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Based on interview and meeting minutes review, the provider failed to ensure all aspects of the hospital operations (physician services, telemedicine, contracted services, and credentialing) were part of the comprehensive quality assurance performance improvement (QAPI) program. Findings include:

1. Interview on 6/4/14 at 2:00 p.m. with the chief nursing officer and review of the provider's 2014 quality coordinating committee (QAPI) monitoring schedule revealed:
*The quality coordinating committee reviewed their QAPI program.
*The 2014 schedule revealed which areas of the hospital operation that would have been reviewed each month.
*The department or area of review scheduled for a particular month was responsible for reviewing the data or issue they were monitoring and for reporting any updates.
*They had utilized telemedicine for about two years.
*Telemedicine or credentialing had not been reviewed.
*They had not reviewed any of the contracted services.
*The staff accountant had oversight of contracted services.

Review of the provider's list of contracted services revealed they had a three page list of contracted services.

Interview on 6/5/14 at 7:45 a.m. with the staff accountant revealed she had not been involved in the QAPI program. She was unaware of any review of contracted services having been part of that QI program.

Interview on 6/5/14 at 10:00 a.m. with recorder J and review of the 2013 and 2014 Quality Coordinating Council minutes revealed:
*They had met monthly.
*They had not reviewed the following aspects of the hospital:
*Credentialing.
*Contracted services.
*Physician services.
*Telemedicine.

Review of the provider's 2014 QI plan revealed the program objectives included:
*"To increase the probability of desired outcomes, including patient/customer and physician satisfaction by assessing and improving those governance, managerial, clinical, and support processes that most affect those outcomes.
*To ensure the components of the QI program are ongoing by defining a comprehensive organized program wherein all the QA activities interface.
*To systematically evaluate patient care practices and professional performance of [name of hospital].
*To establish priorities for the investigation and resolution of issues and problems by focusing on those with the greatest potential impact for improving patient care outcomes, patient satisfaction and patient safety.
*To coordinate Medical Staff QI activities with those of the organization's and integrate efforts whenever appropriate. Specifically, Medical Staff QI activities relative to regulatory review, infection control, risk management, and patient safety will be carried out collaboratively."

Based on record review, interview, and policy review, the provider failed to ensure one of five sampled intensive care unit (ICU) patients (26) who had general anesthesia had a consent for an epidural procedure post-surgery. Findings include:

1. Review of patient 26's 5/31/14 anesthesia record revealed she:
*Had a surgical procedure on 5/31/14 for a small bowel obstruction.
*Was in surgery from 1:44 p.m. to 2:04 p.m.
*Had received a general anesthetic (a combination of medications inhaled or received through a needle in a vein to cause an unconscious state) for the surgical procedure.

Continued review of patient 26's 5/31/14 anesthesia record revealed documentation at 5:53 p.m. "To ICU. Will place epidural (catheter placed into spinal area for injection of medication) for pain relief. Epidural put in post-operatively (op) for pain control."

Review of patient 26's 5/31/14 at 7:26 p.m. acute anesthesia procedure by the certified registered nurse anesthetist K revealed:
*The procedure done was "continuous epidural for post-operative pain relief."
*"The plan, risks, complications, and alternatives were discussed postoperatively with patient and spouse and all questions answered. The patient agreed to the epidural at this time."

Interview on 6/4/14 at 10:10 a.m. with the director of the emergency room/ICU G regarding patient 26 revealed:
*The consent for the epidural should have been obtained prior to her surgical procedure.
*Since the patient was recovering from general anesthesia her spouse should have given permission for the epidural.
*There was no written informed consent by the patient or her spouse.

Review of Patricia A. Potter and Anne Griffin Perry, Fundamentals of Nursing, 8 th ED., St. Louis, MO, pg. 302, revealed:
*General anesthesia causes amnesia (forgetfulness).
*As a person awakens from anesthesia they might experience confusion, disorientation, or difficulty thinking clearly. It might take some time before the effects of general anesthesia wears off.
*The patient or his/her representative needs to sign a separate special consent or treatment form before the performance of a specialized procedure.
*The consent must be obtained and witnessed when the patient is not under the influence of medications.
*If a patient is unconscious a consent must be obtained from a person legally authorized to give it on the patient's behalf.

Review of the provider's October 2013 Patient Consents Authorizations and Refusal policy revealed "The signature from the patient or other authorized individual should have been obtained before any pre-operative or other medication is given. These medications might affect the decision-making ability of the patient."

Based on observation, interview, record review, and policy review, the provider failed to store medications at the appropriate temperatures in one of one emergency room (ER) blanket warmer according to manufacturer's recommendations for the following:
*Four of four vials of Mannitol [administered intravenous (IV) for intracranial (in the brain) pressure after a head injury] was stored and monitored at the correct temperature.
*Multiple IV bags of Sodium Chloride [Normal Saline (NS)] and Lactated Ringers (LR) were stored and monitored at the appropriate temperatures.
*Two of two nitroglycerin [(NTG) (used for chest pain during heart attacks) 1/150 grain bottles given sublingually (under the tongue)] were stored at room temperature.
Findings include:

1. Observation on 6/3/14 at 9:30 a.m. in the ER revealed:
*Four vials of Mannitol 25 percent (%) solution. There was no date on the vials as to when they had been placed in the warmer. The label on the Mannitol stated the maximum temperature for the medication was 98.6 Fahrenheit (F).
*Multiple IV solution bags of LR and NS were in the blanket warmer. There were no dates on the IV solution as to when the bags had been placed in the warmer.
*The temperature in the blanket warmer was 110 degrees F.
*There were two bottles of NTG 1/150 grain placed in the refrigerator. The instructions on the bottle stated to store the medication at room temperature (68-77 degrees F). The refrigerator temperature was 38 degrees F.

Interview on 6/4/14 at 9:45 a.m. with pharmacist K regarding the above findings revealed:
*The Mannitol and the IV solutions of LR and NS were not stored at the appropriate temperatures.
*There were no policies in reference to the warming of the Mannitol or the IV fluids.

Review of the manufacturer's insert for the Mannitol revealed:
*Exposure to temperatures above 77 degrees F. during transport and storage would lead to minor losses in moisture content. Higher temperatures would lead to greater losses.
*Store at 68 to 77 degrees F.

Review of the manufacturer's insert for the Sodium Chloride solution revealed:
*Exposure of pharmaceutical products to heat should have been minimized.
*Avoid excessive heat.
*It was recommended the product should have been stored at room temperature (77 degrees F.); brief exposure up to 104 degrees F. would not adversely affect the product.

Review of the manufacturer's insert for the Lactated Ringers solution revealed:
*Exposure of pharmaceutical products to heat should have been minimized.
*Avoid excessive heat.
*It was recommended the product should have been stored at room temperature 77 degrees F.

Review of the provider's April 2014 Drug Procurement, Storage, Security, Handling, and Inventory Control policy revealed:
*ER warmer the temperature should have been kept between 108 and 110 degrees F.
*Mannitol should have been replaced on the 1st and the 15th of the month.
*Normal Saline should have been replaced on the 1st and the 15th of the month. Every Monday the LR should have been taken from ER.
*An orange sticker should have been placed on each IV bag with the current date.

Upon request from pharmacist K there was no policy provided for the storage of the NTG tablets.

Based on interview and meeting minutes review, the provider failed to ensure required committee members (physicians) participated in the utilization review (UR) committee meetings. Findings include:

1. Interview on 6/4/14 at 2:30 p.m. with case manager/registered nurse E revealed:
*She had participated in the UR committee meetings.
*The coordinator of the UR meetings had recently resigned.
*The UR meetings had not occurred for two months due to the transition with staff.
*The usual participants included the chief financial officer, case managers, health information managers, the director of quality improvement, chief nursing officer, business office manager, and the admissions coordinator.
*They had not had physicians at the meetings for quite some time.

Interview on 6/5/14 at 8:00 a.m. with the chief financial officer revealed:
*He was a participant in the UR meetings.
*He confirmed there had not been physician participation at the UR meetings.

Random review of UR/Case Management meeting minutes for 2014 revealed:
*They had not met for two months.
*They had not had physician participation in the committee meetings.

Review of the provider's November 2011 UR policy revealed:
*"The UR Team is responsible for certification of eligible Medicare recipients for swing bed and Transitional Care Unit.
*Certification is based on Medicare/Medicaid Guidelines for Skilled Level of Care and is subject to restrictions and laws set by the State of South Dakota.
*The UR Committee may involve Case Management, QI/RM (quality improvement/risk management) coordinator, Health Information Management, Social Services, Rehabilitative Services, external Physician advisers or physician advisor, designee, transitional care unit (TCU) clinical reimbursement specialist, Medical Staff, Administration, and other members as deemed necessary."

Based on observation, label review, testing, interview, and policy review, the provider failed to maintain and ensure the cleanliness, and/or safety, and/or quality of the following:
*Three of three in-use wet task buckets in the laundry had not been labeled to identify the product inside and avoid misuse.
*Three of three in-use hand sanitizers were outdated.
*The inside of one of one mangle (machine for pressing fabrics) in the laundry room had hanging layers of dust in it.
*The only soiled linen sorting table had gouged, chipped, damaged wood and laminate.
*Chemicals and cleaners were found intermingled with patient care items on one of one operating floor in the outpatient surgery unit (OSU).
*Chemicals and cleaners were stored in two of two patient use bathrooms in the post-operative area of OSU.
*The only Mist O Gen Tube Accessory Dryer in the respiratory therapy department had last been tested in 1984.
Findings include:

1. Observation on 6/4/14 from 8:30 a.m. to 10:00 a.m. of the OSU revealed:
Chemicals and cleaners were stored intermingled with hygienic paper goods (toilet paper and paper towels) on the housekeeping cart and in the housekeeping closet in the post-operative area. Chemicals and cleaners were stored in both patient restrooms. An open bucket of what appeared to be cleaner was in one restroom. Interview with the director of patient services at the time of the observation confirmed those findings. She stated she was not aware of the housekeeping procedure for OSU but agreed chemicals and cleaners should not have been stored with hygienic paper goods. She agreed chemicals and cleaners should not have been stored in the two patient use bathrooms. She confirmed the OSU could have patients with impaired reasoning skills who had access to those cleaners and chemicals.

Review of the provider's March 2013 safety policy revealed "8. Chemicals. c) Chemicals are not left where a patient or child could get a hold of them."

2. Observation on 6/4/14 from 10:50 a.m. to 11:20 a.m. of the laundry area revealed:
*Three in-use wet task buckets were not labeled to identify the product and avoid mis-use. Interview with the laundry supervisor at the time of the observations confirmed those findings. She stated she was not aware the buckets needed a label to identify the contents.
*Three in-use hand sanitizers had expired in January 2014. Interview with the laundry supervisor at the time of the observations confirmed those findings. She stated she was not aware the hand sanitizers had an expiration date.
*The inside of the mangle had layers of dust and debris that laid on the equipment. The dust and debris also hung like vines inside the unit. Interview with the laundry supervisor and the director of plant operations at the time of the observations confirmed those findings. The laundry supervisor stated she had the equipment in the laundry room on a weekly cleaning schedule. She stated it was hard to reach inside the mangle to get it clean.
*The soiled linen sorting table had chipped and broken laminate. The wood was gouged and scraped. The chipped and broken laminate was not cleanable, was sharp to the touch, and was a safety concern due to the sharp edges. The gouged and scraped wood was not cleanable.

Review of the linen services department safety policy dated November 2011 revealed "III. Equipment Safety Precautions. C. All equipment is cleaned on a rotating basis by Linen Services personnel with an approved germicide. IV. Chemical Safety Precautions. B. All containers are labeled properly as to the contents."

3. Observation on 6/4/14 at 2:10 p.m. revealed a Mist O Gen Tube Accessory Dryer in-use in the respiratory therapy department. A bio-medical inspection sticker could not be located on the machine. An old green safety sticker indicated the machine had last been checked in 1984. Interview with the director of plant operations confirmed those findings. He stated he had never seen that piece of equipment.

Interview on 6/4/14 at 2:30 p.m. with the bio-medical supervisor revealed he was not aware that piece of equipment was in service in the respiratory department. He stated he had never seen that type of machine and would need to contact the manufacturer for guidelines or remove it from service.

Based on observation, record review, interview, and policy review, the provider failed to maintain the temperature and humidity levels in four of four operating rooms (OR) within safe parameters. Findings include:

1. Observation on 6/3/14 at 3:00 p.m. revealed thermometers and hygrometers (device to check humidity) were in-use in the four ORs. Interview with the OR nurse manager at the time of the observations revealed a daily log was kept of the temperature and humidity for each OR.

Review of the OR temperature and humidity log for April, May, and June 2014 revealed:
*The reference used for the OR temperature and humidity logs was Berry and Kohn Operating Room Technique, 2001. The safe parameters listed were "Room Temp: 68-75 and Room Humidity: 45-60%."
*Eighty-one of eighty-three temperature and humidity readings recorded for April were out of range.
*Seventy-four of eighty-three temperature readings and fifty-nine of eighty-three humidity readings recorded for May were out of range.
*Eight of eight temperature and humidity readings recorded for June were out of range.

Interview on 6/3/14 with the OR nurse manager confirmed most of the readings that were recorded on the log sheets were out of range. She stated the nurses were to inform her or call plant operations if the temperature or humidity was out of the safe parameters. Review of the logs revealed the plant operations had only been notified one time in three months. The OR nurse manager revealed she should have reviewed the monthly logs to ensure the levels were maintained. She could not confirm if the temperature readings were recorded in Fahrenheit or centigrade.

Review of the provider's infection control policy dated February 2008 revealed "K. Engineering. 6. Relative humidity is maintained between 50-60%. 7. Room temperature is maintained at 62-74 F."

A. Based on observation, interview, policy review, and manufacturer's processing instructions, revealed the provider failed to ensure:
*The high-level disinfectant was tested prior to each use when disinfecting multi-use breathing tubes used during patient respiratory function testing for one of one respiratory care department.
*The manufacturer's discard directions had not been followed for the use of Cidex OPA high-level disinfectant in one of one respiratory care department.
*In accordance with the manufacturer's reprocessing instructions a tracking system had been implemented for the number of times multi-use breathing tubes were high-level disinfected in one of one respiratory care department.
Findings include:

1. Observation on 6/4/14 from 1:30 p.m. to 3:30 p.m. in the respiratory therapy department soiled work room revealed:
*An in-use tube accessory dryer with ripped and dirty plastic curtains and an undated piece of filter on top of the unit.
*A blue tub with the lid ajar labeled "Cidex."
*A face mask, gloves, and a two compartment sink.

Observation and interview on 6/4/14 at 2:40 p.m. with respiratory therapist (RT) L confirmed the above findings. He stated respiratory therapy staff changed the Cidex every twenty-eight days but did not test the solution daily.

Observation and interview on 6/4/14 at 2:55 p.m. with RT M confirmed:
*They had not followed the provider's policy for use of Cidex.
*They had not followed the routine maintenance for the tube accessory dryer.
*At one time they had a routine to clean and/or change the curtains around the dryer and replace the filter on top monthly.
*The curtains had not been changed or cleaned in a long time.
*The filter had not been dated, so she could not determine the last time it was changed.
*Two mouthpieces were inside the tube accessory dryer.
*The mouthpieces had been disinfected with Cidex, rinsed, and then placed inside the tube dryer.
*They had no policy or procedure in place to follow the mouthpiece manufacturer's cleaning and disinfecting guidelines.
*They would take the dried mouthpieces and place them in plastic bags and place them back into use in the examination (exam) room.

Review of the piles of plastic bags with mouthpieces in a tote in the cabinet of the exam room revealed:
*There was no date on the bag when the mouthpieces had been disinfected.
*There was no number on the bag to indicate how many times each mouthpiece had been disinfected.
*Several of the bags with mouthpieces had not been zipped shut and were open.
*Interview with RT M at the time of the observation revealed some of the mouthpieces would not fit tightly on the breath analyzer. She stated another RT would use duct tape to hold the breathing piece in place for the patient. RT M was aware that was not a proper procedure.

Review of the manufacturer's guidelines for the mouthpieces revealed:
*"1. Discard the mouthpiece after single use.
*2. Use a pulmonary function barrier filter.
*3. Or, clean and disinfect the mouthpiece between uses. The mouthpiece may be cleaned and disinfected a maximum of 20 times."
*4."Warning: Cleaning agents such as Cidex OPA may dramatically discolor and potentially shrink the mouthpiece. Failing to comply with these cleaning procedures or exceeding the recommended cleaning time will degrade product integrity or may reduce the accuracy of tests performed."

Review of the provider's Use of CidexPlus OPA Solution policy dated March 2013 revealed:
*"1. B. use OPA solution in a well-ventilated area and in closed containers with tight fitting lids. C. Personnel will wear appropriate Personal Protective Equipment (PPE) designed to protect skin, nose, mouth, eyes, and clothing as per OSHA standard.
*II. A. 5. Document date solution was poured from the original container and the date its reuse life ends (not to exceed 14 days).
*II. B. 2. Keep lids/covers (snug fitting, air tight) on soaking containers closed. 5. Solution expires after 14 days and must be discarded regardless of volume remaining. C.2. Test solution prior to each use with the recommended test strip.
*IV. D. Personnel attend in-service safety programs designed specifically for those performing disinfection with glutaraldehyde (solution to disinfect items). E. 6. Competencies will be completed yearly for staff using OPA."

Review of the provider's Respiratory Care policy dated January 2012 revealed "V. B. 3. a. Cidex solution is changed every 28 days."

B. Based on observation, interview, record review, policy review, and reference review, the provider failed to ensure:
*Supplies and equipment were maintained in a safe and sanitary manner to prevent potential cross-contamination and spread of communicable diseases in four of four patient care areas (operating room [OR], procedure room, preoperative patient area, and post-anesthesia care unit).
*Single use oxygen connecting tubing was not reused for patients in one of one outpatient surgical unit (OSU).
*Staff wore protective personal equipment when cleaning contaminated colonoscopy scopes in one of one operating room soiled work room.
*A soap dispenser had been installed in the medical unit clean supply room.
Findings include:

1.a. Random observation on 6/3/14 from 1:30 p.m. to 3:00 p.m. revealed four cardboard boxes on the floor outside the OR suite supply room door. The cardboard boxes were the outside shipping containers for the items inside the box. Interview with the director of patient services at the time of the observation confirmed the finding. She stated she was aware outside shipping containers should not be brought into a clean area of the OR suite. She stated there was no policy or procedure (P/P) regarding clean supplies in the OR suite.

Review of the Association of periOperative Registered Nurses (AORN) Standards and Recommended Practices, 2014 Edition, Denver, CO, page 120, revealed: "Supplies and equipment should be removed from external shipping containers and web-edged or corrugated cardboard boxes in the unrestricted area before transfer into the surgical suite."

b. In the OR procedure room an endoscope cabinet did not have ventilation vents and was a closed cabinet. The blue eggcrate cushion on the bottom of the endoscope cabinet was discolored and stained. The blue cushion had spots of brown and tan directly under the hanging scopes. Interview with the director of patient services at the time of the observation confirmed the finding. She was aware the cabinet was not designed to store and hang clean scopes. She was unaware how often the cushion was changed, but she confirmed it appeared to be dirty. She was not able to provide a policy regarding the construction or cleanliness of the scope cabinet.

Review of the 2014 AORN Standards and Recommended Practices revealed: "Flexible endoscopes should be stored in a closed cabinet with venting that allows air circulation around the flexible scopes with internal surfaces composed of cleanable materials."

c. Six scopes were hung in the cabinet in the endoscopy procedure room of the OR suite. Interview with the director of patient operations at the time of the observation revealed each scope had a serial number. The scopes were logged on a check sheet each time they were processed. She was not aware if the scopes were reprocessed after five to seven days of non-use.

Review of the scope checklist revealed six different scopes had been processed from 3/31/14 to 6/5/14. Six of six scopes had gone over the five to seven day guideline throughout the months of April, May, and the first four days of June for reprocessing. Further review of the scope checklist revealed the following: "5/16/14; Colon; A425; no entry under 'VO #'; initials 'SS'; and a handwritten note that stated 'Decontam [decontamination] wouldn't work.' No other comments were noted to confirm scope A425 had been reprocessed to ensure disinfection was completed.

d. Observation on 6/4/14 from 1:30 p.m. to 3:30 p.m. in the soiled utility room of the pre-op area revealed clean crutches were hung on the wall and clean toilet seat covers were stored under the sink drain line. Interview with the director of plant operations at the time of the observation confirmed the findings. He was not aware why the clean crutches and the clean toilet seat covers had been stored in a soiled utility room. Further interview with an unidentified nurse at the time of the observation also confirmed the finding. She was aware the items should not be stored in a soiled utility room. She stated they were short on space and that was the only area they could use for storage.




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2. Observation on 6/4/14 at 9:05 a.m. in the outpatient surgery unit with patient 45 during her colonoscopy [a procedure to visualize a person's colon (bowels)] revealed:
*The patient was connected to a seven foot oxygen tubing. There was an oxygen extension tubing (to make the oxygen tubing longer to reach the oxygen meter on the wall) attached to the patient's oxygen tubing.
*After the procedure was completed the patient's oxygen tubing was disconnected from the oxygen extension tubing. The oxygen extension tubing was wrapped around the oxygen flow meter adapter/connector by registered nurse (RN) F.

Interview on 6/4/14 at 9:30 a.m. with RN F regarding the oxygen extension tubing revealed:
*The tubing was changed weekly.
*Multiple patients would use the oxygen extension tubing throughout the week.

Review of the package insert on the oxygen extension tubing with the operating room director revealed the tubing was for single patient use only.

Interview with the surgical services director immediately following the review of the oxygen extension tubing manufacturer's insert confirmed the tubing should have been changed with each patient use.

Review of the provider's January 2011 Infection Control policy revealed disposable equipment should have been discarded after single use.




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3. Observation on 6/3/14 at 9:15 a.m. of the medical surgical floor's clean supply room revealed a hand sink without a soap dispenser.



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4. Observation on 6/3/14 at 1:15 p.m. in the post-anesthesia care unit (PACU) of patient 6's care revealed RN N:
*Remove the too large blood pressure cuff from the patient's left arm and applied a smaller size blood pressure cuff.
*Had not disinfected the large blood pressure but placed it amongst other blood pressure cuffs stored on a shelf.
*Obtained alcohol pad, cotton ball, lancet, and a glucometer from a docking station at the nurses desk. RN N then:
-Placed all supplies on the bed sheets covering the patient.
-Obtained a fingerstick blood glucose.
-Had not disinfected the glucometer after use and returned it to the docking station at the nursing station.

Interview on 6/3/14 at 2:35 p.m. with the director of surgery revealed:
*RN N should have disinfected the blood pressure cuff after removing it from patient 6's arm. It should not have been returned to general storage for use on other patients.
*The glucometer should have been disinfected after each use to prevent potential cross-contamination to other patients.

Interview on 6/3/14 at 3:55 p.m. with RN N revealed:
*The blood pressure cuff for patient 6 was too large, she had removed it, and put on a smaller cuff.
*She had not disinfected the blood pressure cuff prior to storing it on the shelf with other clean blood pressure cuffs.
*She had called housekeeping and assumed they would clean the blood pressure cuff but was not sure they did.
*She had used the glucometer to obtain patient 6's fingerstick blood sugar and had not disinfected it prior to returning it to the docking station.
*She would have disinfected the glucometer before use on another patient.

Review of the provider's May 2011 Environmental Services policy, section f, daily recovery room cleaning revealed the daily cleaning duties had not included disinfecting patient care equipment and supplies.

5. Observation on 6/4/14 at 8:25 a.m. in the soiled decontamination room of surgical technician (ST) C cleaning an endoscope revealed:
*He removed his protective cover apron, carried the endoscope over to the Medivator, and proceeded to position the scope into the Medivator for high-level disinfection.
*He had difficulty positioning the scope within the Medivator.
*The contaminated scope touched his unprotected scrub uniform and his lower forearms.

Interview on 6/4/14 at 7:40 a.m. with the director of surgery revealed ST C should have worn the protective apron as long as he was working with the contaminated endoscope.

C. Based on observation, interview, and policy review, the provider failed to ensure after colonoscopy procedures leak testing was performed to assess integrity of the external and internal channels for two of two endoscopic colonoscopy scopes (flexible tube with camera attachment to view the lower intestines) prior to high-level disinfection. Findings include:

1. Observation and interview on 6/4/14 at 8:25 a.m. with ST C in the OR soiled work room revealed:
*He had not completed a leak test prior to cleaning the colonoscopy scope with an enzymatic cleaner.
*He should have completed a leak test by connecting a pressure gauge to the scope and applied pressure until the gauge read 190 pounds per square inch (psi). A decreased reading on the pressure gauge indicted the scope protective covering had a leak.
*He stated a leak test was performed to check for leaks in the colonoscopy scope outer covering.

Observation and interview on 6/4/14 at 12:10 p.m. with ST C in the OR soiled work room revealed he had completed leak testing using a pressure gauge. During the test ST C had not manipulated the control knobs to move the flexible tubing to check for potential leakage.

Interview on 6/5/14 at 9:30 a.m. with the director of surgery revealed ST C should have conducted leak testing with the pressure gauge and placed the scope in water to check for leaks.

Review of the provider's March 2013 Endoscopes-Use and Care policy revealed:
*"Endoscopes and related equipment should be inspected for integrity, function, and cleanliness at the following times:
-before use,
-during the procedure,
-immediately after decontamination, and
-before disinfection or sterilization."
*"Pre-use testing and proper use of endoscopes, endoscopic accessories, and related equipment minimize the risk for adverse patient outcomes."
*"Pressure (i.e., leak) tests should be performed on used fiber-optic endoscopes before they are immersed in cleaning solutions or water."
*The leak test should have been performed as follows:
-"Before submersing scope in the water attach the leak tester and do a dry test to identify any major leak problems.
-Submerse endoscope in warm water with the leak tester still under pressure and watch for bubbles while flexing the tip for at least 1 minute.
*If leak test fails, remove from water and dry outside of scope. Place in red biohazard bag and call Biomed."

Review of the Association of periOperative Registered Nurses (AORN), Perioperative Standards and Recommended Practices, 2014 Edition, Denver, CO., revealed:
*Page 531, "In the decontamination area and before cleaning, pressure (i.e., leak) tests should be performed on flexible endoscopes with leak testing capabilities.
*Leak tests determined if there are any openings in the external surfaces and internal channels that would permit fluid to enter the internal body of the endoscope.
*During leak testing, the flexible endoscope control knobs should be manipulated in all directions. Manipulating the flexible endoscope control knobs in all directions exposes the surfaces to the maximum extension, thereby revealing small perforations, if present."

Based on record review and interview, the provider failed to ensure the credentialing book was organized and updated with current privilege listings for all practitioners with surgical privileges at the facility. Findings include:

1. Review of the provider's privilege binder containing listing of all practitioners with surgical privileges revealed:
*The book was located in the post-anesthesia recovery area.
*The privilege list for the period 2012-2014 were located in the binder.
*The privilege lists for six practitioners that were no longer practicing at the facility.
*The privilege lists for three practitioners that were not known to the recovery room nurse or the director of surgery.

Interview on 6/3/14 at 3:04 p.m. in the post-anesthesia care unit (PACU) with the director of surgical services regarding the privileging binder revealed:
*The binder was disorganized, had privileges for staff no longer practicing at the facility, and practitioners they did not know. That made it difficult to locate any given practitioner's privilege in the binder.
*Current and expired privilege listing for the same surgeon was located in the binder but not in the same section of the binder. That made it difficult for staff to locate a current privilege list for any given practitioner.
*Practitioners went through the credentialing process every two years and a review of their privileges were completed at that time. Current listing of practitioners' privileges should have been available for staff use in the surgical suite.
*The practitioners' privilege listings were not computerized and this binder was the only source the surgical staff had available to review privilege listings.

Based on record review, interview, and policy review, the provider failed to ensure:
*Physician's orders were followed for ventilator changes for one of two sampled intensive care unit (ICU) patients (29) who was on a ventilator.
*Physician's orders were present for ventilator changes made for one of two sampled ICU patients (29) who was on a ventilator.
Findings include:

1. Review of patient 29's medical record revealed she was intubated (had placement of a flexible plastic tube into the windpipe to maintain an open airway) on the following dates:
*3/3/14 through 3/8/14.
*3/9/14 through 3/11/14.
*3/24/14 and then was transferred to another acute care hospital.

Review of patient 29's 3/3/14 at 3:10 p.m. physician's orders revealed:
*Ventilator settings assist control (AC) 20, volume control (vT) 400, positive end-expiratory pressure (PEEP) 5, and FiO2 (percent of hemoglobin bound with oxygen in the arteries) 1.0.
*Titrate FiO2 to keep spO2 (percent of oxygen in the blood) (88-90 percent (%).

Review of patient 29's physician's orders from 3/3/14 at 3:53 p.m. revealed "Increase PEEP to 10."

Review of patient 29's 3/3/14 continuous mechanical ventilation record from 2:15 p.m. through 6:00 p.m. revealed the following documentation by respiratory therapist (RT) H:
*3/3/14 at 2:15 p.m.
-AC 14.
-vT 470.
-PEEP 3.1.
-SpO2 90 %.
*3/3/14 at 4:15 p.m.
-SpO2 96 %.
*3/3/14 at 6:00 p.m.
-PEEP 11.
*SpO2 95 %.

Review of patient 29's 3/3/14 arterial blood gas (ABG) [measures levels of oxygen (PO2) and carbon dioxide (CO2) in a blood sample] revealed:
*3/3/14 at 2:52 p.m. PO2 level 118 (normal 83 to 100 millimeters of hemoglobin).
*3/3/14 at 5:39 p.m. PO2 122.

Interview on 6/4/14 at 3:35 p.m. with registered nurse H regarding patient 29 revealed:
*There had not been initial physician's orders for the ventilator settings at 2:15 p.m.
*The physician's orders for the range of SpO2 to be between 88-90% was not followed.
*The PO2 levels were high and indicative of respiratory acidosis (to much acid in the blood).

Review of patient 29's physician's orders from 3/9/14 at 6:50 p.m. revealed "Ventilator settings: PEEP 10."

Review of patient 29's 3/9/14 and 3/10/14 continuous mechanical ventilation record revealed documentation the PEEP was set at 10.

Review of patient 29's 3/24/14 physician's progress notes revealed:
*"I have already spoken to critical care on two occasions today, and they have recommended that we intubate should her respiratory status decline."
*"At this point she has declined appreciably. I will call anesthesia and will proceed with rapid sequence intubation."

Review of patient 29's medical record revealed no physician's orders for ventilator settings on 3/24/14.

Interview on 6/5/14 at 9:25 a.m. with registered RT I regarding patient 29 revealed:
*Some of the physicians left the ventilator settings orders open-ended and allowed the RTs to adjust the ventilators without precise orders.
*Some of the physicians would not give any ventilator setting orders. The settings were left up to the discretion of the RTs.
*He confirmed there were no initial orders for the ventilator settings on 3/3/14 at 2:15 p.m. and on 3/24/14.
*The physician's orders were not followed to keep the SpO2 at 88-90% on 3/3/14.
*Physician's orders were required for all ventilator setting changes.
*He had not followed the physician's orders for the PEEP setting of 10 on 3/9/14.
*RTs had not been trained to enter physicians' orders into the electronic medical record.
*Some of the physicians would give verbal orders for ventilator changes and not enter them into the electronic medical record.
*There were no written physician's orders to change the AC on 3/3/14 at 8:00 p.m.
*He confirmed physician's orders had not been carried out appropriately and was not properly documented in the electronic medical record.

Review of the provider's August 2012 Therapeutic and Diagnostic Order policy revealed "RT care staff will verify the orders are on the chart before any therapy is initiated."

Review of Patricia A. Potter and Anne Griffin Perry, Fundamentals of Nursing, 6th ED., St. Louis, MO, pg 419, revealed:
*"The physician is responsible for directing medical treatment."
*"The physician should write all orders. If a verbal order is necessary, it should be written and signed by the physician as soon as possible."

Based on record review, interview, and policy review, the provider failed to ensure physician's orders for ventilator changes for one of two sampled patients (29) in the intensive care unit were documented. Findings include:

1. Review of patient 29's medical record revealed incomplete documentation for the ventilator changes on:
*3/3/14 through 3/8/14.
*3/9/14 through 3/11/14.
*3/24/14 when she was transferred to another acute care hospital.

Refer to A1163.

A. Based on observation, interview, policy review, and manufacturer's processing instructions, revealed the provider failed to ensure:
*The high-level disinfectant was tested prior to each use when disinfecting multi-use breathing tubes used during patient respiratory function testing for one of one respiratory care department.
*The manufacturer's discard directions had not been followed for the use of Cidex OPA high-level disinfectant in one of one respiratory care department.
*In accordance with the manufacturer's reprocessing instructions a tracking system had been implemented for the number of times multi-use breathing tubes were high-level disinfected in one of one respiratory care department.
Findings include:

1. Observation on 6/4/14 from 1:30 p.m. to 3:30 p.m. in the respiratory therapy department soiled work room revealed:
*An in-use tube accessory dryer with ripped and dirty plastic curtains and an undated piece of filter on top of the unit.
*A blue tub with the lid ajar labeled "Cidex."
*A face mask, gloves, and a two compartment sink.

Observation and interview on 6/4/14 at 2:40 p.m. with respiratory therapist (RT) L confirmed the above findings. He stated respiratory therapy staff changed the Cidex every twenty-eight days but did not test the solution daily.

Observation and interview on 6/4/14 at 2:55 p.m. with RT M confirmed:
*They had not followed the provider's policy for use of Cidex.
*They had not followed the routine maintenance for the tube accessory dryer.
*At one time they had a routine to clean and/or change the curtains around the dryer and replace the filter on top monthly.
*The curtains had not been changed or cleaned in a long time.
*The filter had not been dated, so she could not determine the last time it was changed.
*Two mouthpieces were inside the tube accessory dryer.
*The mouthpieces had been disinfected with Cidex, rinsed, and then placed inside the tube dryer.
*They had no policy or procedure in place to follow the mouthpiece manufacturer's cleaning and disinfecting guidelines.
*They would take the dried mouthpieces and place them in plastic bags and place them back into use in the examination (exam) room.

Review of the piles of plastic bags with mouthpieces in a tote in the cabinet of the exam room revealed:
*There was no date on the bag when the mouthpieces had been disinfected.
*There was no number on the bag to indicate how many times each mouthpiece had been disinfected.
*Several of the bags with mouthpieces had not been zipped shut and were open.
*Interview with RT M at the time of the observation revealed some of the mouthpieces would not fit tightly on the breath analyzer. She stated another RT would use duct tape to hold the breathing piece in place for the patient. RT M was aware that was not a proper procedure.

Review of the manufacturer's guidelines for the mouthpieces revealed:
*"1. Discard the mouthpiece after single use.
*2. Use a pulmonary function barrier filter.
*3. Or, clean and disinfect the mouthpiece between uses. The mouthpiece may be cleaned and disinfected a maximum of 20 times."
*4."Warning: Cleaning agents such as Cidex OPA may dramatically discolor and potentially shrink the mouthpiece. Failing to comply with these cleaning procedures or exceeding the recommended cleaning time will degrade product integrity or may reduce the accuracy of tests performed."

Review of the provider's Use of CidexPlus OPA Solution policy dated March 2013 revealed:
*"1. B. use OPA solution in a well-ventilated area and in closed containers with tight fitting lids. C. Personnel will wear appropriate Personal Protective Equipment (PPE) designed to protect skin, nose, mouth, eyes, and clothing as per OSHA standard.
*II. A. 5. Document date solution was poured from the original container and the date its reuse life ends (not to exceed 14 days).
*II. B. 2. Keep lids/covers (snug fitting, air tight) on soaking containers closed. 5. Solution expires after 14 days and must be discarded regardless of volume remaining. C.2. Test solution prior to each use with the recommended test strip.
*IV. D. Personnel attend in-service safety programs designed specifically for those performing disinfection with glutaraldehyde (solution to disinfect items). E. 6. Competencies will be completed yearly for staff using OPA."

Review of the provider's Respiratory Care policy dated January 2012 revealed "V. B. 3. a. Cidex solution is changed every 28 days."

B. Based on observation, interview, record review, policy review, and reference review, the provider failed to ensure:
*Supplies and equipment were maintained in a safe and sanitary manner to prevent potential cross-contamination and spread of communicable diseases in four of four patient care areas (operating room [OR], procedure room, preoperative patient area, and post-anesthesia care unit).
*Single use oxygen connecting tubing was not reused for patients in one of one outpatient surgical unit (OSU).
*Staff wore protective personal equipment when cleaning contaminated colonoscopy scopes in one of one operating room soiled work room.
*A soap dispenser had been installed in the medical unit clean supply room.
Findings include:

1.a. Random observation on 6/3/14 from 1:30 p.m. to 3:00 p.m. revealed four cardboard boxes on the floor outside the OR suite supply room door. The cardboard boxes were the outside shipping containers for the items inside the box. Interview with the director of patient services at the time of the observation confirmed the finding. She stated she was aware outside shipping containers should not be brought into a clean area of the OR suite. She stated there was no policy or procedure (P/P) regarding clean supplies in the OR suite.

Review of the Association of periOperative Registered Nurses (AORN) Standards and Recommended Practices, 2014 Edition, Denver, CO, page 120, revealed: "Supplies and equipment should be removed from external shipping containers and web-edged or corrugated cardboard boxes in the unrestricted area before transfer into the surgical suite."

b. In the OR procedure room an endoscope cabinet did not have ventilation vents and was a closed cabinet. The blue eggcrate cushion on the bottom of the endoscope cabinet was discolored and stained. The blue cushion had spots of brown and tan directly under the hanging scopes. Interview with the director of patient services at the time of the observation confirmed the finding. She was aware the cabinet was not designed to store and hang clean scopes. She was unaware how often the cushion was changed, but she confirmed it appeared to be dirty. She was not able to provide a policy regarding the construction or cleanliness of the scope cabinet.

Review of the 2014 AORN Standards and Recommended Practices revealed: "Flexible endoscopes should be stored in a closed cabinet with venting that allows air circulation around the flexible scopes with internal surfaces composed of cleanable materials."

c. Six scopes were hung in the cabinet in the endoscopy procedure room of the OR suite. Interview with the director of patient operations at the time of the observation revealed each scope had a serial number. The scopes were logged on a check sheet each time they were processed. She was not aware if the scopes were reprocessed after five to seven days of non-use.

Review of the scope checklist revealed six different scopes had been processed from 3/31/14 to 6/5/14. Six of six scopes had gone over the five to seven day guideline throughout the months of April, May, and the first four days of June for reprocessing. Further review of the scope checklist revealed the following: "5/16/14; Colon; A425; no entry under 'VO #'; initials 'SS'; and a handwritten note that stated 'Decontam [decontamination] wouldn't work.' No other comments were noted to confirm scope A425 had been reprocessed to ensure disinfection was completed.

d. Observation on 6/4/14 from 1:30 p.m. to 3:30 p.m. in the soiled utility room of the pre-op area revealed clean crutches were hung on the wall and clean toilet seat covers were stored under the sink drain line. Interview with the director of plant operations at the ti