The operating rooms (ORs) are subject to several standards set by governmental and private not-for-profit agencies. Accreditation by these agencies is a way through which a healthcare organization is recognized as offering quality healthcare that meets established standards. This chapter provides a brief history of Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) and the influence of their standards on the perioperative arena.
The Joint Commission
Almost a century ago in 1919, minimum standards for hospitals were developed by the American College of Surgeons (ACS), as a result of Dr. Earnest A. Codman’s vision for standardization based on “end result” of treatment. Over the next 30 years, the quality of care in the hospitals improved, and more than 3,200 US hospitals approved and embraced these standards. In 1951, ACS collaborated with the American College of Physicians, American Medical Association, America Hospital Association and the Canadian Medical Association to form the Joint Commission on Accreditation of Hospitals (JCAH). In 1952, ACS formally transferred their Hospital Standardization Program to JCAH and accreditation process began in 1953. As the scope of JCAH expanded, it was renamed in 1987 as the Joint Commission for Accreditation of Health Care Organizations (JCAHO), which was then shortened to The Joint Commission in 2007 [1].
In 1965, the Congress passed the Social Security Amendments with a provision that hospitals accredited by JCAH were “deemed” to be in compliance with most of the Medicare Conditions of Participation for Hospitals. This gave the commission authority and power to determine whether a healthcare organization would be eligible to receive Medicare reimbursement. Over the years, TJC standards have improved and expanded to hold hospitals to optimal standards rather than minimal standards. All TJC standards are compiled in the Comprehensive Accreditation Manual for Hospitals (CAMH) [2]. There are more than 250 standards that pertain to patient safety and quality of care. These standards are divided into chapters for each accreditation program, for example the Hospital Accreditation program has 19 chapters. TJC assesses both processes and outcomes during their inspection, the philosophy being that good processes lead to favorable outcomes and not all outcomes are easily measurable. TJC surveys are random and unannounced and held at least once every 39 months.
The Centers for Medicare and Medicaid Services
In 1965, President Lyndon Johnson signed the Social Security Act, and Medicare and Medicaid were enacted as Title XVIII and Title XIX of this act. As a result health coverage was extended to almost all Americans aged 65 or older, low-income children deprived of parental support, the elderly, the blind, and individuals with disabilities. In 1966 when Medicare was implemented and more than 19 million individuals enrolled. In 1977, the government established Health Care Financing Administration (HCFA) which was responsible for the Coordination of Medicare and Medicaid. In 2001, HCFA was renamed Centers for Medicare and Medicaid Services to reflect increased emphasis on responsiveness to beneficiaries and providers, and on improving the quality of care that the beneficiaries received [3].
CMS establishes Conditions of Participation (CoP) for all facilities that participate in the Medicare and Medicaid programs. CoPs are first published in the Federal register and subsequently the standards with interpretive guidelines and survey procedures are published in the State Operations Manual (SOM) for certification of hospitals [4].
All facilities participating in the Medicare and Medicaid programs are required to undergo an initial CMS inspection, followed by surveys on a regular basis to ensure compliance with Federal health and safety standards. CMS contracts with state agencies to conduct these inspections. If any deficiencies are found during the initial certification or recertification process, the facility has to bear the full cost of a revisit survey to ascertain that corrective action has been implemented. Initially, TJC was given authority by Congress to determine whether hospitals met the requirements for Medicare reimbursement. In 2008, this automatic authority was eliminated. Since July 2010, TJC’s accreditation program is required to meet all CMS standards.
With a few exceptions, the majority of the CMS and TJC standards apply directly or indirectly to the OR. The OR managers have to familiarize themselves with these standards and establish policies and procedures to ingrain these standards into the daily practice and culture of the OR environment. Discussion of all applicable standards is beyond the scope of this chapter. Instead, chapter gives a broad overview of some of the standards as they apply to the OR suite. The reader is encouraged to look up the SOM and the CAMH for details and also be aware that the standards and interpretive guidelines are subject to periodic change and updates [5].
CMS and TJC Standards in the OR
Patient Rights
CMS and TJC have standards that protect and promote patients’ rights. Many of these standards apply throughout the perioperative period including the right to privacy, confidentiality of medical records, the right to participate in decisions about their care, treatment and services, and the right to receive safe care (CMS §482.13; TJC RI.01.01.01, EC.01.01.01-EP3,EP4, IM.02.01.01). Informed consent process is a right that the patients or their representatives may need to exercise after receiving adequate information and disclosures about anticipated benefits, risks and alternative therapies. Federal and state laws or regulations set minimum requirements for informed consent (CMS §482.24(c)(2)(v)). Hospitals are required to have policies and procedures that also protect the patient’s right to request or refuse a procedure or treatment.
Per CMS and TJC standards, Medical staff is responsible for determining which procedures or treatments require informed consent. Due to the procedural nature of the OR, the physicians and staff taking care of operative patients should be aware of the policies that apply when documenting various forms of informed consent particularly, consent for surgery and anesthesia, consent for transfusion of blood or blood products, consent for producing images or recordings of the procedure for purposes other than patient care, consent for participation in perioperative research and clinical trials. TJC and CMS inspections of the perioperative area include determining the proper execution of informed consent.
Although not directly applicable to the OR, restraints are used on rare occasions in the postanesthesia care unit (PACU). CMS and TJC require that hospitals have policies regarding the use of restraints including documenting the rationale for use, using least restrictive interventions, age specific monitoring, early discontinuation, staff training and reporting requirements (CMS §482.13(e); TJC PC.03.05). The PACU staff must be appropriately trained and be aware of the policies and procedures that apply to the use of restraints.
Surgical Services
Scope and Standards for Surgical Services
CMS recommends ACS definition of surgery and requires that the hospitals have appropriate organization, equipment and qualified personnel to ensure the health and safety of the patient (CMS §482.51; TJC LD.03.06.01, IC.01.01.01). Accreditation survey generally includes observation of practices in the inpatient and outpatient OR suites for adherence to acceptable standards of practice. Acceptable standards of practice include recommendations by nationally recognized professional organizations (ACS, American Medical Association, American Society of Anesthesiologists, Association of Operating Room Nurses, etc.), federal agencies and state regulations. The needs of the population should guide the types surgical services provided directly or through referral and agreements (CMS §482.51(b); TJC LD.04.03.01). Policies governing surgical care, including postoperative care (CMS §482.51(b)(4)) should be designed to achieve the highest standard of clinical practice. CMS interpretive guidelines for standard §482.51(b) in SOM provides a comprehensive list of policies governing surgical care which OR staff could be asked about during survey.
Provider Qualifications and Scope of Practice
Per CMS, the OR supervisor has to be a Registered Nurse, Doctor of Medicine, or Doctor of Osteopathy. Both TJC and CMS require that the hospital determines the appropriate qualifications for OR supervisors and is able to provide surveyors with a position description with required qualifications (CMS §482.51(a)(1), TJC HR.01.02.01). Per CMS regulations, all scrub and circulatory duties performed by technologists or licensed practical nurses must be supervised by a qualified registered nurse (CMS §482.51(a)(2), §482.51(a)(3); TJCPC.03.01.01-EP5).
The process of privileging and credentialing of all practitioners including surgeons, is a function of organized medical staff and is subject to surveyor review (TJC MS.03.01.01, MS.06.01.07, MS.06.01.09). TJC requires that information from ongoing professional practice evaluation be factored into the decision to maintain privileges (TJC MS.08.01.03). A current roster of each practitioner’s privileges must be maintained in the OR suite and at the request of the surveyors, the OR staff must be able to demonstrate how to check a practitioner’s privileges (CMS §482.51(a)(4)).
Patient Assessment and Documentation Requirements
This section pertains to CMS standard §482.51(b)(1). TJC standards also reflect CMS requirements for patient assessment and documentation (PC.01.02.03-EP4 and EP5, MS.03.01.01-EP6, RC.01.03.01-EP3 and EP4). According to these standards, prior to surgery or administration of anesthesia, a medical history and physical exam must be completed and documented and should be timed and dated no more than 30 days before or 24 h after admission (or registration). If the medical history and physical exam is completed and documented within 30 days prior to admission, an updated physical exam must be completed and documented within 24 h of admission. These standards apply to all cases even if surgery occurs within 24 h of admission the only exception being emergencies. Survey procedures include a review of patient’s medical records to confirm compliance with these standards.
TJC requires that the operative report written or dictated before the patient leaves the operative suite for the next level of care, unless accompanied by the practitioner to the next area of care where it can be completed. It is common practice for surgeons to write a brief operative summary immediately after the surgery, in which case a detailed report can be completed and authenticated in a timeframe specified by the hospital (CMS §482.51(b)(6)), RC.02.01.03-EP 5 and EP 6). The surgeons should be aware of the minimum requirements of an operative report. Generally a review of approximately six surgical reports is performed during CMS surveys to verify it includes specified information and is signed and dated by the surgeon. These standards were prevalent when this chapter was written and the reader is advised to look for the most recent updates.
Informed Consent for Surgery
CMS and TJC specify minimal requirements for informed consent policy (CMS §482.51(b)(2), TJC RI.01.03.01). A properly executed surgical consent is required to be patient’s medical record prior to surgery. The only exception to this regulation is emergency surgery to save a patient’s life or limb. Appropriate documentation in the patient’s medical record by the surgeon is considered acceptable under most circumstances, however different approaches may be used depending on the local regulations and hospital policy.
Since most surgeries are performed under anesthesia, CMS recommends that the hospitals extend their surgical consent policy to include anesthesia. CMS and TJC recommend that hospitals have policies for handling Do-Not-Resuscitate (DNR) in the perioperative period. Since survival and functional outcome of resuscitation in the OR differs greatly from resuscitation on the hospital wards, and automatic upholding or discontinuation of DNR is no longer practiced. American Society of Anesthesiologists’ Ethical Guidelines for the Anesthesia Care of Patients with Do-Not-Resuscitate Orders or Other Directives That Limit Treatment recommend that a discussion should transpire before surgery and that DNR orders be revised to allow intubation and resuscitation that would constitute a part of administering anesthesia (ACS and AORN guidelines formulated later also reflect ASA standards) [6]. Any modification to existing DNR order should be made in accordance to the patient’s goals and values and documented in the patient’s medical record.
Anesthesia Services
Scope and Standard of Anesthesia Services
Standards on anesthesia services are perhaps among the most complex and controvertible, and the interpretive guidelines have undergone several updates. The scope of anesthesia services was expanded in December 2009 into two categories: (1) anesthesia including general, regional, and monitored anesthesia care, and (2) analgesia and sedation with increased emphasis being on ability to rescue if level of sedation became deeper than intended. CMS requires that anesthesia services throughout the hospital, including all off-site locations, be organized into a single service under the direction of a doctor of medicine or doctor of osteopathy (CMS §482.52). Services provided should be consistent with the needs of the hospital. Anesthesia services policies must designed to ensure the delivery of care is consistent with recognized standards (for example, ASA standards) and address important issues pertaining to staff responsibilities, documentation and reporting requirements, protocol for supportive life functions, patient safety and consent issues.
Qualifications and Scope of Practice
The hospital’s policies and procedures must define the circumstances when a nonanesthesiologist MD or DO can administer or supervise anesthesia services, for example procedural sedation as determined by the state scope of practice law. Medical staff bylaws must specify criteria for obtaining and maintaining sedation privileges. The type and complexity of procedures for which each individual practitioner who may administer anesthesia must be specified in his or her privileges (CMS §482. 22(c)(6), TJC MS.03.01.01-EP 2). Providers with sedation privileges should have credentials for rescuing patients from various levels of sedation (TJC MS.06.01.01-EP1). CMS requires supervision of anesthesiologist’s assistants and certified registered nurse anesthetists while providing anesthesia services, by an anesthesiologist who is available to furnish assistance and direction (or supervision in case of a CRNA) throughout the performance of the procedure (CMS §482.52 (a), TJC PC.03.01.01). CRNA supervision by an anesthesiologist is not obligatory in states that have opted out of the CRNA supervision requirement (CMS §482.52 (a)(c)).
Patient Assessment and Documentation Requirements
In February 2011, Anesthesia CoPs were updated to align preoperative assessment and documentation with standards for surgical services. According to these standards, prior to administration of anesthesia, a preanesthesia evaluation must be completed and documented no more than 30 days prior to procedure requiring anesthesia; however, certain elements of the history, risk assessment, physical exam and discussion of risks and benefits have to be completed within a 48-h time frame before administering anesthesia (CMS §482.52(b)(1), TJC PC.03.01.03-EP8 and EP 18). Per CMS standards, preanesthesia evaluation can only be performed by a practitioners qualified to administer anesthesia (CMS §482. 52(a)).
Postoperative evaluation should be performed by a practitioner qualified to administer anesthesia, and completed within 48 h of the patient being moved to the designated recovery area. The postoperative evaluation is performed after the patient has sufficiently recovered from anesthesia (CMS §482.52(b), TJC PC.03.01.07-EP1, EP2, EP7, EP8). The 48-h timeframe for postoperative evaluation also applies to outpatients unless state law and hospital policy specify more stringent standards. CMS, TJC, and the American Society of Anesthesiologists specify minimal requirements for preanesthesia evaluation, anesthesia intraoperative documentation and postanesthesia evaluation [7]. Accreditation surveys generally include review of anesthesia records to verify that current documentation standards are met. Due to frequent updates to anesthesia standards, the reader is advised to check for latest updates.
TJC’s National Patient Safety Goal
The National Patient Safety Goal (NPSG) was developed by the Patient Safety Advisory Group of TJC in 2002. The goal was to help accredited hospitals address most challenging patient safety issues. The NPSG that apply to the perioperative environment are summarized below. Where CMS or TJC has corresponding or related standards, a reference is to the standard is provided. NPSG is revised annually and new goals may be added.
Identify patients correctly
NPSG.01.01.01: Use at least two patient identifiers when providing care, treatment, and services. This also applies to labeling of blood samples and specimens.
NPSG.01.03.01: Eliminate transfusion errors related to patient misidentification. This NPSG requires two-person (qualified per hospital policy and state law) verification that the blood component matches to the order and patient, with one verifier being the transfusionist.
Improve communication
Safe use of medication
NPSG.03.04.01: Label all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings. Recommendations for labeling include medication name, strength, quantity, diluent and volume (if not apparent from the container), expiration date when not used within 24 h expiration time or when expiration occurs in less than 24 h. Two-person verification is required when the medication is not prepared by the person administering it. This safety goal also requires that medications be reviewed by entering and exiting staff.
NPSG.03.05.01: Reduce the likelihood of patient harm associated with the use of anticoagulant therapy. Perioperatively, this standard requires use of approved protocols for the initiation, maintenance and monitoring of anticoagulant therapy and use of infusion pump when heparin is administered continuously.
NPSG.03.06.01: Maintain and communicate accurate patient medication information. Transferring accurate medication information is critical in the perioperative period where several handoffs can occur during the episode of care.
Other medication safety standards in the OR are discussed under a separate section in this chapter.
Alarm System Safety
NPSG.06.01.01: Improve the safety of clinical alarm systems. This standard requires the use of clinically appropriate alarms and set parameters to improve patient safety. Policies and procedures should be established for alarm management and should address issues like designating authority to change alarm parameters, periodic checking of alarm settings and alarm function.
Prevent infection
NPSG.07.01.01: Comply with either the current CDC hand hygiene guidelines or the current WHO hand hygiene guidelines. The standard requires implementation of a hospital-wide goal-based hand hygiene improvement program (TJC IC.01.04.01-EP5, IC.03.01.01-EP3).
NPSG.07.03.01: Implement evidence-based practices to prevent healthcare-associated infections due to multidrug-resistant organisms in acute care hospitals. The standard requires implementation of policies and practices that apply organization-wide as well as to the perioperative environment, aimed at reducing the risk of transmitting multidrug-resistant organisms. This includes targeted risk assessment, surveillance programs, provider and patient’s family education, and reporting outcome data to stakeholders.
NPSG.07.04.01: Implement evidence-based practices to prevent central line-associated bloodstream infections. Per this standard, the policies and practices aimed at reducing the risk of central line-associated bloodstream infections must be implemented and complied with. These policies and practices must be aligned with state and national regulatory requirements and professional organization guidelines. Some provisions in this NPSG are the use of standardized supply cart or kit that contains all necessary components for the insertion of central lines, use of standardized protocol for hand hygiene, aseptic skin prep and sterile barrier precautions, use of a standardized protocol to disinfect catheter hubs and injection ports before accessing them, and avoiding femoral vein for central line insertion unless other sites are unavailable.
NPSG.07.05.01: Implement evidence-based practices for preventing surgical site infections. Elements of performance include implementation of educational, preventive and surveillance strategies. This goal requires measurement of surgical site infection rates for up to 30 or 90 days following surgical procedures based on National Healthcare Safety Network procedural codes.
CMS condition of participation §482.42 on Infection control, requires that healthcare-associated infection prevention be a part of the hospital-wide infection control program. Hospitals that employ alcohol-based skin preparations in anesthetizing locations are required to have appropriate policies and procedures to reduce the associated risk of fire. Failure to implement appropriate measures to reduce the risk of fires associated with the use of alcohol-based skin preparations in anesthetizing locations is considered a condition-level noncompliance.
NPSG.07.05.01: Prevent indwelling catheter-associated urinary tract infections. This goal applies to adult patients only and requires using evidence-based criteria for perioperative placement of indwelling urinary catheters. Examples include critically ill patients who need accurate urinary output measurements, prolonged duration of surgery, patients anticipated to receive large volume infusions, and patients undergoing urologic surgery of the genitourinary tract.
Universal Protocol
The Universal Protocol focuses on eliminating all wrong-person, wrong-site, and wrong-procedure events with the consistent use of a standardized checklist type protocol. It applies to all surgical as well nonsurgical invasive procedures that expose patients to more than minimal risk. It includes the following three standards.
UP.01.01.01: Conduct a preprocedure verification process. This NPSG requires implementation of a preprocedure protocol to verify the correct procedure, for the correct patient, at the correct site, with patient involvement if possible. Use of a standardized list to verify at a minimum relevant documentation (for example, history and physical, signed procedure consent form, nursing assessment, and preanesthesia assessment), diagnostic and radiology test results, and any special requirements, matched to the patient.
UP.01.02.01: Mark the procedure site. The standard requires marking of procedure site, side and level if applicable, before the procedure is performed, and with patient involvement if possible. Marking should preferably be done by a licensed practitioner who is accountable for the procedure and will be present when the procedure is performed. If hospital policy allows, a designated qualified practitioner may perform site marking to meet this standard. The mark should be visible after skin prep and draping. Exceptions for site marking include mucosal surfaces, perineum, teeth, premature infants and patient refusal.
UP.01.03.01: A time-out is performed before the procedure. This requires performing a standardized time out immediately before the procedure, initiated by a designated member of the team. The members of the procedural team should agree on at least three elements: correct patient, correct site, procedure to be done. The completion of the time out should be documented.
Medication Safety
Medication safety presents a unique challenge in the OR environment. Medication errors are amongst the most common errors in anesthesia because of the practice where an anesthesia provider orders, dispenses and administers a drug, and monitors the patient in the absence of double checks and other safety measures taken when medications are ordered and administered on the hospital wards. Twelve out of 20 medications categories designated as “high-alert medications” by Institute for Safe Medication Practices are commonly stocked in anesthesia carts [8]. Appropriate safeguards must be in place to prevent errors with the use of risky medications especially ones that are in look-alike containers, are highly concentrated and those that may need dilution before administration (TJC MM 01.02.01). ASA statement on Labeling of Pharmaceuticals for the Use in Anesthesiology recommends color coded, legible labels consistent with American Society for Testing and Materials International and the International Organization for Standardization. The purpose is to enhance visual features in accordance with human factors to prevent errors of syringe swaps [9].
CMS and TJC standards require all noncontrolled medications to be locked when a patient care procedural area is not staffed by a healthcare professional (CMS §482.25(b)(2)) [10]. Medications listed in Schedules II–V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be locked and accurate records of the disposition of all controlled substances must be maintained (CMS §482.25(b)(2)(ii), §482.25(a)(3), TJC MM.01.01.03) by the hospital pharmacy. The hospitals are required to have policy and procedures for reporting diversion, managing recalls and expired drugs, and reporting errors and adverse reactions through a hospital-wide medication safety program (CMS §482.25(b) (6)(7)(8), TJC MM.07.01.03). The professional staff must have access to Information relating to drug indications, interactions, side effects, toxicology, dosage, and routes of administration 24 h a day, 7 days a week (CMS §482.25(b)(8), TJC IM.03.01.01).
In the PACU, verbal orders must be minimized to avoid medication errors, and should be authenticated promptly according to state law or hospital policy (CMS§482.24(c)(1)(iii), TJC RC.02.03.07-EP4).
Environmental and Occupational Safety
Physical Environment and Facilities
Most standards in CMS CoP §482.41 Physical Environment apply to the OR environment and pertain not only to physical construction and planning of the perioperative areas but also to emergency preparedness plans and capabilities to ensure patient safety and well-being (TJC Life Safety Standards). All hospitals participating in Medicare are required to comply with Life Safety Code requirements of the National Fire Protection Association (NPFA), unless State fire and safety codes are more stringent and protect patients adequately (CMS §482.41(b), TJC EC.02.03.01). Operating and recovery rooms are required to have emergency power and lighting (CMS§482.41(a) (1), TJC EC.02.05.03, NPFA 101, 2000 edition). The OR must have a fire response and evacuation plan as a part of the larger hospital plan (CMS §482.41(b)(7) TJC EC.02.05.07). All new staff must be oriented to fire safety and must know how to contain fire, use the fire extinguisher and evacuate safely. The staff should be able to describe the key safety steps if asked by TJC surveyor.
Infection Control and Occupational Safety
CDDC has published extensive guidelines for infection control in case of both nosocomial and occupational acquired infections [11, 12]. Occupational Safety and Health Administration in section IV off its manual addresses several occupational hazards in healthcare facilities and recommends preventive measures [13]. Exposure to blood-borne pathogens, laser use and laser smoke, multidrug resistant organisms, surgical instruments/equipment and anesthesia equipment in the OR make it a unique and high-risk environment for infection control. American Society of Anesthesiologists’ recommendations for infection control and AORN guidelines are specifically directed to the Perioperative environment [14, 15].
Quality Assurance and Performance Improvement
TJC and CMS identify the OR as a high-risk area and require that the anesthesia and surgical services be a part of the organization-wide quality assurance performance improvement program (QA/PI). QA/PI activities that apply to the perioperative environment are broadly categorized below.
Data Collection
Leaders are the motivating force behind quality driven organizations and CMS requires hospital leaders (governing body) to set priorities and determine the detail and frequency of data collection for performance improvement activities. Data collection sources can include a variety of sources like patient charts, staff, observation, interviews etc. to identify vulnerable areas and direct performance improvement activities. Priority is given to high-volume, high-risk, or problem-prone processes, perioperative processes being amongst them (TJC PI. 01.01.01). Participation in Medicare requires data collection in the following procedural areas:
Surgery and other procedures that place patients at risk of disability or death
Significant discrepancies between preoperative and postoperative diagnoses
Adverse events related to using moderate or deep sedation or anesthesia.
The use of blood and blood components
All reported and confirmed transfusion reactions
Results of resuscitation
Significant medication errors
Significant adverse drug reactions
Patient perception of the safety and quality of care, treatment, and services
TJC also recommends data collection on staff opinions and needs, staff perceptions of risk to individuals, their suggestions for improving patient safety and willingness to report adverse events.
Data Compilation and Analysis
Statistical analysis and display of data helps in trending and identification of opportunities for improvement. TJC requires that any undesirable trends or variation should include staffing analysis (TJC recommends use of National Quality Forum Nursing Sensitive Measures). Organization-wide safety programs must establish a method of communicating critical information to hospital leaders, so that prompt actions can be taken to resolve any problems identified (Box 30.1).
Box 30.1. Emergency Management Standards by JCAHO
1. Develop a management plan that addresses emergency management. Four phases of emergency management are:
mitigation
preparedness
response
recovery
2. Perform a health vulnerability analysis
Establish emergency procedures in response to a hazard vulnerability analysis
Define the organization’s roles with other community agencies
Notify external authorities
Notify hospital personnel when emergency procedures initiated
Assign available personnel to cover necessary positions
The following activities must be managed:
. . . patient/resident activities;
. . . staff activities.
Staff /family support
Logistics of critical supplies
Security
Evacuation of facility, if necessary
Establish internal/external communications
Establish orientation/education programs
Monitor ongoing drills and real emergencies
Determine how an annual evaluation will occur
Provide alternate means of meeting essential building and utility needs
Identify radioactive and biological isolation decontamination needs
Clarify alternate responsibility of personnel
3. Involve community-wide response
4. Reestablish and continue operations after disaster
Ongoing Performance Improvement
As quality measures evolve, healthcare organizations need to be able to adapt and prioritize performance improvement opportunities. CMS and TJC in particular, evaluate healthcare facilities’ care processes that enhance safety and produce the best outcomes for their patients. Ever since TJC adopted the its mission of “continuously improve healthcare for the public, in collaboration with other stakeholders, by evaluating healthcare organizations and inspiring them to excel in providing safe and effective care of the highest quality and value,” the cramming mentality before an inspection has become a phenomenon of the past. Instead, TJC standards set benchmarks that accredited institutions must meet or exceed on a continued basis. Creating a culture of safety through leadership involvement, organization-wide safety programs, education of the staff, effective communication of changes and safety tips to frontline providers and visible evidence of safe practices through posters and pocket cards can help achieve and maintain accreditation.
References
Introduction
As healthcare and technology progress, the need for anesthesia services escalates both in and out of the operating room (OR). Ideally, individuals with the most training and experience with sedation would administer it. Owing to the high volume of cases that require sedation, however, many nonanesthesiologists are providing this service. Today, sedation is administered by both anesthesia professionals (anesthesiologists, certified registered nurse anesthetists, and anesthesiologist assistants) and nonanesthesia professionals (physicians, dentists, registered nurses, physician assistants, etc.). Generally, sedation is optimal for procedures that are quick and/or noninvasive (Table 31.1). Although general anesthesia can be performed for every procedure that could otherwise be done with sedation, sedation is preferred by many patients and healthcare providers. Depending on the knowledge and experience of the person providing sedation, sedation may offer a quicker recovery time and may be less invasive compared with general anesthesia.
Table 31.1 Examples of Procedures Performed under Moderate Sedation Under the Direction of Non-Anesthesia Practitioners
| Head and neck | Superficial thoracic | Extremity procedures | Gastrointestinal/ abdominal | Vascular | Gynecologic/urologic | Emergency department/ radiology |
|---|---|---|---|---|---|---|
| Dental extractions | Breast augmentation | Carpal tunnel release | Endoscopic retrograde cholangiopancreatography | Hemodialysis access placement | Dilatation and curettage | Reduction of dislocation or fracture |
| Blepharoplasty | Breast biopsy | Trigger finger release | Colonoscopy | Pacemaker insertion | Fulguration of vaginal lesions | Complex suturing |
| Rhytidoplasty | Bronchoscopy | Removal of pins/wires/screws | Endoscopic ultrasound | Angiography | Fulguration of anal lesions | Insertion of elective chest tube |
| Rhinoplasty | Chest tube insertion | Closed reduction | Gastroscopy | Cardiac catheterization | Cystoscopy | MRI |
| Laceration | Radiofrequency ablation | Incision and drainage of Bartholin’s cyst | Arteriograms | |||
| Cataract | Electrophysiologic testing | Vasectomy | Liver biopsy |
Advances in interventional medicine have allowed procedures, which typically took place in the OR, to be performed outside of the OR (OOOR). Nowadays procedures done with sedation, both in the OR and OOOR, are increasing in complexity, and the patients receiving these procedures are having more comorbidities. Despite this, many patients receiving sedation do not necessarily require the presence of an anesthesiologist. The American Society of Anesthesiologists’ (ASA) Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals states that “only physicians, dentists, or podiatrists who are qualified by education, training, and licensure to administer moderate sedation should supervise the administration of moderate sedation.” The ASA Statement on Granting Privileges to Nonanesthesiologist Supervising Deep Sedation by Individuals Who Are Not Anesthesia Professionals states that “due to a significant risk that patients who receive deep sedation may enter a state of general anesthesia, privileges to administer deep sedation should be granted only to practitioners who are qualified to administer general anesthesia or to appropriately supervise anesthesia professionals.” The aforementioned ASA statements address education, training, licensure, supervision, performance evaluation, and improvement requirements for a sedation program involving nonanesthesia providers [1–3]. Although the ASA guidelines are generally supported by most regulatory agencies, there are many other professional societies that have their own standards and guidelines on procedural sedation (see Appendix: Professional Guidelines and Standards). For example, the American Nurses Association’s Procedural Sedation Consensus Statement states that procedural sedation medications can be administered by a Registered Nurse (RN) only in the presence of a physician, advanced practiced registered nurse or other healthcare professional qualified and trained for procedural sedation.
Definitions of Sedation
It is important to realize that sedation and general anesthesia are on a continuum. There are different levels of sedation, but they can easily blend with one another and evolve into general anesthesia. Each patient responds differently to sedation medications, and thus, even if the healthcare practitioner intended on delivering moderate sedation, a deep sedation or even a general anesthetic can occur. The ASA defines sedation levels according to responsiveness, airway, spontaneous ventilation, and cardiovascular function (Table 31.2). According to the ASA, there are three levels of sedation, which culminate in general anesthesia [4].
Minimal sedation – this is primarily done for anxiolysis. Patients respond normally to verbal commands, are able to maintain a patent airway, are spontaneously breathing and have an unchanged cardiovascular system.
Moderate sedation – this was previously known as “conscious sedation.” It is a drug-induced state in which there is a depression of consciousness. However, patients still have a purposeful response to verbal commands, plus or minus light tactile stimulation. Patients continue to maintain a patent airway without any intervention and have adequate spontaneous ventilation. The cardiovascular system is usually unchanged.
Deep sedation – consciousness is depressed significantly and patients require repeated or painful stimuli to evoke a purposeful response. An intervention may be required for patients to maintain a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually unchanged.
General anesthesia – consciousness is lost and patients are unarousable even to painful stimulation. Patients often need assistance in maintaining a patent airway and with ventilation, as this is frequently inadequate. Positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.
Table 31.2 Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia
| Minimal sedation | Moderate sedation/analgesia (conscious sedation) | Deep sedation/analgesia | General anesthesia | |
|---|---|---|---|---|
| Responsiveness | Normal | Purposefula response to verbal or tactile stimulation | Purposefula response after repeated or painful stimulation | Unarousable even with painful stimulus |
| Airway | Unaffected | No intervention required | Intervention may be required | Intervention often required |
| Spontaneous ventilation | Unaffected | Adequate | May be inadequate | Frequently inadequate |
| Cardiovascular function | Unaffected | Usually maintained | Usually maintained | May be impaired |
a Reflex withdrawal from a painful stimulus is not considered a purposeful response.
Clinically there is not a clear distinction between the levels of sedation and because the levels of sedation can quickly progress into general anesthesia, the ASA standard is that healthcare providers should be able to rescue patients from any level of sedation and return them to the original intended level of sedation.
Preprocedure Evaluation
Before the procedure, it is imperative to review the patient’s medical history, preprocedure labs, diagnostic tests and physically examine the patient. This includes reviewing nil per os status, medications and drug allergies, previous anesthesia and/or sedation experiences, and health problems. It is critical to recognize the comorbidities that place a patient at higher risk for sedation; these comorbidities include, but are not limited to, morbid obesity, extremes of age, sleep apnea, and an anticipated difficult airway. Patients with multiple systemic comorbidities (ASA physical status III–V; see Box 31.1) also are at an increased risk for complications (Table 31.3). The presence of these factors should prompt an anesthesiology consult. The physical examination portion should include obtaining the patient’s height, weight, and baseline vital signs along with assessing the airway. The ability to identify a potentially difficult airway is essential. Lastly, before giving any sedation medications, one must ensure that appropriate consents have been completed.
Box 31.1. ASA Physical Status Classification System
| ASA physical status I | A normal healthy patient |
| ASA physical status II | A patient with mild systemic disease |
| ASA physical status III | A patient with severe systemic disease |
| ASA physical status IV | A patient with severe systemic disease that is a constant threat to life |
| ASA physical status V | A moribund patient who is not expected to survive without the operation |
| ASA physical status VI | A declared brain-dead patient whose organs are being removed for donor purposes |
Table 31.3 Medication Chart
| Drug | Sedational amnesia | Anxiolysis | Analgesia | Route/dose | Onset (min) | Peak (min) | Duration (min) | Comments |
|---|---|---|---|---|---|---|---|---|
| Sedative/hypnotics* | ||||||||
| Midazolam (Versed) | Yes | Yes | No | IV: 0.5–1 mg (titrate to effect up to 5–10 mg/h) | 0.5–1 | 3–5 | 10–30 | Minimal cardiorespiratory depression |
| IM: 0.08 mg/kg | 10–15 | 20–45 | 60–120 | Reduce dose when used in combination with opioids | ||||
| Midazolam is benzodiazepine of choice for short procedures | ||||||||
| Antagonist: flumazenil | ||||||||
| Diazepam (Valium) | Yes | Yes | No | IV: 2–3 mg (titrate to effect up to 15 mg) | 1–2 | 8–15 | 15–45 | |
| PO: 5–10 mg | 30–60 | 45–60 | 60–100 | |||||
| Lorazepam (Ativan) | Yes | Yes | No | IV: 0.25 mg (titrate to effect up to 2 mg) | 1–2 | 15–20 | 60–120 | |
| PO: 2–4 mg | 60–120 | 120 | >480 | |||||
| Opioids* | ||||||||
| Fentanyl | No | No | Yes | IV: 28–50 μg intermittent boluses | 1–2 | 5 | 30–40 | Respiratory depression decreased |
| Meperidine (Demerol) | No | No | Yes | IV: 2.5–75 mg | 3–5 | 5–7 | 63–180 | Response to hypercarbia and hypoxia |
| Synergistic sedative and respiratory depressant effects (reduce dose with sedatives) | ||||||||
| Nausea, vomiting | ||||||||
| Meperidine: histamine release | ||||||||
| Antagonist: naloxone | ||||||||
| Reversal agents (antagonists) | ||||||||
| Flumazenil (Anexate) | No | No | No | IV: 0.1–0.2 mg (titrate to effect to max of 5 mg) | 1–2 | 5–10 | 45–90 | Short-acting, repeat doses may be required |
| Avoid in patients receiving benzodiazepines for seizure control | ||||||||
| Caution with chronic benzodiazepine therapy (withdrawal effect) or with tricyclic antidepressants | ||||||||
| Naloxome (Narcan) | No | No | No | IV: 0.02–1.04 mg (titrate to effect) | 1–2 | 2–3 | 30–60 | Short-acting, repeat doses may be required |
| May cause hypertension and tachycardia | ||||||||
| Pulmonary edema reported | ||||||||
* Alterations in dosing may be indicated based upon the clinical situation and the practitioner’s experience with these agents. Individual dosages may vary depending on age and coexistent diseases. Doses should be reduced for sicker patients and in the elderly. When using drug combinations, the potential for significant respiratory impairment and airway obstruction is increased. Drugs should be titrated to achieve optimal effect, and sufficient time for dose effect should be allowed before administering an additional dose or another medication.
Monitors and Equipment
Once sedation has started, proper monitoring of the patient’s oxygenation, ventilation, circulation, and level of consciousness must be continually assessed; therefore, it is necessary for the person administrating sedation to be present throughout the entire procedure and to have no other responsibilities. Oxygenation is monitored via continuous pulse oximetry, and every patient should receive supplemental oxygen. Supplemental oxygen along with pulse oximetry can prevent and detect hypoxemia, but neither is ideal for the identification of hypoventilation, airway obstruction, or apnea. In fact, supplemental oxygen can mask problems with ventilation. Ventilation is monitored by continuously observing patient chest movement, evaluating airway patency, and auscultating breath sounds. The ASA Standards for Basic Anesthetic Monitoring state that “During moderate and deep sedation the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure, or equipment” [5]. Capnography can significantly aid in monitoring ventilation and alerts sedation providers to hypoventilation/apnea much more quickly than clinical observation alone. Evaluation of circulation is done via continuous electrocardiogram and measuring blood pressure at least every 5 min; circulation can also be assessed by palpating pulses and auscultating heart sounds. A patient’s level of consciousness is easily monitored by talking to and/or stimulating the patient. The ASA Standards for Basic Anesthetic Monitoring also state that, “Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected” [5]. Although not every procedure done with sedation will require the monitoring of temperature, sedation providers should be cognizant of when it is needed. Before every procedure, it is necessary to ensure the availability of monitors and equipment and that they are functioning correctly (Box 31.2). Despite this, monitors can malfunction at any time during the procedure; thus, no monitor is more valuable than the vigilant healthcare provider.
Medications
An important aspect of safely providing sedation is knowing the pharmacologic profiles of the common medications used. Although a plethora of medications exist that will provide sedation and/or analgesia, the agents most commonly used are benzodiazepines and opioids (Table 31.3). Both are easily titratable and their actions can be mitigated by reversal agents. Because benzodiazepines and opioids are commonly given together, one must acknowledge that their actions and side effects are synergistic and must be careful to avoid oversedation and/or respiratory depression. Although benzodiazepines lack analgesic properties, they are anxiolytics, anticonvulsants, sedatives, and amnestics.
Box 31.2. Equipment Needed for Moderate and Deep Sedation
Oxygen source
Airway equipment – including a self-inflating oxygen delivery system capable of delivering 100 percent oxygen
Suction source with suction catheters
Pulse oximeter with audible alarms
Cardiac monitor with audible alarms
Blood pressure device and stethoscope
Capnography
Emergency cart and defibrillator
Medications to be used for the procedure and their reversal agents
Fluid bags of either 0.9 percent normal saline or lactated Ringer’s solution
Of the benzodiazepines, midazolam is very popular because of its quick onset, short duration of action, and favorable hemodynamic profile. In situations of oversedation, flumazenil is the reversal agent for benzodiazepines. It is usually given in increments of 0.2 mg and is titrated to effect (i.e., desired level of consciousness). It has a quick onset and a half-life shorter than most benzodiazepines; thus, to avoid resedation, flumazenil may have to be administered more than once.
Unlike benzodiazepines, opioids are primarily analgesics. Opioids are administered to prevent and alleviate pain and as an adjunct to sedatives/hypnotics, such as benzodiazepines. Of the opioids, fentanyl is very popular because of its quick onset, short duration of action, and favorable hemodynamic profile. In situations of undesired respiratory depression or excessive sedation, naloxone is the reversal agent for opioids. It is usually given in increments of 0.04 mg and is titrated to effect (i.e., respiratory rate over eight breaths per minute). In cases in which long-acting opioids have been given, it may be necessary to readminister naloxone to avoid repeated respiratory depression.
Recovery and Discharge
After receiving sedation, patients should continue to be monitored in a postsedation recovery area until time of discharge. This is because many complications can occur during the postoperative period, with respiratory depression and aspiration being the most common. How long patients must spend in the recovery area and how frequent their vital signs should be monitored and recorded are dependent on the institution, but commonly, vital signs are recorded every 10 min for a minimum of 30 min. Before being discharged, patients must meet certain criteria. These criteria are also dependent on the institution, but generally include adequate oxygenation and ventilation, hemodynamic stability, and return to baseline level of consciousness. The Aldrete scoring system [6] was one of the first sets of objective discharge criteria used (Box 31.3); a minimum score of 9 out of 10 allowed for discharge. Along with the appropriate monitors, the recovery area must also have the same equipment that was available during the time of sedation in case a patient was to require resuscitation. Many complications occur during the recovery period because of inadequate monitoring, equipment, and personnel training. If a patient is being discharged home, the patient must receive both verbal and written discharge instructions. It is optimal that the person taking the patient home also be present for these instructions, as the patient may not remember everything. Instructions usually include any activity or diet restrictions specific to the procedure performed and any problems the patient should anticipate.
Regulation
Unlike the Center for Medicare and Medicaid Services (CMS), which is a federal agency, the Joint Commission is “an independent not-for-profit organization” (About The Joint Commission, 2012). Although they each have their own regulations and standards, they also operate together to ensure patient safety at an institutional level. The Joint Commission audits and accredits institutions to ensure that they hold up to the regulations and standards put forth by the Joint Commission and CMS. According to the CMS Condition of Participation, “If the hospital furnishes anesthesia services, [the services] must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The [hospital’s anesthesiology department] is responsible for all anesthesia administered in the hospital” [7], whether it was administered by anesthesia providers or nonanesthesia providers. The CMS and The Joint Commission dictate anesthesia/sedation care preoperatively, intraoperatively, and postoperatively (Box 31.4). The CMS orders that patients must be assessed within 48 h of receiving sedation, monitored intraoperatively with proper documentation as proof, and appropriately cared for postoperatively.
Box 31.3. Aldrete Scoring System
Respiration
Able to take deep breath and cough = 2
Dyspnea/shallow breathing = 1
Apnea = 0
Oxygen saturation
SaO2 >95 percent on room air = 2
SaO2 >90–95 percent on room air = 1
SaO2 <90 percent even with supplemental O2 = 0
Consciousness
Fully awake = 2
Arousable on calling = 1
Not responding = 0
Circulation
BP ±20 mm Hg baseline = 2
BP ±20–50 mm Hg baseline = 1
BP ±50 mm Hg baseline = 0
Activity
Able to move 4 extremities = 2
Able to move 2 extremities = 1
Able to move 0 extremities = 0
Note: Monitoring may be discontinued and patient discharged to home or appropriate unit when Aldrete score is 9 or greater.
Credentialing and Competency
Although on a national level, The Joint Commission requires all institutions to verify a practitioner’s state license, Drug Enforcement Administration number, and education and training prior to granting the privilege of administrating sedation, the specific credentialing and training one must possess is determined by individual institutions. The ASA has set forth different requirements for practitioners administrating moderate versus deep sedation, which may be viewed in entirety on their website. Owing to the high potential for deep sedation to evolve into general anesthesia, the ASA states that practitioners administrating deep sedation should also be able to provide general anesthesia safely. The CMS additionally adds that only anesthesia providers (anesthesiologists, nurse anesthetists, and anesthesiology assistants), physicians, dentists, oral surgeons, and podiatrists should be granted the privilege of providing deep sedation. A practitioner providing deep sedation must be trained in advanced cardiac life support and/or pediatric advanced life support, depending on the patient population receiving deep sedation. A physician, dentist, oral surgeon, and podiatrist must be present to supervise moderate sedation, which can be administered by the aforementioned, in addition to anesthesia providers, registered nurses, and physician assistants. A practitioner administrating any level of sedation should possess the skills to rescue a patient in case the patient enters a deeper level of sedation than intended and return the patient to the intended level of sedation. Hence, it is absolutely crucial that the practitioner performing the procedure and the practitioner administering sedation are separate individuals, with the latter solely focused on monitoring the patient and immediately available in case cardiopulmonary compromise were to occur. Generally, “the Joint Commission requires that sedation providers have adequate training to administer the sedative drugs effectively and safely, the skills to monitor the patient’s response to the medications given, and the expertise needed to manage all potential complications” [8]. In addition, practitioners should be able to identify the varying levels of sedation, which will allow them to intervene appropriately when the patient is being under- or oversedated. Not only should the practitioner have comprehensive knowledge about the sedative drugs, but also about the available reversal agents. Anticipating and recognizing patients’ varying response to medications is needed and allows the practitioner to maintain patient hemodynamic stability. Understanding the physiology of oxygenation and ventilation and the ability to differentiate between normal and abnormal vital signs and cardiac rhythms and then relate them to the patient’s current state is a necessary skill. Also, practitioners providing all levels of sedation should be competent in assessing and managing the airway and be able to determine when an anesthesiology consultation is needed.
Box 31.4. Summary of the Joint Commission Standards for Moderate Sedation
1. Moderate sedation must be administered by a qualified provider.
2. Patients who will receive moderate sedation must be assessed prior to sedation/procedure.
3. The provider must discuss risks and options with the patient or his/her family prior to sedation/procedure.
4. The provider must reassess the patient immediately before the sedation is initiated.
5. Monitoring of the patient’s oxygenation, ventilation, and circulation during sedation is mandatory.
6. Postsedation assessment in the recovery area is necessary before the patient is discharged.
7. A qualified provider must discharge the patient from the postsedation recovery area or discharge must be based on established criteria.
Education
To ensure practitioners have the essential knowledge and skills that are crucial to being a competent sedation provider, institutions must develop educational programs that identify and assess these knowledge and skills. Traditionally, knowledge is obtained via lectures and assessed via written tests. Although this method facilitates basic science knowledge, it is not proficient at teaching and validating clinical skills, reasoning, and decision-making behavior. The latter can be done with simulation-based education, which creates real-life clinical scenarios. No matter the method taken, the institution is obligated to routinely validate and assess the knowledge and skills required, as the responsibilities of sedation practitioners change due to the emergence of new technology and procedures.
Quality Improvement and Risk Assessment
Internally, institutions need a process to address quality improvement and risk assessment to ensure the institution’s policies and practices are at the best clinical standard to minimize potential risks of injury. This process provides the ultimate goal of delivering patient safety. Through review and evaluation of institutional policies, quality of care, and patient outcomes, the quality improvement processes improve the practice of sedation. This confirms adherence to standards of care and can systematically be done by regularly reviewing charts chosen at random, and by direct observation of care. The risk assessment processes are responsible for analyzing situations in which an adverse patient outcome has occurred or almost occurred. By investigating all the factors that contributed to or caused an adverse patient outcome, changes can be made to prevent such events in the future. The Joint Commission mandates that all sentinel events (i.e., wrong-site or wrong-patient surgery) be reviewed with a root cause analysis.
“The University of HealthSystem Consortium (UHC), an alliance of academic medical centers and affiliated hospitals that focus on excellence in quality, safety, and cost-effectiveness, recommends the following . . . patient outcomes” be monitored and documented: deaths, aspirations, reversal agent used, unplanned transfer to higher level of care, cardiac/ respiratory arrest, medications administered other than those approved, inability to complete procedure as planned, and emergency procedures without a licensed independent practitioner present [7].
Outcomes
Examining the ASA Closed Claims Project data on procedures performed with sedation or monitored anesthesia care, the most common etiology of death or permanent brain damage is respiratory depression due to oversedation [9, 10]. The use of propofol in combination with benzodiazepines and/or opioids increased the incidence of respiratory depression. Most of these events were deemed preventable either by better monitoring techniques, in particular capnography, or enhanced vigilance by the sedation provider. As a result, the ASA considers capnography a standard monitor.
Controversies
Because the use of propofol increases the risk of moderate sedation slipping into deep sedation or even general anesthesia, the ASA Statement on Safe Use of Propofol [11] says that when propofol is administered, patients “should receive care consistent with that required for deep sedation” and that the nonanesthesia provider “should be qualified to rescue patients whose level of sedation becomes deeper than initially intended and who enter, if briefly, a state of general anesthesia.” Whether or not propofol can safely be administered by nonanesthesia providers remains a topic of controversy. The studies that have been done on propofol administration by nonanesthesia providers have not shown an increased incidence of severe adverse patient outcome, such as airway compromise requiring bag mask ventilation and/or endotracheal intubation, but these studies do not take into account the incidence and magnitude of respiratory obstruction, hypoventilation, or hemodynamic compromise [12–17]. Future studies that completely investigate the safety of propofol administration by nonanesthesia providers are needed.
Future of Sedation
Increasing patient safety during procedural sedation may lie in the use of new medications and new medication delivery techniques. Fospropofol, the prodrug of propofol, has been approved by the Food and Drug Administration (FDA) for the sedation of adults. The slower onset and longer duration of action of fospropofol make it possibly advantageous in minimizing the risk of oversedation. The pharmacokinetic profile of fospropofol is still in progress, but its use as a sedative drug is promising. Because fospropofol gets converted to propofol, its package insert also says that it “should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the diagnostic or therapeutic procedure” (Lusedra Warnings and Precautions).
Similar to patient-controlled analgesia, patient-controlled sedation/analgesia (PCSA) enables patients to control how much sedation/analgesia they receives and when. With the push of a button, patients can have medications (i.e., midazolam, fentanyl) delivered; and with the lockout interval, bolus doses, and maximum infusion rate set by the healthcare provider, the risk of oversedation is minimized. Such PCSA offers high patient satisfaction, and patients tend to use less medication compared with healthcare provider administration of sedation/analgesia.
Computer-assisted personalized sedation (CAPS) is a program that monitors a patient’s vital signs and level of responsiveness and then determines if and when a patient receives sedation medications. If a patient is being oversedated, as determined by vital signs and lack of responsiveness, then the delivery of sedation medications will be paused or stopped and the delivery of oxygen will increase. The CAPS is not meant to replace the sedation provider, but instead aid in providing sedation; it has not been approved by the FDA at this time.
Summary
In conclusion, it is important for sedation providers to realize that there are distinctly different levels of sedation, but that clinically it may be difficult to differentiate between them. Each institution offering sedation services must follow the federal and state regulations on moderate and deep sedation, and sedation providers must have the appropriate qualifications [18]. The specific education and training required of sedation providers differs between institutions. Although most institutions adopt the ASA guidelines and standards, each professional society also has its own set of guidelines. In the end, whether sedation is administered by an anesthesia or nonanesthesia provider, patient safety is of utmost concern.
Appendix: Professional Guidelines and Standards (the following organizations have guidelines that pertain to the administration of procedural sedation. Please visit their individual websites for up-to-date information)
American Academy of Pediatrics and American Academy of Pediatric Dentistry
American Association of Critical-Care Nurses
American Association of Nurse Anesthetists
American Association of Oral and Maxillofacial Surgeons
American College of Cardiology and American Heart Association
American College of Emergency Physicians
American College of Radiology and Society of Interventional Radiology
American Dental Association
American Nurses Association
American Society for Gastrointestinal Endoscopy
American Society of Anesthesiologists
Association of Perioperative Registered Nurses
Centers for Medicare and Medicaid Services
Society of Critical Care Medicine
The Joint Commission
University Health System Consortium
References
Introduction
Although many healthcare providers are familiar with an electronic health record (EHR) and use it routinely, anesthesiologists have a unique understanding of how information is used throughout the perioperative period. Anesthesiologists are responsible for knowing all aspects of the patient’s medical history, and therefore review all relevant sections of the patient’s chart. Most other medical specialties work with only one portion of the record, review notes and laboratory data and then write a series of recommendations. Radiologists may view the patient’s admitting data, read an x-ray, and then dictate a note into the chart. Anesthesiology, however, is one of the most information-intense medical specialties. Anesthesiologists also produce a highly detailed record of the intraoperative course, which may include imaging (from a cardiac echocardiogram or fluoroscopic images of a nerve block), laboratory data (e.g., arterial blood gas analysis), and consultations.
Health information technology is a broad topic, and anesthesia informatics is the subject of large textbooks. However, it is possible to summarize key points of health information technology as they pertain to management of the perioperative suite. This chapter discusses anesthesia information management systems (AIMS) and operating room (OR) information systems, with special attention to benefits, implementation, and obstacles to deployment. It also discusses the Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) regulations and how they impact medical care. Lastly, a brief discussion of communication in the perioperative environment explains how technology can facilitate transmission of important information.
Medical Information Systems
For many years, the medical profession was slow to adopt information technology. While most other industries used computers to track inventory, schedule workers, and bill for products and services, physicians relied on handwritten notes and slips of paper glued into charts. Computers were used mainly for billing and transmitting laboratory results. The first anesthesia information management systems were developed by physicians who were also computer enthusiasts. These early systems were designed for the needs of a specific practice, usually only interfaced with one type of physiologic monitor, and were little more than a record generator. The primary advantages of these early systems were that they relieved the anesthesia provider of the task of writing vital signs down every few minutes and they created a legible replacement of a paper record.
Healthcare professionals and institutions are now rapidly incorporating computer systems into every aspect of medical practice. Information technology is now being rapidly embraced as an aid to OR management. AIMS create a comprehensive, legible record of the patient’s course throughout the perioperative period. Scheduling systems are used to manage the flow of patients through the OR, postanesthesia care unit (PACU), and ICUs. Radiofrequency identification technology is used to track patients, equipment, instruments, pharmaceuticals, and blood products.
Medical information systems can provide critical information at the point of care, facilitate communication between healthcare providers, and track outcomes – all of which have the potential to increase efficiency while making patients safer. OR information systems can also integrate information such as guidelines and protocols with patient information, affecting clinician behavior by making specific recommendations. Clinical decision support extends the physician’s knowledge base by placing information into context with regard to a specific patient.
Anesthesia Information Management Systems
AIMS are a specialized form of an EHR that automatically collect, store, and present patient data that are gathered during the perioperative period. Modern AIMS are composed of an integrated suite of hardware and software that can interface with a variety of physiologic monitors and anesthesia machines. These systems can usually be interfaced with other hospital information systems, such as a laboratory information systems and the patient’s EHR, bringing the comprehensive medical record to the point of care within the perioperative suite. Although most of the functionality of an AIMS involves collecting and storing data from the perioperative period, many systems include a preoperative evaluation module, automated paging capabilities, and many other features.
Benefits of AIMS
The promise of AIMS is to improve patient safety and the quality of care, and these benefits are beginning to be realized. The Anesthesia Patient Safety Foundation stated over a decade ago that the Foundation “endorses and advocates the use of automated record keeping in the perioperative period and the subsequent retrieval and analysis of the data to improve patient safety” [1]. Although AIMS are costly and complex to implement and maintain, their advantages are rapidly becoming apparent and these systems are likely, with financial “encouragement” from government agencies, to become a de facto standard of care.
The adoption of AIMS has been accelerating over the past several years. Although fewer than 10 percent of ORs were estimated to have an AIMS installed in 2007 [2], a more recent survey reveals that 24 percent of ORs had installed a system by 2010, with 13 percent in the process of installation and another 13 percent actively evaluating a system [3]. There are several reasons for this rapid growth in the number of planned and installed AIMS, including patient safety, quality management, economic factors, research facilitation, education, and compliance with government regulations. Given the density of information generated by modern physiologic monitors, AIMS are the only practical way to collect and interpret all of the data generated during the perioperative period.
National organizations whose purpose is to analyze perioperative data to detect ways to improve quality and outcomes, such as the National Surgical Quality Improvement Program, Multicenter Perioperative Outcomes Group, and the Anesthesia Quality Institute (AQI), depend upon receiving data in digital form. This information, as well as that analyzed by institutional QI committees, can help to identify areas in which patient care can be improved. This information can also be used for maintenance of board certification: The American Board of Anesthesiology offers credit as part of its MOCA 2.0 program to physicians who develop and implement an improvement plan based on data from national quality data registries or patient feedback surveys.
Benefits to individual patients include an accessible and legible record that is integrated into the EHR and available to the care team at the point of care. Dexter et al. were able to significantly reduce waiting and nil per os times of children undergoing endoscopic procedures by analyzing information from an OR information system and applying a statistical model for case scheduling [4].
The AIMS can provide decision support and enhance compliance with guidelines such as those of the Surgical Care Improvement Project and pay-for-performance measures [5]. In an outpatient surgery center, a new antibiotic prophylaxis form combined with prebuilt order sets improved compliance with timely antibiotic administration to over 90 percent while saving an estimated $8,500 per year in pharmacy costs [6]. An AIMS developed by the Massachusetts General Hospital and Vanderbilt University, and General Electric’s Centricity, incorporates modules that prompt users to administer an antibiotic prior to surgical incision and then document compliance [7], which has been shown to decrease surgical infection rate [8]. In addition, AIMS can generate alerts for drug interactions or patient allergies, decreasing the possibility of an adverse event. Lastly, a recent study suggests that automated reminders can reduce the frequency of prolonged gaps in blood pressure management during surgical procedures [9]. Economics is an important factor in the decision to implement perioperative information management systems, and in many cases, drives the choice of a specific product. The OR is one of the largest revenue streams within most healthcare institutions, and managers can use information generated from AIMS and OR information systems to track outcomes, scheduling and operational efficiency, and, and formulate strategic plans. Most payers now require electronic documentation of patient encounters as a condition of reimbursement for healthcare services, a significant motivator in the decision to purchase an AIMS.
The primary financial benefits of an AIMS include a reduction in drug costs, improved charge capture, reduced staffing costs, and improved OR and scheduling efficiency. The AIMS probably do not decrease anesthesia time [10], but they can improve OR turnover and scheduling efficiency. Epstein et al. were able to infer a patient’s correct room location using vital signs transmitted from a monitor to the AIMS, something that could not be done using an AIMS or OR information management system alone. This enabled them to efficiently track patients as they moved, for example, from a block room to the OR for an orthopedic procedure [9]. By analyzing aggregate data, it is possible to determine actual mean procedure durations for specific surgeons, which can make scheduling ORs more efficient. In one novel application of real-time data analysis, a group of electrical engineers was able to interpret multichannel audio and video recordings to detect the specific phase of surgery. The authors postulate that their technique may be used to automatically detect adverse events [11]. Although this technique remains to be validated and implemented, the use of real-time data analysis is an intriguing possibility.
An AIMS has the potential to offer a significant return on investment through increased payments (and avoidance of withheld payments) from Physician Quality Reporting System initiatives, improved charge capture, and better documentation. At the University of Chicago, the procedural team and anesthesia team automatically receive a page when the preoperative workup is complete and the room is ready to receive the patient. The AIMS can also automatically search for missing documentation and alert the appropriate provider. At the Massachusetts General Hospital, customized software written for the AIMS automatically identifies missing procedure attestations and alerts the appropriate provider. This system has significantly increased collection of appropriate physician fees for services that had previously not been reimbursed [12].
An AIMS can facilitate clinical research through a large patient database that can be queried in order to find ways to improve clinical practice. Many healthcare payers are beginning to offer incentives to institutions that benchmark their care to determine the incidence of complications and the quality of their patient outcomes. This process will likely become a de facto requirement within the next few years. The AQI is a nonprofit foundation that was created by the American Society of Anesthesiologists to maintain a comprehensive, national clinical outcomes registry. The AQI relies on AIMS to provide the clinical information needed to objectively evaluate anesthesia practice patterns and ultimately improve patient care. At the present time, the AQI is using this information to provide benchmarking information to participating practices.
Implementation of an AIMS
Despite their benefits, there are significant obstacles to the adoption of an AIMS. Specific challenges include adapting preexisting workflows to the new system, training providers, device integration, creating downtime procedures, and tracking errors in charting and billing that may occur during the transition. Many healthcare professionals view the implementation of information technology as a goal in and of itself, but successful adaption of an EHR or other information system requires a fundamentally different approach. Information systems should be viewed as a solution to a specific problem or as a way to meet a defined goal. Before choosing a system, it is critically important to identify the problems that must be solved or the needs that must be met. This will make it possible to identify a solution that meets these exact needs.
The cost of installing and maintaining a system is substantial, and includes the “upfront” charges for hardware and software, the costs of customizing the product, and ongoing support and maintenance. This cost has been estimated to be as high as $4,000–6,000 per OR and between $14,000 and $45,000 for installation of a server [13]. The return on investment depends upon the financial and management practices at each institution, but usually includes improvements in scheduling, decreased drug costs, improved charge capture, and improved coding.
Because of the high cost of installation, a healthcare institution may choose an AIMS as part of the purchase of a larger information system. The benefits to the institution of choosing such a system include compatibility with other parts of the EHR, and possibly a discounted price. The system chosen by the hospital may, however, not be the ideal one for the practice model. Often, a hospital may choose a particular EHR to purchase and implement without considering the capabilities of that system’s anesthesia module. The anesthesiologists who will be using the system must therefore be involved with all aspects of the purchase and implementation. An AIMS does not simply replace a paper chart with an electronic one; successful adoption of this complex system requires substantial changes in workflow.
During the purchase process, the initial focus is almost exclusively on clinical implementation, but it is essential to plan for how the product will be used, which types of reports are required, and how the existing workflow integrates with the system. Consideration should be given to the functionality that will be required (e.g., preoperative evaluation or postanesthesia care unit documentation), the variety of anesthetizing locations at which workstations must be installed, support services that will be provided after the initial deployment, and initial and ongoing training for users. Maintenance and system upgrades should also be considered, as should backups of the data and the purchase of redundant hardware to minimize downtime in the event of a system failure.
It is important for the anesthesia department to identify a clinical champion who will work with the vendor during the initial design and customization. The champion should have a background in both clinical anesthesia and information technology and work with the vendor and healthcare institution information services personnel to facilitate all stages of implementation [14]. S/he should create a committee of advisors and super users representing the different interests and sections of the department. A comprehensive plan should be outlined and distributed to all members of the department well in advance of the scheduled implementation. This plan should include the strategy that will be used for the “go-live” (“Big Bang” or a phased implementation), as well as a training schedule and a contingency plan that will be implemented in the event of a system failure [13].
If the goal of purchasing an AIMS is to produce a paper printout of an anesthesia record at the end of an anesthetic, this functionality is likely to be available “out of the box.” Reports that have been built into the software are usually generic in nature, however, and generally do not include custom elements have been added to the database. If the goal of implementing an AIMS is to archive electronic medical records, push and pull information to and from an institutional EHR, track drug usage, or create customized reports, then additional resources and planning will be required, and this will incur additional planning, time, and costs. It is not uncommon to discover that the system does not produce reports that the physicians or institution consider to be essential. Technical or licensing restrictions may not even permit the data to be directly accessible. It is therefore imperative that all of the anticipated requirements be carefully thought out and clearly specified in the request for proposal. Additional items that should be considered include “paging modules” that will allow staff to be notified at specific milestones, integration with hospital, laboratory, pharmacy, and staffing systems, and the ability to interface with a billing system.
The new system and changes in workflow are a distraction that may temporarily impede patient care. Moreover, the presence of a computer on the anesthesia gas machine may tempt personnel to use it for online shopping, catching up on email, or other extraneous purposes during periods of low workload. Although there are no studies of how computer use affects anesthesia care in the OR, a recent study may provide clues. Observers found that anesthesia providers read books or magazines during periods of low workload in 35 percent of cases. Although vigilance did not appear to be impaired, performance of manual tasks, record keeping, and interacting with others was decreased [15]. It seems logical that implementing a new, unfamiliar system would have a similar effect. In addition, texting, calling, browsing, and other nonmedical use of digital technology can be tracked and would be deemed discoverable and admissible in a legal complaint. Inappropriate use can be minimized through the implementation of “appropriate use” policies, content filters, and education.
Security and Patient Confidentiality
HIPAA and HITECH
The HIPAA of 1996 was enacted to protect workers and their families from losing healthcare insurance coverage when they change or lose a job. Title II of HIPAA required the establishment of national standards for exchanging healthcare information and for the creation of a national identifier for healthcare providers, institutions, and insurers. The HIPAA also established sweeping requirements for the security and privacy of health information. These requirements are meant to improve the efficiency of healthcare by facilitating electronic data interchange between healthcare providers, payers, and governmental agencies. Although HIPAA has fundamentally changed the healthcare infrastructure in the United States, most physicians are aware of HIPAA because of the Privacy Rule.
The HIPAA Privacy and Security Rules define protected health information (PHI) as any information that is held by a healthcare provider, a payer, or their business associates that concerns health status, medical treatment, or insurance payments and that can be linked to a specific individual. This has been broadly interpreted to cover a patient’s entire medical record. The Security Rule describes three types of safeguards that must be put into place by “covered entities.” Administrative safeguards describe how a covered entity will comply with the rules and include policies and procedures that govern the protection and use of PHI. These policies are developed and enforced by a privacy officer. Physical safeguards cover all aspects of the hardware and software used to store PHI. These rules mandate that access to computers be limited only to authorized personnel and that access be closely monitored and controlled. Computers or devices (such as a laptop or tablet computer) that store PHI must be protected against unauthorized use. In general, storing PHI on a personal device should be discouraged because of the possibility that it could be lost or stolen. Technical safeguards cover the security of PHI as it is transmitted from one entity to another. Health information must be encrypted when transmitted over an open network (e.g., the Internet). Before information is transmitted, both parties must authenticate each other, either by a password system (if computers are used) or by a telephone call-back (for a conversation).
HITECH was enacted as part of the 2009 American Recovery and Reinvestment Act and gives the US Department of Health and Human Services the authority to establish a set of programs, incentives, and penalties for adoption and use of certified EHR systems (see www.cms.gov/EHRIncentivePrograms/). The requirements of HITECH build upon the HIPAA regulations, which deal primarily with electronic data interchange, security, and privacy. The HITECH regulations cover content of the record, quality management, and transmission of health information. The Centers for Medicare and Medicaid Services (CMS) has proposed a set of requirements for “meaningful use” of electronic records in five areas under HITECH:
improve quality, safety, and efficiency, and reduce health disparities
engage patients and families in their healthcare
improve care coordination
improve population and public health
insure adequate privacy and security of health information
The CMS defines a “meaningful EHR user” as a healthcare provider who uses a “certified” EHR for purposes such as order entry or e-prescribing; uses electronic transmission of data for the purposes of healthcare coordination; and submits clinical quality measures to an approved government agency. Healthcare providers who comply with these requirements through 2015 receive a small incentive payment, whereas providers who fail to meet the 2015 deadline for implementation may receive a reduction in Medicare payment as a penalty.
Although no AIMS have been certified as meeting “meaningful use” criteria, many of these systems fulfill the functions required in HITECH. For example, many AIMS offer decision support for items such as perioperative antibiotic administration. In addition, AIMS have the potential to automatically report disease conditions for which registries exist (e.g., malignant hyperthermia). They also meet many of the goals for quality, safety, and efficiency. Those AIMS that use accepted standards, such as SNOMED or HL-7, may allow devices to communicate with each other and with other AIMS. An AIMS can record vascular access or regional anesthesia techniques performed using ultrasound guidance, or transesophageal echocardiography utilized during cardiac surgery. The Epic EHR (Epic, Verona, Wisconsin, USA) has a feature called “Care Everywhere,” which allows a healthcare provider to access patient records that were created at other institutions that use Epic.
Communication in the OR
Anesthesiologists work in a dynamic environment in which information critical to patient care must be quickly and accurately exchanged. Cellular telephones, tablets, laptops, and other electronic tools can improve patient care by providing rapid access to vital information from any location. Effective communication has been shown to be a critical component of safety in high-risk environments. Failure to convey information quickly and accurately has been shown to be a root cause of medical errors; one study found that communication failures were the second most prevalent cause of medical errors [16]. Reliable information technology tools are critical to patient safety in the perioperative environment. Ideally, a core communication infrastructure should be created that is compatible with new devices. In many cases, such a system can be installed using readily available equipment.
Voice Communication
A variety of options are available to facilitate voice communication within a hospital or other healthcare institution. Besides cell phone signal repeaters making intrahospital use possible, WiFi networks can be used to carry voice conversations. Voice-over Internet Protocol has become a common alternative to traditional telephone service. Either generic or specialized systems can be installed in the healthcare environment. These advantages, combined with the low cost and wide availability of WiFi equipment, make this technology well suited for many healthcare applications.
Paging and Text Messaging
Many communications experts recommend that healthcare institutions retain paging systems to transmit extremely urgent information. Despite their “one-way,” asynchronous nature, paging systems do offer several advantages: they allow a simple message (e.g., a “Code Blue” page) to be conveyed simultaneously to a group of people. If the paging transmitter is in the hospital, messages can be sent very quickly. If, however, a commercial paging service is used, the latency period is specified in the terms of service and may allow up to an hour for a message to be sent out.
Some OR management systems include modules that can automatically alert specific members of the care team when certain milestones are reached, sending a message to the transport service to bring the next patient to the OR when the previous patient is transferred to the PACU, for example. This has the potential to improve OR efficiency. In one study, an AIMS automatically paged the attending anesthesiologist if allergy information had not been entered into the medical record. This significantly decreased the incidence of incomplete charts [17]. Clinical alerting systems that automatically send laboratory results to alphanumeric pagers have been shown to improve patient care and are installed in a growing number of hospitals [18]. Epstein et al. have developed an automated staff recall system that uses short text messages and is accessible from an AIMS. In the event of a mass casualty incident, such a system can potentially reduce the amount of time required for a hospital to mount a response [19].
Advanced Communication Tools
The advent of low-cost tablet computers combined with high-speed WiFi networks has resulted in the development of systems that provide unprecedented access to information. The Department of Anesthesiology at Vanderbilt University has designed a comprehensive information management and documentation suite called the Vanderbilt Perioperative Information Management System. This system integrates data from physiologic monitors, the hospital information system, and in-room video cameras. This information is presented to anesthesiologists throughout the institution and can be accessed from laptop computers, desktop computers, display boards in the perioperative suite, and tablet computers [20].
Summary
Implementation of a comprehensive information technology program in the OR can improve patient care while maximizing efficiency and helping to capture reimbursement for services. Anesthesiologists have a unique understanding of how information flows through the hospital, and have historically been at the forefront of initiatives to improve patient safety. Using an AIMS in the perioperative period can facilitate efficient scheduling, improve patient care by providing access to critical information, and create a legible record that is available throughout the healthcare institution. Ever more widespread is the ability to make these records available to perioperative physicians at whichever care center the patient chooses (or finds him/herself needing care). A well-thought-out communication infrastructure can also improve patient safety by allowing patient information, reference materials, or clinical guidelines to be sent to the point of care. Modern communication tools also allow anesthesiologists to convey information to each other without leaving the patient’s bedside. The discipline of anesthesia informatics is relatively new, but it has the potential to make dramatic improvements to the practice of perioperative medicine.
References
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