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How to Master the Art of Recordkeeping

Imagine starting a position at a new hospital only to discover that your department is in disarray. There are issues with the equipment: sterilizers beyond their useful life cycle and a broken washer, to name a few. The department recordkeeping is entirely manual and there are stacks of records that need to be organized and catalogued. Many of the records are illegible, incomplete, and some of the required monitoring is not being done. To make things worse, you’re told that the surveyors may arrive at any moment. Given the challenging circumstances, what can you do to regain control and get your department ready for the accreditation survey?

In an SPD, many processes require detailed and accurate recordkeeping, and the accreditation surveyor is likely to review them all. Ideally, an SPD has electronic systems for instrument tracking and record maintenance. However, if your facility uses a manual system, you can still keep records organized by creating simple forms to collect necessary information. To make recordkeeping more manageable, whether electronic or manual, it’s best to divide tasks in simple work sections: procedures, education, equipment, sterilization monitoring, and quality audit records.

Procedures

  • The first part of the process is to have up-to-date policies and procedures. These detailed protocols are necessary to maintain process consistency and to set expectations for tasks’ performance. The protocols should be in accordance with regulatory and accrediting agencies, as well as the manufacturer’s instructions for use (IFUs). The documents must be kept up to date, which means that they should be modified with each process change. Also, the technicians must be familiar with the protocols and policies and have easy access to the procedure book.
  • It is a demanding task to maintain a hard-copy book containing IFUs for all medical devices, equipment, and instruments available in the department. There are online services that can simplify this task; however, if an online subscription is not available in your facility, you must ensure that you have the latest version of each IFU on file, and that the technicians are following the steps in detail. A surveyor may ask you to pull a sterile item from the shelf, and request to view its IFU to verify that it was processed accordingly. If the surveyor observes any variance in the IFU steps, you may receive a “threat to life” citation.

Equipment
There are many different types of equipment in the SPD. Each piece of equipment requires active steps to perform to the manufacturers’ specifications. It is essential to stay on target and have the proper documentation for the following:

  • Preventive maintenance (PM) records: Usually, these records are kept by the clinical engineering (CE) department; however, it is up to the SPD manager to ensure that the CE has custody of these records. Otherwise, the equipment manufacturer should be able to provide electronic records of the PM performed on the equipment and the SPD can maintain a folder or binder organized by date sequence.
  • Equipment routine maintenance: All processing equipment maintenance checks must be done in accordance with schedules outlined in the IFU. These checks are not only there to ensure proper maintenance, they are also designed to monitor the efficacy and efficiency of the processing equipment to reduce risk to personnel and patients. Documentation supporting the execution of the routine maintenance checks is evidence of a proactive approach to avoid malfunction of the equipment.
    • Equipment safety checks: The CE performs safety checks on some of the equipment managed by the SPD. During a safety check, each instrument receives a control label with its instrument number and expiration date. All equipment should be further inspected during cleaning to ensure that the labels stay in place and are not past expiration. This is a collaborative effort, rather than an individual responsibility. Everyone should work together to perform monthly equipment checks to ensure that the equipment is compliant.
    • Environmental monitoring: Ensuring the environment is within the temperature and humidity guidelines can be challenging, especially in older facilities. High temperatures and humidity can affect the performance of many of the products we use and the sterility of our packages. Create a data collection sheet for the team to record these parameters and report when there is a variance. This document should also list the actions taken when the required parameters were not achieved.
    • High-Level Disinfection (HLD) monitoring and recordkeeping: Automated HLD processors require safety checks on air filters, solutions, and hoses at regular intervals. These maintenance checks must also be recorded.

Education
Education and training are the foundation for excellent processes, preventing errors, and creating a culture of trust. If the technicians are trained, they will perform their task with confidence.

It is critical to have documentation of the training provided to technicians. Every critical task that they perform must be verified with a skills competency assessment and each competency should be based on the protocol for the task. Create a monthly plan listing the training topics and post it in the department.

Quality monitoring
To ensure every instrument or medical device processed in the SPD does not pose a threat to any of our patients, we must have a comprehensive quality monitoring process. Most of the tasks performed in SPDs require inspection and verification of successful completion. But without documenting these tasks, there is no evidence of the effort the SPD makes to promote patient safety. There are several quality checks that should be conducted in an SPD:

  • Water quality: Testing the quality of the water ensures detergent efficacy. Some detergents do not perform well with hard water or high pH levels.
  • Residual soil: This test should be performed after the cleaning process is completed to ensure all bioburden was removed and the instrument is ready for assembly.
  • Instrument assembly: Document functionality test, scissors sharpness, accuracy, and residual soil.
  • Equipment cleaning performance: Cleaning verification challenge tests for washers, ultrasonic cleaners, and cart washers must be performed and documented to ensure the equipment is performing according to the manufacturer’s specifications.
  • Surface testing for residual soil: This test can be performed with an adenosine triphosphate (ATP) swabbing device. This test is usually performed on flexible endoscopes.
  • Detergent injector tests: How do we know if detergent injectors are performing to specification? Some sensors may sound an alarm if there is no detergent in the dispenser; however, there have been occasions in which the sensors don’t work, and the technicians don’t notice that there is no detergent being injected in the cycle. The best practice is to mark the level of the detergent every day using a marker to ensure that the level is moving.

Sterilization monitoring
Several factors can influence and affect the outcome of the sterilization cycle. Steam, temperature, and pressure must all reach the specific parameters set by the equipment manufacturer in order to reach the sterilization point. But how can we be certain or prove that the parameters were met and the packages are safe for use? How can we recall items from the load if a process failure occurs? Documentation establishes accountability by ensuring that the sterilization process is monitored as it is occurring and that cycle parameters have been met. Correctly documenting every step of the process facilitates having the correct information when a recall of trays is necessary. When the documentation process for sterilization is manual, the information may not always be legible. This makes it difficult to know which items have been sterilized. Also, in the event of a recall, it’s extremely challenging to assess which trays or packages need to be recalled. Sterilization quality control relies heavily on historical data, especially when quality assurance measures yield conflicting evidence. Therefore, creating sheets that can facilitate the documentation process is critical. These records should be retained according to the state and hospital record retention policy. In addition to thoroughly documenting loads, there are other components of the process that must be documented.

  • Physical monitors – all process recording devices such as the printouts, gauges, time, and pressure readers. These parameters should be checked for every load to ensure that the cycle was successful. Printouts should be part of the load record document and must be verified at the end of the cycle for completion.
  • Biological cultures – AAMI ST79 recommends loads to be monitored with a PCD at least weekly and on every load that contains implants. We must carefully ensure that every biological record is completed with the outcome of the incubation period. The vial lot control number, load number, sterilization, and incubation date and time must be entered in the record. All read-out outcomes should be verified with a signature.

Cataloguing, organizing, filling, and maintaining SPD records is a tedious but necessary task. Sterilization records should be stored in a location that is easily accessible and protected from water and other kinds of damage. The SPD manager must design a system that can facilitate the collection and storage of data in the event of a recall as a result of process failures. Whether using a manual or electronic system, consistency and standardization of the documentation process will ensure that all the proper steps are followed. 


Mary Olivera, MHA, CRCST, CHL, FCS has over 30 years of experience in numerous roles in healthcare sterile processing, distribution, and materials management. Ms. Olivera participates in monitoring, surveying, and training interdepartmental staff in the proper cleaning, decontamination, and sterilization practices, and has been highly committed to the standardization of interdepartmental processes. A regular recruit on expert panels regarding sterile processing and a past president of the New York State Central Service organization, she continues to play a major role in promoting higher educational requirements for central service professionals to increase patient safety.

Ms. Olivera brings to the table extensive knowledge of Joint Commission, DNV-GL, AAMI, OSHA, CDC, and DoH regulations. She specializes in budgeting, change management, inventory management, process re-engineering, program and project management, vendor relationships, quality control, Six Sigma, supply chain, and total quality management.

Ms. Olivera is an educator and has published numerous articles related to sterile processing, surgical services, process improvement, and guides to achieve successful accreditation surveys.

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