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Based on observations and interviews, the facility failed to ensure medications, supplies, and equipment commonly used in the Emergency Department (ED) were readily available for patient use. Specifically, the facility failed to remove expired medications and supplies in the patient care areas.

Findings:

Cross Reference to 0202 and 0203 for finding related to the facilities failure to remove expired medications and supplies from being available for patient use.

Based on observations and interviews the facility failed to ensure drugs and biologicals commonly used in life-saving procedures were readily available for patient care. Specifically the facility failed to remove expired medications from patient care areas.

Findings:

1. A tour of the Emergency Department was conducted with the Director of Nursing (DON) on 08/15/12 at 11:20 a.m. It was discovered during observations that the department had available for patient use the following expired medications:
6 1-Liter bags of Normal Saline expiration date 10/10 found in ambulance bay cabinet
Saline bullets (3 ml) expiration dates 3 in 1/10 and 2 in 5/11
7 Benzoin Tincture swab sticks expiration date 06/12
1 Liter bag of Lactated Ringers expiration date 09/11

2. At the time of observation the above expired medications were confirmed with the DON.

Based on observations and interviews the facility failed to ensure equipment and supplies commonly used in life-saving procedures were readily available for patient use. Specifically, the facility failed to remove expired and unusable supplies from patient care areas.

Findings:

1. A tour of the Emergency Department was conducted with the Director of Nursing (DON) on 08/15/12 at 1120 a.m. It was discovered during observations that the department had available for patient use the following expired and usuable supplies:
1 precipitous delivery kit expired for greater than 1 year
Multiple blood collection tubes expired for 6 months or greater
Ethilon 6-0 suture box with expiration date of 7/12 that contained:
2 sutures with expiration date of 1/12
1 suture with expiration date of 07/08
8 sutures with expiration date of 07/12
Multiple IV catheters expired between 1 month and 4 years
2 foley catheters with expiration dates 11/09 and 12/10
1 Delee suction tubing expiration date 9/11
3 surgical exam gloves expiration dates 1/12, 12/11 and 04/12
In the procedure room there was a clear box labeled "chest tube" that contained an open suture kit unusable for patient care

2. At the time of observation, the above expired and unusable items were confirmed with the DON.

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, patient care, and food areas.

Findings:

1. The facility failed to ensure that there was documentation of the monitoring of the temperature of the patient food refrigerator on the patient care unit.

a. A review of the facility's policy titled, "Refrigerated Storage", stated, "Each refrigerator must have a thermometer that is easily visible. Refrigerator temperatures must be recorded daily for each refrigerator in the facility."

A review of the facility's policy titled, "Freezer Storage", stated, "Each freezer must have a thermometer that is easily visible. Freezer temperatures must be recorded daily."

b. Observations on the patient care unit were conducted with the facility's Director of Nursing (DON) on 08/15/12 at 10:45 a.m. The patient care unit had a refrigerator and freezer for the storage of patient food items. There was no log or documentation of the recording of temperatures of either the freezer or refrigerator. The DON stated at the time of the observation that the nutrition services staff recorded the temperature of the refrigerator/freezer.

c. An interview was conducted with the Food Services Manager on 08/15/12 at 3:15 p.m. S/he stated that the nutrition services staff did not record the temperatures of the refrigerator or freezer on the patient care unit and that s/he thought that the patient care unit staff monitored and recorded the temperatures. S/he provided documentation of the temperatures that were recorded by the nutrition services personnel which only included the refrigerators and freezers in the kitchen area.

d. A subsequent interview with the DON on 08/15/12 at 3:21 p.m. was conducted. S/he stated that the facility staff would begin to record the temperatures of the refrigerator and freezer on the patient care unit.

2. The facility failed to ensure that there was a method to monitor the temperature of pharmaceuticals in the perioperative and outpatient clinics.

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 at an outpatient clinic of the hospital on 08/17/12 at 8:03 a.m. The clinic had a refrigerator that contained medications. The clinic staff checked the temperature once a day on business days. The refrigerator temperature was not checked on days when the clinic was not open and was not constantly monitored by other means. The facility staff would not know if the refrigerator had lost power while staff were not present, possibly affecting the efficacy/stability of the medications stored.

Observations were conducted of the perioperative department of the hospital on 08/15/12 at 3:25 p.m. The department had a refrigerator that contained medications. The department staff was expected to check the temperature once a day on days when the department was operating. The refrigerator temperature was not checked on days when the clinic was not open and was not constantly monitored by other means. The facility staff would not know if the refrigerator had lost power while staff were not present, possibly affecting the efficacy/stability of the medications stored.

c. A review of the perioperative departments documentation of temperature checks of the medication refrigerator on 08/15/12 revealed that the temperature was documented on 06/15/12, 06/18/12, 06/19/12, 06/20/12, 06/21/12, 07/06/12, 08/13/12, and 08/14/12. The facility's Director of Nursing and the perioperative nurse both confirmed the lack of documentation of temperatures of the refrigerator and could not explain the absence of documentation.

3. The facility failed to ensure that there was consistent documentation of the monitoring of the temperature and humidity levels of the operating areas.

a. A review of the 2006 Guidelines for Design and Construction of Health Care Facilities by the American Institute of Architects Academy of Architecture for Health (AIA) page 130 stated that the Operating rooms must be kept at a relative humidity of 30-60% and a temperature of 68-73 degrees Fahrenheit.

b. A review of the perioperative departments documentation of temperature/humidity checks of the surgical suite on 08/15/12 revealed that the temperature and humidity was documented on 05/22/12, 05/25/12, 05/26/12, 05/27/12, 05/28/12, 06/02/12, 06/03/12, 06/05/12, 06/06/12, 08/01/12, 08/02/12, 08/06/12, 08/07/12, 08/08/12, 08/09/12, 08/10/12, 08/13/12, and 08/14/12. The facility's Director of Nursing and the perioperative nurse both confirmed the lack of documentation of temperatures/humidity readings of the surgical suite and could not explain the absence of documentation.

Based on facility document review and staff interview the facility failed to ensure that all records of patients cared for by nurse practitioners or physician assistants were signed by a doctor of medicine or osteopathy.

Findings:

1. An interview was conducted with the Practice Manager of the hospital's clinics on 08/16/12 at 4:22 p.m. S/he stated that the hospital did not currently require physicians to review and sign the records of patients cared for by physician assistants in the clinics of the hospital unless they were required to do so by the Colorado Board of Medicine when the physician assistants were new.

2. The hospital was unable to provide documentation that reflected a physician signing the outpatient records of patients cared for by physician assistants.

Based on the manner and degree of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Provision of Services. The facility failed to ensure that services provided to patients were performed in a safe and effective manner that adhered to facility policies/procedures and standards of practice.

The facility failed to meet the following standards under the Condition of Participation of Provision of Services:

C0276 - Patient Care Policies: The facility failed to maintain proper storage of drugs and biologicals.

C0278 - Patient Care Policies: The facility failed to ensure that practices in the facility's outpatient clinic were guided by policies that would prevent communicable diseases.

C0282 - Laboratory Services: The facility failed to provide blood glucose testing to patients in a manner that met the manufacturer's specifications and standards of practice.

Based on observations and interviews, the facility failed to maintain proper storage of drugs and biologicals.

Findings:

1. 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..."

2. A review was conducted of the facility policy titled "Use of Multiple dose Vials". It stated each multiple dose vial will be labeled at the time opened with the following information: date, time, and initial of person opening the vial.

3. A tour of the patient care unit was conducted on 08/15/12 at 10:45 a.m. with the Director of Nursing (DON). A box of unopened one liter bags of normal saline was noted sitting on the floor next to the supply warmer. The box was brought to the DON's attention and she asked a staff member to stock the saline into the warmer and the rest in the medication room. She acknowledged storing medications and supplies on the floor was inappropriate.

a. In the medication room on the patient care unit there were multiple saline syringes with expiration date of 04/10 and a bottle of iodine with expiration date of 05/11. The DON verified the expired supplies.

4. A tour of the Emergency Department (ED) was conducted on 08/15/12 at 11:20 a.m. with the DON. The following undated open medications were found during observation:
A box in the supply closet with 6 open undated multidose vials of lidocaine
The procedure room had an open undated multidose vial of lidocaine on the counter and two open undated bottles of alcohol
A trauma room with a clear box labeled "chest tube" that contained 2 open undated multidose vials of lidocaine

a. At the time of observation, the above open undated medications were verified with the DON.

5. A tour of the radiology department was conducted on 08/16/12 at 1045 with the Radiology Manager (RM). A warmer in the cat scan room was stocked with bottles of IV contrast, two were open and undated. The RM removed the bottles and stated he would discard them.

a. When asked about the procedure of using the warmer, the RM stated the contrast had been kept in the warmer since before he was an employee and there was no policy or procedure on its use. He stated the temperature was kept at 38.5 degrees Celsius but did not have manufacturer's guideline for the storage of the IV contrast. The RM also confirmed a temperature log was not kept.

b. The x-ray room was observed to have an opened undated bottle of alcohol expiration date 11/11 and a 1 liter bag of Lactated Ringers expiration date 05/12 sitting on shelf. The expired supplies were verified by the RM at the time of observation.

6. An offsite clinic was toured on 08/17/12 at 8:05 a.m. with the Program Manager.
The following open undated medications were noted during observation:
1 open undated liter bottle of sterile water in a supply closet
1 open undated liter bottle of sterile water in the medication refrigerator
1 open undated multidose vial of magnesium in a plastic bag prescribed to a specific patient in the medication refrigerator
1 open undated multidose vial of lidocaine and 1 open undated multidose vial of depotestosterone in the medication cabinet

a. At the time of observation, the open undated medications were verified with the Program Manager.

Based on observations and staff interview the facility failed to ensure that practices in the facility's outpatient clinic were guided by policies that would prevent communicable diseases.

Findings:

1. The facility's staff in the outpatient clinic decontaminated instruments used in the facility in the same sink that handwashing was performed, which exposed facility staff to possible contaminants that could increase the likelihood of the spread of communicable diseases.

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 Cleaning and Care of Surgical Instruments and Powered Equipment," page 433, in pertinent part: "Instruments should not be decontaminated in scrub or hand sinks. Cleaning soiled instruments in a scrub or hand sink can contaminate the sink and faucet, which also may be used for clean activities (eg, hand washing, surgical hand antisepsis)."

b. Observations of the facility's offsite clinic were conducted on 08/17/12 at 8:30 a.m. with the practice manager and a nurse from the clinic. It was observed that the facility had an area with a chair for laboratory draws and equipment for laboratory testing. Under the only sink in the area there was enzymatic detergent for the decontamination of surgical instruments.

c. An interview was conducted with the nurse of the clinic at the time of the above observation. S/he stated that the facility staff utilized a plastic bucket to mix the enzymatic detergent and water for the decontamination of instruments prior to sterilization. S/he stated that the facility did not have a sink to perform the decontamination of instruments and that the used water from the bucket was discarded down the sink that would also be used for hand washing. S/he stated that the sink was not routinely decontaminated after the disposal of the soiled water.

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. Observations of the facility's offsite clinic were conducted on 08/17/12 at 8:30 a.m. with the practice manager and a nurse from the clinic. It was observed that the facility had an area with a chair for laboratory draws and equipment for laboratory testing that was utilized as an area for the decontamination of surgical instruments. Another area in the clinic contained a refrigerator, microwave, and various condiments for staff consumption for meal breaks. The area contained the autoclave sterilizer that was used by the facility for surgical instrument sterilization.

c. An interview was conducted with the nurse of the clinic at the time of the above observation. S/he stated that the facility had limited space and had recently received the autoclave for the instrument sterilization.

Based on observations, facility document review, and staff interview the facility failed to provide blood glucose testing to patients in a manner that met the manufacturer's specifications and standards of practice.

Findings:

1. The facility failed to ensure that a point-of-care glucose monitor used in the perioperative department had a quality control test completed and documented on a regular basis. Additionally, the facility failed to ensure that non-expired control solution was available for such testing.

a. A review of the facility's policy titled "Glucose Monitoring" revealed the following: "Procedure: Insure that the glucometer has been calibrated within the past 24 hours. (should be done on night shift every am)."

b. Observations conducted on 08/15/12 at 3:30 p.m. revealed that the perioperative department had a point-of-care blood glucose monitor. Quality control solution that was with the monitor had a manufacturer's expiration dates of 01/2011, 11/2011, and 12/2011. There was not any other quality control solution that was not beyond the manufacturer's expiration date.

c. The facility was unable to provide a log that documented the performance of quality control/calibration by facility staff. The facility's Chief Nursing Officer (CNO) stated that there was not one for review on 08/15/12 at 3:35 p.m.

d. An interview was conducted with the Perioperative Nurse on 08/15/12 at 3:35 p.m. S/he stated that the glucometer was often used in the pre-operative/post-anesthesia care unit during days when cataract surgery was performed as many of the patients are diabetic. S/he stated that s/he was not aware that there needed to be a log for the documentation of the quality control being performed on the glucometer.

e. An interview was conducted with the CNO on 08/15/12 at 3:35 p.m. S/he stated that there should be a log for staff to document the quality control being performed on the glucometer in each unit where such testing was performed.

Based on observations and interviews, the facility failed to ensure the confidentiality of medical record information.

Findings:

1. A review of the facilities policy titled "Storage and Security of Medical Records" stated all medical records shall be housed in physically secure areas under the immediate control of the Medical Record Director. Areas housing health information shall be restricted to authorized personnel.

2. During a tour of the radiology department on 08/16/12 at 10:45 a.m. with the Radiology Manager (RM), a room in the department was noted to be for x-ray film storage. The RM was asked about the security of the room and s/he stated it remained locked and only radiology staff and maintenance personnel have a key. When asked where the key was kept, the RM opened a drawer in the unlocked radiology reading room and obtained the key. The RM verified they key was not in a secure location and anyone could gain access to the stored x-ray films.

Based on observations, facility document review, and staff interview the facility failed to be in compliance with the Condition of Participation of Surgical Services. The facility failed to ensure that surgical procedures were being performed in a safe manner.

Findings:

1. The facility failed to ensure that instruments for surgery were properly sterilized following manufacturer's specifications and nationally recognized standards.

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 Cleaning and Care of Surgical Instruments and Powered Equipment," pages 441 and 442, in pertinent part: "Special precautions should be taken for reprocessing ophthalmic surgical instruments: Toxic anterior segment syndrome (TASS) can result from contaminants introduce into the eye during ophthalmic surgery. An incidence of TASS can cause serious damage to a patient ' s intraocular tissue and result in vision loss ... Most case of TASS appear to result from inadequate instrument cleaning and sterilization... After manual or ultrasonic cleaning, instruments should be wiped with alcohol before preparation for sterilization. Wiping with alcohol disinfects the instruments and renders them safe to handle. After cleaning and disinfection, instruments contacting viscoelastic material should be inspected for residue under magnification ... An adequate inventory of instruments should be provided to allow for thorough instrument cleaning and sterilization. An adequate inventory of instruments facilitates compliance with proper decontamination and sterilization processes. Adequate time should be provided for thorough instrument cleaning and sterilization. Time constraints may create a disincentive for personnel to adhere to decontamination procedures and may result in noncompliance."

b. A review of the facility's policy titled, "Flash Sterilization", last revised 06/04/09 stated: "It is the policy of Rio Grande Hospital Outpatient Surgery to reduce the potential risk of surgical site infections by using the flash sterilization cycle only when it is absolutely necessary as is the case for Ophthalmology cases and Urology procedures when outsourcing companies provide the instruments/supplies/equipment.
1. Flash sterilization will not be used as an alternative to buying more instruments, supplies, to save time or for convenience. It should be used only when absolutely necessary."

c. Observations of the surgical services department of the hospital were conducted with the Perioperative Nurse on 08/15/12. At 3:45 p.m. s/he stated that the hospital primarily performed cataract surgery, urology procedures, and endoscopy. S/he stated that s/he was the individual in the hospital that processed the instruments used in surgery. S/he stated that the hospital did not own any instruments for cataract surgery and stated that on days when cataract procedures were performed the surgeon would bring in the instruments. S/he stated that the cataract instruments were "always flashed" since the hospital did not own the instruments and had many cases on the days that cataract surgery is performed.

d. An interview was conducted with the hospital's Chief Executive Officer (CEO) on 08/16/12 at 5:15 p.m. The CEO stated that when s/he had spoken to the surgeon that primarily performed cataract surgery at the hospital, the surgeon stated that s/he would provide more trays to the hospital to allow the full processing of the instruments to avoid the use of flash sterilization as the primary method of sterilization.