FROM THE CLAIMS CONSULTANT
by: Stan Strasner, Senior Claims Consultant
It is important that a hospital have a designated schedule for maintenance and cleaning of their equipment. These schedules should cover in house testing as well as preventive maintenance. They should be easily accessible and readily available for the staff to see. This will also serve to potentially mitigate any legal claims against the facility if the facility can produce a written maintenance schedule. Making sure that lab equipment is properly calibrated can prevent serious consequences as will be seen later in the article. Each unit should have a designated person to handle maintenance and cleaning.
Two examples of what can happen when equipment is not maintained properly are as follows: in the first case, a patient had an open heart procedure and after the procedure he was prescribed Coumadin and was instructed to visit the lab at the facility several times for blood analysis while he was on the Coumadin. After this had gone on for a while, he received a call from the lab telling him to discontinue taking the Coumadin immediately. It turns out that he had a large fluid mass in his lung and that a substantial amount of dark, red fluid removed from his lung. He was subsequently told that the lab equipment being used by the hospital for his blood results had not been calibrated properly resulting in several misdiagnoses of lab results.
Next, a TENS unit at a facility that was being used for rehab burned a patient significantly on her back and buttocks. The cause for the malfunction is ongoing although at this point it certainly would appear to be equipment malfunction rather than employee error.
If there is an issue with equipment, it is important to look at possible avenues of recovery from a manufacturer or company that may service the equipment. In the case of the previous example of the TENS unit, the manufacturer has taken it for testing. If a warranty is still in effect, then a manufacturer should certainly be put on notice of a problem. Even if there is not a warranty still in effect, if a piece of equipment malfunctions, all avenues of possible recovery should be explored. If a piece of equipment is taken out of a facility for testing then there needs to be clear documentation on who took possession and when. Also, whenever possible, have the manufacturer do the post incident testing at the hospital.
However, if that is not an option and the equipment is taken back to the manufacturers’/testing location, the hospital should first have it tested by a bio-med person of the hospitals’ choice in the likelihood that the manufacturer that the manufacturer says (as they normally do) that there is no issue with the product and the incident was due to user error.
FROM THE PATIENT SAFETY CONSULTANT
by Michelle Schouest, RN, BSN, Senior Patient Safety Consultant
Many decisions are based on the results of medical equipment in the hospital. Lab results, radiology results and monitors to name a few. Because of this it is imperative that equipment be handled appropriately, properly maintained, and calibrated to ensure reliability. With frequent use of equipment comes the increased probability that one or more of these pieces of equipment will be involved in incidents within the facility. When this occurs it is vitally important to handle the equipment appropriately in order to obtain valuable information in the investigation of the event.
When a piece of equipment is involved an occurrence the following should take place:
- The equipment should be sequestered
- All incident related products should be labeled with the patient’s name, date and time of incident, and signature of person that collected and secured the device.
- Store in a locked area away from other devices
- Photos of the environment the device was used in should be taken as well as any injury that occurred.
- Consult with appropriate parties regarding storage of data in the memory of the device and ensure memory is secured.
- No suspect device should be returned to service until it has been properly evaluated and eliminated as a possible cause of patient harm.
Just as it is important to properly sequester equipment after an incident it is equally important to perform and document regular service maintenance. Hospitals have a legal duty to maintain safe equipment. This can be accomplished via in house staff, the manufacturer, or a third party organization. The Joint Commission’s requirements for accreditation standard EC.02.04.01 requires hospitals to inspect, test, and maintain medical equipment; documentation that these actions have been completed is also required for all equipment. Hospitals should have policies on the care and maintenance of equipment and be able to provide documentation that the policies are followed and consider the below recommendations:
- Determine the service needs for the devices within the hospital
- Determine if the required maintenance can be carried out by hospital employed staff, the manufacturer, or a third party (see the attached article for more information and considerations on this topic)
- Regardless of the type of equipment service the facility chooses, ensure that service is carried out as scheduled, performed properly, and is well documented.
- Ensure that service contracts are periodically reviewed, services evaluated and negotiate.
For more related risk reduction consultation or should you have questions about this subject matter, please contact your Claims and Risk Service Team members:
|Mike Walsh, AIC, CPCU
Liability Claims Manager
|Stacie Jenkins, RN, MSN
Sr. Director of Quality & Patent Safety
|Allison Rachal, RN-BC
Sr. Patient Safety Consultant
|Michelle Schouest, RN, BSN
Sr. Patient Safety Consultant