Compliance & Security Announcements
Timeless Medical Systems® utilizes enterprise-grade best practices to protect our customers’ data, and works with independent experts to verify its security, privacy, and compliance controls, and has achieved SOC 2 Type 2 and HIPAA reports against stringent standards.
About HIPAA
HIPAA is a federal law that requires the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. This rigorous, independent assessment of our compliance serves as validation of our dedication and adherence to the highest standards to protect your sensitive patient health information.
About SOC 2
Earning SOC 2 Type 2 “no exceptions” attestation means that our systems controls’ design has met the rigorous standards for security and privacy compliance laid out in the “System and Organization Controls” (SOC) guidance.
Developed by the Assurance Services Executive Committee (ASEC) of the AICPA, the Trust Services Criteria is the set of control criteria to be used when evaluating the suitability of the design and operating effectiveness of controls relevant to the security, availability, and confidentiality of the information processed by the systems at an entity, a division, or an operating unit of an entity.
Reporting
We work with an independent auditor to maintain SOC 2 and HIPAA reports, which objectively certifies our controls to ensure the continuous security of our customers’ data.
Continuous Security Control Monitoring
Timeless Medical Systems® uses Drata’s automated platform to continuously monitor its 100+ internal security controls against the highest possible standards across the organization. With Drata, Timeless Medical Systems® has real-time visibility across the organization to ensure the end-to-end security and compliance posture of our systems. Automated alerts and evidence collection allows Timeless Medical Systems® to confidently prove its commitment to protecting your sensitive health information any day of the year, while fostering a security-first mindset and culture of compliance across the organization.
Employee Trainings
Security is a company-wide endeavor. All employees complete an annual security & HIPAA training program and employ best practices when handling customer data.
Penetration Tests
Timeless Medical Systems® works with industry leading security firms to perform annual network and application layer penetration tests.
Secure Software Development
Timeless Medical Systems® utilizes a variety of manual and automatic data security and vulnerability checks throughout the software development lifecycle.
Data Encryption
Data is encrypted both in-transit using TLS and at rest.
We welcome all customers and prospects who are interested in discussing our commitment to security and reviewing our SOC compliance reports to contact us at: infosec@timelessmedical.com
How Tracking Infant Feeding Near Misses Improves Patient Safety
Understanding Near Misses and Preventable Adverse Events
Improving patient safety and reducing the incidence of medical errors or “preventable adverse events” is a key goal of healthcare organizations. According to the Agency for Healthcare Research and Quality (AHRQ), a preventable adverse event is an incident that is “avoidable by any means currently available” while a near miss is an “unsafe situation that is indistinguishable from a preventable adverse event except for the outcome.”1 It is often by chance that a near miss does not reach a patient. To monitor and seek ways to reduce errors, most organizations have safety reporting systems that allow staff to report errors and near misses. However, despite that the frequency of near misses is significantly higher than actual adverse events (potentially 7-100 times more frequent), reporting of near misses is much lower.2 Safety reporting systems allow hospital leaders to evaluate trends and areas of vulnerability to continually improve processes. Having knowledge and understanding of near misses is an important key to determining potential failure points within a process. As the healthcare industry has learned from other sectors (particularly the airline industry), analyzing near miss data provides an important opportunity to evaluate and create systems that can prevent adverse events and improve safety.2 Many experts believe that near miss data within the healthcare setting should be analyzed more extensively than is currently being done and that this data is underutilized in helping to prevent future problems.2,3 By monitoring and evaluating near misses, an organization gains insight into potential “loopholes” of current processes and allows them to design or redesign systems with checkpoints to prevent near misses from becoming preventable errors.2-4
In the context of providing infant feedings within the hospital setting, an infant receiving the wrong human milk (HM), fortifier, or formula would be considered a preventable adverse event. Scanning the wrong HM, fortifier, or formula at the time of preparation and/or feeding, but having the bar code scanning system prevent the error by alerting the clinician, would be considered a near miss.
Use of Bar Code Scanning Technology to Prevent Errors
The use of bar code scanning technology in place of manual two-person verification processes to reduce risk of human error has become common in healthcare.4-8 One common use of bar code scanning is during the administration of products where the bar code on the item being administered is scanned against the bar code on the patient’s armband to confirm the correct product is being administered.5,9-13 There are many benefits of bar code scanning over using a manual two-person visual verification process. Scanning is more efficient, has a lower risk of human error, and eliminates potential for confirmation bias.10,11 At present, scanning HM at the time of feeding is common while practices with regards to scanning HM at the time of feeding preparation as well as the scanning of formulas and fortifiers vary significantly between healthcare organizations.
Published research supports that bar code scanning of HM, fortifiers, and formulas reduces errors by preventing the error from reaching the patient.9-11,14 However, little emphasis has been placed on using near miss data from scanning HM, fortifiers, and formulas to modify processes and prevent future errors.
Evaluating Bar Code Scanning Near Miss Data to Improve Processes
The use of a bar code scanning system for infant feedings increases the data available for analysis. As many published studies have noted, the number of near misses identified when scanning technology was implemented was significantly higher than actual errors manually reported prior to scanning implementation, leading many authors to postulate that actual preventable adverse events were likely much higher than realized when systems were not in place to capture them.9-11 One organization noted that 55% of potential failure points for HM handling and administration were undetectable prior to implementation of bar code scanning.11 Therefore, having the ability to review and sort near miss data to identify those potential failure points can help improve safety in a variety of ways.
- Identifying the location/area most likely to have near misses One study, in a hospital using centralized feeding preparation with dedicated technicians, found that 75% of wrong HM scans occurred at the bedside at the time of feeding with the nurse who had 1-3 patients to care for as opposed to in the preparation room where technicians may be preparing feedings for 50 infants at a time.11 Without evaluating near miss data, they would have been unaware of this trend and would not have been able to use that data to focus educational efforts for staff. It also reinforced that even with centralized preparation and dedicated technicians, scanning needed to be used consistently throughout the entire process (from preparation through feeding) to ensure patient safety. Such data could also help identify if a particular unit or shift was more likely to have near misses so that follow-up training or analysis could occur. For example, organizations could evaluate if near misses were more likely to occur on the night shift or in a step-down nursery and use that data to modify workflows or focus educational campaigns.
- Identifying most common types of near misses Research data from different healthcare organizations has found that attempts to use expired HM was more common than attempts to use the wrong patient’s HM.9-11 In these cases, this near miss data highlighted an area of vulnerability that neither organization knew was a problem prior to using bar code scanning technology.9-11 This near miss data could help an organization determine if changes in processes are warranted. For example, if having feedings expire before use was identified as an issue, a hospital may determine that preparing feedings twice daily rather than once daily would be more appropriate. Alternatively, if the use of additives near their expiration date/time was identified as the cause of the problem, processes could be modified as to when opened additives are discarded.
- Providing actual data to share with the healthcare team In healthcare, we often suspect we know the reason for an issue, but we do not always have the data to support those suspicions. Having concrete data as to when and where near misses are occurring and sharing this with staff on its own can improve safety. Often merely highlighting an issue can help reduce risk by bringing awareness. In one study, after determining the location of the majority of the near misses, the organization began sharing near miss data with bedside staff on a quarterly basis to emphasize how frequent such errors could occur and to reinforce the importance of not skipping the scanning step.11
Timeless Medical Systems now offers preparation room consulting services covering many aspects including equipment and layout design, FTE calculations, training and certifications for prep room technicians, and even creating daily workflows to optimize efficiencies. Our very experienced and skilled Clinical Team Members have 1st hand experience in creating and implementing centralized preparation rooms and processes in some of the largest most prestigious hospitals throughout North America. If you are interested in learning more about these consulting services, please contact sales@timelessmedical.com.
References:
- Agency for Healthcare Quality and Research. Adverse events, near misses, and errors. Patient Safety Network. September 7, 2019. https://psnet.ahrq.gov/primer/adverse-events-near-misses-and-errors. Accessed February 22, 2023.
- Aspden P, Corrigan JM, Wolcott J, Erickson SM, eds. Patient Safety: Achieving a New Standard for Care. Washington, DC: The National Academies Press; 2004. https://doi.org/10.17226/10863
- Sheikhtaheri A. Near Misses and Their Importance for Improving Patient Safety. Iran J Public Health. 2014;43(6):853-854.
- Sameera V, Bindra A, Rath GP. Human errors and their prevention in healthcare. J Anaesthesiol Clin Pharmacol. 2021;37(3):328-335. doi: 10.4103/joacp.JOACP_364_19. Epub 2021 Oct 12. PMID: 34759539; PMCID: PMC8562433.
- Steele C, Collins EA, eds. Infant and Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. 3rd ed. Chicago, IL: Academy of Nutrition and Dietetics; 2019.
- Spatz DL, Edwards TM. The use of human milk and breastfeeding in the neonatal intensive care unit: position statement 3065. Adv Neonatal Care. 2016;16(4):254.
- Moro GE, Arslanoglu S, Bertino E, et al. American Academy of Pediatrics; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Human milk in feeding premature infants: consensus statement. J Pediatr Gastroenterol Nutr. 2015;61(suppl 1):S16-S19.
- Malone A, Carney LN, Carrera AL, Mays A. ASPEN Enteral Nutrition Handbook. 2nd ed. Silver Spring, MD: American Society for Parenteral and Enteral Nutrition; 2019.
- Oza-Frank R, Kachoria R, Dail J, Green J, Walls K, McClead RE. A quality improvement project to decrease human milk errors in the NICU. Pediatrics. 2017;139(2):e2 0154451.
- Steele C, Bixby C. Centralized breastmilk handling and bar code scanning improve safety and reduce breastmilk administration errors. Breastfeeding Med. 2014;9(9):426-429.
- Steele C, Bixby C. Bar code scanning of human milk and enteral formulas improves efficiency and patient safety: a 7-year review. Nutr in Clin Pract. 2022;37(4):921-928. https://doi.org/10.1002/ncp.10765.
- Steele C. Safe handling of human milk within the hospital setting. Neonatal Intensive Care- The J of Perinatol Neonatol. 2020;33(3):11-14.
- Steele C. Best practices for handling and administration of expressed human milk and donor human milk for hospitalized preterm infants. Frontiers in Nutrition. 2018;5(76):1-5. doi: 10.3389/fnut.2018.00076.
- Alessi S, Rengifo J, Steele C, Kaur G, Desai P. Improving Comprehensive Enteral Feeding Handling Processes in a Level 4 NICU: A Quality Improvement Project. Pediatric Academic Societies (PAS) Abstract. E-PAS2023:369.10. https://2023.pas-meeting.org/searchbyposterbucket.asp?f=PosterCustomField14&pfp=BrowseByPosterTopic
Staffing Your Hospital Infant Feeding Preparation Room
Hospitals are increasingly recognizing the value of using dedicated staff within a centralized location for human milk (HM) and formula preparation to reduce risk of contamination and preparation errors. The key is getting the right staff in place to perform this important function.
Why use dedicated staff?
- Use of dedicated staff allows them to focus solely on feeding preparation without other distractions and patient care duties.
- Published data supports that the use of dedicated technicians for feeding preparation improves patient safety by reducing frequency of errors.1,2,3
- In a six-year analysis of a 114-bed neonatal intensive care unit (NICU), wrong HM, expired HM, and wrong fortifier scans when their bedside nurses were preparing feedings were compared to wrong scans when dedicated technicians were preparing feedings. Researchers found that incorrect scans per 1,000 bottles decreased from 97 to 14 when dedicated technicians were utilized.1
- A review within a level IV NICU found that wrong HM scans decreased by 88% when feeding preparation responsibilities were moved from the bedside nurse to dedicated technicians.2 In addition, expired HM scans and wrong fortifier scans per 1,000 feeding preparations decreased from 40.9 to 5.3.2
- A seven-year review in a 104 bed level IV NICU found that 75% of wrong HM scans occurred at the bedside.3
- Use of technicians for feeding preparation provides the bedside nurse additional time to focus on direct patient care duties including assisting parents with skin-to-skin and direct breastfeeding. It also allows registered nurses to work at the top of their scope.
Education and skills
Many hospitals are unsure of where to start to find appropriate candidates. The goal of an infant feeding preparation operation is to provide safe and accurately prepared human milk and formula feedings to the right patient at the right time. While there is not a uniform job description or educational requirement for an infant feeding preparation technician at this time, to accomplish this goal the candidate should have a skill set that includes:4
- Knowledge of infection control measures and aseptic technique
- Understanding of proper handling of HM and formulas
- Critical thinking skills
- Basic math skills
- Attention to detail
- Good written and verbal communication
- Strong time management skills
- Pharmacy technician
- Medical technologist
- Certified nursing assistant (CNA)
- Licensed practical nurse (LPN) or licensed vocational nurse (LVN)
- Certified dietary manager (CDM)
Selecting non-technical staff from within an organization can still have benefits. Internal candidates have a knowledge of the organization and may have some familiarity with some of the hospital computer systems. Some examples of internal candidates could include:
- Food service employees: Knowledge of aseptic technique and proper food handling.
- Supply chain employees: Knowledge of products, ordering, and hospital units.
- Sterile processing employees: Knowledge of aseptic technique.
- Unit support or nursing assistants: Knowledge of aseptic technique, hospital units, and hospital computer systems.
Timeless Medical Systems now offers preparation room consulting services covering many aspects including equipment and layout design, FTE calculations, training and certifications for prep room technicians, and even creating daily workflows to optimize efficiencies. Our very experienced and skilled Clinical Team Members have 1st hand experience in creating and implementing centralized preparation rooms and processes in some of the largest most prestigious hospitals throughout North America. If you are interested in learning more about these consulting services, please contact sales@timelessmedical.com.
References:
- Oza-Frank R, et al. A Quality Improvement Project to Decrease Human Milk Errors in the NICU. Pediatrics. 2017;139(2). DOI: 10.1542/peds.2015-4451.
- Alessi S, Rengifo J, Steele C, Kaur G, Desai P. Improving Comprehensive Enteral Feeding Handling Processes in a Level 4 NICU: A Quality Improvement Project. Pediatric Academic Societies Abstract April 2023.
- Steele C, Bixby C. Bar Code Scanning of Human Milk and Enteral Formulas Improves Efficiency and Patient Safety: A 7-Year Review Nutrition in Clinical Practice. 2021;1-8. https://doi.org/10.1002/ncp.10765
- Steele C, Collins E, eds. Infant and Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. 3rd ed. Chicago, IL: Academy of Nutrition and Dietetics; 2018.
- Ohio State University. Infant Feeding Technician Certificate Course. https://foodindustries.osu.edu/infant
- Columbus State Community College. Formula / Human Milk Technician Certificate Program https://www.cscc.edu/for-business/formula-tech.shtml
Want to Build or Optimize Your Infant Feeding Prep Room?
Hospitals are increasingly recognizing the value of dedicated centralized human milk (HM) and formula preparation area to reduce risk of contamination and preparation errors. However, whether you are remodeling an existing area or building an entire new one, deciding how to configure such a space can be overwhelming. The good news is that there are many resources to help organizations design infant feeding preparation rooms including Infant and Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities (3rd edition) from the Academy of Nutrition and Dietetics and Guidelines for Design and Construction of Hospital and Health Care Facilities from The Facilities Guidelines Institute (1,2).
The location of feeding preparation within the facility should be based on available space and volume of feedings to be prepared (1). Even hospitals without a dedicated centralized infant feeding preparation room must designate a specific preparation location that supports aseptic technique away from the bedside used solely for the purpose of HM and formula preparation (1,2). Infant feeding preparation within a direct patient care area is never acceptable (1,2). This area should be away from traffic flow (patients, staff, and visitors) and protected from airborne contamination (such as drafts and vents). While the room configuration basics may vary based on dimensions and anticipated volume of feedings, here are five (5) tips to help plan whatever space you have available.
- Ensure workflow in the room moves from clean to dirty to maintain an aseptic preparation space (1,2). While an anteroom where staff may wash their hands, don appropriate personal protective equipment, and perform administrative (non-preparation) tasks is ideal, it is not required if the space is configured appropriately (1). Think about how staff will enter the space and the order of the tasks they will be performing. Use of visual barriers such as a splash guard or a table/counter that denotes “entry” into the aseptic preparation space may serve as a reminder to promote good habits to prevent contamination of the clean area.
Image 2: Clear, enclosed drawers
- Consider ease of access for those preparing feedings when storing supplies. Bins with lids are common because they keep supplies from coming in contact with dust, debris, or other contaminants and may be stacked to allow for more storage. However, in the middle of preparing feedings (particularly for large operations), it is often cumbersome to pull out bins (particularly if others are stacked on top), remove lids, and obtain supplies while maintaining aseptic technique. It is not uncommon to see lids on these types of bins missing or not snapped into place to make it easier to get to supplies, eliminating the benefit of having enclosed storage. Built-in drawers offer easier access but are often not cleaned well before restocking—dust and debris are often seen in the bottle of supply drawers (look in the bottom of your own silverware drawer some time!). Clear plastic drawers that allow for easy access during preparation (as well as ease of closing after use), stacking without having to move to get into lower drawers, and easy clean up by running through the dishwasher or wiping with an appropriate sanitizing solution are an efficient alternative.
- Laminar flow hoods are not required for infant feeding preparation. While laminar flow hoods provide an additional barrier to potential contaminants, they are commonly used in the preparation of sterile products (1,3,4). Using a laminar flow hood when preparing nonsterile products, such as HM and powdered formulas, will not result in a sterile final product and is not a substitute for aseptic technique (1,3,4). Many people are surprised to learn that their own hospital pharmacies likely do not use laminar flow hoods to prepare oral medications (which are not sterile) because it is not a requirement (1). Eliminating a hood from the plans may open up other space options and reduce costs (particularly if a hospital will be having multiple staff preparing feedings at a time).
- Feeding preparation stations in the workspace should be configured with the proper technology. In the age of electronic orders and bar code scanning of HM and formulas, computer access in the preparation area is critical for staff to be able to confirm feeding orders, recipes, and feeding components. However, because computers are a known source of touch contamination, equipment should be selected to minimize this risk (1). Ensuring that all equipment is raised off the preparation area ensures that the entire work surface is thoroughly cleaned and sanitized before and after each feeding preparation. This may be achieved by:
- Using an adjustable arm to mount a computer to the wall or underside of a cabinet
- Mounting a cradle to hold bar code scanners
- Mounting trays on the wall or under built in cabinetry to hold label printers
Selecting touch screen computers or silicone keyboard covers that may be wiped with appropriate sanitizers is of equal importance to minimize risk of contamination (1). When designing a preparation area, confirm there are the appropriate outlets and data ports required for the technology needed (1).
- Adequate refrigerator and freezer storage capacity is important. Pharmacy or laboratory grade units ensure proper storage temperatures; use of consumer refrigerators and freezers is not recommended (1,3,4). Refrigerators and freezers should be located in secure areas or use keypad locking technology to prevent unauthorized access (1,4). Patients should each have their own bins in the refrigerators and freezers to prevent bottles of stored milk or prepared feedings from being mixed up with another patient. Long narrow bins that run the depth of the unit allow available space to be optimized while preventing any patient’s bin being stored behind another patient’s bin (improving efficiency and reducing risk of placing something in the wrong bin). Purchasing additional shelves for the refrigerators and freezers allows for increased storage capacity without stacking bins on top of each other (just be sure not to fill a unit so full that you don’t have adequate airflow). If the room will also be used for facility-prepared formulas, plan for enough refrigerator space to store unopened bottles of sterile water and concentrated liquid formulas. By using chilled ingredients, the finished product reaches the appropriate holding temperatures much quicker than using room temperature ingredients, reducing risk of microbial growth (1).
Image 3: Deep, narrow freezer bins and extra freezer shelves
Setting up an infant feeding preparation room can be a daunting task. Ensuring an appropriate physical space is the first step. Published resources can make the task easier, but don’t hesitate to seek expert guidance along the way. Having the right information to guide you can save time and prevent costly or frustrating design errors.
References:
- Steele C, Collins E, eds. Infant and Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. 3rd ed. Chicago, IL: Academy of Nutrition and Dietetics; 2018.
- The Facilities Guidelines Institute. Guidelines for Design and Construction of Hospital and Health Care Facilities. Washington, DC: American Institute of Architects (2014). p. 91–2. Standard A2.1-7.2.3.2(3) and Standard 2.1-7.2.3.3(5).
- Steele C. Safe Handling of Human Milk within the Hospital Setting. Neonatal Intensive Care. 2020;33(3):11-14.
- Steele C. Best Practices for Handling and Administration of Expressed Human Milk and Donor Human Milk for Hospitalized Preterm Infants. Frontiers in Nutr. 2018;5(76):1-5. doi:10.3389/fnut.2018.00076
