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1440 N MAIN ST

SPEARFISH, SD 57783

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on record review, interview, and policy review, the provider failed to ensure one of one sampled intensive care patient (9) had a consent for insertion of an invasive arterial blood pressure monitoring line. Findings include:

1. Review of patient 9's medical record revealed:
*He had an invasive arterial blood pressure monitoring line placed in the intensive care unit on 9/9/13 at 3:50 p.m. after having blood pressure problems in the operating room.
*No record of any consent for that procedure was present.

Interview on 9/10/13 at 2:00 p.m. with charge nurse M regarding patient 9's arterial line revealed:
*She was present at the time the arterial line had been placed.
*The team had discussed getting a consent for the procedure but had decided not to.
*The patient's first arterial line had clotted, and a new line had been placed around 8:00 p.m. on 9/9/13. She was unable to tell me what time for sure the line had been started as the anesthetist had not documented it.
*No consent form had been completed for the second procedure noted above.
*A consent should have been sought for the procedures above.

Interview on 9/10/13 at 3:30 p.m. with the chief anesthetist revealed a written consent should have been obtained for the above noted procedures.

Review of the provider's undated consent policy revealed patient consent should have been sought for invasive procedures.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on record review, interview, and policy review, the provider failed to ensure surgical services, anesthesia services, sterilization services, and physical therapy services were incorporated into the provider's quality assurance program. Findings include:

1. Interview and policy review on 9/12/13 at 8:15 a.m. with the director of quality assurance and the director of patient services revealed:
*Surgical services, anesthesia services, sterilization services, and physical therapy services were not incorporated into the provider's quality assurance program.
*According to the provider's February 2013 Performance Improvement Plan high risk problem prone areas with potential severe adverse outcomes should have been identified as high priority.
*Both agreed all the areas identified above should have been incorporated into the provider's quality assurance program.
*Both agreed surgical services, anesthesia services, and sterilization services were high risk problem prone areas of the hospital.
2. Interview and policy review on 9-10-13 at 11:15 a.m. with the director of rehabilitation services revealed:
*The rehabilitation services were not incorporated into the provider's quality assurance program.
*Review of the provider's performance improvement manual showed no quality assurance studies submitted for rehabilitation services.

NURSING CARE PLAN

Tag No.: A0396

Based on record review, interview, and policy review, the provider failed to ensure 6 of 12 sampled patients (1, 2, 3, 5, 18, and 19) reviewed had comprehensive individualized care plans. Findings include:

1. Review of patient 1's medical record revealed:
*She had been admitted on 9/9/13.
*She had been discharged on 9/10/13.
*Her admission diagnosis had been an abdominal tumor, and she had a bowel resection.
*Her care plan had not addressed general post operative care.

2. Review of patient 2's medical record revealed:
*She had been admitted on 9/9/13.
*Her admission diagnosis had been a head injury from a fall with a laceration to her face.
*Her care plan had not addressed the head trauma, neurological checks, or the potential for falls.

3. Review of patient 3's medical record revealed:
*She had been admitted on 9/7/13.
*She had been discharged on 9/10/13.
*She had been admitted for abdominal pain, nausea, and vomiting.
*Her care plan had not addressed the above areas and was not individualized.

4. Review of patient 5's medical record revealed:
*She had been admitted on 9/9/13.
*She had been discharged on 9/10/13.
*She had been admitted for a total hip replacement.
*Her care plan had not addressed the hip replacement.

5. Review of patient 18's medical record revealed:
*She had been admitted on 5/31/13.
*She had been discharged on 6/2/13.
*She had been admitted for hypoglycemia (low blood sugar), diabetes, and renal (kidney) failure.
*Her care plan had not addressed any issues related to the diabetes.

6. Review of patient 19's medical record revealed:
*She had been admitted on 8/28/13.
*She had been discharged on 9/5/13.
*She had been admitted for a total right knee replacement.
*Her care plan had not addressed the knee replacement.

7. An interview and review of the above patients' records with the director of medical/surgical and intensive care areas on 9/11/13 between 10:00 a.m. and 11:30 a.m. revealed:
*The above reviewed care plans had not been individualized.
*Within their electronic records they had a list of care plan problems that could have been selected to individualize those patients' care plans.
*For instance the patients that had the joint replacements should have had the joint revision care plan identified.
-That process had not been done.
*She had identified not individualizing care plans as a problem in the past.
*She had provided training to the nurses on that but had not followed up to see that it was being done.
*They had not established a care plan policy.

SECURE STORAGE

Tag No.: A0502

30170

Based on observation, interview, and policy review, the provider failed to prevent unauthorized access of medications (med) in:
*One of one observed surgical control room.
*One of three observed anesthesia medication med carts.
Findings include:

1. Observation on 9/10/13 at 8:40 a.m. in the surgical control room revealed:
*An unsecured refrigerator with the following meds:
-Methergine (used for obstetrical patients).
*IV (intravenous) start kits that had included lidocaine for injection.
-Hemabate (used for intramuscular [IM] injection for obstetrical patients).
-Assorted insulin pens (used for diabetics).

Interview on 9/10/13 at 8:50 a.m. with registered nurse (RN) G regarding the unsecured meds in the refrigerator revealed the meds were not secured to prevent access by unauthorized staff.

2. Observation on 9/10/13 at 8:55 a.m. of the anesthesia med cart in operating room (OR) one revealed:
*The med cart was unlocked.
*There were multiple anesthesia medications.
*There were two staff members, housekeeper B and surgical technician (tech) C in the OR cleaning and setting up for the next procedure, who were unauthorized to have access to those medications.

Interview on 9/10/13 at 9:10 a.m. with RN G regarding the unsecured IV meds revealed the anesthesia cart should have been locked after use to prevent unauthorized access to those medications.

3. Review of the provider's September 2013 Medication Security policy revealed:
*Access to medications should have been limited.
*All meds would be stored securely to prevent unauthorized access.
*All scheduled controlled substances would be kept double-locked in patient control areas.
*Meds that required refrigeration should have been stored securely.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

30170

Based on observation, interview, and policy review, the provider failed to ensure schedule II (controlled) medications (med) were not accessible to unauthorized personnel in one of three observed anesthesia carts in the operating suite and in one of one anesthesia med storage room.
Findings include:

1. Observation on 9/10/13 at 8:55 a.m. of the anesthesia med cart in surgical suite one revealed:
*The cart was unlocked, and there were controlled intravenous (IV) meds accessible that included:
-Fentanyl (narcotic pain med).
-Morphine (narcotic pain med).
-Versed (sedative).
-Ketamine (anesthetic).
*There were two staff members, housekeeper B and surgical technician C, in the operating room (OR) cleaning and setting up for the next procedure whom were unauthorized to have access to those medications.

Interview on 9/10/13 at 9:30 a.m. with the anesthesia director regarding the unlocked anesthesia med cart revealed that med cart should have been locked after use to prevent unauthorized access to controlled meds.

Review of the provider's September 2013 Medication Security policy revealed:
*All scheduled controlled substances should have been kept double-locked in patient control areas.
*All medications should have been stored securely to prevent unauthorized access.
*Cabinets or doors should have been locked when not in attendance or use.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

30170

Based on observation, interview, and policy review, the provider failed to ensure medications were monitored and inspected for outdates in one of one surgical suite and in one of one anesthesia medication (med) storage area. Findings include:

1. Observation on 9/10/13 at 8:55 a.m. in the surgical suite revealed an outdated vial of Lidocaine 2% that had expired on 6/1/13.

2. Observation on 9/11/13 at 7:30 a.m. of the anesthesia med storage room revealed:
* One vial of vecuronium bromide (muscle relaxant used for surgery) 10 milligrams (mg) that had expired April 2013.
*One vial of succinylcholine (muscle relaxant used for surgery) 200 mg that had expired July 1, 2013.
*Two vials of phenylephrine (used to increase blood pressure in patients) 1 mg per ten milliliters (ml) that had expired on 6/24/13.

3. Interview on 9/11/13 at 9:00 a.m. with the anesthesia director regarding the expired meds revealed:
*There was a need to improve the monitoring of outdated meds to ensure the safety of surgical patients.
*There was no formal process in place for checking the expiration of medications.

Review of the provider's November 2012 Unusable Controlled Substances policy revealed any expired/unusable controlled substances present would have been stored in a separate location in the lockable cabinet.

MONITORING RADIATION EXPOSURE

Tag No.: A0538

Based on observation, interview, and policy review, the provider failed to ensure:
*All staff potentially exposed to radiation were utilizing the film badges provided to them for one of one surgery department and one of one anesthesia department.
*Annual radiation safety training had occurred for one of one medical imaging department, one of one anesthesia department, and one of one surgery department.
Findings include:

1. Observation of an orthopedic procedure by surveyors in the surgical suite on the morning of 9/10/13 revealed surgery personnel and anaesthesia personnel had not utilized the film badges provided for them. Radiation emitting equipment was utilized during the procedure.

Interview on 9/11/13 at 7:25 a.m. with the medical imaging director revealed:
*Surgery and anaesthesia personnel had been provided film badges and had been instructed to wear them on the outside of the lead apron during surgeries in which radiation producing equipment was utilized. She was not aware they were not utilizing them.
*They had not received any radiation safety training. Medical imaging personnel received that training in their radiologic technology education training but the provider had not offered any additional radiation safety training to other staff.

Interview with registered nurse G on 9/11/13 at 2:10 p.m. revealed the surgery personnel had not received training in radiation safety. Surgery personnel had been instructed to use the film badges during cases that utilized radiation emitting equipment.

Review of Medical Imaging department policies revealed:
*A radiation safety training policy had not been developed.
*The film badge policy stated personnel frequently exposed to radiation should utilize film badges.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

30170

Based on observation, interview, and policy review, the provider failed to ensure an appropriate sanitary environment, hand hygiene, single-use item utilization, and sterilization in one of three surgical suites, one of one anesthesia area, one of one sterilization area, and one of one emergency room. Findings include:

1. Observation on 9/10/13 at 8:55 a.m. in operating room one revealed:
*One intravenous (IV) Abbocath #16 had expired June 2011.
*An opened esophogeal stethoscope with a temperature sensor.
*Three opened endotracheal tubes (ET) (used for intubation for surgery).
*An ET tube opened and setting on top of the anesthesia med cart and covered with a blue towel.
*A blue container of medications (meds) placed on the floor by the anesthesia med cart.
*A vial of Lidocaine 2% expired on 6/1/13.
*A used bag of 3000 milliliters (ml) of normal saline with epinephrine setting in the sink in the sub-sterile area.

2. Observation on 9/10/13 at 9:30 a.m. in operating room three revealed eight opened ET tubes that had been discarded in the trash by staff after the findings in operating room one above.

3. Observation on 9/10/13 from 10:20 a.m. through 12:45 p.m. in operating room one revealed:
*Circulating registered nurse (RN) D removed and reapplied her gloves multiple times throughout the surgical procedure and had never washed or sanitized her hands.
*At 10:25 a.m. surgeon K entered the surgical suite with hands and arms dripping wet, and then placed three sets of sterile gloves on his hands.
*At 10:32 a.m. anesthetist J drew up IV propofol without prior sanitizing the top of the vial with an alcohol pad.
*At 10:52 a.m. circulating RN D had touched the discarded gloves of surgeon K with her bare hands, discarded the gloves, and then placed clean gloves on her hands without sanitizing or washing her hands.
*At 11:02 a.m. surgeon K removed his surgical attire and left the surgical suite without washing his hands.
*At 11:22 a.m. surgeon K returned to the surgical suite rubbing his wet hands and placed sterile gloves on his hands.
*At 11:28 a.m. there was visible blood splatter on the floor, and staff were walking and wheeling a cart through the blood on the floor.
*At 11:30 a.m. circulating nurse D entered the sub-sterile area with gloved hands and retrieved a blood syringe, returned to the surgical suite, and removed her gloves without washing or sanitizing her hands.
*At 11:30 a.m. circulating nurse D and surgical technician C placed visibly blood soaked items in regular garbage bags.
*At 11:35 a.m. circulating nurse D rubbed her left ear with her gloved hands, and then placed clean patient supplies in a drawer with those same gloved hands.
*At 11:45 a.m. circulating nurse D and surgical technician C drew medication to have been used by the surgeon for the procedure without prepping the Fibrin and Evicel with an alcohol pad prior to drawing the meds up in the syringes. Circulating nurse D placed a Marcaine vial in her shirt pocket.
*At 11:55 a.m. circulating nurse D entered the sub-sterile area with the used IV bag of normal saline and epinephrine solution (used for irrigation of the surgical site during the procedure) and emptied it in the sink.
*At 12:17 p.m. surgeon K and anesthetist I left the surgical suite area without washing or sanitizing their hands.

Observation on 9/10/13 at 12:40 p.m. of anesthetist I revealed he:
*Had used the ultrasound machine to access a nerve block on pt. 13. After the use of the ultrasound machine he sprayed it with the quaternary solution, and then immediately wiped the solution off.
*Used CholaPrep with Tint to prepare pt. 13's upper thigh for a nerve block but did not wait the appropriate time prior to inserting the needle for the nerve block.

Review of the ChloraPrep instruction sheet revealed allow the solution to completely dry a minimum of three minutes on hairless skin and up to one hour in hair.

Interview immediately after anesthetist I had returned the ultrasound machine to the clean utility room revealed he:
*Had not finished cleaning the machine.
*Should not have returned the ultrasound machine to the clean utility room without the proper cleaning.

Interview on 9/10/13 at 12:45 p.m. with housekeeper B in the surgical suite regarding the cleaning of the surgical area revealed she:
*Was unsure if the blood on the floor in the surgical suite was actually considered a blood spill.
*Would wipe the anesthesia med carts off with a cleaner and return the blue towel to the top of the cart.
*Would mop up the blood with a mop, then change the water, and then remop the floor.

4. Observation on 9/11/13 at 7:30 a.m. in the anesthesia storage room revealed:
*Seven epidural (for use in the spine) catheters that had expired May 2013.
*Four anesthesia trays left over from previous surgeries placed on the counter.
*Several opened single-use packages of suction catheters and epidural supplies were in the cupboards.
*Opened syringes of medication with broken seals were in the refrigerator.

5. Observation on 9/11/13 at 7:50 a.m. of the airway cart in the hallway across from the anesthesia storage room revealed:
*Intubation sets that had expired on 6/20/12.
*Emergency cricothyrotomy catheter set that had expired July 2013.
*Tracheal tube exchanger that was opened.

6. Observation on 9/11/13 at 8:00 a.m. of the anesthesia cart in the hallway revealed:
*A 14 gauge (Ga) IV Abbocath that had expired in January 2013.
*A 16 Ga IV Abbocath that had expired in January 2011.
*Three opened laryngoscope blades (used to assist with placement of the ET tubes).
*An opened ET tube.

7. Observation on 9/11/13 at 8:20 a.m. of operating room three revealed:
*A 16 Ga IV Abbocath that had expired in June 2011.
*A 22 Ga. IV Abbocath that had expired in June 2013.
*A can of HurriCaine spray with the tip not appropriately covered.
*A specimen container half full of a brownish tan substance undated and with no appropriate label.

Interview with RN G during the above observation revealed:
*The brownish tan substance was Monsels and was used for bleeding.
*She agreed the substance was not appropriately labeled and dated.

8. Observation on 9/11/13 at 8:30 a.m. in operating room four revealed:
*A 16 Ga IV Abbocath that had expired in September 2012.
*Two 14 Ga IV Abbocaths that had expired March 2013 and January 2013.

Interview on 9/11/13 at 9:00 a.m. with the anesthesia director revealed:
*Medications were not monitored for outdates.
*Outdated items were not monitored.
*Infection control practices needed to have been improved upon.
*Items opened for single-patient use should not have been re-sterilized once the package had been opened.

9. Observation on 9/11/13 at 9:30 a.m. in the central supply area revealed:
*Cidex test strips used to test the high level disinfectant for appropriate levels was opened and not dated.
*Rapicide test strips used in the Medivator machine for testing the appropriate levels for disinfecting had been opened and undated.
*The instructions on the bottles indicated once they had been opened the strips were only good for ninety days.

Interview on 9/11/13 during the above observation of the central supply area with central supply technician E revealed:
*She was unaware the strips were only good for ninety days once the test strip bottles had been opened.
*The enzymatic cleaner used for disinfecting gastroscopes and colonoscopes had not had the appropriate ratio of disinfectant to the water amount.
*She would add one squirt of disinfectant to the sink she pre-cleaned instruments in but had no means of measuring the amount of water she used to dilute that disinfectant.

Interview on 9/11/13 at 2:10 p.m. with surgical technician H regarding the observations in the central supply area revealed:
*There should have been dates placed on the Cidex and Rapicide test strips when they were opened.
*The enzymatic cleaner should have had the appropriate amount of water added to it when mixed for use.

10. Observation on 9/12/13 at 7:25 a.m. on the medical-surgical wing revealed certified nursing assistant L was carrying a used, uncovered patient ice pack into the clean utility room.

Interview with certified nursing assistant (CNA) L during the observation revealed:
*She would return the ice pack to the refrigerator with unused ice packs after each patient use.
*She would not return the ice pack to the refrigerator in a special cover.
*There was no special cleaning procedure that had to be done prior to returning the ice pack to the refrigerator that she was aware of.

Interview on 9/12/13 at 10:00 a.m. with the director of nursing and the interim infection control nurse revealed they were in agreement there were infection control issues. Those issues would need to be addressed.

Review of the provider's February 2012 Hand Hygiene policy revealed:
*All employees were to practice proper and appropriate hand hygiene.
*Decontamination of hands was accomplished using a combination of proper handwashing and the use of alcohol-based hand rub.
*When hands were visibly dirty or contaminated wash with soap and water.
*If hands were not visibly soiled use an alcohol-based hand rub for routine decontamination.
*Decontaminate hands before direct contact with patients, prior to performing invasive procedures, prior to preparing or handling medications, after contact with patient or after contact with the environment around the patient such as equipment or other high-touch surfaces, after contact with blood, oral secretion, and mucous membranes.
*Gloves should have been worn whenever there was anticipated contact with blood or body fluids, but gloves did not eliminate the need for proper hand hygiene.
*Decontaminate hands after handling items or work surfaces potentially contaminated with a patient's blood or body fluids.

Review of the Avagard solution instructions on the bottle revealed allow solution to dry prior to donning gloves.




26180

11. Observation on 9/10/13 at 11:30 a.m. in the kitchen during the set-up of meal trays revealed cook A:
*Put on a pair of gloves and she was not observed changing during those gloves the rest of the meal process.
*Touched each paper menu before setting up each tray.
*Left the set-up area twice, opened the door to the walk-in freezer, and brought a serving of ice cream to the trays.
*Opened the oven door and pulled out the tray with the entrees on it.
*Removed the tin foil from each entree.
*Touched each piece of ready-to-eat food with her gloved hands including:
-Chicken breasts.
-A hamburger patty.
-A hamburger bun.
-Twice baked potatoes.
-Sliced cheese.
*Moved entree items around on the plates with her gloved hands.
*Shaped a mound of shaved turkey with her gloved hands.
*Created a well in the scoop of mashed potatoes with the bottom of the bowl they had come in.

Observation and interview on 9/11/13 at 9:30 a.m. with cook A revealed she was removing frozen breaded meat patties with her gloved hands.

Interview on 9/11/13 at 9:40 a.m. with the dietary manager (DM) and cook A revealed:
*The paper menus were not clean. They were touched by many people.
*The practice of touching ready-to-eat food was not sanitary after touching other surfaces.
*The cook confirmed she rearranged food on the plates with her gloved hands and touched ready-to-eat foods multiple times.
*The cook confirmed she had opened the cardboard box before touching the meat.
-She agreed the cardboard box was not clean.
*They agreed using the bottom of a bowl that had been in the oven was not a sanitary practice.

Review of the provider's February 2013 Food Preparation Practices policy revealed:
*"Handling of food requires precautions in order to safeguard sanitation."
*"Handle utensils, cups, glasses and dishes in such a way as to avoid touching surfaces with which food or drink will come into contact."
*"Use tongs when serving rolls, pickles, plate cakes, and pies with a spatula."

Review of the provider's February 2013 Disposable Gloves policy revealed:
*"Disposable gloves should be worn when handling food in a manner that a utensil is not feasible in the food areas and in the cafeteria.
*Immediately after finishing a task remove gloves and wash hands thoroughly."

12. Observation on 9/10/13 at 10:00 a.m. in the cardiac room of the emergency department revealed an opened Slim Body Skin Stapler package in a drawer. Interview at that time with the director of the emergency department revealed that package should not have been placed back in the drawer after it had been opened.

DELIVERY OF ANESTHESIA SERVICES

Tag No.: A1002

Based on interview and policy review, the provider failed to have policies and procedures in place for patient post-anesthesia assessments for one of one anesthesia department. Findings include:

1. Interview on 9/5/13 at 3:30 p.m. with the chief anesthetist revealed:
*The anesthesia department had no post-anesthesia assessment policy.
*Not all patients had been receiving post-anesthesia assessments prior to discharge. Refer to A1005, findings 1 through 3.
*She agreed that regulation was not being met when it was reviewed with her.

Interview on 9/5/13 at 11:00 a.m. with the director of patient services revealed anesthesia should have had a policy in place to ensure proper post-anesthesia assessments were being done according to the regulations.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

27457

Based on record review and interview, the provider failed to ensure post-anesthesia assessments were completed for two of four sampled surgical patients (13 and 59). Findings include:

1. Review of patient 13's medical record revealed:
*She had same-day surgery under general anesthesia on 9/10/13.
*She had no documented post-anesthesia assessment prior to discharge home.

2. Review of patient 59's medical record revealed:
*She had surgery under general anesthesia on 3/11/13.
*She had been discharged to her home on 3/12/13.
*She had no documented post-anesthesia assessment prior to discharge home.
*A phone call had been made to her on 3/13/13 to discuss any concerns related to the anesthesia.

3. Interview on 9/12/13 at 9:40 a.m. with the chief anesthetist revealed:
*No post-anesthesia assessment policy and procedure was in place. Refer to A1002, finding 1.
*Anesthesia relied on the registered nurse to complete the post-anesthesia assessment prior to discharge for same-day surgery patients.
*After review of this regulation she agreed post-anesthesia assessments were not being completed according to the regulation.

SECURE STORAGE

Tag No.: A0502

30170

Based on observation, interview, and policy review, the provider failed to prevent unauthorized access of medications (med) in:
*One of one observed surgical control room.
*One of three observed anesthesia medication med carts.
Findings include:

1. Observation on 9/10/13 at 8:40 a.m. in the surgical control room revealed:
*An unsecured refrigerator with the following meds:
-Methergine (used for obstetrical patients).
*IV (intravenous) start kits that had included lidocaine for injection.
-Hemabate (used for intramuscular [IM] injection for obstetrical patients).
-Assorted insulin pens (used for diabetics).

Interview on 9/10/13 at 8:50 a.m. with registered nurse (RN) G regarding the unsecured meds in the refrigerator revealed the meds were not secured to prevent access by unauthorized staff.

2. Observation on 9/10/13 at 8:55 a.m. of the anesthesia med cart in operating room (OR) one revealed:
*The med cart was unlocked.
*There were multiple anesthesia medications.
*There were two staff members, housekeeper B and surgical technician (tech) C in the OR cleaning and setting up for the next procedure, who were unauthorized to have access to those medications.

Interview on 9/10/13 at 9:10 a.m. with RN G regarding the unsecured IV meds revealed the anesthesia cart should have been locked after use to prevent unauthorized access to those medications.

3. Review of the provider's September 2013 Medication Security policy revealed:
*Access to medications should have been limited.
*All meds would be stored securely to prevent unauthorized access.
*All scheduled controlled substances would be kept double-locked in patient control areas.
*Meds that required refrigeration should have been stored securely.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

30170

Based on observation, interview, and policy review, the provider failed to ensure schedule II (controlled) medications (med) were not accessible to unauthorized personnel in one of three observed anesthesia carts in the operating suite and in one of one anesthesia med storage room.
Findings include:

1. Observation on 9/10/13 at 8:55 a.m. of the anesthesia med cart in surgical suite one revealed:
*The cart was unlocked, and there were controlled intravenous (IV) meds accessible that included:
-Fentanyl (narcotic pain med).
-Morphine (narcotic pain med).
-Versed (sedative).
-Ketamine (anesthetic).
*There were two staff members, housekeeper B and surgical technician C, in the operating room (OR) cleaning and setting up for the next procedure whom were unauthorized to have access to those medications.

Interview on 9/10/13 at 9:30 a.m. with the anesthesia director regarding the unlocked anesthesia med cart revealed that med cart should have been locked after use to prevent unauthorized access to controlled meds.

Review of the provider's September 2013 Medication Security policy revealed:
*All scheduled controlled substances should have been kept double-locked in patient control areas.
*All medications should have been stored securely to prevent unauthorized access.
*Cabinets or doors should have been locked when not in attendance or use.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

30170

Based on observation, interview, and policy review, the provider failed to ensure an appropriate sanitary environment, hand hygiene, single-use item utilization, and sterilization in one of three surgical suites, one of one anesthesia area, one of one sterilization area, and one of one emergency room. Findings include:

1. Observation on 9/10/13 at 8:55 a.m. in operating room one revealed:
*One intravenous (IV) Abbocath #16 had expired June 2011.
*An opened esophogeal stethoscope with a temperature sensor.
*Three opened endotracheal tubes (ET) (used for intubation for surgery).
*An ET tube opened and setting on top of the anesthesia med cart and covered with a blue towel.
*A blue container of medications (meds) placed on the floor by the anesthesia med cart.
*A vial of Lidocaine 2% expired on 6/1/13.
*A used bag of 3000 milliliters (ml) of normal saline with epinephrine setting in the sink in the sub-sterile area.

2. Observation on 9/10/13 at 9:30 a.m. in operating room three revealed eight opened ET tubes that had been discarded in the trash by staff after the findings in operating room one above.

3. Observation on 9/10/13 from 10:20 a.m. through 12:45 p.m. in operating room one revealed:
*Circulating registered nurse (RN) D removed and reapplied her gloves multiple times throughout the surgical procedure and had never washed or sanitized her hands.
*At 10:25 a.m. surgeon K entered the surgical suite with hands and arms dripping wet, and then placed three sets of sterile gloves on his hands.
*At 10:32 a.m. anesthetist J drew up IV propofol without prior sanitizing the top of the vial with an alcohol pad.
*At 10:52 a.m. circulating RN D had touched the discarded gloves of surgeon K with her bare hands, discarded the gloves, and then placed clean gloves on her hands without sanitizing or washing her hands.
*At 11:02 a.m. surgeon K removed his surgical attire and left the surgical suite without washing his hands.
*At 11:22 a.m. surgeon K returned to the surgical suite rubbing his wet hands and placed sterile gloves on his hands.
*At 11:28 a.m. there was visible blood splatter on the floor, and staff were walking and wheeling a cart through the blood on the floor.
*At 11:30 a.m. circulating nurse D entered the sub-sterile area with gloved hands and retrieved a blood syringe, returned to the surgical suite, and removed her gloves without washing or sanitizing her hands.
*At 11:30 a.m. circulating nurse D and surgical technician C placed visibly blood soaked items in regular garbage bags.
*At 11:35 a.m. circulating nurse D rubbed her left ear with her gloved hands, and then placed clean patient supplies in a drawer with those same gloved hands.
*At 11:45 a.m. circulating nurse D and surgical technician C drew medication to have been used by the surgeon for the procedure without prepping the Fibrin and Evicel with an alcohol pad prior to drawing the meds up in the syringes. Circulating nurse D placed a Marcaine vial in her shirt pocket.
*At 11:55 a.m. circulating nurse D entered the sub-sterile area with the used IV bag of normal saline and epinephrine solution (used for irrigation of the surgical site during the procedure) and emptied it in the sink.
*At 12:17 p.m. surgeon K and anesthetist I left the surgical suite area without washing or sanitizing their hands.

Observation on 9/10/13 at 12:40 p.m. of anesthetist I revealed he:
*Had used the ultrasound machine to access a nerve block on pt. 13. After the use of the ultrasound machine he sprayed it with the quaternary solution, and then immediately wiped the solution off.
*Used CholaPrep with Tint to prepare pt. 13's upper thigh for a nerve block but did not wait the appropriate time prior to inserting the needle for the nerve block.

Review of the ChloraPrep instruction sheet revealed allow the solution to completely dry a minimum of three minutes on hairless skin and up to one hour in hair.

Interview immediately after anesthetist I had returned the ultrasound machine to the clean utility room revealed he:
*Had not finished cleaning the machine.
*Should not have returned the ultrasound machine to the clean utility room without the proper cleaning.

Interview on 9/10/13 at 12:45 p.m. with housekeeper B in the surgical suite regarding the cleaning of the surgical area revealed she:
*Was unsure if the blood on the floor in the surgical suite was actually considered a blood spill.
*Would wipe the anesthesia med carts off with a cleaner and return the blue towel to the top of the cart.
*Would mop up the blood with a mop, then change the water, and then remop the floor.

4. Observation on 9/11/13 at 7:30 a.m. in the anesthesia storage room revealed:
*Seven epidural (for use in the spine) catheters that had expired May 2013.
*Four anesthesia trays left over from previous surgeries placed on the counter.
*Several opened single-use packages of suction catheters and epidural supplies were in the cupboards.
*Opened syringes of medication with broken seals were in the refrigerator.

5. Observation on 9/11/13 at 7:50 a.m. of the airway cart in the hallway across from the anesthesia storage room revealed:
*Intubation sets that had expired on 6/20/12.
*Emergency cricothyrotomy catheter set that had expired July 2013.
*Tracheal tube exchanger that was opened.

6. Observation on 9/11/13 at 8:00 a.m. of the anesthesia cart in the hallway revealed:
*A 14 gauge (Ga) IV Abbocath that had expired in January 2013.
*A 16 Ga IV Abbocath that had expired in January 2011.
*Three opened laryngoscope blades (used to assist with placement of the ET tubes).
*An opened ET tube.

7. Observation on 9/11/13 at 8:20 a.m. of operating room three revealed:
*A 16 Ga IV Abbocath that had expired in June 2011.
*A 22 Ga. IV Abbocath that had expired in June 2013.
*A can of HurriCaine spray with the tip not appropriately covered.
*A specimen container half full of a brownish tan substance undated and with no appropriate label.

Interview with RN G during the above observation revealed:
*The brownish tan substance was Monsels and was used for bleeding.
*She agreed the substance was not appropriately labeled and dated.

8. Observation on 9/11/13 at 8:30 a.m. in operating room four revealed:
*A 16 Ga IV Abbocath that had expired in September 2012.
*Two 14 Ga IV Abbocaths that had expired March 2013 and January 2013.

Interview on 9/11/13 at 9:00 a.m. with the anesthesia director revealed:
*Medications were not monitored for outdates.
*Outdated items were not monitored.
*Infection control practices needed to have been improved upon.
*Items opened for single-patient use should not have been re-sterilized once the package had been opened.

9. Observation on 9/11/13 at 9:30 a.m. in the central supply area revealed:
*Cidex test strips used to test the high level disinfectant for appropriate levels was opened and not dated.
*Rapicide test strips used in the Medivator machine for testing the appropriate levels for disinfecting had been opened and undated.
*The instructions on the bottles indicated once they had been opened the strips were only good for ninety days.

Interview on 9/11/13 during the above observation of the central supply area with central supply technician E revealed:
*She was unaware the strips were only good for ninety days once the test strip bottles had been opened.
*The enzymatic cleaner used for disinfecting gastroscopes and colonoscopes had not had the appropriate ratio of disinfectant to the water amount.
*She would add one squirt of disinfectant to the sink she pre-cleaned instruments in but had no means of measuring the amount of water she used to dilute that disinfectant.

Interview on 9/11/13 at 2:10 p.m. with surgical technician H regarding the observations in the central supply area revealed:
*There should have been dates placed on the Cidex and Rapicide test strips when they were opened.
*The enzymatic cleaner should have had the appropriate amount of water added to it when mixed for use.

10. Observation on 9/12/13 at 7:25 a.m. on the medical-surgical wing revealed certified nursing assistant L was carrying a used, uncovered patient ice pack into the clean utility room.

Interview with certified

UNUSABLE DRUGS NOT USED

Tag No.: A0505

30170

Based on observation, interview, and policy review, the provider failed to ensure medications were monitored and inspected for outdates in one of one surgical suite and in one of one anesthesia medication (med) storage area. Findings include:

1. Observation on 9/10/13 at 8:55 a.m. in the surgical suite revealed an outdated vial of Lidocaine 2% that had expired on 6/1/13.

2. Observation on 9/11/13 at 7:30 a.m. of the anesthesia med storage room revealed:
* One vial of vecuronium bromide (muscle relaxant used for surgery) 10 milligrams (mg) that had expired April 2013.
*One vial of succinylcholine (muscle relaxant used for surgery) 200 mg that had expired July 1, 2013.
*Two vials of phenylephrine (used to increase blood pressure in patients) 1 mg per ten milliliters (ml) that had expired on 6/24/13.

3. Interview on 9/11/13 at 9:00 a.m. with the anesthesia director regarding the expired meds revealed:
*There was a need to improve the monitoring of outdated meds to ensure the safety of surgical patients.
*There was no formal process in place for checking the expiration of medications.

Review of the provider's November 2012 Unusable Controlled Substances policy revealed any expired/unusable controlled substances present would have been stored in a separate location in the lockable cabinet.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

27457

Based on record review and interview, the provider failed to ensure post-anesthesia assessments were completed for two of four sampled surgical patients (13 and 59). Findings include:

1. Review of patient 13's medical record revealed:
*She had same-day surgery under general anesthesia on 9/10/13.
*She had no documented post-anesthesia assessment prior to discharge home.

2. Review of patient 59's medical record revealed:
*She had surgery under general anesthesia on 3/11/13.
*She had been discharged to her home on 3/12/13.
*She had no documented post-anesthesia assessment prior to discharge home.
*A phone call had been made to her on 3/13/13 to discuss any concerns related to the anesthesia.

3. Interview on 9/12/13 at 9:40 a.m. with the chief anesthetist revealed:
*No post-anesthesia assessment policy and procedure was in place. Refer to A1002, finding 1.
*Anesthesia relied on the registered nurse to complete the post-anesthesia assessment prior to discharge for same-day surgery patients.
*After review of this regulation she agreed post-anesthesia assessments were not being completed according to the regulation.