HospitalInspections.org

Based on observation, policy review, and interview, the provider failed to ensure outdated and otherwise unusable medications were not available for patient use in:
*Two of eight observed emergency department treatment rooms (1 and 5) where opened irrigation solutions were stored.
*Six of seven observed areas (pharmacy, emergency room, obstetrics area, operating room one, same-day surgery, and radiology) where opened multiple-dose vials were stored.
Findings include:

1. Observation on 3/13/12 at 9:30 a.m. of emergency department treatment rooms 1 and 5 revealed each had an opened pour bottle of normal saline irrigation solution. The bottles were not marked with a date when they were opened.

Interview at the above time with the emergency department supervisor revealed it was her understanding the above bottles should have been:
*Marked with the date they had been opened.
*Discarded twenty-four hours after they had been first opened.

Review of the manufacturer's product insert for irrigation solutions revised May 2009 revealed:
*The irrigation solution contained no bacteriostat, antimicrobial agent, or added buffer and was intended only for use as single-dose or short procedure irrigation.
*When smaller volumes were required the unused portion should have been discarded.
*The irrigation solution should not have been administered unless the solution was clear, the seal was intact, and the container was undamaged.

2. Observation on 3/13/12 at 9:45 a.m. of the emergency department laceration cart revealed:
*Six opened lidocaine injection multiple-dose vials not marked with a date when opened.
*One opened bupivacaine injection multiple-dose vial not marked with a date when opened.

3. Observation on 3/13/12 at 1:30 p.m. of the pharmacy refrigerator revealed three opened multiple-dose vials of lorazepam injection and not marked with a date when opened.

Interview with the director of pharmacy at the above time revealed:
*The above vials had been in use on patient areas and had been returned to the pharmacy.
*It was his understanding the vials could have been used until they reached the manufacturer's assigned expiration date even though they had been opened.
*He did not have any specific information from the manufacturer of the lorazepam vials stating how long they could have remained in use after they had been opened.

4. Observation on 3/13/12 at 2:00 p.m. of a medication cabinet in the obstetrics area revealed one opened multiple-dose vial of betamethasone injection not marked with a date when opened.

Review of the manufacturer's package insert for betamethasone injection dated December 2009 revealed it did not have any directions for storage of a multiple-dose vial after it had been opened.



26691

5. Observation on 3/13/12 at 1:55 p.m. of one of two same-day surgery rooms revealed one opened ten milliliter bottle of lidocaine injection not marked with a date when opened.

Interview at that time with the surgery supervisor confirmed that finding. She further revealed all multi-dose vials should have been labeled with the open date. She was unsure how long that bottle of lidocaine had been opened.



11933

6. Observation on 3/14/12 at 2:30 p.m. of the locked storage cabinet in radiology #1 revealed a 30 milliliter vial of bupivacaine multiple-dose medication had been opened and not dated.

Interview at that time with a radiology technician confirmed the vial was opened and had not been dated. He further confirmed he did not know when the vial had been opened. He thought they usually discarded them after each patient.

Surveyor 20880
7. Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, effective 6/1/08, revealed the beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives was twenty-eight days, unless otherwise specified by the manufacturer.

8. Review of the provider's pharmacy policy for infection control revised January 2008 revealed multiple-dose vials:
*Could have been used until the stated expiration date unless:
- It was thought they were contaminated. Then the vial should have been discarded immediately.
- The manufacturer had a different stated expiration procedure to establish a beyond-use date.
*Should have been stored after opening according to directions on the manufacturer's package insert.

Based on observation, interview, and policy review, the provider failed to ensure supplies were monitored for expiration dates in five of five patient care areas (obstetrical [OB] unit, urology clinic, Mallard Pointe surgery center, material management department, and the intensive care unit). Findings include:

1. Observation on 3/12/12 at 4:15 p.m. in the nursery on the OB unit revealed the following outdated supplies:
*One 26 gauge (G) by 19 millimeter (mm) intravenous catheter (IV cath) expired July 2010.
*One 22G by 1 inch (") IV cath expired May 2011.
*Twenty-five 24G by 3" IV caths expired December 2011.
*Four 24G by 3/4" IV caths expired January 2011.
*One 24G by 3/4" IV cath expired September 2007.
*Fifty 24G by 3/4" IV caths expired January 2012.
*Eleven 22G by 1" IV caths expired May 2010.
*Nine 22G by 3 1/2" IV caths expired November 2009.
*One 24G by 2 3/4" IV cath expired November 2010.
*One Pedicap carbon dioxide detector expired November 2009.
*One opened package of 100 temperature probe covers expired October 2006.
*One unopened package of 100 temperature probe covers expired December 2005.

Interview on 3/12/12 at 4:30 p.m. with the OB services manager revealed the registered nurses in the nursery were responsible for checking for outdated or expired supplies. She stated she was unsure why the above items had remained in the nursery available for use.

2. Observation on 3/13/12 at 12:40 p.m. at the urology clinic revealed the following outdated supplies:
*In examination (exam) room 4 one bottle of acetic acid 4 percent (%) solution expired 2/25/11.
*In exam rooms 1 and 2 and procedure room B hand sanitizer expired November 2011.
*In procedure room B two bottles of chlorhexidine gluconate 2% expired December 2011.
*In procedure room B six bags of low calcium 2.5 millicurie/liter with 1.5% dextrose of peritoneal dialysis units expired February 2012.
*In the traveling urology storage cart:
-One Sofsilk C 16 3/8 30 millimeter (mm) suture expired February 2012.
-One percutaneous suprapubic catheter (cath) set expired December 2011.
-One male urethral dilation balloon cath set expired October 2011.
*In the medication refrigerator four Bard collagen implant skin tests with 0.3% lidocaine expired
March 2011.
*In procedure room A:
-Four pressure transmission tubing blue sets expired March 2011.
-Three pressure transmission tubing red sets expired March 2011.
-One infusion pump tube set with clamping chamber expired September 2011.
-One cath tray expired August 2008.
-One iodoform packing strip 1/2" by 5 yards expired November 2011.
-One iodoform packing strip 1/4" by 5 yards expired August 2011.
-Twelve 1/8" by 3" steri-strips expired June 2010.
-Two culture swabs expired February 2012.

Interview on 3/13/12 at 2:10 p.m. with registered nurse A revealed he was responsible for ensuring outdated or expired supplies were removed from service. He stated he had little time to devote to that activity, but he was "embarrassed" those items had remained on the shelf for use.

Review of the provider's undated operating room/materials management supply area management responsibilities policy revealed:
*All carts and supply areas were to have been reviewed for outdated products.
*All products with sterility expiration dates within a six month window were to have been tagged with a sticker.
*Items with pending outdates were to have been written on a sheet for review.
*Areas of responsibility were to have been checked monthly.



25107

3. Observation on 3/13/12 starting at 10:30 a.m. in the urology clinic revealed the following outdated supplies:
*In the supply storage room four bags of 1000 milliliters sterile water for irrigation expired January 2012.
*In the fluid warmer located in procedure room A four bags of 1000 milliliters sterile water for irrigation expired January 2012.

Interview on 3/13/12 starting at 1:30 p.m. with registered nurse first assist A revealed:
*He was not aware those fluids had expired.
*The clinic performed five to thirteen procedures per day and operated three days a week. Each procedure took one bag of fluid. The fluid inventory turned over about every two weeks. He was not sure how the fluids could have expired. He thought the fluids might have expired in central supply.
*He had not been checking the fluids for outdates, because they used them so often.

4. Observation on 3/14/12 at 10:30 a.m. in operating room 4 of Mallard Pointe surgery center revealed:
*Both sodalime canisters on the anesthesia machine had expired December 2011.
*One sodalime canister was dated with a sharpie marker with a last changed date in January 2012.

Interview on 3/14/12 at 10:45 a.m. with certified registered nurse anesthetist (CRNA) C revealed:
*CRNAs who worked at Mallard Pointe surgery center were responsible for maintaining the anesthesia machine.
*He agreed the expired sodalime canisters should not have been used. He had no explanation why the expiration date had not been followed.



15036

5. Interview on 3/14/12 at 1:35 p.m. with the director of the material management department (MMD) revealed:
*Inventory of medical supplies in the MMD was done each year in January and June.
*Prior to inventory week the staff checked for outdated supplies 30 days, 60 days, and 90 days in advance.
*The last time MMD inventory week had occurred had been in January 2012.

Observation on 3/14/12 at 11:25 a.m. in the MMD revealed the following outdated supplies:
*One box of Bard safety universal introducer kits expired October 2011.
*One-half box of Bard access systems expired January 2012.
*One Site Right needle guide kit expired January 2012.
*Three 22 gauge spinal needles expired January 2012.
*One box of 3M remover lotion expired February 2012.

Review of the provider's MMD inventory checklist/policy revealed the following was to have occurred prior to the biannual inventory week:
*At 30 days cleaning and organizing was completed in the department.
*At 60 days the staff reviewed all returns, backorders, on-hand inventory, and checked the department for outdates.
*At 90 days the staff reviewed all returns, backorders, and on-hand inventory and made adjustments as needed.

Based on observation, interview, label review, and policy review, the provider failed to:
*Follow manufacturer's instructions for the testing and rinsing of Metricide OPA Plus high level disinfectant in the urology clinic.
*Maintain one of two procedure rooms (A) in the urology clinic in a sanitary manner.
*Store supplies in a manner to protect them from contamination in one of two procedure rooms (A) in the urology clinic.
*Ensure two of two physicians (D and E) in operating room one, and one of one physician (G) in the cardiac catheter procedure room completed proper hand hygiene prior to leaving those areas after the completion of their procedures.
*Ensure a policy was established for staff attire in one of one cardiac catheter procedure room.
*Ensure the rehabilitation clinic monitored temperatures and performed cleaning for one of one hydrocollator.
Findings include:

1. Observation and interview on 3/13/12 at 1:40 p.m. with registered nurse first assist (RNFA) A in procedure room A revealed:
*The urology clinic had been open for about two years.
*The procedure room was used to perform cystoscopy cases. The provider would perform between five to thirteen cases per day on Mondays, Wednesdays, and Thursdays.
*The procedure room had only one two compartment sink and no other hand sink. The cystoscopes were cleaned in one compartment of the two compartment sink of the procedure room. A board had been placed over the second compartment of the sink and a tub of Metricide OPA Plus had been placed on the board. The Metricide OPA Plus was used to high level disinfect the cystoscopes.
*The procedure room was equipped with an automatic scope processor, but it had been put out of order due to improper water supply. While the automatic scope processor was out of order the cystoscopes were being cleaned and disinfected manually.
*The Metricide OPA Plus was tested daily when procedures were performed and was not tested each time a cystoscope was high level disinfected.
*After the scopes were high level disinfected they would be moved to a single tub of sterile rinse water. The scopes would be rinsed thoroughly in the rinse water. Scopes were never rinsed in more than one tub of water.
*He was not aware the Metricide OPA Plus solution should have been tested each time it was used.
*He was not aware the scopes should have been rinsed in three separate large volumes of water after being placed in Metricide OPA Plus.

Review of the label for Metricide OPA Plus revealed:
*"The ortho-phthalaldehyde concentration of Metricide OPA Plus solution during its use-life must be verified by the Metricide OPA Plus Test strips prior to each use, to determine that the MRC (minimum required concentration) of 0.3% is present."
*"Following removal from Metricide OPA Plus Solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume (e.g., 9 liters) of water. Use sterile water unless potable water is acceptable.
-Keep the device totally immersed for a minimum of 1 minute in duration, unless a longer time is specified by the reusable device manufacturer.
-Manually flush all lumens with large volumes (not less than 100 ml) of rinse water unless otherwise noted by the device manufacturer.
-Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Do not reuse the water for rinsing or any other purpose.
-Repeat the procedure TWO (2) additional times, for a total of THREE (3) RINSES, with large volumes of fresh water, at least 9 liters each rinse, to remove Metricide OPA Plus Solution residues. Residues may cause serious side effects. SEE WARNINGS. THREE (3) SEPARATE, LARGE VOLUME WATER IMMERSION RINSES ARE REQUIRED. THE VOLUME OF WATER USED IN EACH RINSE CYCLE SHOULD BE AT LEAST 9 LITERS."

Interview on 3/14/12 at 11:50 a.m. with the quality risk manager revealed she agreed the manufacture's label for Metricide OPA Plus should have been followed.

2. Observation and interview on 3/13/12 at 1:40: p.m. with RNFA A in procedure room A revealed:
*The procedure room was used for performing cystoscopy and was also the place where the contaminated cystoscopes were cleaned (photo 1 and 2).
*After a procedure was performed the remaining sterile water used during the procedure would be moved to the two compartment sink and flushed through the cystoscope.
*While the sterile water was flushing the scope RNFA A would clean the bed and surrounding area with a disinfectant and would prepare it for another procedure. The bed and surrounding area would be approximately four to ten feet away from the sink and rinse water where the scopes were cleaned.
*After he was done cleaning the bed and surrounding area he would go back to the two compartment sink and finish cleaning the cystoscope by flushing, scrubbing, rinsing, high level disinfection, clean water rinsing, and forced air drying.
*When he was done cleaning the scope the procedure room would be ready for another patient.
*He agreed cleaning the contaminated scopes should not have happened in a procedure room. There was no soiled utility room to clean and process the cystoscopes.

Interview on 3/13/12 at 2:27 p.m. with clinic manager B revealed:
*She had been with the provider for a year and a half. The procedure room had been set-up and was in place before she had started.
*She understood this surveyor's concern with infection control and agreed scopes should not have been cleaned in the procedure room.

Interview on 3/14/12 at 11:50 a.m. with the quality risk manager revealed she agreed scopes should not have been cleaned and disinfected in a procedure room.

Review of the Association of periOperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices, 2010 Edition, Denver, CO, page 413, revealed:
*"Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed.
*Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross-contamination.
*The decontamination area should be physically separated from clean patient care areas and include a door. This area should contain, but not limited to,
-sinks to manually clean flexible endoscopes,
-hand-washing facilities,
-eyewash stations,
-automated equipment consistent with the types of flexible endoscopes to be decontaminated,
-adaptors and accessories to connect the flexible endoscopes with cleaning equipment and utilities,
-leak testing equipment,
-low-pressure air,
-closed storage facilities, and
-proper ventilation."
*"The decontamination area should be supplied at a minimum with
-enzymatic detergent,
-soft-bristle brushes,
-cleaning cloths,
-alcohol, and
-personal protective equipment (PPE)."

3. Observation and interview on 3/13/12 at 1:40 p.m. with RNFA A in procedure room A revealed:
*The procedure room was used for performing cystoscopy and was also the place where the contaminated cystoscopes were cleaned.
* An unprotected wire rack used for storing many patient care supplies was next to the procedure table and the area where scopes were cleaned, disinfected, and rinsed (photo 1 and 2).
*The supplies were stored there, so the physician had access to anything he would need while performing procedures.
*He agreed the clean supplies should not have been stored unprotected in an area where procedures were performed and cystoscopes were cleaned.

Interview on 3/13/12 at 2:27 p.m. with clinic manager B revealed she agreed the clean supplies should not have been stored in an area where they could have become contaminated.

Interview on 3/14/12 at 11:50 a.m. with the quality risk manager revealed she agreed clean supplies should not have been stored in an area where they could have become contaminated.



26691

4. Observations on 3/13/12 from 9:15 a.m. through 9:45 a.m. of patient 23's surgical procedure in operating room (OR) one revealed:
*While assisting physician D with the surgical procedure physician E received a call on his cell phone.
*After removing the sterile glove from his right hand and the right sleeve of his sterile gown, he reached into his pocket with his ungloved hand and retrieved his phone.
*While talking on his cell phone he removed the sterile glove from his left hand and the left sleeve of his sterile gown and placed them in the soiled personal protective equipment (PPE) receptacle.
*While still talking on the phone physician E left the operating room without washing or sanitizing his hands and walked down the hallway toward the nurse's station.
*When the surgical procedure was completed physician D removed his sterile gown and gloves and placed them in the soiled PPE receptacle.
*Without washing or sanitizing his hands physician D picked up his cell phone and patient 23's chart. He then left the OR and went to the nurse's station.

Interview at that time with the director of surgical services revealed physician D was going to the nurse's station to write in patient 23's chart.

Interview on 3/14/12 at 8:45 a.m. with the director of surgical services and at 10:15 a.m. with the director of quality assurance/risk management confirmed both physician D and physician E should have washed or sanitized their hands after removing their gloves and before leaving the OR.

Review of the provider's infection control policy and procedure for general hand hygiene revised October 2010 revealed in the absence of a true emergency all personnel should have always decontaminated their hands by performing antiseptic hand rub or antiseptic handwash when:
*Entering or leaving a room.
*After removing gloves.



15036

5. Observation on 3/13/12 at 10:45 a.m. of patient 46's cardiac catherization (cath) procedure revealed:
*Physician G entered the cardiac cath procedure room after performing a hand scrub. Physician G was wearing a mask, and he donned sterile gloves and a sterile gown. He was not wearing a surgical cap to cover his hair. Prior to the start of the patient's cardiac cath he tore the bottom ties off his mask with his sterile gloves.
*The cardiac cath technician was wearing a cloth surgical cap, mask, sterile gown, and sterile gloves.
*The circulating nurse wore a mask and a cloth surgical cap.
*At the conclusion of patient 46's cardiac catherization physician G removed his mask, gloves, gown, and exited the procedure room. Without washing or sanitizing his hands physician G entered the cath lab viewing area, touched computers, dictated, and left the area.

Interview with physician G immediately after the conclusion of the cath procedure revealed:
*He never wore head covering; it was not required in cardiac cath rooms.
*He had worked in other states that did not require physicians to wear a mask or head covering.

Interview on 3/14/12 at 3:25 p.m. with the cardiac cath director revealed:
*Physician G should have washed his hands or performed hand hygiene after removing his mask, gown, and gloves immediately after leaving the procedure room.
*Outside the cath lab there was a hand sink for handwashing and hand sanitizer mounted on the wall for use.
*Physician G did not always wear a hat during cath procedures. She was aware staff in other healthcare facilities did not always mask or wear hair protection.
*She did not have a policy regarding staff attire in the cath lab.



18560

6. Observation on 3/12/12 at 4:35 p.m. revealed a hydrocollator in the Prairie Lakes Rehabilitation Services department. Interview at that time with the coordinator of therapy services revealed the hydrocollator was cleaned once a quarter. She stated there was no record of when the hydrocollator had been cleaned or the temperature had been checked.

Review on 3/14/12 at 2:30 p.m. with the patient representative of the hydrocollator's operation manual revealed:
*The tank should have been drained and cleaned systematically a minimum of every two weeks.
*The temperature of the water should have been checked with a thermometer after every adjustment before the hot packs were used.

Based on record review and interview, the provider failed to ensure documentation for two of five swing bed patients (18 and 19) had been given information regarding the patient's bill of rights. Findings include:

1. Review of the medical record for patient 18 revealed:
*The patient had been admitted to swing bed on 12/16/11 and discharged on 12/23/11.
*No documentation indicated the patient's bill of rights had been given to the patient.

2. Review of the medical record for patient 19 revealed:
*The patient had been admitted to swing bed on 11/30/11 and discharged on 12/6/11.
*No documentation indicated the patient's bill of rights had been given to the patient.

Interview on 3/14/12 at 1:45 p.m. with the quality risk management director and the director for medical and surgical services confirmed the documentation that indicated the patient's bill of rights had been given to patients 18 and 19 were not in the medical records. They further stated staff thought it only had to be completed for Medicare age patients and not the younger patients.

Review of the swing bed policy for admission revised June 2006 revealed "Social Services would explain the Swing Bed Program to the patient and/or family. The Swing Bed Program Booklet, Patient's Bill of Rights and Patient Responsibilities would be reviewed. After answering patient and/or family questions, Social Services would have obtained the signature for the Swing Bed Patient."

Based on observation, interview, and policy review, the provider failed to ensure supplies were monitored for expiration dates in five of five patient care areas (obstetrical [OB] unit, urology clinic, Mallard Pointe surgery center, material management department, and the intensive care unit). Findings include:

1. Observation on 3/12/12 at 4:15 p.m. in the nursery on the OB unit revealed the following outdated supplies:
*One 26 gauge (G) by 19 millimeter (mm) intravenous catheter (IV cath) expired July 2010.
*One 22G by 1 inch (") IV cath expired May 2011.
*Twenty-five 24G by 3" IV caths expired December 2011.
*Four 24G by 3/4" IV caths expired January 2011.
*One 24G by 3/4" IV cath expired September 2007.
*Fifty 24G by 3/4" IV caths expired January 2012.
*Eleven 22G by 1" IV caths expired May 2010.
*Nine 22G by 3 1/2" IV caths expired November 2009.
*One 24G by 2 3/4" IV cath expired November 2010.
*One Pedicap carbon dioxide detector expired November 2009.
*One opened package of 100 temperature probe covers expired October 2006.
*One unopened package of 100 temperature probe covers expired December 2005.

Interview on 3/12/12 at 4:30 p.m. with the OB services manager revealed the registered nurses in the nursery were responsible for checking for outdated or expired supplies. She stated she was unsure why the above items had remained in the nursery available for use.

2. Observation on 3/13/12 at 12:40 p.m. at the urology clinic revealed the following outdated supplies:
*In examination (exam) room 4 one bottle of acetic acid 4 percent (%) solution expired 2/25/11.
*In exam rooms 1 and 2 and procedure room B hand sanitizer expired November 2011.
*In procedure room B two bottles of chlorhexidine gluconate 2% expired December 2011.
*In procedure room B six bags of low calcium 2.5 millicurie/liter with 1.5% dextrose of peritoneal dialysis units expired February 2012.
*In the traveling urology storage cart:
-One Sofsilk C 16 3/8 30 millimeter (mm) suture expired February 2012.
-One percutaneous suprapubic catheter (cath) set expired December 2011.
-One male urethral dilation balloon cath set expired October 2011.
*In the medication refrigerator four Bard collagen implant skin tests with 0.3% lidocaine expired
March 2011.
*In procedure room A:
-Four pressure transmission tubing blue sets expired March 2011.
-Three pressure transmission tubing red sets expired March 2011.
-One infusion pump tube set with clamping chamber expired September 2011.
-One cath tray expired August 2008.
-One iodoform packing strip 1/2" by 5 yards expired November 2011.
-One iodoform packing strip 1/4" by 5 yards expired August 2011.
-Twelve 1/8" by 3" steri-strips expired June 2010.
-Two culture swabs expired February 2012.

Interview on 3/13/12 at 2:10 p.m. with registered nurse A revealed he was responsible for ensuring outdated or expired supplies were removed from service. He stated he had little time to devote to that activity, but he was "embarrassed" those items had remained on the shelf for use.

Review of the provider's undated operating room/materials management supply area management responsibilities policy revealed:
*All carts and supply areas were to have been reviewed for outdated products.
*All products with sterility expiration dates within a six month window were to have been tagged with a sticker.
*Items with pending outdates were to have been written on a sheet for review.
*Areas of responsibility were to have been checked monthly.



25107

3. Observation on 3/13/12 starting at 10:30 a.m. in the urology clinic revealed the following outdated supplies:
*In the supply storage room four bags of 1000 milliliters sterile water for irrigation expired January 2012.
*In the fluid warmer located in procedure room A four bags of 1000 milliliters sterile water for irrigation expired January 2012.

Interview on 3/13/12 starting at 1:30 p.m. with registered nurse first assist A revealed:
*He was not aware those fluids had expired.
*The clinic performed five to thirteen procedures per day and operated three days a week. Each procedure took one bag of fluid. The fluid inventory turned over about every two weeks. He was not sure how the fluids could have expired. He thought the fluids might have expired in central supply.
*He had not been checking the fluids for outdates, because they used them so often.

4. Observation on 3/14/12 at 10:30 a.m. in operating room 4 of Mallard Pointe surgery center revealed:
*Both sodalime canisters on the anesthesia machine had expired December 2011.
*One sodalime canister was dated with a sharpie marker with a last changed date in January 2012.

Interview on 3/14/12 at 10:45 a.m. with certified registered nurse anesthetist (CRNA) C revealed:
*CRNAs who worked at Mallard Pointe surgery center were responsible for maintaining the anesthesia machine.
*He agreed the expired sodalime canisters should not have been used. He had no explanation why the expiration date had not been followed.



15036

5. Interview on 3/14/12 at 1:35 p.m. with the director of the material management department (MMD) revealed:
*Inventory of medical supplies in the MMD was done each year in January and June.
*Prior to inventory week the staff checked for outdated supplies 30 days, 60 days, and 90 days in advance.
*The last time MMD inventory week had occurred had been in January 2012.

Observation on 3/14/12 at 11:25 a.m. in the MMD revealed the following outdated supplies:
*One box of Bard safety universal introducer kits expired October 2011.
*One-half box of Bard access systems expired January 2012.
*One Site Right needle guide kit expired January 2012.
*Three 22 gauge spinal needles expired January 2012.
*One box of 3M remover lotion expired February 2012.

Review of the provider's MMD inventory checklist/policy revealed the following was to have occurred prior to the biannual inventory week:
*At 30 days cleaning and organizing was completed in the department.
*At 60 days the staff reviewed all returns, backorders, on-hand inventory, and checked the department for outdates.
*At 90 days the staff reviewed all returns, backorders, and on-hand inventory and made adjustments as needed.

Based on observation, interview, label review, and policy review, the provider failed to:
*Follow manufacturer's instructions for the testing and rinsing of Metricide OPA Plus high level disinfectant in the urology clinic.
*Maintain one of two procedure rooms (A) in the urology clinic in a sanitary manner.
*Store supplies in a manner to protect them from contamination in one of two procedure rooms (A) in the urology clinic.
*Ensure two of two physicians (D and E) in operating room one, and one of one physician (G) in the cardiac catheter procedure room completed proper hand hygiene prior to leaving those areas after the completion of their procedures.
*Ensure a policy was established for staff attire in one of one cardiac catheter procedure room.
*Ensure the rehabilitation clinic monitored temperatures and performed cleaning for one of one hydrocollator.
Findings include:

1. Observation and interview on 3/13/12 at 1:40 p.m. with registered nurse first assist (RNFA) A in procedure room A revealed:
*The urology clinic had been open for about two years.
*The procedure room was used to perform cystoscopy cases. The provider would perform between five to thirteen cases per day on Mondays, Wednesdays, and Thursdays.
*The procedure room had only one two compartment sink and no other hand sink. The cystoscopes were cleaned in one compartment of the two compartment sink of the procedure room. A board had been placed over the second compartment of the sink and a tub of Metricide OPA Plus had been placed on the board. The Metricide OPA Plus was used to high level disinfect the cystoscopes.
*The procedure room was equipped with an automatic scope processor, but it had been put out of order due to improper water supply. While the automatic scope processor was out of order the cystoscopes were being cleaned and disinfected manually.
*The Metricide OPA Plus was tested daily when procedures were performed and was not tested each time a cystoscope was high level disinfected.
*After the scopes were high level disinfected they would be moved to a single tub of sterile rinse water. The scopes would be rinsed thoroughly in the rinse water. Scopes were never rinsed in more than one tub of water.
*He was not aware the Metricide OPA Plus solution should have been tested each time it was used.
*He was not aware the scopes should have been rinsed in three separate large volumes of water after being placed in Metricide OPA Plus.

Review of the label for Metricide OPA Plus revealed:
*"The ortho-phthalaldehyde concentration of Metricide OPA Plus solution during its use-life must be verified by the Metricide OPA Plus Test strips prior to each use, to determine that the MRC (minimum required concentration) of 0.3% is present."
*"Following removal from Metricide OPA Plus Solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume (e.g., 9 liters) of water. Use sterile water unless potable water is acceptable.
-Keep the device totally immersed for a minimum of 1 minute in duration, unless a longer time is specified by the reusable device manufacturer.
-Manually flush all lumens with large volumes (not less than 100 ml) of rinse water unless otherwise noted by the device manufacturer.
-Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Do not reuse the water for rinsing or any other purpose.
-Repeat the procedure TWO (2) additional times, for a total of THREE (3) RINSES, with large volumes of fresh water, at least 9 liters each rinse, to remove Metricide OPA Plus Solution residues. Residues may cause serious side effects. SEE WARNINGS. THREE (3) SEPARATE, LARGE VOLUME WATER IMMERSION RINSES ARE REQUIRED. THE VOLUME OF WATER USED IN EACH RINSE CYCLE SHOULD BE AT LEAST 9 LITERS."

Interview on 3/14/12 at 11:50 a.m. with the quality risk manager revealed she agreed the manufacture's label for Metricide OPA Plus should have been followed.

2. Observation and interview on 3/13/12 at 1:40: p.m. with RNFA A in procedure room A revealed:
*The procedure room was used for performing cystoscopy and was also the place where the contaminated cystoscopes were cleaned (photo 1 and 2).
*After a procedure was performed the remaining sterile water used during the procedure would be moved to the two compartment sink and flushed through the cystoscope.
*While the sterile water was flushing the scope RNFA A would clean the bed and surrounding area with a disinfectant and would prepare it for another procedure. The bed and surrounding area would be approximately four to ten feet away from the sink and rinse water where the scopes were cleaned.
*After he was done cleaning the bed and surrounding area he would go back to the two compartment sink and finish cleaning the cystoscope by flushing, scrubbing, rinsing, high level disinfection, clean water rinsing, and forced air drying.
*When he was done cleaning the scope the procedure room would be ready for another patient.
*He agreed cleaning the contaminated scopes should not have happened in a procedure room. There was no soiled utility room to clean and process the cystoscopes.

Interview on 3/13/12 at 2:27 p.m. with clinic manager B revealed:
*She had been with the provider for a year and a half. The procedure room had been set-up and was in place before she had started.
*She understood this surveyor's concern with infection control and agreed scopes should not have been cleaned in the procedure room.

Interview on 3/14/12 at 11:50 a.m. with the quality risk manager revealed she agreed scopes should not have been cleaned and disinfected in a procedure room.

Review of the Association of periOperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices, 2010 Edition, Denver, CO, page 413, revealed:
*"Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed.
*Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross-contamination.
*The decontamination area should be physically separated from clean patient care areas and include a door. This area should contain, but not limited to,
-sinks to manually clean flexible endoscopes,
-hand-washing facilities,
-eyewash stations,
-automated equipment consistent with the types of flexible endoscopes to be decontaminated,
-adaptors and accessories to connect the flexible endoscopes with cleaning equipment and utilities,
-leak testing equipment,
-low-pressure air,
-closed storage facilities, and
-proper ventilation."
*"The decontamination area should be supplied at a minimum with
-enzymatic detergent,
-soft-bristle brushes,
-cleaning cloths,
-alcohol, and
-personal protective equipment (PPE)."

3. Observation and interview on 3/13/12 at 1:40 p.m. with RNFA A in procedure room A revealed:
*The procedure room was used for performing cystoscopy and was also the place where the contaminated cystoscopes were cleaned.
* An unprotected wire rack used for storing many patient care supplies was next to the procedure table and the area where scopes were cleaned, disinfected, and rinsed (photo 1 and 2).
*The supplies were stored there, so the physician had access to anything he would need while performing procedures.
*He agreed the clean supplies should not have been stored unprotected in an area where procedures were performed and cystoscopes were cleaned.

Interview on 3/13/12 at 2:27 p.m. with clinic manager B revealed she agreed the clean supplies should not have been stored in an area where they could have become contaminated.

Interview on 3/14/12 at 11:50 a.m. with the quality risk manager revealed she agreed clean supplies should not have been stored in an area where they could have become contaminated.



26691

4. Observations on 3/13/12 from 9:15 a.m. through 9:45 a.m. of patient 23's surgical procedure in op

Based on observation, policy review, and interview, the provider failed to ensure outdated and otherwise unusable medications were not available for patient use in:
*Two of eight observed emergency department treatment rooms (1 and 5) where opened irrigation solutions were stored.
*Six of seven observed areas (pharmacy, emergency room, obstetrics area, operating room one, same-day surgery, and radiology) where opened multiple-dose vials were stored.
Findings include:

1. Observation on 3/13/12 at 9:30 a.m. of emergency department treatment rooms 1 and 5 revealed each had an opened pour bottle of normal saline irrigation solution. The bottles were not marked with a date when they were opened.

Interview at the above time with the emergency department supervisor revealed it was her understanding the above bottles should have been:
*Marked with the date they had been opened.
*Discarded twenty-four hours after they had been first opened.

Review of the manufacturer's product insert for irrigation solutions revised May 2009 revealed:
*The irrigation solution contained no bacteriostat, antimicrobial agent, or added buffer and was intended only for use as single-dose or short procedure irrigation.
*When smaller volumes were required the unused portion should have been discarded.
*The irrigation solution should not have been administered unless the solution was clear, the seal was intact, and the container was undamaged.

2. Observation on 3/13/12 at 9:45 a.m. of the emergency department laceration cart revealed:
*Six opened lidocaine injection multiple-dose vials not marked with a date when opened.
*One opened bupivacaine injection multiple-dose vial not marked with a date when opened.

3. Observation on 3/13/12 at 1:30 p.m. of the pharmacy refrigerator revealed three opened multiple-dose vials of lorazepam injection and not marked with a date when opened.

Interview with the director of pharmacy at the above time revealed:
*The above vials had been in use on patient areas and had been returned to the pharmacy.
*It was his understanding the vials could have been used until they reached the manufacturer's assigned expiration date even though they had been opened.
*He did not have any specific information from the manufacturer of the lorazepam vials stating how long they could have remained in use after they had been opened.

4. Observation on 3/13/12 at 2:00 p.m. of a medication cabinet in the obstetrics area revealed one opened multiple-dose vial of betamethasone injection not marked with a date when opened.

Review of the manufacturer's package insert for betamethasone injection dated December 2009 revealed it did not have any directions for storage of a multiple-dose vial after it had been opened.



26691

5. Observation on 3/13/12 at 1:55 p.m. of one of two same-day surgery rooms revealed one opened ten milliliter bottle of lidocaine injection not marked with a date when opened.

Interview at that time with the surgery supervisor confirmed that finding. She further revealed all multi-dose vials should have been labeled with the open date. She was unsure how long that bottle of lidocaine had been opened.



11933

6. Observation on 3/14/12 at 2:30 p.m. of the locked storage cabinet in radiology #1 revealed a 30 milliliter vial of bupivacaine multiple-dose medication had been opened and not dated.

Interview at that time with a radiology technician confirmed the vial was opened and had not been dated. He further confirmed he did not know when the vial had been opened. He thought they usually discarded them after each patient.

Surveyor 20880
7. Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations, effective 6/1/08, revealed the beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives was twenty-eight days, unless otherwise specified by the manufacturer.

8. Review of the provider's pharmacy policy for infection control revised January 2008 revealed multiple-dose vials:
*Could have been used until the stated expiration date unless:
- It was thought they were contaminated. Then the vial should have been discarded immediately.
- The manufacturer had a different stated expiration procedure to establish a beyond-use date.
*Should have been stored after opening according to directions on the manufacturer's package insert.