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Witness Testimony of William Schoenhard, FACHE, Deputy Under Secretary for Health for Operations and Management, Veterans Health Administration, U.S. Department of Veterans Affairs

Mr. Chairman and members of the Committee: thank you for the invitation to appear before you today to discuss the Bruce W. Carter Department of Veterans Affairs Medical Center (VAMC), in Miami, Florida.  I am accompanied today by Mr. Nevin M. Weaver, FACHE, Network Director for Veterans Integrated Service Network (VISN) 8; and Ms. Mary D. Berrocal, MBA, Director, Miami VA Healthcare System.

All of VA’s facilities, including the Bruce W. Carter (Miami) VAMC, are committed to providing the best care for our Nation’s Veterans. We want all Veterans who seek VA medical care to have a safe and positive experience. Among our ongoing actions to realize this objective, we have established a new model of patient-centered care, instituted more rigorous measures to ensure staff members are properly trained to handle patient needs, and developed enhanced protocols and policies to ensure compliance, verification, and confirmation with these standards so we deliver Veterans the very best care available. These efforts have produced significant results; last month, 20 VAMCs in 15 different states across the country were recognized by the independent Joint Commission as Top Performers on key quality measures in 2010. The Joint Commission recognized a total of 405 hospitals with this distinction, meaning that VA received a disproportionately large share of commendations for its health care system.

VA has attained this success through a culture of continuous improvement, which is manifested in every one of the more than 1,400 sites of care in the VA health care system. This is especially true of the Miami VAMC. Over the course of the past 2 years, the Miami facility has responded to concerns regarding the quality of patient care. 

Since VA identified concerns relating to reprocessing of reusable medical equipment in 2009, VA has taken aggressive action to inform, test, and support all patients who may have been potentially exposed to improperly reprocessed equipment.  Additionally, we have increased our inspection and audits of reusable medical equipment reprocessing. My written statement will provide an overview of the Miami VAMC, describe efforts undertaken locally to improve patient safety through policy compliance, and review the facility’s management of its budget. I will emphasize the role of leadership, performance measurement, and a culture of patient safety throughout.

Overview of the Miami VAMC

The Miami VA Healthcare System serves an estimated 285,000 Veterans in three counties in South Florida:  Miami-Dade, Broward, and Monroe. This Healthcare System’s parent facility is the Bruce W. Carter VAMC, which provides comprehensive medical, surgical, and psychiatric services.  It is home to an AIDS/HIV Center, a Prosthetic Treatment Center, a Spinal Cord Injury Rehabilitative Center, and a Geriatric Research, Education and Clinical Center. The Miami VAMC operates 191 hospital beds and oversees six community-based outpatient clinics (CBOC) in Homestead (Miami-Dade), Key Largo (Monroe), Pembroke Pines, Hollywood, Deerfield Beach, and Coral Springs (Broward), in addition to two outpatient clinics in Sunrise (Broward) and Key West (Monroe).

The Miami VA Healthcare System was recently approved as a kidney and liver Transplant Center, and these procedures will be performed in a state-of-the-art operating room scheduled to open in the third quarter of fiscal year (FY) 2012. The facility also conducts open heart surgery for other VA facilities in Florida.  It is recognized as the Epilepsy Center of Excellence for the Southeast Region, as a Multiple Sclerosis Center of Excellence, and as a Center for Excellence in Spinal Cord Injury Research. In FY 2011, the Miami VA Healthcare System received the Silver Plus performance award from the American Heart Association/American Stroke Association for excellence in stroke care.

The Miami VAMC has continued to improve its performance and management and has met VA’s target for the “fully successful” level in 2010; it is on target to meet the same level in 2011.  In FY 2010, the facility demonstrated overall improvement and sustained improvement for both critical and non-critical performance measures.  For example, through aggressive efforts involving retraining of personnel on scheduling and new leadership in the Health Administration Service, Miami has continued to show substantial improvement in its access measures in the delivery of both primary and specialty care.

In March 2009, in follow up to a national review of endoscopic equipment, the Miami VAMC’s quality control staff identified concerns about reprocessing of reusable medical equipment.  VA then initiated an intensive review of patient medical records for Veterans who had specific endoscopic procedures with specific types of equipment at the Miami VA Healthcare System between May 2004 and March 12, 2009. VA contacted Veterans identified during this review and offered screening for viruses that were potentially associated with reusable medical equipment that was not reprocessed according to manufacturer’s instructions. In May 2010, the Miami VAMC discovered more potential Veterans who may have had procedures performed during this time period, and subsequently identified 91 additional Veterans, whom we also notified and offered testing.  VA also convened a national Clinical Risk Assessment Advisory Board to make recommendations to the Principal Deputy Under Secretary for Health as to the clinical risk and whether larger-scale notifications or disclosures should be made to Veterans.

The VISN 8 Network Director convened two Administrative Investigation Boards (AIB), and VA also convened a national AIB to review issues associated with this event. The national AIB conducted a thorough review, gathering facts and circumstances surrounding the procedures used to determine the patients in a potential risk pool and our notification requirements. This AIB made several recommendations to improve these procedures, particularly with regard to identifying patients potentially at risk. The AIB concluded that the Miami VA Healthcare System responded promptly upon finding that equipment tubing was not being reprocessed in accordance with manufacturers’ instructions. The AIB further recommended that VA develop national, standardized processes to identify patients potentially at risk. Finally, the AIB credited the staff whose efforts made this process work as well as it did and commended them for their ethical practices and transparency in reporting this event. Miami has taken action to address all AIB recommendations.

Patient Safety

The Miami VA Healthcare System has been recognized consistently by VA’s National Center for Patient Safety through its Cornerstone Recognition Program, which was established in 2008. The Cornerstone Recognition Program recognizes the good work done at VA facilities and enhances the root cause analysis (RCA) process. The RCA process promotes patient safety by identifying the most fundamental reason a problem occurred. RCAs are focused on finding vulnerabilities in the system and remedying them to prevent a recurrence. The Miami VA Healthcare System received RCA Bronze awards in 2008 and 2009 and was recognized with the RCA Gold award in 2010. These awards signify that the Miami Patient Safety Program is meeting the RCA requirements as outlined in Veterans Health Administration (VHA) Handbook 1050.01 (“VHA National Patient Safety Improvement Handbook,” published March 4, 2011).

The number of RCAs conducted at Miami in the past year is comparable to the number performed at other facilities of a similar or higher complexity, and survey results indicate that Miami’s scores are well within the normal range in VA for a culture of safety. VA conducted a total of 33 RCAs related to patient safety at the Miami VAMC between January 1, 2009, and September 23, 2011. The facility completed and approved all RCAs within the required 45 day timeframe.

Between August 2009, and August 2011, the Miami Patient Safety Program has demonstrated 100 percent compliance with responding to Patient Safety Alerts issued from VA’s National Center for Patient Safety. The most recent Patient Safety Program review in 2009 identified no issues or deficiencies in the Miami Patient Safety Program structure. A new report is pending and is scheduled to be published within the next month.

The Miami VAMC has instituted a number of measures and processes to ensure compliance and user competence in reprocessing reusable medical equipment (RME). The Miami VAMC’s RME Committee has an active RME Quality Management (QM) interdisciplinary team that conducts observations of processes related to set-up, use, pre-cleaning, cleaning, reprocessing, transport, and storage of RME. The QM Team performs an annual risk assessment, which considers frequency of use and risk factors to guide random selection for observation. These review processes also validate current equipment against the Equipment Inventory List and match standard operating procedures, manufacturers’ manuals, and user competency assessments.

The Miami VAMC has developed a “double review” process to ensure Sterile Processing Department standard operating procedures (SOP) accurately reflect the manufacturer’s written instructions. These SOPs are reviewed by an independent expert and an Infection Control practitioner who concurs with the final draft.

In response to an RCA action, Miami VAMC conducted a wall-to-wall RME instrument inventory in April 2011 to ensure that all RME was fully accounted for and properly documented. This review also verified that all RME reprocessing instructions are reflected in written SOPs and document user competence. The Sterile Processing Department obtained the services of a contracted company to conduct an inventory of surgical instruments so that a new computerized online count sheet system could be implemented. The Miami VAMC complies with the infection control reporting processes outlined in VHA Directive 2009-004 (“Use and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health Administration Facilities,” published February 9, 2009).

The Associate Director for Patient Care Services is responsible for the RME process at the Miami VA Healthcare System and works with internal organizations to ensure RME issues are reported and addressed at least once per month. The Miami VAMC has renovated and upgraded its Sterile Processing Department areas and those at the Broward County VA Outpatient Clinic to meet the standards established by the Association for the Advancement of Medical Instrumentation (AAMI). All rooms have traffic-controlled doors and require proper attire, and temperature control, humidity, and pressure are managed by the Engineering Graphic Control. The Associate Director for Patient Care Services at the Miami VA Health Care System has completed a course for certification by the International Association of Healthcare Central Services and Material Management (IAHCSMM). Currently, 80 percent of technicians in the Sterile Processing Department at the Miami VAMC have attained IAHCSMM certification.  All staff at the Miami VAMC will be certified within 6 months of employment in the Sterile Processing Department.

We are fully supporting the Sterile Processing Department’s staffing with appropriate supervision, education, leadership, and program support. The Miami VAMC has either purchased or obligated funds to purchase equipment to support RME cleaning, reprocessing, and sterilization. The facility is using enzymatic spray to moisten debris on instruments and ensure their preparedness for the Sterile Processing Department’s cleaning and disinfection. The Miami VAMC has replaced single layer aprons used by staff in the decontamination room with new chemical-resistant brands of impermeable gowns.

In April 2011, VA’s Office of the Inspector General conducted a Combined Assessment Program (CAP) review, which resulted in six recommendations relating to RME. We appreciate the OIG’s recommendations, and the Miami VAMC has strengthened its processes to mitigate and prevent reoccurrence of the findings. All actions in response to the OIG’s recommendations have been successfully completed with the exception of one that requires special construction; the Miami VAMC is installing air ducts, a new wall, and a custom made sink, per the OIG’s recommendations, and these modifications will be complete within the next 120 days.

Budget Management

For more than 14 years, VHA has used the Veterans Equitable Resource Allocation (VERA) model to allocate the majority of its appropriated resources to VISNs. This model captures medical care delivered at each VA site and weights more intensive or complex care to better align resources with the complexity of care provided.  On average, VERA funds comprise 78 percent of the VISN’s total operating budget, and another 14 percent of the VISN’s budget comes from appropriations in the form of specific purpose dollars. The remaining eight percent of VISN budgets come from non-appropriated sources, such as Medical Care Cost Recovery funds.

VHA employs a similar model to develop budgets for its medical centers. Beginning in FY 2011, VHA initiated a standardized funding distribution model that all VISNs use to distribute VERA funding to their facilities. This model is based on the same principles as the VERA model, but it aligns dollars with those stations that provide the greatest volume and the highest intensity of care. The model provides VISNs the flexibility to initiate new programs or strategies, such as providing funding for a new CBOC or shifting resources from one facility to another. When the national facility distribution model was released in FY 2011, preliminary results suggested a $4 million reduction in the Miami VAMC’s VERA budget.  Key drivers to that recommendation were 2 prior years of zero growth in unique patient workload in Miami. The facility’s overall workload represented 10.5 percent of the VISN’s workload and was subsequently adjusted upward by $14 million at the beginning of FY 2011. This represented a three percent increase over FY 2010 levels. While final fiscal year data are not yet available, preliminary figures show the Miami VAMC’s total operating budget from all funding sources was $453 million; an 8.3 percent increase over FY 2010 totals.

Mindful of budget constraints, Miami leadership conducted a complete review of the organization and identified efficiencies that can be realized in many areas. These efforts will improve how the facility does business without compromising patient care or the quality of care; for example, some sections will combine administrative resources. Similarly, the facility will centralize the travel and overtime budget for better control, reduce non-emergency equipment and furniture purchases, and renegotiate or cancel non-critical contracts. Other efficiencies were realized in the area of beneficiary travel, records coding, monitoring of patients in the community, and increasing third party collections. The combined result of these actions yielded a cost avoidance of approximately $13 million in FY 2011.

Conclusion

VISN 8 and the Miami VAMC have demonstrated considerable improvement over the past several years and have aligned resources, leadership, and emphasis to realize a better, safer, and more accountable environment for patient care. There has been notable progress, but there will always be challenges, and we will continue to work to overcome them so we can provide the best care to our Nation’s Veterans. We appreciate the opportunity to discuss this facility’s work, and we look forward to your recommendations. This concludes my prepared statement.  My colleagues and I are prepared to answer your questions.