JCI Accreditation Standards for Hospitals and Academic Medical Centers (AMC) PDF
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This document outlines the proposed new standards and requirements for JCI accreditation of hospitals and academic medical centers, focusing on the International Patient Safety Goals (IPSG) chapter. It details newly added or revised requirements, presented in red font.
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JCI Accreditation Standards for Hospitals and Academic Medical Centers (AMC), 8th Edition Draft Standards for Field Review Proposed New Standards and Requiremen...
JCI Accreditation Standards for Hospitals and Academic Medical Centers (AMC), 8th Edition Draft Standards for Field Review Proposed New Standards and Requirements Note: This document does not include all standards for Hospitals and Academic Medical Centers (AMC), 8th Edition. The standards in this document are the proposed requirements in the International Patient Safety Goals (IPSG) chapter only. To participate in the field review of other chapters of the hospital and AMC standards, please refer back to the JCIA website. As a reminder, the field review focuses on newly added or significantly revised requirements. To identify the difference: Standards, measurable elements, intents, and guidance that are new or have undergone significant changes that have impacted the intent of the requirement are in RED font. Standards, measurable elements, intents, and guidance that are in BLACK font may have undergone changes, but the intents remained the same. Prior to the publication, a complete summary of changes will be included in the manual along with an updated and complete reference list for each chapter. Field Review Questionnaire: To participate in the field review of this chapter, please complete the survey below: https://www.surveymonkey.com/r/JD8HVVR Field Review Period: October 23- November 13, 2023 CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE International Patient Safety Goals (IPSG) Overview This chapter addresses the International Patient Safety Goals (IPSG), as required for implementation as of 1 January 2011 in all organizations accredited by Joint Commission International (JCI) under the International Standards for Hospitals. The purpose of the International Patient Safety Goals is to promote specific improvements in patient safety. The goals highlight problematic areas in health care and describe evidence- and expert-based consensus solutions to these problems. Recognizing that sound system design is intrinsic to the delivery of safe, high-quality health care, the goals generally focus on systemwide solutions, wherever possible. The goals are structured in the same manner as the other standards, including a standard (goal statement), an intent statement, and measurable elements (MEs). The goals are scored similar to other standards as “met,” “partially met,” or “not met.” The accreditation decision rules include compliance with the goals as a separate decision rule. Goals The following is a list of all standards for this function. They are presented here for your convenience without their intent statements, guidance, or measurable elements. For more information about these standards, please see the next section in this chapter, Goals, Intents, and Measurable Elements. Goal 1: Identify Patients Correctly IPSG.1 The hospital implements a process to improve accuracy of patient identifications. Goal 2: Improve Effective Communication IPSG.2 The hospital implements a process for reporting critical results of diagnostic tests. IPSG.2 The hospital implements a standardized process for handover communication. Goal 3: Improve the Safety of Medications IPSG.3 The hospital implements a process to improve the safety of high-alert medications. IPSG.3.1 The hospital implements a process to improve the safety of look-alike/sound-alike medications. IPSG.3.2 The hospital implements a process to manage the safe use of concentrated electrolytes. Goal 4: Ensure Safe Surgery IPSG.4 The hospital implements a process for the preoperative verification and surgical/invasive procedure site marking. IPSG.4.1 The hospital implements a process for the time-out that is performed immediately prior to the start of the surgical/invasive procedure and the sign-out that is conducted after the procedure. Goal 5: Reduce the Risk of Health Care–Associated Infections IPSG.5 The hospital implements evidence-based hand-hygiene guidelines to reduce the risk of health care– associated infections. Goal 6 Preventing Diagnostic Errors IPSG.6 The hospital implements processes to reduce harm caused by diagnostic errors. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Goals, Standards, Intents, Guidance, and Measurable Elements Goal 1: Identify Patients Correctly Standard IPSG.1 The hospital implements a process to improve accuracy of patient identifications. Intent of IPSG.1 Incorrect patient identification can result in wrong person and wrong procedure and treatment errors, medication errors, diagnostic errors, and more that may result in patient harm. Guidance for IPSG.1 Correctly identifying a patient and matching them with intended treatment and services must be performed in all care settings. The identification process used throughout the hospital requires the use of two patient identifiers, such as the patient’s name, identification number, birth date, a bar-coded wristband, or other ways. The patient’s room number or location in the hospital cannot be used for identification. The two different patient identifiers used may be different in different circumstances; however, the two identifiers used must be consistent within an area. It is a best practice that the patient be involved in the identification process to whatever extent possible. There are special circumstances in which the hospital may need to develop a specific process for patient identification. The process considers the unique needs of the patients, and staff use the process for patient identification in these special circumstances to prevent error. Two different patient identifiers are required in any circumstance involving patient interventions. Patients are identified before providing treatments, performing procedures, and before any diagnostic procedures are performed. The hospital should include the following in its patient identification practices: Involve the patient in the identification process whenever possible Include special circumstances in the identification process, for example, o Comatose or confused/disoriented patients with no identification o Newborn patients when the parents have not immediately chosen a name, such as using the mother’s given name in addition to “baby boy or baby girl” and the parents’ surname. For Example: “Baby Girl Mariam Khan” instead of “Baby Girl Khan”, or “Baby Boy Maria Silva” instead of “Baby Boy Silva” in the event more than one baby of the same gender has the same last name, and adding a third name such as the father’s given name or the mother’s middle name if there is the likelihood of two or more patients on the ward with the same given and surname. Organizations that allow different identifiers to be used in different care areas or scenarios, must ensure that the process is consistent in these circumstances, for example, o A patient’s name and date of birth are used in verbal interactions with the patient on the ward; these same two identifiers must be used in all verbal interactions with the patient o A patient’s name and identification number or medical record number are used during the time-out for surgical/invasive procedures, to label specimens, or to report diagnostic tests, and the like; these same two identifiers must be used in all similar circumstances. Patients are identified before providing treatments, performing procedures, before any diagnostic procedures, and before any other treatments, cares, or interventions intended for a specific patient; this includes labeling any treatments and medications intended for a specific patient, for example, CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE o Blood samples and pathology samples o Dietary trays o Expressed mother’s milk Measurable Elements of IPSG.1 ❑ 1. The hospital uses at least two patient identifiers, that do not include the use of the patient’s room number or location in the hospital, to identify the patient and to label elements associated with the patient’s care and treatment plan. ❑ 2. The hospital identifies patients with at least two identifiers before performing diagnostic procedures, providing treatments, and performing other procedures. ❑ 3. The hospital ensures the correct identification of patients in special circumstances, such as the comatose patient or newborn who is not immediately named. Goal 2: Improve Effective Communication Standard IPSG.2 The hospital implements a process for reporting critical results of diagnostic tests. Intent of IPSG.2 Patient harm can result when critical results of diagnostic tests are not reported and acted upon in a timely manner. Guidance for IPSG.2 A critical result is defined as a variance from normal range that represents a pathophysiologic state that is high-risk or life-threatening, is considered urgent or emergent, and in which immediate medical action is likely necessary to preserve life or prevent a catastrophic event. This is different from an abnormal result, which is defined as a result that is outside of the expected range for the test but is not an urgent or emergent life threat. It is also important to distinguish between critical tests (the diagnostic tests themselves, some of which hospitals may define as being critical by nature) and critical test results (meaning the outcome of any diagnostic test that indicates a very serious or life-threatening condition). The standard and measurable elements are concerned with critical test results (outcomes) from any diagnostic test, and these critical result parameters and the response to them must be established by the hospital. For example: the hospital may define a critical result for potassium levels as being below 2.5 mmol/L or above 6.0 mmol/L, indicating potentially life-threatening hypokalemia or hyperkalemia. Hospital health care practitioners may consider a result to be very serious in some clinical situations where the result is not in the defined critical range, such as a mildly low potassium level in the setting of digitalis toxicity. However, those clinical decisions are separate from the purposes of compliance with this standard, which requires the hospital to formally define the parameters of absolute critical ranges for tests, as in the example of critical potassium levels above, and establish a procedure for reporting and response. Diagnostic tests include all tests, such as laboratory, imaging, and cardiac diagnostics. Critical results may also be produced from any diagnostic tests performed at the bedside, such as point-of-care blood testing, portable imaging, and 12-lead electrocardiograms. Diagnostic tests that produce defined test results that may indicate a threat to life are different from continuous electronic monitoring, such as cardiac telemetry, continuous EEG (electroencephalogram) monitoring, or fetal monitoring. Continuous electronic monitoring is a clinical assessment tool used to detect changes in the patient’s condition over time that may identify a threat to life but is not designed to produce a defined critical result. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE A formal reporting system is used throughout the hospital that clearly identifies how critical results of diagnostic tests are communicated to health care practitioners and how the information is documented and acted upon. The objective is to provide the critical results within an established time frame so that the responsible licensed health care provider can evaluate its significance and act upon the results within a defined time frame. The organization must identify tests that may have critical results and educate clinical staff on what these tests are and how to recognize a critical result. The organization should implement a protocol that describes how critical results are recognized, documented, and communicated to the provider responsible for the patient’s care, and the time frames for reporting and responding to critical results. This should include how to proceed when the individual performing the test is also the individual responsible for interpreting and responding to the test, for example, when a cardiologist performs and interprets the 12-lead electrocardiogram on the patient they are treating, or when the same practitioner who performs the test is the same practitioner who is treating the patient. In addition to clearly identifying how results are communicated and the required time frame for doing so, the organization must implement a protocol that describes how the treating practitioner is expected to respond and in what timeframe. The hospital must then monitor compliance with the above protocols and time frames for critical results and act when negative trends are observed, or adverse events occur. Measurable Elements of IPSG.2 1. The hospital defines critical test results that may represent urgent or emergent life-threatening values for diagnostic tests. 2. The hospital develops a formal reporting process that identifies how critical results of diagnostic tests are reported/communicated to health care practitioners and the expected timeframe for reporting and acting upon the critical results. 3. The hospital identifies what critical result information is documented in the medical record. 4. The hospital monitors the timeframe for reporting and acting upon critical results, and documents actions taken when timeframes are not met. Standard IPSG.2.1 The hospital implements a standardized process for handover communication. Intent of IPSG.2.1 Breakdowns in communication can occur during any handover of patient care and can result in patient safety events. Guidance for IPSG.2.1 Handover communications can also be referred to as handoff communications. Handovers of patient care within a hospital occur: between health care practitioners (for example, physician to physician, physician to nurse, nurse to nurse, and so on); between different levels of care in the same hospital (for example, when the patient is moved from an intensive care unit to a medical unit or from an emergency department to the operating theatre); from inpatient units to diagnostic or other treatment departments, such as radiology or physical therapy; and between staff and patients/families, such as at discharge. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Interruptions and other distractions from unit activities can inhibit clear communication of important patient information. Standardized, critical content and processes for communication between the patient, family, caregiver, and health care team can significantly improve the outcomes related to handovers of patient care. Standardized forms, tools, or methods support a consistent and complete handover process. The content of the handover communication and the form, tool, or method used are standardized for the type of handover. The handover process may be different for different types of handovers within the hospital. For example, handovers of patient care for the emergency department to a medical ward may require a different process or different content than handovers from the operating theatre to the intensive care unit; however, the handovers are standardized for the type of handover occurring. Safe practices for effective communication include the following: Use of standardized, critical content and processes for communication between the patient, family, health care practitioner, and others involved in the patient’s care during handovers of patient care Use of standardized methods, forms, or tools to facilitate consistent and complete handovers of patient care The handover process must allow for the participants to have an opportunity to clarify information during the handover process, by providing the opportunity to ask questions, or for discussion between the giver and the receiver of information. However, it is acceptable for the discussion to take place outside of in-person interactions, such as by phone, text, or other communication format. Handover forms or tools, if used by the hospital, are not required to be part of the medical record. In addition, the detailed information communicated during the handover is not required to be documented in the medical record; however, the hospital may want to have documentation that the handover occurred. For example, the health care practitioner would record that he or she completed the handover and to whom he or she transferred responsibility for care, and then sign, date, and time the entry. Measurable Elements of IPSG.2.1 ❑ 1. The hospital implements a standardized procedure to communicate critical information between health care practitioners during handovers of patient care. ❑ 2. The hospital uses standardized forms, tools, or methods that support a consistent and complete handover process that includes the opportunity for all staff involved to clarify information and ask questions. ❑ 3. The hospital collects, analyzes, tracks and trends data for patient safety events related to handovers. Goal 3: Improve the Safety of Medications Standard IPSG.3 The hospital implements a process to improve the safety of high-alert medications. Intent of IPSG.3 High-alert medication errors can lead to patient injury or death and potentially additional costs associated with caring for these patients. Guidance for IPSG.3 CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE The Institute for Safe Medication Practices (ISMP) defines high-alert medications as “... drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.” The most frequently cited examples of high-alert medications include insulin, opioids, chemotherapeutic agents, antithrombotic agents, anticoagulants, thrombolytics, medications with a narrow therapeutic range (for example, digitalis), neuromuscular blocking agents, and epidural or intrathecal medications. Examples of lists of high-alert medications are available from organizations such as ISMP and WHO. For safe management, the hospital needs to develop its own list(s) of high-alert medications based on its unique utilization patterns of medications its own internal data about near misses (or close calls), medication errors and sentinel events safety issues published in professional literature. The list includes medications identified as high risk for adverse outcomes. Information from the literature and/or Ministry of Health may also be useful in helping to identify which medications should be included. This list is updated at least annually. The list may need to be updated more frequently if there are additions or changes to hospital services, patient populations, or new medications added to the hospital formulary that are deemed high risk. Some high alert medications/categories (such as neuromuscular blockade medication) have their own specific set of risks in addition to those that exist based on the high alert category alone. Strategies to prevent harm should be based on the specific risk profile of that medication/category, in that case. Some high alert medications may not require additional strategies in addition to the standardized strategies adopted by the hospital. It is up to the hospital to determine when a tailored strategy in addition to standardized measures is necessary. For example: neuromuscular blockade medications can be inadvertently retrieved from refrigerated storage when stored along with other refrigerated medications. An example of a strategy to mitigate this risk is to store neuromuscular blockade agents segregated from other medications, such as in lidded containers, with prominent warning labels on the container and the medications inside. Other examples are chemotherapy agents, due to the complexity of medication orders and protocols, and properties of some of the medications such as those that can cause tissue necrosis when extravasation occurs. Examples of strategies for those medications include chemotherapy ordering protocols, use of central lines for administration, patient monitoring protocols during administration, and readily available extravasation kits. A specific example of a high-alert medication best practice identified by ISMP relates to the dispensing of vincristine (and other vinca alkaloids) in a minibag of a compatible solution and not in a syringe. Significant adverse events resulting in severe neurological damage and often death have occurred from the inadvertent administration of vinca alkaloids via the intrathecal route. In organizations in which vinca alkaloids are dispensed in a minibag, there have been no reported cases of accidental administration of a vinca alkaloid by the intrathecal route. This best practice is supported by ISMP The Joint Commission and Joint Commission International the World Health Organization (WHO), the American Society of Clinical Oncology (ASCO), the Oncology Nursing Society (ONS), and the National Comprehensive Cancer Network. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE However, the overall process for managing high alert medications must still be standardized throughout the hospital, such as standard high alert medication labeling and requiring a double-check process. The examples of additional tailored risk mitigation strategies should be in addition to the hospital’s standardized process. Additional guidance for this is explained below. The hospital must educate clinical and technical staff handling high-risk medication on the standardized process, the risks related to each medication, and the risk mitigation strategies for each medication. The hospital must develop a list of high-alert medications stocked and used in the hospital. The list of high-alert medications must be Up to date, and reviewed at least annually, and when new medications are added to the formulary known by clinical staff, and accompanied by robust, well-developed risk reduction strategies that decrease the risk of errors and minimize harm. Strategies should be applicable to all hospital departments and services, and sustainable over time. According to the ISMP, examples of these are: Standardizing processes associated with ordering, storage, preparation, and administration of these medications Improving access to information about these drugs Limiting access to high-alert medications Using additional labels and automated alerts Building redundancies into the medication management process such as automated or independent double checks, fail-safe methods such as pumps with locking mechanisms, and reducing available options, such as limiting available concentrations of the same medication The hospital’s risk mitigation interventions must be evident in the overall medication management program, and in the clinical areas where these medications are used. For example, IV heparin used in neonatal intensive care units may require different safety strategies than IV heparin in the emergency department, and this should be evident in those areas. However, general strategies such as special labels for high alert medications and a double-check process must be standardized throughout the hospital to avoid confusion. Measurable Elements of IPSG.3 ❑ 1. The hospital identifies in writing its list of high-alert medications ❑ 2. The hospital implements a risk mitigation strategy for reducing the risk of harm from high-alert medications that is uniform throughout the hospital and, in addition, includes tailored strategies for specific medications when necessary. ❑ 3. The hospital reviews and, as necessary, revises its list of high-alert medications annually at minimum. Standard IPSG.3.1 The hospital implements a process to improve safety of look-alike/sound-alike (LASA)medications. Intent of IPSG.3.1 Medications which have similar product packaging or with names that sound similar, can easily be confused by healthcare practitioners and may lead to potentially harmful medication errors. Guidance for IPSG.3.1 CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Look-alike/sound-alike (LASA) names are medicine names that look or sound the same as other medicine names when written or spoken. Look-alike medicine packaging refers to medicine containers or primary packaging that looks like that of another medicine. There are many medication names that sound or look like other medication names; for example, dopamine and dobutamine both sound alike and the printed names may also look alike in some languages such as English. Confusing names are a common cause of medication errors throughout the world. Contributing to this confusion are: incomplete knowledge of drug names; newly available products; similar packaging or labeling; similar clinical use; and illegible prescriptions or misunderstanding during issuing of verbal orders. Hospitals must institute risk management strategies to avoid confusion with LASA medications and enhance patient safety. The hospital must determine which medications require safeguards to prevent LASA related confusion that can cause errors. Strategies should include but are not limited to: Using both the brand and generic names on prescriptions and labels Including the medication’s purpose on the prescriptions Configuring safeguards in computerized medication ordering systems to require a minimum number of letters, such as at least five letters, when health care practitioners are searching for a medication Changing the appearance of look-alike medication names, for example: using “TALLman lettering” on labels such as DOBUTamine and DOPamine or oxyBUTYnin and oxyCONTIN The hospital should also stay updated on emerging strategies to prevent LASA errors when applicable and when available resources allow, for example: Configuration of computer selection screens and drop-down menus in prescription systems to prevent LASA names from appearing adjacent to each other. Automated dispensing by means of electronic devices and serialization technology. Use of a closed-loop system with barcode technology to enhance the readability of look-alike labels. Consideration of potential LASA errors when reordering stock or making purchasing decisions. The hospital should keep its list of LASA medications updated regularly, as new medications are approved or trade names of drugs change. The risks for LASA related errors are not limited to prescribing and dispensing. Other strategies to prevent LASA errors include avoiding storage of these medications in close proximity to each other, where a healthcare practitioner could inadvertently retrieve the wrong one for dispensing or administration. The hospitals’ process should also include a mechanism to evaluate whether a LASA risk exists when the hospital must substitute medications to address shortages, for example, when substituting another brand of medication that has packaging similar to a different medication in the existing formulary, or which has a different trade name from the original that is similar to another medication. The hospital should implement a comprehensive approach to LASA medication management, from the point of medication stock ordering where decisions are made regarding brands (trade names of medications, label appearances), throughout the continuum to the staff who handle and administer them. Measurable Elements of IPSG.3.1 ❑ 1. The hospital identifies in writing its list of look-alike/sound-alike medications. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE ❑ 2. The hospital implements a process for managing look-alike/sound-alike medications that is comprehensive and uniform throughout the hospital. ❑ 3. The hospital reviews and revises, when necessary, its list of look-alike/sound-alike medications annually at minimum. Standard IPSG.3.2 The hospital implements a process to manage the safe use of concentrated electrolytes. Intent of IPSG.3.2 The incorrect or unintentional administration of concentrated electrolytes can be deadly errors, and the most effective means to reduce or to eliminate these occurrences is to implement a process for managing concentrated electrolytes. Guidance for IPSG.3.2 Concentrated electrolytes are vials of concentrated forms of electrolytes that require dilution or other preparation before IV administration. These include but are not limited to: potassium chloride, potassium phosphate, sodium chloride, magnesium sulfate. Concentrated electrolytes should not be available as unit stock on any patient care units (including in operating room/anesthesia regular stock) as much as is possible given the pharmacy capabilities. It is important to distinguish that the standard excludes concentrated forms of electrolytes such as 3-5% saline for infusion, because it is already diluted and prepared for infusion rather than being stocked in vials that require dilution before administration. Electrolytes should not be dispensed in their concentrated form to patient care units for individual patients. The exceptions to this recommendation are for vials contained in a cardiac surgery kit or a cardiac surgery locked storage area and available only to the operating team, magnesium sulfate contained in emergency carts, or in areas where patients with preeclampsia may be treated (labor and delivery, emergency department, or intensive care unit), and concentrated sodium in areas treating patients who may suffer from increased intracranial pressure (intensive care unit, emergency department, and operating room), and other special areas and circumstances defined by the hospital policy and procedures. The hospital can use labeling practices to decrease the risk of inadvertent administration of concentrated electrolytes, when it is possible for a single vial to be removed or transported from an open bin, box, or container. The individual vial must be labeled in addition to the storage container. Only qualified and trained individuals should have access to these vials. Wherever concentrated electrolytes are stored, they must be clearly labeled with appropriate warnings (for example, CONCENTRATED electrolyte—Dilute before administration) and segregated from other medications. Administration of electrolyte replacement therapy for hypokalemia, hyponatremia, and hypophosphatemia is safest when standardized guidelines and/or protocols with prediluted electrolytes (such as 20mEq of Potassium Chloride in 100cc of normal saline) are used, and the dispensing or handling of concentrated electrolyte vials on the patient care units is prohibited. Measurable Elements of IPSG.3.2 ❑ 1. Only qualified and trained individuals have access to concentrated electrolytes, and they are labeled with appropriate warnings and segregated from other medications throughout the storage and dispensing process. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE ❑ 2. The hospital only stores vials of concentrated electrolytes outside of the pharmacy for emergency situations or specific purposes and these are clearly identified in hospital policy. Goal 4: Ensure Safe Surgery Standard IPSG.4 The hospital implements a process for the preoperative verification and surgical/invasive procedure site marking. Intent of IPSG.4 Wrong-patient, wrong-site, and wrong-procedures or surgery present a risk for significant patient safety events that result in patient injury. Guidance for IPSG.4 Wrong-patient, wrong-site, and wrong-procedure surgery events can result from ineffective or inadequate communication between members of the team performing the surgical or invasive procedure. The following are common risk factors for the above: lack of a standardized process for marking the procedure site, Use of materials or media that can easily be removed, such as tape, or ink that washes off during the skin preparation process, lack of patient involvement in the site marking inadequate patient assessment, inadequate medical record review, a culture that does not support open communication among team members, problems related to illegible handwriting, and the use of abbreviations Surgical and invasive procedures include all procedures involving an incision or puncture, including, but not limited to, open surgical procedures, percutaneous aspiration, selected injections, biopsy, percutaneous cardiac and vascular diagnostic or interventional procedures, laparoscopies, and endoscopies. Organizations need to identify all areas within the hospital where surgical and invasive procedures take place; for example, the cardiac catheterization lab, interventional radiology department, gastrointestinal lab intensive care or critical care units The approach the hospital takes to ensuring safe surgery applies to all areas of the hospital in which surgical and invasive procedures occur. The (US) Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery™ is based in part on the principle of using multiple strategies to achieve the goal of always identifying the correct patient, correct procedure, and correct site. The essential elements of the Universal Protocol are CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE the preoperative verification process; marking the surgical site; and the time-out is held immediately before the start of the procedure. Preoperative Verification Process Preoperative verification is an ongoing process of information gathering and confirmation. The purpose of the preoperative verification process is to verify the correct patient, procedure, and site; ensure that all relevant documents, images, and studies are available, properly labeled, and displayed; and verify that any required blood products, special medical equipment, and/or implants are present. Marking the Site Marking the surgical/invasive site involves the patient and is done with an instantly recognizable and unambiguous mark. Ideally, an “X” is not used as the mark as it may be interpreted as “not here” or “wrong side” and could potentially lead to errors in patient care, as well as other ambiguous marks such as a line or a dot. The mark must be consistent throughout the hospital. The site is marked in all cases involving laterality, multiple structures (fingers, toes, lesions), or multiple levels (spine). The (US) Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery™ is based in part on the principle of using multiple strategies to achieve the goal of always identifying the correct patient, correct procedure, and correct site. The essential elements of the Universal Protocol are the preoperative verification process; marking the surgical site; and the time-out that is held immediately before the start of the procedure Preoperative Verification Process There are various elements of the preoperative verification process that can be completed before the patient arrives at the preoperative area—such as ensuring that documents, imaging, test results, and paperwork are properly labeled and match the patient’s identifiers. Waiting until the time-out to complete the preoperative verification process may unnecessarily delay surgery if paperwork or imaging are not labeled or available when surgery is about to begin. It is more likely that portions of the preoperative verification may occur more than once and in more than one place. For example, the surgical informed consent may be obtained in the surgeon’s office, and then verification that it has been completed may take place in the preoperative holding area. Marking the Surgical Site Marking of the surgical site can be performed in the Preoperative Holding Area, Day Surgery Unit (DSU) and in patient units, prior to entering the operating/ procedure room by a physician who will be participating during the entire procedure. In cases of surgical procedures, the surgeon responsible typically performs the surgery and therefore would mark the site. There are different titles used for the responsible surgeon, such as attending or consulting surgeon. For nonsurgical invasive procedures, it may be a general physician who will do the procedure. The hospital should identify who is authorized to perform surgical site marking in policy and procedure, or medical staff governing documents. There are circumstances when a trainee or other authorized designee may perform the site marking—this is when the trainee performs the entire procedure, requiring minimal or no supervision from the responsible surgeon or physician. In these circumstances, the trainee marks the surgical site. When a trainee is in the role of assisting the surgeon or physician responsible, only the surgeon or physician may perform the site marking. The site marking may take place any time before the surgical/invasive procedure begins, as long as the patient is actively involved in the site marking whenever possible and the mark is visible after the patient is prepped and draped. Examples of when patient participation may not be possible include: patients who are not competent to make health care decisions, CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE children, and patients requiring emergent surgery. The hospital has a procedure for identifying the correct site in cases where site marking may cause harm, such as premature infants, or when a patient refuses site marking. The site mark must be located where it will be visible after draping of the surgical site, so that it can be verified during the final time out. Measurable Elements of IPSG.4 ❑ 1. The hospital implements a preoperative verification process using a checklist or other mechanism to document that includes verification that: a) the informed consent is appropriate to the procedure; b) the correct patient, correct procedure, and correct site are verified; c) and that all required documents, blood products, medical equipment, and implantable medical devices are on hand, correct, and functional. ❑ 2. The hospital uses an instantly recognizable and unambiguous mark for identifying the surgical/invasive site that is consistent throughout the hospital. ❑ 3. The surgical/invasive site marking process includes: a) marking is done by the person performing the procedure b) involving the patient in the marking process c) alternative site-marking process for cases where marking may result in harm d) alternative site-identification process for patients who refuse site-marking e) alternative site marking techniques for situations where routine site-marking is not possible (e.g., laser, stereotactic radiosurgery, dental, etc.) should be defined in the policy. Standard IPSG.4.1 The hospital implements a process for a time-out that is performed immediately prior to the start of the surgical/invasive procedure and the sign-out that is conducted after the procedure. Intent of IPSG.4.1 The time-out allows any unanswered questions or confusion to be resolved and provides a final opportunity to identify potential errors such as wrong site surgery, surgery on the wrong patient, or the wrong surgical procedure on the right patient. The sign-out process after surgery allows for identification of areas needing improvement, and discussion of what went well during the surgery to assist the hospital in making decisions about overall surgery processes. Guidance for IPSG.4.1 The time-out process applies to all surgical and nonsurgical invasive procedures. Evidence indicates that procedures that place the patient at the most risk include those that involve general anesthesia or deep sedation, although other procedures may also affect patient safety. Hospitals can enhance safety by correctly identifying the patient, the appropriate procedure, and the correct site of the procedure. The time-out requirement is based on the following principles: Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented. A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success. To the extent possible, the patient and, as needed, the family are involved in the process. Consistent implementation of a standardized protocol is most effective in achieving safety. The time-out is implemented most successfully in hospitals with a culture that promotes teamwork and where all individuals feel empowered to protect patient safety. A hospital should consider its culture when designing processes to meet the time-out requirement. In some hospitals, it may be necessary to be more prescriptive on certain elements of the Universal Protocol or to create processes that are not specifically addressed within these requirements. Hospitals should identify the timing and location of the preprocedural verification and site marking based on what works best for their own unique circumstances. The frequency and scope of the preprocedural verification will depend on the type and complexity of the procedure. The three components of the Universal Protocol are not necessarily presented in chronological order (although the preprocedural verification and site marking precede the final verification in the time-out). Preprocedural verification, site marking, and the time-out procedures should be as consistent as possible throughout the hospital. The purpose of the time-out is to conduct a final assessment to ensure that the correct patient, site, and procedure are identified. This requirement focuses on those minimum features of the time-out. Some believe that it is important to conduct the time-out before anesthesia for several reasons, including involvement of the patient. A hospital may conduct the time-out before anesthesia or may add another time-out at that time. During a time-out, activities are suspended to the extent possible so that team members can focus on active confirmation of the patient, site, and procedure. A designated member of the team initiates the time-out, and it includes active communication among all relevant members of the procedure team. The procedure is not started until all questions or concerns are resolved. The time-out is most effective when it is conducted consistently across the hospital. Time-Out The time-out is held immediately before the start of the procedure with all team members present. During the time-out, the team agrees on the following components: Correct patient identity (Also see IPSG.1) Correct procedure to be done Correct surgical/invasive procedure site The time-out is conducted in the location at which the procedure will be done where the patient is present and involves the active participation of the entire team. The patient does not have to participate in the time-out. Completion of the time-out is documented and includes the date and time the time-out was completed. The hospital determines the amount and type of any additional documentation. If the leading physician must leave the room, for example, in a long or multi-part surgery, a complete handover to the responsible physician must occur and include components of the time-out. This activity must be documented. Sign-Out The WHO Surgical Safety Checklist includes a sign-out process, which is conducted in the area where the procedure was performed before the patient leaves. The following components of the sign-out are verbally confirmed by a member of the team, typically a nurse: Name of the surgical/invasive procedure that was recorded/written Completion of instrument, sponge, and needle counts (as applicable) Labeling of specimens (when specimens are present during the sign-out process, labels are read aloud, including patient name) CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Any equipment problems to be addressed (as applicable) What went well, any problems noted, with follow-up interventions through quality improvement activities as necessary. Measurable Elements of IPSG.4.1 ❑ 1. The full team actively participates in a time-out process, which includes the following elements in the area in which the surgical/invasive procedure will be performed, immediately before starting the procedure and this is documented: a) Correct patient identity b) Correct procedure to be done c) Correct surgical/invasive procedure site ❑ 2. Before the patient leaves the area in which the surgical/invasive procedure was performed, a sign-out process is conducted, which includes at least the following: a) Name of the surgical/invasive procedure that was recorded/written b) Completion of instrument, sponge, and needle counts, as applicable c) Labeling of specimens d) Any equipment problems to be addressed, as applicable ❑ 3. When surgical/invasive procedures are performed, including medical and dental procedures done in settings other than the operating theatre, the hospital uses uniform processes to ensure safe surgery. ❑ 4. When two or more separate procedures are being performed on the same patient by different surgeons, the team must perform another time-out before each new procedure is initiated. Goal 5: Reduce the Risk of Health Care–Associated Infections Standard IPSG.5 The hospital implements evidence-based hand-hygiene guidelines to reduce the risk of healthcare-associated infections. Intent of IPSG.5 Proper hand hygiene is central to the elimination of hospital-associated and other infections. Guidance for IPSG.5 Evidence-based hand-hygiene guidelines are available from the World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), and various other national and international organizations. The hospital must adopt and implement current evidence-based hand-hygiene guidelines. This includes efforts to standardize hand hygiene compliance data collection, and ensure the data are valid, such as use of trained observers. Resources from the WHO and CDC include resources for training hand hygiene observers. Hand-hygiene guidelines should be posted in appropriate areas, and staff should be educated in proper handwashing and hand-disinfection procedures. Soap, running water, disinfectants, and single-use towels are located in those areas where handwashing and hand-disinfecting procedures are required. Air dryers are not used to dry hands in patient care areas. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Measurable Elements of IPSG.5 ❑ 1. The hospital adopts current evidence-based hand-hygiene guidelines. ❑ 2. The hospital implements an evidence-based hand-hygiene program throughout the hospital. ❑ 3. The hospital collects and analyzes data for compliance with Handwashing and hand-disinfection procedures in accordance with evidence-based hand-hygiene guidelines throughout the hospital. Goal 6: Reduce harm caused by diagnostic errors Standard IPSG.6 The hospital implements processes to reduce harm caused by diagnostic errors. Intent of IPSG.6 Diagnostic errors are one of the leading causes of preventable harm in health care, and hospitals have a responsibility to minimize harm to their patients by identifying and addressing causes of diagnostic errors. Guidance for IPSG.6 Diagnostic errors are diagnoses that are missed, wrong, or delayed as detected by subsequent definitive test findings. According to the Society of Diagnostic Medicine, A delayed diagnosis refers to a case where the diagnosis should have been made earlier. Delayed diagnosis of cancer is by far the leading entity in this category. A wrong diagnosis occurs, for example, if a patient truly having a myocardial infarction is told their pain is from acid indigestion. The original diagnosis is found to be incorrect because the true cause is discovered later. A missed diagnosis refers to a patient whose medical complaints are never explained. Many patients with chronic fatigue, or chronic pain fall into this category, as well as patients with more specific complaints that are never accurately diagnosed. Diagnostic errors were found to make up 17% of preventable errors in patients in one study (Harvard). Another study (Johns Hopkins) found that the most common diagnostic errors were related to vascular events, cancer, and infections. These are also the largest cause of medical malpractice claims. The causes of diagnostic errors are complex, and rarely due to the fault of an individual clinician or staff member. Factors leading to diagnostic errors include diagnostic complexity, breakdowns in communication or care coordination, lost test results, equipment malfunctions, availability of specialty clinicians, and cognitive errors or bias. An example of cognitive error/bias is a patient with a chronic pain diagnosis such as neck pain, who presents to an emergency department with complaints of neck pain and is treated according to the chronic pain diagnosis, but the characteristics of the patient’s pain differs from previously documented complaints and is due to another cause such as an acute myocardial infarction. Closed-loop communication is an essential method to reduce diagnostic errors, and it means every test result is always sent, received, acknowledged, and acted upon. This requires care coordination throughout the continuum to hand off test results, interpret the results, and communicate them in language patients can understand. Implementing a closed-loop communication process requires a number of interventions, such as redesigning communication processes, improving patient engagement, establishing data-driven measures to monitor and act on diagnostic results communication on an ongoing basis, and evaluating patient outcomes. The following can improve communication of test results: Identify workflows and processes that are at risk for mishandling of test results and implement procedures with redundancies to ensure test results are received by someone responsible for the affected patient's care, and that CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE errors will be more likely to be caught early. These procedures should address handovers of information between clinicians and care transitions between clinical settings. Establish standardized processes to ensure timely communication of abnormal test results to a clinician responsible for follow-up care. Notify patients of life-threatening test results through verbal means and ensure it was received and understood by the patient. Implement a process to escalate to an alternate responsible health care practitioner any abnormal test result that remains unacknowledged after a pre-specified time period. Ensure that test results are communicated to a back-up provider in a timely fashion if the ordering provider is not available. The necessary timeliness is dependent on the significance of the test result. Optimize health information technology (IT) capabilities to communicate test results. Health IT can be used to automate the abovementioned actions and help measure effectiveness. However, IT systems should not be the only method of communication of abnormal test results to responsible health care practitioners and patients (see also third bullet point above). Closing the follow-up loop may be affected by several non-technical factors, including user behaviors, EHR usage practices, policies, training, organizational factors and workflow. Improve patient portal(s) to help patients access test results and better track their medical histories. While many patients find the portals confusing and lacking important context for test results, there are some ways to improve them, including: Ensure the portal is accessible on both large-format computers and hand-held devices. Provide and promote patient access to EHRs, optimally including real time clinical notes and diagnostic testing results. Explain the test results directly in the portal. Provide patients easy access to support services as needed for action and follow up. Give patients personalized or contextual information to help them understand what to do with the results. Create consensus and standards on timing and best practices for the portal’s release of normal and abnormal test results. However, communication with patients about abnormal test results must still include verbal communication (see third bullet point above). Clinicians should not assume their patients will make use of online portals. Some patients may be uncomfortable or unfamiliar with online portals and would prefer direct person-to-person communication. Clinicians should not rely solely on portals to communicate abnormal test results and should contact their patients directly when action is necessary. It is a strongly recommended practice to communicate all test results, normal and abnormal, to patients to avoid a “no news is good news” assumption on the part of patients. Areas of focus for diagnostic errors include: Screening and diagnostic radiology Pathology Laboratory (infectious disease/microbiology, newborn disease screenings – including metabolic disorders, and results indicative of disease processes with or without signs and symptoms) Care coordination (delayed communication – other health care practitioners and patients, patient return after having been seen, patient appointments, Measurable Elements of IPSG.6 1. The hospital leaders conduct a data-driven and risk-based assessment to identify at least one priority diagnostic area of focus annually a) Radiology CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE b) Pathology c) Laboratory/Microbiology d) Care Coordination 2. The hospital conducts an intensive analysis for causes of diagnostic error in the selected focus area(s). 3. The hospital implements evidence-based interventions based on data analysis with the intent to improve the diagnostic area(s) of focus. 4. The hospital evaluates the effectiveness of the intervention(s) for improvement of the diagnostic area(s) of focus. 5. The hospital educates and supports clinical staff on diagnostic errors that includes at minimum: a) The definition of diagnostic error b) The causes of diagnostic errors c) Time frames for responses and follow up d) Procedure to report diagnostic errors e) Clinical education and resources when cognitive errors are involved in diagnostic errors f) A “no blame” and “learning” culture with systems focus when diagnostic errors occur 6. The hospital tracks and trends diagnostic errors on an ongoing basis and adjusts areas of focus as needed based on the data. 7. The hospital defines a time period for acknowledgment of abnormal diagnostic results by a responsible health care practitioner that is monitored on an ongoing basis. 8. The hospital establishes a mechanism for escalation of abnormal test results to an alternate provider when the defined time period for acknowledgement is exceeded that is monitored on an ongoing basis. References Patient Identification de Souza Gomes APT, et al. The importance of newborn identification to the delivery of safe patient care. Cogitare Enfermagem. 2017 Jul;22(3):e49501. https://doi.org/10.5380/ce.v22i3.49501. ECRI Institute. ECRI Institute PSO Deep Dive: Patient Identification: Executive Summary. Aug 2016. Accessed Jan 3, 2020. https://assets.ecri.org/PDF/Deep-Dives/Deep-Dive-Patient-ID-Exec-Summary.pdf. ECRI Institute. Patient Identification Errors. Jun 2016. Accessed Jan 3, 2020. https://www.ecri.org/Resources/HIT/Patient%20ID/Patient_Identification_Evidence_Based_Literature_final.pdf. ECRI Partnership for Health IT and Patient Safety. Health IT Safe Practices: Toolkit for the Safe Use of Health IT for Patient Identification. Feb 2017. 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Accessed Jan 3, 2020. https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_17_Oct_2015_10_20_15.pdf. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE Effective Communication Buurman BM, et al. Improving handoff communication from hospital to home: The development, implementation and evaluation of a personalized patient discharge letter. Int J Qual Health Care. 2016 Jun;28(3):384–390. https://doi.org/10.1093/intqhc/mzw046. Desai KN, Chaudhari S. Analysis of critical values in NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited hematology and clinical pathology laboratory. Annals of Applied Bio-Sciences. 2017 Feb 14;4(1): A-14–A-18. https://doi.org/10.21276/AABS.2017.1317. Nasarwanji MF, Badir A, Gurses AP. Standardizing handoff communication: Content analysis of 27 handoff mnemonics. J Nurs Care Qual. 2016 Jul–Sep;31(3):238–244. https://doi.org/10.1097/NCQ.0000000000000174. Patton LJ, et al. Ensuring safe transfer of pediatric patients: A quality improvement project to standardize handoff communication. J Pediatr Nurs. 2017 May–Jun;34:44–52. https://doi.org/10.1016/j.pedn.2017.01.004. Starmer AJ, et al. Effects of the I-PASS handoff bundle on communication quality and workflow. BMJ Qual Saf. 2017 Dec;26(12):949–957. https://doi.org/10.1136/bmjqs-2016-006224. The Joint Commission. Inadequate hand-off communication. Sentinel Event Alert, Issue 58. Sep 12, 2017. Accessed Jan 3, 2020. https://e- handoff.com/wp-content/uploads/2017/09/Joint-Commision-Handoff-Communication-Alert.pdf. High-Alert Medications Ferracini FT, et al. Using positive deviance to reduce medication errors in a tertiary care hospital. BMC Pharmacol Toxicol. 2016 Aug 7;17(1):36. https://doi.org/10.1186/s40360-016-0082-9. Institute for Safe Medication Practices. ISMP List of High-Alert Medications in Acute Care Settings. 2018. Accessed Jan 3, 2020. https://www.ismp.org/sites/default/files/attachments/2018-08/highAlert2018-Acute-Final.pdf. Tyynismaa L, et al. Identifying high-alert medications in a university hospital by applying data from the medication error reporting system. J Patient Saf. Epub 2017 Jun 1. doi: https://doi.org/10.1097/PTS.0000000000000388. World Health Organization (2019). Medication Safety in High-Risk Situations. 2019. Accessed Jan 3, 2020. https://apps.who.int/iris/bitstream/handle/10665/325131/WHO-UHC-SDS-2019.10-eng.pdf?ua=1. Safe Surgery Brussa D, et al. Safe surgery for all: Early lessons from implementing a national government-driven surgical plan in Ethiopia. World J Surg. 2017 Dec;41(12):3038–3045. https://doi.org/10.1007/s00268-017-4271-5. Carbral RA, et al. Use of a surgical safety checklist to improve team communication. AORN J. 2016 Sep;104(3):206–216. https://doi.org/10.1016/j.aorn.2016.06.019. Jain D, Sharma R, Reddy S. WHO Safe Surgery Checklist: Barriers to universal acceptance. J Anaesthesiol Clin Pharmacol. 2018 Jan– Mar;34(1):7–10. Ragusa PS, et al. Effectiveness of surgical safety checklists in improving patient safety. Orthopedics. 2016 Mar–Apr;39(2):e307–e310. https://doi.org/10.3928/01477447-20160301-02. World Health Organization. Surgical Safety Checklist. (Updated: Jan 1, 2009.) Accessed Jan 3, 2020. https://apps.who.int/iris/bitstream/handle/10665/44186/9789241598590_eng_Checklist.pdf?sequence=2. Health Care–Associated Infections Cassini A, et al. Burden of six healthcare-associated infections on European population health: Estimating incidence-based disability- adjusted life years through a population prevalence-based modelling study. PLOS Med. 2016 Oct 18;13(10):e1002150. https://doi.org/10.1371/journal.pmed.1002150. Sickbert-Bennett EE, et al. Reduction of healthcare-associated infections by exceeding high compliance with hand hygiene practices. Emerg Infect Dis. 2016 Sep;22(9):1628–1630. https://doi.org/10.3201/eid2209.151440. World Health Organization. Clean Care Is Safer Care: The Evidence for Clean Hands. Accessed Jan 3, 2020. https://www.who.int/gpsc/country_work/en. Zingg W, et al. Hospital organisation, management, and structure for prevention of health-care-associated infection: A systematic review and expert consensus. Lancet Infect Dis. 2015 Feb;15(2):212–224. https://doi.org/10.1016/S1473-3099(14)70854-0. Erratum in: Lancet Infect Dis. 2015 Mar;15(3):263. https://doi.org/10.1016/S1473-3099(15)70069-1. CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE New References 8th Edition Diagnostic Safety and Quality | Agency for Healthcare Research and Quality (ahrq.gov) Safety recommendations to address diagnostic errors | The Joint Commission Harnessing Event Report Data to Identify Diagnostic Error During the COVID-19 Pandemic | The Joint Commission Quick Safety 52: Advancing safety with closed-loop communication of test results | The Joint Commission Quick Safety 28: Cognitive biases in health care | The Joint Commission https://www.ncbi.nlm.nih.gov/books/NBK555525/ https://www.improvediagnosis.org/what-is-diagnostic-error/ https://psnet.ahrq.gov/primer/diagnostic-errors https://www.uptodate.com/contents/diagnostic-errors chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://apps.who.int/iris/bitstream/handle/10665/252410/9789241511636-eng.pdf https://academyhealth.org/blog/2023-02/translating-research-practice-recommended-practices-hospitals-reduce-diagnostic-errors https://www.leapfroggroup.org/news-events/preventing-patient-harm-and-death-diagnostic-errors-new-leapfrog-report-identifies-29 https://www.ahrq.gov/topics/diagnostic-safety-and-quality.html https://www.improvediagnosis.org/news_posts/the-administration-and-congress-agree-reducing-harm-from-diagnostic-error-is-an-urgent-patient-safety- priority/ https://www.qualityforum.org/ProjectDescription.aspx?projectID=90704 Add reference for additional LASA stratgies content: Lizano-Díez et al. BMC Health Services Research (2020) 20:63 CONFIDENTIAL PROPOSED REQUIREMENTS FOR FIELD REVIEW PURPOSE ONLY DO NOT COPY – DO NOT DISTRIBUTE