The Legislative Budget and Finance Committee’s (LBFC) report, Quality Assurance for Specialized Clinical Services, resulting from a House Resolution with a unanimous vote, criticized the manner in which the Pa. Department of Health (DOH) monitors cardiac procedures, particularly a cardiac catheterization demonstration project now active at 11 sites throughout Pa. that permits community hospitals without open heart surgery programs to perform elective therapeutic cardiac catheterizations – also known as percutaneous coronary intervention (PCI) – while also removing the requirement that those hospitals report to the DOH cases in which they perform emergency PCI.

The report suggests that DOH follow-up of cardiac catheterization deaths may be lacking, that PCIs performed in the waiver program are being done contrary to national quality benchmarks and against American College of Cardiology (ACC) guidelines, and that the DOH’s oversight of the program may be lacking, while the report also makes specific recommendations to improve quality assurance of the services.

An appraisal of the waiver program highlights the tension between enhancing access by patients in underserved regions to potentially lifesaving medical services, while ensuring that proliferation of highly specialized clinical services does not erode quality of care or endanger patients.

While DOH says it agrees with, and plans to implement, many of LBFC’s recommendations regarding the PCI waiver program, it maintains that its oversight activities are dictated by statutory and regulatory constraints – which themselves are currently targets of reform. Legislation introduced in the Pa. General Assembly would require the DOH to incorporate an external expert advisory committee apparatus into its quality oversight protocols. Hospital licensure regulations, which spell out the DOH’s quality oversight authority, are some 20 years old, and a preliminary revised version is finally forthcoming – with an anticipated public release this month.

Quality assurance issues raised by the PCI waiver program, its oversight by the DOH, and LBFC recommendations should also be considered within the broader context of other state entities that play a role in health care quality, including the Pennsylvania Health Care Cost Containment Council (PHC4), Patient Safety Authority, and state medical boards, each of which has seen enhancement to its monitoring capabilities.

LBFC Report Criticizes DOH

House Resolution 356 of 2003, and the LBFC report it prompted, were both grounded in the premise that Pa. lost an important quality assurance tool when its CON program sunset at the end of 1996, stripping the DOH of statutory authority to constrain proliferation of highly specialized clinical services and to require facilities to maintain annual proficiency volumes for these services, as per national practice guidelines – e.g., 450 open heart surgeries and 300 adult angiography cases per year at each facility.

The resolution said that proliferation of health care services erodes quality when procedure and treatment volume is diluted at each individual facility, while duplication of equipment and staff at more facilities also adds costs to the system. The resolution’s lead sponsor, Pa. Rep. Phyllis Mundy (D-Luzerne), had originally planned to introduce legislation to restore health facility performance standards, including proficiency volume, as a condition of licensure – "My version of CON," says Mundy, who withdrew the amendment in return for the LBFC study of post-CON effects on health care quality and cost.

"My view is that regulation of health care in Pa. is very weak," according to Mundy. If the DOH finds a hospital is out of compliance with reporting requirements or with licensure regulations, it asks for a plan of correction and issues a $500 daily fine, she says. "I find the health department regulations are toothless. They haven’t sanctioned a single hospital since the MCARE Act of 2003, and I can’t believe there are no hospitals that are not in compliance."

The resolution directed the LBFC to study issues related to quality assurance in health care services that involve "specialized technical medical procedures and require extraordinary expertise and resources to be effective," including organ transplant, cardiac catheterization and open heart surgery. Specifically, the committee was charged with examining standards for clinically effective care developed by national accreditation and specialty organizations, including standards for the minimum number of cases a facility must treat in order to ensure clinical proficiency.

To prepare its report, the LBFC consulted with health care experts, the DOH, the Pennsylvania Medical Society and the Hospital & HealthSystem Association of Pennsylvania; examined peer reviewed and published research focusing on quality performance measures; and reviewed approaches taken in other states, according to Maryanne Nardone, the committee’s project manager. The committee analyzed data from the DOH’s annual hospital questionnaire and from the PHC4, although risk adjusted performance data were not available, limiting comparisons to national and other state data.

States that regulate highly specialized clinical services – either through CON and/or licensure – typically rely on national practice guidelines, including provider proficiency volumes as part of their quality assurance activities, the LBFC report noted. With 23 open heart surgery programs having been established since CON sunset, facility proliferation has diluted volume at one-third of Pa.’s open heart programs below proficiency volume benchmarks established in other states, the report said, and mortality rates of a handful of Pa. programs have come to exceed national benchmarks.

While the report also scrutinized Pa.’s organ transplant programs, it concluded that those programs as a group perform as well as programs nationally.

It was cardiac catheterization, and particularly the DOH’s oversight of the PCI waiver program, that comprised the bulk of the report’s critique, which can be summarized as follows:

· Some facilities performing PCI failed to meet minimum mortality thresholds established by AHRQ, and the DOH did not pursue follow-up investigations.

· While current regulations permit outpatient catheterization only on low-risk patients, they do not clearly define "low-risk," and there is no indication that the DOH investigated patient deaths reported to the PHC4 from 1999 to 2003 during outpatient diagnostic catheterizations (45 deaths) and therapeutic PCI (26 deaths).

· DOH initially denied hospitals’ PCI waiver requests, then reversed its decisions without public announcement.

· ACC’s Pa. Chapter explicitly recommends against elective PCI at facilities without open heart surgery on-site, and the DOH did not respond to offers from the group to provide expert assistance in making a decision.

· Patient consent forms were not standard across waiver program sites, withholding from patients important information about participation risk, including in some instances ACC’s policy position.

· Key benchmarks, such as proficiency volumes, were not required for participation in the waiver program, and the DOH has rejected the premise that failure to achieve a certain volume is a reliable indicator of poor quality.

· DOH failed to require certain information needed to ensure compliance with waiver program participation guidelines.

· DOH permitted hospitals to violate some quality benchmarks that were required for participation in the waiver program.

Reviewing PHC4 data from 2000 to 2003, the report noted that 87 percent of the 155,000 PCIs the committee studied were performed by facilities with more than 400 PCIs annually – the recommended volume set by the federal Agency for Healthcare Research and Quality (AHRQ), and had an average annual observed (in-hospital) mortality rate of 1.35 percent – in line with AHRQ’s expected rate. New York’s PCI mortality rate, however, is one-half that of Pa.’s, and it requires a minimum annual proficiency volume of 400, as well as active cardiac oversight committee involvement – neither of which is required by current DOH regulations, the report notes.

Pa. facilities performing fewer than 400 PCIs per year had a 1.41 percent mortality rate, with six facilities performing fewer than 200 procedures annually having rates greater than 1.46 percent – the benchmark above which the AHRQ says should trigger a quality assurance review. Facilities with fewer than 100 procedures annually had a mortality rate of 1.73 percent.

PCI Waiver Program

Current hospital regulations require that elective PCIs be performed only at health care facilities that have on-site open heart surgery, as a backup to treat unexpected complications of the intervention. According to the LBFC report, the DOH used a committee of its medical, nursing and legal staff to review requests by several hospitals for exceptions to that regulation and, while deliberations are not open to the public, the committee recommended denial of the hospitals’ requests.

All hospitals were denied their waiver applications and filed administrative appeals, while the DOH reached settlement agreements with each of the hospitals prior to the commencement of any formal appeals process, according to LBFC Project Manager Nardone, who adds that no statute or regulation limited the authority of the DOH from denying the waiver applications.

The DOH’s settlement agreements create two-year demonstration projects during which time elective PCIs could be performed without on-site open heart surgery, while the LBFC report notes that DOH did not in all cases publish notices of its waiver denial reversals in the Pennsylvania Bulletin, as required by statute.

At the time the DOH denied waiver applications, there was a flurry of research about the effectiveness and safety of emergency PCI at hospitals without open heart backup on-site, which Nardone believes may have fueled optimism in the clinical community – and perhaps among DOH staff – about the safety of elective PCI without open heart backup on-site, and led them to believe that there was more positive clinical research than actually existed on the latter.

While current Pa. regulations do allow hospitals without on-site open heart surgery to perform emergency (as opposed to elective) PCI, the exceptions removed the requirement for hospitals to report the circumstances of the intervention to the DOH within 72 hours.

American College of Cardiology guidelines currently recommend against allowing elective PCI without open heart backup, and the LBFC report said that the DOH has not formally consulted with the ACC’s Pa. Chapter in its decision to grant the waivers, although the DOH did recently request to meet with it.

The DOH once had a Cardiac Catheterization Oversight Committee, which according to the LBFC report it convened three times in 1991, then again in 1995 – when it found that hospitals were performing low volumes of diagnostic and therapeutic catheterizations (as determined by the then-active CON statute) and the committee found no quality problems at those hospitals. The committee has not been formally reconvened since, the report noted.

In 2003, the report said, the ACC’s Pa. Chapter advised the DOH of its concerns for patient safety with the waiver project, calling the waivers "potentially hazardous" and noting that one in 300 patients undergoing elective PCI needs urgent bypass surgery, according to the American College of Cardiology National Cardiovascular Data Registry (NCDR).

The waiver grants are controversial, the report maintained, since medical researchers are not in agreement that the benefits to patients outweigh the increased risks associated with PCI without open heart backup on-site. The question is a moving target as additional data materializes, but the practice is still contraindicated based on the absence of compelling evidence from randomized trials of a favorable risk/benefit ratio, according to A.J. Conrad Smith, M.D., president of the ACC’s Pa. Chapter. Johns Hopkins Hospital is finalizing the design of a national trial of elective PCI without on-site open heart surgery backup, he notes, for which participating hospitals must have the capacity to perform 200 PCIs per year, perform certain PCIs using a defined protocol, and develop a quality and error management program. "The ACC continually looks at data and will revise its guidelines occasionally," says Smith.

As for the DOH’s decision to allow the waiver program, "We had no say in it. We were not consulted," says Smith, who notes that ACC’s Pa. Chapter offered to be involved and overtures were made, but the DOH moved forward without ACC input.

Better oversight of the PCI waiver program is needed, says Smith. Noting that participating hospitals are required to report data to the NCDR, Smith says he sent a letter to the DOH this June stating that there are many subtleties in evaluating NCDR data – including complications and outcomes, risk stratification, procedure volume, access to services, timelines of care provision, the consent process – and once again offering an advisory board of community and academic physicians to help the DOH evaluate the PCI waiver program. Smith says he had a conference call with the DOH in January and looks forward to a continuing dialogue.

In 2004 the DOH began to require new PCI waiver program sites to indicate explicitly that both the DOH and the ACC recommend that patients undergo non-emergency PCI in a hospital with open heart surgery on-site, although the new requirement did not apply to hospitals that received the waiver in 2002 and 2003.

The LBFC was critical of DOH oversight of the three PCI waiver sites that operated in 2003 – the first year of data available on the program: Somerset Hospital, Uniontown Hospital in Fayette County, and Monongahela Valley Hospital in Washington County.

According to the LBFC report, the DOH does not receive all of the information that is required to assess compliance with participation criteria for the PCI waiver program. Participating hospitals are required to report data to the NCDR, while the DOH receives a version of those data that is designed by the waiver sites themselves. Absent from those reports, the LBFC said, were data to verify adherence to some ACC/American Hospital Association guidelines – which were adopted by the DOH as waiver program participation criteria – including the number of emergency PCIs performed at the hospital (36 required per year) and the number of PCIs performed by each physician (75 required per year), while the reports also did not demonstrate relevant patient selection criteria are being followed, or that the procedures were subject to peer review – including procedures involving patient death.

Smith acknowledges that the NCDR database was designed for comparisons among institutions, not for monitoring PCI waiver programs at individual institutions, and it does not, for example, identify number of PCIs performed by individual physicians. Expert auditing of the data is needed to improve oversight of the waiver program, he maintains.

The LBFC report also indicated that all three hospitals participating in the waiver program’s first year, 2003, were violating a criterion of participation: that emergency PCI be performed within 120 minutes of a patient’s arrival at the hospital. According to the LBFC, one of the three hospitals did not meet the criterion for any of its patients, while two of the three did not meet the criterion for 60 percent or more of their patients.

Accuracy of reporting is also a concern, as the LBFC identified discrepancies between PCI procedure volumes in 2003 that one hospital reported to the NCDR and to the PHC4 – with one patient death in the catheterization lab reported to the former, and no patient deaths reported to the latter. The hospital told LBFC staff that two PCI-related patient deaths had occurred in 2003, and that the reporting discrepancies were caused by different data systems’ reporting categories, and by coding confusion.

The LBFC report recommended several reforms, including that the DOH should:

· Routinely review hospital cardiac data to identify programs not meeting AHRQ and other recognized performance benchmarks, and to identify programs that may not be in compliance with existing licensure provisions.

· Form a cardiac oversight committee working with the ACC’s Pa. Chapter, to develop clinical guidelines to inform hospital regulations, develop performance criteria – including complication rates and mortality and proficiency volumes – for highly specialized cardiac services, and develop guidelines for peer review.

· Institute a moratorium on approving additional PCI program waivers.

· Require all current PCI waiver sites to join a national clinical trial and comply with all of its supervisory requirements and protocols.

DOH Response

In a written response to the LBFC dated April 8, included in the appendix of the report, the DOH agreed not to consider any further applications for PCI waiver program approvals. In its official notice of moratorium, the DOH noted that there is ongoing discussion in the medical community concerning the issue of providing elective PCI at hospitals without on-site open heart surgical services, that it believes the waivers granted were appropriate, and that there are a sufficient number of hospitals in the demonstration project to provide relevant and useful data on the matter.

The DOH also agreed to make participation in a national clinical trial a condition of renewal for all waiver sites.

The DOH plans to host an informational meeting this month among representatives from waiver hospitals and investigators from Johns Hopkins Hospital who are putting together the national PCI clinical trial.

The first three hospitals that were granted PCI waivers – Somerset, Uniontown and Monongahela – had their two-year demonstration intervals expire at the beginning of this year, and have been allowed to continue until discussions with the Johns Hopkins representatives are completed, according to Richard Lee, DOH’s deputy secretary for quality assurance.

ACC’s Pa. Chapter applauds the DOH moratorium and believes that requiring existing PCI waiver sites to participate in the Johns Hopkins PCI clinical trial would be an effective way to monitor the safety of the programs and identify outliers early on, says Smith.

The DOH also agreed to work with ACC’s Pa. Chapter, and asked it to make recommendations regarding the use of waivers and methods of evaluations, but is still waiting to receive those recommendations, according to Lee. The DOH hopes to consult with the ACC about details of PCI clinical trial participation, he adds.

In overseeing cardiac care, the DOH does not identify hospital cardiac programs not meeting AHRQ and other recognized performance benchmarks, but said it routinely reviews PHC4 cardiac catheterization reports as a resource for its regular site survey process during which it selects a sample of patient charts to review. "We believe that this approach satisfies the requirements of our regulations, without being unduly burdensome to providers, or consume inordinate amounts of staff time trying to evaluate complex data reports. If either our walk through, or chart review indicates a quality problem85we expand the number of charts reviewed, and look at facility clinical procedures for these services. If we need additional information, we look at national benchmark data," the DOH wrote in its response to the LBFC report.

"The regulatory audit process is not capable of reviewing 100 percent of all patient records, and won’t find every violation out there," according to Lee. DOH staff includes clinicians who review PHC4 and NCDR data and Lee says he dispatched a physician to investigate the PCI-related reporting discrepancy and two patient deaths that had occurred at one PCI waiver site in 2003. The on-site investigation found no clinical problem and the deaths involved very sick patients, while the hospital was asked to correct its reporting problem, Lee adds.

The DOH disagrees with the LBFC criticism that it does not receive sufficiently detailed data to monitor safety and compliance with the PCI waiver program. While it is true that the NCDR does not specify the number of emergency PCIs performed at a hospital or by an individual physician – specific volumes of which are waiver program participation criteria – the DOH has the authority to ask the hospitals directly for those figures, according to DOH spokesperson Richard McGarvey.

The LBFC was incorrect in its criticism that all three waiver hospitals participating in 2003 were violating a waiver program criterion that emergency PCI be performed within 120 minutes of a patient’s arrival at the hospital (an ACC guideline), because the DOH cited as participation criteria ACC literature that did not include a 120 minute requirement, says McGarvey.

In response to the LBFC’s allegation that Pa. regulations permit outpatient catheterization only on low-risk patients, but do not define low-risk, McGarvey cites the relevant regulation: "High-risk cardiac catheterization – Cardiac catheterization which presents a high risk of significant cardiac complication. The term includes diagnostic cardiac catheterization procedures that present a high risk of significant cardiac complication, PTCA, pediatric cardiac catheterization and therapeutic electrophysiology except for the implantation of routine permanent pacemakers. Low-risk cardiac catheterization - Cardiac catheterization which is not high-risk cardiac catheterization."

The LBFC also said there is no indication that the DOH investigated 71 outpatient catheterization deaths reported to the PHC4 from 1999 to 2003, and McGarvey notes that the DOH does not normally investigate patient deaths, and that the LBFC would not disclose the names of the hospitals in question for further examination. To determine possible regulatory violations, DOH surveyors look at patient deaths that are reported as unexpected, while the new Patient Safety Authority event reporting system tags serious events involving patient deaths – all of which are scrutinized by DOH surveyors, McGarvey adds.

In its written response to the LBFC, the DOH also questioned the accuracy and depth of the information included in the report because the DOH was asked not to share a draft of the report with other entities, including PCI waiver hospitals, to evaluate the report’s findings – including the outpatient catheterization deaths.

The DOH was particularly critical of LBFC’s fixation on the CON model as the foundation of LBFC’s criticisms, which it said uses "a set of non-marketplace supply restriction regulations and a highly complex quantitative analysis of outcome benchmarks." The validity of such a policy framework has been seriously questioned by the U.S. Department of Justice and the World Health Organization, the DOH maintained, and has been rejected by the Pa. General Assembly. Statutory sunset of CON, said the DOH, removed any legal authority for it to establish or enforce quality benchmarks, and current regulations do not have explicit facility performance requirements. "It is an unfair allegation to hold us accountable to a standard that far exceeds our legislative or regulatory authority," says Lee. "You’re beating a horse that doesn’t exist anymore," he adds.

Facility performance expectations and DOH enforcement methods are embodied in DOH regulations and the Health Care Facility Act, which direct the DOH to conduct full license surveys in each hospital at least every two years and to receive and manage consumer complaints, while the DOH said it has improved those activities to substantially increase the amount of oversight in health care facilities over the last several years, Lee adds.

Although existing statute does not require them, the DOH has the authority to try to include proficiency volume benchmarks in future regulations, but could not predict their fate after the regulatory review process – which would entail debate from interest groups, the legislature and the Independent Regulatory Review Commission, according to McGarvey.

The Pa. General Assembly has also moved beyond the regulatory model of oversight by blending it with a learning model, the DOH added in its written comments to the LBFC, as embodied by its creation of the Patient Safety Authority, whose detailed reporting requirements for adverse medical events, near misses and infrastructure failures greatly enhances the DOH’s capacity to detect and evaluate problem areas, while simultaneously requiring facilities to establish patient safety infrastructures and encouraging proactive self-improvement.

In response to LBFC criticisms of the PCI waiver program, the DOH said that any comprehensive study of the issue should show that there is ongoing discussion in this area and that it is far from settled. Lee acknowledges that current ACC guidelines recommend that elective PCI be provided only in hospitals with open heart surgical facilities, and that that position had a fair amount of influence on DOH’s initially denying waiver requests. After discussions with hospital representatives, cardiac surgeons and cardiologists, the DOH learned that "there are a number of reputable cardiologists, including members of the ACC’s Pa. Chapter, who do not agree with their organization’s position, but there are not enough votes to change that position," says Lee.

In granting PCI waivers to hospitals that have petitioned for them, DOH said it determined that it would balance the potential risk with the benefits of making the service available to more Pennsylvanians, and it said that hospitals participating in the waiver program were able to show that they would be providing PCI services to individuals who otherwise would have to travel substantial additional distances to access the services. "The fundamental argument presented to us was that some people in rural and medically underserved areas will not drive 75 minutes to receive this service," he adds. Somerset, Uniontown, Jameson and Chambersburg hospitals, for example are in counties that had no open heart programs. In the case of a waiver appeal from a place like Philadelphia’s Jeanes Hospital, with 10 open heart programs in the county, they made the case that their catchment area was medically underserved and access to PCI was still impeded, says Lee.

The DOH’s waiver decision reversal also entailed some legal strategy. Hospitals came to the DOH and made a case that PCI could be done safely without open heart backup. The DOH agreed, but with conditions and to a limited amount of facilities, by starting the demonstration projects and not opening it up to all hospitals in the state, says McGarvey. By using the mechanism of settlement agreements to grant the waivers, he adds, the DOH has retained some enforcement authority: if the DOH would lose a hospital’s administrative appeal before a judge, it would not be able to enforce Pa.’s regulation against PCI without on-site cardiac surgery, and any hospital could start doing high-risk PCI. By entering settlement agreements before any administrative appeals could be adjudicated, the DOH ensured that participating hospitals were legally accountable to specific participation criteria for the waiver program, he notes.

Criteria spelled out in existing PCI waiver settlement agreements include:

· Following certain ACC guidelines for emergency PCI.

· Reporting monthly to DOH all transfers of emergency or elective PCI patients to other hospitals.

· Reporting PCI data to the NCDR and authorizing release of these data to the DOH.

· Obtaining training and support of one or more tertiary hospitals with PCI experience, and entering into transfer agreements with one or more hospitals that provide open heart surgery.

· Notifying patients that the elective PCI procedure is being done under a waiver from the DOH’s regulations and that the DOH and ACC recommend that patients undergo the procedure in a hospital with on-site open heart surgery available.

· Agreeing to correct any material breach of the settlement agreement within 30 days or face possible waiver revocation. If the DOH believes there is an immediate threat to patient health and safety, it may issue a limited license to exclude emergency and PCI services.

Hospitals in the PCI project must fill out a standardized record for every patient who undergoes PCI and submit that data to the NCDR, which sends each hospital a confidential institutional quarterly and annual report that addresses outcomes such as success, adverse events and mortality, and compares a hospital’s performance to an NCDR benchmark, to a national average of all member hospitals, and to a peer group based on PCI volume.

The DOH website also notes that hospitals in the PCI project must share their NCDR institutional reports with the DOH, which uses them to monitor outcomes and help prevent or minimize harm to patients. The DOH will decide whether a hospital’s two-year waiver is renewed as experience and data accumulate, although it does not currently intend to grant any additional waiver requests to participate in the PCI project, as per the LBFC’s recommendation.

The DOH said that, while it does not agree that all hospitals should be permitted to provide PCI services, it is also being responsive to the Pa. General Assembly’s direction to encourage innovation and continuous development of improved methods of care.

The DOH also said that action may be warranted regarding the regulations that govern PCI, e.g., dropping regulations against PCI without on-site open heart surgery, keeping the regulations and allowing waivers, or keeping the regulations with no waivers.

Broader Reform

Critique and defense of the manner in which cardiac care is overseen in the state raises broader questions about the efficacy of Pa.’s current regulatory apparatus, and about the regulatory approach to quality assurance itself. While defending its regulatory oversight activities, the DOH also alluded to the importance of blending regulatory enforcement with an educational paradigm, as conceived by the rationale for the Patient Safety Authority.

While Lee says the DOH intends to continue to implement the moratorium on additional PCI waivers, he notes that any regulation or statute is malleable and subject to legal pressure. The moratorium would not have any impact on a hospital that was denied waiver program participation and chose to move forward with an appeal, says McGarvey, who notes that one hospital – Nazareth – has applied for the waiver since the moratorium, and has not yet received an official response from the DOH.

Some legislators are advocating a quasi-return to CON to strengthen perceived regulatory weaknesses in health care quality oversight. Last year’s HB 2771 – a revised version of which has been introduced this year as HB 1547 – is designed to build more accountability into the regulations and beef up DOH’s authority to establish health and safety standards for health care facilities. The bill would require the DOH to promulgate regulations that include clinical quality indicators for specialized clinical services and a formalized process for analyzing those data. Rather than specify proficiency volumes legislatively, as CON did, the bill calls for the establishment of a clinical advisory committee that would develop the quality indicators and analyze performance data, conduct clinical peer review and recommend licensure actions against a hospital that failed to meet key quality indicators and correct deficiencies.

Pa. Rep. Katharine M. Watson (R- Bucks), lead sponsor of both versions of the bill, believes that such formalized protocols and infrastructure – including the restoration of proficiency volume standards – are needed to spell out DOH duties and set a statewide standard of quality assurance in health care, particularly high-end specialty procedures. The clinical advisory committee could also assist the DOH in revising Pa.’s outdated hospital regulations, says Watson. "The ongoing practice of hospitals policing themselves shouldn’t be the standard," Watson adds.

While procedure volume benchmarks are correlated with quality outcomes, the expertise of an involved advisory board is needed to look beyond volume, says Smith, of the ACC’s Pa. Chapter. In a letter to the DOH, ACC volunteered members to serve on such a committee, should the legislature enact the bill.

Pa. Rep. Thomas M. Tigue (D-Luzerne/Monroe), who was a cosponsor HR 356 which prompted the LBFC report, says the report issues an alert signal about DOH’s quality assurance oversight activities, and he believes that the state’s health care quality can and should be improved, either legislatively or through beefed up regulation. Tigue is also a cosponsor of Watson’s HB 1547, which aims to do both.

Rep. Mundy, HR 356’s lead sponsor and proponent of CON-type regulation, believes that the LBFC report is symptomatic of broader inadequacy of state oversight, but is skeptical that the DOH has sufficient authority to make improvements on its own, even through an approach like HB 1547.

Another approach, she says, is to relieve some of DOH’s more onerous oversight duties by providing incentives to hospitals to improve care quality. She points to her HB 743, which would provide a 20 percent discount on medical liability insurance premiums to hospitals that implement and agree to be audited by a total quality management health care entity that can reduce medical errors by, for example, meeting specific quality benchmarks and implementing certain error prevention protocols.

The DOH has first-rate staff for providing excellent quality assurance, but the vigor of the its regulatory apparatus is impeded because the department is embedded in an administration that must answer to multiple competing forces, i.e., consumer groups that want more regulation and provider groups that want less administrative burdens, says Karen Wolk Feinstein, president of the Jewish Healthcare Foundation of Pittsburgh, which released a "report card" on the DOH two years ago. Feinstein believes that the DOH could and should be an important part of protecting the health of the population, and that health care regulations will garner more buy-in and efficacy if they are more evidence-based, designed through a collaboration of researchers, providers and regulators. An educational approach to quality improvement must be accompanied by effective regulatory oversight, Feinstein believes. "You need the carrot and the stick. There has to be some regulatory apparatus to assure compliance with best practices."

A central question is whether patients are receiving appropriate care, or are being pushed to certain institutions for financial reasons, says Carla Zema, Ph.D., former director of the Pittsburgh Regional Healthcare Initiative’s (PRHI) cardiac and critical care initiative. Given that services such as PCI and open heart surgery can be lucrative for institutions, there is probably overuse or misuse of some of these services and it is difficult for any regulator to assess that, she believes. No regulation has the ability to drive quality without better data interpretation, and the DOH must retain an expert clinical advisory committee to ensure that facilities are giving appropriate therapies to appropriate patients, Zema maintains. "It is difficult for an external entity like the DOH to come into a facility for two weeks and understand all the pieces that truly impact quality and safety," she adds.

Replacing old regulations while integrating the activities of the state’s existing health care quality agencies is the best approach to reform, according to Ann Torregrossa, senior policy manager for the Office of Health Care Reform (OHCR). The OHCR has recently received a Health Resources and Services Administration grant to conduct state planning on how best to improve patient outcomes while lowering health care costs and preserving access, and has issued an RFP to solicit consultant expertise on the issue, with a strategic plan from Pa. due to the Dept. of Health and Human Services by August 2006, she adds.

Various Pa. agencies play crucial roles in providing data to weigh quality assurance policy options, and she illustrates several: PHC4 data have revealed that almost one-third of hospital charges are for additional days for adverse medical events, avoidable complications and medical errors; and that the state’s hospital readmission rates within 30 days of discharge are over 14 percent. The Patient Safety Authority seeks to encourage a safe and secure way for health care facilities to report things that went wrong, to determine root causes, and to put interventions in place. The medical boards are now receiving reports of all medical malpractice lawsuits filed against physicians and have increased the number of adverse actions against physicians. The PRHI has been a model effort in educating hospitals and physicians on root cause analysis. The Jewish Healthcare Foundation of Pittsburgh offers a fellowship program that pays a hospital system $25,000 to send a physician and team for one week of training in root cause analysis.

Regulation also plays a role, and the DOH is in the process of revising its hospital licensure regulations, which the OHCR has been reviewing, says Torregrossa. Current regulations are more than 20 years old and have relied on complaints and site visits for quality assurance, she adds, noting that a lot of people don’t file complaints, and on-site inspections only require what the regulations say – which don’t always focus on what is important.

"We want to look at regulations in a different way, and require hospitals to have quality assurance mechanisms in place to assure that problems don’t occur and to correct problems when they occur," she adds.