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Based on observation, interview, and policy review, the provider failed to ensure one of two observed surgical patients (21) received an allergy arm band/identification prior to surgery. Findings include:

1. Review of patient 21's pre-operative medical record revealed:
*She had an allergy to the antibiotic Keflex.
*No nursing documentation existed that indicated the patient allergy arm band/identification had been applied.

Observation on 11/29/11 from 9:30 a.m. through 11:40 a.m. of patient 21 in the pre-operative and operative areas revealed:
*She did not have an allergy band applied in the pre-operative area.
*Unidentified surgical staff present at the time of transfer to the operative area did not check for the presence of an allergy band/identification prior to transporting her. Once in the operative area no staff member verified that an allergy band/identification was on the patient.

Interview and observation on 11/29/11 at 11:55 a.m. with the director of surgical services revealed:
*She had confirmed the patient did not have an allergy band/identification.
*She agreed the patient should have had an allergy band/identification on prior to being brought to surgery. She further agreed nursing staff should have verified the allergy band/identification was on prior to transferring the patient to surgery.

Review of the provider's reviewed/revised November 2011 color coded alert system policy revealed:
*A red color coded clip should have been applied to the patient's wrist band indicating she had an allergy.
*During the initial assessment of the patient the nurse or a designated staff member was to apply the appropriate color coded clip to the patient's wrist band. That application was to have been documented in the patient's medical record.
*Nurses were to reconfirm the color coded alert presence before invasive procedures and at the time of transfer.

Review of Patricia A. Potter and Anne Griffin Perry, Fundamentals of Nursing, 6th Ed., St. Louis, Mo., 2005, p. 1602 revealed "The nurse ensures that a list of the client's allergies is noted appropriately in the client's chart and/or the hospital computer system, as well as any other places designated by institutional policy, such as an allergy band."

Based on record review, interview, and medical staff rule review, the provider failed to ensure one of two observed surgical patients (21) had appropriately authenticated, noted, dated, and timed post-operative anesthesia orders. Findings include:

1. Review of patient 21's post-operative anesthesia orders noted by nursing on 11/29/11 at 3:10 p.m. revealed:
*The patient had post-operative anesthesia orders for a schedule II narcotic hydromorphone and the anti-nausea medication ondansetron.
*The above orders were not signed, dated, and timed by the physician.
*Nursing staff noted the above orders as valid orders on 11/29/11 at 3:10 p.m.

Interview on 11/30/11 at 8:30 a.m. with the director of anesthesia revealed:
*He agreed the above orders were not valid orders as they had not been signed, dated, and timed by the physician.
*He agreed the orders should not have been noted/validated by nursing staff as they had not been signed, dated, and timed by the physician. He also agreed those orders had not been identified as verbal or telephone orders.
*He believed the orders were written by physician F as he was able to identify his hand writing. He also noted that physician F was the anesthesiologist assigned to patient 21's case that day.

Review of the provider's revised 8/3/11 rules and regulations of the medical staff revealed:
*All orders made by a member of the medical staff must have been authenticated.
*Every medical record entry should have been dated and timed.
*For verbal orders the name of the physician who gave that order should had been written, followed by the name of the person who had received that order, and the name of the person who had implemented that order.

Based on observation, policy review, and interview, the provider failed to ensure outdated and otherwise unusable medications were not available to patient use for:
*Two of four opened NovoLog insulins stored in patient bins in the Regional Rehabilitation Institute (RRI).
*Medications stored in a refrigerator in the Regional Heart Doctors Clinic.
*Seven syringes of injectable lidocaine pre-filled by the pharmacy and stored in two intravenous (IV) trays in the hospital pre-operative area.
*Twenty-three syringes of injectable famotidine pre-filled by the pharmacy and stored in a refrigerator in the hospital pre-operative area.
Findings include:

1. Observation on 11/30/11 at 10:50 a.m. of medications in patient bins in the RRI medication room revealed two opened vials of NovoLog insulin marked with an opening date of 10/24/11.

Interview at the above time with the RRI director of nursing revealed:
*Both vials of NovoLog had been opened while the patients were at the main hospital.
*The vials had been transferred from the main hospital to the RRI along with the patients.
*The vials should have been removed from use 28 days after they were opened.

Review of the provider's policy for use of single-dose and multiple-dose containers of sterile injectable mediations reviewed on October 2011 revealed:
*All sterile injectable multiple-dose containers were to have been labeled with an expiration date 28 days from the initial date they were opened.
*Any multiple-dose vials not marked with an expiration date should have been discarded on either the 1st or 15th day of the month.




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2. Observation on 11/30/11 at 2:00 p.m. revealed a medication refrigerator in the lower level of the Regional Heart Doctors clinic. That refrigerator contained medications that included purified protein derivative (for tuberculosis testing), Cardizem, Definity, and Novolin R insulin. The thermometer for that refrigerator had a reading of 32.9 degrees Fahrenheit (F) at the above time.

Review of the provider's thermometer reading sheet revealed from 10/14/11 through 11/30/11 (excluding weekends) there were 23 recorded temperatures that were under 36 degrees F.

Review of the manufacturer's labels for the medications stored in the above refrigerator revealed safe storage temperatures were to have been between 36 degrees F and 46 degrees F. The top of that sheet had a handwritten note that stated "32-40 degrees refrig. zone."

Interview on 11/30/11 at 2:00 p.m. with the director of clinical services revealed he was not aware of what the safe range for refrigerated medications should have been.







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3. Observation and interview on 11/28/11 at 3:46 p.m. of pre-operative room 13 revealed:
*Three prefilled syringes of one percent lidocaine with the outdate of 11/25/11 were found in the IV tray in a cabinet at the back of the room.
*The director of anesthesia who also managed the pre and post-operative nursing areas agreed the above medications were outdated and should have been disposed of and not available for use.

4. Observation and interview on 11/28/11 at 4:00 p.m. of the the pre-operative automated medication dispensing unit room revealed:
*Four prefilled syringes of one percent lidocaine with the outdate of 11/25/11 were found in the IV tray by the automated medication dispensing unit.
*Twenty-three syringes of famotidine were found in a refrigerator next to the automated medication dispensing unit. That refrigerator had no thermometer or documentation with it indicating the refrigerator's temperature was being checked.
*The director of anesthesia agreed the above lidocaine syringes were outdated and should have been disposed of and not available for use.
*The director of anesthesia confirmed the refrigerator was not being monitored by nursing or pharmacy. He also confirmed he was unable to validate the contents of that refrigerator as suitable for patient use.
*The director of anesthesia confirmed all refrigerators used to store medication were to be monitored daily to ensure appropriate medication storage temperatures were maintained.

Review of the provider's reviewed/revised July 2011 drug storage policy revealed medications that required refrigeration must have been stored at a maintained temperature between 36 and 46 degrees Fahrenheit.

Based on observation, testing, interview, policy review, and quality control check sheet review, the provider failed to comply with proper food handling practices, instill appropriate food safety guidance to food service workers, and maintain food service equipment. Findings include:

1. Observation on 11/29/11 at 9:30 a.m. revealed the following conditions in the Regional Behavioral Health Center (RBHC) kitchen:
a. Two of two handwashing sink basins were dry to the touch, and there were no paper towels in the waste baskets by the sinks. Interview with cook A at the time of the observations confirmed those findings. She stated she did not use those handsinks and used the handsink located in the employee bathroom in the back of the kitchen. Additional observation during the kitchen review revealed cook A engaged in food preparation and handling of clean dishes without washing her hands.
b. Two of two opened cardboard boxes with plastic spoons were taped along the seams with duct tape. Interview with cook A at the time of the observation confirmed that finding. She stated they had always used those boxes and had taped them when they had started to fall apart.
c. Knife, utensil, and storage drawers were dirty. The inside of those drawers had layers of dried liquid debris, crumbs, and other hard pieces of unidentified food and grease particles. Interview with cook A at the time of the observations confirmed those findings. She stated she was aware some of the drawers needed to be cleaned, but staff had not been able to get to them on the regular cleaning schedule.
d. Bulk food bins of sugar and flour were dirty. The outside white surface of those bins had started to turn black and brown with layers of dirty fingerprints and dried food debris. Interview with cook A at the time of the observations confirmed those findings. She stated she was aware some of the food containers needed to be cleaned, but staff had not been able to get to them on the regular cleaning schedule.
e. The Kitchen Aide countertop mixer was dirty. The splash area above the beater attachment area had layers and layers of dried food debris that was a rainbow of colors. That dried food debris could be picked loose with a fingernail. Interview with cook A at the time of the observation confirmed that finding. She stated the mixer was to be cleaned after each use but apparently had been forgotten.
f. Food scales had aluminum foil taped in place on the platform. Interview with cook A at the time of the observation confirmed that finding. She stated they had always covered the platforms with aluminum foil, and then would wipe the foil clean when it became dirty. She was not aware the platform could not be covered in foil as it created an uncleanable surface with possible ripples, rips, and tears in the foil.
g. Clean utensils, bowls, pots, and pans drained on towels throughout the kitchen. Interview with cook A at the time of the observations confirmed those findings. She stated there was not enough room for the utensils and food containers to dry after they came out of the dishwasher. Therefore she would drain them on cloth towels in kitchen.
h. The condiment trays in the dining room were dirty. The salt, pepper, creamer, and sugar trays had a dusty layer of food on the bottom. Interview with cook A at the time of the observations confirmed those findings. She stated she was aware some of the drawers and trays needed to be cleaned. She stated staff had not been able to get to them on the regular cleaning schedule.

Interview with the food service director (FSD) at 10:30 a.m. on that same day revealed he was not aware of the food handling practices or the cleanliness of the kitchen. He stated he had tried to go over to the RBHC kitchen at least once a week.

Review of the policy titled Proper Cleaning and Sanitizing of Equipment and dated July 2011 revealed: "Food contact surfaces and utensils shall be clean to sight and touch, free of encrusted grease deposits, other soiled accumulations, and shall be sanitized using a two step method. Non-food contact surfaces and utensils shall be clean."

Review of the quality control check sheet for the fourth quarter of 2011 revealed the cleaning check lists were not completed by two of three cooks.

A. Based on observation, testing, and interview, the provider failed to maintain the following areas in durable and cleanable condition:
- The wall in the trash and soiled linen holding room of central sterilization (CS).
- The floor under and around the cleaning chemicals for the cart washing station in CS.
- The wall behind the hopper in CS.
- The south wall in the reading room of the procedure area in the lithotripsy trailer.
Findings include:

1. Observation at 3:30 p.m. on 11/29/11 revealed the gypsum board wall in the soiled linen/trash holding room of CS was gouged and scraped (photo 7). The gouge was approximately one to two inches wide and three feet long creating an uncleanable surface. The gouge had exposed the layer of chalk below the paper surface of the gypsum board. Interview with the CS supervisor and director of surgical services (DSS) at the time of the observation confirmed that finding. The CS stated she was aware the wall was damaged but had not placed a work order for the repair.

2. Observation at 3:35 p.m. on that same day revealed a cart washing area in CS. The floor of the chemical closet and surrounding floor of that closet were badly discolored (photo 9). The wax had been eroded and pitted from the cleaners and chemicals used to wash and disinfect the carts. Interview with the CS supervisor and DSS at the time of the observation confirmed that finding. The DSS revealed she was not aware of the condition of the floors. The CS supervisor revealed she was aware the discoloration came from the chemicals and cleaners used for the carts. She was also aware the layer of wax had started to erode and deteriorate from the same chemicals and cleaners. She stated she had not contacted housekeeping to have the wax stripped, the floor deep cleaned, and then waxed.

3. Observation at 3:45 p.m. on that same day revealed the wall behind the hopper in CS was eroded, and the paint had peeled and bubbled (photo 8). That area was the size of a football and was directly behind the flush fixture of the hopper. Interview with the CS supervisor and DSS at the time of the observation confirmed that finding. The DSS revealed she was not aware of the condition of the wall. The CS supervisor revealed she was aware of the condition of the wall but had not placed a work order for the repair.

4. Observation at 11:00 a.m. on 11/30/11 revealed an area half of the approximate ten feet by seven foot south wall of the reading room in the lithotripsy trailer had exposed paper backed insulation. Interview with the director of safety and security at the time of the observation confirmed that finding. He stated he was not aware of the condition of the trailer as it was a contracted service.

Review of the agreement between the lithotripsy company (Midwest) and Rapid City Regional Hospital dated 9/20/09 with an expiration of 9/20/12 revealed:
- "Equipment and Maintenance: Midwest shall be responsible of all maintenance, repair and upkeep to the Lithotripter and the unit in which the Lithotripter is transported.
- Licensing/Regulatory Requirements: Midwest shall comply with and maintain all federal and state licensing and regulatory requirements as may be applicable from time to time to Midwest's performance under the Agreement."

B. Based on observation and interview, the lithotripsy trailer dark room was not maintained. The ventilation fan and grate had been covered with sacks. The handwashing sink had been turned off. Findings include:

1. Observation at 11:15 a.m. on 11/30/11 revealed a dark room in the lithotripsy trailer. Upon opening the door to the dark room the surveyor and DSS were overwhelmed from odors of the chemicals used in film exposure. The ventilation fan and grate for that room had been covered completely with sacks that were taped in place. The approximate five gallon containers of chemicals used for film exposure were still stored in that room. Interview with the director of safety and security revealed the provider had not used the dark room. He stated the provider used digital x-ray. Testing of the hand sink in that room revealed the water had been turned off. Interview with the director of safety and security at the time of the observations confirmed all the above findings. He stated he was not aware of the condition of the trailer as it was a contracted service.

Review of the agreement between the lithotripsy company (Midwest) and Rapid City Regional Hospital dated 9/20/09 with an expiration of 9/20/12 revealed:
- "Equipment and Maintenance: Midwest shall be responsible of all maintenance, repair and upkeep to the Lithotripter and the unit in which the Lithotripter is transported.
- Licensing/Regulatory Requirements: Midwest shall comply with and maintain all federal and state licensing and regulatory requirements as may be applicable from time to time to Midwest's performance under the Agreement."

Based on observation, interview, and policy review, the provider failed to store medical supplies in a sanitary manner. Medical supplies were stored under exposed sewer lines in the one of one central supply. Findings include:

1. Observation and interview on 11/29/11 at 11:00 a.m. in the central supply area with the materials supervisor revealed:
*Multiple sewer pipes ran across the length and width of the entire central supply area.
*Medical supplies were stored under the sewer pipes in closed and opened shipping containers. Some of the medical supplies had been removed from the shipping containers (Photos 1, 2, and 3).
*Occasionally the sewer pipes would leak onto the medical supplies. The last leak was in the spring of 2011.

Interview on 11/30/11 at 1:45 p.m. with the materials supervisor revealed:
*When medical supplies were found with contamination the supplies were removed and discarded. All of the supplies were supposed to be checked for the integrity of the packaging before being removed from the central supply area.
*The materials supervisor agreed storing medical supplies under exposed sewer pipes was not a good practice. He also agreed checking packaging for contamination might not identify all contaminated products.

Review of the February 2008 storage and distribution of supplies policy revealed "Storage of supplies shall be done under conditions, which tend to preserve, not threaten the integrity of the packaging."

A. Based on observation, label review, policy review, and interview, the provider failed to ensure the common-use linens in the Regional Sleep Health Center were disinfected when washed. Findings include:

1. Observation, label review, and interview on 11/29/11 at 1:38 p.m. in the Regional Sleep Health Center with the director of rehabilitation and the Regional Sleep Health Center supervisor revealed:
*The Regional Sleep Health Center was responsible for washing their own common-use linens. Common-use linens were towels and bedding.
*They used Dazzle plus concentrated detergent with bleach to wash all common-use linens.
*They were not aware the detergent was hydrogen peroxide based and did not contain any chlorine.
*They were not aware the product label did not make any claim to disinfect and did not have an environmental protection agency registration number.
*The product had been obtained through the hospital environmental services. They had assumed the product was approved if it came from environmental services.

Phone interview on 11/29/11 at 1:40 p.m. with the technical support help line for the laundry detergent revealed the product was not a disinfectant.

Review of the June 2010 provider's sleep equipment and environmental cleaning policy revealed "Cleaning of linens is done daily by staff. Each load washed will contain a solution of 10% bleach (about a cup)."

Interview on 11/30/11 at 1:34 p.m. with the director of rehabilitation and the director of environmental services revealed:
*The current policy was not being followed.
*The policy had not been updated to reflect changes in the laundry procedure.
*The director of environmental services confirmed he was not aware the detergent was not labeled as a laundry disinfectant.

B. Based on observation, label review, and interview, the provider failed to ensure the environmental surfaces of equipment in the Regional Rehabilitation Institute were being properly disinfected. Findings include:

1. Observation, label review, and interview on 11/30/11 at 9:25 a.m. in the pain management area with patient care technician G revealed:
*PDI Super Sani-Cloth wipes were used to wipe down the environmental surfaces of chairs and equipment between patients.
*The surface dried within seconds after being wiped down.
*She did not know what the contact time was for the PDI Super Sani-Cloth wipes.
*The contact time listed on the label stated the surfaces were to remain wet for two minutes.

Observation and interview on 11/30/11 at 9:42 a.m. in the rehabilitation gym with the director of environmental services revealed:
*The surfaces of the rehabilitation tables would remain wet for twenty seconds in the wettest area. Other areas that had been wiped down would dry before twenty seconds.
*The director of environmental services agreed the surfaces were dry in twenty seconds.

Interview on 11/30/11 at 9:45 a.m. with the pain management team leader/registered nurse revealed she was not aware the surfaces were to remain wet for two minutes when using the PDI Super Sani-Cloth wipes.

Interview on 11/30/11 at 1:34 p.m. with the director of rehabilitation and the director of environmental services revealed:
*There was no policy for cleaning the equipment in the Regional Rehabilitation Institute. The cleaning of equipment would follow the standard precaution guidelines and should have been disinfected between uses.
*The director of environmental services agreed the two minute contact time was not being met.
*Both agreed the equipment cleaned with the PDI Super Sani-Cloth wipes was not being disinfected because the contact time was not being met.



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C. Based on interview, policy review, and procedure review, the provider failed to have complete written procedures for sanitizing, disinfecting, and/or sterilizing work areas, equipment, and solutions used for patient care in the Regional Heart Doctors clinic. Findings include:

1. Interview on 11/29/11 at 11:00 a.m. with the director of outpatient cardiac services revealed:
*He was not aware of the chemicals used to clean, sanitize, or disinfect the clinic.
*Review of the outdated service contract for janitorial services revealed it was signed and agreed to on June 18, 2002.
*No policies or procedures could be produced for cleaning, sanitizing, or disinfecting floors, sinks, walls, toilets, or any other equipment in the Regional Heart Doctors clinic.




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D. Based on observation, interview, and policy review, the provider failed to ensure one of five observations of medication administration was completed with proper hand hygiene and good infection control technique. Findings include:

1. Observation on 11/29/11 at 8:30 a.m. of patient 48 for administration of medication revealed:
*Registered nurse (RN) C prepared the nine oral medications to be given at the bedside.
*The entry for Mephyton 5 milligram (mg), two pills appeared twice on the electronic medication administration (eMAR) record.
*RN C decided to check the physician's order for clarification on the dosage to be given.
*RN C removed one of the Mephyton pills from the medication cup that contained all the other eight unwrapped pills with her bare hands.
*The other pills were also touched by her unprotected hand.
*RN C had not washed her hands upon entering the patient's room nor did she wear gloves.

2. Observation on 11/29/11 at 8:45 a.m. of patient 49 for administration of medication revealed:
*RN C entered the room administered the patient's oral medication and gave an insulin injection.
*RN C left the room, washed her hands, but turned the faucet off with her bare wet hands.
*RN C proceeded to touch the medication administration stand and left the patient's room.

3. Observation on 11/29/11 at 9:40 a.m. revealed physician E entered patient 49's room and did as follows with his bare hands:
*He did not wash his hands upon entering the patient's room.
*He touched the patient's ankles to assess for edema.
*He listened to the patient's lung sounds touching the patient's chest and back area.
*He touched a blood soaked dressing, loosened it from the patient's abdomen, and assessed the area.
*He left the patient's room without washing his hands after touching the soiled dressing.
*He went to the charting area and touched the dictation machines.

4. Interview on 11/30/11 at 8:45 a.m. with the nursing director of the medical floor confirmed RN C should not have touched the pill with her bare hands, should have turned the water faucet off with a clean paper towel, and should have washed her hands before and after caring for the patient.

Interview on 11/30/11 at 3:00 p.m. with the vice president of quality/safety risk management confirmed the above information was correct regarding the medication administration by the nurse. She further confirmed the physician should have washed his hands before and after a patient examination. She confirmed there was not a policy regarding picking up a pill with bare hands.

Review of the provider's revised September 2011 hand hygiene policy revealed:
*Clean hands before having direct contact with patients.
*Clean hands after contact with a patient's intact skin.
*Clean hands after contact with a contaminated body site.
*Use a paper towel to shut off the faucet to avoid contaminating the hands.



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E. Based on observation, interview, testing, and interview, the provider failed to follow appropriate policy and procedure for cleaning and disinfection for one of one contact precautions room on the thrid floor. Correct procedures were not followed for the cleaning and disinfection of Methicillin Resistant Staphylococcus aureus (MRSA) at the Regional Behavioral Health Center (RBHC) Findings include:

1. Observation at 9:00 a.m. on 11/29/11 revealed a patient's room had precautionary signage at the RBHC. Interview with the supervisor at the time of the observation revealed a patient had a positive history for MRSA on the left knee. She stated the wound had since closed, but they had kept the area covered with a bandage. Interview with housekeeper B at the time of the observation confirmed she was aware of the isolation room. She stated she was aware MRSA was very infectious. Housekeeper B revealed she would pour pure bleach on her wet task wiping cloths and wipe down the isolation bedroom and bathroom. She stated she had thought the quaternary disinfectant on the wet task was not enough and wanted to use bleach.

Interview at 11:00 a.m. on that same day with the director of environmental services revealed he was not aware housekeeper B was not following proper policy and procedure for the disinfection of an isolation room. He stated the quaternary disinfectant that was used in the wet task bucket was sufficient to kill MRSA and additional bleach was not needed.

F. Based on observation, testing, and interview, the provider failed to maintain the following equipment durable and cleanable that were used by patientss:
- The commode used in one of two cancer care institute (CCI) bathrooms had chipped paint and chrome.
- The portable activated coagulation time (ACT) cart in operating room (OR) 10 had chipped and missing pieces of edging.
- The metal brace supports for the bed in OR 9 had large areas of chipped and missing paint.
Findings include:

1. Observation at 10:45 a.m. on 11/29/11 revealed a commode in the C chemotherapy CCI restroom. That commode had a painted wooden seat. The paint on that seat was chipped and scratched in several places the size of pencil erasers and pencil lead. The chrome plated arm rests were also chipped. Those chips were the size of quarter pound packages of butter and had rough edges. Interview with the DES at the time of the observation confirmed that finding. He stated he was not aware of the condition of that commode. He stated it appeared that commode was one of the original commodes, as the others no longer had wooden seats.

2. Observation at 2:00 p.m. on that same day revealed an ACT cart in OR 10. That portable cart had the vinyl strapping cover removed or ripped from the wooden edges of the cart (photo 6). The exposed wooden edges varied over the entire edge of the cart and were approximately three-fourths inches wide and four to six inches long. Interview with the director of surgical services (DSS) at the time of the observation confirmed that finding. She stated she was not aware of the condition of that ACT cart.

3. Observation at 2:20 p.m. on that same day revealed a surgical bed in OR 9. The metal supports of that surgical bed had chipped and scratched paint the size of baseballs and ping pong balls (photos 4 and 5). Interview with the DSS at the time of the observation confirmed that finding. She stated she was not aware of the condition of that bed.

G. Based on observation, testing, and interview, the provider failed to identify and instruct personnel on the use of and precautionary statements for the wet task bucket in the equipment cleaning room of the central sterilization (CS) area. Findings include:

1. Observation at 3:45 p.m. on 11/29/11 revealed an unlabeled wet task bucket in the bottom of the sink in the equipment cleaning room of the CS area. Interview with the CS supervisor at the time of the observation revealed those wet task wipes were used to wipe down intravenous pumps before they were returned to the OR. Closer observation revealed neither a label or other identifier had been applied to that bucket. The CS supervisor stated an enzymatic cleaner and bleach were added to the wipes in that bucket. Testing of that solution at that time revealed no test results could be obtained for bleach, but the solution tested positive for a quaternary disinfectant. The supervisor revealed she was not really sure what was added to the bucket as the supply distribution person filled the bucket. The CS supervisor also revealed she was not sure what the directions were for use of the solution in that wet task bucket. Continued interview with the DSS at the time of the above observations and testing confirmed the above findings. She stated staff were aware all wet task buckets were to be labeled to identify the product. She also agreed the material safety data sheet for the disinfecting solution should have been available to CS staff for emergency procedures.

H. Based on observation, interview, label review, and policy review, the provider failed to follow current manufacturer guidelines for the disinfectant used in the microbiology laboratory. Findings include:

1. Observation at 2:00 p.m. on 11/30/11 revealed a one gallon container of TB-Cide Plus on the floor of the microbiology lab. Review of that container revealed an opened date of 3/9/10 and an affixed tag with the written statement of "indefinite" under the expiration date. Continued label review revealed no guidelines given for the expiration or efficacy of the product. Per phone call to the manufacturing company at that time revealed the product was only good one year from the manufacturing date on the container. Complete review of the container revealed there was no manufacturing date. Upon relaying that information to the company representative they revealed they could give no guidelines as the container in-use in the lab was no longer used by the company. Interview with the director of the lab revealed she was unaware when that product had been purchased. Continued interview with the microbiology supervisor revealed he would make up a solution of TB-Cide Plus with water in a five gallon container to wipe down the inside of the hood used in the lab. He stated he had no way to check the efficacy of the mixed product. He revealed the policy and procedure for use of the TB-Cide Plus had not been updated for several years.


Review of the provider's February 2011 general chemistry policy revealed the following under guidelines: equipment, controls, reagents, and techniques are controlled by specific procedures as outlined in manufacturer guidelines.

I. Based on observation and interview, the provider failed to follow good infection control practices and policy and procedures for cleaning and disinfecting the pathology laboratory (lab). Findings include:

1. Observation at 3:30 p.m. on 11/30/11 revealed the pathology room/frozen section room directly adjacent to the microbiology lab. A cutting board, scalpel, and tweezers sat on top of the counter in that room. The white cutting board had deep scratches and grooves that were embedded with unknown brown and black debris that made the board appear grey in color. The scalpel and tweezers had dried pieces of debris on them. Further down the counter was a basket of old, dusty, and dirty laboratory and medical equipment (tongs, scalpels, tweezers, picks, slides, etc.). The countertop, shelves, hood, and other work areas were also visibly dirty and soiled. Interview with the director of the lab at the time of the observation confirmed those findings. She stated doctor H did not disinfect before, after, or between use when preparing a pathological specimen. The director stated doctor H had told her the utensils, cutting board, and countertop needed to only be cleaned and not disinfected. The director stated she had only seen doctor H clean the utensils and room but never use disinfectant. The director agreed the utensils, equipment, and room needed a thorough cleaning and disinfection. She stated she had relayed this information to doctor H repeatedly but had been ignored.

Review of the provider's February 2011 general chemistry policy revealed the following under guidelines: equipment, controls, reagents, and techniques are controlled by specific procedures as outlined in manufacturer guidelines, College of American Pathologists (CAP) and Joint Commission requirements, and department procedures. Review of the provider's October 2011 laboratory exposure control policy and procedure revealed:
- "Surgical Pathology: Trimmings and sections of the tissue are considered infectious.
- All equipment, work surfaces, and sinks are decontaminated with an appropriate disinfectant (e.g. a 1:10 solution of bleach or other disinfectant) immediately:
a. After the completion of a procedure.
b. When surfaces are overtly contaminated.
c. After any spill of blood or potentially infections material.
d. At the end of the work shift."



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J. Observation on 11/28/11 from 3:40 p.m. through 4:10 p.m. in the pre-operative area revealed:
*All the pre-operative rooms had large floor model sharps containers that were only half closed. Those containers were located directly under the cabinet mounted patient warming devices. The cords and tubing of those warming devices were both on top of and inside the partially full contaminated sharps containers.
*Used tape rolls were being returned to the clean utility room, and then were intermixed with the clean supply of tape.

Interview on 11/28/11 at 3:50 p.m. with the director of anesthesia and the director of surgical services revealed they agreed:
*The patient warming devices in the pre-operative area were being cross-contaminated by the sharps containers below them.
*Used tape should not have been returned to the clean supply room as it could have potentially cross-contaminated the clean supply of tape.

K. Observation and interview on 11/28/11 at 4:20 p.m. with the director of anesthesia and the director of surgical services of the soiled utility room in the post anesthesia care unit revealed:
*All of the cupboards were filled with holiday decorating supplies.
*The director of anesthesia stated that was where they had always stored thier holiday decorating supplies.
*When the director of surgical services was asked if clean supplies of any kind should be stored in a dirty area she responded "no."

L. Observation on 11/29/11 at 11:00 a.m. of the cleaning of operating room 6 by this surveyor revealed:
*Blood spills on the floor were sprayed with phenolic disinfecting and cleaning concentrate then within a minute were mopped up. That area was wet with that chemical for less than two minutes after mopping.
*Cleaning of all of the other surfaces in the operating room was also done with phenolic disinfecting and cleaning concentrate. Those surfaces were wet with that chemical for two minutes or less.

Interview and chemical label review on 11/29/11 at 11:30 a.m. with the director of surgical services, director of anesthesia, and the housekeeping supervisor for the operating room area revealed:
*The label called for that chemical to have a wet contact time with surfaces for ten minutes for all viruses and bacteria it claimed to be effective against with the exception of the AIDS virus. The AIDS virus called for a one minute wet contact time.
*The director of surgical services and the director of anesthesia were not aware of the required contact time of that chemical.
*The housekeeping supervisor was aware of the contact time and stated chemical contact time was monitored and maintained at the end of the day cleaning that she and her staff completed. However she and her staff did not monitor the cleaning process between surgical cases.

Review of APIC Text of infection Control and Epidemiology, Volume II, 3rd Ed., Washington, DC., 2009, p. 100-3, revealed:
*Staff responsible for the use and training of other staff on the use of chemical agents should know the "Manufacturer's specifications for use, including dilution and contact time."
*Chemicals should have been used according to the manufacturer's instructions.
*Organic matter/blood spills should have first been removed/absorbed from the surface prior to disinfecting it.

M. Observation on 11/29/11 at 2:00 p.m. of physician J after performing surgery on patient 21 revealed:
*The physician's gown, gloves, scrub bottoms, and shoe covers were heavily soiled with blood.
*The physician removed his grossly contaminated personal protective equipment. Then without washing or cleansing his hands proceed to write orders and handle the patient's chart. He then handled multiple other clean surfaces in the operating room as well as his personal cell phone and watch.

Review of the provider's reviewed/revised November 2011 exposure control plan revealed "Employees wash their hands immediately, or as soon as feasible, after removal of gloves or other personal protective equipment."

N. Interview on 11/30/11 at 3:50 p.m. with the director of infection control and the assistant infection control nurse revealed they both agreed findings J, K, L, and M were breaches in infection control and did not meet the provider's infection control policies.



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O. Based on record review, observation, policy review, and interview, the provider failed to follow hospital policy and procedures for one of one acute dialysis patients (53) in contact isolation. Findings include:

1. Review of patient 53's medical record revealed:
*She had been admitted on 11/9/11 with a diagnosis of right foot pain with peripheral arterial disease.
*She had a prior history of MRSA of the ear on 8/17/11.
*A nurse's note stated she should be placed in contact precautions because of MRSA history, and the physician should be notified.
*A physician's order dated 11/9/11 at 11:13 p.m. for contact isolation.
*Care plan assessment on 11/28/11 at 8:59 a.m. had listed the patient as contact precautions for isolation.
*Care plan assessment on 11/28/11 at 8:15 p.m. had changed her isolation status to standard precautions.
*There was no negative nasal swab culture in the chart.
*No physician's order had been obtained to remove her from contact isolation.

Observation on 11/30/11 from 9:30 a.m. through 10:05 a.m. regarding patient 53 revealed:
*She had received dialysis treatment in the acute dialysis treatment room.
*No contact precautions sign was posted at the isolation room entrance.
*Dialysis staff had not worn a different gown when they entered the isolation room.
*The director of dialysis contacted the director of infection control to help locate a physician's order to discontinue contact isolation.
*The director of dialysis directed staff to post contact isolation signage after she had received a return phone call from the director of infection control.

Interview on 11/30/11 at 9:55 a.m. with the director of dialysis revealed:
*Staff had contacted patient 53's nurses and they had stated the patient had been taken off contact isolation precautions the day before.
*She confirmed contact isolation precautions had not been performed in dialysis that day.

Interview on 11/30/11 at 10:08 a.m. with the director of infection control revealed:
*Patient 53's history of positive MRSA had triggered the use of contact isolation precautions.
*The patient had a physician's order for contact isolation.
*A physician's order to discontinue contact isolation had not been obtained.
*She confirmed the patient should have been in contact isolation.
*She confirmed a negative nasal swab culture for MRSA had been obtained.
*She confirmed the patient's removal from contact isolation had not followed hospital policy.

Interview on 11/30/11 at 11:05 a.m. with registered nurse (RN) D revealed:
*She had heard in the morning report patient 53 had been removed from contact isolation.
*The patient had been placed in contact isolation after she had received a phone call from the director of infection earlier that day.

Review of the provider's October 2011 contact precautions policy revealed:
*A gown should have been worn to enter the patient's room and removed after leaving.
*A negative nasal swab had been required to remove the patient from contact isolation.



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P. Based on observation, label review, and interview, the provider failed to:
- Monitor expiration dates on hand sanitizers at the Regional Heart Doctors clinic.
- Make available hand sanitizers or supplies to perform hand hygiene at the Regional Heart Doctors clinic.
- Make available proper disinfecting wipes for surface disinfection at the Regional Heart Doctors clinic.
- Monitor expiration dates on medical supplies at the Regional Heart Doctors clinic.
Findings include:

1. Observation on 11/30/11 from 1:00 p.m. through 2:30 p.m. at the Regional Heart Doctors clinic revealed:
*Outdated alcohol foam hand sanitizer in the following areas:
-Blood draw area - expired January 2011.
-Research medication storage/chart room - expired June 2011.
-Heart failure clinic room - expired August 2011.
-Examination (exam) room 10 -expired August 2011.
-Exam room 17 - expired August 2011.
*No hand sanitizer or sink in exam room 12.
*No surface disinfectant for the exam tables and surfaces in exam room 9.
*Household Clorox wipes available in exam room 8.
*No paper towels available in one of three hand washing sinks in the nurse's work area.

Interview on 11/30/11 at 2:30 p.m. with the director of cardiac services and the director of clinical services revealed they were not aware:
*Alcohol foam hand sanitizers would have a beyond use date.
*No disinfectant was available in exam room 9.
*Household Clorox wipes were not an approved disinfectant for medical facilities.
*Exam room 12 did not have any hand sanitizer available.







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2. Observation on 11/30/11 from 1:00 p.m. through 2:30 p.m. at the Regional Heart Doctors clinic revealed:
*Approximately twenty bottles of Betadine with expiration dates of September 2009 and available for use in exam room 18.
*One alcohol foam hand sanitizer with an expiration date of April 2009 and one gel hand sanitizer with an expiration date of February 2009 in the Pacemaker ICD services room.

Interview with the director of clinical services at the time of the above observations confirmed the above bottles of Betadine and hand sanitizers had expired and were available for use. He was not sure why those bottles of Betadine had been in that exam room or if they had been in use by staff.

Q. Continued interview with the director of infection control at 10:30 a.m. on 12/1/11 revealed she did not sit in on the meetings for environmental services. She stated she was unaware what their decisions were for contract services, products used, and safe infection control practices, policies, and procedures.

Based on observation, interview, and record review, the provider failed to ensure one of two observed surgical patients (21) had appropriately completed pre-anesthesia evaluation. Findings include:

1. Observation on 11/29/11 at 9:45 a.m. of physician F performing the pre-anesthesia evaluation revealed the physician did not perform any type of oral or airway examination during the course of his examination.

Review of patient 21's pre-operative medical record revealed she had multiple dental issues including a partial plate, chipped teeth, and loose teeth.

Review of the physician's notes and pre-procedure assessment form dated 11/29/11 revealed the physician:
*Did not document the airway evaluation (i.e. Malampatti score).
*Did not document the American Society of Anesthesiologist physical status classification system score (ASA score).

Observation on 11/29/11 from 12:03 p.m. through 2:30 p.m. in patient 21's surgical suite revealed:
*The patient was sedated and prepared for intubation by certified nurse anesthetist (CRNA) I. At the time of intubation the CRNA was very surprised to see that the patient had a tooth that was barely attached and was at severe risk of becoming totally dislodged. Physician F was notified by CRNA I at that time. It was decided by CRNA I and physician F to continue with the intubation with the loose tooth in place.
*At the end of the surgical case the patient was extubated. After the extubation the tooth was extracted with two fingers by CRNA I. At the time of that extraction the patient was still very sedated and was unable to protect her own airway.

Interview on 11/30/11 at 8:30 a.m. with the director of anesthesia revealed:
*He agreed oral evaluation, airway evaluation, and ASA class were all components of the anesthesia pre-procedure assessment.
*He agreed physician F had not documented the airway evaluation or ASA class for patient 21. He stated those two evaluations should have been completed per the provider's form for physician pre-procedure assessment.
*He was unsure as to why physician F had not performed an oral and airway examination at the time he was observed by this surveyor performing his pre-procedure assessment.
*He agreed that the very loose tooth in patient 21's mouth could have been aspirated due to dislodgement of the tooth during intubation or after extubation.
*He agreed appropriate oral and airway evaluation prior to going to surgery would have prevented CRNA I from being surprised by patient 21's poor dentition at the time of intubation.

Review of the provider's revised 8/3/11 rules and regulations of the medical staff revealed "Prior to the initiation of anesthesia or moderate sedation to deep sedation, a pre-anesthesia or pre-sedation assessment shall be conducted and documented."

Based on observation, policy review, and interview, the provider failed to ensure outdated and otherwise unusable medications were not available to patient use for:
*Two of four opened NovoLog insulins stored in patient bins in the Regional Rehabilitation Institute (RRI).
*Medications stored in a refrigerator in the Regional Heart Doctors Clinic.
*Seven syringes of injectable lidocaine pre-filled by the pharmacy and stored in two intravenous (IV) trays in the hospital pre-operative area.
*Twenty-three syringes of injectable famotidine pre-filled by the pharmacy and stored in a refrigerator in the hospital pre-operative area.
Findings include:

1. Observation on 11/30/11 at 10:50 a.m. of medications in patient bins in the RRI medication room revealed two opened vials of NovoLog insulin marked with an opening date of 10/24/11.

Interview at the above time with the RRI director of nursing revealed:
*Both vials of NovoLog had been opened while the patients were at the main hospital.
*The vials had been transferred from the main hospital to the RRI along with the patients.
*The vials should have been removed from use 28 days after they were opened.

Review of the provider's policy for use of single-dose and multiple-dose containers of sterile injectable mediations reviewed on October 2011 revealed:
*All sterile injectable multiple-dose containers were to have been labeled with an expiration date 28 days from the initial date they were opened.
*Any multiple-dose vials not marked with an expiration date should have been discarded on either the 1st or 15th day of the month.




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2. Observation on 11/30/11 at 2:00 p.m. revealed a medication refrigerator in the lower level of the Regional Heart Doctors clinic. That refrigerator contained medications that included purified protein derivative (for tuberculosis testing), Cardizem, Definity, and Novolin R insulin. The thermometer for that refrigerator had a reading of 32.9 degrees Fahrenheit (F) at the above time.

Review of the provider's thermometer reading sheet revealed from 10/14/11 through 11/30/11 (excluding weekends) there were 23 recorded temperatures that were under 36 degrees F.

Review of the manufacturer's labels for the medications stored in the above refrigerator revealed safe storage temperatures were to have been between 36 degrees F and 46 degrees F. The top of that sheet had a handwritten note that stated "32-40 degrees refrig. zone."

Interview on 11/30/11 at 2:00 p.m. with the director of clinical services revealed he was not aware of what the safe range for refrigerated medications should have been.







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3. Observation and interview on 11/28/11 at 3:46 p.m. of pre-operative room 13 revealed:
*Three prefilled syringes of one percent lidocaine with the outdate of 11/25/11 were found in the IV tray in a cabinet at the back of the room.
*The director of anesthesia who also managed the pre and post-operative nursing areas agreed the above medications were outdated and should have been disposed of and not available for use.

4. Observation and interview on 11/28/11 at 4:00 p.m. of the the pre-operative automated medication dispensing unit room revealed:
*Four prefilled syringes of one percent lidocaine with the outdate of 11/25/11 were found in the IV tray by the automated medication dispensing unit.
*Twenty-three syringes of famotidine were found in a refrigerator next to the automated medication dispensing unit. That refrigerator had no thermometer or documentation with it indicating the refrigerator's temperature was being checked.
*The director of anesthesia agreed the above lidocaine syringes were outdated and should have been disposed of and not available for use.
*The director of anesthesia confirmed the refrigerator was not being monitored by nursing or pharmacy. He also confirmed he was unable to validate the contents of that refrigerator as suitable for patient use.
*The director of anesthesia confirmed all refrigerators used to store medication were to be monitored daily to ensure appropriate medication storage temperatures were maintained.

Review of the provider's reviewed/revised July 2011 drug storage policy revealed medications that required refrigeration must have been stored at a maintained temperature between 36 and 46 degrees Fahrenheit.

A. Based on observation, label review, policy review, and interview, the provider failed to ensure the common-use linens in the Regional Sleep Health Center were disinfected when washed. Findings include:

1. Observation, label review, and interview on 11/29/11 at 1:38 p.m. in the Regional Sleep Health Center with the director of rehabilitation and the Regional Sleep Health Center supervisor revealed:
*The Regional Sleep Health Center was responsible for washing their own common-use linens. Common-use linens were towels and bedding.
*They used Dazzle plus concentrated detergent with bleach to wash all common-use linens.
*They were not aware the detergent was hydrogen peroxide based and did not contain any chlorine.
*They were not aware the product label did not make any claim to disinfect and did not have an environmental protection agency registration number.
*The product had been obtained through the hospital environmental services. They had assumed the product was approved if it came from environmental services.

Phone interview on 11/29/11 at 1:40 p.m. with the technical support help line for the laundry detergent revealed the product was not a disinfectant.

Review of the June 2010 provider's sleep equipment and environmental cleaning policy revealed "Cleaning of linens is done daily by staff. Each load washed will contain a solution of 10% bleach (about a cup)."

Interview on 11/30/11 at 1:34 p.m. with the director of rehabilitation and the director of environmental services revealed:
*The current policy was not being followed.
*The policy had not been updated to reflect changes in the laundry procedure.
*The director of environmental services confirmed he was not aware the detergent was not labeled as a laundry disinfectant.

B. Based on observation, label review, and interview, the provider failed to ensure the environmental surfaces of equipment in the Regional Rehabilitation Institute were being properly disinfected. Findings include:

1. Observation, label review, and interview on 11/30/11 at 9:25 a.m. in the pain management area with patient care technician G revealed:
*PDI Super Sani-Cloth wipes were used to wipe down the environmental surfaces of chairs and equipment between patients.
*The surface dried within seconds after being wiped down.
*She did not know what the contact time was for the PDI Super Sani-Cloth wipes.
*The contact time listed on the label stated the surfaces were to remain wet for two minutes.

Observation and interview on 11/30/11 at 9:42 a.m. in the rehabilitation gym with the director of environmental services revealed:
*The surfaces of the rehabilitation tables would remain wet for twenty seconds in the wettest area. Other areas that had been wiped down would dry before twenty seconds.
*The director of environmental services agreed the surfaces were dry in twenty seconds.

Interview on 11/30/11 at 9:45 a.m. with the pain management team leader/registered nurse revealed she was not aware the surfaces were to remain wet for two minutes when using the PDI Super Sani-Cloth wipes.

Interview on 11/30/11 at 1:34 p.m. with the director of rehabilitation and the director of environmental services revealed:
*There was no policy for cleaning the equipment in the Regional Rehabilitation Institute. The cleaning of equipment would follow the standard precaution guidelines and should have been disinfected between uses.
*The director of environmental services agreed the two minute contact time was not being met.
*Both agreed the equipment cleaned with the PDI Super Sani-Cloth wipes was not being disinfected because the contact time was not being met.



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C. Based on interview, policy review, and procedure review, the provider failed to have complete written procedures for sanitizing, disinfecting, and/or sterilizing work areas, equipment, and solutions used for patient care in the Regional Heart Doctors clinic. Findings include:

1. Interview on 11/29/11 at 11:00 a.m. with the director of outpatient cardiac services revealed:
*He was not aware of the chemicals used to clean, sanitize, or disinfect the clinic.
*Review of the outdated service contract for janitorial services revealed it was signed and agreed to on June 18, 2002.
*No policies or procedures could be produced for cleaning, sanitizing, or disinfecting floors, sinks, walls, toilets, or any other equipment in the Regional Heart Doctors clinic.




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D. Based on observation, interview, and policy review, the provider failed to ensure one of five observations of medication administration was completed with proper hand hygiene and good infection control technique. Findings include:

1. Observation on 11/29/11 at 8:30 a.m. of patient 48 for administration of medication revealed:
*Registered nurse (RN) C prepared the nine oral medications to be given at the bedside.
*The entry for Mephyton 5 milligram (mg), two pills appeared twice on the electronic medication administration (eMAR) record.
*RN C decided to check the physician's order for clarification on the dosage to be given.
*RN C removed one of the Mephyton pills from the medication cup that contained all the other eight unwrapped pills with her bare hands.
*The other pills were also touched by her unprotected hand.
*RN C had not washed her hands upon entering the patient's room nor did she wear gloves.

2. Observation on 11/29/11 at 8:45 a.m. of patient 49 for administration of medication revealed:
*RN C entered the room administered the patient's oral medication and gave an insulin injection.
*RN C left the room, washed her hands, but turned the faucet off with her bare wet hands.
*RN C proceeded to touch the medication administration stand and left the patient's room.

3. Observation on 11/29/11 at 9:40 a.m. revealed physician E entered patient 49's room and did as follows with his bare hands:
*He did not wash his hands upon entering the patient's room.
*He touched the patient's ankles to assess for edema.
*He listened to the patient's lung sounds touching the patient's chest and back area.
*He touched a blood soaked dressing, loosened it from the patient's abdomen, and assessed the area.
*He left the patient's room without washing his hands after touching the soiled dressing.
*He went to the charting area and touched the dictation machines.

4. Interview on 11/30/11 at 8:45 a.m. with the nursing director of the medical floor confirmed RN C should not have touched the pill with her bare hands, should have turned the water faucet off with a clean paper towel, and should have washed her hands before and after caring for the patient.

Interview on 11/30/11 at 3:00 p.m. with the vice president of quality/safety risk management confirmed the above information was correct regarding the medication administration by the nurse. She further confirmed the physician should have washed his hands before and after a patient examination. She confirmed there was not a policy regarding picking up a pill with bare hands.

Review of the provider's revised September 2011 hand hygiene policy revealed:
*Clean hands before having direct contact with patients.
*Clean hands after contact with a patient's intact skin.
*Clean hands after contact with a contaminated body site.
*Use a paper towel to shut off the faucet to avoid contaminating the hands.



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E. Based on observation, interview, testing, and interview, the provider failed to follow appropriate policy and procedure for cleaning and disinfection for one of one contact precautions room on the thrid floor. Correct procedures were not followed for the cleaning and disinfection of Methicillin Resistant Staphylococcus aureus (MRSA) at the Regional Behavioral Health Center (RBHC) Findings include:

1. Observation at 9:00 a.m. on 11/29/11 revealed a patient's room had precautionary signage at the RBHC. Interview with the supervisor at the time of the observation revealed a patient had a positive history for MRSA on the left knee. She stated the wound had since closed, but they had kept the area covered with a bandage. Interview with housekeeper B at the time of the observation confirmed she was aware of the isolation room. She stated sh