Spotlight on physician practice risks

Physician practices reside at the heart of the care delivery continuum, with a substantial proportion of patient diagnoses, referrals, and care transitions occurring in these settings. While acute care settings are highly regulated and audited frequently, clinical processes in the ambulatory setting are subject to far less regulatory oversight. No matter their size or whether they are independent or part of a group, physician practices that lack properly designed patient safety and care quality processes expose themselves to several risks, including patient harm, malpractice claims, and reputational damage.

As more care shifts from inpatient to ambulatory care settings, healthcare leaders need to be aware of safety and quality risks within physician practices as they look to design processes and workflows to prevent patient harm, improve care quality, and reduce financial losses. Following is a list of questions that practices should ask in three notable risk areas – medication management, orders for referrals and testing, and high-level disinfection (HLD) of flexible endoscopes – that they should consider as priorities for risk monitoring, auditing, and continuous process improvement.

Medication management in physician practices

Medication management is a high-risk area where issues are commonly found. One specific focus is on sample medications and medication management (storage and administration).

For organizations that carry sample medications in their practices, patients can face risks if processes do not exist for proper storage and tracking of these drugs. If the Food and Drug Administration (FDA) issues a recall, for example, the physician practice needs a reliable tracking system in place for contacting affected patients. Also, practices should have procedures in place for providing educational materials to patients along with the sample medications to help avoid adverse effects on patient safety.

Risk assessment questions to consider regarding sample medications include:

• Does the practice have a sample management program in place?
• If the practice has medication samples, are they located in a sample closet? Is the closet locked, and is access controlled?
• Are there processes in place for tracking access to sample medications?
• Does the practice track and keep logs regarding the distribution of sample medications? If not, is it using its electronic health record (EHR) to document the distribution of samples?
• If the practice is using its EHR to document distribution, is staff able to pull timely reports showing who received the medications in the event of an FDA recall?
• Does a staff member in the practice routinely inspect sample medications for expiration?
• Does the practice perform a perpetual inventory count for each sample medication?
• Does the practice document the discarding of expired medications?
• Are sample medications labeled with directions for use?
• Does the practice provide educational materials for each sample medication to patients and track that this information was given?

Many physician practices store medications to administer on-site, and staff should keep in mind several considerations for proper medication management (storage and administration). Each medication will have specific manufacturer’s instructions for storage, and the Centers for Disease Control and Prevention (CDC) provides safety and compliance guidelines regarding refrigeration, which some medicines and many vaccines require. Improper storage of medications can result in patient harm (for example, an improperly stored vaccine administered to a patient might result in poor protection against disease), financial losses due to wasted medications, and reputational risk (loss of patient confidence in the practice if, for example, revaccination is required).

Risk assessment questions to consider regarding medication management (storage and administration) include:

• Does the practice follow CDC recommendations regarding cold chain product storage, including monitoring of temperatures and implementation of temperature excursion processes?
• Does the practice track inventory of patient-owned medications that it stores?
• If the practice stores controlled substances, does it follow United States Drug Enforcement Administration requirements and state-specific regulations over these substances?
• Is the practice labeling and administering these medications correctly? For example, does the practice use two unique identifiers to make sure the correct medication is given to the correct patient?
• Does the practice have bar code medication administration capabilities?
• Has the physician practice implemented a quality process for verifying steps are taken to meet compliance with CDC vaccine handling and storage?¹
• Does each vaccine storage unit have a temperature monitoring device to keep track of temperature history?
• Does each storage unit’s thermometer meet CDC standards for alarm parameters and memory?
• Does the practice use a temperature log (the CDC recommends a “digital data logger”) that includes details regarding how long a unit has been operating outside the recommended temperature range?
• Is there a process in place for reviewing the temperature log for compliance?
• Are there processes in place for handling a faulty refrigerator?
• Are multidose medication vials (for example, lidocaine) kept and accessed from a dedicated, clean medication preparation area (for example, a nurses’ station) and away from immediate patient treatment areas?
• Is the practice following CDC/United States Pharmacopeia guidance for use and discarding of multidose medication vials?²
• Are quality assurance processes in place to verify that expired medications are dated and discarded? For example, is there a weekly “sweep checklist” that medical assistants (MAs) can use to record that each exam room meets quality standards? MAs can lead this process with a supervisor verifying the lists.

Physician practice orders for referrals and testing

Timely consultation and receipt of results improve the accuracy of diagnoses and provision of care. Having “closed-loop” processes for referrals and testing orders is essential for patient safety, as these processes can verify if vital tests are performed and results are received and followed up on as part of a patient’s care.

Risk assessment questions to consider regarding referrals and testing include:

• Does the practice have a closed-loop process to track referral orders and orders for diagnostic tests in each phase, from point of order to current status?
• Can staff view the test status for the scheduling process, including preauthorization, and track when the test was completed?
• Can staff confirm test results have been received? Once they receive results, can the staff verify if the results were reviewed by the ordering provider, that the patient was notified of the results, and that follow-up occurred?
• Are results for tests performed at the point of care (for example, hemoglobin A1C tests conducted in office during an annual exam) entered in the practice’s EHR?
• Can practice staff run reports or set reminders in the EHR to follow up on outstanding items for high-risk patient populations (for example, eye exams for diabetic patients)? If yes, is the practice using that functionality? If no, does the practice have another way to track these patients?
• Does the practice have a process for reviewing outstanding referrals or test orders?
• Does the practice have a quality team that reviews referral and test order processes for process improvement?

Infection prevention in physician practices: High-level disinfection of flexible endoscopes

While flexible scopes are most often thought of in the context of inpatient settings, many physician specialties – including urology; ear, nose, and throat (ENT); and gastrointestinal practices – perform procedures using such scopes. High-level disinfection involves the cleaning of flexible scopes to make sure bacteria, viruses, and bloodborne pathogens are not transferred to patients.

Like inpatient settings, ambulatory practices must follow safety standards to prevent patient harm. In March 2022, the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) released a new standard outlining flexible endoscope processing: ANSI/AAMI ST91:2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.³ The revised version of the standard includes updates to several areas, including some that physician practices should review and incorporate and common areas to address during risk assessment discussions.

Some questions to ask to comply with the new flexible endoscope standard include:

• The standard now includes designation of high-risk endoscopes, which are those typically associated with infectious outbreaks, such as elevator channel scopes, endoscopes, bronchoscopes, ureteroscopes, cystoscopes, and endobronchial scopes. Has the practice reviewed and verified what scopes it uses and designated if they are considered high-risk endoscopes?
• Has the practice prioritized verification testing in its risk assessment, and has it documented evidence of that prioritization (for example, how did the organization decide which endoscopes are high risk and why)?
• If the practice has experienced infectious outbreaks or processing breakdowns, has it designated its own high-risk scopes even if outside those listed in the standard?
• If the practice uses high-risk scopes, has it provided cleaning verification and testing after every use cycle? Does the practice have a process in place to verify this?
• What previously was referred to as the “precleaning” step is now known as “point-of-use treatment.” Does the practice have a process, using tags or labels, to capture the time point-of-use treatment occurred?
• Does the practice have a delay-of-reprocessing policy or procedure for a delay of greater than one hour in reprocessing scopes as well as a verification process for delay-of-reprocessing events?
• For quality control, does the practice perform and document leak testing on each scope every day the practice is open? Does the practice have a process for leak test failures?
• Does the practice maintain quality logs of HLD processes, including keeping track of water monitoring, HLD solution expiration date and temperature, testing strips used to test HLD solution and results, and any enzymatic solutions used (per manufacturers’ instructions)?
• For hooded or air uptake systems like the Glutaraldehyde User Station (GUS), does staff monitor how often filters are changed?
• Does the practice have a process for solution or machine failures?
• If using an automated endoscope reprocessor (AER), does the practice document and maintain quality logs for all filter changes, water testing, and quality controls required by the manufacturers’ instructions for use? Does the practice conduct periodic microbial monitoring of AER final rinse water to prove the AER is not contaminated?
• If the physician practice rents its space, does staff know the contact information for the facilities management staff in charge of water quality and heating, ventilating, and air-conditioning systems?

Questions to ask about the new standards’ greater focus on certification, training, and staff competencies include:

• Are personnel performing HLD processes certified within two years of their initial training in performing HLD processes?
• Do training and competency verification occur prior to an individual performing high-level disinfection independently?
• Do education and training occur annually, at designated time intervals, and when new scopes, processes, and products are introduced to the practice?
• Do training programs include tracking, monitoring, and oversight?

Consider an independent assessment

These are some of the common risk areas for physician practices to keep in mind when conducting risk assessments of care quality and safety-related processes and procedures. As with all quality and safety initiatives, it’s important to note that these are not “one-and-done” processes. Successful safety and quality programs include continual monitoring of the required steps for compliance and sustainability. In an ever-changing healthcare industry, providing frequent education and training for staff is vital for keeping up with the latest safety and quality standards.

To stay up to date and create sustainable quality and safety assurance processes, physician practices should consider reaching out to internal experts (if the physician practice is part of a larger healthcare system) or third-party specialists knowledgeable about physician practice risks to provide thorough risk assessments and audit plans. These additional resources can help physician practices address clinical processes and workflows to protect the patients at the center of the care they provide.

¹ “Vaccine Storage and Handling Toolkit,” Centers for Disease Control and Prevention, page last reviewed July 11, 2019, https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html
² “Questions About Multi-Dose Vials,” Centers for Disease Control and Prevention, page last reviewed June 20, 2019, https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html
³ Susan Klacik, “A Closer Look at ST91:2021 for Endoscope Processing,” AAMI, March 3, 2022, https://array.aami.org/content/news/closer-look-st91-2021-endoscope-processing