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Based on observation, review of humidity log sheets, and staff interview, the facility failed to maintain humidity at an acceptable level in 2 of 3 operating rooms (ORs). The findings were:

1. Continuous observation in OR #2 on 3/23/16 from 9:16 AM to 10:56 AM revealed the humidity was 26 percent. This was observed prior to and during surgery for patient #21.

2. Review of the facility's temperature and humidity control log sheets showed the humidity range should be 30% to 60%. Review of the January to March 2016 log sheets revealed the following:
a. In January 2016 the humidity in OR #2 was documented less than 30% on 14 of 18 days.
b. In February 2016 the humidity was documented less than 30% on 18 of 20 days in OR #1 and on 17 of 20 days in OR #2.
c. In March 2016 the humidity was documented less than 30% on 17 of 17 days in OR #1 and OR #2.

3. During an interview on 3/23/16 at 1:30 PM sterilization tech #1, who was responsible for documenting the humidity, stated he was not sure if the equipment and supplies used in the ORs could be affected by a lower humidity level.

4. On 3/23/16 at 2:10 PM the CNO stated the facility did not have anything to show that the equipment and supplies used in the ORs would not be affected by lower humidity. He stated the maintenance department was going to be increasing the humidity in the ORs.

5. According to "Relative Humidity Levels in the Operating Room Joint Communication to Healthcare Delivery Organizations, January 2015" (developed at a multi-organization stakeholder meeting convened by AAMI [Association for the Advancement of Medical Instrumentation], website: , accessed 3/29/16), "...relative humidity can impact the shelf life and product integrity of sterile supplies...other consumables for some electrosurgical products also are humidity-sensitive...relative humidity may affect the operation of some electro-medical equipment used in the OR...this equipment may malfunction unexpectedly. Too low humidity levels may also impact calibration...Before establishing or re-establishing the low end design RH [relative humidity] levels below 30% in the OR, healthcare facilities should assess the impact of lower RH on the equipment and supplies being used...Have you determined what the IFUs say about humidity levels for each item in the HDO's [healthcare delivery organization] existing inventory of supplies and equipment used in the OR?"

Based on observation, review of professional standards and policies, and staff interview, the facility failed to ensure instruments were properly sterilized in 5 of 6 locations where sterilization was performed (refer to C278). This systemic systems failure resulted in a determination that the facility failed to meet the Condition of Participation for Provision of Services.

Based on observation, review of professional standards and policies, and staff and manufacturer employee interview, the facility failed to ensure instruments were properly sterilized in 5 of 6 locations where sterilization was performed (Afton Clinic, Afton Therapy Services, Salt River Orthopaedics, Thayne Clinic, Alpine Clinic). In addition, the facility failed to store equipment in a manner to prevent contamination in 3 of 3 storage carts and failed to practice safe injection techniques during 1 of 1 surgical procedure observed. The findings were:

Regarding sterilization of instruments:

1. Observation on 3/23/16 at 11 AM at the provider-based Thayne Family Clinic revealed a table-top autoclave (ValueKlave). Further observation revealed packaged instruments in a cabinet that had been sterilized in the autoclave. The packaged instruments contained a chemical indicator. However, interview with medical assistant #1 at that time revealed the facility did not do biological indicators for the autoclave.

2. Observation on 3/23/16 at 11:40 PM at the provider-based Afton Family Clinic revealed a table-top autoclave (Ritter M11 UltraClave). Observation of packaged instruments that were sterilized in the autoclave revealed chemical indicators. However, interview at that time with the physician clinic director revealed biological indicators were not done.

3. Observation on 3/23/16 at 11:50 at the provider-based Salt River Orthopaedics revealed a table-top autoclave (Ritter M9 UltraClave). Observation of packaged instruments that were sterilized in the autoclave revealed chemical indicators. However, interview at that time with the physician clinic director revealed biological indicators were not done.

4. Observation on 3/23/16 at 2:20 PM at Afton Therapy Services (outpatient rehabilitation) showed a table-top autoclave (Ritter M7 SpeedClave). Observation of packaged instruments sterilized in the autoclave revealed chemical indicators. However, interview with rehab aide #1 at that time revealed they did not do biological indicators.

5. Observation on 3/24/16 at 11:30 AM at the provider-based Alpine Family Clinic revealed a table-top autoclave (Ritter M7 SpeedClave). Observation of packaged instruments sterilized in the autoclave revealed chemical indicators. However, interview with the clinic manager at that time revealed they did not do biological indicators.

6. Review of the facility's policy "Sterilization Process (Physician Offices)" (04/07) revealed it did not address biological indicators.

7. During an interview on 3/23/16 at 1:30 PM sterilization tech #1 stated although biological indicators were done for the autoclaves in the facility, they probably weren't done in the physician clinics because he was not aware that the smaller autoclaves were held to the same standards. He was not aware that the 2008 CDC [Centers for Disease Control] guidance on sterilization addressed the smaller autoclaves.

8. Review of the CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" showed "...Portable (table-top) steam sterilizers are used in outpatient, dental, and rural clinics. These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization should be monitored by mechanical, chemical, and biological indicators." Further, "...biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process...Steam and low temperature sterilizers should be monitored at least weekly..."

Regarding breech in infection control practices related to laryngoscope blades and endotracheal tubes:

1. Observations of anesthesia cart #1 on 3/23/16 at 4:30 PM revealed unpackaged reusable laryngoscope blades and opened sterile packaged endotracheal tubes were stored in a drawer and on top of the cart with various other unpackaged articles and supplies. Continued observation revealed the opened and uncovered laryngoscope blades and opened packages of endotracheal tubes remained on the top of the cart during terminal cleaning. During an interview on 3/24/16 at 7:30 AM, CRNA #1 stated opened sterile packaged laryngoscope blades and endotracheal tubes, were routinely stored on top of the anesthesia carts in preparation for use on the following day or future use at a another time.

2. Observation of anesthesia cart #2 on 3/24/16 at 7:28 AM revealed unpackaged reusable laryngoscope blades were stored in a drawer and on top of the cart with various other unpackaged articles and supplies. Further observation revealed three opened packages of endotracheal tubes on top of the anesthesia cart. Interview with the operating room director at that time verified the laryngoscope blades and endotracheal tubes were packaged sterile items. Interview with the operating room director and CRNA #1 on 3/24/16 at 7:30 AM revealed they were not aware that storing them in this manner increased the risk of recontamination.

3. Observation on 3/24/16 at 7:40 AM revealed unpackaged disposable laryngoscope blades were grouped together in various sections of one drawer in the emergency department cart. Interview with the CNO and emergency department nurse during the observation revealed they did not know whether removing disposable laryngoscope blades from the sterile package increased the risk of contamination when stored in drawers for extended periods of time before use. Interview on 3/28/16 at 11:15 AM with the manufacturer's representative revealed the disposable laryngoscope blades should remain packaged until use to avoid contamination.

4. Review of the 2015 Edition of Guidelines for Preoperative Practice, published by AORN, revealed the following recommendation: "XII.c. Cleaned and disinfected laryngoscope blades and handles should be packaged and stored in a manner that prevents contamination. Packaging assists in preventing recontamination of items that have been high-level disinfected. Packaging of laryngoscope blades to prevent recontamination is a CDC recommendation."

5. According to the CDC's HICPAC document titled Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, laryngoscopes should be kept free from contamination until the time of use. Once opened, there is potential for microorganisms to settle on the equipment the longer it remains open and unused. In addition, increased handling of the opened unused blade increases the probability of contamination. Ensure that the storage area provides protection against dust, moisture, temperature and humidity extremes.

Regarding unsafe injection practices:

1. On 3/23/16 from 9:16 AM to 10:56 AM before and during surgery for patient #21, CRNA #1 was observed drawing up and administering medications to the patient. The observation revealed the CRNA did not disinfect the intravenous (IV) insertion port prior to administering the medications. Continued observation revealed the CRNA also withdrew medications from medication vials without disinfecting and did not consistently disinfect medication vials prior to piercing the septum.

2. During an interview on 3/23/16 at 11:10 AM, the operating room director stated failing to disinfect IV ports and vial stoppers is not an acceptable standard of practice.

3. According to the CDC recommendations for Safe Injection Practices, updated 2011, the septum on the medication vial and IV ports should be disinfected before piercing. The Association for Professionals in Infection Control and Epidemiology (APIC) standards for safe injection practices, published in the American Journal of Infection Control, April 2010, recommends IV ports, vial stoppers, and access diaphragms be disinfected prior to each use.

Based on medical record review, staff interview, and review of policies, the facility failed to ensure effective pain relief for 5 of 9 patients (#1, #4, #8, #9, #18) who received PRN pain medication. The findings were:

1. Review of the medical record for patient #1 revealed s/he was admitted with a diagnosis of abscess to the foot. Review of the care plan for pain showed the goal was "pain will remain at a tolerable level." Review of physician orders showed the patient was ordered Norco 5/325 mg 1 to 2 tabs every 4 hours PRN for pain. Review of the MAR showed the patient was given 2 tabs of the PRN Norco on 3/19/16 at 10:45 AM and 3:19 PM and on 3/20/16 at 11:04 AM. Further review of the MAR and review of nursing notes showed no evidence the effectiveness of the PRN pain medication was evaluated.

2. Review of the medical record for patient #4 revealed she was admitted for labor and delivery of a newborn. Review of the care plan showed pain was controlled using Ibuprofen. Review of physician orders showed the patient was ordered Motrin 600 mg every 6 hours PRN for pain. Review of the MAR revealed the patient was given the PRN Motrin six times from 3/20/16 through 3/22/16. Further review of the MAR and review of nursing notes showed no documentation to show the medication was effective.

3. Review of the 3/21/16 physician's note revealed patient #8 required pain management after knee surgery. Review of the physician's orders showed Oxycodone 5 to 15 mg was ordered on 3/21/16 for pain every 4 hours PRN. Further review revealed the physician changed the order on 3/23/16 to immediate release Oxycodone 5 to 10 mg every 4 hours PRN. Review of the MAR showed the resident received the pain medication 2 times on 3/21/16, 4 times on 3/22/16 and 2 times on 3/23/16. Further review of the MAR and nursing notes showed no evidence the effectiveness of the PRN pain medication or non-pharmacological interventions were evaluated.

4. Review of the 3/19/16 physician's progress note for patient #9 showed the patient was admitted due to complaints of severe lower back pain. Review of the nursing assessment, dated 3/21/16, showed the patient described the pain as sharp and debilitating...makes walking excruciating. Review of the nursing assessment, dated 3/22/16, showed the patient reported the pain was radiated from the lower spine to his/her legs and was debilitating...very painful to walk. Review of the physician's orders showed Oxycodone/APP 7.5/325 mg was ordered for pain every 4 hours PRN on 3/21/16. Review of the MAR revealed the patient received Oxycodone/APP 2 times on 3/21/16 and 3 times on 3/22/16. Further review of the MAR and nursing notes showed no evidence the effectiveness of the PRN pain medication or non-pharmacological interventions were evaluated.

5. Review of the medical record for patient #18 revealed s/he required pain management after having lumbar spinal surgery on 12/29/16. Further review revealed Hydrocodone 1 to 2 tablets every 4 hours PRN was ordered on 12/29/16. According to the MAR, the patient received the pain medication 3 times on 12/29/16, 2 times on 12/30/16 and 2 times on 12/31/16. Further review of the MAR and nursing notes showed no evidence the effectiveness of the PRN pain medication or non-pharmacological interventions were evaluated.

6. Review of the policy and procedure for pain management, revised 10/2/15, revealed the following directions were included in the procedures for effective pain management:
a. Reassess the patient's pain level and quality approximately 15 to 30 minutes after parenteral pain medication or approximately 60 minutes after oral pain medication.
b. Record the pain-relief method selected and the patient's rating of pain before and after pain management interventions.
c. Use the flow sheet to document pain assessment findings.
d. Summarize your actions, including the name and dosage of any medication given and the patient's response.

7. During an interview on 3/23/16 at 2:50 PM the CNO acknowledged there was a lack of documentation related to the effectiveness of PRN oral pain medications.

Based on medical record review, staff interview, and policies and procedures review, the facility failed to ensure individualized and comprehensive care plans were developed for 2 of 21 sample patients (#14, #18). The findings were:

1. Review of the medical record for patient #14 showed s/he was admitted on 1/2/16 with diagnosed that included renal failure, sepsis, and spinal dysgenesis. Review of the 1/2/16 to 1/6/16 nursing notes showed nursing care included the following: central venous pressure monitoring, urinary catheter care, antibiotic therapy, medication administration for nausea, disposal briefs for fecal incontinence, monitoring fluids and electrolytes, physical therapy, medication administration for leg spasms, and monitoring telemetry. Review of the care plan showed specific care plan goals for this patient were the following: receive antibiotics as scheduled, vital signs remain within normal limits, have no complaints of pain, and "uses call light appropriately". This review revealed goals for all of the identified problems and care areas were not developed. Further review of the care plan showed teaching and discharge planning were identified problems but goals and specific individualized needs in these areas were not incorporated into the care plan.

2. Review of the physician's notes showed patient #18 had a lumbar spinal fusion on 12/29/15. Review of the physician's orders, dated 12/29/15, showed staff were directed to apply anti-embolus hose, maintain the urinary catheter, monitor oxygen saturation levels, maintain intravenous therapy, perform neurological assessments, and administer pain medication as needed. Review of the care plan showed the following goals: maintain vital signs within normal limits, and verbalize adequate pain control. This review revealed additional goals that addressed the patient's individualized needs were not developed. Further review showed teaching and discharge planning were identified problems but goals and specific individualized needs in these areas were not incorporated into the care plan.

3. During an interview on 3/24/16 at 9:45 AM the CNO acknowledge the care plan goals were not individualized; and they were aware of the need to improve the care planning process. He further stated the challenge has been working with the care plan computer software.

4. Review of the policy and procedure titled, "Care Planning", revised January 2015, showed the plan of care should include standards of care created by general admission status, orders created by the physician related to care and individual goals related to the reason for the stay. This review also showed instructions for staff on each shift to assess the plans of care and update as necessary.

Based on medical record review and staff interview, the facility failed to ensure the medical record for 1 of 9 sample patients (#16) was complete. The findings were:

Review of the medical record for patient #16 showed the patient was admitted as an inpatient on 2/18/16 after receiving treatment in the emergency department. This review also showed the patient became unresponsive and exhibited signs and symptoms of neurological changes an hour and fifteen minutes after admission. According to the nursing documentation the patient was transported to the radiology department at 4:50 PM. Review of the physician's documentation, dated 2/18/16 at 6:09 PM, showed the physician discussed the radiology results with a physician at another hospital who agreed to accept the transfer. Review of the emergency transport report showed the ambulance departed from the hospital at 6:18 PM. Review of the nursing documentation showed the patient's vital signs and oxygen saturation level were checked prior to departure, but additional documentation of the nursing care, monitoring, and assessments that were provided from 4:50 PM until 6:18 PM that day was lacking. Interview with the CNO on 3/24/26 at 8:10 AM revealed the patient had injuries due to trauma and his/her condition was unstable. At that time he verified all of the nursing care, monitoring, and assessments provided after 4:50 PM were not documented in the medical record as it should have been.

Based on observation, review of humidity logs and quality assurance (QA) documentation, and staff interview, the facility failed to ensure it had an effective quality assurance program to identify problems. The findings were:

1. Review of the facility's temperature and humidity control log sheets showed the humidity range should be 30% to 60% . Review of the January to March 2016 log sheets revealed the following:
a. In January 2016 the humidity in OR #2 was documented less than 30% on 14 of 18 days.
b. In February 2016 the humidity was documented less than 30% on 18 of 20 days in OR #1 and on 17 of 20 days in OR #2.
c. In March 2016 the humidity was documented less than 30% on 17 of 17 days in OR #1 and OR #2.

Review of the facility's QA documentation showed an indicator for "Temperature and Humidity Checks," which indicated the facility was at 100% for January and February 2016. During an interview on 3/24/16 at 10:01 AM the QA director stated they were monitoring for completion of the temperature/humidity logs. She acknowledged that the issue with the low humidity in the ORs had not been picked up during the QA process.

2. Observations on 3/23/16 revealed the facility was not doing biological indicators to ensure instruments were being properly sterilized at 5 of 6 locations where sterilization was performed (refer to C278 for details).

Review of the facility's QA documentation showed an indicator for "Biological Monitoring" for the Sterile Processing Department. The indicator was 100% for January and February 2016. During an interview on 3/24/16 at 9:15 AM the QA director stated the indicators for sterile processing was only for the department at the hospital; it did not capture information from the other physician clinics where sterilization was also performed. Therefore, the issue of no biological indicators had not been identified through the QA process.

Based on medical record review, staff interview, and review of policies, the facility failed to ensure the organ procurement organization (OPO) was notified of the death for 1 of 3 expired patients reviewed. The findings were:

1. Review of the closed medical record revealed patient #13 expired in the facility on 12/16/15. Review of the "Record of Death" form showed no evidence the OPO was notified of the death; that section of the form was not filled out. During an interview on 3/23/16 at 2:50 PM, the CNO confirmed there lacked evidence to show the OPO was notified of the death.

2. Review of the facility's policy "Organ Procurement" (5/11) revealed "...All deaths at Star Valley Medical Center shall be reported to [name of OPO] hotline (hereinafter referred to as the Tissue Donation Hotline) for evaluation of donation potential."