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Based on facility tours and staff interviews, the facility failed to maintain a safe environment to protect the health and safety of patients.
This failure contributed to the potential use of expired supplies during patient procedures.

FINDINGS:

1. The facility failed to ensure that supplies used during patient procedures were not expired.

a) On 02/19/13 at 8:30 a.m., a tour of the facility's Acute Care Unit was conducted with the facility's Chief of Nursing. During the tour, the Acute Care Unit's crash cart was viewed and contained two laboratory blood tubes, with manufacturer's expiration dates of 12/12 and 01/13. The facility's Chief of Nursing verified the manufacturer's expiration dates and immediately discarded the items.

b) On 02/19/13 at 11:15 a.m., a tour of the facility's Surgical Suite was conducted with the facility's Operating Room (OR) Manager. During the tour, the facility's Malignant Hyperthermia cart was viewed and contained the following expired items: 6 sixteen gauge intravenous catheters with a manufacturer's expiration date of 10/12, 4 ten milliliter saline syringes with a manufacturer's expiration date of 02/01/13, 6 twenty-four gauge intravenous catheters with a manufacturer's expiration date of 08/12, 3 green topped laboratory blood tubes with a manufacturer's expiration date of 11/12, 3 orange topped laboratory blood tubes with a manufacturer's expiration date of 11/13, 2 arterial blood gas kits with a manufacturer's expiration date of 11/12, 5 Lidocaine urojet kits with a manufacturer's expiration date of 01/13, and one tube of lubricating jelly with a manufacturer's expiration date of 12/12. The malignant hyperthermia cart also contained an opened package containing a 10 milliliter syringe, and also an opened package containing a suctioning kit and sterile gloves. The facility's OR Manager verified these findings and immediately discarded the items. S/he further stated that it was his/her expectation that expired supplies would be removed from the cart when they reached their expiration date, and that opened packages would be discarded, as the sterility of these items could not be guaranteed.

c) During the same tour of the Surgical Suite, the Post Anesthesia Care Unit (PACU) was toured with facility's OR Manager. During the tour, the PACU's crash cart was viewed and contained the following expired items: 4 eighteen gauge intravenous catheters with manufacturer's expiration dates ranging from 09/12 to 10/12, 1 twenty-four gauge intravenous catheter with a manufacturer's expiration date of 08/12, and 1 central line kit with a manufacturer's expiration date of 03/08. The facility's OR manager verified the manufacturer's expiration dates and immediately discarded the items.

d) On 02/19/13 at 3:00 p.m., a tour of the facility's Specialty Clinic was conducted with the Specialty Clinic Manager. During the tour, a specimen container labeled, "Hibicleanse," was viewed inside a cupboard in a patient examination room. The specimen container that contained the Hibicleanse was not labeled with a date to indicate when the Hibicleanse had been put into the specimen container, or with a date as to indicate when the Hibicleanse would expire. The Specialty Clinic Manager verified the surveyor findings and stated that individual containers of Hibicleanse were well stocked in the facility, and that it was his/her expectation that the Hibicleanse would be kept in its original container, and not poured into specimen containers.

2. The facility failed to ensure that all patient care items were properly labeled to prevent staff from using potentially harmful items during patient procedures.

a) On 02/19/13 at 11:15 a.m., a tour of the facility's Surgical Suite was conducted with the facility's Operating Room (OR) Manager. During the tour, the facility's Procedure room and Operating Room were viewed. In the Procedure room, a 1000 milliliter bottle containing a blue liquid and labeled, "Sterile Water," was observed on the floor. The OR Manager identified the blue liquid as, "Endozine," which s/he stated was used for cleaning surgical instruments. The OR Manager stated that the Endozine should have been properly labeled and not contained in a bottle labeled, "Sterile Water." The OR manager further stated that the Endozine should not have been stored on the floor of the Procedure Room.

Based on observations, facility document review, and staff interview the facility failed to ensure that there was proper temperature controls in place for all pharmaceutical storage areas. Additionally the facility failed to ensure that a suitable humidity and temperature level was monitored and maintained in the surgical patient care areas.

Findings:

1. The facility failed to ensure that there was a method to monitor the temperature of pharmaceuticals in the pharmacy department.

a. A review of the Food and Drug Administration's (FDA) guidelines found at 21CFR205.50 revealed: "Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
The State licensing law shall include the following minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees:
(c)Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).
(2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.
(3) The recordkeeping requirements in paragraph (f) of this section shall be followed for all stored drugs."

A review of the State of Colorado's Board of Pharmacy Rules and Regulations state at 5.01.31 (e) that "(8) A refrigerator, dedicated to storing only drugs, meeting the compendia requirements and with an accurate thermometer in the refrigerator. The temperature of which shall be maintained between two and eight degrees Celsius (2 and 8 degrees C.) or thirty-six and forty-six degrees Fahrenheit (36 and 46 degrees F.). The temperature shall be either manually or electronically monitored each calendar day."

b. Observations were conducted of the facility's pharmacy department on 02/20/13 at 10:39 a.m. with the facility's Pharmacist. The pharmacy contained a refrigerator in which multiple refrigerated medications were stored. The refrigerator contained a thermometer and the refrigerator had a log on the outside of the door that was completed by pharmacy staff each day the pharmacy was in operation.

c. An interview was conducted with the facility's Pharmacist during the times of the observations. S/he stated that the pharmacy was staffed only Monday through Friday. S/he stated that the refrigerator that was in the pharmacy did not have a continuous monitor to notify the facility's staff if the temperature had gone beyond the acceptable limits at any time and that the facility's staff did not check the temperature on the weekends.

2. The facility's surgical department did not ensure and maintain a suitable temperature and humidity level for patient care. This failure had the potential to result in increased risk of infection or surgical fire.

a. Review of the facility's policy titled "Environmental Control of the Perioperative Setting" revealed that the facility expected that "relative humidity should be maintained between 30% and 60% within the perioperative area." The policy stated that low humidity increased the risk of fires and for infection. The policy required that the "maintenance department will provide written documentation of the temperature and humidity in the various areas of the perioperative setting" and that "the documentation will be stored in the Surgery Department." The policy further required that corrective actions will be discussed and implemented to obtain the required temperature and humidity levels specified in the policy.

b. A tour of the surgical department of the hospital was conducted on 02/19/13 at 11:12 a.m. with the Director of Surgical Services. It was observed that in one of the procedure rooms, there was a temperature and humidity measuring instrument. The humidity listed was 18% which was confirmed with the Director. When asked how the facility monitored the temperature and humidity of the surgical areas, she said that she was not sure, but thought that the facility's maintenance department was monitoring those parameters.

c. The facility's Director of Maintenance provided the readings from the operating rooms for the months of January and February of 2013. Review of the logs revealed that the humidity in the operating rooms remained consistently below 30% and had been as low as 6%. The logs did not contain values that had been within 30-60% at any time during the past two months.

Based on observations and interviews, the facility failed to maintain proper storage of drugs and biologicals. The facility did not have a policy that reflected the current standard of practice for the use of multiple dose vials in healthcare settings. Additionally the facility failed to ensure that medications brought into the facility for the use on patients were stored appropriately.

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 the following, in pertinent parts:
"The transmission of bloodborne viruses and other microbial pathogens to patients during routine healthcare procedures continues to occur due to unsafe and improper injection, infusion and medication vial practices being used by healthcare professionals within various clinical settings throughout the United States ...
APIC strongly supports adherence to the following safe injection, infusion and medication vial practices ...
Vials
?Always follow the manufacturer's instructions for storage and use...
?Discard single-dose vials after use. Never use them again for another patient.
?If a multidose vial must be used, it should be used for a single patient whenever
possible. The risk of transmission posed by inappropriate handling of multi-dose vials has been clearly demonstrated and mandates a practice of one vial per one patient whenever possible. Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient...
?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. A review of the facility's policy titled "Multiple Dose Medication Vials (MDVs)" revealed that the facility's policy allowed the storage of multiple dose vials for 30 days after initial use rather than the 28 days specified in the current standards of practice.

c. Observations of the medication storage area of the Emergency Department was conducted with the Chief Nursing Officer (CNO) on 02/18/13 at 3:24 p.m. A multiple dose vial of Lidocaine was noted to be in the area with a handwritten date, indicating when it was first used, of 01/05/13. The CNO confirmed the finding and discarded the vial.

2. The facility had medication stored improperly in the surgical services department.

a. Observations of the facility's post-anesthesia care unit was conducted with the Director of Surgical Services on 02/19/13 at 11:19 a.m. The medication refrigerator contained an unlabeled bottle with an applicator attached that contained a liquid. Additionally, there was a prescription bottle of liquid (C-ENT nasal spray) that had listed on its label 11/15/11.

b. The Director of Surgical Services confirmed the above findings and stated that one of the facility's medical staff members brought both items into the facility and had failed to remove them. S/he confirmed that neither of the two findings were appropriate for medication storage.

c. An interview was conducted with the facility's pharmacist on 02/20/13 at 10:39 a.m. S/he stated that s/he inspects the ancillary areas of the hospital quarterly to check for improper medication practices. S/he confirmed that the above findings were inappropriate and stated that the facility's medical staff were expected to take any medications brought with them away from the facility when they were done for the day.

The facility failed to implement a system for identifying, reporting, investigating, and controlling infections and communicable diseases that could potentially harm patients and personnel.

Based on observations and staff interviews, the facility failed to ensure that facility practices were performed in a manner that would prevent communicable diseases.

FINDINGS:

1. The facility did not ensure that cleaning solutions were properly diluted to ensure effective cleaning and disinfection of equipment used during patient procedures.

a) On 02/19/13 at 11:15 a.m., a tour of the facility's surgical area was conducted with the facility's Operating Room (OR) Manager. During the tour, the facility's endoscope cleaning area was viewed and an interview was conducted with the OR Manager. The OR Manager was asked to explain the cleaning process for the endoscopes. The OR Manager stated s/he cleaned the endoscopes in a cleaning solution that s/he mixed prior to putting them in the endoscope washer. When asked how the cleaning solution was mixed, s/he stated that s/he mixed the solution, labeled,"Endozine," in an amount of water that s/he estimated was approximately 2 to 4 gallons and then administered a half ounce of cleaning solution per gallon. S/he stated there was no marking on the sink to indicate the level of water in the sink or how many gallons it could hold. S/he then read the manufacturer's instructions on the "Endozine" to the surveyors, which stated,"to administer one half ounce of solution per one gallon of water." The facility's OR manager was unable to verbalize how s/he was able comply with the manufacturer's instructions without knowing the exact amount of water contained in the sink.

b) During the same tour, the facility's sterile instrument cleaning area was viewed and an interview was conducted with the OR Manager. The OR Manager was asked to explain the cleaning process for the sterile instruments. The OR Manager stated s/he cleaned the surgical instruments in a cleaning solution that s/he mixed prior to putting them through the washer. When asked how the cleaning solution was mixed, s/he stated that s/he mixed the solution, labeled,"Endozine," in an amount of water that s/he estimated was approximately 2 to 4 gallons and then administered a half ounce of cleaning solution per gallon. S/he stated there was no marking on the sink to indicate the level of water in the sink or how many gallons it could hold. S/he then read the manufacturer's instructions on the "Endozine" to the surveyors, which stated,"to administer one half ounce of solution per one gallon of water." The facility's OR manager was unable to verbalize how s/he was able comply with the manufacturer's instructions without knowing the exact amount of water contained in the sink.

2. The outpatient clinic did not have a separate area/room for the sterilization of instruments from an area that staff used for a break room and food storage area.

a) A review of the the 2011 Edition of the Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Setting by the Association of PeriOperative Registered Nurses (AORN) stated the following within, "Recommended Practices for Sterilization the Perioperative Practice Setting," pages 463 and 464, in pertinent part: "Items to be sterilized should be cleaned, decontaminated, sterilized, and stored in a controlled environment and in accordance with AORN's 'Recommended Practices for Cleaning and Caring of Instruments and Powered Equipment' and the manufacturer's written instructions. Functional workflow patterns should be established to create and maintain physical separation between the decontamination and sterilization areas."

b) On 02/20/13 at 8:15 a.m., a tour of the facility's outpatient clinic was conducted with the facility's Certified Medical Assistant. During the tour, the facility's autoclave, which was used for sterilizing equipment used during patient procedures, was viewed. The autoclave was kept on a counter in a break room that was utilized by both the outpatient clinic staff and the staff of an adjoining dental practice. The room contained a refrigerator, microwave, and various food items for staff consumption during breaks. There was also a pool of clear liquid on the counter near the autoclave that was identified by staff as water.

c) During the tour, an interview was conducted with the clinic's Certified Medical Assistant. S/he stated that the facility routinely performed sterilization using the autoclave in the staff break room, as there was no other area used for sterilization on the premises.

The facility failed to maintain records for each patient that contained evidence of properly executed informed consents.

Based on document reviews and staff interviews, the facility failed to ensure that all patients were provided informed consents to ensure that patients were informed about and consented to all aspects of their treatment plans.

FINDINGS:

1. Patient medical records did not contain signed informed consents that authorized admission to the facility.

a) On 02/20/13 at 2:00 p.m., a review of 20 patient medical records was conducted with the facility's Medical Records Manager. Two out of 20 sampled patient medical records (Sample Patient #1 and Sample Patient #19's) were reviewed and did not contain a signed consent for admission to the facility. Both medical records contained a, "Conditions of Admission," form, which contained a signature area for the patient to sign and consent for admission to the facility. In both medical records, the signature area on the, "Conditions of Admission," form was left blank and was not signed by the patient. The facility's Medical Records Manager verified these findings.

b) On 02/20/13 at 3:00 p.m., the facility's policy entitled, "Informed Consent," was reviewed. The policy stated that, "A general consent is included on the conditions of admission form. This general consent is obtained in writing (whenever possible) from the patient or (if the patient is incompetent) his/her legal representation by hospital staff at the time of admission or registration for hospital services." The facility's Chief of Nursing verified this was the current policy.


c) On 02/20/13 at 3:45 p.m., an interview was conducted with the facility's Chief of Nursing. The Chief of Nursing stated that it was his/her expectation that any patient being admitted to the facility would have signed the consent for admissions. S/he stated that it was also his/her expectation that if the patient was unable to sign the consent, that the patient's Power of Attorney would be contacted and a verbal consent would be obtained by two staff members. The facility's Chief of Nursing stated the verbal consent should have been documented on the patient's consent form.

2. Patient medical records did not contain signed informed consents that authorized physician staff to perform invasive procedures on patients.

a) On 02/20/13 at 2:00 p.m., a review of 20 patient medical records was conducted with the facility's Medical Records Manager. One out of 20 patient medical records sampled (Sample Patient #13's) revealed that the patient underwent a debridement procedure while hospitalized. The patient's medical record did not contain any documentation of informed consent regarding the procedure, signed by the patient, to authorize the physician to perform the debridement. The Medical Records Manager verified that Sample Patient #13's medical record did not contain an informed consent for the debridement.

b) On 02/20/13 at 3:00 p.m., the facility's policy entitled, "Informed Consent Surgical and/or Procedural," was reviewed. The policy stated that, "An informed consent must be on the chart prior to the procedure. The physician performing the procedure must disclose to the patient any information necessary to enable the patient to evaluate a proposed procedure before submitting to it." The facility's Chief of Nursing verified this was the current policy.

c) On 02/20/13 at 3:00 p.m., the facility's policy entitled, "Informed Consent," was reviewed. The policy stated,"(Facility Name) respects the patient's right to be informed of surgical or medical procedures which are to be rendered and the patient's right to accept or refuse such surgical or medical procedure. Being consistent with quality patient care, informed consent must be obtained and documented pursuant to this policy before proceeding with surgical or medical procedures." The policy further stated,"Informed consent is required for procedures that are complex, invasive, and/or involve the risk of serious injury."The facility's Chief of Nursing verified this was the current policy.

d) On 02/20/13 at 3:45 p.m., an interview was conducted with the facility's Chief of Nursing. The Chief of Nursing stated that it was his/her expectation that any patient undergoing an invasive procedure, such as a debridement, would have spoken with the physician performing the procedure, and would have signed an informed consent to authorize the physician to perform the procedure.

3. Patient medical records did not contain signed informed consents that authorized the transfer of the patient to another medical facility.

a) On 02/20/13 at 2:00 p.m., a review of 20 patient medical records was conducted with the facility's Medical Records Manager. One of 20 patient medical records sampled (Sample Patient #14's) revealed that the patient had been transferred to another facility. Sample Patient #14's,"Patient Transfer Form", was reviewed and contained an area for the patient to sign and consent for the transfer. Sample Patient #14's consent to transfer was not signed by the patient. There was no documentation in the patient's medical record to indicate that the patient was unable to sign the consent. The facility's Medical Records Manager verified that that Sample Patient #14's transfer form was not signed.

b) On 02/20/13 at 3:45 p.m., an interview was conducted with the facility's Chief of Nursing. The Chief of Nursing stated that it was his/her expectation that any patient being transferred to another facility would have signed the patient transfer form to authorize the transfer.

Based on observations and interviews and review of facility policies/procedures the facility failed to ensure the confidentiality of medical record information by providing safeguards against loss and unauthorized use.

This failure had the potential to lead to unauthorized individuals accessing confidential records or for records to be lost.

Findings:

1. The facility did not restrict access to medical records to those individuals with a need for access of medical records.

a. A review of the facility's policy titled "Health Information Management - Scope of Service" revealed that the "scope of services include, but is not limited to the following: assures that the medical records are confidential, secure, current, authenticated, and legible and complete as according to regulation. Monitors medical records that are checked out to another department. Assures that the medical records are protected and locked. Access to the record is limited to authorized personnel only."

b. A tour was conducted of the medical records department with the Health Information Management Director on 02/19/13 at 1:34 p.m. The department had shelving that was able to be locked at night. However, the shelves that would remain exposed when the shelves were secured also contained records. The Director confirmed that the shelves on the end were not able to be secured and that ancillary non-clinical staff had access to the department after hours when staff are absent from the department, potentially allowing unauthorized access to records.

c. A tour of the Surgical Services Department of the hospital was conducted with the Director of Surgical Services on 02/19/13 at 02/19/13 at 12:30 p.m. revealed that there was a filing cabinet without locks that contained medical records of patients. The Director confirmed that the cabinets could not be locked and that ancillary non-clinical staff had access to the department after hours when staff are absent from the department, potentially allowing unauthorized access to those records.

d. A tour of the Rehabilitation Department was conducted on 02/19/13 at 11:05 a.m. with the Director of Rehabilitation Services. The department had an office with filing cabinets that contained medical records of therapy patients. She stated that the records were not kept further secured than the door to the office being locked. She confirmed that ancillary non-clinical staff had access to the department after hours when staff are absent from the department, potentially allowing unauthorized access to those records.

e. A tour of one of the facility's offsite clinics was conducted with the Clinic Manager on 02/19/13 at 2:56 p.m. The facility had medical records on open shelving in a reception area. The area had a door that locked, but also had a large window that opened into the lobby that was shared with a completely separate entity not associated with the hospital. The Clinic Manager confirmed that the records were not kept further secured than the door to the reception being locked. She also confirmed that ancillary non-clinical staff had access to the department after hours when staff are absent from the department, potentially allowing unauthorized access to those records.

f. A tour of another offsite clinic of the hospital was conducted with the Clinic Manager on 02/20/13 at 8:13 a.m. The facility had medical records locked in a cabinet. Staff stated that the keys to the cabinet of medical records was kept in an unlocked drawer in the clinic. She confirmed that ancillary non-clinical staff had access to the department after hours when staff are absent from the department, potentially allowing unauthorized access to those records.