Prevention of errors and patient safety: oncology nurses' perspectives

Martha Polovich B.F. Lewis School of Nursing & Health Professions, Georgia State University, Atlanta, USA KEY POINTS

• The environments where oncology patients receive care are complex, with many opportunities for mistakes.

• Oncology nurses participate in almost every aspect of patient care and therefore have a crucial role in the prevention of medical errors.

• Error prevention can be achieved by procedural, technological, and practice interventions when combined with a culture that values patient safety.

Introduction Cancer treatment usually involves multiple types of healthcare professionals working together as a team, and almost always includes nurses. Oncology nurses participate in the care of persons with cancer from prevention, screening, detection, diagnosis, treatment, to follow-up. Nurses function in multiple roles influencing cancer patients' decisions, treatment, and outcomes. Responsibilities vary depending on the setting (e.g., inpatient or outpatient), but nurses are often involved in implementing plans of care, coordinating patient care, and communicating with patients about their disease and treatment.

Medical errors can occur in any aspect of oncology care over the disease trajectory. Errors can impact the survival of patients who have potentially curable illnesses, making error prevention a high priority. As coordinators of care, oncology nurses may be responsible for gathering data used in treatment planning; scheduling tests, procedures, treatments or office visits; reporting test results to providers; and interpreting complex information for patients and their significant others. Because of their proximity to patients, nurses see themselves as the final defense against errors.

An adverse event (AE) is any "unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medical treatment or procedure" [1] or patient injury resulting from medical intervention. [2] An error is defined as failure to perform a planned action or using a wrong plan. [2] Not all AEs related to cancer treatment occur as a result of an error; some are related to the inherent toxicity of the therapies or the underlying condition of the patient. However, errors are preventable AEs that can result in patients experiencing severe symptoms, increased treatment toxicity, and decreased quality of life.

This chapter uses vignettes to describe various types of errors that can occur in oncology. Most are from the author's own clinical experience over more than 30 years as an oncology nurse. Two of the vignettes come from published accounts of serious medication errors. All clearly demonstrate that, despite skill and good intentions, humans make mistakes. Most mistakes occur because of a combination of individual and system failures. It is not the author's intent to criticize fellow healthcare providers, but to illustrate that errors are always possible, given the right set of circumstances. By reviewing the examples and examining the contributing factors, readers can identify strategies to prevent similar errors in their practice settings.

Patient misidentification Incorrect patient identification at the point of care can result in medication errors, performing unnecessary diagnostic or laboratory tests, and unintended interventions; [3] however, wrong patient errors may occur in any aspect of patient care. [4] The occurrence of this type of error in oncology is unknown. Misidentification errors may not be discovered because nurses are unaware that they have occurred. [3]

Accessing the wrong medical record can result in misfiling errors (test results, progress notes, or documentation forms); in reliance on wrong patient data for decision-making; in order entry errors; or in medication errors when medication administration records (MARs) are mixed up. [4] Electronic medical records do not completely eliminate these types of errors; in fact, patient identification errors may be an unintended consequence of computerized provider order entry (CPOE). Some of the contributing factors include having more than one electronic chart open simultaneously, patients with similar names, patients with the same conditions being cared for by the same practitioners, and distractions. [5, 6]

A nurse was checking laboratory results for a patient before administering chemotherapy The nurse printed out the complete blood count reports for several patients, and inadvertently checked the report for the wrong patient. The nurse notified the pharmacy to prepare the dose, when the patient's treatment should have been held due to neutropenia.

Case Study 5.2

A physician was writing orders for chemotherapy for two breast cancer patients at the same time. Both were to receive the same regimen, but the planned doses were different. After calculating the doses and ordering the patient-specific doses, the physician mixed up the identification labels and applied them to the wrong order forms.

Case Study 5.3

Two patients were scheduled to receive the same chemotherapy at different doses on the same day The patients were seated next to one another in the infusion room. When the medication arrived, two nurses checked the chemotherapy and placed the IV bags and the MARs on a table between the patients. The nurse accidentally hung the wrong IV on the first patient, which was discovered when hanging the chemotherapy on the second patient.

Specimens that are mislabeled at the time of collection can lead to treatment decisions being made based on wrong patient data. In the blood transfusion process, mislabeling of blood samples used for cross-match can result in a serious or even fatal transfusion reaction.

Using armbands does not eliminate wrong patient errors. Misidentification can still occur if a wrong armband is applied to a patient during the registration process, if two patients have the same or similar names, or if healthcare workers fail to check the armband every time. Relying on verbal affirmation of patients' names can result in misidentification. Non-English speaking patients or patients with a hearing impairment may respond when called by an incorrect name. [3]

Chemotherapy errors Medications are commonly used in the treatment of cancer. Antineoplastic drugs include cytotoxic agents, biotherapy agents, biological agents, or any combination of them. For simplicity, the various classes of antineoplastic drugs will be referred to as chemotherapy. These drugs often have a very narrow therapeutic range or window - meaning the difference between doses that are ineffective, therapeutic, or toxic is small. [7] This leaves little room for error. Even when cancer therapies are delivered as intended, patients can experience serious AEs, including treatment-related death. Because AEs are common with anticancer therapies, errors may go undetected.

A medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm."[8] Medication-related errors can occur during any stage of medication management from prescription, preparation, dispensing, to administration. In addition to drug administration, a customary nursing responsibility, oncology nurses participate in other aspects of medication handling. Advanced practice nurses (APNs) are often responsible for prescribing cancer-related drugs, depending on the practice setting. It is common for nurses to prepare drugs for administration in settings where pharmacists are not employed. Whether nurses themselves prescribe or prepare medications, they share the responsibility for appropriateness and accuracy when administering medications. Because nurses are closer to the patient, with fewer opportunities to identify errors, they represent a final opportunity to prevent medication errors.

Cancer is in some ways similar to other chronic illnesses, in that treatment usually takes place over months or years. However, few chronic illnesses are treated with drugs as toxic as those used in cancer. Patients can experience serious adverse events, including treatment-related death even when the intended treatment is administered. When chemotherapy errors do occur, they are more likely to result in patient harm. [9] For example, in one study over a two-year period of time, one-third of the detected chemotherapy-related medication errors had the potential for serious morbidity. [10]

The literature describes many individual and system factors that contribute to medication errors (Table 5.1). While most are not specific to chemotherapy, they are applicable. Some of these factors include distraction or work interruptions, understaffing, practitioner lack of knowledge or experience, worker fatigue, complicated drug schedules, unclear or ambiguous orders, illegible handwriting, lack of current resources, and difficult in reading or understanding drug packaging or labels. [11-15] These factors may contribute to errors in any stage of drug handling, from prescribing to administration.

Work interruptions have been implicated in medication prescribing [18] and administration errors. [13, 19] Events that distract the practitioner, such as the need to perform multiple tasks, communicate with other professionals, or respond to patient requests are common. In a busy infusion center, for instance, a nurse is required to move continuously among several patients who each require assessment, monitoring, and multiple medications. This type of environment and complex workload is filled with interruptions that may result in errors. Nurse stress and fatigue also contribute to medication errors. [12]

Individual factors Fatigue Hours worked Stress Nurse knowledge/skill/experience Miscommunication Misreading labels/instructions Miscalculations Pump programming Non-adherence to procedures Organization/system factors Nurse work load Volume of medications administered Patient acuity New staff Label design Insufficient training Distractions/interruptions Look-alike, sound-alike drugs Inadequate protocols/ policies Data from Schulmeister, [12] Carlton & Blegen, 2006, [14] Karavasiliadou & Athanasakis, 2006, [15] Institute for Safe Medication Practice, 2014. [16, 17]

Wrong drug errors Many chemotherapy drugs have long, difficult to pronounce and hard to spell generic names. Trade names are shorter and are designed to be easier to remember. Despite review by the Food and Drug Administration's [FDA] Division of Medication Error Prevention and Analysis prior to approval of new drug names, [20] many are sufficiently similar to result in mix-up. The ISMP maintains a list of "Confused Drug Names" (also known as look-alike, sound-alike "LASA" drugs). Approximately 30 drugs on the list (many with multiple names) are chemotherapy agents or supportive care drugs commonly used in oncology patients. Similar drug names can contribute to errors in prescribing, transcription, and pharmacy order entry due to legibility, picking the wrong drug in a drop-down menu, or using abbreviations. Storing similarly named products in close proximity can contribute to the preparation of a wrong drug, which may not be identified at the point of administration based on their appearance.

Docetaxel (Taxotere®) was ordered for a patient undergoing treatment for breast cancer. The nurse checking the drug noticed that, although the IV bag was labeled correctly, the IV bag contained a red solution instead of being colorless, and returned it to the pharmacy. Upon investigation, it was discovered that chemotherapy drugs were stored alphabetically by generic name in a designated area of the pharmacy. The docetaxel and doxorubicin (Adriamycin®) vials were kept in adjacent bins, and the inexperienced pharmacist picked the wrong drug vial.

Dosing errors Safe and effective doses of chemotherapy agents are determined in clinical trials. All of these drugs are associated with side-effects, many of which are dose-limiting. The goal of drug therapy for cancer is maximum tumor cell kill while minimizing toxicity to normal tissues and organs. Often this balance is difficult to achieve. Signs and symptoms of organ toxicity are evaluated periodically during treatment. One grading scale is the Common Terminology Criteria for Adverse Events (CTCAE). [1] AE severity is graded on the following scale: 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), and 5 (death related to the AE). Side-effects graded 3 or 4 often require dose modification or interruption.

Failure to adjust chemotherapy doses following severe or life-threatening toxicity is a potential dosing error. This type of error may occur due to incomplete patient assessment, inaccurate grading of toxicity, failure to obtain or communicate results of recent diagnostic tests, or questionable judgment.

Case Study 5.5

AT is a 60-year-old female patient with uterine sarcoma. Her therapy includes vincristine (Oncovin®), an intravenous (IV) chemotherapy drug that is associated with neurologic toxicity, including peripheral and autonomic neuropathy. [21] Following the second dose of vincristine, AT developed a paralytic ileus, which required hospitalization (grade 3). The vincristine was repeated the following month at the same dose, resulting in recurrence of the paralytic ileus.

Case Study 5.6

PG is a 54-year-old female patient with breast cancer. She is undergoing treatment that includes weekly IV trastuzumab (Herceptin®) for 52 weeks. Heart failure is a potential toxicity, especially in patients who have received prior anthracylines, chemotherapy agents that are associated with heart muscle damage. [22] Monitoring of left ventricular ejection fraction (LVEF), a measure of heart muscle function, is recommended prior to therapy and periodically. Treatment should be held in patients who develop clinically significant changes in LVEF. [22] PG developed symptoms (grade 3) of heart failure after four months of therapy without undergoing evaluation of LVEF.

Patient-specific chemotherapy doses are determined using patient data including weight, body surface area (based on height and weight), or laboratory results reflecting a patient's organ function. Using inaccurate measurements of height or weight or referring to previous laboratory test results can lead to inaccurate dosing.

Case Study 5.7

LD, a 41-year-old female with ovarian cancer, is scheduled to receive IV paclitaxel (Taxol®) and cisplatin (Platinol®). LD's height was recorded as 55 inches instead of 5 feet 5 inches. The body surface area and chemotherapy doses were calculated based on the incorrect height, resulting in a dosing error. The calculation was correct, but was performed using inaccurate data.

Case Study 5.8

70-year-old RT is receiving carboplatin (Paraplatin®) as part of treatment for lung cancer. The carboplatin dose is ordered based on RT's calculated creatinine clearance (CrCl), an estimation of kidney function. The third dose of carboplatin was calculated based on the serum creatinine obtained before the first dose, six weeks earlier. The patient experienced excess toxicity (grade 3 febrile neutropenia) due to an undetected change in renal function that resulted in decreased drug clearance.

Infusion pumps are often used for IV drugs to control the rate and duration of an infusion. Many types of infusion pumps exist, each with different design and programming steps. While some pumps are programmed to deliver a specific volume over time (e.g., milliliters per hour), other pumps determine the rate of infusion based on planned infusion time (e.g., 30 minutes), by prescribed dose (e.g., milligrams per kilogram per minute), some with choices of mode or dosing unit. A nurse's lack of familiarity with or infrequent use of pumps, together with design differences between pumps, can contribute to infusion rate errors.

Case Study 5.9

A 43-year-old female patient received 4000 mg/m2 of 5-fluorouracil over four hours instead of four days due to inaccurate programming of the ambulatory infusion pump. [17] This rate error resulted in an accidental overdose and the patient's death from multi-organ failure (grade 5) three weeks later.

Calculation errors The calculations used to determine chemotherapy doses vary in complexity, and can involve multiple mathematical formulas. Converting patient measurements (e.g., pounds to kilograms or inches to centimeters) before entering data into the computation adds a step and another opportunity for error. Mathematical errors during the prescribing process can result in dosing errors if not identified prior to drug preparation or administration. Even when calculators are used, incorrect data entry can result in mistakes.

Case Study 5.10

AB is to begin treatment for metastatic colon cancer with bevacizumab (Avastin®). The drug is ordered at 10 milligrams per kilogram every two weeks in combination with other chemotherapy agents. The prescriber made a mathematical error in converting the patient's weight from pounds to kilograms, resulting in a dosing error.

Case Study 5.11

CT, a 45-year-old female, is scheduled to receive carboplatin (Paraplatin®) for cervical cancer. The prescriber failed to adjust the calculated CrCl by 15% as required for females, resulting in a dosing error.

Scheduling errors Scheduling of chemotherapy treatment is extremely important for patients with cancer. Because the major characteristic of cancer is uncontrolled growth, delays in initiation of treatment or missed treatments can adversely affect patient survival. Tumor cell kill occurs as a result of chemotherapy administration, but normal tissues and organs require time to recover from the side-effects of the drugs. During the time away from treatment, surviving tumor cells continue to grow. Treatment delays in addition to dose reductions result in decreased relative total dose intensity (RTDI) (ratio of actual dose to the planned dose over time expressed as a percentage). [23] Several studies suggest that maintaining a RTDI of at least 85% increases patients' overall survival. [23-25]

Most IV chemotherapy regimens are designed to be administered in cycles that are repeated at intervals of one to four weeks. Treatment is ordered for a particular day (e.g., "Day 1 of a 21-day cycle" or "Days 1 through 5 of a 28-day cycle"). Oral antineoplastic agents may be administered cyclically or continuously, depending on the mechanism of action of the individual drug. The schedule of administration is critical both for antitumor effectiveness and to minimize side-effects. Scheduling errors can result in less than optimal tumor response or excess toxicity.

Case Study 5.12

CC is scheduled continuous infusion (CI) of fluorouracil for the treatment of advanced colon cancer. The regimen indicates the CI should be administered for five days. The patient is given an appointment to return to the infusion center daily for the infusion pump to be refilled. The nurse caring for the patient on the first day inadvertently writes the wrong date for the appointment to discontinue the infusion. The infusion is stopped on the fourth day, resulting in an accidental 20% dose reduction.

Case Study 5.13

TC is receiving paclitaxel protein-bound (Abraxane®) and carboplatin (Paraplatin®) for lung cancer. The regimen calls for paclitaxel protein-bound to be given IV on days 1, 8, and 15 of a 21-day cycle and the carboplatin on day 1 only. [26] The patient received the carboplatin on both days 1 and 8 due to confusion over the day of treatment. The patient experienced neutropenia and fever (grade 3) by day 14, requiring hospitalization.

Case Study 5.14

OA is given a prescription for oral capecitabine (Xeloda®) to take at home. The drug is ordered twice daily for 14 days, followed by 7 days off (one cycle). The patient finished the 14 days of therapy, had the prescription refilled and started the next cycle without waiting a week, resulting in grade 3 diarrhea (>7 stools per day over baseline).

Wrong route of administration Patients can experience harm when chemotherapy is administered by the incorrect route. Vesicant chemotherapy given other than IV may result in tissue damage. When that occurs due to IV extravasation (leakage of a vesicant drug outside the vein into surrounding tissues), it is an accident that is not always preventable. [27] Vesicant extravasation may occur due to the poor condition of patients' veins or unidentified mechanical failure of an IV access device. Should vesicant extravasation occur during administration without appropriate patient monitoring or when ordered by or changed to the intramuscular (IM) or subcutaneous (SQ) route, it is an error.

Tissue damage from vesicant drug extravasation varies from mild discomfort to necrosis requiring skin grafts. [28] Failure to intervene promptly when extravasation occurs can be considered an error. Only a few antidotes are available to minimize extravasation injury from certain drugs, making prevention preferable whenever possible. [29-31]

A serious wrong-route chemotherapy error involves the inadvertent intrathecal (IT) administration of drugs meant for IV administration. This error has occurred with neurotoxic agents such as vincristine and bortezomib. The outcome for patients is almost always fatal. [32, 33] This type of error may be the result of mislabeling of drugs or a mix-up of drug syringes when a patient is scheduled to receive both IV and IT therapy on the same day.

Case Study 5.15

A 21-year-old male was being treated for non-Hodgkin's lymphoma. A syringe containing vincristine for another patient had been accidentally delivered to the patient's bedside. A physician administered vincristine via a spinal route, believing it was a different medication. The error was not recognized and the patient died three days later. [34].

Summary The types of errors that occur in oncology are similar to those that can occur in other patient populations; however, the consequences of errors in oncology are potentially serious. Some adverse outcomes include:

• Compromised survival from treatment delays or dose reductions.

• Serious side effects from dose errors.

• Harm from wrong-route errors.

Nurses recognize the seriousness of medical errors in oncology patients and the need to develop and adopt interventions to improve patient safety.

Strategies to prevent medical errors in oncology Medical errors in oncology occur due to a combination of system failures in healthcare organizations in combination with failure of individual healthcare providers. Accrediting bodies, such as the Joint Commission (TJC), establish standards that address general safety measures applicable to all healthcare organizations. [35] The ISMP makes recommendations for best practices related to all medications and also for high-risk medications (e.g., anticoagulants and chemotherapy). [9] In addition to these groups, professional associations influence the performance of healthcare professionals and the healthcare settings by adopting professional standards specific to oncology patient care. Error prevention can only be achieved by procedural, technological, and practice interventions that support healthcare providers to practice safely, together with a culture that values patient safety. [2]

Some indicators of a positive safety climate are the presence of policies and procedures related to safety, the availability of education and training for safe practice, and the promotion of an environment where safe practices are valued and reinforced. [36, 37] Team members collaborate in implementing procedures aimed at error prevention. Open communication allows for questioning by any team member when safety is concerned.

Four professional organizations that have published guidelines regarding safety in oncology are:

The Oncology Nursing Society (ONS): A professional association of 35 000 members representing nurses in cancer care. ONS has published guidelines for chemotherapy, scope and standards of oncology nursing practice, oncology nursing education, and patient and public education.

The American Society of Clinical Oncology (ASCO): A professional society of 35 000 members representing all oncology professionals, most of whom are physicians. Guidelines for safety are incorporated in the Quality Oncology Practice Initiative (QOPI) program (http://www.asco.org/quality-guidelines/ asco-ons-standards-safe-chemotherapy-administration).

The American Society of Health System Pharmacists (ASHP): A professional society of 40 000 pharmacists. In 2002, ASHP published guidelines for preventing chemotherapy errors. [42] Updated guidelines are due to be published in 2015. The American College of Surgeons Commission on Cancer (CoC): A consortium of 50 member organizations dedicated to improving survival and quality of life for cancer patients. The CoC has developed standards that address several aspects of oncology patient quality and safety. [43]

Strategies to prevent patient misidentification Identifying patients correctly remains the number one National Patient Safety Goal from TJC. [44] Identification (ID) has traditionally been facilitated by patients wearing armbands that include the patients' name, date of birth, medical record number, and sometimes other information. Checking an armband has historically been the most common way for nurses to verify the right patient. However, armbands are not always used in outpatient care settings such as offices, clinics, or infusion centers. Other mechanisms for verifying patient ID are sometimes used, such as computer-generated patient ID labels, name tags, patient photographs, or biometric scanning devices. Photographs are less than ideal, since patients' appearance can change due to hair loss or weight loss over time.

When armbands, labels, or name tags are used, the accuracy of the information must be verified before applying them to the patient. Registration personnel should check a driver's license or other photo ID in addition to asking the patient their complete name, date of birth, or other unique identifier. Nurses should confirm that the information on the band is correct. The same two identifiers must be printed on the patient armband, every page of the medical record, the MAR, and medication labels so they can be verified before any intervention. Patients should be instructed to show their armband to staff who approach them regarding tests, procedures, or medications. If armbands are removed, they should be re-applied as soon as possible. [3]

In settings where armbands are not used, patients should be asked to state their full name and a second unique identifier before every test, medication, or treatment. Verification should not be passive (e.g., "Are you Mary Smith?") to avoid misunderstanding that may occur due to language barriers, hearing problems, inattention, or cognitive changes.

Prior to high-risk drug administration or performance of invasive procedures, two personnel should independently verify a patient's identity in the presence of the patient. For some procedures, such as IT drug administration, a "time-out" is recommended. A time-out is defined as a short meeting held immediately before a procedure for the purpose of verifying a patient's ID, the correct procedure and site, and any other information that is pertinent to the intervention. [35] The time-out procedure should be documented in the medical record.

Patient specimens should be labeled as soon as possible after their collection in the presence of the patient. Avoid printing labels for more than one patient's specimens at a time to prevent any mix-up, and verify the correctness of the patient information on the label. [3]

When accessing information from a medical record, all healthcare professionals should ensure that they have the correct chart. Each page of the chart should be labeled with two identifiers to facilitate this. When using electronic medical records (EMRs), prudent practice suggests having only one patient chart open at a time. Some kind of warning system should be in place regarding same or similar patient names. Nurses should establish a routine for checking the patient name and second identifier on printed reports of diagnostic or laboratory tests. These practices have the goal of minimizing the chance of wrong patient mistakes.

Barcoding is a technological solution for verifying patient ID. Barcode scanning is commonly used for point-of-care testing such as serum glucose, and in some settings for medication administration. For medication safety, barcode systems can interface with the medical record so that the patient, drug, and orders can be verified. The accuracy depends on applying the correct barcode to the patient during registration, leaving the barcode on the patient (e.g., not affixing it to bedrails or other surfaces), and replacing barcodes that become unreadable over time. Nurses should avoid using workarounds that bypass the built-in safety of the scanning process. [45]

Prevention of chemotherapy errors ONS, ASCO, ASHP, and several other stakeholders collaborated to develop standards that focus on patient safety related to chemotherapy administration. The initial 31 standards applicable to adults with cancer in outpatient settings were published concurrently in both ONS and ASCO journals in 2009. [46, 47] The standards have been updated to extend to inpatient settings [48, 49] and to the management of patients receiving oral antineoplastic agents, [50, 51] and now consist of 36 voluntary, literature-based, consensus standards.

The ASCO/ONS Chemotherapy Administration Safety Standards provide guidance to organizations and practitioners in developing uniform procedures for the safe management of chemotherapy. The recommendations are aimed at more than error reduction; their implementation ensures that practitioners provide evidence-based care related to pharmacologic treatment for cancer. However, a substantial number of the provisions in the standards address the safe processes for chemotherapy administration from treatment planning, prescribing, preparation, administration, patient monitoring, and follow-up. Nurses participated in standard development and are responsible for their implementation in clinical settings.

Guidelines and standards specify that organizations must limit chemotherapy ordering, preparation, and administration to qualified individuals. Because specialized knowledge is necessary for managing chemotherapy, this has the potential to minimize errors due to lack of practitioner knowledge or experience. A creden-tialing process is essential for physicians, physician assistants (PAs), and advanced practice nurses (APNs) who order chemotherapy. Nurses must be informed of the practitioners who are approved to order chemotherapy in their setting. A policy defining the process of handling orders from unapproved prescribers is necessary. The qualifications for pharmacists, pharmacy technicians, or nurses who prepare chemotherapy and for clinical staff (physicians, PAs, APNs, or nurses) who administer chemotherapy by any route should also be clearly defined. [42, 43, 50]

ONS maintains the position that registered nurses (RNs) with specialized education can provide a safe level of care for patients receiving chemotherapy.

[52] In addition to education, ONS recommends that RNs participate in a clinical practicum under the supervision of an experienced preceptor. Confirming initial competency is essential prior to independent chemotherapy administration, and ongoing competency should be validated at specified intervals. Organizations are obligated to verify initial education and training for clinical staff responsible for chemotherapy, and continuing education and competency requirements must be specified. [42, 50] In settings where chemotherapy administration occurs infrequently, maintaining competency may be difficult. Defining the process in low-volume settings is essential for these high-risk procedures.

Organizational policies should define prescribing requirements for chemotherapy. Providers are expected to use standardized, written or electronic orders that comprise all required elements for injectable and oral agents. [50] Requiring that

Table 5.2 Chemotherapy safety prescribing requirements and rationale for error reduction.

Required order

Types of errors

element

minimized or prevented

No verbal orders (except hold or stop)

Many types of errors, including wrong drug, wrong dose, wrong patient

Use of standardized order forms,

Many types of errors, including

written or electronic

omission errors, wrong schedule

All drugs listed by generic name

LASA drug errors

Two patient identifiers

Wrong patient errors

Date

Scheduling errors

Diagnosis

Wrong patient, wrong regimen errors

Regimen name/cycle number

Wrong regimen, scheduling errors

Protocol name/number

Wrong regimen errors in research

Criteria to treat (e.g., laboratory

Preventable toxicity

results)

Allergies

Allergic reactions

Dose calculation method

Miscalculation errors

Height, weight, other patient variables

Miscalculation errors

Drug dose

Dosing errors

No trailing zeros; leading zeros for

Dosing errors

doses < 1 mg

Route/rate of administration

Dosing errors, preventable toxicity

Duration of infusion

Dosing errors, preventable toxicity

Supportive care treatments

Preventable toxicity

Sequence of drugs

Preventable toxicity, altered effectiveness

Number dispensed (oral agents)

Dosing errors

Duration of therapy (oral agents)

Scheduling and dosing errors

Number of refills (oral agents)

Scheduling and dosing errors

Time limited orders

Scheduling and dosing errors

Procedure for communicating discontinuation of therapy (oral agents)

Data from Polovich et al., 2014 [38]; American Society of Health System Pharmacists, 2002 [42]; and Neussetal., 2013 [50]

orders incorporate the patient-specific information used to calculate doses and the dose calculation method allows nurses to verify the accuracy of calculations and the final patient-specific dose. Nurses should consider orders that do not contain all elements incomplete and unacceptable. The standards applicable to chemotherapy prescribing and the types of errors they affect are listed in Table 5.2.

Reviewing and verifying the accuracy and appropriateness of orders for chemotherapy is a long-standing practice for nurses and pharmacists. There are multiple checkpoints in the medication verification procedure at which this occurs. When nurses both prepare and administer chemotherapy, all of the checkpoints become their responsibility. The following are opportunities for error identification and intervention for chemotherapy administered in healthcare settings: [42]

1 Order authorization (e.g., signature or approval).

2 Order evaluation before preparation.

3 Product evaluation before preparation.

4 Documentation of preparation (e.g., use of "log" or worksheet).

5 Order evaluation when product is dispensed.

6 Product evaluation by nurse before administration.

7 Product checked with patient before administration.

ASCO, ONS, and ASHP all recommend independent double-checking of all calculations used to determine chemotherapy doses by a minimum of two practitioners. [38, 42, 50] Independent verification means that the second practitioner performs re-calculations without cues from the first to minimize confirmation bias. Any difference in dose is investigated to determine the reason for non-agreement (e.g., calculation error; use of different formulas; use of different data; or rounding). Small dose changes can occur due to minor variations in patient data (e.g., weight) between ordering and administering the treatment. Although there is little published evidence to suggest acceptable dose variability, 5 or 10% is commonly used in clinical practice. [53, 54] Organizations should establish a policy that specifies acceptable variance between ordered doses and re-calculated doses, and nurses and pharmacists should have the authority to suspend treatment until the accuracy of the dose is clarified.

A calculator is recommended for all mathematical computations, even simple ones. Areas where chemotherapy is checked should have calculators or access to a computer to use an online calculator. To avoid errors that can occur during conversion from one measurement system to another, measure and document patients' height and weight only in centimeters and kilograms. [55, 56]

Because of the high number of tasks involved in chemotherapy administration, checklists are useful in that they provide specific reminders to verify the accuracy and appropriateness of treatment-related orders. Items in checklists should appear in the same sequence as they do in clinical practice to fit more easily into the workflow. Using checklists for chemotherapy or other high-risk procedures has the potential to reduce clinical decision errors. [57]

Wrong drug errors can be minimized by prohibiting verbal orders for chemotherapy. Use of generic names in drug orders rather than trade names, nicknames, or abbreviations reduces confusion when drugs have similar names. Standard order forms, either pre-printed on paper or electronic, can also decrease mix-ups between LASA drug names. Using Tall Man Letters, which is a mix of upper and lowercase letters (e.g. DOXOrubicin or vinCRIStine), draws attention to the differences between LASA drugs, and is suggested as a strategy to reduce wrong-drug errors. [58, 59]

Some strategies have been suggested for preventing wrong-route errors related to inadvertent IT drug administration. Several neurotoxic drugs have been accidentally administered by the IT route instead of IV, but vincristine is the drug most commonly implicated in this error. [32] In addition to a two-person time-out procedure, the Joint Commission recommends: (i) establishing a list of drugs for IT use; (ii) banning all injectable drugs from the designated location during IT procedures; (iii) preparing IT drugs in pharmacy close to the administration time; and (iv) labeling the drugs "For intrathecal use only."[60]

Smart pump technology has been available for several years and has the potential to prevent errors or alert nurses to potential errors. [61] Many oncology settings use these devices with built-in dose limits and infusion rates for various chemotherapy agents and supportive care medications. Nurses have the ability to bypass the drug dictionary and enter the rate and volume manually; indeed this function may be needed when new drugs, doses, or concentrations are ordered and the library has not been updated. This essentially bypasses the error-reduction software, defeating the purpose of the technology. Pumps cannot detect the wrong drug - only programming that falls outside of the library's parameters.

Pumps designed for patients to receive infusions at home have some safeguards to promote safety. They often have locks to prevent changes to the infusion rate and to prevent the removal of the drug container. Patients may have the ability to replace the pump batteries or turn the pump off if instructed to do so by the nurse. The specific functions of individual ambulatory infusion devices vary based on their intended use. The accuracy of drug delivery is related to correct programming and the correct concentration of the drug.

Using a smart pump does not replace the need for two-nurse independent double-checks. [61] This practice of verifying the correct patient, drug, dose, route, rate, and so on is essential to preventing errors. When an infusion pump is used, double-checks include verifying the accuracy of the programming and documenting that this occurred. [50]

The patient's role in error reduction Current recommendations suggest that medical errors can be reduced when oncology patients are included as "vigilant partners" in error prevention. [62] Patients often receive care from multiple healthcare professionals, but they personally experience every office visit, consultation or treatment. [62] They are capable of identifying potential errors, such as when they observe variation in care from one visit to the next. However, patients' ability to participate in safety processes depends on the provision of specific information.

Nurses can engage patients in safety by informing patients of the plan of care. For instance, informing a patient that a particular diagnostic test is planned every three months during their treatment encourages the patient to remind the provider to schedule the test. Providing a patient with a description of their treatment regimen allows patients to notice and question unexpected changes. Patients can be included in several aspects of the chemotherapy double-check by showing them the medication label, pointing out the drug names and doses, and verifying their name and second identifier before drug administration.

Summary Medical errors in oncology care may have catastrophic effects on patient outcomes. The busy environments where oncology patients receive care may contribute to errors. Oncology nurses are closely involved in every aspect of the care of persons with cancer, and therefore have many opportunities to prevent error occurrence. Oncology nursing practices should be designed to maximize patient safety. These include adopting procedures based on national standards, implementing multiple redundancies for high-risk procedures, using technology to increase safety, open communication among all care providers, and striving for an environment where safety is valued.

References

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CHAPTER 6

Prevention of errors and patient safety from the oncologist's perspective

Meghan E.C. Shea, Nie Bohlen, and Inga T. Lennes Division of Hematology/Oncology, Harvard Medical School and Massachusetts General Hospital, USA KEY POINTS

• Oncology is a uniquely challenging field with high stakes, vulnerable patients, and chemother-apeutics with narrow therapeutic indices.

• Chemotherapy administration always involves multiple disciplines that depend on one another to defend against administration errors.

• The explosion of oral chemotherapeutics poses new challenges regarding administration, dispensing, and monitoring of patient symptoms.

• Assessment tools, such as QOPI, provide a starting place for oncology practices to evaluate the quality of current oncology care.

• Safety issues cross disciplines within oncology, including radiation oncology and surgical oncology, and attention to all aspects of oncology care is necessary to prevent errors in any setting.

Case Study 6.1 A Hard Lesson.

A well-known Boston journalist and mother of two young children died due to an error in ordering chemotherapy. In 1995, the newspaper headlines exploded with 28 front-page headlines with reports of this woman's death and another woman's irreversible heart damage. Betsy Lehman was 39-years-old and had breast cancer. She was admitted to Dana Farber Cancer Institute (DFCI) on November 14 for her third cycle of cyclophosphomide, which was part of a dose-escalating phase 1 clinical trial where she planned to undergo an autologous stem cell transplant. She was to receive a total dose of 6520 milligrams of cyclophosphomide, based on her body surface area, divided over four days. However, the oncologist-in-training ordered 6520 milligrams to be given each day for four days. [1] Following administration of the medication, her husband recalled "she was dealing with horrendous symptoms. I guess it was called mucositis. The whole lining of her gut from one end to the other was shedding. She was vomiting sheets of tissue. They said this was the worst they'd ever seen. But the doctors said this was all normal."[2] She was found pulseless and died on December 3.

The error was discovered during a routine data check over two months after Ms. Lehman's death.

"It was a blunder compounded or overlooked by at least a dozen physicians, nurses and pharmacists, including some of the institution's senior staff," the Boston Globe said. [1] Human error alone was cited initially though root cause revealed much more. Many factors contributed to the error reaching the patient, such as minimal double-checks for accuracy. A fellow's orders did not require an attending oncologist's signature, and research protocols were not available to nurses or pharmacists. Additionally, the research protocol interchangeably listed both the total daily dose and the total dose. The computer system did not provide any warnings of exceeding maximum dosing. Dr. David Livingston, physician-in-chief at DFCI in 1995, "profoundly regretted what has occurred, assumes full responsibility for these tragic events and has taken additional precautions to ensure that they do not happen again."[1]

Two decades later - "Dana Farber has emerged as one of the most safety- conscious hospitals in America, with computers that trigger alarms at potential overdoses, a hypervigilant error-reporting system, and a top executive who pushes measures in pursuit of the old physician's promise to 'first do no harm.'"[3] This hard lesson sparked change. Interdisciplinary groups now help in the design and implementation of chemotherapy protocols. Attending physicians must co-sign chemotherapy orders written by oncologists-in-training. Dosages are only expressed in terms of daily dose and to override the computer's dosage that physician must provide the pharmacist with new scientific evidence that a higher dose may be safe and effective. And lastly, though perhaps most importantly, the culture has changed; pharmacists and nurses are encouraged to independently check and question.

"Humbled is the word that comes to mind. What people have to do in this work is to figure out how to keep the same vigilant edge they had the first or second time they took care of a patient. You have to keep remembering what the stakes are," Hester Hill (social worker, friend of Lehman). [4]

No one knows how many cancer patients become victims of chemotherapy overdoses, even fatal ones, because such tragedies are almost never reported. An unpublished survey by the Institute for Safe Medication Practices, a nonprofit group that monitors medication errors, found four carbon copies of the Dana-Farber overdoses in a one-year period among 161 US hospitals. [5] Oncology is a uniquely challenging field in which to ensure and deliver safe, quality care. The stakes are high and the risks ever present with a very ill and vulnerable patient population, an armory of toxic and potentially lethal drugs, and the rapid development of new therapeutics and combinations of treatments. The landmark 1999 Institute of Medicine (IOM) report titled "Ensuring Quality Cancer Care" concluded that, for many Americans, there is a wide gap between what could be construed as the ideal and the reality of their experience with cancer care. And in 1999, the National Cancer Policy Board called attention to the issue of the quality of cancer care in the United States. [6]

Chemotherapy safety Chemotherapy administration is an unregulated process aside from the safety regulations and recommendations applicable to all other areas of healthcare, where quality assessment is voluntary and differs among institutions and practices. While accidental overdoses are extremely unlikely with an electronic ordering system, a review of reported chemotherapy errors at the DFCI in 2006 revealed an error rate of 3% in adult patients and 26% of those were felt to be serious. [7] Similarly, a prospective evaluation of 22 216 consecutive chemotherapy orders at the University Medical Center Freiberg in Germany demonstrated 17% medical and administration errors, of which 3.8% were an error in the chemotherapy, 4.5% patient data, and 8.7% missing informed consent. In this center, only 3 of the 3792 errors reached the patient, which the authors attributed to their multidisciplinary team approaches to reviewing orders and error monitoring. [8] While these error rates compare favorably with published medication error rates of 7.4% in non-chemotherapy facilities in the United States, the nature of errors in the oncology setting may have more serious consequences for patients. [9] A one-year prospective study to identify medication errors during chemotherapy showed of 6607 prescriptions written that 5.2% contained at least one error, and of these errors 13% would have resulted in temporary injury and 5.2% in permanent damage or death. Most of the errors were intercepted prior to administration to patients; only 13 medication errors reached the patients and of those only two patients required additional monitoring. [10]

Case Study 6.2 Wrong Medicine.

Excerpt from narrative of safety report at Massachusetts General Hospital Cancer Center:

A patient with a new diagnosis of lung adenocarcinoma was seen in clinic by an oncology fellow, one month into fellowship, and the oncology attending physician. The note for that visit stated the plan was for a pemetrexed-containing chemotherapy regimen.

The patient was prescribed IM vitamin B12, as well as folate supplementation in anticipation of chemotherapy.

Two weeks later the patient returned to clinic for treatment. The fellow and the attending physician saw the patient and reviewed the plan for chemotherapy. Standard protocol in the practice was for the fellow to enter the chemotherapy orders and the attending to cosign the orders before review by the infusion nurse and pharmacist.

The chemotherapy regimens are selected from a drop down menu in the chemotherapy order entry computer program. The lung cancer regimen containing pemetrexed was positioned next to the regimen containing paclitaxel. The paclitaxel regimen was chosen instead of the intended pemetrexed regimen. The attending physician signed the orders while seeing another patient who was distraught discussing end of life issues. Distracted by the conversation with the second patient, the attending did not double-check the orders before signing them.

After the attending co-signed the orders, the infusion nurse activated the orders, sending them to the pharmacy to be mixed and dispensed. The infusion nurse had prepared for the intended pemetrexed regimen, as that was delineated in the previous visit notes and was indicated in the scheduling system. The infusion nurse stated that when the orders were written for a different regimen, she assumed the physicians had changed their plans for treatment. A copy of the consent form (indicating the pemetrexed regimen) was sent to pharmacy. The pharmacist reviewing the orders looked quickly at the consent and thought the consent was for the paclitaxel regimen, although it actually specified pemetrexed. The pharmacist was a recent graduate and this was her first week off orientation.

The patient received the paclitaxel regimen. This error was discovered later that evening when the fellow was reviewing the patient's chart. The patient was informed of the error by the fellow and the attending, and it was disclosed with apologies to the patient. The patient suffered no side-effects from the unintended regimen, and the patient was continued on treatment with the paclitaxel regimen as it was also a reasonable treatment choice for this patient.

The error outlined above is a good example of the Swiss cheese model of accident causation or the cumulative act effect (Figure 6.1). In the reported error scenario, there were several layers of defense to guard against a chemotherapy administration error purposely designed into the system: attending co-signature of fellow chemotherapy orders, the chemotherapy order entry computer system that restrained the possible choice of regimen and doses, and the double checks by nursing and pharmacy. Each of these barriers could be considered a "slice of cheese” in the model. In a perfect system, each layer would be intact with specific vulnerabilities or "holes in the cheese," but none of the individual layers would line up to create a vulnerability in the entire process. However, when the holes do rarely align, there is the potential for the accident to reach the victim, in this case with the unintended chemotherapy reaching the patient. The possible vulnerabilities can be classified into active failures or latent conditions that predispose the system to errors. In this case, we would consider the act of choosing the wrong regimen (fellow), the act of not completely reviewing the orders (attending physician), and the act of incompletely reviewing the orders and consent form (nurse and pharmacist) active failures in the system. But it is not enough to only focus on the personnel involved in the error. In system-based root-cause analysis, we also consider the latent conditions that can contribute to errors: production pressure from a busy clinic or infusion day, distractions during work from other patients with urgent needs, inexperience of trainees, and a laborious and confusing system for communication between clinics and infusion staff. Quality improvement efforts

Figure 6.1 The Swiss Cheese Model of how errors can escape a system of defenses, barriers and safeguards. Source: Reason J. BMJ 2000; 230: 768-770. Reproduced with permission of BMJ.

must address not only the active failures, but also the latent conditions that can predispose a system to errors.

With the advent of targeted therapeutics, chemotherapy is more often being taken at home in the form of a pill. There has been an explosion of oral chemother-apeutics available in the past ten years. Oral chemotherapy has brought new safety concerns, including administration by the patient or caregiver, handling of drugs, and monitoring of adverse effects often with a narrow therapeutic index. [11] Parenteral (intravenous (IV)) chemotherapy ensures patients interact with providers on a regular schedule, whereas with oral chemotherapy it can be dispensed by specialty, local, or mail order pharmacies with variable follow-up scheduled with practitioners. [12]

Computerized provider order entry (CPOE) is the preferred method to ordering as it provides a safeguard for dose, route of administration, dosing frequency or interval, and duration, yet a survey of National Cancer Institute cancer centers showed that in 2007, 71% oral chemotherapy were still handwritten. Additionally, the survey found only one-third required informed consent. And nearly a quarter of cancer centers had no formalized process for monitoring patients on oral chemotherapy, yet nearly a quarter of centers had a serious drug event with oral chemotherapy reported. [13] Patients falsely perceive oral drugs as safer. [14] In a study of 69 children with acute lymphoblastic leukemia taking oral chemotherapy, 10% had a medication error with 71% in administration and 29% in prescribing. [15] Oral chemotherapy administration is so complex that some have suggested that specialty clinics, analogous to anti-coagulation clinics, be developed so they can sufficiently monitor compliance and toxicity. In a pilot, those patients in the specialty clinic had decreased incidence of adverse drug event (ADE), non-adherence, drug interactions, and medication errors over time. [16] Fortunately, in 2013 the American Society of Clinical Oncology (ASCO)/Oncology of Nursing Society (ONS) Chemotherapy Administration Safety Standards included administration and management of oral chemotherapy, which is an initial step to help guide cancer centers and oncology practices. [11]

Quality assessment tools ASCO answered the call for quality assessment and instituted a formal accreditation for oncology practices with a program called Quality Oncology Practice Initiative (QOPI). QOPI is a voluntary, fee-based program designed to review a programs' adherence to a set of practice guidelines. [17] In the pilot study, Neuss et al. showed that QOPI provides rapid and objective measurement of practice quality, as well as allowing comparisons across practices and over time. It is a tool for practice self-examination that can promote excellence in cancer care. QOPI incorporates consensus, evidence-based standards, practice guidelines, and Joint Commission requirements. In the pilot, each practice reviewed 85 records (including 10 deceased). The practices found variations; for instance, consent for chemotherapy varied widely (2-100%), though some form of consent was in 62% of medical records at minimum. Additionally, they found that the use of white blood cell stimulating factor use according to guidelines ranged from 0-88%. [17]

Since 2009 QOPI certification has been available, 206 oncology practices have participated, however this is less than 15% of all practicing medical oncologists. Once QOPI certification is obtained, then the practice applies for on-site peer review, where an auditing team examines the practice adherence to 17 assessment standards (Table 6.1). The 17 standards include staff training, chemotherapy planning documentation, ordering, drug preparation, and chemotherapy administration, as well as monitoring and assessment. [18] Of the 111 practices audited, only two practices met all 17 standards, thus 98% of practices had some level of discrepancy between reported operations and what was observed during the audit. An example of a standard that was challenging for practices to meet was proper qualifications of the staff responsible for prescribing, preparing, and administering chemotherapy. Only 40.4% of practices during the on-site review met this standard. Many practices did not have any policies that listed the specific protocols and policies for chemotherapy administration in place. However, all practices documented a toxicity assessment that is required for planning subsequent treatment. Notably, most oncology practices modified their patient protocols for treatment after an on-site visit. [18]

An update in 2013 from Neuss et al. revealed that despite focusing on basic principles regarding documentation of care for patients with cancer, the mean adherence score to the guidelines in a set of 156 oncology groups was 71%. [19] And some measures have shown no change despite the demonstrated opportunity for improvement. The goal remains that the QOPI certification process lead to Table 6.1 QOPI Standards for Certification. Summary of the 17 assessment standards required for QOPI certification.

Staffing Related Standards

1. Practice has policies, procedures, and/or guidelines for verification of training and continuing education for clinical staff.

Chemotherapy Planning: Chart Documentation Standards

2. Prior to prescribing a new chemotherapy regimen, chart documentation available to the prescriber includes:

A. Pathologic confirmation or verification of initial diagnosis B. Initial cancer stage or current cancer status C. Complete medical history and physician examination D. Presence or absence of allergies and history of other hypersensitivity reactions E. Documentation of patient's comprehension regarding medication regimens F. Assessment regarding psychosocial concerns and need for support G. The chemotherapy treatment plan H. For oral chemotherapy, the frequency of office visits and monitoring that is appropriate to the agent and is defined in the treatment plan General Chemotherapy Practice Standards

3. The practice maintains a policy for how informed consent is obtained and documented for chemotherapy.

Chemotherapy Order Standards

4. Order forms inclusively list all chemotherapy agents in the regimen and their individual dosing parameters. All mediations within the order set are listed using full generic names and follow Joint Commission standards regarding abbreviations.

Drug Preparation

5. A second person independently verifies each order for chemotherapy prior to preparation.

6. Chemotherapy drugs are labeled immediately upon preparation.

7. Practices that administer intrathecal medication maintain policies specifying that intrathecal medication will:

A. not be prepared during preparation of any other agents B. be stored, once prepared, in an isolated container or location with a uniquely identifiable intrathecal medication label C. be delivered to the patient only with other medication for administration into the central nervous system Chemotherapy Administration

8. Prior to administration, at least two practitioners or personnel approved by the practice to prepare or administer chemotherapy:

A. verify patient identification using at least two identifiers B. confirm with the patient his/her planned treatment, drug route, and symptom management C. verify the accuracy of:

° drug name

° drug dose ° drug volume ° rate of administration ° expiration dates/times ° appearance and physical integrity of the drugs D. sign to indicate verification was done

9. Extravasation management procedures are defined; antidote orders sets and antidotes are accessible Monitoring and Assessment

10. Practice maintains protocols for response to life-threatening emergencies, including escalation of patient support beyond basic life support.

11. On each clinical visit during chemotherapy administration, practice staff assess and document in the medical record:

A. changes in clinical status, weight B. changes in performance status C. allergies, previous reactions, and treatment-related toxicities D. patient psychosocial concerns and need for support

12. On each clinical visit during chemotherapy administration, practice staff assess and document the patient's current medications, including over-the-counter medications and complementary and alternative therapies. Any changes in the patient's medications are reviewed by a practitioner during the same visit.

13. The practice maintains a referral list for psychosocial and other supportive care services.

14. The practice establishes a procedure for documentation and follow-up for patients who miss office visits and treatments.

15. The practice has policies and procedures that identify:

A. a process to provide 24/7 triage to a practitioner for care of toxicities B. consistent documentation and communication of toxicity across sites of care with in the practice

16. Toxicity assessment documentation is available for planning subsequent treatment cycles

17. The practice has a process to track cumulative doses of chemotherapy agents associated with a risk of cumulative toxicity Adapted from Neuss et al., 2013 12.

greater uniformity in care, however greater attention must be paid to those metrics that have proved difficult to improve over time.

The QOPI program has its limitations. It only captures a fraction of the total care experience and it depends on medical record selection, which may not be done at random. With the on-site audits, discrepancies exist between what practices report and what is observed. [18] Most significantly, the current quality practice improvement tool is not as widespread as one would hope, with approximately 15% of oncology practices participating. QOPI measures processes of care routinely provided in outpatient oncology practices, though measurement does not always translate into improvement. [20] However, in 2014, the ASCO annual conference is offering a workshop on the tools of quality improvement to move a practice beyond measurement to action.

Other efforts have attempted to measure and address quality cancer care. The Florida Initiative for Quality Cancer Care (FIQCC) was a voluntary practice-based quality measurement and improvement project. FIQCC assessed 11 oncology practices in Florida, where trained abstractors reviewed medical records of breast,

non-small cell lung, and colon cancer patients. Quality indicators were derived from ASCO, National Comprehensive Cancer Network (NCCN), National Initiative on Cancer Care Quality (NICCQ), and QOPI. The indicators varied for the cancer type. Each site received feedback as to where there was a need for quality improvement. [21] Like QOPI certification, the FIQCC was an observational exercise aimed at promoting improvement by discerning gaps in performance.

Radiation oncology and surgical oncology Cancer care is multidisciplinary and involves a team of physicians, often radiation oncologists and surgeons specializing in oncology care. More than half of cancer patients receive radiation therapy. In 2010, the New York Times wrote a series of articles highlighting the safety of radiation. Specifically, reporters told the stories of two patients who died after receiving extremely high doses of radiation from linear accelerators, deaths that might not have occurred if technologists and others responsible for the operation of the devices had not made dosing errors. Radiation is an invaluable life-saver, however when serious accidents occur, though rare, they can be deadly.

In June of 2010, the New York Times reported that a Philadelphia hospital gave the wrong radiation dose to more than 90 patients with prostate cancer - and did not report or disclose the error. [22] In 2005, a Florida hospital disclosed that 77 brain cancer patients had received 50% more radiation than prescribed because one of the most powerful linear accelerators had been programmed incorrectly for nearly a year. [22] Identifying radiation injuries can be difficult as the damage may not be evident for years. New York State, a leader in the field for monitoring radiotherapy and errors, noted 621 mistakes from 2001 to 2008. Most were minor and caused no immediate injury to the patient. In 133 of the errors, the device used to modulate the radiation beams contributed to the error. [22]

Given the potentially catastrophic outcome of an error within the field of radiation oncology, in many practices across the country there are checks in place, such as weekly review of films and charts. Even with thorough review, errors still occur at rates that have ranged from 0.06-4.66%, depending on how errors were quantified. [23] In 2010, the federal government held hearings to evaluate the role of federal oversight of medical radiation. Many of the concerns were raised around licensing and credentialing of technicians, which varies state to state. [24] Dr. Geoffrey Ibbott, director of the Radiological Physics Center, reported in 2008 that among hospitals seeking admission into clinical trials, nearly 30% failed to accurately irradiate an object, called a phantom, which mimicked the human head and neck. The hospitals were all using Intensity Modulated Radiation Therapy (IMRT) that shapes and varies the intensity of radiation beams to more accurately attack the tumor. ''This is a sobering statistic, especially considering that this is a sample of those institutions that felt confident enough in their IMRT planning and delivery process to apply for credentialing and presumably expected to pass,''

said a task group investigating IMRT guidelines for the American Association of Physicist in Medicine. [25]

Case Study 6.3 Faulty Programming.

Case reported in the New York Times: [22]

Diagnosed with a tongue cancer, Mr. Scott Jerome-Parks chose to undergo chemotherapy and radiation. He presented to the hospital for his fifth radiation session. His physician decided to protect his teeth and to do this needed to rework the radiation field. While the medical physicist was saving her work with the updated plan, the computer froze and displayed an error message. She was asked to save her work before the program aborted; she said "yes." The radiation oncologist approved the new plan. In the days following, friends and family recall noting changes in Mr. Jerome-Parks' appearance. Mr. Paul Bibbo, a friend from church, recalled blurting out: ''My goodness, look at him. His head and his whole neck were swollen.'' After concerns had been raised by Mr. Jerome-Parks' friends and family, the medical physicist ran a test to verify the treatment plan. She discovered that the multi-leaf collimator, which was supposed to focus the beam precisely on his tumor, had been wide open. She repeated the test two more times; same result. He had received radiation to his entire neck from the base of his skull to his larynx. The error was disclosed to him by his physician, who told him of the error and of his grim prognosis as a consequence.

Progressively he declined; he became deaf, unable to swallow, his vision blurred, and he struggled with severe pain in his mouth and throat from ulcers and burns. Eventually, the radiation overdose led to his inability to breathe. He died at age of 43 from the fatal radiation overdose.

On three consecutive days, he had received wayward beams of radiation to his brainstem and neck due to a computer error programming the linear accelerator. The software required that three essential programming instructions be saved in sequence: first, the quantity or dose of radiation in the beam; then a digital image of the treatment area; and finally, instructions that guide the multi-leaf collimator. Due to the computer crashing, the instructions had not been saved, and as a result, the patient received nearly six times the prescribed dose.

The American Society for Radiation Oncology (ASTRO) Board of Directors, as part of the ASTRO's Target Safely Campaign, has focused on the role of peer review as an important component of a quality assurance program. [26] Brundage et al. assessed the real-time pretreatment review of 3052 treatment plans over eight years. They concluded that pre-radiation therapy peer review was feasible, and that plan modifications were recommended in approximately 8% of cases. [26] A similar prospective study noted peer review-recommended changes in 8 of 208 patients (~4%). A post-treatment peer audit of ~80 cases also noted that nearly 5% of patients had apparent controversial or concerning medical decisions, such as treatment intent, dose, and fractionation. [27] ASTRO proposes taking different approaches with technical and human aspects of radiation therapy (Figure 6.2). [26]

Because 50 to 65% of inpatient adverse events are experienced by surgical patients, and 75% of these occur intra-operatively, the operating room (OR) is a Figure 6.2 A quality management program must address medical and qualitative steps (left side) as well as technical and quantifiable process-related steps (right side) to implement change. Source: Marks et al., 2013 [26]. Reproduced with permission of Elsevier.

high-impact area for safety improvements. [28] Faulty communication has been cited by the Joint Commission and in surgical malpractice claims as the most common behavioral problem. Checklists have helped and ensure a standardized approach, though most of communication cannot be programmed. A study across Veterans Affairs Medical centers and academic hospitals found OR team members who reported higher level of positive communication and collaboration with attending and resident physicians had lower risk-adjusted morbidity rates; [29] further stressing that across specialties, the culture of safety is an important element to safe, quality care.

Recommendations for safer oncologic care The Betsy Lehman case and many others can ensure change and teach oncologists and the public alike that safety must be a core property of our system of care rather than an empty mantra. [30] Making patients safe requires ongoing efforts to improve practices, training, information technology, and culture. Senior leaders must supply resources and leadership while promoting engagement and innovation by frontline clinicians. [31] A survey in 1996 following the Lehman case, published by Fischer et al., sent to the 215 members of ASCO with (70% response) created the following recommendations [32]:

• Restrict writing of chemotherapy to physicians board-certified or board-eligible in hematology or medical, pediatric or gynecologic oncology and their approved fellows.

° Fellows have orders co-signed.

° Verbal orders are unacceptable.

• Dispensation of drugs limited to oncology certified pharmacists.

• Administration of chemotherapy by chemo-certified nurses.

• Standard orders used (ideally computer).

• Procedures to regulate ordering of anti-neoplastic drugs for non-malignant indications.

• Process to prevent chemotherapy errors It is the responsibility of clinical and administrative leaders to design systems that prevent error and use information technology as a powerful tool to deliver cancer care safely. Order set templates and electronic order entry are two examples that have improved care, and in the next ten years we will see electronic health record systems transform the operations and protocols for administering chemotherapy. Order entry systems that prompt providers for documentation also have been shown to improve frequency of documentation of code status.

[33] Clinical practices should focus on safety of oral chemotherapy and refer to the ASCO/ONS Chemotherapy Administration Safety Standards, as this mode of chemotherapy delivery will increase in the future. [18]

Safety reporting and root cause analysis of incidents should be expected as a mechanism for monitoring and evaluating current practices. It is important to have a system to track and review errors. Specifically in radiation therapy, ASTRO has called for the establishment of an anonymous reporting system of errors, similar to the airline industry. Documenting and reviewing near-miss events is critical as these may be sentinel for future potential serious mistakes. Oncologists should cultivate a culture of safety to ensure people feel comfortable reporting and seeking ways to make care safer for patients. Oncology practices should be participating and utilizing assessment tools, such as QOPI, to ensure compliance with safety standards.

Collaboration with other institutions and with patients and their families to create a safer care environment is imperative. Oncology care is multidisciplinary and often care is carried out in multiple venues and across institutions. Patients navigate multiple systems and interact with multiple providers, and they often assume streamlined communication amongst these systems and providers exists - though in reality, gaps and pitfalls in communication expose patients to an unacceptable risk of harm.

Campaigns, such as the "You CAN" led at DFCI, have targeted partnering patients and families with providers to address three leading hazards in the ambulatory oncology practice: wrong chemotherapy administration, infections due to inadequate hand hygiene, and failure to communicate dose adjustments of chemotherapy. The You CAN campaign educated patients to "Check - Ask - Notify." Weingart et al. showed that the You CAN campaign did improve, though not statistically significantly, the patients' perception of teamwork and communication. Twenty percent of patients indicated that they changed their behavior due to the campaign, and 100% of patients recalled nursing briefing them on the medication prior to administration (compared to 87% prior to the campaign). [34] Other initiatives such as "Speak Up" by the Joint Commission urges patients to take an active role in their healthcare with brochures and videos that target subjects such as medication safety, communication about your pain, and reducing the spread of infections. [35]. It is imperative that we practice transparency with our patients and that we learn from them on how to provide the utmost quality and safe care.

References

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CHAPTER 7

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