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Based on observations and interviews, the facility failed to ensure the facility's sterilizer/autoclave received annual preventive maintenance.

This failure created the potential for patient harm due to lack of maintenance of this equipment which could contribute to the spread of infectious organisms if not properly maintained and correctly functioning.

Findings:

1. The main facility's sterilizer/autoclave was overdue for preventive maintenance.

a) On 08/14/13 at 10:31 a.m., the sterilizer/autoclave in the main, inpatient facility was noted to have a preventive maintenance sticker dated 12/11. The facility's Chief Compliance Officer confirmed this dated and stated this was the date the equipment last received preventive maintenance.

b) On 08/15/13, the facility's CCO stated the sterilizer/autoclave located in the main, inpatient facility was not found on the master list of equipment to be maintained. S/he stated environmental staff believed the contracted vendor who provided preventive maintance for this equipment was discontinued and had not been replaced. The CCO stated s/he could provide no documentation that the equipment had received preventive maintenance since 12/11 and the expectation was the equipment would be maintained annually.

Based on observations, interviews, and document review, the facility failed to ensure that medications available for patient use were appropriately stored.

This failure created the potential for patients to receive chemically altered medications by storing them in a refrigerator that was improperly monitored.

Findings:

1. The facility did not continuously monitor temperatures in refrigerators used to store patient medications.

a) On 08/13/13 at 10:30 a.m., the facility's document titled, "Refrigerator Pharmaceutical Storage Temperature Log," was reviewed for the months of June, July, and August of 2013. The medication refrigerator in the Acute Care Unit was missing temperature documentation on 07/10/13. The medication refrigerator in the Extended Care Unit was missing temperature documentation on 06/01/13, 06/15/13, 06/16/13, 06/23/13, and 07/09/13. The medication refrigerator in the Emergency Room was missing temperature documentation on 06/16/13, and 06/23/13. The medication refrigerator in the Pharmacy Room was missing temperature documentation on 06/16/13, 06/23/13, and 07/03/13.

b) On 08/13/13 at 10:35 a.m., the Chief Compliance Officer (CCO) was interviewed regarding temperature documentation of medication refrigerators. The CCO confirmed the temperature documentation was missing on the above mentioned dates and that the expectation would be to have consistent, daily, temperature documentation on all medication refrigerators.

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Based on observations and interviews, the facility failed to ensure the proper storage of medications and the proper discarding of single use bags of saline.

This failure created the potential for erroneous test results, expired medications to be administered to patients, and the potential for the spread of infectious organisms between patients as products intended for single use were used for more than 1 patient.

Findings:

1. The facility did not follow current standards of practice for multiple dose vials.

a) A position paper from the Association of Professionals in Infection Control and Epidemiology (APIC) titled, "Safe Injection, Infusion and Medication Vial Practices in Healthcare" published July 30th, 2009 stated, "Dispose of opened multidose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised..."

b) On 08/14/13 at 9:30 a.m., the medication room of the facility's outpatient clinic was toured. Opened multiple dose vials of Humalog, testosterone cypionate, and Kenalog-40 were found without labels stating either the date of when vials had been opened or the date of when the vials should be disposed of.

c) On 08/14/13 at 9:35 a.m., the clinic's Nurse Manager was interviewed regarding the multiple dose vials. The Nurse Manager confirmed the multiple dose vials were opened and that there was no indication of when the vials were to be disposed of. In addiction, the Nurse Manager stated that the expectation would be for multiple dose vials to be discarded 28 days after opening.

d) During the survey dates 08/12/13 through 08/16/13, facility policies were reviewed. No facility policy was found regarding the use and disposal of multiple dose medication vials. The facility's Chief Compliance Officer confirmed that surveyors had received all facility policies and written guidance related to medication administration.


2. The facility did not ensure that bags of normal saline, intended for single use only, were discarded after being used for 1 patient.

a) On 08/13/13 at 11:59 a.m., observation of the Facilty's computed tomography (CT) room was conducted. A 250 milliliter bag of normal saline was found hanging from an IV pole with approximately 1/4 of the saline remaining in the bag. The bag was dated with a marker. The Director of Radiology was interviewed about the partially used bag of saline and stated the saline was used to bolus patients receiving contrast for CTs. S/he stated the saline could be used on multiple patients and was dated as staff was expected to discard the bags after 24 hours. It was noted the bag was labeled by the manufacturer "single use container." The Director was asked about how proper infection control could be maintained when a produced designated single use was used on multiple patients. The Director stated the practice of using bags of saline for multiple patients was not viewed as an infection control issue.
b) On 08/13/13 at 1:06 p.m., an interview was conducted with the facility's Chief Compliance Officer (CCO) to discuss the facility's Infection Control program and policies. The CCO stated the Facilty used the Association for Professionals in Infection Control and Epidemiology (APIC) for guidance around some infection control practices. The practice of using single use bags of saline for more than 1 patient in the CT room was shared with the CCO. APIC's position paper on the use of intravenous (IV) solutions being used for no more than 1 patient was shared with the facility's CCO by one of the surveyors. The paper titled, "APIC position paper: Safe injection, infusion, and medication vial practices in health care," published July 30, 2009, stated, "Never use IV solution containers (eg, bags, bottles) to obtain flush solutions or for any other purpose for more than 1 patient."
c) During the survey dates 08/12/13 through 08/16/13, facility policies were reviewed. No facility policy was found regarding IV solution usage in the radiology department. The facility's Chief Compliance Officer confirmed that surveyors had received all facility policies and written guidance related to the radiology department.
3. The facility did not ensure that glucometer testing solution was being used within its expiration date.
a) On 08/13/13 at 2:42 p.m., the facility's Extended Care Unit (ECU) was toured. An opened box of glucometer testing solution was found with the dates of "11/11" and "2/11/13" written on the lid of the box. The Charge Nurse of the ECU (Charge Nurse #1) verified the dates on the box and stated that he/she was unclear of the meaning of the dates.

b) On 08/14/13 at 9:30 a.m., the medication room of the facility's outpatient clinic was toured. Two bottles of glucometer testing solution were found with the expiration dates of "6/2012." The Chief Compliance Officer (CCO) and Medical Assistant #1 verified that the expiration dates were accurate. The CCO stated that the expectation would be to discard the testing solution bottles within 3 months of opening them.

c) During the survey dates 08/12/13 through 08/16/13, facility policies were reviewed. No facility policy was found regarding the maintenance of glucometers. The facility's Chief Compliance Officer confirmed that surveyors had received all facility policies and written guidance related to the operations of the facility and nursing responsibilities.

Based on observation and interview the facility failed to ensure that all food stored in refrigerators, and in the pantry section of the kitchen were labeled to identify the contents of containers, open date, expiration/discard date, and manufacturer's expiration date, to prevent the use of contaminated or "spoiled" food products in the preparation and serving of meals to patients.

This failure created the potential for expired food to be served to patients and to cause illness.

Findings:

1. Food items were found in the facility's kitchen unlabeled, and without expiration dates, or dates indicating when the items were opened and when the items should be discarded.

a) On 08/14/13 at 2:50 p.m., observation of the facility's kitchen was conducted with the facility's Dietary Director and the facility's Chief Compliance Officer (CCO). In the pantry section used for the storage of dry food items, small containers of dry items, without labels, were found sealed by twist ties, with no date indicating when they were opened or when the items should be discarded. In one of the kitchen freezers, bags of bread were found with no date indicating when the bread was placed in the freezer or of when it should be discarded. In the refrigerator inside the pantry area, large containers of condiments were found which had no expiration date from the manufacturer, no date indicating when the products were opened and refrigerated and no date indicating when the products should be discarded. In the same refrigerator, a package of meat was noted on the bottom shelf. The Director stated it was placed there from the freezer in order to thaw. The package contained no date indicating when it was placed in the refrigerator to thaw, a use by date, or when it should be discarded. In the refrigerator in the main kitchen, 4 ounce containers of vanilla shakes were found with no expiration date and no date indicating when these were moved from the freezer to the refrigerator. The freezing of these items and moving to the refrigerator to thaw was explained by the facility's Dietary Director.

b) During the observation of the facility's kitchen, the Dietary Director was interviewed regarding how staff would know when to discard food items to ensure patient health and safety. The Director stated certain general time frames for discarding categories of food items, but could not state how staff could know when to discard individual items found in the refrigerators and freezer and in the pantry area which stored dry food items. The Director confirmed there were no postings in the kitchen for staff to refer to for guidance regarding when food items should be discarded or when items should be discarded after being opened. The Director stated s/he was the staff person who typically stocked food orders when they arrived, and discarded food items throughout the facility. The director could not state how other staff members would now how to correctly handle and discard food items in his/her absence.

c) During the survey dates 08/12/13 through 08/16/13, facility policies were reviewed. No facility policy was found that instructed staff how to store and label food items, including open food items, how food items should be safely stored in refrigerators and freezers, and that stored food items should be dated in a way that indicted when the item would expire and should the be discarded. In addition to lack of a specific policy or policies, no other guidance to staff regarding these issues could be produced by the facility's Dietary Director. The facility's Chief Compliance Officer and the facility's Dietary Director confirmed that surveyors had received all facility policies and written guidance related to the dietary department.

Based on observation and interview, the facility failed to ensure patient medical records were secure and protected from unauthorized use.

This failure created the potential for unauthorized individuals to gain access to patient medical records and patient identifiers, such as social security numbers and other protected health information.

Findings:

1. The facility's outpatient clinic did not ensure the security of the records after hours when contracted housekeeping services had access to this area.

a) On 08/14/13 at 9:35 a.m., observation of the facility's outpatient clinic was conducted. Patient medical records were observed in an area behind the patient registration desk in a storage system that could be locked. Clinic staff confirmed the system was locked at the end of each business and the key to unlock the records was placed in a drawer at the registration desk. It was noted that the drawer had no lock which meant the key to patient medical records was not secured. The clinic's Nurse Manager stated contracted housekeeping staff cleaned the facility at 6:00 a.m., before staff arrived, and that housekeeping had access to this area of the facility. The Manager confirmed housekeeping staff had access to the unsecured key to patient medical records when staff was not present in the clinic. The Manager stated understanding that patient medical records were not secure, as the key to unlock the records could be accessed from the unlocked drawer after office hours.

Based on staff interviews and a review of facility documents, the facility failed to assign a staff member as a designated requestor for approaching potential donor families and requesting organ or tissue donation.

This failure created the potential for patient families to be inappropriately consulted with regards to organ or tissue donation.

Findings:

1. The facility did not have a properly trained staff member assigned as a designated requestor for organ or tissue donation.

a) On 08/15/13 at 10:10 a.m., the Director of Nursing (DON) was interviewed regarding the facility's organ, tissue and eye procurement program. The DON stated that there had not been a designated requestor in the facility for the last 5 or 6 months.

b) On 08/16/13 at 9:30 a.m., the facility's document titled, "Haxtun Hospital District/Heritage Living Center Nursing Department Protocol Organ/Tissue Donation" (undated), was reviewed. The Chief Compliance Officer (CCO) verified that the document was a current protocol. The document stated, "Designated healthcare professionals, trained by Donor Alliance Organ Procurement Organization (OPO), will offer the option of donation to all appropriate families."