VAMC managers did not properly supervise SPD assets, which resulted in the cancellation of 81 surgeries in November of 2003 and February of 2004. In addition, we found serious deficiencies in the process that provides sterilized surgical instruments and equipment to the Operating Room (OR).

The SPD Service cleans, processes, stores, and distributes sterile and non-sterile supplies, instruments, and medical equipment for clinical use. SPD has significant surgical support responsibility to ensure that all necessary supplies and equipment are sterilized and readily available for operative procedures. SPD inefficiencies and errors at the VAMC have negatively impacted patient care activities.

To prepare for surgeries, OR nursing employees review surgeries scheduled for the next day and complete "pick tickets" that identify items needed for each upcoming surgical case. SPD employees are supposed to stock OR case carts based on the pick ticket requests. In the past year, OR nurses noted an increase in the number of supplies or instruments missing from case carts. The OR Nurse Manager attributed this to the retirements of skilled SPD employees. The OR nurse manager told us that she addressed individual case cart deficiencies directly with the SPD supervisor as they arose. She also told us that, in mid-October 2003, she notified the Nurse Executive of ongoing SPD problems after she could not locate urinals for patients waiting in the OR surgical holding area. The Medical Center Director and Chief of Staff (COS) cancelled 37 elective surgeries scheduled for November 19-21, and November 24 in response to the issues raised by the following cases that occurred between September 26 and November 6, 2003:

1. • A urologic surgery was cancelled because the laser was not on the surgical case cart.
2. • An orthopedic surgery was cancelled because the sterile instruments made available for this procedure were past the sterilization expiration date. The patient scheduled for the procedure had been medicated for surgery prior to cancellation.

VA Office of Inspector General 3

Managers informed us that they cancelled the 37 elective surgeries in November 2003 to allow the facility an opportunity to "take a pause, regroup, and be sure it is right". All 37 elective surgeries were rescheduled, and the last rescheduled surgery was completed on January 23, 2004. Urgent and emergent surgical cases were completed as scheduled, and were not affected by the stand-down. According to the COS and OR nurse manager, SPD performance improved for a brief time after the surgery stand-down, only to deteriorate again soon thereafter. The COS, Associate Medical Center Director, Chief of Acquisition and Material Management Service (A&MM), Nurse Executive, and the OR Nurse manager held daily meetings to discuss OR needs and SPD support.

From February 17-20, 2004, the Director and other senior managers cancelled the following surgeries as a result of several incidents the previous week that compromised quality patient care and safety:

A total of 44 elective surgical procedures were cancelled in February 2004. Five patients’ surgeries were completed within 72 hours of the original scheduled surgery dates. The

VA Office of Inspector General 4

VA Office of Inspector General 5

We found that the BPVAMC Dialysis Unit has not developed sufficient internal policies and procedures and lacked an adequate organizational structure to ensure that the quality of care provided to dialysis patients meets acceptable standards.

Although BPVAMC has various procedures relating to several aspects of dialysis patient care, it does not have a comprehensive policy manual, dialysis nursing scope of practice, or standards of nephrology practice. The BPVAMC Chief Nurse, Acute Care, and the Director of Dialysis stated that the Dialysis Unit previously had a policy manual but was unable to locate it during our visit. The lack of clear policies and procedures has resulted in Dialysis Unit clinical and technical staff following inconsistent practices. For example, we interviewed three dialysis staff about blood leak management procedures. All three described different steps to follow in the event of blood leaks. We reviewed the Dialysis Unit procedure for blood leak management and found it to be unclear and open to differing interpretations.

We found that many of the problems the Dialysis Unit has experienced are directly or indirectly attributable to operational deficiencies and weaknesses in the program’s organizational structure. ...

Bay Pines Radiology Backlog Unacceptable and Affects Patient Care According to VA OIG

   ...Radiology Service had extensive backlogs for film and image interpretations. Once radiological examinations are completed, a radiologist must review the films or images produced and provide a diagnostic interpretation. The time frame within which a radiological study should be interpreted depends on the type of examination and the urgency of the request. According to facility guidelines, “stat” (emergency) requests require the examination to be performed and its interpretation completed within 1 hour. “Urgent” requests require the examination and interpretation within 2 hours. “Routine” requests require the examination within 30 days and image interpretation within 4 days of examination completion.
    Image interpretation backlogs have been a long-standing problem at the BPVAMC. A February 26, 2003, memorandum from the Chief, Clinical Diagnostic Support Service (CDSS) to the Chief of Staff reported that, “As of February 26th, the CDSS Imaging section has reduced the backlog of unread exams from 3000+ to 900 over the past 2 weeks,” and that “…it is our hope that by mid March [2003] the section will be able to perform a 48 hour or less turn around time for all imaging exams.” However, as of February 24, 2004, there remained 1,099 unread examinations, with some routine MRI examinations dating back to December 9, 2003.
    The Acting Chief, Radiology Service, reported that delays in image interpretation were the result of management’s failure to listen to his needs and their denial of his repeated requests for resources. In May 2001, Radiology Service phased in various components of the Picture Archive Communication System (PACS) program, which allows radiologists and other providers to view digital images on computer workstations, thus obviating the need for hard copy films. By July 2003, all radiographic images (with the exception of mammograms) were available on and interpreted from PACS. This enhanced technology resulted in an increase in the number images needing interpretation.
    Timely interpretations are critical to quality patient care. Delayed interpretations of radiological examinations can result in delayed diagnosis and, for some patients, a delay in instituting potentially life-saving treatment.

One case in which a delay in interpretation resulted in a poor outcome was identified, as follows:
On June 17, 2003, a veteran was seen at a CBOC for a complaint of chronic back pain and numbness that extended down his right leg. His physical exam did not localize to a specific anatomical area. A diagnosis of low back pain was made with plans to obtain spine films at a future date if the pain continued. On October 31, 2003, the veteran called a BPVAMC health care provider to indicate that he was experiencing abdominal pain that felt like a “rope tightening.” The veteran was offered and accepted an appointment with a primary care provider on November 20, 2003. At this visit, the patient offered the same complaints of abdominal pain and indicated that he had decreased sensation from his “mid-abdomen down.” Upon examination he was found to have a decreased sensation to a sharp pin below the T8 thoracic spine level. The provider assessed the patient to have thoracic spine disease and ordered an MRI. The MRI was performed on November 21, 2003, but not interpreted until December 16, 2003, at which time it was recognized that this patient had a T3 thoracic spinal cord tumor. The patient was seen in clinic on December 17, 2003, and informed of the results of his MRI. During this visit he indicated that his symptoms had progressed. The patient was then referred to a civilian neurosurgeon and had spinal surgery on January 9, 2004. Postoperatively, he has significant paralysis in both lower extremities and is incontinent. VA  OIG Report August 12, 2004

Bay Pines VA Physicians Fail to Follow Up on Lung Cancer Cases

There Were Long Delays in Diagnosing Lung Cancer

    We reviewed 10 patient medical records that were referred to us to assess the length of time between the first radiological evidence of suspicious lung lesions and definitive diagnosis. In six of these cases, the time elapsed from first detection of a lesion on chest x-ray (CXR) to tissue diagnosis ranged from 49 days to 126 days (mean 82 days). In 2 of the remaining 4 cases, a clinical decision by a physician to monitor the abnormality with serial CT scans was made. In the third of the remaining 4 cases, no physician followed up on the abnormal CXR. In the fourth case, appropriate work-up was scheduled, but the patient did not keep numerous appointments for further evaluation. The clinical presentation and ensuing events for 2 of these 10 cases are detailed below:
• On August 13, 2003, the patient had a CXR that revealed a patchy density in the left upper lung region that suggested the presence of either an inflammatory process or a cancer (or both). The radiologist indicated that this CXR was, “abnormal, needs attention.” On October 23, 2003, the patient had a chest CT scan that was interpreted as showing a lung lesion consistent with malignancy. On November 25, 2003, he was seen by a pulmonologist who scheduled a chest CT scan with biopsy for December 24, 2003. However, on December 13, 2003, before that biopsy was performed, the patient presented to the medical center’s emergency room with a fever, and was admitted to the medical center whereupon a new CXR showed that the lung mass had increased to five times its previous size. On December 17, 2003, he had a chest CT with biopsy that was positive for non-small cell lung cancer. The total elapsed time from the initial suspicious CXR to a definitive diagnosis of non-small cell lung cancer was 126 days.

• On September 11, 2003, the patient had a CXR that showed increasing fibroganulomatous changes (i.e., evidence of active inflammation and scarring) that had developed since the patient’s previous CXR 5 months earlier. On October 24, 2003, the patient had a chest CT scan that showed a density in his left lower lung extending to the left hilum (the base of the tracheobronchial tree). The cause of this abnormality was not known, and a lung cancer could not be excluded on the basis of the radiological tests alone. On December 31, 2003, the patient had a bronchoscopy with biopsy that revealed a small cell lung cancer. The time elapsed from the CXR showing an active and progressing process in the patient’s lungs until the definitive diagnosis that small cell lung cancer was the cause of this process was 112 days.VA  OIG Report August 12, 2004