
Ottawa, Kansas

James Nichols, PhD, DABCC, FACB: I've seen several job descriptions posted on the AACC POCT listserv. The listserv is an e-mail forum available to anyone with an interest on the topic, free of charge. You can sign-up on the AACC website, at www.aacc.org, and then post a question regarding job descriptions, or review the listserv archives, as I remember this question being posted several times in the past few months.

How do you successfully barcode a neonate armband? Is the armband actually placed on the baby?
Baltimore, MD

James Nichols, PhD, DABCC, FACB: Barcoding neonates is NOT easy! Our previous identification system had a set of paired wristbands that matched the baby to the correct parent. When we implemented barcoding, we needed a similar system of paired wristbands while adding the ability to barcode the bands. Unfortunately, all of the products that we’ve trialed are too big for the infants, and indeed, many times the band is posted on the crib rather than on the infant. We have encouraged staff, however, to place the band around the ankle and leave the barcode hanging off the band which allows for positively identifying the baby with a band too big for the infant, and provides the barcode as part of the band hanging off of the leg. This may be an alternative for you to consider.

How many laboratory FTE does Baystate devote to managing such a large POC program?
West Haven, CT

James Nichols, PhD, DABCC, FACB: We have 1 full-time FTE devoted as "POC Coordinator" and 3 part-time (20 hours a week) staff to assist her. At our affiliate hospital, we have a part time Medical technologist (2 - 3 days a week) devoted to POCT, and at our smallest affiliate (32 beds) POCT is handled by one of the lab staff on a part-time basis. We've tried to fully push the management of POCT onto the nursing unit, through self-management, so that the POCT staff are responsible for troubleshooting broken devices, implementing new devices and reviewing areas for performance improvement on the nursing units, while the units themselves handle the day-to day operations, staff training, competencies, etc.

Is there any new developments for POC testing on Lactate (whole blood, serum, or plasma). There has been a request for this from our unit Emergency, to detect for sepsis.
Mississauga, Ontario

James Nichols, PhD, DABCC, FACB: Lactate is available on a number of bench-top and hand-held blood gas analyzers on the market. I am not aware of any major developments that have improved the performance of the test on these devices, although some recent literature has indicated renewed interest in the clinical utility of the test as you noted.

Regarding accuracy assessment of POC glucose: If technique of correlation meets criteria, and evaluation of lot reagent strips meet criteria, and reference method mean is well within external proficiency survey reports when looking at accuracy, is it possible for meters to go off in it's accuracy, due to adjustment that may be required in the calibration factor? Has this even been studied? Please answer this one!!!! From Marie Hoy , Canada.
Mississauga, Ontario

James Nichols, PhD, DABCC, FACB: I’ve learned that anything is possible when it comes to POCT! So, advance planning is the key to proving not just initial accuracy, but also predicting what could go wrong on the nursing unit. As you indicated, some devices require a calibration factor to be entered into the glucose meter in order to obtain the correct result. It is possible to validate a lot of strips using the correct calibration code, then send those strips onto the unit for use in patient care, and have a meter that is programmed with the incorrect calibration code. This definitely could happen, but I am not aware of any literature that indicates or measures the frequency of this occurrence. This is one of the reasons why manufacturers recommend performing liquid, external QC on every glucose meter, each day of use. I would hope that the ranges on your QC are not so wide that you would be able to pick up an incorrectly calibrated meter within at least the first 24hours of a new lot of test strips being implemented, or the calibration code being changed. Other things could also happen that would throw off the accuracy of the strips, such as incorrect storage, leaving the cap off the bottle of strips, getting the strips wet, etc. Liquid QC on the affected strips should also pick up such issues in accuracy if they are of sufficient magnitude to affect patient care.

I will be moving in to a new hospital with a PathNet T.H.I.S. from Cerner Corpn. of Kansas City, USA. There are 2 Roche Onmi C Blood Gas Analyser in the lab and 3 Roche Omni S Blood Gas Analyser being placed at 3 wards as SCN, CCU and ICU. All the analysers will be linked up by Omnilink server provided by Roche which will be interphased to the Cerner PathNet system. The lab will be responsible for the maintenance and the QA of all the units. Kindly advise on how to go about implementing the whole program. Thank you. Yours sincerely, Meing-Choi Chan 4/5/2005
Johor Bahru, Malaysia.

James Nichols, PhD, DABCC, FACB: Wow, your question is far reaching and I am not certain that I can address all of the aspects of implementing new devices in this forum. However, I would recommend two things to get you started. First, have your information specialists or computer technicians involved in the implementation, as interfacing and connectivity are not straightforward and will need the input of these individuals. Second, I would refer to the guidelines or recommendations of the agency accrediting your hospital. CAP has checklists of questions that must be considered to remain accredited by that agency for example, and those questions have specific items that need to be considered before using a new device for patient care. This would get you the fundamentals to implement a new device, but there are many who go through the same process every day, so look to the manufacturer for other contacts of individuals who have set up similar systems or consult the AACC listserv for others involved in POCT who have implemented similar systems. Hope this helps.

Does POCT operate under the lab's CLIA certificate or does each floor have their own? I also thought I read that you were switching from a JCAHO POCT survey to CAP. If that is correct I am curious about the reasons for the switch. We are CAP inspected.
Jackson, MI

James Nichols, PhD, DABCC, FACB: We have one CLIA certificate for the core laboratory and a separate CLIA certificate for POCT at Baystate. We switched from JCAHO to CAP about four years ago for a number of reasons. Mainly, CAP has a more defined checklist and the inspections are conducted by peers (ie laboratorians) who operate similar laboratories, where JCAHO inspections may be conducted by a clinical nurse, pharmacist, or hospital administrator who don't fully understand laboratory operations, the basis of quality control, preanalytic variables, etc. So we strongly felt that we were getting a better inspection when someone from the laboratory was inspecting us rather than spending the whole day explaining what QC is and why we have to run it.

What have you found to be the most effective way to deal with non-compliance issues - such as failing to run QC or running QC that is expired - short of denying nursing ability to contiune performing the test?
Columbia, Missouri

James Nichols, PhD, DABCC, FACB: I truly believe that the best compliance comes from the units that understand why it is important to do something, not just dictating to the staff that it must be done. Communication of the why is the most important step. Explain and give the facts of what could happen when QC is not performed, what could go wrong with a device and how QC prevents these errors. Staff are very attuned with the new JCAHO patient safety goals to the issue of medical errors. If you speak to nursing in their language and relate issues to patient care in a manner that they can relate, they will be much more likely to comply in the future, because they will remember why it is important the next time the device reminds them to perform QC. Use of examples helps, but also incorporating these errors into the quality performance plan of the unit and monitors of other mistakes on the unit can help as well. In other words, treat POCT like any other patient care activity and role POCT into the other unit’s performance plans (like storage of drugs and food on the unit, monitoring refrigerator temperatures for patient meds, same as monitoring temperatures for POCT, etc.

tell me about the comparablity of poct results and laboratory results? accuracy of SMBG in post prandial state? when a physician should seek a lab if he is using the poct?
chennai, India

James Nichols, PhD, DABCC, FACB: We do not mandate that a physician should perform a specific action for any POCT or laboratory result. While there is literature and recommendations from peer societies regarding agreement of POCT and lab results, we don't specifically require that a physician collect a lab result when the POCT glucose is 500 mg/dL or 30 mg/dL, for instance. This would set us up for noncompliance during our next inspection. Instead we give the clinician several options to choose from when the POCT result is critical or does not match the clinical situation: 1) repeat the test with a new specimen 2) send a test for laboratory confirmation 3) take clinical action, ie feed if the glucose value is low enough 4) do nothing, because the value is part of an expected trend.

We have several sites that do POCT, all but one of these sites use the Clinitek 50. Our OB floor uses the visual method for urinalysis because of the extra cost of bringing in automation. How can I convince them to be standardized with the rest of our sites?
Laurinburg, North Carolina

James Nichols, PhD, DABCC, FACB: In this situation, the OB floor has to be convinced of that the benefits of automation outweigh the expense of bringing in the device. Expense in their minds may also include the intangibles like staff retraining, increased documentation and other operational issues. I would clearly lay out the advantages and disadvantages of both visual and automation options to the unit management. Include hospital administration in the meeting, as they may be more amenable to "standardization" concepts, and perhaps bring some advocates from the other units who used to do visual testing and now like the automation.

Should POC devices be using EQC options? Or should they stick to manufacturer recommendations that were issued before EQC options? Orange, CT

James Nichols, PhD, DABCC, FACB: I am a bit confused by this question since the notion of EQC involves some type of internal or alternative QC, not just reducing the frequency with which one performs external, liquid QC. So manufacturers are necessarily involved in the implementation of an alternative type of QC since they must first add it to the device, before we as consumers can consider it as an equivalent option. When thinking about Equivalent QC, I like to consider devices like continuous glucose monitors, transcutaneous bilirubin devices, or even indwelling catheters which cannot have traditional external QC. There is no place to insert the sample and no means ensuring that the external QC would act the same as the specimen utilized by these types of devices. In this instance, there is no such thing as an “equivalent” QC, so a better term would be alternative QC. For such devices, I like the option #4 which is currently being drafted by a group from CLSI (formerly NCCLS), which would assess what aspects of the device are controlled through the manufacturing process and where the risks remain which need to be considered by consumers of the device. Risk assessment allows the laboratory director to determine both the likelihood of an event occurring as well as prioritize preventive measures to ensure the quality of the test result. Some of these measure might include liquid, external QC, but others may include internal checks or development of an internal line on the device.

When a QC result is out-of-control on its liquid QC, is it acceptable to repeat the test for a second result? Is it acceptable to repeat the test again after that, if the result is still out-of-control?
Orange CT

James Nichols, PhD, DABCC, FACB: When QC is out of control, the operator needs to think about why this event occurred. Something has gone wrong which generated a result outside of defined acceptability which indicates that the test is an exception and should make the operator stop and think. Repeating the test may be totally acceptable, particularly if the operator believes that they didn’t apply enough specimen, or got a bubble in the sample, or something else happened during test performance. Many times, though, the operator may not know why the test didn’t work, in that case simply repeating the test could repeat the error. We also need to realize that the ranges on QC statistically allow for the probability of failure simply due to random chance. In this case, repeating the specimen, may provide successful results, since the chance of a second test failure is very improbably. This is why many lab directors find it acceptable to repeat the test, and if the second test also fails, to stop and take corrective action of some type (open a new bottle of control solution, new bottle of strips/cartridges, call the supervisor for assistance).

Are there specific criteria that moderate complexity tests should meet in order to be incorporated into POC use (test procedure steps to a minimum, minimal sample preparation, etc.)?
NJ

James Nichols, PhD, DABCC, FACB: The answer to this question depends on the agency accrediting your POCT program. CAP for instance, does not recognize test complexity and treats all POCT the same, while CLIA does require different validations depending on the complexity of the test when implementing a new device. Virtually any type of device can be made point of care, by simply moving it onto the nursing unit. This doesn’t mean that the device will be simple, easy to use by clinical staff. So some recognition of the ability of staff to operate a device will vary depending on the device. I can’t make general recommendations for what fits POC and what doesn’t as the capabilities of staff and unique aspects of a given site with a specific device are variable. These are the considerations that the director on the POCT license need to consider. Use of a committee for POCT consisting of clinical and laboratory staff can also help deflect some of the heat from a single individual when the answer is “NO” to a request to implement a specific device.

My question concerns perioperative glucose monitoring in cardiac surgery for guioding intensive insulin therapy. We currently do STAT testing in the main lab to take advantage of our big analyzer's low CVs, but we're consuidering POCT for this. Any advice? We'd have to purchase new POCT equipment because CVs on our existing system are higher than we'd like for this application, but we'll make the investment if I can show that decreased TAT would help surgical staff. Tacoma, WA

James Nichols, PhD, DABCC, FACB: A few items for you to consider when implementing intensive insulin therapy testing. First, most of the literature conducted on intensive insulin therapy was based on glucose meters, despite their limitations (imprecision, etc.). Intraoperative use of glucose meters, particularly for cardiac patients, need to consider the hematocrit of the patients. If your glucose meter can't read accurately less than 25% hematocrit and your cardiac patients typically get to 20% or lower, you might want to look for a different device. If precision is a concern, you could also consider a blood gas analyzer, as many have glucose electrodes that give much better precision than glucose meters and do not have limitations of patient hematocrit that the meters have. For hematocrit reasons we do not utilize glucose meters in the operating room. Instead, we've implemented a blood gas analyzer with glucose electrodes available (the istat) for use during surgery. This allows the advantage of testing blood gases on the same sample. Once patients reach recovery and are transferred to the intensive care unit, their hematocrits are more normal, the patient is off of bypass, and we can start reusing the glucose meters.

If a particular POCT location consistently does not comply with regulations (e.g. documentation, maintaining accession logs, etc..) what should we do about it? What about if staffs invlved are physicians (Hospital ED or physicians offices). Can we remove POCT from these locations? Thank you
Rochester, NY

James Nichols, PhD, DABCC, FACB: Noncompliance is something that eventually hits all POCT programs and is an issue that needs to be addressed. I believe that the best approach is to recognize the unique abilities of the staff at that site, but to also encourage an awareness of why regulations exist. Communication is key, and the better we as laboratorians can express the intent of the regulations to clinical staff, the more likely they will be to comply. Use of examples and speaking in their language also helps. Noncompliance is a "medical error" and if staff understand the consequences of not complying with the regulations in terms of patient care, they will better relate to the need to comply. Examples of consequences that happened to patients when compliance wasn't followed will be a reminder to staff the next time the device calls for QC, or the staff see the log next to the test kits. It is difficult to achieve 100% compliance, but those staff that understand why it is important to comply and the consequences of noncompliance will be more successful than staff that don't understand and have been preached or dictated to. So not just the message, but how the message is communicated is equally important in achieving staff compliance.

With limited resources, i.e.laboratory staff/time and IT, what do you consider the most important areas to concentrate on for delivery of successful POCT. For example where the glucose meters in use are not capable of downloading results and logging of data is manual.
London, England

James Nichols, PhD, DABCC, FACB: Limited resources is one of the biggest problems we all face, not just in POCT, but in the core lab, on the nursing units and in health-care in general. Automation is key to preventing wasted time. Having staff perform routine functions over and over again (like logging data) is redundant and a poor use of limited staff, so getting manual testing automated is a key aspect to improving the efficiency of staff performing POCT and supervision of POCT. I'd also review or do a workflow analysis of how your staff are spending their time. Ask if all of the functions are necessary, can't be consolidated into different job catagories (like secretarial staff instead of Medical Technologist) or if the job can't be automated. Often just assessing where time is being spent, can help people better manage their time and reduce unnecessary tasks.

what is the best way to increase qc compliance in the ER
newyork,newyork

James Nichols, PhD, DABCC, FACB: Compliance with regulations or QC is difficult, if staff do not understand why they are performing the task and the consequences in terms of patient care, of not performing QC. Devices that can remind staff to perform QC every 8 hours or every day, can help with compliance, and those that lock out devices from patient care if QC is not performed or fails, also increase compliance. However, the best means of improving compliance is communication. Staff need to understand why they are doing a task and what could happen if the task isn't done correctly. You can always threaten to remove testing, but it is better for staff to manage their processes. Try including "compliance with QC" as a benchmark for performance improvement on the unit. This should be part of the other clinical monitors that staff must do for patient care (like monitoring refrigerator temperatures for patient medications, etc.). Try to make POCT as much a part of patient care on the unit, not a separate process, and speak to the staff in terms that they understand. Use of key words and hot issues, like medical errors, can help, since everyone is now attuned to JCAHO patient safety goals. If you explain that noncompliance with QC is a "medical error" and can lead to inappropriate patient care (give some examples), then staff will be reminded of those examples when the device calls for QC.

Dr. Nichols, In your presentation you stated that your original patient identification error rate was 5%. In your graph of glucose patient identification errors it appears that there were 47 errors in January 02. Were there only 940 tests performed that month? Does this figure include the ED population that have been tested but not registered with a number? We have an average of 700 glucose errors a month (2% error rate). We perform about 45,000 glucose tests/month. Our errors include everything that does not cross the interface ie, transpription, arbitrary numbers, and emergency numbers.
Hartford, CT

James Nichols, PhD, DABCC, FACB: The graph in the presentation was from one nursing unit, our intensive care unit, not the entire hospital. Hospital-wide we are now averaging less than 100 total errors a month, based on a glucose and blood gas volume of over 500,000 tests a year.

According to JCAHO's 2005 Waived Testing Standards, competency must be documented by two methods. In our facility, we train our users initially, have each perform a yearly competency and distribute survey samples randomly. Are we meeting this requirement?
Erie, PA

James Nichols, PhD, DABCC, FACB: My interpretation of the JCAHO standard means that competency checks must contain two different means of determining that the operator is competent. Several options include: * watching the operator perform the test * performing a blind sample and documenting that the operator achieved the correct result * performing a QC test * taking a written exam * performing a patient specimen that is split and performed by another operator at the same time or sent to the lab for confirmation JCAHO, I believe gives some other options as well, but the expectation is that two of these would be performed and documented as part of the annual competency

How do you enforce the requirement of scanning the barcode/entering the patient ID# at the bedside? Sometimes operators scan or manually enter the number into the POCT device PRIOR to entering the patient's room, sometimes causing misidentification issues. Obviously, this is because they have access to the patient barcodes/ID numbers on charts and labels at the nurses's desk and get the number there as opposed to the armband. It seems like no amount of training, retraining, and even stiff disciplinary action helps. This problem is much worse for us with PCX testing than with i-STAT testing. I have noticed this seems to stem from the fact that the majority of our PCX tests are done by less professional staff such as patient care techs as opposed to RN's or LPN's, and as a group they are less responsible, don't appreciate the implications of misidentifications, and just disregard the rules...like you said, they don't understand the WHY and I don't know if they can be TAUGHT the WHY. Our facility, like most, considers PCX testing to be so simple that it is a waste of an RN's time and the RN's are better off freed up to perform more professional duties that require their expertise. This line of thought is also seen in our QI monitors (such as misidentifications) in that we have many more misidentifications occurring with PCX testing than with i-STAT. Almost all our i-STAT testing is performed by more professional staff such RN's, Resp. therapists, radiologic techs, CV Techs, cath lab techs, and so on who are simply more conscientious and understand the reason for the rules. I would like your comments on this subject. Thanks.
Huntsville, AL

James Nichols, PhD, DABCC, FACB: The level of staff performing the test is clearly a consideration when implementing POCT, but training is also a key. Despite the educational level of the staff performing glucose meters versus blood gas testing in your institution, if your training program approaches the barcoding issue in terms that the level of staff can understand, I believe you may have better compliance. We likewise have nursing aids, or nurse techs performing glucose meter testing, while respiratory therapists and nurses perform the i-stat testing. But compliance with barcode scanning is just like any other task and if approached as a part of patient care (not a separate lab requirement), you may improve your success rates. We have incorporated barcode errors into our unit performance monitors and is held as a "near miss" medical error by the hospital quality performance committee. So emphasis and reemphasis of the issue up and down the administrative chain is very key. The message has to be delivered clearly during training and recertification, as well as be reenforced at every opportunity by multiple staff, not just laboratory POCT staff.

Jim, How do you handle requests from MD's for new devices/new tests? These sales reps go straight to the the MD's and sell it to them and then they demand the LAB administration implement it. Our chief pathologist who also oversees POCT is very diplomatic and great in working with me on such requests and most of the MD's do NOT get what they ask for, but it still bothers me sometimes when they do if I don't see the need or it's hard to manage. These MD's don't always understand the management, QC, and training costs, in addition to moving backwards in terms of standardization. Somtimes I don't see the need for the test or at least the test at the POC. It's like the MD's are not given the burden of proof to show accuracy, precision, significance, etc. I'm expected to do that after the fact! And then when it doesn't work as stated by the manufacturer, it creates a nightmare. Just wondering how you deal with this. Do you have final say on such issues? This is the first hospital where I have never had a Ph.D. on site for consultation. Our lab administrator is great a Med tech. with an MBA and our chief pathologist is also great, but I see a lapse sometime in expertise related to the question above and also with QC, Correlations, and Cal-Ver review and so on. Any suggestions? Sorry, this was kind of 2 in 1. Thanks.
Huntsville, AL

James Nichols, PhD, DABCC, FACB: Start a POCT Committee. While state, CLIA, CAP and JCAHO all hold the medical director on the POCT license as responsible for implementation of new devices, a POCT committee consisting of representation from nursing, clinical staff, hospital administration, finance, purchasing and the lab can help defer the heat and make the decision for you. Just because a clinician requests a test, doesn't automatically mean the test is going to be available. There are technical issues, financial/budgeting issues, and patient care issues to consider. I've found our POCT committee to be very useful in deflecting the heat and agression from a clinician when they get the "No" answer, as there is noone to directly blame or attack. So a committee can really help in discussing the issues with a particular request and help reason a response. This doesn't require a PhD or MBA onsite, and can work within the committee structure of your institution. We require all POCT requests to be signed by the department director of the requesting physician and have budget approval before the request is brought to the committee, as we've found that many requests are brought by a single individual without the awareness of their department and/or recognition of the cost or resource (staff) involved in the request.

Why JCAHO to CAP? What is your 3 strike rule?
St. Louis, Missouri

James Nichols, PhD, DABCC, FACB: We switched from JCAHO to CAP for several reasons. CAP has a defined checklist and the inspection is conducted by peers (laboratorians) who understand and manage similar laboratories. We've had a number of lab inspections under JCAHO by individuals who didn't know the first thing about the laboratory, and unfortunately, we spent alot of the inspection time, just explaining what QC is, and why it is important to perform QC rather than actually performing an indepth inspection. The 3-strike rule as we called it, was patterned after baseball. Three errors and the operator was out. In other words, if the operator made three identification errors, they were automatically locked out of the POCT device and could not perform any additional testing until they were retrained. This was moderately successful, but we had much better compliance once we communicated to the operators WHY it was important to not make the errors in the first place and what the consequences of patient identification errors were to patient care

What is your experience of transcutaneous monitoring of bilirubin. Is it a viable alternative to a bilirubinometer particularly where there is a large ethnic population?
London,England

James Nichols, PhD, DABCC, FACB: Our neonatologists have been very interested in transcutaneous bilirubin, especially after the recent pediatric society recommendations that every newborn should be monitored for jaundice before discharge from the hospital. Unfortunately, the devices that we've examined don't provide great correlation to the lab bilirubins. We also have a large ethnic population, and there are definite biases in the different devices to consider. In general, the devices also underestimated bilirubin, so a different cutoff for treatment based on a separate algorithm has to be considered when implementing. Most importantly, we were also concerned about the limitations of the devices, primarily: 1) They were not approved as a replacement for lab bilirubins, so we were concerned about how staff were going to be utilizing the devices in conjunction with collecting chemistry specimens 2) The devices could not be utilized on patients undergoing phototherapy (this precluded those babies with diagnosed jaundice) 3) The devices needed to be calibrated periodically, against a photocheck, but there was no lockout feature or data management to guarantee that staff actually performed the checks. 4) There was no data management to track patient testing. Our clinicians agreed to continue to monitor babies by core lab bilirubins until the devices address some of these concerns.

How should we go about impressing on Nursing staff the importance and value of CAP survey specimens and what would be a good tactic for addressing survey failures without generating resentment?
West Haven, CT

James Nichols, PhD, DABCC, FACB: Consider treating CAP specimens as a component of patient care and/or operator competency. We've incorporated our CAP specimens as a monitor of unit compliance which is included with all of the other clinical performance monitors on the unit (medication dating, etc.) When failures occur, the unit has 30 days to respond or their ability to continue performing POCT is in jeopardy (by nursing, not by the laboratory), enforcement in other words is peer enforced, not from a separate department. We have a working group where the laboratory meets with nursing on a monthly basis and raises issues like this. It is then up to nursing administration to take action. This separates POCT away from the laboratory and makes POCT more of a patient care activity. I believe that how we deliver the message is as important as the message itself. And if the laboratory voice isn't being heard, try delivering the message from their peers (nursing) or from hospital administration (their direct bosses).

How are you handling the "Read back verification" of panic values in the POCT setting? Is nursing under the same requirements as the lab with repeating and reporting panic values? Thank you! Lura Wilhelm
Bend, Oregon

James Nichols, PhD, DABCC, FACB: We perform read-back on all critical values in the laboratory. This includes POCT, however, POCT is a bit unique. For nursing staff, acting under a clinical protocol (like insulin therapy), the staff performing the test is the same as the staff taking clinical action, so no communication needs to be made. For our nursing TA's and other staff, the test does need to be communicated to a clinician (doctor or nurse) who can take clinical action. This documentation always used to be documented by a comment in the glucose meter or istat. We now changed the policy to indicate that the result was communicated and read back verified by use of the same comment.

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