Department of Veterans Affairs 

Office of Inspector General 

Healthcare Inspection 

Alleged Mismanagement of Resources 

and Patient Safety Issues 

VA Northern Indiana Health Care System 

Fort Wayne and Marion, Indiana 

Report No. 09-02346-90 March 2, 2010

VA Office of Inspector General 

Washington, DC 20420 
To Report Suspected Wrongdoing in VA Programs and Operations: 

Telephone: 1-800-488-8244 

E-Mail: vaoighotline@va.gov

(Hotline Information: http://www4.va.gov/oig/contacts/hotline.asp) 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

Contents 

Page 

Executive Summary ..............................................................................................i

Purpose ................................................................................................................. 1 

Background .......................................................................................................... 1 

Scope and Methodology ...................................................................................... 4 

Inspection Results ............................................................................................... 4

Issue 1 Instrumentation Problems Persist with Sets and Peel Packages .......................... 4

Issue 2 Ongoing Reusable Medical Equipment Issues. ................................................... 5

Issue 3 SPD Stocking and Dating of Supplies ................................................................. 6 

Issue 4 Pharmacy Stocking of OR, PACU, and EU Medications ................................... 8 

Issue 5 Management Issues .............................................................................................. 8

Issue 6 Other Quality of Care Concerns Identified ......................................................... 9 

Conclusions ........................................................................................................ 10 

Recommendations ............................................................................................. 10 

Comments ........................................................................................................... 11 

Appendixes

A. VISN Director Comments ....................................................................................... 12

B. Acting System Director Comments ......................................................................... 13

C. OIG Contact and Staff Acknowledgments ............................................................... 18

D. Report Distribution .................................................................................................. 19

VA Office of Inspector General 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

Executive Summary 

The VA Office of Inspector General, Office of Healthcare Inspections received 

allegations regarding mismanagement of resources and patient safety issues at the VA 

Northern Indiana Health Care System (the system) in Fort Wayne and Marion, Indiana. 

The purpose of the review was to determine whether the allegations had merit. 

The complainant made the following allegations pertaining to: persistent instrumentation 

problems with Operating Room (OR) sets and peel packages; ongoing reusable medical 

equipment issues; Supply, Processing, and Distribution (SPD) stocking and dating of 

supplies; pharmacy stocking of Operating Room, Post Anesthesia Care Unit, Endoscopy 

Unit (OR, PACU, EU) medications; and management issues. 

We substantiated the allegation that OR sets and peel packages continue returning from 

the Marion campus’ SPD incorrectly as previously noted by a number of external 

reviewers. We substantiated the allegation that SPD technicians were unable to identify 

instruments, and pictures of instruments to assemble instrument sets, as previously 

recommended, would have been helpful. 

We did not substantiate that two new HQ180AL model endoscopes were damaged by 

improper handling. We were unable to substantiate or refute the allegation that leak 

testing was not consistently done on the B-K 8800 rectal probe. We did not substantiate 

that endoscopic procedures must be conducted in the small OR because the air handling 

system in the larger ORs cannot pass inspections. 

We did not substantiate the allegation that assigned OR, PACU, EU supply technician 

was reassigned numerous times to cover the entire hospital so no one administered 

Integrated Funds Control Point Activity, Accounting and Procurement labels and 

routinely monitored for outdated supplies. 

We substantiated the allegation that an ankle fusion procedure, which required an 

implant, was canceled and rescheduled three times, however we did not find that 

cancellations were all related to the system’s inability to provide the implant and 

instrumentation sets. 

We were unable to substantiate or refute the allegation that pharmacy technicians remove 

expired medications and don’t always replace them. We substantiated the allegation that 

specific medication was ordered but not present 7 days later so pharmacy borrowed the 

medication from a local hospital. We were unable to substantiate or refute the allegation 

that outdated medication was found on an anesthesia medication cart because we could 

not rule out that expired medications were found during the system’s internal inspections. 

We did not substantiate the allegation that Sodasorb® for the anesthesia machine was 

expired, resulting in the delay of a surgical case. 

VA Office of Inspector General i 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

VA Office of Inspector General ii 

We substantiated the allegation that the OR, PACU, EU nurse manager is responsible for 

providing coverage in other areas of the hospital and is unavailable to guide staff. 

We found other quality of care issues with the Fort Wayne Campus’ environment and 

maintenance that needed to be addressed. 

We recommended that the Veterans Integrated Service Network Director ensure that the 

Acting System Director correct OR and SPD instrumentation problems, take action to 

ensure that all SPD supplies and equipment are properly managed and ready for patient 

care as required by Veterans Health Administration policy, review the OR, PACU, EU 

nurse manager supervisory roles and responsibilities to ensure they are appropriate, and 

require that identified environmental and maintenance concerns be addressed. 
DEPARTMENT OF VETERANS AFFAIRS

Office of Inspector General 

Washington, DC 20420 

TO: Director, Veterans In Partnership (10N11) 

SUBJECT: Healthcare Inspection – Alleged Mismanagement of Resources and 

Patient Safety Issues, VA Northern Indiana Health Care System, 

Fort Wayne and Marion, Indiana 

Purpose 

The VA Office of Inspector General (OIG), Office of Healthcare Inspections received 

allegations regarding mismanagement of resources and patient safety issues at the VA 

Northern Indiana Health Care System (the system) in Fort Wayne and Marion, IN. The 

purpose of the inspection was to determine the validity of the allegations. 

Background 

Located in Fort Wayne and Marion, IN, the system is part of Veterans Integrated Service 

Network (VISN) 11. The Fort Wayne facility provides inpatient medical and surgical 

care and has an Intensive Care Unit (ICU). The Marion facility provides chronic and 

acute psychiatric care and long term care, serving as the psychiatric referral hospital for 

veterans throughout the state of Indiana. The Fort Wayne and Marion campuses are 

located approximately 56 miles apart. The system has 22 medical/surgical and 4 ICU 

beds, 75 acute psychiatry beds, and 150 community living center beds. Outpatient care is 

provided at three community based outpatient clinics in South Bend, Muncie, and 

Goshen, Indiana. The system serves a veteran population of about 85,000 throughout 26 

counties in Indiana and 3 counties in Ohio. 

The complainant made the following allegations: 

1. Instrumentation problems persist with operating room (OR) sets and peel 

packages. 

(a) Sterile sets and peel packages are returning from the Marion Supply, 

Processing, and Distribution (SPD) incorrectly in the following manner: 

damaged, single packed instruments when a set is required, two of the same 

size items when different sizes are required, and sets contain multiple 

instruments that have been identified as needing replacement or repair. 

VA Office of Inspector General 1 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

VA Office of Inspector General 2 

(b) Staff are unable to identify instruments. 

2. Ongoing reusable medical equipment (RME) issues. 

(a) Two new HQ180AL1

 endoscopes were damaged by improper handling. 

(b) Leak testing2

 was not consistently done on the B-K 8800 rectal probe3 prior to 

being placed in the STERIS SYSTEM 1®.4

(c) Endoscopic procedures are conducted in the small OR because air handling 

systems in the larger ORs cannot pass inspections. 

3. SPD stocking and dating of supplies. 

(a) Assigned OR, Post Anesthesia Care Unit (PACU), Endoscopy Unit (EU) 

supply technician was reassigned numerous times to cover the entire hospital 

so no one administered Integrated Funds Control Point Activity, Accounting 

and Procurement5

 (IFCAP) labels and routinely monitored for outdated 

supplies. 

(b) An ankle fusion procedure, which required an implant, was canceled and 

rescheduled three times. 

4. Pharmacy stocking of OR, PACU, EU medications. 

(a) Pharmacy technicians removed expired medications and don’t always return 

them. 

(b) Specific medication was ordered but not present 7 days later so Pharmacy 

borrowed the medication from a local hospital. 

(c) Outdated medication was found on an anesthesia medication cart. 

(d) Sodasorb®6

 for the anesthesia machine was expired, resulting in the delay of a 

surgical case. 

5. Management issues. The OR, PACU, EU nurse manager is responsible for 

providing coverage in other areas of the hospital and is unavailable to guide staff. 

 

1

 Scope model number identified by the complainant to describe a specific endoscope. 

2

 The determination of any openings in the external surfaces and internal channels that would permit fluid to enter 

the internal body of the endoscope. 

3

 Device used to perform prostate biopsies. 

4

 A brand name for a low temperature sterile processing system for immersible surgical and diagnostic devices. 

5

 VA database system used to manage the receipt, distribution, and stock maintenance of items received from the 

supply warehouse and/or outside vendor. 

6

 An absorbent that removes carbon dioxide safely from anesthesia systems during surgery. 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

Instrumentation problems, sterilization issues, and SPD process issues have been noted 

by a number of external reviewers over the last 3 years. On September 4–6, 2007, 

Veterans Health Administration’s (VHA) SPD Executive Manager conducted a site visit 

at the system. They identified problems with instrument sets, the transportation of 

supplies and instruments between the two campuses, sterilization records, outdated 

supplies, and staff competencies. 

A General Surgery Service external site visit was conducted by a physician and registered 

nurse (RN) October 11–12, 2007. The report cited numerous issues including a lack of 

surgery-specific instruments and sutures, and incorrect instruments within sets. In midOctober 2007, the System Director “halted” complex abdominal and major surgeries, 

including colon and gall bladder surgeries, pending review of their surgical program and 

to allow time for rebuilding the surgery program. 

VHA’s Office of the Medical Inspector conducted a quality of care review at the system 

on December 5–7, 2007. They also noted problems with instrument sets and challenges 

in sterilization due to the transporting of instruments between the two campuses. 

A National Surgical Quality Improvement Program (NSQIP) site visit was conducted 

March 4–5, 2008. The review team noted that sterile packs received in the OR varied 

daily and often did not include the required instruments. Additionally, the team noted 

challenges in having surgical activities at one campus and the main SPD sterilization 

activities located at the other. On May 27, 2008, an external review team recommended 

that managers develop Standard Operating Procedures (SOPs) regarding outdated 

supplies; establish quality management tools to track instrument set accuracy, supply 

availability, and sterilization; and develop plans for routine instrument set maintenance. 

On June 3–4, 2009, another site visit was conducted by a VISN 11 team as part of an 

ongoing initiative to ensure the safety of veteran patients. The purpose of the visit was to 

review how the system processed and cleaned all types and models of scopes. During the 

Marion campus visit, the team noted inadequate measuring of solution used for cleaning 

scopes, a lack of preventive maintenance (PM) labels on equipment, and a lack of 

training/competency records for a new employee who conducted sterilization. During the 

Fort Wayne campus visit, the team noted that some equipment lacked PM labels, there 

was a lack of training/competency records for employees, and that there were no 

biomedical engineering safety stickers on equipment. 

October 5–9, 2009, VISN 11 Director initiated a training enhancement period for system 

staff. In preparation, 86 patients with scheduled surgical procedures were notified of 

rescheduling, or in cases where the procedures were urgent, referrals to fee basis 

providers were made. Focus for the training included assessment of compliance with 

previously established action plans, developing and teaching OR supply procedures and 

practices, and assessing training for specific surgical supply management. 

VA Office of Inspector General 3 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

November 3, 2009, the System Director retired, and effective November 9, an Acting 

System Director was appointed. 

Scope and Methodology 

We conducted an onsite visit July 28–31, 2009, which included both Fort Wayne and 

Marion campuses, and interviewed the complainant, system senior managers, and other 

clinical and administrative staff who were knowledgeable about the allegations. We 

reviewed pertinent documents to include VHA and system policies and procedures, The 

Joint Commission (JC) standards, and selected administrative and management 

documents related to the allegations. We requested and reviewed SPD reprocessing 

methods used throughout VHA’s medical facilities. We monitored and followed up on 

the most recent system and VISN 11 changes and developments involving management 

actions to improve the quality of care for patients from the onsite visit through 

December 2, 2009. 

We conducted the inspection in accordance with Quality Standards for Inspections

published by the President’s Council on Integrity and Efficiency.

Inspection Results 

Issue 1: Instrumentation Problems Persist with OR Sets and Peel Packages. 

Complaint (a): Sets and peel packages are still returning from the Marion SPD 

incorrectly. 

We substantiated the allegation. The system has a history of instrumentation problems 

that have been noted by a number of external reviewers. Our inspection revealed that 

these problems have not been resolved. OR staff provided us with a log of instrument 

count sheets used to document problems for calendar years (CY) 2008 and 2009–July 9. 

The table below summarizes the types of problems and number of occurrences. 

Instrument 

damaged and 

needs to be 

replaced 

Instrument 

needs to be 

sharpened 

or repaired 

Improper 

sterilization 

(i.e., metal to 

metal, tape or 

tags not 

removed) 

Wrong 

instrument 

in case/set 

Instrument 

missing 

from set 

Set 

contaminated 

by 

compromised 

wrapping or 

debris on 

instrument(s) 

CY 2008 13 10 6 7 4 21 

CY 2009 – 

July 9 

14 5 3 9 16 4 

VA Office of Inspector General 4 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

Managers had not taken appropriate actions to address ongoing instrument problems. 

Some of these issues caused patient surgical delays, cancellations, and other problems. 

Complaint (b): Staff are unable to identify instruments. 

We substantiated the allegation. During the September 4–6, 2007, site visit, VHA’s SPD 

Executive Manager recommended staff training on instrument identification and that 

pictures be taken of each instrument and instrument set to aid SPD staff in putting the sets 

together. This need was also cited during the March 2008 NSQIP site visit. SPD 

technicians reported that instrument training was completed. However, pictures had not 

been taken, and SPD technicians acknowledged that this would be helpful in recognition 

of instruments and assembly of instrument sets. 

Issue 2: Ongoing Reusable Medical Equipment Issues. 

Complaint (a): Two new HQ180AL scopes were damaged by improper handling.

We did not substantiate the allegation. The complainant alleged that two HQ180AL 

(model number) endoscopes were damaged. However, the system does not have any 

endoscopes of that model. The system has in inventory eight CF H180AL colonoscopes, 

five PCF H180AL colonoscopes, and eight GIF H180AL gastroscopes. We requested 

repair records and associated costs for all scopes sent for repair during the 12 months 

prior to our inspection. Four of the colonoscopes were sent for repair. Of these, one 

colonoscope required two separate repairs, and three colonoscopes required one repair 

each. None of the gastroscopes required repair during that timeframe. 

Providers told us that the system’s scopes were of high quality. They also stated that 

scope repairs are to be expected, proportionate to high-volume usage and the rigorous 

cleaning process. None of the providers or nursing staff interviewed had concerns or 

were aware of any complaints regarding improper handling of scopes. 

We inspected the room where scopes are stored prior to use, and noted that employees 

followed manufacturer recommendations for scope storage. Employees properly 

demonstrated scope handling, and they correctly articulated how scopes are managed 

during the cleaning process. On March 9, 2009, the endoscope manufacturer 

representative was onsite to conduct in-service training including pre-cleaning, leak 

testing, manual cleaning, automated endoscope reprocessor high-level disinfection, 

manual high-level disinfection, rinsing, alcohol flush, and endoscope storage. Staff 

competency was assessed and verified for employees responsible for endoscope 

reprocessing. 

VA Office of Inspector General 5 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

VA Office of Inspector General 6 

Complaint (b): Leak testing was not consistently done on the B-K 8800 rectal probe 

prior to being placed in the STERIS SYSTEM 1. 

We were unable to substantiate or refute the allegation because we could not be certain 

that leak testing was always done before placement in the STERIS SYSTEM 1. 

Like other endoscopes, the B-K 8800 rectal probe is categorized as RME. All RME must 

be checked regularly to maintain a high level of safety, and proper pre-cleaning is 

essential for the success of any disinfection or sterilization process. Providers told us that 

once a biopsy is completed in the OR, the rectal probe is wiped down with a disinfectant 

and then sent to SPD for further reprocessing. We inspected the SPD department and 

reviewed competency records for staff responsible for RME cleaning and disinfection. 

Leak testing supplies were available in the department, and competency records indicated 

that staff had been appropriately trained on reprocessing RME, which includes leak 

testing. 

Complaint (c): Endoscopic procedures must be conducted in the small OR because the 

air handling system in the larger ORs cannot pass inspections.

We did not substantiate the allegation. We inspected the EU and ORs at the Fort Wayne 

campus. Staff were conducting endoscopic procedures in the small OR, room 307, 

because one of the two endoscopy procedure rooms, room 368, was under construction. 

The nurse manager did not report air handling concerns with the EU or the OR. In 

addition, we reviewed OR air handling records and found conditions to be within normal 

ranges for air conditioning and ventilation. Unlike ORs, endoscopy procedure rooms do 

not require a dedicated air handling unit. Heating, ventilation, and air conditioning in 

endoscopy procedure rooms can be maintained similar to examination rooms.7

During our July 30 inspection, an endoscopic procedure was in progress in room 366, 

while the second endoscopy procedure room, room 368, remained unused. The OR staff 

reported that room 368 was not ready for use because construction had not been 

completed. Engineering staff told us that construction for room 368 began on July 26, 

2008, and was completed on July 9, 2009. OR staff requested installation of a different 

lighting system for room 368, and, therefore, elected to continue to perform endoscopic 

procedures in room 366 until the new lighting system was installed. 

Issue 3: SPD Stocking and Dating of Supplies. 

Complaint (a): Assigned OR, PACU, EU Supply Technician was reassigned numerous 

times to cover the entire hospital so no one administered IFCAP labels and routinely 

monitored for outdated supplies.

 

7

 Department of Veterans Affairs, Office of Facilities Management, Strategic Management Office, Facilities Quality 

Service. 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

VA Office of Inspector General 7 

We did not substantiate the allegation. While the SPD staff assigned to the OR, PACU, 

and EU covered additional clinical areas, we did not find missing IFCAP labels during 

our inspection of those clinical areas. In addition, we did not find any expired disposable 

supplies. 

However, at the Fort Wayne SPD, we found sterile gloves without expiration dates on the 

packages. The SPD supervisor and technicians told us that there was a coded “expiration 

date sheet” which would show the date of expiration for each item; however, the 

supervisor could not provide us with this document. Staff in all clinical areas must 

ensure the integrity of products and that items are not used beyond the expiration dates. 

Complaint (b): An ankle fusion procedure, which required an implant, was canceled 

and rescheduled three times. 

We substantiated the allegation. However, we did not find that cancellations were all 

related to the system’s inability to provide the implant and instrumentation sets. 

A patient was scheduled for an ankle fusion in Same Day Surgery (SDS) on January 23, 

2009. This surgery was canceled and rescheduled for February 13 because the patient 

developed acute left hand and wrist gout. 

On February 6, the patient was seen in SDS nursing pre-operative instructions clinic; and 

on February 11, he was seen by his podiatrist to obtain consent for surgery. The 

podiatrist informed the patient that the screw set that had been ordered had not yet arrived 

and that the patient would be notified whether the surgery would take place as scheduled. 

After seeing his podiatrist, the patient went to walk-in triage clinic and complained of 

pain in his left wrist. An RN documented that the patient’s left wrist and hand were 

reddened, swollen, and painful to touch. The patient was treated in the Emergency 

Department and the surgery that was rescheduled for February 13 was canceled and 

rescheduled again for February 20. 

On February 19, the podiatrist documented that the February 20 surgery was canceled 

“because SPD failed to process the implants in a timely manner despite repeated 

notifications.” Documentation notes that the podiatrist “declined to set up another 

surgery time” and that the patient would be referred to fee basis.8

 A fee basis consult 

was written the following day. 

 

On April 9, the podiatrist documented that the patient called and stated that the fee basis 

physician “declined to do surgery” and said that he needed a leg brace. That same day 

the podiatrist entered a consult for a “brace double upright for left shoe” as recommended 

by the fee basis physician. On June 30, the patient was seen by his primary care provider 

8

Program designed to assist veterans who cannot easily receive care at a VA Medical Center. 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

who documented: “Has had problems with left ankle, now wearing steel ankle brace 

which seems to be helping. Able to walk much better.” 

Issue 4: Pharmacy Stocking of OR, PACU, EU Medications. 

Complaint (a): Pharmacy Technicians remove expired medications and don’t always 

replace them.

We were unable to substantiate or refute the allegation. The complainant explained that 

expired medications are removed from service and not replaced. The complainant 

reported an incident where eye ointment was required for a surgical case and none was 

available. Four expired eye ointments were removed and not replenished, leaving none 

for patient surgeries. Staff we interviewed could not identify any specific expired 

medications or instances where medications were not replenished. We reviewed the 

Surgical and Anesthesia Care Committee minutes, and this issue was not identified as 

being problematic. 

Complaint (b): Specific medication was ordered but not present 7 days later so 

Pharmacy borrowed the medication from a local hospital. 

We substantiated the allegation. The Chief of Pharmacy indicated that it is a common 

practice to borrow or purchase medications from the community hospital if a medication 

is placed on backorder. We were told this process is supported by system policy but the 

Chief of Pharmacy could not recall the name or specific details of the policy. 

Complaint (c): Outdated medication was found on an anesthesia medication cart.

We were unable to substantiate or refute the allegation because we could not rule out that 

expired medications were found during the system’s internal inspections. During our 

inspection of the OR and anesthesia carts, we did not find expired medications. 

Managers were not aware of any problems with expired medications. We reviewed the 

Employee and Patient Safety Committee/Environment of Care Board meeting minutes 

from October 2008–June 2009, and this issue was not identified as being problematic. 

Complaint (d): Sodasorb for the anesthesia machine was expired, resulting in the delay 

of a surgical case.

We did not substantiate the allegation. We did not find expired Sodasorb during our 

inspection. Managers were unaware of any surgical case that was delayed due to 

problems with this product. We reviewed the surgical delay schedule and did not find 

documentation to support this allegation. 

VA Office of Inspector General 8 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

Issue 5: Management Issues. 

Complaint: OR, PACU, EU Nurse Manager is responsible for providing coverage in 

other areas of the hospital and is unavailable to guide staff. 

We substantiated the allegation. The complainant stated that the former nurse manager 

during the 2007 external review was covering SDS; OR; PACU; EU; eye clinic; ear, 

nose, and throat clinic; and surgery clinic. In a subsequent General Surgery Service site 

visit, it was also noted that the nurse manager continued managing multiple tasks and 

responsibilities outside of the OR and was unable to provide appropriate support to the 

OR activities. Both teams recommended a review of the nurse manager’s roles and 

responsibilities. On May 27, 2008, during a follow-up General Surgery Service review, 

the team noted that a new OR manager had been hired and this led to “significant 

improvement.” Additional external reviews conducted after the May 27 review, have not 

cited nurse manager coverage issues in their reports. 

We interviewed the nurse manager and the Associate Director for Patient Care Services 

who described the OR nurse manager duties to include coverage of the OR, PACU, SDS, 

EU, and podiatry. The OR nurse manager reported having 18 employees under her 

direction. The OR nurse manager was required to cover “once in awhile” for other 

inpatient areas such as the ICU and the medicine unit. The Fort Wayne campus filled a 

nurse manager vacancy; therefore, assignment to cover other areas has been minimal 

“during the last couple months.” 

Staff interviewed had differing opinions regarding the nurse manager’s availability. All 

of them acknowledged that the manager has multiple units to cover and is also 

unavailable at times due to other administrative assignments and meetings. 

Issue 6: Other Quality of Care Concerns Identified. 

Environmental and Maintenance Concerns Identified at the Fort Wayne Campus. 

We inspected the OR, PACU, EU, and SPD areas at both campuses. We also inspected 

the truck used to transport sterile and soiled instruments between the campuses. 

VHA and the JC have established guidelines regarding maintenance of the environment 

in VA medical facilities, particularly related to infection control, safety, and sanitation. 

Additionally, medical centers must take action to ensure that areas requiring high levels 

of sanitation, such as the OR and SPD, are appropriately maintained. During inspections 

at the Fort Wayne campus, we noted stained or damaged ceiling tiles in the anesthesia 

area (room 314), in the endoscopy procedure room (room 368), and in the EU storage 

area (room 369). 

In the Fort Wayne SPD, we found holes, penetrations, and cracks in the ceiling and walls 

in the clean room. There were holes in the wall surrounding the area where pipes 

VA Office of Inspector General 9 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

inserted in both the upper and lower areas of the cement wall. There was peeling paint 

over the field where endoscopes were reprocessed. A water leak was found under the 

cabinet for the STERIS SYSTEM 1, and the STERIS SYSTEM 1 filters were in standing 

water. The SPD supervisor and technician had been aware of the water leak but thought 

the issue was resolved. The leak had been fixed 2 days prior to our inspection, but water 

remained. The light banks were not flush with the ceiling, and visible cracks and peeling 

paint were noted. Air vents in the SPD were stained and unclean. There was an open 

drain in the floor with a grate ajar that appeared dirty and rusty. 

Instruments and flexible endoscopes that require sterilization are processed at the Marion 

campus. Surgery and endoscopic procedures are performed on the Fort Wayne campus. 

An enclosed truck is used to transport sterile and non-sterile items in case carts between 

the two campuses. An inspection of the truck was conducted at the Fort Wayne location. 

We noted an accumulation of debris on the grooved floor surface of the truck. The 

truck’s interior compartment door had oil and dirt on its surfaces. 

The truck was refrigerated; however, the driver was unable to articulate how temperature 

and humidity controls were maintained. The driver stated that the truck is cleaned 

weekly on Fridays and is spot cleaned as needed. The truck was not cleaned between 

trips from one campus to the other. This included the transport of non-sterile items, 

followed by the transport of sterile items. Sterile instrument pans inside the case carts did 

not have any additional dust or moisture protection such as plastic wrap. 

Conclusions 

There are continued surgical program issues related to the overall lack of an appropriately 

managed and safe infrastructure relative to the delivery of patient care in the OR. 

Extensive reviews conducted by VHA’s own independent reviewers show that ongoing 

issues that negatively affected the quality of care for patients have not been corrected. 

The numerous recommendations, action plans, and staff efforts to ensure a safe 

environment were not fully implemented or followed up as required. Attempts to resolve 

SPD issues to support operative services and provisions for safe patient care are lacking. 

Management’s oversight and abilities to recognize and to follow up on issues were not 

effective. Substandard environmental conditions and system maintenance problems must 

be corrected in order to provide safe patient care. 

The VISN Director effected several personnel changes as a result of the concerns 

regarding surgical services at the system and reported that personnel actions would be 

accomplished in accordance with Federal requirements. Management continues to follow 

up and correct prior recommendations from external reviews as well as their own most 

recent internal reviews. 

VA Office of Inspector General 10 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS 

VA Office of Inspector General 11 

Recommendations 

Recommendation 1. We recommended that the VISN Director ensure that the Acting 

System Director correct OR and SPD instrumentation problems. 

Recommendation 2. We recommended that the VISN Director ensure that the Acting 

System Director takes action to ensure that all SPD supplies and equipment are properly 

managed and ready for patient care as required by VHA policy. 

Recommendation 3. We recommended that the VISN Director require the Acting 

System Director to review the OR, PACU, EU nurse manager supervisory roles and 

responsibilities to ensure they are appropriate. 

Recommendation 4. We recommended that the VISN Director ensure that the Acting 

System Director requires that identified environmental and maintenance concerns be 

addressed. 

Comments 

The VISN and Acting System Directors concurred with the findings and 

recommendations of this inspection and provided acceptable improvement plans (see 

Appendixes A and B, pages 12–17, for the full text of the Directors’ comments). We will 

follow up on the planned actions until they are completed. 

 (original signed by:)

JOHN D. DAIGH, JR., M.D. 

Assistant Inspector General for 

Healthcare Inspections 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

Appendix A 

VISN Director Comments 

VA Office of Inspector General 12 

Department of 

Veterans Affairs Memorandum

Date: February 10, 2010 

From: Director, Veterans In Partnership Network (10N11) 

Subject: Response to Draft Report – Healthcare Inspection – Alleged 

Mismanagement of Resources and Patient Safety Issues, VA 

Northern Indiana Health Care System, Fort Wayne and Marion, 

Indiana

To: Director, Chicago Office of Healthcare Inspections (54CH) 

Thru: Director, Management Review Service (10B5) 

Per your request, attached is the response from VA Northern Indiana Health 

Care System. If you have any questions, please contact James Rice, 

VISN 11 QMO, at (734) 222-4314. 

Michael S. Finegan 

Attachment 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

Appendix B 

Acting System Director Comments 

VA Office of Inspector General 13 

Department of 

Veterans Affairs Memorandum

Date: February 10, 2010 

From: Acting Director, VA Northern Indiana Health Care System 

(610A4/00) 

Subject: Response to Draft Report – Healthcare Inspection – Alleged 

Mismanagement of Resources and Patient Safety Issues, VA 

Northern Indiana Health Care System, Fort Wayne and Marion, 

Indiana

To: Director, Veterans In Partnership Network (10N11) 

Per your request, attached is the response from VA Northern Indiana Health 

Care System. If you have any questions, please contact Kimberly L. 

Radant at 260-426-5431, extension 71504. 

Kimberly L. Radant, MS, RN 

Attachment 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

Acting System Director’s Comments 

to Office of Inspector General’s Report 

The following Acting Director’s comments are submitted in response to the 

recommendations in the Office of Inspector General’s report: 

OIG Recommendations

Recommendation 1. We recommended that the VISN Director ensure 

that the Acting System Director correct OR and SPD instrumentation 

problems. 

Concur Target Completion Date: Closed 

 Exception: Instrument Picture Target – April 1, 2010 

VISN and VA Northern Indiana Health Care System (VANIHCS) staff has 

reviewed numerous instrument sets on a recurring basis since issues were 

identified. OR and SPD staff have collaborated to determine the 

appropriate contents in sets and basins, cups have been removed, and count 

sheets are being updated. Staff education has been completed regarding the 

proper assembly of instrument sets. A “just-in-time” communication 

system has been set up to identify and correct any issues that occur with 

instrument sets. 

Multiple instrument sets have been processed through “test” runs. An 

interdisciplinary review of instruments sets indicates they are looking clean, 

and instances of minor water spotting are rare. No linen, debris, or other 

particulate matter has been observed. 

Staff in SPD has begun to send all instrumentation that is damaged or in 

need of repair to Bio-Medical Engineering. Bio-Medical Engineering 

repairs or recommends replacement of the instrumentation as needed. BioMedical Engineering is also a full participant in the newly developed 

communication processes. 

Staff has removed all known tape from instrumentation. Any remaining 

sterilized sets in remote areas that may contain tape will be immediately 

returned to SPD for tape removal and reprocessing. 

SPD is in the process of obtaining pictures of the instrument sets to assist 

staff in assembly of surgical sets. Education is ongoing to help staff 

identify instrumentation. Approximately 40 percent of the instrument sets 

VA Office of Inspector General 14 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

have pictures associated with them. This portion of the recommendation 

will be completed by April 1, 2010. 

SPD is in the process of developing a written Instrument Set Count Sheet 

procedure. This procedure will require all clinical areas receiving 

instrumentation from SPD to mandatorily fill out the count sheet and return 

it to SPD with any concerns or issues noted. This, in conjunction with the 

“just-in-time” communication chain, should provide improved 

communication and tracking of issues. The count sheet program will be 

incorporated in the SPD Performance Improvement Program and trends 

discussed at the SPD Interdisciplinary Committee. 

While actions have been taken to correct OR/SPD issues, monitoring for 

compliance and sustainability of corrective actions must continue.

Recommendation 2. We recommended that the VISN Director ensure 

that the Acting System Director takes action to ensure that all SPD 

supplies and equipment are properly managed and ready for patient 

care as required by VHA policy. 

Concur Target Completion Date: March 15, 2010 

SPD and Logistics has worked diligently to re-initiate proper generic 

inventory package (GIP) and revamp the IFCAP labeling system at both 

campuses. The goal is to have GIP fully implemented March 1, 2010. 

Reset of primaries at both campuses is complete. Bar code labels and data 

cleanup is in progress. Levels in Fort Wayne primary have been set. Work 

is progressing to secondary closets. Purchasing and posting of stock 

processes have been reviewed and improvement initiated. 

Facility outdate policy is complete and signed. The facility is still finding 

occasional outdated items, and this information is shared with staff and 

addressed on a “just-in-time” basis. This has improved since last fall. We 

continue to conduct regular outdate rounds, and we anticipate the rebuild of 

GIP will assist in the effort of reducing and removal of outdated items. An 

education module in Learning Management System has been assigned to all 

identified staff requiring knowledge to complete outdates of supplies. Over 

59 percent of the staff has completed this module, with an expected 

completion of remaining staff by March 15, 2010. 

VANIHCS SPD has posted the expiration data sheet for gloves and 

catheters in all areas where these items are stocked to assist with outdating. 

These specifically are items that do not have a clear expiration date on the 

packaging but rather have a shelf life determined by manufacturer 

VA Office of Inspector General 15 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

guidance. During Environment of Care (EOC) rounds, staff members 

completing rounds are required to assess supplies and check for outdated 

items. 

It is anticipated that OR morning report and OR/SPD communication chain 

will prevent any episodes where a procedure is cancelled because the 

instruments for the procedure were not sterilized or available in advance of 

the procedure.

Recommendation 3. We recommended that the VISN Director require 

the Acting System Director to review the OR, PACU, EU nurse 

manager supervisory roles and responsibilities to ensure they are 

appropriate. 

Concur Target Completion Date: Closed 

The Associate Director for Patient Care Services has determined the OR 

nurse manager will not be responsible to routinely cover other units in the 

absence of the nurse manager. This ensures the OR nurse manager is able 

to assist OR staff members as issues arise. The OR nurse manager is the 

direct supervisor for 20 staff members. The Acting Director has noted that 

the OR staff is acutely aware of and concerned any time anyone is detailed 

from the OR or when other duties are assigned to staff within the OR. 

Efforts will be made to utilize the communication chain to discuss such 

concerns and promote understanding and flexibility as workload demands 

fluctuate and require the adjusting of assignments, not just of the OR 

supervisor, but of the OR nursing staff as well.

Recommendation 4. We recommended that the VISN Director ensure 

that the Acting System Director requires that identified environmental 

and maintenance concerns be addressed. 

Concur Target Completion Date: Closed 

On July 31, 2009, all stained and damaged ceiling tiles were replaced. All 

holes and cracks in walls and ceilings of the clean room in SPD were 

repaired, and all signs of peeling paint were removed. Engineering repaired 

the leak below the STERIS SYSTEM 1, and there is no further evidence of 

water. These repairs and replacements in the SPD area were validated by 

the VISN during a visit August 5, 2009, and during subsequent EOC rounds 

by the VANIHCS staff. Environmental Management Service cleans this 

area on a daily basis. Cleaning schedules for SPD staff have been 

developed for both campuses. 

VA Office of Inspector General 16 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

VA Office of Inspector General 17 

VANIHCS developed an SPD Transport Truck SOP for the 

decontamination of the vehicle. This SOP was developed with the 

assistance of Infection Control and Safety. The SPD transport truck is 

decontaminated by wiping the inside walls, ceiling, and floor with 

enzymatic cleaner after each trip. Weekly, the truck is taken off post to be 

power washed. This is in compliance with the SPD Transport Truck SOP. 

Appropriate staff members have been educated, and their competency has 

been validated. 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

Appendix C 

OIG Contact and Staff Acknowledgments 

OIG Contact Verena Briley-Hudson, MN, RN 

Director, Chicago Office of Healthcare Inspections 

(708) 202-2672 

Acknowledgments Lisa Barnes, MSW, Team Leader 

Judy Brown, Program Assistant 

Paula Chapman, CTRS 

Reba Ransom, RN, MSN 

Roberta Thompson, MSW 

Ann Ver Linden, RN 

VA Office of Inspector General 18 
Alleged Mismanagement of Resources and Patient Safety Issues, VA Northern Indiana HCS

Appendix D 

Report Distribution 

VA Distribution

Office of the Secretary 

Veterans Health Administration 

Assistant Secretaries 

General Counsel 

Director, Veterans In Partnership Network (10N11) 

Director, VA Northern Indiana Health Care System (610A4/00) 

Non-VA Distribution

House Committee on Veterans’ Affairs 

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

House Committee on Oversight and Government Reform 

Senate Committee on Veterans’ Affairs 

Senate Appropriations Subcommittee on Military Construction, Veterans Affairs, and 

Related Agencies 

Senate Committee on Homeland Security and Governmental Affairs 

National Veterans Service Organizations 

Government Accountability Office 

Office of Management and Budget 

U.S. Senate: Evan Bayh, Sherrod Brown, Richard G. Lugar, George V. Voinovich 

U.S. House of Representatives: Dan Burton, Joe Donnelly, Robert E. Latta, Mike Pence, 

Mark E. Souder 

This report is available at http://www.va.gov/oig/publications/reports-list.asp. 

To Report Suspected Wrongdoing in VA Programs and Operations 

Call the OIG Hotline – (800) 488-8244 

VA Office of Inspector General 19