HospitalInspections.org

Based on interview, observation, and record review, the provider failed to inform each patient of patient rights in advance of furnishing or discontinuing patient care for all same-day surgery patients and all out-patients. Findings include:

1. Interview on 1/24/12 at 8:50 a.m. with patient 20 in his hospital room revealed he:
*Was admitted earlier that morning at the admissions desk by the front entrance of the hospital.
*Was to have surgery on his right knee.
*Was not sure what his patient rights were.
*Did not remember anyone discussing his patient rights with him when he was admitted earlier that morning.
*Had not received any papers since the time of his admission that informed him of his patient rights.

Interview on 1/24/12 at 9:10 a.m. with registered nurse A revealed:
*Nursing staff had not given patient 20 any information on patient rights.
*She did not think patient 20 would get information on his patient rights due to the fact he was a same-day surgical patient. She further stated she did not believe any same-day surgery patients received written or verbal information on patient rights.

Interview and record review on 1/24/12 at 3:30 p.m. with registration clerk B and nurse manager C in the registration area revealed:
*Patient 20 had not received any written or verbal information on patient rights.
*Same-day surgery patients and out-patients had not been given any information on patient rights.
*The only document given to same-day surgery patients and out-patients was the provider's 3/22/10 notice of privacy practices booklet.
*Patient rights were not posted in any areas of the hospital.
*The provider's patient rights document was only given to in-patients.
*The provider had no formal written policy related to who or when patients received information on patient rights.

Based on interview, observation, and record review, the provider failed to
*Inform all same-day surgery patients and all out-patients how to file a grievance.
*Inform all in-patients excluding swing bed patients how to contact the South Dakota Department of Health with a grievance.
Findings include:

1. Interview on 1/24/12 at 8:50 a.m. with patient 20 in his hospital room revealed he:
*Was admitted earlier that morning at the admissions desk by the front entrance of the hospital.
*Was to have surgery on his right knee.
*Was not sure whom to contact if he had a grievance.
*Did not remember anyone discussing the provider's grievance process with him when he was admitted earlier that morning.
*Had not received any papers since the time of his admission that informed him of the provider's grievance process.

Interview on 1/24/12 at 9:10 a.m. with registered nurse A revealed:
*Nursing staff had not given patient 20 any information on how to submit a grievance.
*She did not think patient 20 would get information on the provider's grievance process due to the fact he was a same-day surgical patient. She further stated she did not believe any same-day surgery patients received written or verbal information on how to file a grievance.

Interview and record review on 1/24/12 at 3:30 p.m. with registration clerk B and nurse manager C in the registration area revealed:
*Patient 20 had not received any written or verbal information on how to file a grievance.
*Same-day surgery patients and out-patients were not given any information on how to file a grievance.
*The only document given to same-day surgery patients and out-patients was the provider's 3/22/10 notice of privacy practices booklet.
*The provider's grievance process was not posted in any areas of the hospital.
*The provider's patient grievance process document was only given to in-patients.
*The provider had no formal written policy related to who or when patients received information on how to file a grievance.

2. Review of the provider's information given to all in-patients excluding swing bed patients revealed that information had not informed those patients on how to contact the South Dakota Department of Health with a grievance.

Interview on 1/24/12 at 4:05 p.m. with nurse manager C revealed she agreed the above reviewed information would not inform those patients on how to contact the South Dakota Department of Health with a grievance.

Based on observation and interview, the provider failed to ensure paper medical records were stored in an area protected from potential water and sewage damage for two of two basement medical record storage areas. Findings include:

1. Observation and interview on 1/25/12 at 10:40 a.m. with the director of medical records revealed:
*The provider's paper medical records were being stored in the basement of the facility.
*The basement area had multiple sewage and water lines running directly above and next to the unprotected paper medical records (photos 1, 2, 3, 4, and 5).
*A significant water leak had occured four years ago from a leaking kitchen dishwasher waste line. Multiple records had to be cleaned and dried as a result of that leak.
*The week prior to this survey another waste water leak had occurred. However that leak had not resulted in the medical records becoming wet or contaminated with waste water.
*The provider never covered the records stored in that area.
*She agreed the records were not being stored in a manner to protect them from potential water and sewage damage.

Interview on 1/25/12 at 12:10 a.m. with the chief excutive officer (CEO) revealed he:
*Had recently been hired as the CEO and had not yet seen the medical records storage area in the basement.*Was not aware the paper medical records were being stored unprotected below water and sewage lines.
*Agreed the records were not being stored in a manner to protect them from potential water and sewage damage.

Based on observation and interview, the provider failed to ensure scheduled medications were properly secured in two of three anesthesia carts in the surgical suite. Findings include:

1. Observation on 1/24/12 at 9:19 a.m. of the anesthesia cart of certified registered nurse anesthetist (CRNA) D revealed:
*The anesthesia cart was parked in the main corridor of the surgical suite and was unlocked. The CRNA left that cart unlocked and walked out of site of that cart for several minutes. While the cart was unattended multiple staff who were unauthorized to access that cart walked by it.
*On top of that cart the CRNA left a 50 milliliter (ml) syringe of Diprivan.
*Inside the unlocked cart this surveyor had access to multiple scheduled medication and anesthetics.

2. Observation on 1/24/12 at 9:25 a.m. of the anesthesia cart of CRNA E revealed:
*The cart was taken to operating room A by CRNA E. Once in the operating room syringes of Versed and Fentanyl were placed on the top of that cart along with the lock for the cart with the keys in it. CRNA E then left that operating suite and went back to the anesthesia work room. That cart was left in operating room A unattended for fifthteen minutes.
*Inside the unlocked cart this surveyor had access to multiple scheduled medication and anesthetics including two 50 ml bottles of Fentanyl.

Interview and policy review on 1/24/12 at 1:00 p.m. with the chief nursing officer revealed she:
*Was in charge of the provider's CRNAs.
*Agreed the above observed anesthesia carts should have always been secured when the CRNAs were not directly monitoring their carts.
*Agreed leaving medication unsecured could have resulted in diversion of medications.
*Agreed CRNAs were not following the provider's 9/1/11 controlled substances policy related to proper security of scheduled medications.

Based on observation, interview, and policy review, the provider failed to ensure three of three anesthesia medication carts and one of one anesthesia medication refrigerator in the surgical area had been properly audited for expired and properly labeled medications. Findings include:

1. Audit on 1/23/12 at 1:15 p.m. of the contents of the three anesthesia medication carts located in the surgical area revealed the following medications were expired and not properly labeled:
-One vial of atropine labeled as opened 1/10/12 had a factory expiration date of October 2011.
-Two multi-dose vials of Versed half used were unlabeled as to when they were opened.
-Two multi-dose vials of flumazenil one was marked opened 12/5/11, and one was marked opened 12/19/11.
-One unopened vial of atropine had expired October 2011.
-One multi-dose vial of neostigmine was labeled as opened November 2010.
-One multi-dose vial of succinylcholine was labeled as opened 11/17/11.

2. Audit on 1/23/12 at 1:35 p.m. of the medications and fluids in the anesthesia medication refrigerator revealed the following fluids were expired:
-Three 1000 milliliter (ml) bottles of saline had expired on 1/4/06.
-Two 1000 ml bags of lactated ringers intravenous solution had expired on 1/11/08.
-One 1000 ml bag of sterile water had expired on 1/1/12.

Interview on 1/23/12 at 1:40 p.m. with certified registered nurse anesthetist (CRNA) E revealed:
*The CRNAs were all responsible for ensuring all the medication in the anesthesia carts and anesthesia refrigerator were not expired and were properly labeled.
*He agreed multi-dose vials of medication should have been labeled with the date they had been opened and then discarded twenty eight days after that labeled opened date. He confirmed that had not occurred in the multi-dose vials noted above.
*He confirmed the above expired medications and fluids noted above should had been disposed of. CRNA E confirmed he would discard all of the medications and fluids noted above.
*Pharmacy did not normally audit the anesthesia carts and refrigerator as that was the CRNAs responsibility.
*Anesthesia did not have a policy related to auditing medications and fluids for expiration in their anesthesia carts and refrigerator.
*He confirmed based on the above findings patients had received expired medications.

Interview and policy review on 1/23/12 at 2:00 p.m. with the director of pharmacy revealed:
*He confirmed anesthesia was not following the provider's 10/1/09 infection control for the pharmacy policy that outlined the proper use and labeling of multi-dose vials.
*He confirmed it was anesthesia's responsibility to audit its medications and fluids for expiration as pharmacy did not regularly monitor them.

Based on observation, interview, and label review, the provider failed to supply adequate ventilation in the respiratory rehabilitation room where Cidex OPA was used. Findings include:

1. Observation and interview on 1/24/12 at 11:00 a.m. in the respiratory rehabilitation room with employee H revealed:
*Cidex OPA was used to disinfect respiratory therapy masks.
*The Cidex OPA was put into a plastic bucket with the lid resting on top. The lid was not tightly sealed. The bucket was stored in a cabinet. A strong smell of Cidex OPA was present when the cabinet was opened.
*The room was not equipped with any supplemental ventilation other than the normal building ventilation.

Interview on 1/25/12 at 3:00 p.m. with the director of quality management and the infection control nurse revealed they were not aware Cidex OPA was being used in the respiratory rehabilitation room.

Review of the Cidex OPA label revealed:
*"Use CIDEX OPA Solution in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air."
*"Avoid exposure to ortho-phthalaldehyde vapors, as they may be irritating to the respiratory tract and eyes."

25107

Based on observation, interview, manufacturer's instructions, and perioperative standards, the provider failed to:
*Properly monitor the sterilization and high level disinfection processes located in the hospital and eye clinic areas.
*Properly investigate identified surgical site infections for patients with documented surgical site infections.
*Have a method in place to evaluate if same-day surgery patients developed a surgical site infection.
Findings include:

1. Observation and interview on 1/24/12 at 3:30 p.m. in the eye clinic procedure room with employee I revealed:
*The sterilizer was used to process instruments that were used in eye surgeries.
*No biological monitors were used when processing the equipment. The only indicator was the chemical indicator on the packaging.
*No log or tracking method was kept for the processing of instruments. Instruments were not dated when processed.
*There was no instrument recall process.
*There were no policies and procedures for the operation or maintenance of the sterilizer.
*She had received training from the company who had installed the sterilizer two or three years ago. There was no documentation of the training provided.
*She was not aware biological monitoring should have been performed on the sterilizer.
*The sterilizer was used about once every two weeks to process instruments.

Review of the M9 UltraClave Steam Sterilizer installation and operation manual revealed:
*Prior to installation and operating the unit the manual should have been read and understood.
*Process monitors (biological indicators and chemical indicators) should have been included in each sterilization cycle. "Process monitors detect whether the cycle parameters were delivered."

Review of the Association of periOperative Registered Nurses 2010 Perioperative Standards and Recommended Practices, Sterilization and Disinfection, 2010 Edition, Denver, Co., revealed:
*Page 461 - "Process challenge devices (PCDs) should be used with routine process monitoring devices (ie, chemical indicators, biological indicators, physical monitoring devices). Process challenge and process monitoring devices provide information to demonstrate that conditions for sterilization have been met."
*Page 462 - "Biological (BI) and chemical indicators should be used to monitor sterilizer efficacy and assess compliance of monitoring standards established for gravity-displacement and dynamic air-removal sterilizers."
*Page 471:
-"Accurate and complete records are required for process verification and used in sterilizer malfunction analyses. Documentation establishes accountability."
-Every sterilization cycle and modality including steam (e.g. wrapped and unwrapped) should have been documented. "Documentation should include the assigned lot number; contents of each load; and results of physical, chemical, and biological monitors."

2. Observation and interview on 1/24/12 at 1:50 p.m. in the operating room suite with the operating room (OR) manager revealed:
*The facility had multiples of each type of endoscopes.
*There was no process or tracking system for identifying the individual scopes used in cases or how long the scopes had been in storage.
*The OR manager was not aware endoscopes should have been reprocessed prior to use if the endoscope had been stored for a certain period of time.

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., page 411, revealed flexible endoscopes should be reprocessed before use if unused for more then five days. Flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets had been shown to grow organisms after five days of no use.

3. Interview on 1/25/12 at 3:00 p.m. with the infection control nurse and the director of quality management revealed:
*No sterilization and high level disinfection processes were monitored or observed by the infection control nurse.
*They had provided no sterilization training to the eye clinic staff.
*They were not aware the eye clinic had a sterilizer.
*They had never evaluated the infection control processes at the eye clinic.
*They were not aware surgical services reprocessed certain gastrointestinal instruments. Nor was there an infection control policy in place for reprocessing instruments. Refer to A749, findings 8 and 11.
*Infection control rounds/observations were not made in surgical services, central processing, the eye clinic, respiratory therapy, physical therapy, and the sleep laboratory. Refer to A749, finding 1, 2, 3, 4, 5, 6, 7, 9, and 10.
*There had been four documented surgical site infections (SSI) identified in 2011 per the infection control nurse's data. When asked to see the infection control programs investigation into those SSIs the infection control nurse stated no investigation had been conducted into the potential causes of those SSIs. They further stated they were not aware of policies and procedures that outlined the investigative process when SSIs were identified.
*No means for identifying SSIs in same-day surgery patients had been established.
*The infection control nurse had not been designated in writing as the provider of infection control services. Refer to A748, finding 1.
*They agreed the sterilizer in the eye clinic should not be operated until appropriate training and complete policies and procedures for sterilizer operation were put in place.

Based on interview, employee file review, and regulation review, the provider failed to have the infection control nurse designated in writing. Findings include:

1. Interview, employee file review, and regulation review on 1/25/12 at 3:00 p.m. with the director of quality management and the infection control nurse revealed:
*The director of quality management was the direct supervisor of the infection control nurse.
*The infection control nurse had taken on that role roughly a year ago.
*Neither of them were aware the regulations required the hospital to designate the infection control nurse in writing. Both agreed that designation had not occurred.
*They agreed according to Central for Medicare and Medicaid Services hospital regulations the infection control nurse should have been designated in writing when she had taken over the infection control nurse position.

Based on observation, interview, label review, manufacturer's instruction review, record review, and policy review, the provider failed to ensure a safe and sanitary environment in the respritory rehabilitation room, operating room suites, sleep laboratory, physical therapy, and ambulance garage. Findings include:

1. Observation, interview, and label review on 1/24/12 at 11:00 a.m. in the respiratory rehabilitation room with employee H revealed:
*Cidex OPA was used to disinfect respiratory therapy masks.
*She was not responsible for disinfecting mask with Cidex OPA but was familiar with the process. She knew the Cidex was tested with test strips but did not know how often.
*She was not aware the test strips had expiration dates.
*Review of the expiration date on the container of test strips revealed they had expired "2008 - 05."

2. Observation and interview on 1/24/12 from 1:50 p.m. to 2:50 p.m. in the operating room suites with the operating room (OR) manager revealed:
*One of three cases used to store endoscopes had a rusty shelf near the bottom. Caps used to cover the gastroscopes were stored directly on the rusty shelf. The OR manager agreed the rusty shelf was not clean or cleanable.
*Dirty scopes were cleaned in the clean utility room. Clean disposable nonwoven wrap was stored open and exposed in the clean utility room where dirty endoscopes were cleaned. The wrap was used to package clean instruments ready to be sterilized. The OR manager agreed dirty equipment should not have been cleaned in areas where clean supplies were stored.

3. Observation and interview on 1/24/12 at 2:30 p.m. in the sleep laboratory with employee J revealed:
*The sleep lab had two rooms for sleep testing. Both mattresses were cloth type and were not protected from body fluids. The mattresses could not be cleaned between patients.
*She agreed the mattresses were not protected and could not be cleaned between patients.

4. Observation and interview on 1/25/12 from 9:45 a.m. to 10:30 a.m. in the physical therapy area with employee K revealed:
*Cloth towels were used to clean the equipment between patients. The cloth towels were changed daily and were not stored in sanitizer solution between uses. She was not aware cloth towels could harbor and grow bacteria, should not be used multiple times, or should be stored in a sanitizer solution between uses.
*A Hydrocollator was being used to store hot packs. There was no cleaning schedule for the Hydrocollator. The Hydrocollator was put into service new on 9/29/11 and had not been cleaned since. She was not aware of the manufacture's recommendation to clean the Hydrocollator at a minimum of every two weeks. Review of the Hydrocollator operator's manual with employee K verified the minimum cleaning recommendation.

5. Observation and interview on 1/25/12 at 11:20 a.m. in the ambulance garage with the director of ambulance services revealed:
*Two cases of powder free syntectic exam gloves and three cases of isolation gowns were stored on the floor of the ambulance garage. An ambulance was parked within four feet of the supplies. Dirt from the wheel well of the ambulance had fell on to the floor next to the supplies.
*The director of ambulance services was not aware the supplies were to be stored up off of the floor.



27457

6. Audit on 1/23/12 from 1:15 p.m. through 1:35 p.m. of the anesthesia medications and fluids located in the surgical area revealed:
*Expired medications had been actively used
*Multi-dose vials of medications were not properly managed.
Refer to A505, findings 1 and 2.

7. Audit on 1/23/12 at 1:20 p.m. of the anesthesia storage room supply cabinets revealed:
*Two un-packaged intravenous (IV) extension sets had been returned to the supply cabinet with the rest of the clean IV supplies.
*Three Bair Hugger 241 IV fluid warming sets with the expiration date of September 2009 were in the cabinet by the refrigerator.

Interview on 1/23/12 at 1:25 p.m. with certified registered nurse anesthetist E revealed he agreed:
*Expired supplies should have been taken out of circulation.
*Opened packages of supplies opened should not have been returned to the clean supply area.

8. Audit on 1/23/12 at 2:30 p.m. of the gastrointestinal (GI) supplies in operating rooms A, B, and C revealed:
*Operating room A had three un-packaged GI biopsy forceps in plastic biohazard bags with the rest of the clean packaged GI supplies.
*Operating room B had one Gold Probe 350 centimeter GI coagulation probe that had expired February 2011.
*Operating room C had:
-Two Roth Net GI polyp retrieval probes that expired May 2010 and November 2011.
-One rotatable 20 millimeter GI snare that had expired May 2010.

Interview on 1/23/12 at 2:50 p.m. with the operating room manager revealed:
*The biohazard bags that contained GI biopsy forceps in operating room A were reprocessed instruments. She was unable to tell this surveyor when the instruments had been reprocessed or why they had been placed in biohazard bags after they had been reprocessed. She agreed biohazard bags were not the appropriate packaging containers for clean reusable equipment.
*She did not believe the provider had a policy related to reprocessing instruments. However she stated staff had followed the manufacturer's recommendations for the reprocessing of those instruments.
*She agreed the supplies found in operating room B and C were expired and should have been taken out of circulation.

9. Observation on 1/24/12 from 10:20 a.m. through 12:25 p.m. of patient 20's surgery in operating room C revealed:
*The door to the substerile area adjacent to operating room C that contained sterilization equipment and sterile supplies was propped open during the time the patient was being prepared for surgery, at times during the course of surgery, and during the post operative cleaning.
*Dirty supplies and fluids were brought into the adjacent substerile room at the end of the procedure.
*Used irrigation fluid bags were emptied into the adjacent substerile room's sink at the end of the procedure.
*Physician G improperly degloved after the surgery and cross-contaminated both of his hands. That physician was then observed not washing his hands after surgery and then proceeded to cross-contaminate multiple clean surfaces in the physician's dictation area as well as the substerile corridor. That physician left the operating suite and was never observed washing his hands.

Interview on 1/24/12 at 1:25 p.m. with the operating room nurse manager revealed she agreed:
*The substerile room door adjacent to operating room C should had not been left open during the case or during post-operative cleaning.
*She agreed dirty supplies and fluids should not have entered the substerile room adjacent to operating room C.

10. Audit on 1/25/11 at 12:10 p.m. of the intensive care unit supplies revealed the following supplies had expired:
-Four 20 gauge IV cannulas expired December 2010.
-Four 26 gauge IV cannulas expired September 2011
-Two 22 French foley catheters expired January 2011 and December 2011.

Interview on 1/25/12 at 1:00 p.m. with nurse manager C revealed:
*She agreed the expired supplies listed above should have been taken out of service.
*She had believed central supply staff were checking supplies for expiration but was not sure of that.

Interview on 1/25/11 at 1:15 p.m. with nurse manager C revealed she had spoken to central supply staff and had found they had not been checking supplies for expiration.

11. Interview on 1/25/12 at 3:00 p.m. with the infection control nurse and the director of quality management revealed:
*They confirmed findings 1-9 were infection control breaches, had not meet professional standards, and had not meet the provider's infection control policies and procedures.
*The infection control nurse had not made infection control rounds to the areas identified above.
*They were not aware reusable equipment was being utilized in the surgical area nor were there any polices for the use of reusable equipment.
*They were not aware of all the areas that high level disinfection was taking place.

Based on interview and observation, the provider failed to ensure:
*A tracheostomy set was readily available in the operating suite.
*Staff were knowledgeable of the location of the tracheostomy set stored outside of the operating suite.
Findings include:

1. Interview on 1/24/12 at 10:00 a.m. with circulating nurse F in operating room C revealed she was unable to tell this surveyor were the provider stored the tracheostomy set.

Interview on 1/24/12 at 10:05 a.m. with certified registered nurse anesthetist D who was providing anesthesia care in operating room C revealed he knew a cricothyroidotomy set was kept in the anesthesia room but he was not aware where the tracheostomy set was kept.

Interview on 1/24/12 at 10:25 a.m. with circulating nurse F revealed:
*She had spoken with the nurse manager and had found out the tracheostomy set was stored outside the surgical department in the central processing area. That tracheostomy set was stored outside the surgical area, so the emergency department could share that equipment.
*When asked by this surveyor what would occur if the emergency department was using the tracheostomy set, she stated they would not have a tracheostomy set to use as the provider only maintained one tracheostomy set.

Interview and regulation review on 1/25/12 at 9:20 a.m. with the chief nursing officer and the director of quality management revealed they:
*Were not aware the emergency department and the surgical department were sharing a tracheostomy set.
*Agreed if a tracheostomy set was needed it was important to have that readily available in that department.
*Agreed all surgical staff should have been knowledgeable of the location of the tracheostomy set.
*Agreed the tracheostomy set should have been stored in the surgical area, so that piece of emergency equipment was readily available.
*Agreed the surgical department sharing the tracheostomy set with the emergency department could result in surgical services not having a tracheostomy set available at the time of an emergency.

Based on interview and operating log review, the provider failed to have a complete and up-to-date operating log for one of one operating log reviewed. Findings include:

1. Interview, operating log review, and policy review on 1/24/12 at 8:40 a.m. with the operating room manager revealed:
*The operating log did not list the name of the assistant, name of nursing personnel, type of anesthesia, and the pre and post-operative diagnosis.
*The operating log was not formally completed until the end of each month.
*The nurse manager would have to filter through each medical record to get the information not listed in the current log.
*There was no surgical services policy related to maintaining an operating log.

Interview and regulation review on 1/25/12 at 9:20 a.m. with the chief nursing officer and the director of quality management revealed they agreed the operating log:
*Was not complete and up-to-date.
*Had not met the regulation for operating room logs.

Based on observation, interview, label review, manufacturer's instruction review, record review, and policy review, the provider failed to ensure a safe and sanitary environment in the respritory rehabilitation room, operating room suites, sleep laboratory, physical therapy, and ambulance garage. Findings include:

1. Observation, interview, and label review on 1/24/12 at 11:00 a.m. in the respiratory rehabilitation room with employee H revealed:
*Cidex OPA was used to disinfect respiratory therapy masks.
*She was not responsible for disinfecting mask with Cidex OPA but was familiar with the process. She knew the Cidex was tested with test strips but did not know how often.
*She was not aware the test strips had expiration dates.
*Review of the expiration date on the container of test strips revealed they had expired "2008 - 05."

2. Observation and interview on 1/24/12 from 1:50 p.m. to 2:50 p.m. in the operating room suites with the operating room (OR) manager revealed:
*One of three cases used to store endoscopes had a rusty shelf near the bottom. Caps used to cover the gastroscopes were stored directly on the rusty shelf. The OR manager agreed the rusty shelf was not clean or cleanable.
*Dirty scopes were cleaned in the clean utility room. Clean disposable nonwoven wrap was stored open and exposed in the clean utility room where dirty endoscopes were cleaned. The wrap was used to package clean instruments ready to be sterilized. The OR manager agreed dirty equipment should not have been cleaned in areas where clean supplies were stored.

3. Observation and interview on 1/24/12 at 2:30 p.m. in the sleep laboratory with employee J revealed:
*The sleep lab had two rooms for sleep testing. Both mattresses were cloth type and were not protected from body fluids. The mattresses could not be cleaned between patients.
*She agreed the mattresses were not protected and could not be cleaned between patients.

4. Observation and interview on 1/25/12 from 9:45 a.m. to 10:30 a.m. in the physical therapy area with employee K revealed:
*Cloth towels were used to clean the equipment between patients. The cloth towels were changed daily and were not stored in sanitizer solution between uses. She was not aware cloth towels could harbor and grow bacteria, should not be used multiple times, or should be stored in a sanitizer solution between uses.
*A Hydrocollator was being used to store hot packs. There was no cleaning schedule for the Hydrocollator. The Hydrocollator was put into service new on 9/29/11 and had not been cleaned since. She was not aware of the manufacture's recommendation to clean the Hydrocollator at a minimum of every two weeks. Review of the Hydrocollator operator's manual with employee K verified the minimum cleaning recommendation.

5. Observation and interview on 1/25/12 at 11:20 a.m. in the ambulance garage with the director of ambulance services revealed:
*Two cases of powder free syntectic exam gloves and three cases of isolation gowns were stored on the floor of the ambulance garage. An ambulance was parked within four feet of the supplies. Dirt from the wheel well of the ambulance had fell on to the floor next to the supplies.
*The director of ambulance services was not aware the supplies were to be stored up off of the floor.



27457

6. Audit on 1/23/12 from 1:15 p.m. through 1:35 p.m. of the anesthesia medications and fluids located in the surgical area revealed:
*Expired medications had been actively used
*Multi-dose vials of medications were not properly managed.
Refer to A505, findings 1 and 2.

7. Audit on 1/23/12 at 1:20 p.m. of the anesthesia storage room supply cabinets revealed:
*Two un-packaged intravenous (IV) extension sets had been returned to the supply cabinet with the rest of the clean IV supplies.
*Three Bair Hugger 241 IV fluid warming sets with the expiration date of September 2009 were in the cabinet by the refrigerator.

Interview on 1/23/12 at 1:25 p.m. with certified registered nurse anesthetist E revealed he agreed:
*Expired supplies should have been taken out of circulation.
*Opened packages of supplies opened should not have been returned to the clean supply area.

8. Audit on 1/23/12 at 2:30 p.m. of the gastrointestinal (GI) supplies in operating rooms A, B, and C revealed:
*Operating room A had three un-packaged GI biopsy forceps in plastic biohazard bags with the rest of the clean packaged GI supplies.
*Operating room B had one Gold Probe 350 centimeter GI coagulation probe that had expired February 2011.
*Operating room C had:
-Two Roth Net GI polyp retrieval probes that expired May 2010 and November 2011.
-One rotatable 20 millimeter GI snare that had expired May 2010.

Interview on 1/23/12 at 2:50 p.m. with the operating room manager revealed:
*The biohazard bags that contained GI biopsy forceps in operating room A were reprocessed instruments. She was unable to tell this surveyor when the instruments had been reprocessed or why they had been placed in biohazard bags after they had been reprocessed. She agreed biohazard bags were not the appropriate packaging containers for clean reusable equipment.
*She did not believe the provider had a policy related to reprocessing instruments. However she stated staff had followed the manufacturer's recommendations for the reprocessing of those instruments.
*She agreed the supplies found in operating room B and C were expired and should have been taken out of circulation.

9. Observation on 1/24/12 from 10:20 a.m. through 12:25 p.m. of patient 20's surgery in operating room C revealed:
*The door to the substerile area adjacent to operating room C that contained sterilization equipment and sterile supplies was propped open during the time the patient was being prepared for surgery, at times during the course of surgery, and during the post operative cleaning.
*Dirty supplies and fluids were brought into the adjacent substerile room at the end of the procedure.
*Used irrigation fluid bags were emptied into the adjacent substerile room's sink at the end of the procedure.
*Physician G improperly degloved after the surgery and cross-contaminated both of his hands. That physician was then observed not washing his hands after surgery and then proceeded to cross-contaminate multiple clean surfaces in the physician's dictation area as well as the substerile corridor. That physician left the operating suite and was never observed washing his hands.

Interview on 1/24/12 at 1:25 p.m. with the operating room nurse manager revealed she agreed:
*The substerile room door adjacent to operating room C should had not been left open during the case or during post-operative cleaning.
*She agreed dirty supplies and fluids should not have entered the substerile room adjacent to operating room C.

10. Audit on 1/25/11 at 12:10 p.m. of the intensive care unit supplies revealed the following supplies had expired:
-Four 20 gauge IV cannulas expired December 2010.
-Four 26 gauge IV cannulas expired September 2011
-Two 22 French foley catheters expired January 2011 and December 2011.

Interview on 1/25/12 at 1:00 p.m. with nurse manager C revealed:
*She agreed the expired supplies listed above should have been taken out of service.
*She had believed central supply staff were checking supplies for expiration but was not sure of that.

Interview on 1/25/11 at 1:15 p.m. with nurse manager C revealed she had spoken to central supply staff and had found they had not been checking supplies for expiration.

11. Interview on 1/25/12 at 3:00 p.m. with the infection control nurse and the director of quality management revealed:
*They confirmed findings 1-9 were infection control breaches, had not meet professional standards, and had not meet the provider's infection control policies and procedures.
*The infection control nurse had not made infection control rounds to the areas identified above.
*They were not aware reusable equipment was being utilized in the surgical area nor were there any polices for the use of reusable equipment.
*They were not aware of all the areas that high level disinfection was taking place.

25107

Based on observation, interview, manufacturer's instructions, and perioperative standards, the provider failed to:
*Properly monitor the sterilization and high level disinfection processes located in the hospital and eye clinic areas.
*Properly investigate identified surgical site infections for patients with documented surgical site infections.
*Have a method in place to evaluate if same-day surgery patients developed a surgical site infection.
Findings include:

1. Observation and interview on 1/24/12 at 3:30 p.m. in the eye clinic procedure room with employee I revealed:
*The sterilizer was used to process instruments that were used in eye surgeries.
*No biological monitors were used when processing the equipment. The only indicator was the chemical indicator on the packaging.
*No log or tracking method was kept for the processing of instruments. Instruments were not dated when processed.
*There was no instrument recall process.
*There were no policies and procedures for the operation or maintenance of the sterilizer.
*She had received training from the company who had installed the sterilizer two or three years ago. There was no documentation of the training provided.
*She was not aware biological monitoring should have been performed on the sterilizer.
*The sterilizer was used about once every two weeks to process instruments.

Review of the M9 UltraClave Steam Sterilizer installation and operation manual revealed:
*Prior to installation and operating the unit the manual should have been read and understood.
*Process monitors (biological indicators and chemical indicators) should have been included in each sterilization cycle. "Process monitors detect whether the cycle parameters were delivered."

Review of the Association of periOperative Registered Nurses 2010 Perioperative Standards and Recommended Practices, Sterilization and Disinfection, 2010 Edition, Denver, Co., revealed:
*Page 461 - "Process challenge devices (PCDs) should be used with routine process monitoring devices (ie, chemical indicators, biological indicators, physical monitoring devices). Process challenge and process monitoring devices provide information to demonstrate that conditions for sterilization have been met."
*Page 462 - "Biological (BI) and chemical indicators should be used to monitor sterilizer efficacy and assess compliance of monitoring standards established for gravity-displacement and dynamic air-removal sterilizers."
*Page 471:
-"Accurate and complete records are required for process verification and used in sterilizer malfunction analyses. Documentation establishes accountability."
-Every sterilization cycle and modality including steam (e.g. wrapped and unwrapped) should have been documented. "Documentation should include the assigned lot number; contents of each load; and results of physical, chemical, and biological monitors."

2. Observation and interview on 1/24/12 at 1:50 p.m. in the operating room suite with the operating room (OR) manager revealed:
*The facility had multiples of each type of endoscopes.
*There was no process or tracking system for identifying the individual scopes used in cases or how long the scopes had been in storage.
*The OR manager was not aware endoscopes should have been reprocessed prior to use if the endoscope had been stored for a certain period of time.

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., page 411, revealed flexible endoscopes should be reprocessed before use if unused for more then five days. Flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets had been shown to grow organisms after five days of no use.

3. Interview on 1/25/12 at 3:00 p.m. with the infection control nurse and the director of quality management revealed:
*No sterilization and high level disinfection processes were monitored or observed by the infection control nurse.
*They had provided no sterilization training to the eye clinic staff.
*They were not aware the eye clinic had a sterilizer.
*They had never evaluated the infection control processes at the eye clinic.
*They were not aware surgical services reprocessed certain gastrointestinal instruments. Nor was there an infection control policy in place for reprocessing instruments. Refer to A749, findings 8 and 11.
*Infection control rounds/observations were not made in surgical services, central processing, the eye clinic, respiratory therapy, physical therapy, and the sleep laboratory. Refer to A749, finding 1, 2, 3, 4, 5, 6, 7, 9, and 10.
*There had been four documented surgical site infections (SSI) identified in 2011 per the infection control nurse's data. When asked to see the infection control programs investigation into those SSIs the infection control nurse stated no investigation had been conducted into the potential causes of those SSIs. They further stated they were not aware of policies and procedures that outlined the investigative process when SSIs were identified.
*No means for identifying SSIs in same-day surgery patients had been established.
*The infection control nurse had not been designated in writing as the provider of infection control services. Refer to A748, finding 1.
*They agreed the sterilizer in the eye clinic should not be operated until appropriate training and complete policies and procedures for sterilizer operation were put in place.