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Based on interview, documentation reviewed in 8 of 10 medical records of patients for provision of patient's rights notification (Patients 8, 9, 10, 12, 13, 15, 17, and 23), and review of policies and procedures it was determined that the hospital failed to fully develop and implement its policies and procedures to ensure patients or patient representatives were informed of patient's rights in advance of furnishing care whenever possible.

Findings include:

1. The medical record of Patient 8 reflected he/she was admitted to the outpatient Wound Clinic on 01/27/2016 for a diagnosis of open wound of right heel. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their patient rights.

2. The medical record of Patient 9 reflected he/she was admitted to the outpatient Wound Clinic on 01/13/2016 for a diagnosis of open wounds on the right hand. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their patient rights.

3. Similar findings were identified during review of medical records for Patients 10, 12, 13, 15, 17 and 23.

4. During interview on 11/16/2016 at 1050 with the Clinic Manager of the outpatient Wound Clinic, the Clinic Manager stated he/she did not know if Wound Clinic patients were informed of their rights. The Clinic Manager stated there was nothing in the medical records of Patients 8 and 9 reflecting they had received their patient rights.

5. The policy and procedure titled "Patient Rights and Responsibilities, Statement of," dated as effective 06/24/2014, was reviewed. It reflected: "Purpose: To inform patients and employees of the rights and responsibilities of all patients and their parents or guardians. Policy: PeaceHealth Oregon West Network recognizes, protects and promotes the rights and responsibilities of patients and their legally authorized representatives..." The policy and procedure was not fully developed and implemented as it did not include a process for how patients would be informed of their patient's rights.

Based on interview, grievance report documentation reviewed for 4 of 6 patients/patient representatives that submitted a grievance to the hospital (Patients 1, 2, 3 and 4), and review of policies and procedures, it was determined that the hospital failed to provide each patient/patient representative with a written notice of follow-up investigation and resolution that contained the required elements including: the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

1. Grievance report documentation for Patient 2 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 06/15/2016 and the "Grievance Received" date was 06/15/2016. The grievance "Incident Description" reflected the patient submitted a grievance related to lack of staff response to his/her pain and nausea symptoms. There was no documentation of a written notice provided to the patient. This was confirmed on 11/17/2016 at 1100 with the Risk Manager.

2. Grievance report documentation for Patient 3 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 05/17/2016 and the "Grievance Received" date was 05/20/2016. The grievance "Incident Description" reflected the patient's representative submitted a grievance related to the patient's pain medication and complications related to a surgical procedure. There was no documentation of a written notice provided to the patient. This was confirmed on 11/17/2016 at 1115 with the Risk Manager.

3. Grievance report documentation for Patient 1 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 11/05/2015 and the "Grievance Received" date was 11/05/2015. The grievance "Incident Description" reflected the patient submitted a grievance related to his/her PICC line dressing. A written response from the hospital dated 11/06/2015, submitted to the patient in response to the grievance, was reviewed and did not contain the steps taken on behalf of the patient to investigate the grievance or the results of the grievance process. During an interview on 11/17/2016 at 1015 the Risk Manager stated "I agree. I don't see it there."

4. Grievance report documentation for Patient 4 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 01/21/2016 and the "Grievance Received" date was 05/09/2016. The grievance "Incident Description" reflected the patient submitted a grievance related to complications after a surgical procedure. A written response from the hospital dated 06/06/2016, submitted to the patient in response to the grievance, was reviewed and did not contain the results of the investigation and grievance process. During an interview on 11/17/2016 at 1030 the Risk Manager stated "I completely agree."

5. The policy and procedure titled "Patient Complaint and Grievance" dated as effective "02/02/2016" was reviewed. It stipulated that: "...All grievances and investigative or review responses are documented in the electronic incident reporting system. Risk Management is responsible to provide written acknowledgement and resolution of grievances, wherever possible, within 7 to 10 days...The resolution letter contains: A short description of the grievance; A description of the steps taken to investigate the patient's concerns...The results of the investigation; The date of completion...An electronic copy of the letter is attached to the electronic incident report."














37917

Based on interview, documentation reviewed for provision of informed consent in 1 of 1 medical record of a patient who received procedural sedation (Patients 7), and review of policies and procedures it was determined that the hospital failed to implement its policies and procedures to ensure the patient's right to make informed decisions regarding his/her care.

Findings include:

1. The medical record of Patient 7 was reviewed with the ICU Educator. The record reflected the patient was admitted on 11/11/2016 at 0658 for sepsis.

A nurse note on 11/14/2016 at 2030 reflected the patient was administered IV Versed for sedation and IV Fentanyl for a left parietal head abscess drainage procedure.

There was no consent form or other documentation to reflect the patient or patient representative provided informed consent for the procedure.

2. During an interview on 11/15/2016 at 1450 the ICU Educator confirmed the patient received procedural sedation and had a procedure for drainage of a head abscess. The ICU Educator stated there was no informed consent for the procedure and he/she stated "There should have been."

3. The policy and procedure titled "Consent for Treatment," dated as effective 04/15/2014 was reviewed. It stipulated: "Purpose: To outline the process for obtaining signed consent forms and affirm the necessity for consent to treatment." It further stipulated: "...No physician or other healthcare provider may treat a patient without the patient's consent. The patient has the right to refuse treatment at any time and to be informed by his/her physician of the medical consequences of the refusal...procedure-specific consent forms must also be signed prior to performance of the specific procedure."

Based on observation, interview, review of policies and procedures, and other documents it was determined the hospital failed to fully develop and/or implement policies and procedures for infection prevention in the following areas:
* Separation of dirty/contaminated items and clean patient supplies in ED;
* Processes for cleaning contaminated instruments/devices in accordance with manufacturer instructions and fully developed and implemented policies and procedures in Imaging Department, outpatient Wound Clinic and other areas;
* Endoscope reprocessing and storage in accordance with manufacturer instructions;
* Management of injectable and IV medications in Endo Unit, ICU and other areas;
* Management of multi-dose medication vials in ED;
* Management of skin prep and other patient care supplies in Endo Unit;
* Tube feeding practices in ICU;
* Indwelling urinary catheter management in ICU;
* Management of refrigerated food and beverages in ED; and
* Maintaining environmental surfaces in cleanable condition in ICU, SPD and other areas.

Findings include:

1. On 11/15/2016 at approximately 1215, in the ED soiled utility room, a metal bowl containing liquid and a one gallon container of V. Mueller Instrument Enzymatic detergent was observed on the work counter with the CNO and CNA. No measuring container or other provision for measuring the enzymatic was observed. A cardboard box containing Clinitest pregnancy testing supplies and a cardboard box containing Strep A testing supplies were observed on the counter right next to the metal bowl and enzymatic.

* During an interview with the ED Tech and the CNO at the time of the observation, the ED Tech described the process for cleaning contaminated instruments in the soiled utility room. The ED Tech stated he/she mixed enzymatic with water in the metal bowl and then put contaminated instruments in the bowl to soak. The ED Tech stated the manufacturer's instructions on the enzymatic container included that the instruments be soaked in "one to two fluid ounces per gallon of water." However, the ED Tech stated that when he/she prepared the enzymatic and water for cleaning/soaking instruments he/she "just eye-balled" the amount of enzymatic and did not measure it.

2. On 11/16/2016 at 1040 in the outpatient Wound Clinic, a hand wash sink was observed in a patient treatment room with the Clinic Supervisor and CNA.

* During an interview with the CNA at the time of the observation, the CNA described the process for cleaning contaminated instruments. The CNA stated that some instruments were cleaned in the patient treatment room whereas other instruments were sent to SPD for cleaning. The CNA stated that the instruments that were cleaned in the patient treatment room were soaked in Barbicide, rinsed in the hand wash sink, and then put on a towel to dry in the treatment room. He/she stated those instruments did not go to SPD for processing. However, the CNA stated that other instruments used in the clinic were not soaked in Barbicide and instead were soaked in water and then taken to SPD for further processing. The CNA stated he/she knew which instruments to soak in Barbicide because those instruments had a piece of tape on them, whereas instruments that were soaked in water and sent to SPD for processing did not have a piece of tape on them.

* Similar findings were identified on 11/15/2016 at approximately 1515 during tour of the Imaging Department with the Imaging Manager. During the tour, a Trophon ultrasound processor was observed attached to the wall in the Ultrasound Room. One hand wash sink was observed in the room. There was no other sink in the room. Imaging staff present during the observation described the process for cleaning an ultrasound probe after it was used. During description of the process they stated the ultrasound probe was routinely cleaned, rinsed and left in the hand wash sink before processing it in the Trophon ultrasound processor. Staff further stated that on occasions, the ultrasound probe was stored in the hand wash sink for extended periods of time.

* The policy and procedure titled "Care and Handling of Contaminated Reusable Items at Point of Use," dated as effective 10/10/2011, was reviewed. It required that: "...A dedicated, non-patient care area must be provided for storage and handling of contaminated instrumentation...Non-patient care areas for cleaning of contaminated instrumentation should be separate from patient care areas, ideally enclosed and self contained...A dedicated sink in non patient care area for the cleaning of contaminated instruments only, Not a hand wash sink...items shall be immediately transported to area where cleaning procedures can be accomplished away from patient care..."
The policy was not fully developed and implemented. For example, it did not include a process for how cleaning solutions should be managed, including but not limited to consideration of manufacturer's instructions for dilution; and it did not include any information about the stated process of using tape to identify instruments in the outpatient Wound Clinic. In addition, the stated practice of cleaning, rinsing and storing contaminated instruments in a patient treatment room and hand wash sink, was contradictory to the hospital's policy and procedure.

3. A manufacturer's instructions manual for the Olympus model TJF Q180 endoscope was provided and reviewed. The manual was titled "Olympus Reprocessing Manual Instructions Evis Exera II Duodenovideoscope Olympus TJF Type Q180V" and was dated copyright "March, 2015." The instructions in the manual reflected the following:
The "Perform the leakage test" section reflected "...Fill a clean, large basin with the water...With the leakage tester attached, immerse the endoscope in the water and observe for approximately 30 seconds...Confirm that there is no location on the endoscope from which a continuous series of air bubbles emerge...A continuous series of air bubbles emerging from any location on the endoscope indicates a leak at that location."

The "Brush and flush the forceps elevator recess" section in the manual reflected "...With the forceps elevator raised, insert the tip of the 30 ml syringe into the interior of the forceps elevator recess in the detergent solution, and flush the interior of the recess with 30 ml of the detergent solution...Lower the forceps elevator...Insert the 30 ml syringe into the interior the forceps elevator recess in the detergent solution, and flush the interior of the recess with 30 ml of the detergent solution."

The "Storage and Disposal" section reflected "After reprocessing, maintain appropriate...storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscopes or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them. Establish a local policy regarding the method and frequency of cleaning and disinfecting the endoscope storage cabinet, which staff members can access the cabinet, which items can be stored in the cabinet, etc. Store the endoscope and accessories in an endoscope storage cabinet that also protects the equipment from physical damage...To prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to X-rays or ultraviolet rays...Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices...Store only adequately reprocessed endoscopes and accessories in the endoscope storage cabinet."

* On 11/16/2016 at 1455 in the endoscope processing area, the Endo Tech was observed manually cleaning an Olympus model TJF Q180 endoscope. The Endo Tech did not conduct a water leak test in accordance with the manufacturer's instructions. During the observation, the Endo Tech used a 15 ml syringe to flush the areas around the forceps elevator on the endoscope. The Endo Tech did not use a 30 ml syringe to flush the areas around the forceps elevator in accordance with the manufacturer's instructions.

* During an interview with the Endo Tech at the time of the observation, the Endo Tech stated the manufacturer's instructions for the endoscope required that the endoscope be tested for leaks by submerging it in water and watching for bubbles. However, the Endo Tech stated he/she did not submerge the endoscope in water to check for leaks in accordance with the manufacturer's instructions. The Endo Tech stated that the manufacturer's instructions required a 30 ml syringe be used to flush the forceps elevator areas on the endoscope. However, the Endo Tech confirmed he/she did not use a 30 ml syringe to flush the forceps elevator areas.

* On 11/18/2016 at 1220 in the Endo Unit an endoscope storage cabinet was observed with the RN and the Quality Director. The cabinet contained approximately six endoscopes. The RN stated the hospital had one Olympus model TJF Q180 endoscope and six other similar Olympus model endoscopes that were stored in the cabinet. Across the hall from the storage cabinet a metal table was observed in the hallway. The table had five uncovered, unlabeled 1200 ml graduated cylinders on it with numerous small black devices inside them. The RN stated the graduated cylinders contained valves and other accessories for the Olympus model TJF Q180 endoscope and six other similar model endoscopes that were stored in the cabinet.

* The policy and procedure titled "Care and Cleaning of Endoscope," dated as effective 10/10/2011, was reviewed. It stipulated that: "...Endoscopes are to be inspected tested, used and processed according to manufacturers' recommendations...Clean scopes are to be placed in the Endoscopy scope closet by the SPD staff." The policy and procedure was not fully developed and implemented as it did not include a process to ensure appropriate storage of the Olympus model TJF Q180 endoscope and accessories in accordance with the manufacturer's instructions above. For example, the policy did not include the method and frequency of cleaning and disinfecting the storage cabinet, which staff members could access the cabinet, which items could be stored in the cabinet, and environmental considerations such as temperature and humidity.

4. On 11/16/2016 at 1530 in the Endo Reprocessing area, two EvoTech AERs were observed. Each of the AERs had two wall mounted water purification filters attached to it with a cover piece on the front of the the filters. The cover piece for both AERs had a manufacturer label on it that reflected: "Replacement Frequency Carbon Filter: Semi-Annually" and "0.2 Micron Filter Semi-Annually." This was followed by handwritten "7-22-2015" and initials on the label on both AERs. The labels also had a column for recording "Change Dates" and the last recorded date in that column was "4-14-2015" on the label on both AERs. There was no other information to reflect the filters had been changed semi-annually as reflected on the manufacturer label.

5. In Endo Room 1 on 11/16/2016 at 1235, during observation of Patient 11, the following observations were made: A hospital employee prepared three syringes of injectable medications and did not disinfect the rubber septum on the medication vials prior to piercing them and drawing the medications into syringes. A one liter bag of Lactated Ringer's Injection with IV tubing attached to it was observed at the bedside. There was no label or other information on the IV bag or tubing reflecting when it was hung or when it should be changed.

* In ICU on 11/15/2016 at 1510 in Room 4108, during observation of Patient 7, a bag of IV Norepinephrine with IV tubing attached to it was observed hanging at the bedside. The tubing had a sticker attached to it that read "Norepinephrine" and a blank line after each of the following: "Date," "Time," and "RN Init". The tubing also had a red sticker on it that had "Change Saturday" preprinted on it and no date or other information. It was unclear when the tubing was hung and when it should be changed.

* In ICU on 11/15/2016 at 1600 in Room 4110, during observation of Patient 5, a bag of IV Norepinephrine with IV tubing attached to it was observed hanging at the bedside. The tubing had a yellow sticker attached to it that read "Change Wednesday." The sticker also had "Date" and "Time" on it followed by a blank line. It was unclear when the tubing was hung and when it should be changed.

* A "Clinical Skills" document provided titled "Intravenous Therapy: Initiation," with copyright "2006 - 2016," was reviewed: It stipulated: "...Prepare the prescribed IV solution...Prepare the infusion tubing...Apply a label to IV tubing that indicates either when tubing was hung or when tubing should be changed..."

6. On 11/15/2016 at 1120, in the ED an open undated single dose vial of Sensorcaine 30 mL for injection, and an open undated single dose vial of Xylocaine 30 mL for injection was observed in the wound cart available for use. There was no information on the vials reflecting when the vials were opened or when they should be discarded.

* At the time of the observation, the Special Projects RN confirmed the single dose vials were not dated and stated he/she did not know when they were opened.

7. On 11/15/2016 at 1120, in the ED an open undated MDV of Lidocaine 50 mL for injection, and an open undated MDV of Sensorcaine 50 mL for injection was observed in the wound cart available for use. There was no information on the vials reflecting when the vials were opened or when they should be discarded. .

* At the time of the observation, the Special Projects RN confirmed the MDVs were not dated and stated he/she did not know when the they were opened.

* During an interview on 11/17/2016 at 1650 the Senior Quality Facilitator stated the hospital did not have a policy and procedure for managing and dating MDVs.

8. On 11/16/2016 at approximately 1200 in Endo Unit, an endotracheal tube was observed in an open pack in the anesthesia cart available for patient use. There was no information on the package to reflect whether or not the endotracheal tube had been used or when the package was opened. The integrity of the endotracheal tube could not be ensured.

9. On 11/16/2016 at 1245 in Endo Unit, an undated small round metal container with a lid on it was observed on the anesthesia cart. The lid was labeled "alcohol" with a non manufacturer label. The container had multiple gauze pads inside it that were soaking in clear liquid. There was no date or other information on the container including the type and strength of the alcohol, when it expired, or when or if the alcohol and gauze pads were last replaced.

* During an interview with the Anesthesia Tech at the time of the observation, he/she confirmed that the clear liquid inside the metal container was alcohol. The Anesthesia Tech stated that the gauze pads in the container were used for prepping patients' skin for IV insertions, disinfecting the rubber septum on vials of IV medication prior to accessing the vial, and disinfecting patients' IV hubs prior to administering IV medications. The Anesthesia Tech stated that the alcohol inside the metal container was "refilled as needed from a larger container" of alcohol in the anesthesia work room. The Anesthesia Tech stated he/she did not know when the alcohol and gauze pads were last refilled or replaced.

* A policy and procedure for the stated practice of using alcohol transferred from another container for IV skin prep and other IV related tasks was requested, including consideration of expiration and manufacturer instructions for use. No policy and procedure was provided.

10. In ICU on 11/15/2016 at 1510, during observation of Patient 7, a container of Perative Therapeutic Nutrition tube feeding formula with tubing attached to it was observed at the patient's bedside. There was no information on the container or tubing reflecting the date or time they were initiated or last changed. The RN stated the tubing should be changed every 24 hours. However, the RN acknowledged there was no information anywhere on the tube feeding container or tubing reflecting when it was prepared and hung, or when it should be changed.

* During an interview on 11/17/2016 at 1650 the Senior Quality Facilitator stated that the hospital did not have a policy and procedure for managing and dating tube feeding systems.

11. On 11/15/2016 at 1540 in the ICU, observation of Patient 5 reflected he/she had an indwelling urinary catheter. The tubing was positioned on the mattress with the patient's leg resting on top of it. The tubing then extended to to the foot end of the bed where it was attached to a drainage bag. The tubing was not secured to the patient's leg or anchored to anything. This was confirmed with the RN at the time of the observation. The RN stated that the catheter tubing should have been secured to the patient's leg and he/she acknowledged that it was not.

* The undated clinical skills procedure provided titled "Urinary Catheter: Straight and Indwelling (Foley) Catheter Insertion and Specimen" reflected the following: "...Anchor the catheter...Secure catheter tubing to the upper medial aspect of the patient's inner thigh...Securing the catheter minimizes accidental catheter dislodgement and minimizes trauma, meatal necrosis, and bladder spasms from pressure and traction...Ensure that the tubing has no obstructions or kinks..."

12. On 11/15/2016 at 1120, in the ED, the refrigerator used for storage of patient food and beverages was observed and was cluttered, disorganized, and had spilled and open beverage items inside it. Examples included: There were numerous small containers of juice that were tipped over and disorganized. Spilled juice was pooled on the bottom surface of the refrigerator with a package containing large bratwurst-type sausages resting in the spilled juice. The package of sausages had a manufacturer label on it but no other label or information on it reflecting who it was intended for or when it was placed in the refrigerator. Three open pints of milk were observed and were not labeled or dated when they were opened, or when or if they should be discarded. A sign was taped to the door on the inside of the refrigerator that read "No Open Containers in Refrigerator Including Milk or Formula." This was contradictory to the open pints of milk observed. These observations were made with the CNO and the Interim Director of ED.

* The policy and procedure titled "Nursing Unit Refrigerators," dated as effective 10/19/2010, was reviewed. It stipulated that: "...All patient food items are to be covered, labeled, and dated. If intended for a specific patient, the patient's name is to be included on the label...Perishable items with no label are discarded daily...Refrigerators are cleaned by Environmental Services." The policy was not fully developed. For example, it did not specify what the date on the food item label represented (e.g. date the food item was placed in the refrigerator, date the food item was to be discarded, expiration date, or another date), or how frequently the refrigerator was to be checked and cleaned. The policy also did not include that "no open containers" were permitted in the refrigerator as reflected on the sign posted inside the refrigerator.

13. On 11/15/2016 at 1005, in the ED clean utility room, the wall at the room entry and the wall near the baseboard had numerous areas of scraped and chipping paint. Those surfaces were not cleanable. This was observed with the Interim ED Director.

* On 11/15/2016 at 1110 in the ED, chipped and peeling paint was observed on the wall outside Trauma Room 34 near the entry doors. That surface was not cleanable.

* On 11/15/2016 at 1400, in ICU, the edge of the door near the door handle had chipping wood laminate in the soiled utility room. That surface was not cleanable.

* On 11/15/2016 at 1520, in ICU, torn vinyl was observed on the seats of two chairs at a staff computer work station. Those surfaces were not cleanable.

* On 11/16/2016 at 1240 in Endo Unit, a large horizontal scratch was observed on the wood-like surface of the entry door in Endo Room 1. That surface was not cleanable.

* On 11/16/2016 at 1550, in Decontam, the Custom Ultrasonics instrument cleaning machine was visibly dirty and had brown, discolored, peeling areas that were in disrepair on the top edges of the inside of the machine.

* On 11/16/2016 at 1620, in SPD, numerous areas of peeling and gouged paint were observed on the walls in the case cart room. Those surfaces were in disrepair and were not cleanable.

































37917

Based on interview, documentation reviewed in 8 of 10 medical records of patients for provision of patient's rights notification (Patients 8, 9, 10, 12, 13, 15, 17, and 23), and review of policies and procedures it was determined that the hospital failed to fully develop and implement its policies and procedures to ensure patients or patient representatives were informed of patient's rights in advance of furnishing care whenever possible.

Findings include:

1. The medical record of Patient 8 reflected he/she was admitted to the outpatient Wound Clinic on 01/27/2016 for a diagnosis of open wound of right heel. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their patient rights.

2. The medical record of Patient 9 reflected he/she was admitted to the outpatient Wound Clinic on 01/13/2016 for a diagnosis of open wounds on the right hand. There was no documentation in the record to reflect that the patient or the patient's representative had been informed of their patient rights.

3. Similar findings were identified during review of medical records for Patients 10, 12, 13, 15, 17 and 23.

4. During interview on 11/16/2016 at 1050 with the Clinic Manager of the outpatient Wound Clinic, the Clinic Manager stated he/she did not know if Wound Clinic patients were informed of their rights. The Clinic Manager stated there was nothing in the medical records of Patients 8 and 9 reflecting they had received their patient rights.

5. The policy and procedure titled "Patient Rights and Responsibilities, Statement of," dated as effective 06/24/2014, was reviewed. It reflected: "Purpose: To inform patients and employees of the rights and responsibilities of all patients and their parents or guardians. Policy: PeaceHealth Oregon West Network recognizes, protects and promotes the rights and responsibilities of patients and their legally authorized representatives..." The policy and procedure was not fully developed and implemented as it did not include a process for how patients would be informed of their patient's rights.

Based on interview, grievance report documentation reviewed for 4 of 6 patients/patient representatives that submitted a grievance to the hospital (Patients 1, 2, 3 and 4), and review of policies and procedures, it was determined that the hospital failed to provide each patient/patient representative with a written notice of follow-up investigation and resolution that contained the required elements including: the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings include:

1. Grievance report documentation for Patient 2 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 06/15/2016 and the "Grievance Received" date was 06/15/2016. The grievance "Incident Description" reflected the patient submitted a grievance related to lack of staff response to his/her pain and nausea symptoms. There was no documentation of a written notice provided to the patient. This was confirmed on 11/17/2016 at 1100 with the Risk Manager.

2. Grievance report documentation for Patient 3 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 05/17/2016 and the "Grievance Received" date was 05/20/2016. The grievance "Incident Description" reflected the patient's representative submitted a grievance related to the patient's pain medication and complications related to a surgical procedure. There was no documentation of a written notice provided to the patient. This was confirmed on 11/17/2016 at 1115 with the Risk Manager.

3. Grievance report documentation for Patient 1 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 11/05/2015 and the "Grievance Received" date was 11/05/2015. The grievance "Incident Description" reflected the patient submitted a grievance related to his/her PICC line dressing. A written response from the hospital dated 11/06/2015, submitted to the patient in response to the grievance, was reviewed and did not contain the steps taken on behalf of the patient to investigate the grievance or the results of the grievance process. During an interview on 11/17/2016 at 1015 the Risk Manager stated "I agree. I don't see it there."

4. Grievance report documentation for Patient 4 was reviewed with the Risk Manager. The documentation reflected the "Incident Date" was 01/21/2016 and the "Grievance Received" date was 05/09/2016. The grievance "Incident Description" reflected the patient submitted a grievance related to complications after a surgical procedure. A written response from the hospital dated 06/06/2016, submitted to the patient in response to the grievance, was reviewed and did not contain the results of the investigation and grievance process. During an interview on 11/17/2016 at 1030 the Risk Manager stated "I completely agree."

5. The policy and procedure titled "Patient Complaint and Grievance" dated as effective "02/02/2016" was reviewed. It stipulated that: "...All grievances and investigative or review responses are documented in the electronic incident reporting system. Risk Management is responsible to provide written acknowledgement and resolution of grievances, wherever possible, within 7 to 10 days...The resolution letter contains: A short description of the grievance; A description of the steps taken to investigate the patient's concerns...The results of the investigation; The date of completion...An electronic copy of the letter is attached to the electronic incident report."














37917

Based on interview, documentation reviewed for provision of informed consent in 1 of 1 medical record of a patient who received procedural sedation (Patients 7), and review of policies and procedures it was determined that the hospital failed to implement its policies and procedures to ensure the patient's right to make informed decisions regarding his/her care.

Findings include:

1. The medical record of Patient 7 was reviewed with the ICU Educator. The record reflected the patient was admitted on 11/11/2016 at 0658 for sepsis.

A nurse note on 11/14/2016 at 2030 reflected the patient was administered IV Versed for sedation and IV Fentanyl for a left parietal head abscess drainage procedure.

There was no consent form or other documentation to reflect the patient or patient representative provided informed consent for the procedure.

2. During an interview on 11/15/2016 at 1450 the ICU Educator confirmed the patient received procedural sedation and had a procedure for drainage of a head abscess. The ICU Educator stated there was no informed consent for the procedure and he/she stated "There should have been."

3. The policy and procedure titled "Consent for Treatment," dated as effective 04/15/2014 was reviewed. It stipulated: "Purpose: To outline the process for obtaining signed consent forms and affirm the necessity for consent to treatment." It further stipulated: "...No physician or other healthcare provider may treat a patient without the patient's consent. The patient has the right to refuse treatment at any time and to be informed by his/her physician of the medical consequences of the refusal...procedure-specific consent forms must also be signed prior to performance of the specific procedure."

Based on observation, interview, review of policies and procedures, and other documents it was determined the hospital failed to fully develop and/or implement policies and procedures for infection prevention in the following areas:
* Separation of dirty/contaminated items and clean patient supplies in ED;
* Processes for cleaning contaminated instruments/devices in accordance with manufacturer instructions and fully developed and implemented policies and procedures in Imaging Department, outpatient Wound Clinic and other areas;
* Endoscope reprocessing and storage in accordance with manufacturer instructions;
* Management of injectable and IV medications in Endo Unit, ICU and other areas;
* Management of multi-dose medication vials in ED;
* Management of skin prep and other patient care supplies in Endo Unit;
* Tube feeding practices in ICU;
* Indwelling urinary catheter management in ICU;
* Management of refrigerated food and beverages in ED; and
* Maintaining environmental surfaces in cleanable condition in ICU, SPD and other areas.

Findings include:

1. On 11/15/2016 at approximately 1215, in the ED soiled utility room, a metal bowl containing liquid and a one gallon container of V. Mueller Instrument Enzymatic detergent was observed on the work counter with the CNO and CNA. No measuring container or other provision for measuring the enzymatic was observed. A cardboard box containing Clinitest pregnancy testing supplies and a cardboard box containing Strep A testing supplies were observed on the counter right next to the metal bowl and enzymatic.

* During an interview with the ED Tech and the CNO at the time of the observation, the ED Tech described the process for cleaning contaminated instruments in the soiled utility room. The ED Tech stated he/she mixed enzymatic with water in the metal bowl and then put contaminated instruments in the bowl to soak. The ED Tech stated the manufacturer's instructions on the enzymatic container included that the instruments be soaked in "one to two fluid ounces per gallon of water." However, the ED Tech stated that when he/she prepared the enzymatic and water for cleaning/soaking instruments he/she "just eye-balled" the amount of enzymatic and did not measure it.

2. On 11/16/2016 at 1040 in the outpatient Wound Clinic, a hand wash sink was observed in a patient treatment room with the Clinic Supervisor and CNA.

* During an interview with the CNA at the time of the observation, the CNA described the process for cleaning contaminated instruments. The CNA stated that some instruments were cleaned in the patient treatment room whereas other instruments were sent to SPD for cleaning. The CNA stated that the instruments that were cleaned in the patient treatment room were soaked in Barbicide, rinsed in the hand wash sink, and then put on a towel to dry in the treatment room. He/she stated those instruments did not go to SPD for processing. However, the CNA stated that other instruments used in the clinic were not soaked in Barbicide and instead were soaked in water and then taken to SPD for further processing. The CNA stated he/she knew which instruments to soak in Barbicide because those instruments had a piece of tape on them, whereas instruments that were soaked in water and sent to SPD for processing did not have a piece of tape on them.

* Similar findings were identified on 11/15/2016 at approximately 1515 during tour of the Imaging Department with the Imaging Manager. During the tour, a Trophon ultrasound processor was observed attached to the wall in the Ultrasound Room. One hand wash sink was observed in the room. There was no other sink in the room. Imaging staff present during the observation described the process for cleaning an ultrasound probe after it was used. During description of the process they stated the ultrasound probe was routinely cleaned, rinsed and left in the hand wash sink before processing it in the Trophon ultrasound processor. Staff further stated that on occasions, the ultrasound probe was stored in the hand wash sink for extended periods of time.

* The policy and procedure titled "Care and Handling of Contaminated Reusable Items at Point of Use," dated as effective 10/10/2011, was reviewed. It required that: "...A dedicated, non-patient care area must be provided for storage and handling of contaminated instrumentation...Non-patient care areas for cleaning of contaminated instrumentation should be separate from patient care areas, ideally enclosed and self contained...A dedicated sink in non patient care area for the cleaning of contaminated instruments only, Not a hand wash sink...items shall be immediately transported to area where cleaning procedures can be accomplished away from patient care..."
The policy was not fully developed and implemented. For example, it did not include a process for how cleaning solutions should be managed, including but not limited to consideration of manufacturer's instructions for dilution; and it did not include any information about the stated process of using tape to identify instruments in the outpatient Wound Clinic. In addition, the stated practice of cleaning, rinsing and storing contaminated instruments in a patient treatment room and hand wash sink, was contradictory to the hospital's policy and procedure.

3. A manufacturer's instructions manual for the Olympus model TJF Q180 endoscope was provided and reviewed. The manual was titled "Olympus Reprocessing Manual Instructions Evis Exera II Duodenovideoscope Olympus TJF Type Q180V" and was dated copyright "March, 2015." The instructions in the manual reflected the following:
The "Perform the leakage test" section reflected "...Fill a clean, large basin with the water...With the leakage tester attached, immerse the endoscope in the water and observe for approximately 30 seconds...Confirm that there is no location on the endoscope from which a continuous series of air bubbles emerge...A continuous series of air bubbles emerging from any location on the endoscope indicates a leak at that location."

The "Brush and flush the forceps elevator recess" section in the manual reflected "...With the forceps elevator raised, insert the tip of the 30 ml syringe into the interior of the forceps elevator recess in the detergent solution, and flush the interior of the recess with 30 ml of the detergent solution...Lower the forceps elevator...Insert the 30 ml syringe into the interior the forceps elevator recess in the detergent solution, and flush the interior of the recess with 30 ml of the detergent solution."

The "Storage and Disposal" section reflected "After reprocessing, maintain appropriate...storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscopes or accessories become contaminated before subsequent patient procedures, they could pose an infection control risk to patients and/or operators who touch them. Establish a local policy regarding the method and frequency of cleaning and disinfecting the endoscope storage cabinet, which staff members can access the cabinet, which items can be stored in the cabinet, etc. Store the endoscope and accessories in an endoscope storage cabinet that also protects the equipment from physical damage...To prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to X-rays or ultraviolet rays...Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices...Store only adequately reprocessed endoscopes and accessories in the endoscope storage cabinet."

* On 11/16/2016 at 1455 in the endoscope processing area, the Endo Tech was observed manually cleaning an Olympus model TJF Q180 endoscope. The Endo Tech did not conduct a water leak test in accordance with the manufacturer's instructions. During the observation, the Endo Tech used a 15 ml syringe to flush the areas around the forceps elevator on the endoscope. The Endo Tech did not use a 30 ml syringe to flush the areas around the forceps elevator in accordance with the manufacturer's instructions.

* During an interview with the Endo Tech at the time of the observation, the Endo Tech stated the manufacturer's instructions for the endoscope required that the endoscope be tested for leaks by submerging it in water and watching for bubbles. However, the Endo Tech stated he/she did not submerge the endoscope in water to check for leaks in accordance with the manufacturer's instructions. The Endo Tech stated that the manufacturer's instructions required a 30 ml syringe be used to flush the forceps elevator areas on the endoscope. However, the Endo Tech confirmed he/she did not use a 30 ml syringe to flush the forceps elevator areas.

* On 11/18/2016 at 1220 in the Endo Unit an endoscope storage cabinet was observed with the RN and the Quality Director. The cabinet contained approximately six endoscopes. The RN stated the hospital had one Olympus model TJF Q180 endoscope and six other similar Olympus model endoscopes that were stored in the cabinet. Across the hall from the storage cabinet a metal table was observed in the hallway. The table had five uncovered, unlabeled 1200 ml graduated cylinders on it with numerous small black devices inside them. The RN stated the graduated cylinders contained valves and other accessories for the Olympus model TJF Q180 endoscope and six other similar model endoscopes that were stored in the cabinet.

* The policy and procedure titled "Care and Cleaning of Endoscope," dated as effective 10/10/2011, was reviewed. It stipulated that: "...Endoscopes are to be inspected tested, used and processed according to manufacturers' recommendations...Clean scopes are to be placed in the Endoscopy scope closet by the SPD staff." The policy and procedure was not fully developed and implemented as it did not include a process to ensure appropriate storage of the Olympus model TJF Q180 endoscope and accessories in accordance with the manufacturer's instructions above. For example, the policy did not include the method and frequency of cleaning and disinfecting the storage cabinet, which staff members could access the cabinet, which items could be stored in the cabinet, and environmental considerations such as temperature and humidity.

4. On 11/16/2016 at 1530 in the Endo Reprocessing area, two EvoTech AERs were observed. Each of the AERs had two wall mounted water purification filters attached to it with a cover piece on the front of the the filters. The cover piece for both AERs had a manufacturer label on it that reflected: "Replacement Frequency Carbon Filter: Semi-Annually" and "0.2 Micron Filter Semi-Annually." This was followed by handwritten "7-22-2015" and initials on the label on both AERs. The labels also had a column for recording "Change Dates" and the last recorded date in that column was "4-14-2015" on the label on both AERs. There was no other information to reflect the filters had been changed semi-annually as reflected on the manufacturer label.

5. In Endo Room 1 on 11/16/2016 at 1235, during observation of Patient 11, the following observations were made: A hospital employee prepared three syringes of injectable medications and did not disinfect the rubber septum on the medication vials prior to piercing them and drawing the medications into syringes. A one liter bag of Lactated Ringer's Injection with IV tubing attached to it was observed at the bedside. There was no label or other information on the IV bag or tubing reflecting when it was hung or when it should be changed.

* In ICU on 11/15/2016 at 1510 in Room 4108, during observation of Patient 7, a bag of IV Norepinephrine with IV tubing attached to it was observed hanging at the bedside. The tubing had a sticker attached to it that read "Norepinephrine" and a blank line after each of the following: "Date," "Time," and "RN Init". The tubing also had a red sticker on it that had "Change Saturday" preprinted on it and no date or other information. It was unclear when the tubing was hung and when it should be changed.

* In ICU on 11/15/2016 at 1600 in Room 4110, during observation of Patient 5, a bag of IV Norepinephrine with IV tubing attached to it was observed hanging at the bedside. The tubing had a yellow sticker attached to it that read "Change Wednesday." The sticker also had "Date" and "Time" on it followed by a blank line. It was unclear when the tubing was hung and when it should be changed.

* A "Clinical Skills" document provided titled "Intravenous Therapy: Initiation," with copyright "2006 - 2016," was reviewed: It stipulated: "...Prepare the prescribed IV solution...Prepare the infusion tubing...Apply a label to IV tubing that indicates either when tubing was hung or when tubing should be changed..."

6. On 11/15/2016 at 1120, in the ED an open undated single dose vial of Sensorcaine 30 mL for injection, and an open undated single dose vial of Xylocaine 30 mL for injection was observed in the wound cart available for use. There was no information on the vials reflecting when the vials were opened or when they should be discarded.

* At the time of the observation, the Special Projects RN confirmed the single dose vials were not dated and stated he/she did not know when they were opened.

7. On 11/15/2016 at 1120, in the ED an open undated MDV of Lidocaine 50 mL for injection, and an open undated MDV of Sensorcaine 50 mL for injection was observed in the wound cart available for use. There was no information on the vials reflecting when the vials were opened or when they should be discarded. .

* At the time of the observation, the Special Projects RN confirmed the MDVs were not dated and stated he/she did not know when the they were opened.

* During an interview on 11/17/2016 at 1650 the Senior Quality Facilitator stated the hospital did not have a policy and procedure for managing and dating MDVs.

8. On 11/16/2016 at approximately 1200 in Endo Unit, an endotracheal tube was observed in an open pack in the anesthesia cart available for patient use. There was no information on the package to reflect whether or not the endotracheal tube had been used or when the package was opened. The integrity of the endotracheal tube could not be ensured.

9. On 11/16/2016 at 1245 in Endo Unit, an undated small round metal container with a lid on it was observed on the anesthesia cart. The lid was labeled "alcohol" with a non manufacturer label. The container had multiple gauze pads inside it that were soaking in clear liquid. There was no date or other information on the container including the type and strength of the alcohol, when it expired, or when or if the alcohol and gauze pads were last replaced.

* During an interview with the Anesthesia Tech at the time of the observation, he/she confirmed that the clear liquid inside the metal container was alcohol. The Anesthesia Tech stated that the gauze pads in the container were used for prepping patients' skin for IV insertions, disinfecting the rubber septum on vials of IV medication prior to accessing the vial, and disinfecting patients' IV hubs prior to administering IV medications. The Anesthesia Tech stated that the alcohol inside the metal container was "refilled as needed from a larger container" of alcohol in the anesthesia work room. The Anesthesia Tech stated he/she did not know when the alcohol and gauze pads were last refilled or replaced.

* A policy and procedure for the stated practice of using alcohol transferred from another container for IV skin prep and other IV related tasks was requested, including consideration of expiration and manufacturer instructions for use. No policy and procedure was provided.

10. In ICU on 11/15/2016 at 1510, during observation of Patient 7, a container of Perative Therapeutic Nutrition tube feeding formula with tubing attached to it was observed at the patient's bedside. There was no information on the container or tubing reflecting the date or time they were initiated or last changed. The RN stated the tubing should be changed every 24 hours. However, the RN acknowledged there was no information anywhere on the tube feeding container or tubing reflecting when it was prepared and hung, or when it should be changed.

* During an interview on 11/17/2016 at 1650 the Senior Quality Facilitator stated that the hospital did not have a policy and procedure for managing and dating tube feeding systems.

11. On 11/15/2016 at 1540 in the ICU, observation of Patient 5 reflected he/she had an indwelling urinary catheter. The tubing was positioned on the mattress with the patient's leg resting on top of it. The tubing then extended to to the foot end of the bed where it was attached to a drainage bag. The tubing was not secured to the patient's leg or anchored to anything. This was confirmed with the RN at the time of the observation. The RN stated that the catheter tubing should have been secured to the patient's leg and he/she acknowledged that it was not.

* The undated clinical skills procedure provided titled "Urinary Catheter: Straight and Indwelling (Foley) Catheter Insertion and Specimen" reflected the following: "...Anchor the catheter...Secure catheter tubing to the upper medial aspect of the patient's inner thigh...Securing the catheter minimizes accidental catheter dislodgement and minimizes trauma, meatal necrosis, and bladder spasms from pressure and traction...Ensure that the tubing has no obstructions or kinks..."

12. On 11/15/2016 at 1120, in the ED, the refrigerator used for storage of patient food and beverages was observed and was cluttered, disorganized, and had spilled and open beverage items inside it. Examples included: There were numerous small containers of juice that were tipped over and disorganized. Spilled juice was pooled on the bottom surface of the refrigerator with a package containing large bratwurst-type sausages resting in the spilled juice. The package of sausages had a manufacturer label on it but no other label or information on it reflecting who it was intended for or when it was placed in the refrigerator. Three open pints of milk were observed and were not labeled or dated when they were opened, or when or if they should be discarded. A sign was taped to the door on the inside of the refrigerator that read "No Open Containers in Refrigerator Including Milk or Formula." This was contradictory to the open pints of milk observed. These observations were made with the CNO and the Interim Director of ED.

* The policy and procedure titled "Nursing Unit Refrigerators," dated as effective 10/19/2010, was reviewed. It stipulated that: "...All patient food items are to be covered, labeled, and dated. If intended for a specific patient, the patient's name is to be included on the label...Perishable items with no label are discarded daily...Refrigerators are cleaned by Environmental Services." The policy was not fully developed. For example, it did not specify what the date on the food item label represented (e.g. date the food item was placed in the refrigerator, date the food item was to be discarded, expiration date, or another date), or how frequently the refrigerator was to be checked and cleaned. The policy also did not include that "no open containers" were permitted in the refrigerator as reflected on the sign posted inside the refrigerator.

13. On 11/15/2016 at 1005, in the ED clean utility room, the wall at the room entry and the wall near the baseboard had numerous areas of scraped and chipping paint. Those surfaces were not cleanable. This was observed with the Interim ED Director.

* On 11/15/2016 at 1110 in the ED, chipped and peeling paint was observed on the wall outside Trauma Room 34 near the entry doors. That surface was not cleanable.

* On 11/15/2016 at 1400, in ICU, the edge of the door near the door handle had chipping wood laminate in the soiled utility room. That surface was not cleanable.

* On 11/15/2016 at 1520, in ICU, torn vinyl was observed on the seats of two chairs at a staff computer work station. Those surfaces were not cleanable.

* On 11/16/2016 at 1240 in Endo Unit, a large horizontal scratch was observed on the wood-like surface of the entry door in Endo Room 1. That surface was not cleanable.

* On 11/16/2016 at 1550, in Decontam, the Custom Ultrasonics instrument cleaning machine was visibly dirty and had brown, discolored, peeling areas that were in disrepair on the top edges of the inside of the machine.

* On 11/16/2016 at 1620, in SPD, numerous areas of peeling and gouged paint were observed on the walls in the case cart room. Those surfaces were in disrepair and were not cleanable.

































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