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Based on observation, interview, record review, and policy review, the provider failed to ensure three of three observed crash carts (emergency department [ED], medical-surgical department, and intensive care unit [ICU]) containing defibrillators had been checked every shift per policy. Findings include:

1. Random observations on 1/30/17 from 3:00 p.m. through 5:00 p.m. of the ED, medical-surgical department, and ICU revealed:
*Each of those departments contained one or two secured crash carts.
-Those crash carts contained multiple life-saving equipment, medications, and defibrillators.

Review of the LifePak 20 Defibrillator/Monitor Operation Checklist from 11/1/16 through 1/31/17 for the ED revealed for the primary crash cart:
*In November there were nine days that safety checks had not been performed on the defibrillator.
-Those dates had been 11/3/16, 11/9/16, 11/13/16, 11/18/16, 11/20/16, 11/21/16, 11/30/16, and 11/31/16.
--On 11/31/16 neither the day shift nor the night shift staff had performed safety checks on the defibrillator.
*In December there were eight days that safety checks had not been performed on the defibrillator.
-Those dates had been 12/5/16, 12/6/16, 12/15/16, 12/20/16, 12/22/16, 12/24/16, and 12/28/16.
--On 12/15/16 neither the day shift nor the night shift staff had performed safety checks on the defibrillator.
*In January there were six days that safety checks had not been performed on the defibrillator.
-Those dates had been 1/2/17, 1/5/17, 1/8/17, 1/13/17, 1/16/17, and 1/18/17.

Review of the LifePac 20 Defibrillator/Monitor Operation Checklist from 11/1/16 through 1/30/17 for the medical-surgical department revealed:
*In November there were fifteen days that safety checks had not been performed on the defibrillator.
-Those dates had been 11/3/16, 11/5/16, 11/7/16, 11/10/16, 11/11/16, 11/12/16, 11/15/16, 11/16/16, 11/18/16, 11/19/16, 11/20/16, 11/21/16, 11/27/16, 11/29/16, and 11/31/16.
--On 11/16/16 neither the day shift nor the night shift staff had performed safety checks on the defibrillator.
*In December there thirteen days that safety checks had not been performed on the defibrillator.
-Those dates had been 12/4/16, 12/8/16, 12/9/16, 12/10/16, 12/19/16, 12/22/16, 12/25/16, 12/26/16, 12/27/16, 12/29/16, 12/30/16, and 12/31/16.
--On 12/22/16 neither the day shift nor the night shift staff had performed safety checks on the defibrillator.
*In January there had been fifteen days that safety checks had not been performed on the defibrillator.
-Those dates had been 1/3/17, 1/5/17, 1/10/17, 1/11/17, 1/12/17, 1/15/17, 1/16/17, 1/18/17, 1/19/17, 1/20/17, 1/21/17, 1/27/17, 1/29/17, and 1/31/17.
--On 1/16/17 neither the day shift nor the night shift staff had performed safety checks on the defibrillator.

Review of the LifePac 20 Defibrillator/Monitor Operation Checklist from 11/1/16 through 1/30/17 for the ICU department revealed:
*In November there were eight days that safety checks had not been performed on the defibrillator.
-Those dates had been 11/1/16, 11/2/16, 11/11/16, 11/12/16, 11/16/16, 11/23/16, 11/28/16, and 11/30/16.
*In December there were twelve days that safety checks had not been performed on the defibrillator.
-Those dates had been 12/4/16, 12/6/16, 12/9/16, 12/10/16, 12/11/16, 12/12/16, 12/15/16, 12/17/16, 12/18/16, 12/26/16, and 12/31/16.
--On 12/11/16 neither the day shift nor the night shift staff had performed safety checks on the defibrillator.
*In January there were thirteen days that safety checks had not been performed on the defibrillator.
-Those dates had been 1/3/17, 1/5/17, 1/6/17, 1/7/17, 1/8/17, 1/12/17, 1/13/17, 1/23/17, 1/26/17, 1/30/17, and 1/31/17.
--On 1/31/17 neither the day shift nor the night shift had performed safety checks on the defibrillator.

Interview on 1/30/17 at 3:45 p.m. with registered nurse (RN) P revealed:
*The staff should have checked the crash carts every shift.
*The charge nurse scheduled for that shift was responsible to have performed manual safety checks on all of the defibrillators in their area.
*She had confirmed the safety checks for the defibrillator on the ICU were not performed every shift per their policy.

Interview on 1/31/17 at 4:10 p.m. with RN L regarding the above documentation revealed:
*She confirmed the interview with RN P.
*She agreed there was no documentation to support safety checks had been performed on the defibrillators above for every shift from 11/1/16 through 1/31/17.

Interview on 2/1/17 at 10:35 a.m. with the director of nursing confirmed the above interview with RNs P and L.

Review of the provider's October 2016 Code Blue Management policy revealed all departments were to have performed safety checks on the defibrillators twice a day.

A. Based on observation, interview, and policy review, the provider failed to ensure:
*Intravenous (IV) solutions stored in two of two clean utility rooms (medical-surgical department) were not accessible to unauthorized individuals.
*Emergency medications and the key to access those medications were not accessible to unauthorized individuals for one of one sampled infant warming unit on the maternity unit.
Findings include:

1. Observation on 1/30/17 at 3:00 p.m. of the two second floor clean utility rooms revealed numerous bags of IV solutions. The clean utility rooms were not lockable and were accessible to unauthorized individuals.

Interview on 1/30/17 at 4:10 p.m. with the director of inpatient services revealed:
*The clean utility rooms were accessible by unauthorized individuals.
*Those areas had been identified on a mock survey several months ago, but no changes had been made.
*The clean utility rooms stored numerous IV bags in various strengths.

2. Observation on 1/31/17 at 7:30 a.m. on the obstetric unit revealed a locked drawer on an infant warming unit. Staff member GG was able to retrieve the key from a supply cart located in the hallway near the nurses' station and open that drawer.

Interview on 2/2/17 at 8:14 a.m. with RN U revealed:
*She was not aware staff member GG should not have had access to medications stored in the infant warming unit.
*The medications were provided from pharmacy and were stored in a container covered by plastic. They were locked in the bottom drawer.

Surveyor: 32355
3. Interview on 2/2/17 at 1:50 p.m. with pharmacist Z revealed:
*She was the supervisor for the pharmacy department.
*She had confirmed the pharmacy department was responsible for the management and security of all medications within the hospital.
*The pharmacy department had not been aware an unauthorized staff member had access to the medications stored in the infant warming unit.
*She agreed the above process had not ensured those drugs and biologicals were stored in a secured manner.

Review of the provider's 2016 Medication Administration Policy revealed:
*"All drugs and biologicals must be kept in a locked room or container. If the container (cart) is mobile or readily portable, when not in use, it must be stored in a locked room, monitored location, or secured location that will ensure the security of the drugs or biologicals.
*All drugs and biological must be stored in a manner to prevent access by unauthorized individuals.
*Persons without legal access to drugs and biologicals cannot have unmonitored access to drugs or biologicals.
*Persons without legal access to drugs or biologicals cannot have keys to medication storage rooms, carts, cabinets, or containers."
*"All medications must be kept in designated storage areas that are inaccessible to patients and visitors and locked at all times."



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B. Based on observation, interview, and policy review, the provider failed to ensure only authorized personnel had access to medications including one of one intensive care unit (ICU) storage area for pharmaceutical waste containers. Findings include:

1. Observation on 1/30/17 at 4:00 p.m. of the soiled utility room on the ICU revealed:
*The door had been unlocked and allowed for access by the patients, visitors, and all staff.
*Inside the room had been a large red container.
-That container had a lid on it and was labeled "Biohazardous Waste."
-Inside the container were two small black colored garbage bags.

Interview at that time with RN P regarding the above soiled utility room and the biohazardous waste bin revealed she:
*Confirmed the soiled utility room was never locked.
*Agreed:
-That had allowed for unauthorized access by patients and visitors.
-All staff had access to that room.
*The housekeeping staff were responsible for removing/transporting all biohazardous wastes from that room.
-That had included any filled red pharmaceutical waste containers.
*Confirmed Fentanyl pain patches had been accounted for and wasted by two staff members.
-Those pain patches were wasted by placing them inside of the red pharmaceutical waste containers.
*Confirmed when the pharmaceutical waste containers were full the staff would have placed them inside of the soiled utility room, on the floor, and in front of the hopper.
*Would have notified the housekeeping staff to pickup the pharmaceutical waste container after placement in the soiled utility room.
*Did not know where the housekeepers put them after they were removed from the soiled utility room.
*Agreed that process had not ensured the security of those Fentanyl patches from access by unauthorized personnel.

Interview and observation on 1/31/17 at 9:00 a.m. with RN R revealed:
*He had completed administering medications to patient 8.
*The pharmaceutical waste container in patient 8's room had been full.
*He secured the full container shut, removed it from the patient's room, and went into the soiled utility room with it.
-That container was placed on the floor in front of the hopper.
*He left the soiled utility room and called the maintenance department and informed them there was a waste container to be picked up.
*The maintenance department referred him to the housekeeping department.
-The housekeeping department was notified.
*He confirmed:
-That had been his usual process for disposing of the pharmaceutical waste containers.
-All Fentanyl patches would have been destroyed/placed inside of those waste containers.
-The housekeeping department had been responsible for the disposal of all the waste containers.
-He did not know where those containers were disposed of.
*With the current process he had considered waste medications secured from unauthorized access.
*He agreed the Fentanyl patches still contained medication upon disposal.

Interview on 1/31/17 at 4:15 p.m. with RN L revealed she:
*Confirmed:
-The above process observed by RN R.
-All the soiled utility rooms in the facility had been unlocked and not secured from access by all staff, visitors, and patients.
*Agreed the provider was responsible for the Fentanyl patches from the time they entered the facility until they were disposed of.
*Stated "The housekeeping department is responsible for getting rid of the sharps containers."
*Had not considered the medication was unsecured and safe from unauthorized personnel.

Interview on 2/1/17 at 10:50 a.m. with the DON confirmed the observation by RN R and interviews with RNs L and P.

Interview on 2/2/17 at 11:00 a.m. with staff member AA revealed:
*She confirmed:
-The above observations and interviews.
-The soiled utility rooms in the facility were unlocked and allowed access by anyone.
*She stated:
-"Housekeeping had taken care of those sharps containers for 25 years."
-"We even dispose of the pharmacy waste containers."
*The housekeeping department disposed of those containers inside of a large bin located in their service garage.
*The service garage was always locked, but all the housekeeping staff and maintenance staff had access to that garage.

Interview on 2/2/17 at 1:50 p.m. with pharmacist Z confirmed all of the above observations and interviews. She had not considered the Fentanyl pain patches as not being secured from unauthorized staff after placement in those containers.

Review of the provider's 2016 Medication Administration policy revealed:
*"All drugs and biologicals must be kept in a locked room or container. If the container (cart) is mobile or readily portable, when not in use, it must be stored in a locked room, monitored location, or secured location that will ensure the security of the drugs or biological.
*All drugs and biological must be stored in a manner to prevent access by unauthorized individuals.
*Persons without legal access to drugs and biologicals cannot have unmonitored access to drugs or biologicals.
*Persons without legal access to drugs or biologicals cannot have keys to medication storage rooms, carts, cabinets, or containers."

Based on observation, interview, record review, and policy review, the provider failed to ensure sanitary conditions were maintained for:
*One of one sampled patient (10) who received personal care by two of two registered nurses (RN) (P and Q).
*The process of administering medications through a feeding tube for one of one sampled patient (10) by one of one RN (S).
*One of one sampled patient (10) who required tracheotomy and oral suctioning by one of one respiratory therapist (RT) (T).
*One of one patient (28) who required an assessment by one of one physician (BB).
*Four of four observed patients' (5, 15, 40, and 41) laboratory blood draws to prevent potential cross-contamination of patients and laboratory supplies on one of one medical-surgical department.
*Reusable stethoscopes on one of one medical-surgical department.
*One of one reprocessed endoscope prior to storage.
*Multiple two inch by two inch gauze dressings that had been stored sanitarily in six of eight post-operative (post-op) patient rooms (rooms 3, 4, 5, 6, 7, and 8).
Findings include:

1a. Review of patient 10's electronic medical record revealed:
*An admission date of 1/23/17.
*Diagnoses of advanced muscular dystrophy, hypertension, failure to thrive with weight loss, urinary retention, coronary artery disease, reflux, severe disability, and cardiomyopathy.
*He had been bedridden and required full staff support to ensure all of his activities of daily living were met.
*He had required the use of a:
-Foley catheter to assist his bladder with urine drainage.
-Tracheostomy, oxygen, and ventilator to maintain his respiratory status.
-Feeding tube to assist with his swallowing difficulties that had resulted in weight loss, aspiration pneumonia, and failure to thrive.
-Ventilator during hours of sleep only for respiratory support.

Observation on 1/30/17 at 3:15 p.m. of patient 10 revealed:
*He had:
-Been in his bed sleeping.
-Nutritional support of 2.1 jevity continuously infusing through a feeding tube at 45 milliliters (ml) per minute.
-Moist blow-by oxygen support through his tracheotomy at 5 liters per minute.
*Both of his arms and legs were contracted.
-The arms had been bent at the elbows and were positioned on his chest.
-His legs were bent at the knees and required the use of pillows to elevate them off the bed.
*He did not have the capability to spontaneously move his legs, arms, and body without assistance from the staff.
*His overall appearance was thin and frail.

b. Observation on 1/30/17 at 3:15 p.m. with RNs P and Q during personal care for patient 10 revealed:
*They had:
-Prepared to assist the patient with perineal care.
-Washed their hands and put on clean gloves.
*With those clean gloves they:
-Removed his blanket and pillows that had been supporting his legs.
-Turned him onto the right side and removed his soiled incontinent brief.
--That brief had a moderate amount of bowel movement in it.
*RN P:
-Retrieved a package of wet wipes and cleansed the patient's bottom. She had removed a moderate amount of bowel movement.
*With those soiled gloves RN P:
-Assisted RN Q to position the patient onto his back.
-Cleansed the front of his perineal area and removed a small amount of bowel movement. That had included cleansing the Foley catheter tubing.
-Assisted RN Q with applying a clean incontinent brief.
-Moved the tube feeding catheter away from the incontinent brief.
-Placed his call light on his chest.
*At that time they removed their gloves and sanitized their hands.
*RN P had not been observed removing her gloves or sanitizing her hands during the entire process of assisting the patient with personal care.

Observation on 1/31/17 at 9:10 a.m. with RN S during oral care for patient 10 revealed:
*She had prepared to assist the patient with oral care.
*She washed her hands and put on clean gloves.
*With those clean gloves on she had:
-Touched the water faucet handle and turned the water back on.
-Retrieved a plastic water cup and filled it half full of water.
-Brushed his teeth and had the patient rinse his mouth with the water.
-Retrieved a dry wash cloth and wiped off his mouth.
*She removed her gloves and washed her hands.

c. Continued observation on 1/31/17 at 9:20 a.m. of RN S with patient 10 revealed:
*She had prepared to administer his medications through the feeding tube.
*She washed her hands and put on clean gloves.
*With those clean gloves on she had:
-Retrieved several medications from inside a drawer attached to the computer cart.
-Used the scanner to scan those medications into the computer.
-Opened the medication packages and put the medication into a small plastic cup.
-Typed on the keyboard to document the medications into the computer.
--Each of those above processes had been performed several times.
-Retrieved a pill crusher and placed all of those medications inside of the container.
-Crushed all of those medications and placed them back inside a small plastic cup containing a liquid medication.
-Turned the water faucet on and filled a plastic graduate with approximately 100 ml of water.
-Retrieved a 60 cubic centimeter syringe.
-Opened a port on the patient's feeding tube site and administered those medications with the syringe.
-Closed the port, removed her gloves, and washed her hands.

d. Interview on 1/31/17 at 2:10 p.m. with RN P revealed she confirmed the process she had used to provide personal care for patient 10 had not been sanitary. She agreed the process had created the potential for cross-contamination of microorganisms to occur.

Interview on 1/31/17 at 2:20 p.m. with RN S confirmed:
*That had been her usual process to provide oral care and administer medications through a feeding tube.
*She had not been aware she had turned the water faucet on with gloved hands.
*She agreed:
-There should have been a barrier used when touching the water faucet handle.
-Her process for administering patient 10's medications through the feeding tube had not been sanitary.
-Her processes had created the potential for cross-contamination of microorganisms to occur.

2. Observation on 1/31/17 at 7:52 a.m. with RT T with patient 10 revealed:
*She had prepared to:
-Remove the patient's ventilator and place him on blow-by oxygen for the day.
-Suction his tracheostomy after the removal of the ventilator.
-Place his Passy-Muir valve (device inserted into the tracheostomy) after the removal of the ventilator.
*She washed her hands, put on clean gloves, and did the following:
-Retrieved a plastic container that had his Passy-Muir valve in it and opened it.
-Placed that container on his bed.
-Removed his ventilator device and tubing.
-Retrieved a package from a box in the corner of the room.
-Opened that package to reveal a pair of sterile gloves.
-Put on a sterile glove over her right hand.
--She had not removed her soiled glove on her hand prior to applying the sterile glove.
-Retrieved the suctioning catheter and suctioned his tracheostomy.
*He requested to have his mouth suctioned.
-With her left hand she retrieved another package.
-Requested the surveyor to open the package so she could retrieve the Yankauer (device used to suction the mouth).
*Multiple times she had to suction his tracheostomy then his mouth.
*She had placed the Yankauer on his bed sheets between suctioning his mouth and tracheostomy.
-That process had been performed several times.
*After she completed the suctioning process she then placed the Yankauer inside of the opened package.
*Without removing those soiled gloves she:
-Removed the Passy-Muir valve from the container.
-Placed the valve inside of his tracheostomy opening.
*Applied the blow-by oxygen.
*Removed her gloves, washed her hands, and left the room.

Interview on 1/31/17 at 4:20 p.m. with RN L regarding the above observations revealed:
*She was the infection control nurse and quality risk management director.
*She agreed the above processes had not been completed in a sanitary manner.
-Those processes had created the potential for cross-contamination of microorganisms to have occurred for the patient.

Interview on 2/1/17 at 3:30 p.m. with registered respiratory therapist (RRT) CC revealed:
*He agreed:
-The processes observed above by RT T had not been performed in a sanitary manner.
-RT T should have changed her gloves and sanitized between each task and during each different level of care.
-She should not have placed a sterile glove over another glove, especially if dirty. The only time that process would have been done was during an emergency situation.
-The Yankauer should have been placed on a clean barrier or placed back inside of the package between use.
*RT T had been hired in November 2016.
-He had not had the opportunity to observe her during all of the tasks completed above.

Interview on 2/2/17 at 8:30 a.m. with the DON confirmed and supported the interviews with RN L and RRT CC.

Interview on 2/2/17 at 8:45 a.m. with RT T confirmed the processes she had performed to assist patient 10 had not been completed in a sanitary manner. She agreed those processes had created the potential for cross-contamination of microorganisms to occur for the patient.

3. Observation on 2/1/17 at 9:15 a.m. of medical doctor (MD) BB with patient 28 revealed:
*The patient had been admitted into the clinic to have the MD assess him for pain issues in his left leg.
*The MD washed his hands prior to assessing and after assessing the patient.
*After the MD completed washing his hands both times he turned the water faucet off with his left hand.
-No barrier had been used to turn the water faucet off.

Interview on 2/1/17 at 9:40 a.m. with MD BB confirmed he should have used some type of a barrier to turn the water faucet off. He agreed that process had created the potential for cross-contamination of microorganisms to occur.

Review of the provider's November 2015 Hand Hygiene and Handwashing policy revealed:
*Statement of purpose: "To promote hand-hygiene practices and reduce transmission of pathogenic microorganisms to patients and personnel in health care settings."
*"When hands are visibly dirty or contaminated with proteinaceious material or are visibly soiled with blood or other body fluids, wash hands."
*"Decontaminate hands after contact with body fluids or excretions, mucous membranes, nonintact skin, and wound dressings if hands are not visible soiled."
*"Decontaminate hands if moving from a contaminated-body site to a clean-body site during patient care."
*"Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient."
*"Decontaminate hands after removing gloves."
*"When washing hands with soap and water, use towel to turn off the faucet."



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4a. Observation on 1/30/17 at 3:55 p.m. of patient 40's blood draw by laboratory technician (lab tech) A revealed while wearing gloves she:
*Removed old tape and gauze from the patient's arm.
*Applied the tourniquet.
*Cleansed the patient's arm with an alcohol pad.
*Touched the site with her gloved finger.
*Retrieved the used alcohol pad lying on the bed sheet, recleaned the patient's site, and drew the blood sample.
*Removed the tourniquet and used a gauze pad to hold pressure to the patient's arm.
*Removed an unwrapped gauze pad from the stack on the supply caddy and applied a dressing.
*Removed her gloves and performed hand hygiene.

b. Observation on 1/31/17 at 6:10 a.m. of patient 41's blood draw by lab tech B and lab student HH revealed while wearing gloves:
*Lab student HH:
-Was not able to obtain a blood sample from the patient's right hand.
-Held pressure to the site to prevent bleeding.
-Applied a gauze pad and taped it in place.
-Returned the tape role to the supply caddy.
-Removed and discarded opened supply packages from the supply caddy.
*Lab tech B:
-Was not able to obtain a blood sample from the patient's left hand and held pressure with gauze to the site.
- The red square tube holding device sitting on the patient's bed was placed back on the supply caddy by lab student HH.
-The tube holding device was not disinfected before it was placed back on the supply caddy.
-Looked through the supply caddy for another small needle to try again for a blood sample.
-The red tube holding device was replaced back on the patient's bed from the supply caddy by lab student HH.
-Obtained a blood sample.
-Pressure to the site was applied by lab student HH.
-Dropped the syringe of blood on top of the supplies in the caddy.
-Got a gauze pad, tore off a piece of tape, and handed it to lab student HH.
-Returned the tape roll to the caddy.
*Lab student HH removed her contaminated gloves, picked up the supply caddy from the overbed table, and then performed hand hygiene.
*Both staff members exited the patient's room.

c. Observation of lab tech B and lab student HH revealed:
*After leaving patient 41's room they entered patient 15's room.
*The supply caddy was placed on the overbed table and both performed hand hygiene.
*Both applied clean gloves.
*Assembled supplies.
*Applied the tourniquet and obtained a blood sample.
*Used the contaminated roll of tape from the supply caddy to secure a dressing to the patient's right arm.
*Removed their contaminated gloves, lab student HH picked up the supply caddy from the overbed table, and then performed hand hygiene.
*Both staff members exited the patient's room.

d. Observation of lab tech B and lab student HH revealed:
*After leaving patient 15's room they entered patient 5's room:
*Both performed hand hygiene, the supply caddy was placed on the overbed table, and both put on clean gloves.
*The contaminated red tube holder used during patient's 41's blood draw was placed on the patient's bed.
*Obtained a blood sample.
*Returned the contaminated red tube holder back on the supply caddy.
*Wrote on the blood tubes label with a marker from the supply caddy.
*Removed a gauze pad from the stack of unprotected gauze pads, used a strip of tape from the contaminated roll, and applied a dressing to the site.
*Lab student HH picked up the supply caddy from the overbed table and then performed hand hygiene.
*Both exited the patient's room and entered another patient's room to collect blood samples.

e. Interview on 2/1/17 at 9:37 a.m. with the laboratory director revealed:
*There was no policy for disinfecting the lab supply caddies. Disinfection was conducted as needed.
*The red tube holding device was not disinfected between patient use.
*The overbed table in each patients' room was not disinfected after use.
*There was a potential for cross-contamination between patients when supplies were contaminated.
*Both staff members had put on clean gloves upon entering the patients' rooms. Those gloves were not removed until it was time to exit each room.

Review of the provider's October 2015 Infection Control - Equipment Cleaning policy revealed:
*The purpose of the policy:
-"Was to prevent and control transmission of pathogenic organisms from noncritical equipment and environmental surfaces by the consistent use of infection control practices.
-To reduce the risk of hospital-acquired (nosocomial) infection to patients.
-To prevent transmission of infection from patient to patient, between patients and personnel and personnel and personnel."
*Equipment should have been cleaned with a hospital approved cleaner between patients by staff.

Review of the provider's August 2016 Employee Health - Prevention of HBV (Hepatitis B), HCV (Hepatitis C), HIV (human immunodeficiency virus) and Other Bloodborne Pathogen Transmission policy revealed:
*"All healthcare workers must:
-Consider all patients as potentially infected with HIV, HBV, HCV or other blood borne pathogens."
*"All equipment and surfaces are cleaned and disinfected following contact with blood or potentially infectious materials:
-After the completion of medical procedures.
-Immediately when surfaces are overtly contaminated.
-Following any spills of blood or potentially infectious material.
-At the end of the work shift if the surfaces may have been contaminated."

5. Observation and interview on 1/30/17 at 3:40 p.m. at the nurses' station with the director of inpatient medical care services revealed:
*RN C entered the nurses' station and performed hand hygiene. She then:
-Pulled down her face mask and drank from a Styrofoam cup.
-Continued to touch environmental surfaces within the nurses' station.
*They had completed a quality program related to staff hydration and determined the nursing station would be a designated hydration station to ensure staff maintained hydration levels during working hours.
*The staff became busy with patient care and were not able to get away to go to the staff lounge adjacent to the nurses' station.
*Monitoring for compliance was completed by staff members monitoring each other. Compliance would include tops on containers, following hand protocol, and reminding each other of those things.
*She did not have documented compliance monitoring after the hydration station was implemented.

Review of the provider's August 2016 Employee Health - Prevention of HBV, HCV, HIV, and Other Bloodborne Pathogen Transmission policy revealed:
*"Eating, drinking, smoking, applying cosmetics (including lip balm) and haling contact lenses is prohibited in work areas where there is potential for exposure to blood borne pathogens and other infectious materials. Covered drinks may be consumed in staff lounges and designated areas by signage, "Designated Hydration Area."

6. Observation on 2/1/17 at 8:00 a.m. of patient 42's morning assessment by RN II revealed:
*After using the stethoscope to listen to the patient's heart and lung sounds the stethoscope was hung back on a rack in the hallway for use by other staff members.
*The stethoscope had not been disinfected prior to exiting the room or being hung on the stethoscope rack.

Observation on 2/1/17 at 8:33 a.m. revealed physician JJ exited patient 42's room carrying a stethoscope. Without disinfecting the stethoscope he hung it on a rack in the hallway for use by other staff members.

Random observation on 2/2/17 at 4:50 p.m. revealed a staff member walking down the hall with a stethoscope draped over her shoulder. The unidentified staff member without disinfecting it hung the stethoscope on a community use stethoscope rack.

Interview on 2/2/17 at 4:50 p.m. with RN II confirmed stethoscopes should have been disinfected prior to putting them back on the rack. There was a potential for cross-contamination between patients when equipment was not disinfected.

Review of the provider's 2015 Infection Control - Equipment Cleaning policy revealed:
*The purpose of the policy was "To provide a safe environment and to prevent and control transmission of pathogenic organisms from noncritical equipment and environmental surfaces by the consistent use of infection control practices."
*"Equipment must be cleaned or taken out of use until it can be cleaned."
*The policy had not included disinfection guidelines for stethoscopes.



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7. Observation and interview on 1/31/17 from 7:30 a.m. through 8:30 a.m. with surgical technician O during endoscope reprocessing following a patient's colonoscopy revealed:
*Immediately following the procedure she started the cleaning process of the scope.
*Following the initial cleaning she transported the scope to a soiled utility room and placed it into the high level disinfecting machine.
*After the machine had completed the disinfection process she:
-Brought a cart into the soiled utility room.
-Put on gloves and used a test strip to check the disinfectant concentration level.
--Stated the disinfectant passed and used a disinfectant wipe to push a button on the machine.
-Grabbed a pen from her scrub pocket.
-Wrote on the paper printout from the machine and initialed that to indicate it had passed.
-Put the pen back into her pocket.
-Retrieved the disinfected scope from the machine and placed it into a clean plastic tote on the cart.
-Wheeled that cart down the hallway into procedure room B.
-Opened a closet door in the room and wheeled the cart inside.
-Entered a code into the key pad lock and opened the scope storage cabinet.
-Grabbed the scope from the plastic tote and hung it inside the scope storage cabinet.
*Throughout the above process she had not changed her gloves.
*With her gloves on she had touched surfaces that could have been contaminated including the:
-Pen.
-Closet door handle.
-Key pad lock.
-Scope cabinet handle.
*Following the above observation surgical technician O confirmed:
-The above was her usual process.
-The surfaces she had touched with her gloves on could have been potentially contaminated.
-She should not have touched the reprocessed scope with those potentially contaminated gloves.
-The scopes would not have been reprocessed prior to the next patient's procedure if it had been done within the past fourteen days.

Interview on 1/31/17 at 3:45 p.m. with the director of surgical services regarding the above observation revealed:
*She confirmed the surgical technician's gloves would have been potentially contaminated by touching those surfaces.
*Touching the scope with contaminated gloves would have potentially contaminated the reprocessed scope.
*The reprocessed scope should have been handled properly to avoid possible contamination.

Interview on 2/2/17 at 8:15 a.m. with the DON regarding the handling of the reprocessed scope in the above finding confirmed it had not been kept free from potential contamination and should have been.

Review of the provider's October 2016 Cleaning and Processing Flexible Endoscopes and Accessories policy revealed:*The purpose was "To provide guidelines to assist in the care, cleaning, decontamination, maintenance, handling, storage, sterilization and/or disinfection of flexible endoscopes and accessories."
*"9. Transport scopes to storage cabinet after HLD [high-level disinfection] in a clean container with a closed lid."
*There was no mention of glove use or proper handling to keep it free from potential contamination after disinfection.

Review of the provider's October 2016 Cleaning and Use of Endoscope Reprocessor policy revealed:*After the disinfection process was complete:
-The disinfectant concentration should have been tested.
-If the disinfectant passed a button was pushed, and the machine printed out a log.
-The printout was supposed to be initialed for verification.
*To remove the scope from the basin:
-Carefully remove the scope and hang it in a well ventilated scope closet or return into use for the next procedure.
*There was no mention of how to handle the scope after it was reprocessed to keep it free from potential contamination.

8. Observation and interview on 1/30/17 from 2:40 p.m. through 4:00 p.m. with the director of surgical services revealed:
*In the same day surgical area post-op rooms 3, 4, 5, 6, 7, and 8 there were drawers containing opened two inch by two inch gauze dressings.
*Those dressing were usually stored like that.
-They were used for covering the intravenous sites on patients when they were discontinued.
*She confirmed storing the gauze like that was not a good infection control practice.

Interview on 2/2/17 at 8:15 a.m. with the DON regarding the opened gauze dressings in the post-op rooms confirmed they were not stored appropriately for infection control purposes.

A. Based on record review, interview, and policy review, the provider failed to ensure:
*There was a policy and process in place for the orientation training of contracted staff.
*Two of two contracted staff members (D and E) had documented orientation training.
Findings include:

1. Review of certified registered nurse anesthetist (CRNA) D's personnel file revealed:
*He had a contracted start date of 10/5/16.
-That contract had been renewed and would have expired on 4/8/17.
*There was no documentation he had received orientation training.

2. Review of registered nurse E's personnel file revealed:
*She had started her contract in May 2016.
-That contract had been renewed and would have expired on 2/4/17.
*There was no documentation she had received orientation training.

3. Personnel record review and interview on 2/1/17 from 3:00 p.m. through 5:30 p.m. with human resources staff person J revealed:
*She confirmed there was no documentation to support the above contracted staff had received orientation training.
*All staff should have received orientation training.

Interview on 2/1/17 at 5:00 p.m. and again on 2/2/17 at 8:15 a.m. with the director of nursing (DON) regarding contracted staff revealed:
*They should have received orientation training.
-That training should have been documented in their personnel files.
*There was no specific policy related to contracted staff, and there should have been.
*The contracted staff orientation should have followed the policy for all new staff.
*She felt the contacted staff had received training with the education coordinator and the department directors, but that had not been documented.
*It was important for contracted staff to receive orientation specific to their department and for the provider's policies and processes.

Review of the provider's December 2016 Orientation of Patient Services Personnel policy revealed:
*"2. Orientation will be individualized for each employee depending on current competency, training, and experience. Length of orientation is based on assessment/director input."
*"3. Each new hire receives at least the following:
-Job description.
-Orientation checklist (general and/or unit specific).
-Orientation to physical work setting.
-Competency checklist.
-H-net orientation of policy/procedures.
-Scope of practice - Nursing, CRNA, PA.
-Plan for the provision of care.
-Annual (mandatory) required education."
*"5. Unit specific clinical orientation will be conducted by education coordinator/department director/designee and selected preceptors using general/unit specific orientation and competency checklists."



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B. Based on interview, review of the provider's organizational chart, and policy review, the provider failed to ensure nursing services provided by the outpatient wound clinic were supervised under the direction of a registered nurse (RN). Findings include:

1. Interview on 2/1/17 at 8:45 a.m. with RNs W and X during an observation at the outpatient wound clinic revealed:
*The nurses and physical therapy (PT) worked together to perform wound care.
*PT V (supervisor of the rehabilitation services) supervised the wound clinic.

Interview on 2/1/17 at 3:00 p.m. with PT V regarding supervision of the wound clinic staff revealed she supervised those staff. The wound clinic was previously managed by a registered nurse, but that nurse had retired.

Interview on 2/2/17 at 10:30 a.m. with the DON/vice president of patient services revealed:*She did not oversee the outpatient/wound clinic departments.
*The chief executive officer (CEO) was responsible for oversight of those departments.
*There was a nurse supervising the wound clinic until she had retired "a couple years ago."

Review of the provider's July 1, 2015 hospital organizational chart in the provider's 2016/2017 business plan revealed the CEO was listed as head of the ancillary/support services including rehabilitation services.

Interview on 2/2/17 at 11:15 a.m. with the CEO regarding supervision of the wound clinic revealed:*He had taken over supervision of the wound clinic (part of the rehabilitation services) when the wound nurse had retired about a year ago.
*He did not have a nursing license.
*He confirmed the nurses working at the wound clinic should have been supervised by an RN. He had not considered that at the time the nurse had retired.

Review of the provider's June 2016 Provision of Care and Services Outpatient Treatment Area policy revealed the chief nursing executive RN M was to ensure systems of effective delivery of services through qualified nursing personnel.

Review of the July 2016 Vice President of Patient Services Essential Duties and Responsibilities job description had included:
*Review and comply with general hospital and departmental policies and procedures and applicable laws and regulations.
*Develop and implement the organization's plan for providing nursing care to those patients requiring nursing care.

Based on observation, record review, interview, and policy review, the provider failed to:
*Notify a physician of two wounds requiring treatment for one of one sampled patient (36) receiving outpatient wound care.
*Obtain physician's orders to apply dressings to two wounds requiring treatment for one of one sampled patient (36) receiving outpatient wound care.
Findings include:

1. Observation on 2/1/17 at 8:45 a.m. of patient 36 during wound care at an outpatient wound clinic revealed:*He had dressings on his left heel, left knee, and right great toe.
*Registered nurse (RN) W stated the left knee dressing had been changed on 1/30/17, so it did not need to be changed again.
*Physical therapist (PT) X removed the dressing to his left heel and provided treatment, then applied Medi-honey to the wound and covered it with gauze and a dressing.
*RN W removed the bandage to his right toe and cleansed the wound, then applied Medi-honey to the wound and covered it with a dressing.

Review of patient 36's medical record revealed:
*A 11/30/16 physician's order for wound care to a left heel ulcer: "Apply Medi-honey and gauze dressing over ulcer PRN [as needed]."
*A 1/2/17 physician's order for wound care and assessment of the left heel ulcer, and electrical stimulation or ultrasound by PT as needed.
*A 1/31/17 nursing plan of care to recertify patient 36 for wound care and treatment of the left heel ulcer.
*The 2/1/17 wound clinic note by PT X had included all three wounds: left heel, left knee, and right great toe.
*No documentation in the medical record of physician notification of the left knee or right great toe wounds.
*No physician's orders for treatment of the left knee or right great toe.

Interview on 2/1/17 at 3:00 p.m. with the wound clinic supervisor/PT V revealed:*She supervised the physical therapy department and the wound clinic.
*If a patient came to a wound clinic appointment with a new wound the wound clinic would "normally notify the physician of any changes."
*If the wound clinic had orders for wound care they would treat all wounds with that order.
*The wound clinic did not contact the physician each time they treated a new wound.
*The initial wound treatment order (for the left heel) would have been used for the new wounds as well.
*Patient 36 came to the wound clinic on 1/23/17 with a new wound to his left knee.
*He came to the wound clinic on 1/30/17 with the right toe wound.
*The patient was frequently coming to the clinic with new wounds.
*She was not able to locate physician's notification of new wounds in the medical record.
*She was not able to locate physician's orders for the treatment of the left knee or the right great toe.

Interview on 2/2/17 at 10:30 a.m. with the director of nursing regarding patient 36 revealed:*Her expectation was:
-The physician would have been notified with each new wound/change in condition by the staff member who identified the change.
-All new treatments required a new physician's order.
*She did not oversee the wound clinic.
*The wound clinic was overseen by the President/CEO.

The wound clinic supervisor and the director of nursing were asked for a policy for physician's notification. That policy was not received by the end of the survey on 2/2/17.

Review of the provider's February 2016 Wound Care - Evaluation and Treatment policy revealed:
*A physician's order was to have included a medical diagnosis, wound location, and an order for evaluation and treatment of the wound.
*Wound care management was by the clinician's and registered nurses scope of practice.

Review or the South Dakota Board of Nursing RN scope of practice laws: SDCL 36-9-3: The practice of the registered nurse includes:
*"Implementing nursing care through the execution of independent nursing strategies and the provision of regimens requested, ordered, or prescribed by the authorized health care providers."
*"Communicating and collaborating with other health care providers in the management of health care and the implementation of the total health care regimen within and across settings."

Review of Patricia A Potter et al, Fundamentals of Nursing, 9th Ed., St Louis, Mo., 2017, page 311 revealed:*"The health care provider [physician or advanced practice nurse] is responsible for directing medical treatment. Nurses follow health care providers' orders unless they believe the orders are in error, violate agency policy, or are harmful to the patient."
*The nurse was to inform a health care provider after assessing the patient for concerns related to the diagnosis and treatment of the patient.
*"Be certain to document that you notified the health care provider and his or her response, your follow-up, and the patient's response."

Based on observation, record review, interview, and policy review, the provider failed to ensure 2 of 39 sampled patients' (10 and 13) care plans had been reviewed and revised to reflect their current health care status. Findings include:

1. Review of patient 10's electronic medical record revealed:
*An admission date of 1/23/17.
*Diagnoses of advanced muscular dystrophy, hypertension, failure to thrive with weight loss, urinary retention, coronary artery disease, reflux, severe disability, and cardiomyopathy.
*He had been bedridden and required full staff support to ensure all of his activities of daily living were met.
*He had required the use of a:
-Foley catheter to assist his bladder with urine drainage.
-Tracheostomy, oxygen, and ventilator to maintain his respiratory status.
-Feeding tube to assist with his swallowing difficulties resulting in weight loss, aspiration pneumonia, and the failure to thrive.

Observation on 1/30/17 at 3:15 p.m. of patient 10 revealed:
*He had:
-Been in his bed sleeping.
-Nutritional support of 2.1 jevity continuously infusing through a feeding tube at 45 milliliters per minute.
-Moist blow-by oxygen support through his tracheostomy at 5 liters per minute.
*Both of his arms and legs were contracted.
-The arms had been bent at the elbows and were positioned on his chest.
-His legs were bent at the knees and required the use of pillows to elevate them off of the bed.
*He did not have the capability to spontaneously move his legs, arms, and body without assistance from the staff.
*His overall appearance was thin and frail.

Continued review of patient 10's electronic medical record revealed:
*His care plan had been initiated on 1/23/17 with further completion on 1/24/17.
*The care plan did not address the following problem areas:
-Urinary retention with the use of a Foley catheter.
-Failure to thrive with weight loss and the need for a feeding tube for nutritional supplementation.

Interview on 1/31/17 at 4:05 p.m. with registered nurse (RN) L confirmed:
*The care plan initiated on 1/23/17 had not addressed the patient's urinary retention and nutritional problems.
*There were care plans in the electronic medical record that could have been selected for patients with those problem areas.
*All of the above areas of concern for patient 10 should have been found on his care plan and should have been updated to reflect the current level of care he required.

Interview on 2/1/17 at 10:30 a.m. with the director of nursing (DON) confirmed the above interview with RN L.

Review of the provider's November 2016 Clinical Plan of Care revealed:
*Purpose "To direct an interdisciplinary plan of care and measure clinical outcomes."
*"The care of each patient is determined through the interdisciplinary assessment process and established patient outcomes consistent with the other team members."
*"A plan of care is developed at the time of admission using the 'problem list' within computer documentation."
*"The plan of care is revised to reflect status changes as necessary."
*"Staff are responsible to continually update the Plan of Care."



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2. Review of patient 13's electronic medical record revealed:
*An admission date of 7/29/16.
*Diagnoses of abdominal pain, peritonitis, and large pelvic abscess.
*A physician order dated 8/5/16 for total parenteral nutrition (TPN) that provided nutrients through a tube.
*The care plan was not updated to include interventions for TPN nutritional support.

Interview on 2/2/17 at 10:00 a.m. with the director of inpatient services confirmed nursing staff had not addressed the patient's TPN infusion on his care plan.

Review of the provider's November 2016 Clinical Plan of Care policy revealed:
*"The plan of care is revised to reflect status changes as necessary."
*"Staff are responsible to continually update the Plan of Care."