HospitalInspections.org

26632

Based on observation and interview, the provider failed to ensure equipment and supplies were properly monitored or maintained for the provision of emergency care. Multiple supplies and equipment were found outdated or unusable in two of two areas of the emergency treatment area. Findings include:

1. Observation on 3/21/12 at 9:00 a.m. revealed the following outdated supplies and equipment in the emergency treatment area supply room:
*Six Penrose drains expired 3/1/96 and four expired 11/1/95.
*One bone marrow needle expired April 2011.
*Two Tru-Cut biopsy needles expired April 2011.
*One catheter stabilization device dated June 2010.
*Eight oral cleansing and suctioning systems expired November 2009 and four expired August 2010.
*One small nasal speculum, that had been sterilized and was available for use was pitted and rusted.

Interview at 10:00 a.m. on that same day with the purchasing manager confirmed the expiration dates of the above items. She revealed she was not aware those items were outdated. She stated she or her assistant went through the supply room and emergency rooms monthly to check for outdates. She also stated her assistant was to check for the quality and condition of any surgical and treatment equipment and to report any defects to her for replacement.

2. Observation on 3/21/12 at 1:15 p.m. of the single emergency room revealed a Broselow/Hinkle PES (pediatric emergency system) color-coded board. Further observation revealed multiple supplies were past their expiration date but were still available for use. Those supplies included:
*Six intraosseous needles, three with an expiration date of April 2011, and two with an expiration date of June 2011. *Seven tracheostomy tubes, one with an expiration date of September 2009, four with an expiration date of August 2009, one with an expiration date of May 2011, and one with an expiration date of August 2011
*One nasogastric tube expired April 2011.
*One duodenal tube expired November 2010.
*One intubation stylet expired February 2011.
*One intravenous catheter expired September 2009.
*Seven oxygen tube/delivery modules, three with an expiration date of June 2011, and four with expiration dates of July 2011.
*Nine intravenous delivery modules, seven with an expiration date of August 2008, one with an expiration date of July 2008, and one with an expiration date of July 2010.

Further observation of the single emergency room revealed:
*One six ounce bottle of Enfamil Enfolyte expired November 2011.
*One Bair Hugger blood and intravenous fluid warming kit expired November 2011.
*One cricothyrotomy device expired February 2010.

Interview on 3/21/12 at 2:00 p.m. with the director of nurses revealed:
*She agreed those supplies were expired.
*She had been told the purchasing department checked all supplies in the hospital to ensure expired supplies had been removed.

Based on observation, testing, and interview, the provider failed to maintain the integrity, safety, and/or cleanliness for the following:
*The walls surrounding the hopper in the single emergency room (ER) area and the wall under the air conditioner in the x-ray room.
*The ceiling in the small storage room of the single ER.
*The floor underneath and around the oxygen tank in the x-ray room.
*The outside door to the emergency entrance and the outside door by the oxygen storage room.
*The fluorescent and/or incandescent light bulbs were not shielded in the following areas:
-Kitchen.
-Small storage room of the single ER.
-Core supply room for the ERs.
-Soiled linen room.
-Laundry room.
*The back board in the double ER.
*The hood fan in the kitchen.
Findings include:

1. Observation from 9:00 a.m. to 11:30 a.m. on 3/20/12 revealed:
a. The plaster wall under the air conditioner in the x-ray room was cracked and had started to fall off the wall (photo 6). The large cracks resembled three to four foot arcs of lightning that radiated from the top to the bottom of the wall. The walls surrounding the hopper in the alcove of the small storage room next to the single ER had eroded and deteriorated. The plaster covering an area approximately two foot by two foot on each of the three walls surrounding the hopper was flaking and would crumble and fall to the floor with a slight touch (photos 1 and 2). Interview with the maintenance supervisor (MS) at the time of the observations confirmed those findings. He stated he was not aware of the condition of those walls. He stated he had not received any work orders to repair those walls.
b. The painted ceiling surrounding the light fixture in the small storage room of the single ER had peeled and deteriorated away from the gypsum board surface beneath the paint (photo 3).The peeled paint was two to three inches in width and length and resembled petals of a flower. Interview with the MS at the time of the observation confirmed that finding. He stated he was not aware of the condition of that ceiling.
c. The tile floor underneath and around the large oxygen tank in the x-ray room had black scuffs, scrapes, and gouges. The marked floor area was approximately three foot by four foot (photo 5). Interview with the MS at the time of the observation confirmed that finding. He stated he was not aware the floor was in that condition and would have housekeeping strip and rewax the floor.
d. The outside door to the emergency entrance had a gap between the bottom quarter of the door and frame (latching side) approximately 1/2 inch where light was visible. The outside door by the oxygen storage room had a gap between the bottom of door and the threshold (latching side) approximately 1/2 to one inch where light was visible. Interview with the MS at the time of the observation confirmed that finding. He stated he was not aware the weather stripping for those doors needed to be replaced. The MS agreed rodents and insects might have had access through those areas.
e. The fluorescent and/or incandescent light bulbs were not shielded nor were they shatterproof in the following areas:
* Kitchen: Four fluorescent and two energy efficient fluorescent.
* Small storage room by single ER: one incandescent.
* Core supply room for ERs: one fluorescent.
* Soiled linen room: two energy efficient fluorescent and two fluorescent.
* Laundry room: four fluorescent.
Interview with the MS at the time of the observations confirmed those findings. He stated he was not aware those light bulbs were not shielded nor shatterproof.
f. The back board in the double ER room was made from painted plywood and was hanging from the crash cart. Closer observation revealed the painted surface on the plywood had chipped away and had created splintered and bare areas (photo 4). Those splintered and bare areas were hazardous and created an uncleanable surface. Interview with paramedic T at the time of the observation confirmed that finding. He stated he did not use that backboard and agreed it was in poor condition. Paramedic T removed the back board at that time.
g. The fan for the two hoods in the kitchen would not work upon activation of the electrical switch. Interview with the dietary manager at the time of the observation confirmed that finding. She stated that fan had not worked since she had arrived at the facility on 10/1/11. She stated she had placed a work order but had been told parts were not available for the fan unit.

Based on record review, review of medical staff bylaws, and interview, the provider failed to ensure three of three sampled physicians (C, F, and G) and five of five sampled allied health professionals (A, B, D, E, and H) had been credentialed according to the provider's Medical Staff By-Laws Rules and Regulations. Findings include:

1. Review of physician C's credentialing file revealed:
*The current license on file had expired 3/1/10. Information received from the physician's clinic revealed he did have a current license.
*No current Drug Enforcement Administration (DEA) registration was found. Information received from the physician's clinic revealed he did have a current registration.
*No South Dakota Department of Health Controlled Substance certificate. Information received from the physician's clinic revealed he did have a current certificate.
*His last reappointment had been signed 2/26/09.
*No delineation of clinical privileges.
*No current reference checks regarding clinical competence.
*No statement of physical/mental health.
*The last National Practitioner Data Bank or American Medical Association physician profile query had been conducted on 12/29/08.
*No length of time for approval status had been documented.
*The last medical staff and governing body signatures for appointment were dated 2/18/09.
*No current professional liability insurance information had been documented.

Interview on 3/20/12 at 11:05 a.m. with the human resources manager (HRM) revealed she thought physician C had not provided services at the facility for at least two years. Review of medical records from the provider revealed physician C had signed off on medical records as recently as March 2012.

2. Review of resident physician F's credentialing file revealed:
*No delineation of clinical privileges.
*No reference checks regarding clinical competence.
*No statement of physical/mental health.
*No National Practitioner Data Bank or American Medical Association physician profile query.
*No length of time for approval status was documented.
*No current professional liability insurance information had been documented.

3. Review of physician G's credentialing file revealed:
*No delineation of clinical privileges.
*No reference checks regarding clinical competence.
*No statement of physical/mental health.

4. Review of allied health professional A's credentialing file revealed:
*No delineation of clinical privileges.
*No initial reference checks.
*No National Data Bank query.

5. Review of allied health professional B's credentialing file revealed:
*No current license on file. Information received from the allied health professional's clinic revealed she had a current license.
*No current DEA registration was found. Information received from the allied health professional's clinic revealed she had a current registration.
*No South Dakota Department of Health Controlled Substance certificate. Information received from the allied health professional's clinic revealed she had a current certificate.
*No application for reappointment. Her last reappointment had been signed 4/26/07.
*The last delineation of clinical privileges had been outlined on 1/22/04. There was no indication those clinical privileges had changed or had remained the same.
*No current reference checks regarding clinical competence.
*No statement of physical/mental health.
*No National Practitioner Data Bank query had been conducted.
*No length of time for approval status had been documented.
*No medical staff and governing body signatures for appointment.
*No current professional liability insurance information had been documented.

6. Review of allied health professional D's credentialing file revealed:
*No current license on file. Faxed information received from her revealed she had a current license.
*No current DEA registration was found. Faxed information received from her revealed she had a current registration.
*No South Dakota Department of Health Controlled Substance certificate. Faxed information received from her revealed she had a current certificate.
*No application for reappointment. Her last reappointment had been signed 7/13/10 and was for a period of 12 months.
*The last delineation of clinical privileges had been outlined on 5/13/09. There was no indication those clinical privileges had changed or had remained the same.
*No current reference checks regarding clinical competence.
*No statement of physical/mental health.
*No National Practitioner Data Bank query had been conducted.
*No length of time for approval status had been documented.
*No medical staff and governing body signatures for reappointment.
*No current professional liability insurance information had been documented.

7. Review of allied health professional E's credentialing file revealed:
*No application for reappointment. Her last reappointment had been signed on 4/26/07.
*The last delineation of clinical privileges had been outlined on 4/08/05. There was no indication those clinical privileges had changed or had remained the same.
*No current reference checks regarding clinical competence.
*No statement of physical/mental health.
*No National Practitioner Data Bank query had been conducted since 4/26/07.
*No length of time for approval status had been documented.
*No medical staff and governing body signatures for reappointment.
*No current professional liability insurance information had been documented.

8. Review of allied health professional H's credentialing file revealed:
*No application for appointment.
*No delineation of clinical privileges.
*No reference checks regarding clinical competence.
*No statement of physical/mental health.
*No National Practitioner Data Bank query.
*No medical staff and governing body signatures for appointment.
*No current professional liability insurance information had been documented.

Review of the provider's 2004 By-Laws Rules and Regulations on pages 5-7, Article III, qualifications for medical staff membership, revealed:
*An applicant for appointment or reappointment to the medical staff would have the burden of establishing, to the satisfaction of the appropriate committees of the medical staff and board of directors, that he or she met the qualifications, standards, and requirements set forth in the medical staff and facility's bylaws.
*In order to qualify for appointment or reappointment to the medical staff and be granted clinical privileges at the hospital, each practitioner must possess credentials as outlined in the medical staff and facility's bylaws.
*The board of directors would act on appointments, reappointment only after there had been a recommendation from the medical executive committee as provided in those by-laws.
*Initial appointments would be for a period of six months.
*Reappointments would be for a period of not more than 24 months.
*Appointment to the medical staff would confer to the employee only those clinical privileges granted by the board of directors.

Review of the provider's By-Laws Rules and Regulations on pages 10 through 20, Article V, Procedure for Appointment and Reappointment revealed detailed instructions for the:
*Responsibilities of the applicant for appointment.
*Appointment process.
*Reappointment Process.
*Requests for modification of appointments.
*Contract and employed physicians and allied health professionals.

Interview on 3/20/12 at 10:30 a.m. with the HRM revealed:
*She had been in her current position for approximately one year and two months.
*She was in charge of maintaining the credentialing files.
*She was not sure what was involved for the credentialing process.
*The credentialing files and the physician and allied health professional licenses had not been kept current.
*She was unaware of the content of medical staff bylaws.
*She was unaware the provider had forms in place to have been used for the appointment and reappointment process.

Interview on 3/20/12 at 4:30 p.m. with the interim director of nursing and the interim administrator revealed:
*They were not aware the credentialing process had not been completed.
*They agreed changes would need to be made to the credentialing process to ensure all appropriate information was
completed and was maintained on file.

Based on observation, interview, and record review, the provider failed to ensure outdated and unusable medications were not available for use in three of four observed medication storage areas (medication room, emergency room, and central supply room.) Findings include:

1. Observation on 3/20/12 at 4:40 p.m. of the medication room revealed:
*Thirteen normal saline 50 milliliter (ml) partial fill injection bags had expired in November 2011.
*Four dextrose 5 percent (%) 50 ml partial fill injection bags had expired in January 2011.
*Two sodium bicarbonate 8.4% 50 ml injection syringes located in the paramedic drug box had expired 3/1/12.
*One lidocaine 2 gram 250 ml injection bag located in the paramedic drug box had expired January 2012.
*One single-use normal saline irrigation 1000 ml pour bottle had been opened on 11/22/11.
*One single-use normal saline irrigation 250 ml pour bottle had been opened with no date.

Review of a letter dated 3/22/12 from the manufacturer of irrigation solutions revealed the irrigation solutions:
*Contained no microbiologic preservatives.
*Were packaged as single-use items.
*Were labeled with a statement for the unused portion to have been discarded.
*Should have been used promptly after opening to minimize the risk of bacterial growth or pyrogen formation.

Interview on 3/21/12 at 10:30 a.m. with pharmacist S revealed:
*The partial fill injection bags were not distributed by the pharmacy. The injection bags came from central supply. Central supply personnel and nursing staff were responsible for ensuring the injection bags were not past the expiration date.
*It was the responsibility of the paramedic to ensure the products in the paramedic drug box were not past the expiration date. It was her understanding the paramedic drug box had been placed on the ambulance.

Interview on 3/21/12 at 11:30 a.m. with paramedic T revealed:
*He had not yet used the paramedic drug box.
*The paramedic drug box had been placed in the medication room until it was ready for use.

A. Based on observation, interview, record review, and policy review, the provider failed to ensure standards of practice had been provided for one of one out-patient's (29) intravenous (IV) medication administration and dressing change. Findings include:

1. Observation on 3/20/12 from 9:00 a.m. through 9:35 a.m. and again from 10:30 a.m. through 10:45 a.m. of registered nurse (RN) I without washing her hands or using gloves revealed:
*In the medication room she prepared Vancomycin 1 gram in 250 milliliters (ml) of normal saline, Ativan 2 milligram/milliliter (mg/ml), and Toradol 30 mg/ml.
*She did not use alcohol wipes to cleanse the ports of the vials of medication or the port of the 250 ml bag of NS.
*She then carried all the medication supplies to the room where patient 29 was.
*She removed the covering and inspected patient 29's IV site on her left hand.
*She cleansed the port of the IV and administered:
-Ten ml of NS.
-Ativan 0.5 mg.
-Ten ml of NS.
-Toradol 30 mg.
-Ten ml of NS.
*She primed the tubing of the IV Vancomycin, and placed the tubing in the IV pump.
*She cleansed the IV port with the same alcohol pad used previously and attached the IV tubing to the IV port.
*She left the room and without washing or sanitizing her hands she retrieved wound care supplies from the emergency room.
*She brought the wound care supplies back to patient 29's room without washing or sanitizing her hands or donning gloves.
*She placed sterile water and Betadine in a sterile bowl and assisted patient 29 to place her right thumb in the solution.
*She then left the room and sanitized her hands with alcohol foam.
*At 10:35 a.m. she had gloves on and placed a new dressing on patient 29's right thumb.
*She used a roll of tape she had hooked on her stethoscope to secure the dressing and replaced that tape to her stethoscope.
*She touched the IV pump setting pad.
*She then removed her gloves and without sanitizing or washing her hands she:
-Touched the IV pump setting pad.
-Went into the medication room to retrieve a 10 ml NS flush syringe.
-Returned to the room with patient 29 and disconnected the IV tubing from the IV port.
-Cleansed the IV port with an alcohol pad.
-Attached the 10 ml NS flush syringe to the IV port.
-The IV leaked and RN I stopped and disconnected the syringe.
*She then left the room and without washing or sanitizing her hands retrieved the IV supply tray from the nurse's station cupboard.
*She returned to the room and without washing or sanitizing her hands she donned gloves.
*She then removed the IV cannula from patient 29's left wrist and placed two by two inch gauze over the insertion site.
*She had patient 29 hold the gauze and removed her gloves.
*Without washing or sanitizing her hands she removed the roll of tape from her stethoscope and secured the gauze. She replaced the tape back on her stethoscope.
*She then returned the IV supply tray to the cupboard at the nurse's station and used hand sanitizer.

Interview on 3/20/12 at 4:50 p.m. with RN I revealed she agreed she had not followed appropriate infection prevention when administered IV medication and performing the dressing change for patient 29.

Review of patient 29's out-patient record revealed she was receiving IV Vancomycin for an infection to her right thumb. She had methicillin resistant staphylococcus aureus and enterococcus faecalis organisms in that wound.

Review of the provider's revised April 2003 IV administration policy revealed gloves would have been worn during IV procedures in which there was a chance of contact with blood.

Review of the provider's revised September 2002 standard precautions policy revealed:*Handwashing:
-Hands would be have been washed immediately after gloves were removed.
-Between resident contact and when indicated to avoid transfer of microorganisms to other patients or surfaces.
*Gloves:
-Gloves would have been worn when touching blood, body fluids, or contaminated items.
-Gloves would be removed promptly after use and hands would have been washed immediately after the removel of gloves.
*Patient care equipment:
-Single-use items would be properly discarded.



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B. Based on observation and interview, the provider failed to maintain the cleanliness for one of two gurneys in the double emergency room. A wad of gum was stuck beneath the edge of the gurney. Findings include:

1. Observation at 1:45 p.m. on 3/21/12 revealed two gurneys had been cleaned and prepped for the next emergency room patients. Closer observation and inspection of the gurney on the west side of the room revealed an orange wad of substance the size and diameter of a golf ball stuck underneath on the right side (photo 7).

Interview with paramedic T at the time of the above observation confirmed that finding. He stated that wad of substance appeared to be orange gum. He stated the emergency room staff would do a surface clean between patients and housekeeping did a terminal clean once per week. He stated he would let housekeeping know another terminal cleaning needed to be done of the gurney.

Based on record review, interview, and policy review, the provider failed to ensure:
*Six of nine sampled (13, 14, 15, 18, 21, and 22) closed patient records reviewed had documentation for the use and response for as needed (PRN) medication.
*One of one acute care patient (33) record reviewed had documentation for the use and response for PRN medication.
*One of one swing bed patient (34) record reviewed had documentation for the use and response for PRN medication.
*One of nineclosed patient (16) records reviewed had complete documentation for wound care and follow-up from a fall.
*One of three out-patient (29) records reviewed had documentation for intravenous medication that had been administered.
Findings include:

1. Review of patient 13's closed record revealed she had received PRN Motrin 100 milligrams (mg) on 4/28/11 and two times on 4/2911, and Tylenol 100 mg on 4/28/11. There was no documentation of why those medications had been given or if the medication had been effective.

2. Review of patient 15's closed record revealed she had received PRN Tylenol 160 mg on 4/17/11, and ibuprofen 160 mg on 4/17/11, two times on 4/18/11, and on 4/19/11. There was no documentation of why those medications had been given or if the medication had been effective.

3. Review of patient 33's acute care patient record revealed he had received Motrin 110 mg on 3/19/12. There was no documentation of why that medication had been given or if the medication had been effective.

4. Interview on 3/20/12 at 9:00 a.m. with registered nurse (RN) I revealed the reason for use and the effectiveness of PRN medications was not documented on the medication administration record (MAR). She thought PRN medications should have been documented in the nurse's notes.

Interview on 3/20/12 at 1:50 p.m. with the director of nursing revealed it was the expectation that the reason and effectiveness of a PRN medication would have been documented in the nurse's notes.

5. Review of patient 16's closed record revealed:
*He had been admitted on 5/24/11.
*He had diagnoses that included congestive heart failure, diabetes mellitus, peripheral vascular disease, and a left below-the-knee amputation.
*His 5/27/11 discharge summary revealed he had two open areas, one on his left shin and one on his left lateral foot.
*A 5/26/11 progress note indicated a 1 centimeter (cm) diameter ulceration to his right anterior shin and a stage one pressure ulcer to his right foot that measured 1.5 cm in diameter.
*There were no treatment orders for the care of those open areas in the physician's orders.
*The admission nursing assessment indicated he had no identified skin integrity concerns.
*His 24 hour nursing assessments for 5/24/11 indicated his skin was intact, warm, and dry.
*His 24 hour nursing assessment for the day assessment on 5/25/11 revealed he had a decubitus ulcer.
*The 5/25/11 nurse's note at 7:00 a.m. indicated he had open areas on his right shin and foot.
*Those areas had dressings applied at 2:00 p.m.
*There was documentation of his wounds for the day assessments on 5/25/11, 5/26/11, and 5/27/11.
*There was no documentation of his wounds for the night assessments on 5/25/11, 5/26/11, and 5/27/11.
*There was no documentation of how to care for his wounds on the 5/27/11 discharge instructions.

Further review of patient 16's closed record revealed:*He had been found on the floor at 9:15 a.m. on 5/26/11.
*There were no vital signs taken at that time.
*There was no assessment for any injuries he might have sustained.
*His physician had not been notified.

Review of the provider's 11/1/06 wound assessment policy revealed:
*All wounds should have been assessed by an RN.
*For any patient admitted with a wound home health was to be notified, and treatment would be suggested for the care of the wound.

Interview on 3/21/12 at 9:00 a.m. with the director of nursing revealed:
*Each open area should have been measured and a physician's order obtained for the treatment.
*She agreed the documentation was inconsistent for patient 16's wounds and did not follow the provider's policy.
*She agreed no discharge instructions had been provided to patient 16 for wound care.
*She stated an incident report would have been completed for his fall on 5/26/11.

6. Observation on 3/19/12 at 4:30 p.m. revealed out-patient 29 was in a patient room. She was receiving antibiotic intravenous medications.

Review of patient 29's out-patient record on 3/20/12 revealed there was no documentation the antibiotic treatment had been administered.

Interview on 3/21/12 at 9:00 a.m. with the director of nursing revealed:
*She had contacted the RN who had administered the antibiotic for out-patient 29 on 3/19/12.
*She confirmed the RN had not documented anything regarding out-patient 29.

Review of the provider's revised August 2002 documentation policy revealed all treatments and effects would be written.




23059

7. Review of patient 14's closed record revealed he had received PRN albuterol unit dose medication for complaints of chest tightness and harsh cough on 4/9/11 at 2:45 a.m. and on 4/10/11 at 9:30 a.m. No documentation was found indicating whether that medication had provided patient 14 with relief.

8. Review of patient 18's closed record revealed he had received:
*PRN Percocet 5/325 mg for complaints of pain on 12/22/11 at 4:30 p.m. and on 12/23/11 at 2:45 a.m.
*PRN Ativan 0.5 mg for complaints of agitation on 12/24/11 at 1:50 a.m., 12/25/11 at 9:30 p.m., and 12/26/11 at 11:15 a.m.
*PRN Nupercainal cream for complaints of hemorrhoid pain on 12/24/11 at 8:30 a.m., 12/24/11 at 9:30 a.m., 12/24/11 at 10:40 a.m., and 12/24/11 at noon.
No documentation was found indicating whether those medications had provided patient 18 with relief.

8. Review of patient 21's closed record revealed she had received:
*PRN albuterol for complaints of chest tightness and hoarse cough on 2/17/12 at 4:15 p.m.
No documentation was found indicating whether that medication had provided patient 21 with relief.

9. Review of patient 22's closed record revealed he had received:
*PRN ibuprofen 75 mg for complaints of sore throat on 2/28/12 at 10:00 p.m., 2/29/12 at 10:20 a.m., and 3/1/12 at 2:45 p.m.
*PRN acetaminophen 120 mg for complaints of sore throat on 2/29/12 at 12:01 a.m. and on 3/2/12 at 12:15 a.m.
No documentation was found indicating whether those medications had provided patient 22 with relief.




20880

10. Review controlled substance inventory sheets with entries for patient 34 revealed:
*An entry dated 3/19/12 documenting he had been administered temazepam 15 mg at 10 p.m.
*An entry dated 3/20/12 showing he had been administered triazolam 0.25 mg at 9 p.m.

Review of patient 34's PRN medication sheet for 3/19/12 and 3/20/12 revealed there was no documentation on the sheet to show he had been administered the above medications.

Review of patient 34's nurses notes for 3/19/12 and 3/20/12 revealed there were no notations to show he had been administered the above medications.

Based on interview, record review, and policy review, the provider fail to ensure:
*Proper testing was completed for the one autoclave (vacuum steam sterilizer).
*Testing supplies for the sterilizer were maintained and current.
*Training and competency of sterilization staff was appropriately carried out and documented.
*Infection control was fully integrated into the emergency room services and the sterilization and disinfection areas.
*Infection control policies and procedures were developed for the sterilization and disinfection areas.
*Sterilization and disinfection policies and procedures were specific to the emergency rooms.
*A quality assurance program specific to emergency rooms and the sterilization and disinfection areas.
Findings include:

1. Observation and interview on 3/21/12 from 9:15 a.m. to 10:45 a.m. of the sterilization room revealed:
a. The materials manager (MM) revealed her assistant was in charge of performing the disinfection of emergency room instruments. The assistant was also in charge of the sterilization, testing, and documentation for the autoclave. She stated the assistant kept the log book for the autoclave. Review of that log book from January 2011 through October 2011 revealed the last biological tests were completed on 10/14/11. The MM stated she had not conducted any oversight of her assistant and assumed she was doing the tests. The MM revealed she knew the assistant ran the autoclave at least two times per month. Further searching by the MM revealed she located additional tests in a random drawer in the sterilization room. Those additional tests revealed three had been completed in November 2011, two in January 2012, and one in March 2012. No other documentation was recorded or could be found for December 2011 or February 2012.
b. When questioned if the sterilizer was routinely cleaned, the MM stated the assistant had cleaned the autoclave at least every six months. The MM revealed she was not aware if the assistant completed tests after cleaning and reassembling the autoclave. Review of the log book for the autoclave revealed no notations the autoclave had been tested after completion of any cleaning.
c. No Bowie Dick tests could be located for the autoclave. The MM revealed she was not aware of any Bowie Dick test or why the tests were used. She stated she doubted if her assistant was conducting those tests.
d. The one box of biological indicators had expired in February 2012. The two boxes of steam and load record cards had expired in October 2011. The MM revealed she was not aware those testing devices had expired. The MM stated she had not conducted any oversight of her assistant and had assumed she would check for outdates of testing supplies for the sterilizer.
e.. The MM revealed her assistant had received training from the past materials manager approximately one year ago. But she was not aware of any records that were kept documenting that training. No competency checklist was completed at the time of that training.
f.. When questioned how recalls were completed if the biological test results were bad, the MM revealed they had no policy on recalls. She stated all instruments would have to be re-sterilized if a test was bad. Review of the log book revealed direction had been given on how to properly list and record loads and packages with lot numbers. That was to ensure specific instruments and instrument sets could be located should a test show negative results. Review of the documentation by the assistant in the log book revealed she had listed only the different types of instruments and the number (i.e. forceps - 2). Review of the packaged instruments and instrument sets revealed no lot numbers were located or listed on the package.
g. The MM stated the infection control nurse had never reviewed or observed any of the disinfection or sterilization processes. The MM also revealed neither she nor her assistant were included nor reported any findings at the monthly infection control meeting or the monthly quality assurance meetings.
h. The MM revealed the past policies and procedures for the disinfection and sterilization were very old. Review of those policies and procedures revealed they were dated December 1980. They had been marked on, words crossed out, and additional wording, phrases, and directions had been hand written on the policies and procedures. Undated pages from the Association of periOperative Room Nurses (AORN) guidelines revealed an excerpt from Recommended Practice II - Packaging systems should be compatible with the sterilization process. Interview with the MM revealed neither she or her assistant had read the AORN guidelines nor had read any other type of training materials for the autoclave or the sterilization process.

Continued interview with the MM revealed:
*She confirmed no current/updated policies and procedures existed for the sterilization and disinfection areas of the emergency rooms.
*They currently did not have a set of guidelines nor did they follow any standards of practice for sterilization and disinfection.
*The provider did not have a specific set of infection control standards of practice for sterilization and disinfection.
*No formal recall guidelines were in place.
*The assistant materials manager was in charge of disinfection and sterilization of instruments and instrument sets for the emergency rooms. The assistant was currently out on sick leave. In her absence the MM hoped they had enough instruments to cover until she returned. The MM was unsure how to complete the disinfection and sterilization process.
*The current assistant MM had been in the position for a period of approximately one year and had no prior experience in sterilization or infection control.
*The infection control officer did not observe the practices or make rounds of emergency rooms, disinfection, or sterilization.
*She was not aware according to the AORN guidelines a Bowie Dick challenge test should had been performed on the sterilizer. She agreed the Bowie Dick test should have been performed as per the sterilizers manufacturer's instructions and current nursing standards.
*Training for sterilization and disinfection was not documented nor was a list of competencies developed. Training was just passed on from person-to-person with no formal process. No annual training was provided after initial on-the-job training.
*No policies or job descriptions outlined the responsibilities/duties of sterilization staff or emergency area staff.

Review of the Association of periOperative Registered Nurses, Perioperative Standards and Recommended Practices, 2010 Edition, Denver, CO, pages 457-477, revealed:
*The provider should have had policies and procedures for the sterilization and disinfection process. Those policies should have been reviewed periodically and should have been readily available in the practice setting.
*Training of sterilization and disinfection staff should have included review of the provider's policies and procedures.
*Initial and annual training of sterilization staff should have occured.
*The Bowie Dick challenge test should had been run daily to ensure the efficacy of air removal and steam penetration.