Quality Control in the CCL

Abstract Quality control is essential to providing optimal staff and patient safety, as well as the best procedural outcomes possible. While it may seem tedious and mundane at times, high-caliber quality control is necessary to keep the lab operating at peak efficiency. Involving the whole staff in promoting quality control establishes a mindset that values performance, results and safety. Our quality control program is also an extension of shared governance in the cath lab. This philosophy creates a lab that is dedicated to best practices, processes and procedures. It also increases overall staff knowledge and contributes to creating a dedicated learning organization. In this survey, fundamental quality control markers will be surveyed and topical covered to allow staff to reflect upon and revisit their philosophy and commitment to quality control in the cath lab. Introduction In order to provide the safest, highest quality patient care in the cath lab, it is essential to have a comprehensive quality control program in place. Quality control (QC) verifies that equipment and products are meeting the recommended manufacturers’ standards and they are performing at the necessary level to provide safe and effective delivery of care. It also ensures that the necessary supplies are available to provide patient care. Regular QC and maintenance extends equipment life and allows its use to be at peak efficiency. In order to develop and maintain a high-caliber QC program, there needs to be collaborative effort between product vendors and manufacturers, regulatory agencies such as the Joint Commission, point-of-care testing, biomedical maintenance, staff development, the cardiac cath lab staff and other vested parties. By utilizing all available resources, a comprehensive QC program can be designed, maintained, and upgraded as necessary. At Pennsylvania Hospital, quality control is discussed and worked upon both informally and formally. One of the most important vehicles for process evaluation and improvement comes from internal staff meetings, known as shared governance meetings. These meetings between various staff elements offer opportunities to have internal, private discussions to address issues and improve lab efficiency. It is a format where staff can communicate frankly and create their own itinerary for meaningful change. These open dialogues greatly improve staff effectiveness and have been vital in establishing our commitment to excellence in quality control measures. There are many elements to an effective quality control plan and they include setting a quality control schedule, educating staff on the value of the program, training staff to perform these tasks, and maintaining records for verification. Quality control allows optimal delivery of patient care, and promotes stewardship of the limited resources available in the modern healthcare environment. An effective quality control program establishes uniform standards of excellence and enables the staff to understand the value of the processes and practices that are involved to create and maintain it. Although there are guidelines and policies to govern quality control programs, each lab needs to tailor its quality control program to conform to its scope of practice. Many labs have expanded their scopes of practice to include non-cardiac procedures, and there is additional equipment that needs to be evaluated when expanding a lab operations. There is equipment which is standard in all cardiac cath labs, however, and this topical survey is designed for staff to reflect upon and revisit basic precepts for maintaining a high quality, comprehensive QC program. At Pennsylvania Hospital, each day begins with reviewing and updating the schedule, opening the labs, making sure they are properly supplied, and performing comprehensive quality control. Quality control is a foundational concept that needs to be adhered to for promoting patient and staff safety, verifying that the lab’s equipment works properly, and complying with industry- and regulatory-based standards of excellence. The equipment that needs to be “QC’d” includes the AVOXimeter, Hemochron, defibrillator, emergency equipment, fluoroscopic and imaging systems, personal protection equipment, climate control, medical gasses, and the procedural equipment necessary to perform patient care. AVOXimeter The AVOXimeter (ITC, Edison, NJ) needs to be checked on a daily basis to ensure quality control. This includes checking the machine with multi-level cuvette filters, making sure the desiccant in the cuvette bag is not compromised by humidity changes in the lab, and recording the results to verify normal results and trends for the equipment. Additionally, wet QC’s need to be performed weekly, and any time a new bag of cuvettes is introduced into the laboratory. The pathway wavelength needs to be entered into the machine so results for QC and patient testing is accurate. Wet QC is refrigerator stored, and it is important to maintain proper refrigerator temperature so QC results will be accurate. The program is given oversight by Point of Care testing (POCT). They provide advanced monthly QC, and review records for discrepancies and compliance. The independent verification of quality control by POCT also reinforces the integrity of our results. Problems with testing is reported to POCT, and if necessary, biomedical maintenance. POCT discusses findings with the staff to improve processes and solicit feedback. All new staff is trained to perform daily and advanced QC, and there are annual mandatory training sessions to ensure staff competency. Hemochron The Hemochron (ITC) measures the effect of anticoagulation medications. The Electronic System Verification (ESV) wands must be checked every 8 hours to ensure accurate measurements. Wet QC needs to be performed on a monthly basis and any time a new box of Hemochron tubes is introduced into the lab. Wet QC products need to be stored properly so they can produce accurate results, and expiration dates need to be checked on all wet QC product. Additionally, Point of Care testing also conducts reviews of the program and performs their own QC to ensure that the machine results are accurate. Again, this additional testing provides independent confirmation of test results and enhances the value of the QC program. Problems with QC are reported to POCT and, if necessary, biomedical maintenance. As with the Hemochron, mandatory training modules are in place for staff and new hires. Defibrillator and advanced cardiac life support (ACLS) equipment At Pennsylvania Hospital, a Zoll biphasic defibrillator (Chelmsford, MA) is kept in each lab, along with a code cart and an emergency airway management box. The defibrillator needs to be checked on AC and DC power, so it can be depended upon in emergency scenarios. It should always be plugged in and used on AC power, except when necessary. All adjunct equipment, such as airway management equipment, electrocardiogram (ECG) leads and patches, defibrillator and pacing pads, hands-off devices and conduction jelly need to be available, and checked for damage and expiration dates. A functional transcutaneous temporary pacemaker should be available for immediate use. Either combo or pacing pads should be available, based off of the specific model of equipment that is used in the laboratory. A code cart and emergency airway box is supplied to each lab. This allows code teams to support the lab during cardiac and respiratory emergencies, as the code and rapid response teams are used to working with this equipment. Easy access to drugs, airways and other emergency adjunct equipment minimizes the time it takes to respond to crises, and enhances the performance of the lab. These items need to be checked for expiration dates, and defective or missing equipment. Tranvenous pacemaking capability is also available. The equipment needs to be checked daily, and the generator batteries changed on a regular basis, and after use on patients. At Pennsylvania Hospital, a tranvenous pacing catheter and connection wire is placed with the pacemaker generator as a single unit, to make sure it is readily available for use. Expiration dates are checked on the catheter and wire. The intraarotic balloon pump (IABP), which is also used for emergency situations and unstable patients, needs to be checked on a daily basis. It should pass a system startup check, and all connection cables, ECG leads and helium tanks need to be operational and available. Each size balloon pump catheter should be available for use. The helium line should be checked periodically to make sure there is no gas leak. Balloon pump catheters should be available in multiple sizes to accommodate a wide variety of patients. For the Maquet (Wayne, NJ) IABPs, 34cc and 40cc are standard balloon sizes. They are stocked in each lab with a reserve in the cardiothoracic operating room. There should also be a backup plan in case the lab needs to use all of its balloon pumps. Although this occurs infrequently, a good back-up plan allows the staff to always have an IABP available, causing no disruptions of patient service or safety. Ancillary equipment Transport monitors need to be fully charged and ready to transport patients to and from the lab. All of the cables need to be available and in working order. This includes ECG, non-invasive blood pressure (NBP) and SpO2 (saturation of hemoglobin with oxygen as measured by pulse oximetry) cables. If they are defective or not working, they need to be replaced immediately. The monitor should also be fully charged and ready for use at all times. The medical gases need to be checked on a daily basis. Are the oxygen, helium, nitrogen and other medical gasses available and full? Are the wall-mounted units functional? Is there adequate airway support available? This support includes Ambu bags, assorted masks, nasal cannulas and oxygen tanks. This adjunct equipment is essential for patient safety and transport. It is also an important backup system to ensure constant access to oxygen should there be a problem with the wall-mounted units. Fluoroscopic and imaging equipment When the labs are turned on, it is essential to verify that the fluoroscopic and image production systems function properly. The image intensifier, c-arm camera, imaging systems, and table should all be checked when the lab is turned on in the morning. They should be fully functional, and if errors appear, they need to be addressed before patient care begins. The database that stores the images and any archiving systems should be checked. If the equipment has limited storage space, studies need to be removed so the lab can store the information for the day. At Pennsylvania Hospital, all studies are transferred into a master archive system. It is necessary to verify that all runs of each study have successfully transferred into the central archive system before deleting studies from the servers in the lab. Hemodynamic monitoring equipment is also inspected every morning. All of the cables need to be available and in functioning order. The monitors need to be working, and supplemental cables for aortic stenosis (AS) cases, PressureWire (Radi Medical Systems, Wilmington, MA), and Swan-Ganz thermodilution catheters (Edwards Lifesciences, Irvine, CA) needs to be available and working. There should be an adequate supply of transducers and other supplemental equipment to support any hemodynamic measurements that are required during procedures in the lab, including valvular heart disease cases, pericardiocentesis, and other gradient measurements. Personal protection equipment Lead aprons, vests, thyroid shields and patient protection should be checked before use in the lab. Any lead with defects needs to be removed from circulation and given to radiation safety for proper disposal. All personal protection equipment should be available for use and undamaged. Lead needs to be checked on a biannual basis and whenever a new product is introduced into the lab. Film badge monitoring is crucial to personal protection. All personnel working in the lab need to have their badges on at all times, and worn properly to gather accurate data. Radiation Safety monitors staff doses and will address any issues that may arise. Annual reports are given to all lab personnel to monitor their annual and lifetime doses. Climate control The temperature of the lab needs to be controlled for optimal equipment performance. Alarms and sensors are placed in the labs, in the generator rooms, and inside medical refrigerators that ensure proper temperature and humidity. Rooms that do not have proper climate control are in danger of failing, overheating, damaging products, or causing equipment to experience a variety of glitches. Patient comfort is also predicated on a constant temperature and humidity control. Wide fluctuations in these controls not only affect performance, but are matters of comfort for patients and staff. Many important medications and quality control products are kept refrigerated. Therefore, the refrigerator temperature needs to be checked regularly. In an optimal case, there should be a sensor that can record temperatures so staff can make sure there have not been unacceptable temperature fluctuations during off-lab hours that may damage the products requiring refrigeration. Procedural equipment Depending on the scope of practice, a wide array of adjunct procedural equipment may be necessary to maintain a high-level practice. Patient safety and outcomes are dependent upon having the right equipment to perform the cases that the lab has scheduled, and to accommodate emergencies. It is the responsibility of each staff member to make sure the necessary equipment is available for all procedures performed in the lab. When a case requiring specialized equipment is placed on schedule, the staff needs to contact inventory management or other appropriate personnel to procure the necessary equipment. This way, equipment is in the lab when the patient arrives. Regular checks of product expiration dates are also critical, especially for drug-eluting stents which have short shelf lives. Our vendors regularly check inventory, but it is still everyone’s responsibility to make sure that none of the equipment, pharmaceuticals or other materials are outdated. Regular preventative maintenance (PM) scheduling for all equipment is necessary and vital to ensure optimal performance of all lab equipment. Even in the face of high patient volumes and busy schedules, it is important to maintain equipment. Power injectors need to be started and pass system startup checks. If they have problems, it needs to be reported to biomedical maintenance. We have shared resources at Pennsylvania Hospital and can either borrow or lend injectors to the operating room as necessary. Shared resources also help contain costs, and this philosophy is also extended to other equipment that is shared by multiple entities. This can include IVUS, the AngioJet (Possis Medical, Minneapolis, MN), Hemochron units, non-cardiac interventional supplies and other products. Supplemental equipment To supplement quality control, vendors from different companies provide regular training and assist with the QC on advanced imaging modalities such as IVUS, PressureWire, rotational atherectomy, and non-cardiac vascular interventional equipment. These devices need regular quality control, and all of the supplemental equipment it required for these technologies should be available for use. The IVUS archives need to be periodically deleted to create space for future studies. Hands-on training and vendor support allows experienced staff to refresh their skills with advanced technologies, and also provides new hires with critical exposure to these technologies. Staff development and POCT provide hands-on training, computerized competency tests, and other tools to keep the staff proficient in the elements of effective QC. Vendors and application specialists, as well as government and regulatory agencies, provide resources that are also part of the quality control philosophy of the lab. Regular in-services, skills fairs, and other venues provide all staff members the opportunity to keep skill levels high, and enhance quality control, while expanding the knowledge base and overall efficiency of laboratory operations. The equipment is only as effective as its operators. Therefore, quality control should also include creating a quality, knowledge-based staff that can use the technologies that are available. Concluding thoughts A high-caliber quality control program is imperative to provide best practices in the cath lab. In order to provide optimal outcomes and comply with Joint Commission, government, and healthcare industry standards, it is necessary to be vigilant and constantly work on quality control. Successful quality control metrics ensure patient safety and quality care, and build confidence among the staff members. A good quality control program allows each member of the team to focus on the task at hand without worrying about safety and secondary issues. In an emergency, the patients deserve the highest quality care and support. As a cath lab team, we hold ourselves to rigorous scrutiny with quality control to optimize patient care, improve outcomes and deliver state-of-the-art care. We also owe it to our peers to ensure that they are going to work with the best equipment, in functional order, and with the necessary supplies to use the technologies of the lab. In many cases, the most important job is performed before a patient sets foot in the lab. Excellent quality control allows doctors and staff to work with confidence, knowing that the environment promotes safety and optimal care standards. In the Army, we used to say “We do more before 7am than most people do all day.” This philosophy applies to the cath lab as well. Much of the most important and unappreciated work takes place before a patient ever sets foot in the lab. A good quality control program feeds on itself and promotes a deeper commitment to developing a lab that is equipped, serviced and ready to meet the challenges of the day. Richard Merschen can be contacted at Richard.Merschen@uphs.upenn.edu

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