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Based on observation, interview, record review and policy review, the provider failed to ensure:
*The proper privileging was done for one of two surgeons (A).
*One of one visiting physician had been properly credentialed and granted temporary privileges prior to monitoring/supervising one of one patient's (9)Essure procedure.
*A comprehensive infection control program was implemented under the direction of a fully trained infection control officer.
Findings include:

1. Review of patient 36's 6/12/12 surgical consent form revealed she had consented to have an Essure procedure with possible tubal ligation.

Interview on 6/12/12 at 9:35 a.m. with registered nurse B who also served as the operating room supervisor revealed:
*Patient 36 had changed her mind and now wished to have a tubal ligation.
*She was not aware what current privileges physician A had at the facility.

Review of the physician A's credentialing file revealed physician A:
*Did not have privileges to perform Essure procedures at the facility.
*Had privileges to perform tubal ligations.

Review of the operating room log revealed physician A had performed an Essure procedure on patient 9 on 4/4/12.

Review of the 4/13/12 medical staff minutes revealed physician A and his daughter "..did their first Essure procedure here this month and it went very well."

Interview, record review, and medical staff rules review on 6/13/12 at 10:30 a.m. with the administrator revealed:
*He confirmed physician A had performed an Essure procedure on patient 9 on 4/4/12 with the supervision of his daughter who was a practicing medical doctor and had performed the Essure procedure before. When asked by this surveyor for the full name of the physician (daughter) he was only able to provide her first name and stated he was unsure of her last name.
*He had no credentialing file for the daughter.
*No temporary privileges had been given to the daughter.
*He confirmed the daughter was present in the operating room at the time of patient 9's Essure procedure. However no documentation of the daughter's presence was in the operating room log or patient 9's medical record.
*Physician A had finished training in January 2012 and had wanted his daughter present for the case, as she had done several of that type of procedures.
*No documentation existed that patient 9 was informed of the presence of physician A's daughter in the operating room.
*He confirmed the provider's medical staff rules were not followed for proper credentialing and privileging of the above noted physicians.
*He confirmed physician A's daughter's should not have been allowed in the operating room without proper temporary credentialing and privileges.
*He confirmed physician A's daughter presence in the operating room should have been documented in patient 9's medical record and in the operating room log.

2. Review of the entire infection control program revealed a lack of proper supervision and implementation. Refer to C270, findings A1-11.

27457

A. Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Multiple-use equipment and supplies were maintained in a sanitary manner.
*Appropriate hygenic practices were followed in one of one operating room suite.
*Manufacturer's directions for rinsing Metricide from endoscopes was followed.
*Manufacturer's directions were followed for mixing Instra-clean for cleaning surgical instruments.
*Manufacturer's directions were followed for cleaning one of one Hydrocollator in physical therapy.
*Appropriate cleaning pollicizes were developed and followed for the cleaning of isolation rooms and one of one operating room.
*A comprehensive infection control program was implemented under the direction of a fully trained infection control officer.
*High-risk error prone areas of the facility were monitored by the infection control officer.
Findings include:

1. Observation on 6/12/12 at 9:00 a.m. of registered nurse B performing an intravenous (IV) catheter insertion on patient 36 revealed:
*An IV catheter tray full of IV catheter insertion supplies was brought into the patient's room and set on the patient's bed.
*The IV insertion supplies used for patient 36's IV insertion were set on the patient's uncovered adjustable bed table.
*RN B reached in the IV supply tray multiple times cross-contaminating multiple items within that tray.
*When RN B was unable to ascertain IV access two unidentified nurses came to assist. Both of those nurses were also noted to cross-contaminate the contents of the IV tray with their contaminated gloves.
*The cross-contaminated IV tray and its contents were taken back to the nurses station back counter. That IV tray and contents were not cleaned or removed from circulation after being cross-contaminated.
*The IV tray was normally stored right next to the nursing station hand sink exposing it to splashing water.

2. Observation on 6/12/12 at 9:37 a.m. of RN B and RN G inserting a Foley catheter into patient 36 revealed:
*A flashlight was brought into the patient's room to assist with the visualization of the proper area to insert the catheter.
*The above flashlight was exposed to the patient's bedding and bedside table during the course of its use.
*After the Foley catheter was inserted the flashlight was taken back to the nursing station and placed into an cabinet uncleaned and un-disinfected.

3. Observations on 6/12/12 from 9:00 a.m. through 11:30 a.m. of patient 36's surgical case revealed:
*Certified registered nurse anesthetist (CRNA) E never performed hand hygiene during or after the patient's surgery.
*CRNA E cross-contaminated the supplies in his anesthesia cart with his contaminated gloved hands on multiple occasions during the surgery.
*RN B who served as the circulating nurse never performed hand hygiene during or after the patient's surgery.
*Physician A and his medical student did not perform any form of hand hygiene after completing the surgery. Those physicians were observed then going to the nurses station on the floor and cross-contaminating multiple surfaces.
*Surgical technician's C and D were noted removing uncovered contaminated surgical instruments from the operating room into the semi-sterile corridor and then through the propped open dirty utility door. Surgical technician D was also noted removing one basket of surgical instruments from the operating room bare handed.
*Surgical technicians C and D's only personal protective equipment was examination gloves when cleaning instruments in the dirty utility room sink.
*Housekeeping cleaned the operating room between cases and at the end of the day.
*The anesthesia carts and equipment were not cleaned after the end of the procedure.

Interview on 6/12/12 at 11:10 a.m. with housekeeper F in the operating room revealed:
*She was frequently in charge of cleaning the operating room.
*She never cleaned the walls unless they were viably soiled.
*She never cleaned the air vents in the operating room as maintenance was to do that.
*She had not cleaned the anesthesia carts and equipment as the CRNA was responsible to do that.
*No specific terminal cleaning process was in place at the end of the day.

Review of the provider's policy for washing surgery room walls revealed the walls were to be cleaned every six months or as needed on a daily basis.

4. Interview on 6/12/12 at 3:00 p.m. with the director of nursing and RN B who served as the provider's infection control nurse, operating room supervisor, pre, intra, and post-operative nurse, and manager of utilization review regarding findings 1 through 3 revealed:
*They agreed cross-contamination of the IV tray and its contents noted above had occurred.
*They confirmed storing the open IV tray next to the sink subjected it to contamination via water and other materials splashing from the sink.
*They agreed the above flashlight used in patient 36's room should have been cleaned prior to returning it to the nurses station.
*The operating room had no hand sanitizer of any kind available to the circulating nurse or CRNA.
*They confirmed proper hand hygiene had not occurred in the operating room according to their revised March 2012 handwashing policy.
*Surgical instruments should have never been removed from the operating room uncovered.
*Dirty surgical instrument should have never been handled with bare hands.
*They confirmed the surgical technician should have been dressed in water impervious gowns, gloves, and had facial and eye protection to prevent contaminating themselves or their uniforms.
*They were not aware of the specific cleaning processes of the operating room and had not observed that cleaning.

5. Observation, interview, and label review on 6/11/12 at 1:35 p.m. with surgical technicians C and D in the central supply room revealed:
*A portable hood system with one container of Metricide and one container of water was used in the high level disinfection process of endoscopes.
*Endoscopes were rinsed thoroughly multiple times with the water. The water was not changed during the rinsing process.
*They were not aware the Metricide directions stated "Rinse the equipment or medical device by immersing it completely in three separate copious volumes of water. Each rinse should be a minimum of one minute in duration unless otherwise noted by the device or equipment manufacturer. Use fresh portions of water for each rinse. Discard the water following each rinse. Do not reuse the water for rinsing or any other purpose, as it will be contaminated with glutaraldehyde."

6. Observation, interview, and label review on 6/11/12 at 1:50 p.m. with surgical technicians C and D in the soiled utility room in the operating room suite revealed:
*Surgical instruments were cleaned using Instra clean detergent.
*When cleaning instruments they would add two pumps of detergent into a sink with water. They did not know how much water was in the sink or how much detergent was dispensed with two pumps.
*Using an ice cream pail to measure the water in the sink revealed the sink was filled with approximately one and a half gallons of water to two and a half gallons of water depending on which instruments were washed.
*Measuring of the detergent revealed two pumps equaled about one third of an ounce of detergent.
*The label for Instra clean stated "Add 1 to 2 ounces per gallon of water for standard cleaning."
*They were not aware they were not following the label directions for mixing. They also used a bottle of Instra clean in the central supply room for cleaning instruments. They mixed the solution in the soiled utility room the same way they mixed the solution for central supply. They were not aware the two bottles of Instra clean had different instruction.

7. Observation and interview on 6/11/12 at 2:00 p.m. with surgical technicians C and D in the soiled utility room in the operating room suite revealed:
*Wrapped sterile packs, clean scrubs, masks, and booties were stored in the soiled utility room (photo 1 and 2).
*The sterilized packs were placed into the soiled utility room to cool and dry. They were concerned if the packs were left in the central supply room where the air conditioner was blowing on them condensation would form on the instruments in the packs. They had placed the packs on clean pans to keep them from coming in contact with the counter tops in the soiled utility room. They had been brought to the soiled utility room, because there was no other counter space available.
*The clean scrubs were placed into plastic totes with sealed lids to keep them clean. The masks and booties were stored in the cabinets in the soiled utility room.

Interview on 6/12/12 at 1:25 p.m. with surgical technicians C and D revealed:
*They cleaned and disinfected the soiled utility room the same way they cleaned and disinfected all of the other work spaces.
*They agreed sterilized items, clean scrubs, masks, and booties should not have been stored in a soiled utility room.
*They had a lack of space to store those items and tried to do the best they could with what they had.

Review of the provider's July 2009 event related sterilization policy revealed items should have been stored in an environment free of moisture, excessive heat, or contamination.

Review of the provider's undated storage and handling of sterile and non-sterile supplies revealed all sterile linen wrapped supplies should have been stored on enclosed shelving.

8. Random observations from 6/11/12 to 6/12/12 and interview on 6/12/12 at 1:25 p.m. with surgical technicians C and D revealed:
*The door to the soiled utility room in the operating room suite was open and remained in the open position all of the time.
*They were aware there should have been some separation between clean and dirty areas. They had never thought of shutting the door because, it had been that way for ten years.

9. Interview on 6/11/12 at 5:08 p.m. with the head of housekeeping revealed:
*Housekeeping was not always notified of the type of infectious organism when cleaning isolation rooms.
*When they were not notified of the infectious organism.
*They were not given any direction on how to clean the isolation room.
*She used a quaternary ammonia product as a disinfectant. She was not aware the disinfectant she was using was not effective against Clostridium difficile (C. diff).

Interview on 6/12/12 at 10:19 a.m. with the DON revealed the housekeeping staff were notified of the infectious organism in an isolation room, so they could clean accordingly.

Interview on 6/12/12 at 10:23 a.m. with housekeeper F revealed:
*Housekeeping was not always notified by the nursing staff of the infectious organism when cleaning isolation rooms.
*Housekeeping used a quaternary ammonia product as a disinfectant when cleaning isolation rooms. She was not aware if the product she was using was effective against C. diff.
*The provider did not have a policy for cleaning a room isolated with C. diff.

10. Interview and employee record review on 6/12/12 at 4:30 p.m. with the director of nursing and RN B who served as the provider's infection control nurse, operating room supervisor, pre, intra, and post-operative nurse, and manager of utilization review regarding the provider's infection control program revealed:
*RN B had been in charge of the provider's infection control since 2007 after the former infection control provider had left.
*RN B had no training or experience as an infection control provider prior to her taking over the infection control provider position in 2007. Her training since that time had consisted of attending a few state sponsored infection control meetings and viewing some videos she had purchased a few years ago.
*RN B had received no formal annual infection control provider training through the provider.
*RN B had no records of infection control provider training in her employee file.
*RN B had no written documentation she had been appointed the infection control nurse by the governing board.
*RN B spent roughly 5 hours a week or less on the infection control program due to the fact she was responsible for so many areas.
*No specific infection control standards of practice had been adopted by the program.
*No monitoring/auditing of high risk error prone areas such as sterilization and high level disinfection were conducted by RN B. When asked about her monitoring of those areas RN B stated she was not aware she should had been monitoring that.
*No infection control rounds were made by RN B or others acting as her proxy. RN B was not aware infection control rounds should had been made.
*The infection control nurse did not have oversight over the chemicals used in the facility to ensure proper disinfection occurred. She was not aware housekeeping had no policy in regards to cleaning a room isolated for C. diff., and the chemicals used by housekeeping were not effective against C. diff.
*The infection control nurse's only involvement with the quality assurance program was to report collected infection rates to the quality assurance manager.
*No infection control quality projects were currently in place according to RN B.

11. Interview on 6/13/12 at 7:30 a.m. with the head of maintenance in regards to cleaning of vents in the operating room revealed:
*The maintenance department was responsible for cleaning the vents. The vents were cleaned once a year.
*He had noticed the vents were in need of cleaning last week but had not had time to get them cleaned (photo 3).

12. Observation, interview, and operator's manual review, on 6/13/12 at 8:15 a.m. with the therapy director in the therapy room revealed:
*The provider had a Hydrocollator.
*The Hydrocollator was in operation and was cleaned quarterly.
*He was not aware the manufacturer's direction suggested cleaning the Hydrocollator every two weeks.

B. Based on observation, interview, record review, and policy review, the provider failed to:
*Use multiple-dose vials of medication according to current pharmaceutical standards of practice.
*Ensure outdated, improperly labeled, and improperly stored medications were removed from circulation.
*Perform appropriate preventative maintenance for one of one biological safety cabinet in the sub-sterile corridor of the operating suite.
*Have pharmaceutical policies and procedures related to chemotherapy agents use and safety.
*Ensure staff preparing and administering chemotherapy agents had documented initial and continued training and education.
*Have policies, procedures, and processes in place to prevent and detect diversion of scheduled medications.
Findings include:

1. Review on 6/11/12 and on 6/12/12 of the multiple-dose vials being used in all areas of the hospital revealed multiple-dose vials were being kept for up to six months after the labeled opened date.

Interview on 6/11/12 at 2:05 p.m. with the DON revealed it was the provider's policy to keep multiple-dose vials of medications for six months after they were opened.

2. Observations on 6/11/12 from 2:00 p.m. through 4:30 p.m. revealed the following medications were improperly stored, labeled, and kept past their expiration dates:
*Five 10 milligram (mg) per 2 milliliter (ml) vials of compazine in the nurses station medication cupboard had expired May 2012.
*Fifteen 1 mg per 1 ml vials of atropine in the nurses station medication cupboard had expired May 2012.
*Two 400 mg per 40 ml vials of ciprofloxacin in the nurses station medication cupboard had expired on 6/1/12.
*One 30 mg per 1 milliliter of ketorolac in the nurses station medication cupboard had the top protective cover removed and tape placed over the vial. No labeling as to when that vail was opened was documented on that vial.
*Two 10 units per 1 ml vials of oxytocin in the labor and delivery room infant tray had expired February 2012.
*One 20 ml vial of sterile water in the labor and delivery room infant IV tray had been opened with half of its contents used. That vial had no label as to when it had been opened.
*Two 10 mg per 10 ml vials of Versed were found in the anesthesia provider's box in the nurse's station refrigerator. That refrigerator's temperature was 38 degrees Fahrenheit.

Interviews on 6/11/12 from 2:00 p.m. through 4:30 p.m. with the director of nursing and multiple other unidentified nursing staff revealed they confirmed the medications above:
*Were not properly stored and labeled.
*That had expired should had been removed from circulation.
*The Versed should have been stored at a controlled room temperature of 68 to 77 degrees Fahrenheit.

3. Observation and interview on 6/12/12 at 9:50 a.m. with RN B in the semi-sterile corridor of the operating suite revealed:
*A portable hood was located in the hallway next to the scrub sinks and the entrance to the dirty utility where instruments were cleaned.
*The portable hood was used to prepare chemotherapy agents for patient use.

4. Interview and policy review on 6/12/12 at 1:00 p.m. with the DON regarding findings B1-3 revealed:
*She was unable to find a policy related to the use of multiple-dose vials.
*No nursing or pharmaceutical policy was in place describing the proper use of single-dose/single-use vials.
*She was not aware of the Centers for Disease Control (CDC) and United States Pharmacopeial (USP) standards for the proper use of multiple-dose vial medications and single-dose/single-use vial mediations.
*After reviewing the CDC and the USP standards with this surveyor she confirmed:
-The provider had not been properly using multiple-dose vial medications.
-All multiple-dose medication vials should have been removed from circulation twenty-eight days after they had been opened.
-The provider should have had policies in place for multiple-dose vial medications and single- dose/single-use vial medications to ensure patient safety and compliance with current standards of practice as well as federal and state rules/regulations.
*She had no methodology in place to monitor/audit her nurses' scheduled medication use.
*She was unsure what actions she would have taken if she had found a nurse was diverting (stealing) scheduled medications.
*Chemotherapy was mixed in the semi-sterile corridor of the operating room.
*Three RNs had received chemotherapy training at an oncologist's office, and one of those trained was the DON. That training consisted of the oncologist's office nurse showing them how she prepared chemotherapy and giving them a chemotherapy book developed by that office. That training had lasted a few hours and had occurred four years ago. No records or chemotherapy skills list were found that document the above training and experience.
*None of the three RNs administering chemotherapy were certified chemotherapy nurses.
*None of the three RNs administering chemotherapy had any continued or annual training in administering chemotherapy.

Interview on 6/12/12 at 1:40 p.m. with the pharmacist and the DON revealed:
*The pharmacist was not aware nursing staff were using multiple-dose vials of medication six months after opening it. He did not conduct audits of the provider's medications after they left the main pharmacy, as nursing had been doing that. He confirmed CDC and USP standards for multiple-dose vials had not been met.
*They had a policy for multiple-dose vials dated February 2011 and that policy stated they could keep multiple-dose vials for six months. They both confirmed that policy did not meet the standards of practice and regulation.
*No pharmacy policy was in place to address the proper use of single-dose/single-use vials.
*The pharmacist confirmed the medications in finding two had not been properly managed and stored according to the provider's policy on out-dated drugs and manufacturer's instructions.
*They had not provided any continued training/education to the three RNs who were administering chemotherapy. The pharmacist stated he to would have also needed training/education related to chemotherapy, as he had not had any experience with it himself since pharmacist school.
*The pharmacist did not oversee the mixing and administration of chemotherapy and relied on the three RNs noted above for that.
*The portable hood noted above to mix chemotherapy had never been certified.
*No cleaning or preventative maintenance schedule or log existed for the chemotherapy portable hood.
*They had no manufacturer's manual for the chemotherapy portable hood to ensure proper operation, safety, and maintenance occurred.
*The pharmacist did not believe the chemotherapy hood met USP standards. However the provider had continued to use it.
*No pharmaceutical policies existed for chemotherapy other than the book nursing staff had from the oncologist office.
*They had no job description or educational requirements for the chemotherapy nurses.
*He had no process or policies in place to prevent and audit for scheduled medication diversion. They had no policy to address the provider's action in the event a diversion of scheduled medications had occurred.

Interview and manufacturer instruction review on 6/18/12 at 1:10 with senior applications specialist H revealed:
*She was familiar with the portable chemotherapy hood used by the provider. That hood was no longer produced by them.
*The manufacturer had sold and delivered that piece of equipment to the provider on 9/5/07.
*They had tried to contact the administrator via e-mail and phone on multiple occasions in 2008, 2009, 2010, and 2011 to notify him the filter of the hood had to be replaced on an annual basis. The administrator had never contacted the manufacturer back to order the required replacement filter.
*The required replacement filter for that hood could have only been purchased through that manufacturer.
*She was not aware if that hood met the current USP standards for chemotherapy hoods.

Phone interview on 6/18/12 at 2:55 p.m. with South Dakota Board of Pharmacy inspector I revealed:
*The hood being used by the provider did not meet South Dakota pharmacy regulations for chemotherapy hoods.
*The hood was required to have been certified every six months according to South Dakota pharmacy regulations.

Based on observation, interview, record review, and policy review, the provider failed to:
*Ensure the proper surgical site marking for one of one observed surgical patient (36).
*Perform an appropriate surgical time out prior to starting the operation for one of one observed surgical patient (36).
*Ensure privileges of physicians were available in the operating suite, so staff could verify a physician's privileges to perform procedures.
*Ensure only credentialed and privileged physicians conducted and assisted with surgical procedures.
*Ensure the operating suite and its corridor were secured from unauthorized entry.
*Have all the required surgical policies and procedures.
*Ensure a tracheostomy set was available in the operating suite.
Findings include:

1. Observation and interview on 6/12/12 from 8:40 a.m. through 10:30 a.m. of patient 36's pre-operative preparation and surgery revealed:
*The patient's surgical site was never marked prior to the start of the surgical procedure.
*The physician was not in the operating room for a surgical time out. Registered nurse (RN) B spoke to the physician through the operating room door when he was at the scrub sink and informed him of the patient's name and that all her paperwork was in place. Once the physician was in the operating room surgery proceeded without a formal surgical time out.
*RN B was the circulating nurse for the case and had no access to the physician privileges.
*The operating suite and its corridor were not secured for unauthorized entry.

Interview and surgical services policy review on 6/12/12 at 2:30 p.m. with the director of nursing and RN B who served as the operating room supervisor revealed:
*They confirmed no physician's surgical privileges were maintained in the operating room.
*They confirmed the provider's March 2012 verification of correct site for invasive or surgical procedures policy had not been followed. They further confirmed as a result of that policy not being followed patient 36 had not received appropriate surgical site marking or surgical time out.
*They confirmed the surgical suite had no means of being secured from unauthorized entry at any time and agreed it should have been to ensure proper infection control and patient safety.
*They had no surgical policies and procedures that addressed surgical fire or contaminated cases.
*No tracheostomy set was available in the operating suite.

2. Physician credential file review, operating log review, and patient record review on 6/13/12 revealed the provider had allowed non-privileged and non-credentialed physicians to perform and assist with surgery. Refer to C 240, finding 1.

Based on record review and interview, the provider failed to have an interdisciplinary team approach to care planning for two of two sampled swing bed patients (26 and 35). Findings include:

1. Review of patient 26's medical record revealed she had been admitted on 1/13/12 and had been discharged on 1/23/12 (ten day stay). Review of patient 35's medical record revealed he had been admitted on 11/15/11 and had been discharged on 12/2/11 (seventeen day stay).

Interview on 6/11/12 at 9:10 a.m. with the director of nursing revealed she met weekly with each patient's physician and discussed the patient's plan of care. She stated she met with other involved disciplines individually as needed. There were not structured interdisciplinary team meetings to review and revise patients' care plans.

Review of the provider's Swing Bed manual last approved 4/13/12 revealed no policy or procedures related to care conferences.