In recent years, the economic realities of health care reimbursement and a growing consumer demand have lead to a dramatic shift in the way health care is delivered: from in-hospital O.R. settings, to remote interventional settings outside of the O.R., to outpatient facilities, and to physicians’ offices.
What Are the Safety Concerns?
Significant safety issues related to the ambulatory procedural and surgical setting have been identified, including patient and procedure selection, perioperative care, management of complications and patient recovery. Other non-patient-related issues recently highlighted in both academic and popular literature include unqualified proceduralists performing procedures outside of their scope of practice, substandard facilities and lack of qualified personnel. These deficiencies have gradually attracted the attention of the Centers for Medicare & Medicaid Services (CMS), state health departments, medical boards, commercial health insurers and accreditation agencies. The Department of Health and Human Services (HHS), in collaboration with CMS, developed the idea of “value-based purchasing” (VBP), a construct for health care incorporating the National Quality Strategy and Agency for Healthcare Research & Quality (AHRQ) aims for the provision of health care that is both high-quality and cost-effective. Thus the National Quality Strategy goals focus on health care that is patient-centered, reliable, accessible, safe, and efficient while demonstrating reduced costs.
How to Measure Quality and Safety
The CMS value-based purchasing strategy explicitly links facility and physician compensation to the quality of health care outcomes. Initially, quality was assessed using “process measures” such as antibiotics, perioperative temperature and glucose control reportable through the Physician Quality Reporting System (PQRS). In the setting of health care reform and the emergence of Accountable Care Organizations (ACOs), the focus has shifted to outcome measures. In 2014, CMS proposed increasing the number of measures from the current three to nine measures within the three domains of the National Quality Strategy. Advocacy by the ASA leadership helped CMS understand that anesthesiologists might not be able to meet this new threshold due to lack of applicable measures or domains. In December 2013, the CMS confirmed that it would maintain the current clams-based measures applicability validation (MAV) without penalty and would extend this to include registry reporting. CMS also emphasized program participation, maintaining that the 2016 Value-Based Payment Modifier (VBPM) would be based upon 2014 participation in the PQRS.
Outcomes in Ambulatory Anesthesia and Surgery
Outcome metrics used in ambulatory surgery involve appropriate patient selection, avoidance of side effects (e.g., pain, postoperative nausea and vomiting), unanticipated admissions and serious adverse events. The incentives for the shift in cases from the hospital to the outpatient setting include higher efficiency, lower costs and earlier return to the patient’s baseline functional status.1,2
Rates of unanticipated admission in ambulatory surgery are generally considered acceptable in the range of 0.5-1.5 percent.3,4 Unanticipated admissions often result from poor pain control, intractable vomiting or surgical compli-cations. Data from the National Surgical Quality Improvement Project (NSQIP) from 2011 showed that readmissions in plastic surgery were associated with patient factors (procedure type, obesity and anemia) or the development of postoperative complications, either surgical or medical.5 Fleisher and colleagues proposed a risk index for prediction of admission.6 Return to hospital following ambulatory surgery is more difficult to assess due to data limitations. Twersky and colleagues found a rate of 1.3 percent return related to ambulatory surgery,7 and a Canadian study from a health system with unified records found a very low rate of 0.15 percent return to hospital related to the original surgery.8
The data comparing the hospital outpatient versus ambulatory setting require accurate risk adjustment to ensure appropriate comparison. A comparison of inpatient versus outpatient lumbar discectomy from the NSQIP dataset showed that after adjusting for confounders using propensity score matching and multivariate logistic regression analysis, outpatients had lower overall complication rates.9 Similarly, after adjusting for demographic and operative variables, the NSQIP data showed that patients having laparoscopic hysterectomy as outpatients were less likely to experience wound complications, medical complications or deep vein thrombosis and were not more likely to require reoperation.10 Stack and colleagues11 reported on more than 38,000 outpatient thyroidectomies in the University Health System Consortium database. Complications such as wound infection and hematoma were significantly lower.
Updates 2014: Quality Management in Ambulatory Surgery Centers
Starting in October 2012, CMS began a quality program requiring ambulatory surgery centers (ASCs) to report “G-codes” on five measures or face future Medicare payment reductions of 2 percent.12 On all claims, one G-code corresponds to prophylactic I.V. antibiotic administration. An additional G-code is reported if the patient experienced any of four specific adverse events (patient burn, fall, wrong site/side/patient/procedure/implant, and hospital transfer/admission).
Beginning in 2012, CMS required the use of checklists due to their demonstrated efficacy in both quality improvement and patient safety in tertiary care centers. The CMS definition of “safe surgery” checklist applies to all ASC procedures, including those that are generally considered to be diagnostic and pain management procedures (e.g., endoscopies and injections for controlling pain). CMS does not designate one particular checklist; ASCs or office-based facilities may select the checklist that can be adjusted to suit their specific needs, including the World Health Organization, Association of periOperative Registered Nurses (AORN), American Gastroenterological Association (AGA), American College of Gastroenterology, American College of Surgeons, and the Institute for Safety in Office-Based Surgery (ISOBS). The ISOBS has worked to create checklists for both providers and patients to be used in the outpatient setting. As we forge ahead with consistent and widespread implementation of electronic health records, checklists such as these will only become easier to implement and track, making improvements in care more timely and effective.
3. Patient Satisfaction Surveys
The AHRQ and its Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Consortium, in partnership with CMS, developed standardized surveys to collect data on patients’ experiences with and ratings of care. In January 2013, the CMS issued a request for information13 to extend this survey to the ambulatory surgical setting to evaluate care from the perspective of adult patients (>18 years) who have had surgery or procedures in these facilities. The goal is to aid consumers in making informed choices about providers as well as improve the quality of care.
4. Quality Initiatives by Accreditation Agencies
The Joint Commission, the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), and the Accreditation Association of Ambulatory Health Care (AAAHC) have requirements and guidelines for achieving continuous quality improvement activities leading to improved patient care and safety in the ambulatory surgical setting. Internal and external benchmarking – through systematic comparison of products, services or work processes of similar organizations, departments or practitioners – is recommended to identify best practices. Additional sources for comparison include patient satisfaction surveys, financial data, medical/legal issues and outcomes data.
5. Outcome Reporting and Registries
The collection of prospective data in clinical outcome registries is a mechanism to allow more accurate assessment of outcomes and links to causative factors. One example is the Surgical Care Improvement Project (SCIP), a collaboration between CMS, the Joint Commission, the American College of Surgeons and ASA, which initially focused on surgical site infections, venous thromboembolism, perioperative respiratory complications and beta blockade. The Society of Thoracic Surgeons maintains three databases (for adult cardiac, thoracic, and congenital cardiac cases), which led to the development of a risk-adjustment calculator for cardiac surgery, supported research and justification of improved reimbursement for perioperative surgical services.14 The American College of Surgeons (ACS) NSQIP is a prospective, observational database that evolved from the VA hospital program. The ASC-NSQIP collects data on a sample of surgical cases and analyzes observed versus expected outcomes. Although the morbidity and mortality were much lower than inpatient cases, the burden was still significant. Therefore, it is important to continue to monitor outcomes in ambulatory surgery.15
The Anesthesia Quality Institute, founded by ASA, sponsors an incident-reporting framework known as the Anesthesia Incident Reporting System (AIRS) and the National Anesthesia Clinical Outcomes Registry (NACOR). NACOR accepts any electronic data, with the minimum dataset being that available from billing data. To date, NACOR has information from at least 311 practices and 2,506 facilities, representing 22,345 anesthesia providers and 15,504,000 cases. Much of the information is descriptive, giving a profile of age, ASA status, type of anesthesia and surgical duration. Patient outcomes are also reported.
The Society for Ambulatory Anesthesia (SAMBA) has developed a clinical registry of patient outcomes of more than 60,000 ambulatory anesthesia cases, called the SAMBA Clinical Outcomes Registry (SCOR). Initial findings show an overall low incidence of postoperative and post-discharge nausea and vomiting, but a significant incidence in certain case types.16 Similarly, a subset of cases shows an opportunity for improvement in postoperative pain management.
The six domains that define the NQS goals for value-based purchasing are Safety, Patient- and Caregiver-centered experience and outcomes, Care coordination, Clinical care, Population or community health, Efficiency and cost reduction.1 The emergence of ACOs has further shifted attention to outcome measures. The importance of monitoring outcomes in ambulatory surgery has gained CMS attention due to an increasing number of Medicare beneficiaries having outpatient surgery.17
Outcomes of interest include appropriate patient selection, minimizing side effects, avoidance of unanticipated admissions to support an early return to functional status and avoidance of serious adverse events.1 Improved patient-centered care, patient satisfaction and outcomes are part of the medical home concept, which emphasizes periprocedural care coordination between primary care physicians, specialty providers and patients. In this model, outcome registries (e.g., NSQIP, AQI, SCOR) have demonstrated value in understanding best practices and areas for improvement in both surgery and anesthesia.
In 2014, CMS implementation of quality metrics with financial incentives includes reporting of G-codes, the use of a surgical safety checklist, patient satisfaction surveys, and benchmarking activities to generate best clinical practices. The intent of these patient safety initiatives is to significantly reduce costs associated with complications and provide savings to hospitals, patients and insurance companies, resulting in high-quality, cost-effective health care in the ambulatory setting.
1. Shapiro FE, Everett LL, Urman RD. Quality management in outpatient surgical care. Int Anesthesiol Clin. 2014;52(1):97-108.
2. VanLare JM, Conway PH. Value-based purchasing--national programs to move from volume to value. N Engl J Med. 2012;367(4):292–295.
3. Gold BS, Kitz DS, Lecky JH, Neuhaus JM. Unanticipated admission to the hospital following ambulatory surgery. JAMA.1989; 262(21):3008-3010.
4. Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998;45(7):612-619.
5. Fischer JP, Wes A, Nelson JA, Serletti JM, Kovach SJ. Factors associated with readmission following plastic surgery: a review of 10,669 procedures from 2011 American College of Surgeons Nation Surgery Quality Improvement Program data set. Plast Reconstr Surg. 2013;132(3):666-674
6. Fleisher LA, Pasternak LR, Lyles A. A novel index of elevated risk of inpatient hospital admission immediately following outpatient surgery. Arch Surg. 2007;142(3):263-268.
7. Twersky R, Fishman D, Homel P. What happens after discharge? Return hospital visits after ambulatory surgery. Anesth Analg. 1997; 84(2):319-324.
8. Mezei G, Chung F. Return hospital visits and hospital readmissions after ambulatory surgery. Ann Surg. 1999;230(5):721-727.
9. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes SA. Outpatient surgery reduces short-term complications in lumbar discectomy: an analysis of 4310 patients from the ACS-NSQIP database. Spine (Phila Pa 1976). 2013;38(3):264-271. doi:10.1097/BRS.0b013e3182697b57.
10. Khavanin N, Mlodinow A, Milad MP, Bilimoria KY, Kim JY. Comparison of perioperative outcomes in outpatient and inpatient laparoscopic hysterectomy. J Minim Invasive Gynecol. 2013;20(5):604-610.
11. Stack BC Jr, Moore E, Spencer H, Medvedev S, Bodenner DL. Outpatient thyroid surgery data from the University Health System (UHC) Consortium. Otolaryngol Head Neck Surg. 2013;148(5):740-745.
12. Quality reporting. Ambulatory Surgery Center Association website. http://www.ascassociation.org/ASCA/FederalRegulations/Medicare/QualityReporting. Accessed March 14, 2014.
13. Centers for Medicare & Medicaid Services, HHS. Medicare Program; request for information to aid in the design and development of a survey regarding patient experiences with hospital outpatient surgery departments/ambulatory surgery centers and patient-reported outcomes from surgeries and procedures performed in these settings. Fed Regist. 2013;78(17):5459-5461.
14. Shahian DM, Edwards F, Grover FL, et al. The Society of Thoracic Surgeons National Adult Cardiac Database: a continuing commitment to excellence. J Thorac Cardiovasc Surg. 2010;140(5):955-959.
15. Raval MV, Hamilton BH, Ingraham AM, Ko CY, Hall BL. The importance of assessing both inpatient and outpatient surgical quality. Ann Surg. 2011;253(3):611-618.
16. Everett L, Glass P. The SAMBA Clincial Outcomes Registry: description of the first 20,000 cases [abstract A059]. Presented at: Anesthesiology 2012: American Society of Anesthesiologists 2012 Annual Meeting; October 13-17, 2012; Washington, DC. http://www.asaabstracts.com/strands/asaabstracts/abstract.htm;jsessionid=984F9E376ACB8A75075278F5A55A2CB4?year=2012&index=1&absnum=4406. Accessed March 14, 2014.
17. Raval MV, Hamilton BH, Ingraham AM, Ko CY, Hall BL. The importance of assessing both inpatient and outpatient surgical quality. Ann Surg. 2011;253(3):611-618.