VA Health Care: Improved Oversight Needed for Reusable Medical Equipment
Released: 2018-09-04T00:00:00

Letter

Background

In providing health care services to veterans, clinicians at VAMCs use RME, such as endoscopes and surgical instruments, which must be reprocessed between uses. Reprocessing covers a wide range of instruments and has become increasingly complex. VHA has developed policies that VAMCs are required to follow to help ensure that RME is reprocessed correctly. In addition, VHA policy requires that VHA and VISNs oversee VAMCs’ reprocessing of RME and that VAMCs report incidents involving improperly reprocessed RME.

Complexity of RME Reprocessing

According to reports from RME professional associations, the complexity of RME reprocessing has increased as the complexity of medical instruments has increased. While at one time reprocessing surgical and dental instruments such as scalpels and retractors might have been the bulk of a SPS program’s tasks, now SPS programs are responsible for reprocessing complex instruments such as endoscopes. Reprocessing these instruments is a detailed and time-consuming process, and their increasing complexity requires a corresponding increase in the skills and time required to safely reprocess them. (See figure 1 for an example of steps that can be required for endoscope reprocessing.)

VHA Roles and Responsibilities for RME Reprocessing

Within VHA, the National Program Office for Sterile Processing under the VHA Deputy Under Secretary of Health for Operations and Management is responsible for developing RME reprocessing policies. It is also responsible for ensuring that VISNs and their respective VAMCs are adhering to its policies. Each of the 18 VISNs are responsible for ensuring adherence with VHA’s RME policies at the VAMCs within its region. In turn, each of the 170 VAMCs are responsible for implementing VHA’s policies related to RME. Within each VAMC, the SPS department is primarily responsible for reprocessing RME, which is used by clinicians in the operating room and other clinical service lines such as the dental and gastroenterology service. (See fig. 2.) Additionally, the SPS department collaborates with other VAMC departments such as the Environmental Management and Engineering Services on variables that affect RME reprocessing, such as the climate where RME is reprocessed.

VHA Policies for RME Reprocessing and Related Oversight

In March 2016 VHA issued Directive 1116(2)—a comprehensive policy outlining requirements for SPS programs and for overseeing RME reprocessing efforts.

SPS program operation requirements. To help ensure that VAMCs are reprocessing RME correctly, VHA policy establishes various requirements for the SPS programs in VAMCs to follow, such as a requirement that SPS staff monitor sterilizers to ensure that they are functioning properly, use personal protective equipment when performing reprocessing activities, separate dirty and clean RME, and maintain environmental controls. For example, VAMCs are required to maintain certain temperature, humidity, and air flow standards in areas where RME is reprocessed and stored. Additionally, in order to ensure that RME is reprocessed in accordance with manufacturers’ guidelines, VAMCs are required to assess staff on their competence in following the related reprocessing steps.

Oversight requirements. To help ensure that VAMCs are adhering to VHA’s RME policies, VHA requires inspections, reports on incidents of improperly reprocessed RME, and corrective action plans for both non- adherent inspection results and incidents of improperly reprocessed RME.

Inspections. VISNs are required to conduct annual inspections at each VAMC within their VISN and to report their inspection results to the VHA National Program Office for Sterile Processing. The VISN inspections are a key oversight tool for regularly assessing adherence to RME policies in the SPS, gastroenterology, and dental areas within VAMCs and use a standardized inspection checklist known as the SPS Inspection Tool. According to VHA officials, VHA developed the SPS Inspection Tool and generally updates it annually. The most recent fiscal year 2017 SPS Inspection Tool contained 148 requirements. Examples of requirements include those regarding proper storage of RME and following manufacturers’ instructions when reprocessing RME. Although VAMCs are also required to conduct annual self-inspections using the SPS Inspection Tool and report the results to VHA, the VISN annual inspections are a separate and important level of oversight. Finally, according to VHA officials, while not a formal policy, VHA’s National Program Office for Sterile Processing also inspects each VAMC at least once every 3 years. VHA requires VISNs and VAMCs to conduct their own inspections even in years when VHA also conducts inspections.

Incident Reports. VHA collects incident reports or “issue briefs” generated by VAMCs on incidents involving RME to help determine the extent to which VAMCs are adhering to RME policies, among other things. VHA requires VAMCs to report significant clinical incidents or outcomes involving RME that negatively affect groups or a cohort of veterans in an issue brief. According to a VHA official, when VAMC staff report incidents involving RME to their facility leadership, these officials should follow VHA guidance to determine which incidents, if any, should be reported in an issue brief to the VAMC’s VISN. Similarly, VISN officials, in turn, are responsible for determining whether an incident should be reported in an issue brief to VHA.

Corrective Action Plans. Corrective action plans—which detail an approach for addressing any areas of policy non-adherence identified in inspections or incidents identified in issue briefs—are required at both the VISN and VAMC levels. Specifically, both VISNs and VAMCs are required to develop corrective action plans for any deficiencies identified through their inspections, and VAMCs are required to develop corrective action plans for incidents identified in issue briefs. According to a VHA official, VISNs and VAMCs are not required to send corrective action plans from inspections to VHA; however, VAMCs must send their correction action plans to the VISN and also any related to issue briefs to VHA. Further, according to a VHA official, although neither the VAMC nor VISN corrective action plans from inspections are monitored by VHA, VHA does expect VISN officials to inform it of any critical issues that VISNs believe warrant VHA attention. For example, VHA officials would expect VISNs to report instances when RME issues result in the cancellation of procedures for multiple patients or when the VISN discovers a VAMC is lacking documentation of RME reprocessing competency assessments for a large number of their SPS staff.

Reports on Issues Related to RME Reprocessing

A number of recent reports have identified several RME-related issues at VAMCs, including non-adherence to RME policies. The issues have ranged from improperly reprocessed RME being used on patients to the cancellation of medical procedures due to lack of available RME. For example: In March 2018, the VA Office of Inspector General released a report describing problems identified at the Washington, D.C. VAMC, some of which were RME-related. For example, the office determined that ineffective sterile processing contributed to procedure delays due to unavailable RME. The report included specific recommendations, such as ensuring there are clearly defined and effective procedures for replacing missing or broken instruments and implementing a quality assurance program to verify the cleanliness, functionality, and completeness of instrument sets before they are used in clinical areas. The VAMC Director agreed with those recommendations.

In fiscal year 2017, the VA Office of Inspector General reviewed 29 VAMCs and issued reports for each in response to several RME- related complaints received through its reporting hotline. The office identified issues such as staff failure to perform quality control testing on endoscopes or document their competency assessments of SPS staff in employee files. Many of the reports included specific recommendations, such as performing quality control testing on all endoscopes and ensuring SPS staff are assessed for competency at orientation and annually for the types of RME they reprocess. The VAMC Directors agreed with those recommendations.

In 2016, the VA Office of the Medical Inspector released a report that substantiated allegations that SPS practices led to the delivery of RME with bioburden, debris, or both to the operating room. The report included specific recommendations, such as reeducating SPS staff on proper SPS standards and ensuring that all training and assessments of RME reprocessing competency of SPS staff are completed as required. The VAMC Director agreed with those recommendations.

In 2011, we released a report on VA RME that found issues with RME reprocessing. We found, for example, that VHA did not provide specific guidance on the types of RME that require device-specific training and that the guidance VHA did provide on RME reprocessing training was conflicting. We issued several recommendations for improvement, which VA has implemented.

VHA’s Oversight Does Not Provide Reasonable Assurance that VAMCs Are Following RME Policies

VHA Does Not Have Complete Information on Adherence to RME Policies from Inspections of VAMCs

VHA has not ensured that it has complete information from the annual inspections VISNs conduct—a key oversight tool providing the most current VA-wide information on adherence to RME policies—and therefore does not have reasonable assurance that VAMCs are following RME policies intended to ensure veterans are receiving safe care.

For fiscal year 2017, we determined that VHA should have had records of 144 VISN SPS inspection reports to have assurance that all required VISN SPS inspections had been conducted. However, our review shows that as of February 2018, VHA had 105 VISN SPS inspection reports and was missing 39, or more than one quarter of the required inspection reports. We also determined that there were two VISNs from which VHA did not have any fiscal year 2017 reports. For the missing SPS inspection reports, VISN officials suggested several reasons why the inspections were either not conducted or conducted but the reports were not submitted to VHA. For example, officials from one of the VISNs from which VHA had no SPS inspection reports told us that VISN management staffing vacancies prevented it from conducting all of its inspections. An official from the other VISN from which VHA had no SPS inspection reports provided evidence that it had conducted all but one of the inspections, but the official told us the VISN did not submit reports because it has yet to receive information from VHA regarding VISN inspection outcomes, common findings, or best practices and therefore sees no value in submitting them.

VISNs provided us with evidence showing that they conducted 27 of 39 inspections that were missing from VHA’s data. We analyzed these 27 reports to identify the information about non-adherence to RME policy requirements that VHA does not have from these missing VISN inspections. We determined the 10 requirements for which these VAMCs had the most non-adherence were related to quality, training, and environmental issues, among other things, with the extent of non- adherence ranging from 19 to 38 percent. For example, there were 19 and 26 percent non-adherence rates to the requirements that instrument and equipment levels be sufficient to meet workloads and having a process in place to ensure staff receive make-up/repeat training, respectively. (See Appendix I.)

We also found that variation in SPS Inspection Tools and related guidance from VHA resulted in incomplete inspection results for the gastroenterology and dental areas. VHA provided VISNs with three different SPS Inspection Tools throughout the course of fiscal year 2017. Although VHA guidance stated otherwise, only the third SPS Inspection Tool—which was used during the second half of the fiscal year—contained requirements specific to the gastroenterology and dental areas.

A VHA Central Office official told us the office hadn’t been aware that it did not have all of the VISN inspection reports until it took steps to respond to our data request. The official told us VHA granted VISNs a 3- month extension for fiscal year 2017—meaning that VISNs had until the end of December 2017 to submit their inspection results—and had granted similar extensions for at least the past 4 fiscal years as well. For all of those years, the VHA official told us that the office didn’t have all VISN inspection reports, even after granting extensions. As a result, VHA did not have assurance that all of the inspections had been conducted. When asked why VHA hadn’t been aware that it didn’t have all VISN SPS inspection reports, a VHA official said that the office has largely relied on the VISNs to ensure complete inspection result reporting because it hasn’t had the resources to dedicate to monitoring inspections. The official told us that VHA has asked for and just recently received approval to hire a data analyst who could potentially be responsible for monitoring the VISN inspection reports. VHA’s lack of complete information from inspection results is inconsistent with standards for internal control in the federal government regarding monitoring and information that state management should establish and operate monitoring activities and use quality information to achieve the entity’s objectives. Without such controls, VHA lacks reasonable assurance that VAMCs are following RME policies designed to ensure that veterans are receiving safe care.

VHA Does Not Consistently Share Information that Could Help VAMCs Follow RME Policies

We also found that VHA does not consistently share information, particularly inspection results, with VISNs and VAMCs, and that VISNs and VAMCs would like more of this information. Specifically, about two- thirds of VISN and VAMC officials told us that sharing information on the common issues identified in the inspections of other VAMCs as well as potential solutions developed to address these issues would allow VAMCs to be proactive in strengthening their adherence to RME policies and ensuring patient safety. For example, a VAMC official told us that there were problems with equipment designed to sterilize heat- and moisture sensitive devices, and seeing how other VAMCs addressed the problem was helpful for their VAMC. Further, officials from some VISNs said VHA cited their VAMCs for issues that had been found at other facilities and, had the VAMCs been aware of the issue beforehand, they could have corrected or improved their processes earlier.

When asked about sharing inspection results and other information, VHA Central Office officials told us the office doesn’t analyze or share information from VISN inspections because of a lack of resources. A VHA official told us that the office does create an internal report of common issues identified through the third of VAMCs it inspects each year, but the office doesn’t share this report with VISNs and VAMCs because the office lacks the resources needed to prepare reports that are detailed enough to be understood correctly by recipients. According to this official, VHA has occasionally shared information it has identified on common inspection issues through newsletters, national calls, and trainings; however, VHA officials at close to half of the VISNs and VAMCs we spoke to said that they rarely or never get this information. For example, officials from one VISN told us they recall only one or two instances where VHA sent a summary of the top five RME-related issues found during inspections. Insufficient sharing of information is inconsistent with standards for internal control in the federal government regarding communication, which state that management should internally communicate the necessary quality information to achieve the entity’s objectives. Until this sharing becomes a regular practice, VHA is missing an opportunity to help ensure adherence to its RME policies, which are intended to ensure that veterans receive safe care.

VAMCs Report Facing Challenges Related to RME Policies and Workforce Needs, but VHA Has Not Sufficiently Addressed These Challenges

According to interviews with officials from all of the VISNs and selected VAMCs, the top five challenges VAMCs face in operating their SPS programs are related to meeting certain RME policies and challenges addressing SPS workforce needs. In particular, officials told us that VAMCs have challenges (1) meeting two RME policy requirements related to climate control monitoring and a reprocessing transportation deadline, and (2) addressing SPS workforce needs related to lengthy hiring timeframes, the need for consistent overtime, and limited pay and professional growth. (See Table 1.)

Regarding the challenges VAMCs face in meeting RME policy requirements, the majority of VISN and selected VAMC officials interviewed reported experiencing challenges adhering to two requirements from 2016 VHA issued Directive 1116(2).

Climate control monitoring requirement. Officials reported that meeting the climate control monitoring requirement related to airflow and humidity is challenging for their VAMCs. Under the requirement VAMCs must monitor the humidity and airflow in facility areas where RME is reprocessed and stored in order to ensure that humidity levels do not exceed a certain threshold and thereby allow the growth of microorganisms. According to almost all VISN officials, meeting the requirement is a challenge for some, if not all, of their VAMCs and in particular for older VAMCs that lack proper ventilation systems. We also found some instances of non-adherence on this issue in the group of VISN inspection reports we reviewed. In a September 2017 memorandum, VHA relaxed the requirement (e.g., adjusted the thresholds). Additionally, according to a VHA official, VHA wants to renovate all outdated VAMC heating, ventilation, and air conditioning systems to help VAMCs meet the requirement. Further, according to VHA officials, VHA also allows VAMCs to apply for a waiver exempting them from having to meet this requirement if they have an action plan in place that shows they are working toward meeting the requirement.

Reprocessing transportation deadline requirement. Officials reported that meeting the reprocessing transportation deadline was also challenging for their VAMCs. Under the requirement, used RME must be transported to the location where it will be reprocessed within 4 hours of use to prevent bioburden or debris from drying on the instrument and causing challenges with reprocessing. Officials reported this requirement as particularly challenging for VAMCs that must transport their RME to another facility for cleaning, such as community based outpatient clinics in rural areas that must transport their RME to their VAMC’s SPS department. We also found some instances of non-adherence on this issue in the group of VISN inspection reports we reviewed. In June 2016, VHA issued a memorandum allowing the use of a pre-cleaning spray solution that, if used, allows offsite facilities such as community based outpatient clinics to transport that RME within 12 hours instead of the required 4 hours.

VHA has made some adjustments to these requirements, although some officials told us the requirements remain difficult to meet. Specifically, over half of the VISN officials reported that the climate control monitoring requirement continues to be a challenge for their VAMCs. Further, some of the officials told us that meeting the 12-hour reprocessing transportation requirement using the pre-cleaning spray was still challenging, due to the distance between clinics and their VAMC’s SPS department; as a result, some facilities have decided to use disposable medical equipment that does not require reprocessing to avoid this requirement completely. When we shared this information with a VHA official, the official stated that providing general information on how all facilities can meet the climate control monitoring requirement is impossible due to the uniqueness of each facility and that VHA has no further plans to adjust the reprocessing transportation deadline requirement. However, these challenges remain and some officials have expressed frustration with the limited support they’ve received from VHA. In September 2017 we recommended that VHA establish a mechanism by which program offices systematically obtain feedback from VISNs and VAMCs on national policy after implementation and take the appropriate actions. Our findings provide further evidence of the need for VA to address this recommendation.

Regarding the challenges VAMCs face in meeting SPS workforce needs, almost all of the 18 VISN officials and officials from the three selected VAMCs reported experiencing challenges related to lengthy hiring timeframes, need for consistent overtime, and limited pay and professional growth. According to officials, these challenges result in SPS programs having difficulty maintaining sufficient staffing levels.

Lengthy hiring timeframes. Officials reported that the lengthy hiring process for SPS staff creates challenges in maintaining sufficient SPS workforce. For example, officials from one VISN estimated that on average it can take 3 to 4 months for a person to be hired. Officials from a few other VISNs noted that not only does the lengthy hiring process create challenges in recruiting qualified candidates (because they accept other positions where they can be more quickly employed), but that it also results in long periods of time when SPS programs are short-staffed.

Need for overtime. Officials reported that needing their SPS staff to work overtime is a challenge. Specifically, 16 of the 18 VISN officials stated that there is a need for staff at their VAMCs to work overtime either “all, most, or some of the time.” Further, officials from one VISN told us their VAMCs have used overtime to meet the increased workload required to implement VHA’s RME policies; one official noted that the overtime has led to dissatisfaction and retention issues among SPS staff.

Limited pay and professional growth. Officials identified limited pay and professional growth associated with the current pay grade as the biggest SPS workforce challenge. Almost all officials stated that the current pay grade limits the pay and potential for professional growth for the two main SPS positions—medical supply technicians, who are responsible for reprocessing RME, and SPS Chiefs, who have supervisory responsibility. Specifically, the relatively low maximum allowable pay discourages staff from accepting or staying in positions and the current pay grade does not create a career path for SPS medical supply technicians to grow within the SPS department. Officials from one VISN told us that all VAMCs in their VISN have lost SPS staff due to the low pay grade for both positions. VHA officials said a proposed increase in the pay grade for SPS staff has been drafted; however, they do not know when or if it will be made effective.

Further, according to officials with knowledge of the proposed changes, the changes could still be insufficient to recruit and retain SPS staff with the necessary skills and experience.

Some VISN and VAMC officials told us that difficulties maintaining sufficient SPS staff levels have in some instances adversely affected patients’ access to care and increased the potential for reprocessing errors that could affect patient safety. According to these officials, staffing challenges can affect access to care when facilities have to limit or delay care—such as surgeries—because there aren’t enough staff available to process all the necessary RME. An official at one VAMC told us that their SPS staff must review available RME daily to determine whether scheduled surgeries or other procedures can proceed. Further, among the 18 operating room nurse managers who responded to our inquiries, 15 indicated they have experienced operating room delays because of RME issues. In addition, some VISN and VAMC officials told us staffing challenges can potentially have an impact on patient safety, because when SPS staffing is not sufficient, mistakes are more likely to occur. For example, officials told us that if SPS staffing levels are low, particularly if they are low for an extended period of time, there is an increased chance RME will be improperly reprocessed and, if used on a patient, put that patient’s safety at risk. A 2018 VA Office of Inspector General report on the Washington D.C. VAMC found that consistent SPS understaffing was a factor in SPS staff not being available to meet providers’ need for reprocessed RME; according to the report, “veterans were put at risk because important supplies and instruments were not consistently available in patient care areas.”

While VHA is aware of these workforce challenges cited by VISN and VAMC officials, it has not studied SPS staffing at VAMCs. As a result, it does not know whether or to what extent the workforce challenges VISNs and VAMCs report adversely affect VAMCs’ ability to effectively operate their SPS programs and ensure safe care for veterans. A National Program Office of Sterile Processing official indicated that while the office might have access to some of the necessary data from VAMC SPS departments, it does not have all the necessary data or staff needed to assess SPS staffing levels. Furthermore, the official added, conducting such a study would not be the responsibility of her office. Officials from the Workforce Management and Consulting Office said VHA is considering a study of SPS staffing, given the results of the VA Office of Inspector General 2018 review that identified high vacancy rates as a contributing factor to the challenges with the SPS program at the Washington D.C. VAMC. However, VHA does not have definitive plans to complete this type of study or a timeframe for when the decision will be made. Until the study is conducted and actions are taken based on the study, as appropriate, VHA will not have addressed a potential risk to its SPS programs. This is inconsistent with standards for internal control in the federal government for risk assessment, which state that management should identify, analyze, and respond to risks related to achieving defined objectives. Without examining SPS workforce needs, and taking action based on this assessment, as appropriate, VHA lacks reasonable assurance that its approach to SPS staffing helps ensure veterans’ access to care and safety.

Conclusions

The proper reprocessing of surgical instruments and other RME used in medical procedures is critical for ensuring veterans’ access to safe care. We have previously found that VA had not provided enough guidance to ensure SPS staff were reprocessing RME correctly; in 2016, VA issued Directive 1116(2)—with requirements for the SPS program. While this is a good step, our current review shows that VHA needs to strengthen its oversight of VAMCs’ adherence to these requirements. VHA has not ensured that it has complete information from inspections of VAMCs, nor does VHA consistently share inspection results and other information that could help VAMCs meet the requirements. Without analysis of complete information from inspections and consistent sharing of this information, VHA does not have reasonable assurance that VAMCs are following all RME policies, and VHA is missing an opportunity to strengthen VAMCs’ adherence to RME requirements.

Furthermore, officials from some VISNs and selected VAMCs report challenges meeting two RME policy requirements—the climate control and the reprocessing transportation deadline requirements. If VHA implements a recommendation we made in 2017 for the agency to obtain feedback from VISNs and VAMCs on their efforts to implement VHA policies and take the appropriate actions, it could help with these challenges. Additionally, while nearly all of the officials from the 18 VISNs and selected VAMCs interviewed reported challenges maintaining a sufficient SPS workforce, VHA does not know whether the current SPS workforce addresses VAMCs’ SPS workforce needs. VHA officials say that VHA is considering studying its SPS workforce; however, it has not done so or announced a timeframe for doing so. Until it conducts such a study, VHA will not know whether or to what extent reported SPS workforce challenges adversely affect the ability of VAMCs to effectively operate their SPS programs and ensure access to safe care for veterans.

Recommendations for Executive Action

We are making the following three recommendations to VHA:

The Under Secretary of Health should ensure all RME inspections are being conducted and reported as required and that the inspection results VHA has are complete. (Recommendation 1)

The Under Secretary of Health should consistently analyze and share top common RME inspection findings and possible solutions with VISNs and VAMCs. (Recommendation 2)

The Under Secretary of Health should examine the SPS workforce needs and take action based on this assessment, as appropriate. (Recommendation 3)

Agency Comments

We provided a draft of this report to VA for comment. In its written comments, which are provided in appendix III, VA concurred with our recommendations.

In its comments, VA acknowledged the need for complete RME inspection information, stating that VHA will establish an oversight process for reviewing and monitoring findings from site inspections and for reporting this information to VHA leadership. Further, VA noted that VHA will analyze data from RME inspections and share findings and possible solutions with VISNs and VAMCs via a written briefing that will be published on VHA’s website and discussed during educational sessions and national calls. VA also noted that VHA has an interdisciplinary work group that has identified actions it can take to address SPS workforce needs, including implementing an enhanced market-based approach for determining pay levels and developing a staffing model so VAMCs can determine what staffing levels they need to more effectively operate their SPS programs. VA expects VHA to complete all of these actions by July 2019 or earlier.

As agreed with your office, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies to the appropriate congressional committees and the Secretary of Veterans Affairs. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs can be found on the last page of this report. GAO staff who made major contributions to this report are listed in appendix III.

Appendix I: Top VHA Reusable Medical Equipment Issues among Select Veterans Affairs Medical Centers, Fiscal Year 2017

Our review of the 27 fiscal year 2017 inspections of VAMCs conducted by Veterans Integrated Service Networks (VISN) for which VHA did not have inspection reports identified a number of common reusable medical equipment (RME) issues among the select VAMCs. The top 10 are listed in table 2 below.

Appendix II: Percentage of Issue Briefs Related to Reusable Medical Equipment by Category, Fiscal Years 2015-2017

Our review of the Veterans Health Administration (VHA) summary of issue briefs for fiscal years 2015 through 2017 identified three major categories of issues related to reusable medical equipment (RME). See table 3 below for the percentage of all issue briefs that fell into each of these three categories.

Appendix III: Comments from the Department of Veterans Affairs

Appendix IV: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

In addition to the contact named above, Karin Wallestad (Assistant Director), Teresa Tam (Analyst-in-Charge), Kenisha Cantrell, Michael Zose, and Krister Friday made major contributions to this report. Also contributing were Kaitlin Farquharson, Diona Martyn, and Muriel Brown.