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Based on onsite recertification survey completed on 7/8/14, the facility failed to comply with the regulations set forth for Life Safety and, therefore were cited under Life Safety Code tags K11, K18, K25, K38, K50, and K130. See Survey ID# MMHE21 for full details of the cited deficiencies.

Based on observations, staff interviews, and document reviews, the facility failed to ensure that drugs and biologicals were stored appropriately.
The failure created the potential for negative patient outcomes related to administration of excessively heated intravenous (IV) fluids, irrigation fluids, and IV radiologic contrast media and/or administration of these to patients after loss of product integrity.
Findings:
Policy
According to facility policy, IV and Irrigation Solutions Stored in Warmer, the maximum fluid warmer temperature is 40 C or 104 F for IV solution in volumes of 150 ml or greater. Irrigation solutions in bags may be warmed to 45 C or 113 F. Irrigation fluids in screwcap bottles may be heated up to 122 F or 50 C.
1. The facility stored IV fluids and fluids for irrigation in an operating room warming cabinet that displayed a temperature of 116 degrees Fahrenheit (F), jeopardizing the integrity of the solution and creating risk of negative patient outcomes related to excessively heated fluid administration or administration of fluids lacking product reliability.
a) A tour of the operating room was conducted on 6/10/14 at 2:00 p.m., and revealed the following: a warming cabinet containing five 1,000 ml bags of IV lactated ringers solution, two 1,000 ml bags of normal saline solution, one 2,000 ml bag of Normal Saline (NS) for irrigation, two 250 ml bottles of NS for irrigation, four 100 ml bottles of NS for irrigation, and one 1,000 ml bottle of sterile water for irrigation displayed a temperature reading of 116 degrees Fahrenheit (F).
b) The daily temperature log for the warming cabinet in the operating room recorded temperatures of 116 F or higher between May 1, 2014 and June 11, 2014.
c) A review of Baxter Pharmaceutical manufacturer recommendations for storage of IV fluids obtained from the facility on 6/12/14 states, in pertinent parts " ...it is recommended the product be stored at room temperature ...brief exposure up to 40 degrees Celsius (C) does not adversely affect the product ". 40 C is equal to 104 F.
d) A review of an article provided by the facility on 6/12/14, written on behalf of Steris manufacturing cites a warning issued by the ECRI Institute, in pertinent parts: " ...fluid and blanket warmers should be limited to a temperature no higher than 43 degrees Celsius (110 F) to decrease the risk of thermal injuries to patients ". Steris is the manufacturer of the warming cabinet in use in the OR at the facility.
e) The facility failed to remove a fluid warming cabinet from service in the operating room that had a malfunctioning temperature control.
f) The Hospital Shared Services (HSS) representative was interviewed on 6/11/14 at approximately 10:00 a.m. S/he reported that s/he is responsible for validating temperature readings on all facility warming cabinets twice per year. S/he placed a probe in the cabinet during the interview which showed a temperature of 106.5 F to 106. 9F while the cabinet displayed a reading of 117 F. S/he reported s/he received a work order approximately one month ago related to a problem with temperature control of the unit, and that the repair needed to correct the malfunction had not yet been completed. A manual temperature knob on the cabinet was observed at a setting between 110 F and 120 F during the interview. S/he reported that the knob is not normally set in this range. S/he did not know who had changed the knob to those settings.
g) The operating room supervisor was interviewed on 6/10/14 at 2:20 p.m. S/he reported s/he checks the cabinet daily and records the temperature on the log. S/he was unaware that the temperature on the display was high enough to create the potential for negative patient outcomes.
h) The operating room supervisor was interviewed on 6/11/14 at 11:30 a.m., s/he revealed s/he was aware that the warming cabinet was in need of repair approximately one month earlier and that s/he had submitted the repair work order to HSS at that time and did not take the unit out of service.
i) A tour of the facility radiology department was conducted on 6/10/14 at 10:40 a.m., and revealed the following: a warming cabinet containing radiologic IV contrast media did not have a daily temperature log and there was not a device or method to monitor the temperature daily. A sticker was present on the side of the unit showing a handwritten temperature of 96.5 F and the numbers 4/14.
j) The radiology technician was interviewed on 6/10/14 at 10:45 a.m. S/he reported that the warming cabinet for IV contrast media is checked twice per year by the biomedical department and a sticker is placed on the unit denoting the temperature at that time and the date it was taken. S/he reports the numbers 4/14 on the unit indicate the temperature was measured in April of 2014. S/he reported that the radiology department does not monitor the temperature of the unit between the scheduled checks done by the biomedical department.
k) The HSS representative was interviewed on 6/11/14 at 10:00 a.m. S/he reported that HSS is the biomedical department/maintenance provider for patient equipment at the facility, and they validate temperatures on all facility warming cabinets twice per year. S/he reported that HSS places stickers on warming cabinets each time the temperature is validated and these are dated with the month and year the temperature check was performed. S/he reported that the numbers on the IV contrast warming cabinet sticker indicate the unit was validated April of 2014 with a temperature of 96.5 F. S/he also reported that the only way to monitor the temperature between checks is to place a thermometer inside the unit as there is not a display available on the unit itself for temperature readings.

Based on observations, interviews, and review of facility documents, the facility failed to ensure the confidentiality of medical information by providing safeguards against unauthorized use.

This failure had the potential to lead to unauthorized individuals accessing confidential medical information.

Findings:

Policy

According to facility policy, Medical Records Security, Inactive storage of medical records and archived statistical data will be locked at all times with access by Medical Records personnel, Administration or maintenance personnel in the event of an emergency. Medical records shall not be left unattended in areas accessible to unauthorized individuals.

1. The facility surgery logs containing confidential patient information were not secure.

a) On 06/10/14 at 2:05 p.m., a tour of the facility's surgical services area was conducted with the facility's Manager of Surgical Services. There was a log of all surgical patients for 2014 sitting on a desk at the pre/post operative nurses station. This log contained patients names, date of surgery and type of surgery. When asked where they would be after staff had left for the day the Manager stated that they placed the log in a drawer. The drawer where the log would be placed when staff left for the day contained two additional logs for 2013 and 2012. There was no lock on the drawer that contained the logs. The Manager also stated that housekeeping has access to this area and cleans at the end of the day after staff has left.

b) On 02/10/14 at 2:30 p.m., an interview with the Manager of Surgical Services was conducted. The Manager stated that s/he did not think that anyone would access those logs and assumed that they were secure even though there was no lock on the drawer.