True informed consent bolsters patient safety

In this article, I will discuss additional opportunities for urologists to improve the safety of care in their own practices in the context of the National Quality Forum’s best practices.

Dr. DowlingIn the previous installment in my series of articles on patient safety, I discussed some of the National Quality Forum’s “Safe Practices for Better Healthcare” recommendations that are relevant to independent urology practices. Creating and measuring a culture of safety is the first step in a quality management program, followed by identifying and mitigating risks and hazards in the health care setting.

In this article, I will discuss additional opportunities for urologists to improve the safety of care in their own practices in the context of the National Quality Forum’s best practices.

Implementing an informed consent process

Safe Practice 5 is the effective implementation and use of an informed consent process. This recommendation goes beyond fulfilling the medicolegal requirements of your community or state (such as signing a complex form), and speaks to ensuring that the patient truly understands the recommended treatment rationale, benefits, risks, and alternatives. Elements of this practice include using educational documents written at or below fifth grade level and using qualified interpreters when literacy, language proficiency, vision, or hearing may be questionable.

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There are many commercial vendors of patient education solutions including Healthwise, Dialog Medical, StayWell, and the Patient Education Institute. Some of these and other “patient engagement companies” may be silent partners of your electronic health record vendor.

Urologists may wish to conduct a comprehensive review of their own consent process, beginning with determining the office procedures for which they currently obtain informed consent. For example, do you obtain formal consent for injections, bladder instillations, and complicated catheterizations? One measure of a threshold for obtaining formal consent is asking what you would expect to know if you were a patient (without medical training) undergoing a given procedure.

NEXT: Disclosure process incorporating transparency, apology


Most urologists, at some point, will be involved in the care of a patient with a serious unanticipated outcome due to systems failure or human error. Safe Practice 7 calls for a disclosure process in these cases that includes transparent communication, apology, and using the information learned for performance improvement. Often, these cases occur in a hospital setting, and the facility will have policies and procedures in place that conform to this safe practice; in those cases, the treating physician(s) may be an informed participant in the process. However, serious complications can occur outside the hospital setting, and urologists should be familiar with these practices and how adherence to them can improve safety in their own practice environment.

READ: Patient portal efforts don’t end with implementation

The typical independent urology practice employs direct caregivers with different levels of training, including nurses (RN, LVN, or LPN) and medical assistants. Safe Practice 10 calls for ensuring the competency of those direct caregivers by establishing standards for training, supervision, education, assessment, and when needed, performance improvement. Some of these standards are addressed with obtaining and maintaining a license.

Stage 2 of the Electronic Health Care Record Incentive Program has called attention to the required credentials of delegates in computerized provider order entry (CPOE) for medication, lab, and radiology orders, and the Centers for Medicare & Medicaid Services has clarified that such delegates-including medical assistants-need to be certified/credentialed by an entity other than the employer. Urology practices should be familiar with the scope of practice and other standards in their community before determining what constitutes “competency” of their direct caregiving staff.

Standardizing labeling processes

Many urology practices obtain blood, urine, and tissue specimens in their office that are either processed and interpreted on site or packaged and sent to an outside facility. Almost all practices either generate or handle radiology studies also. Safe Practice 14 calls for the implementation of standard policies and procedures for labeling radiographs, lab specimens, and other diagnostic studies. This is a significant source of risk for patient and an opportunity to improve quality and safety in a busy practice. Strand Diagnostics’ know error system has identified this risk of “specimen provenance complications” as contributing to diagnostic error and adverse outcomes.

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Best practices identified in this area include labeling specimens in the presence of the patient and at the time of collection (not ahead of time), using two patient identifiers (medical record number, full name, date of birth, picture, etc.), recording the site and laterality when relevant, and monitoring errors. Examples specific to a urology practice might include avoiding pre-labeling or relabeling prostate biopsy jars, a standard labeling template, confirming the label information with the patient, establishing accountability in the “chain of custody” of a specimen (the same staff member who obtained the specimen fills out the requisition and mails the specimen), and encouraging the reporting of errors by staff members (no retaliation policy).

Bottom line: Safety is an unspoken yet fundamental expectation of all patients, and health care delivery-even in the office-is a complicated and error-prone business. Safe practices based on evidence and experience can be brought to bear in all health care settings-including the urologist’s office.

NEXT: Recommended reading, resources


Recommended reading, resources


Patient engagement resources

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