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A. Based on record review, interview, policy review, and standards of practice review, the provider failed to ensure three of three sampled patients (17, 18, and 49) with significant weight changes had been adequately assessed, documented, and physician notification had been completed. Findings include:

1. Review of patient 49's medical record revealed:
*He had been admitted on 7/13/11.
*He had received hemodialysis on 7/13/11, 7/14/11, 7/15/11, 7/16/11, and 7/18/11.
*His weight on admission was 59.375 kilograms (kg) (1 kg = 2.2 pound).
*His weight on 7/14/11 at 6:00 a.m. was 60.7 kg.
*His weight on 7/15/11 at 6:00 a.m. was 60.6 kg.
*His weight on 7/16/11 at 6:00 a.m. was 60.373 kg.
*His weight on 7/17/11 at 6:00 a.m. was 68.3 kg.
*His weight on 7/18/11 at 6:00 a.m. was 68.2 kg.
*He had no ordered dry weight goals on his acute intermittent hemodialysis physician's orders for 7/13/11 through 7/16/11 and on 7/18/11.

Review of a 7/14/11 nutritional assessment by the registered dietician for patient 49 revealed:
*He was a new hemodialysis patient.
*He had a previous weight of 65.8 kg during a September 2010 hospitalization.
*He had weight loss.
*His goals included his weight was to remain stable.

Review of patient 49's 7/18/11 post hemodialysis assessment revealed no nursing or physician documentation related to his 8.825 kg weight gain.

Interview on 11/2/11 at 3:00 p.m. with the nurse manager for the dialysis unit revealed:*All hemodialysis patients were weighed on their respective units between 5:00 a.m. and 6:00 a.m.
*The post-hemodialysis weight was obtained in the dialysis unit while the patient was in bed.
*She agreed patient 49 had a large weight gain during his hospitalization.
*She agreed there was no documentation that indicated his weight gain had been addressed by the nursing staff or physician.



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2. Review of patient 17's weight records from 10/30/11 through 11/3/11 revealed:
*On 10/30/11 the patient weighed 89.9 kilograms (kg) per bed scale.
*On 10/31/11 the patient weighed 98.5 kg per bed scale.
*On 11/1/11 the patient weighed 99 kg per bed scale.
*On 11/2/11 the patient weighed 99 kg per bed scale.

Review of the patient's entire medical record revealed:
*No nursing or physician notes acknowledging/reporting the significant weight change were documented between 10/30/11 and 10/31/11.
*The patient was admitted with the diagnosis of pneumonia and hypoxia.
*The patient was on a ventilator to support her respiratory system.
*The patient had a history of congestive heart failure and heart bypass surgery.
*The patient's radiology studies on 10/29/11 indicated the patient had an enlarged heart, bilateral lung infiltrates, elements of pulmonary edema, moderate ascites, and presacral edema.
*The intake and output records for 10/30/11 and 10/31/11 indicated the patient's intake was 7898 liters greater than the patient output.
*The patient had received albumin and Lasix to remove fluid starting on 11/1/11 at 12:59 p.m. and again at 10:31 p.m.

Interview on 11/2/11 at 9:50 a.m. with the intensive care (ICU) nurse manager revealed:
*Patients in the ICU were weighed in the early morning hours.
*She agreed no nursing or physician documentation was present on 10/31/11 indicating the physician had been informed or noted the patient's significant weight gain and fluid imbalance. She stated she would assume the physician was aware of the weight change as physicians had access to the electronic medical record.
*She agreed the above noted changes in weight were significant and should have been documented as addressed by nursing personnel.

3. Review of patient 18's weight records from 10/10/11 through 11/1/11 revealed the patient had several significant weight changes:
*On 10/13/11 in the ICU the patient's weight went from 128.5 kg at 12:30 a.m. to 121 kg at 9:00 p.m. The patient was not re-weighed until 10/15/11 at 6:45 p.m.
*On 10/20/11 on the 1 East floor the patient weighed 123.9 kg, then went to 132.7 kg the next day. On 10/22/11 the patient was then noted to have been 137.3 kg.
*On 10/24/11 on the 1 East floor the patient weighed 124.3 kg and on the next day she was 116.8 kg.
*On 10/27/11 on the 1 East floor the patient weighed 113.2 kg and on the next day she was 104 kg.
*On 10/30/11 on the 1 East floor the patient weighted 113.7 kg and on the next day she was 104.1 kg.

Review of the patients entire medical record revealed:
*No nursing or physician notes acknowledging/reporting the significant weight changes were documented between 10/10/11 and 11/1/11.

Interview on 11/1/11 at 2:50 p.m. with the 1 East nurse manager revealed:
*The provider's electronic medical record does not alert staff to significant weight changes. Nursing staff were responsible to note changes and implement appropriate nursing interventions and documentation.
*She thought the weight variances were due to different scales being used, but she was unsure of that.
*The provider had no policy related to weighing patients.
*Re-weights were not required for significant weight changes.
*She agreed the above noted changes in weight were significant and should have been documented and appropriately addressed by nursing personnel.

Interview on 11/2/11 at 9:50 a.m. with the intensive care (ICU) nurse manager confirmed the findings from the above interview.

4. Interview on 11/2/11 at 3:00 p.m. with the director of professional practice revealed:
*She confirmed the statements of the 1 East and ICU nurse managers in findings 2 and 3.
*Significant weight changes should have been noted as addressed by nursing personnel either through re-weighing the patient, physician notification/orders, or nursing documentation.

Review of Patricia A. Potter and Anne Griffin Perry, Fundamentals of Nursing, 6th Ed.,St. Louis, Mo., 2005, pp. 419, 1158, and 1159 revealed:
*The daily weight of a patient is the single most important indicator of the patients fluid status.
*The same scale should be used to weigh the patient as frequently as possible.
*Weight should be determined at the same time each day.
*Scales should be calibrated daily or routinely.
*When bed scales are used it is important to have the same amount of bedding on the bed from day-to-day.
*Intake and output are not as accurate as daily weights in assessing daily fluid balance.
*Appropriate nursing documentation of observations and interventions serves as evidence of what was actually reported or done. That documentation is the proof that the nurse acted reasonably and safely to the information collected.



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B. Based on record review, interview, and policy review, the provider failed to ensure registered nurses documented comprehensive assessments of patients monitored post-operatively for two of two patients (16 and 33) receiving endoscopic procedures. Findings include:

1. Review of patient 16's endoscopy unit data record revealed:
*On 11/1/11 at 9:08 a.m. a colonoscopy procedure was performed with monitored anesthesia care; and the patient was transported back to her room for recovery.
*Vital signs (temperature, pulse, respirations, blood pressure, pain rating, oxygen saturation, and oxygen administration if appropriate was documented at 9:20 a.m. or 9:26 a.m. (writing illegible) and 10:12 a.m. There were no additional vital sign data documented 9:20 a.m. and 10:12 a.m.
*The patient was discharged at 10:14 a.m.

Review of patient 33's endoscopy unit data record revealed:
*On 11/1/11 at 9:58 a.m. a colonoscopy procedure was performed with monitored anesthesia care, and the patient was transported back to her room for recovery.
*Vital sign data was documented at 10:08 a.m. and 10:40 a.m. There were no additional vital sign data documented 10:08 a.m. and 10:55 a.m.
*The patient was discharge at 10:55 a.m.

Review of the endoscopy unit data record for patients 16 and 33 revealed both patients had received an Aldrete score of 10 upon discharge.

Interview on 11/1/11 at 10:15 a.m. with clinic manager V revealed:
*Vital sign data was recorded on the patient's endoscopy unit data record.
*For patients 16 and 33 only two sets of vital sign data had been recorded. Additional vital sign data would have been documented if the patient had encountered problems during recovery.
*Vital sign data was stored on the monitors past the patients' discharge and could be retrieved.

This surveyor requested clinic manager V retrieve the additional vital sign data for patients 16 and 33. After checking both monitors clinic manager V confirmed the vital sign data had been cleared from the monitors used during patient 16 and 33's recovery phase. There was no printout available to put on the patients' charts.

Review of the endoscopy unit data record instructions revealed there was space to record additional vital sign data. For patients receiving "Moderate sedation vital signs should have been taken every 15 minutes until the patient demonstrated a post Aldrete score of at least 8 or a return to pre-procedure baseline level of consciousness, then recheck within 30-60 minutes."

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., page 621, revealed a comprehensive system for documenting patient events and assessments provided a smooth progression of patient care.

Based on observation, policy review, and interview, the provider failed to ensure outdated, mislabeled, or otherwise unusable drugs in multiple randomly observed areas were not available for patient use. Findings include:

1. Observation on 11/2/11 at 11:15 a.m. of the anesthesia cart in the electroconvulsive therapy (ECT) area of the Behavioral Health Center (BHC) revealed:
*Four syringes of intravenous (IV) Brevital prepared by the pharmacy on 10/26/11 and labeled "Refrigerate."
*Two lidocaine syringes with a handwritten label of 10 milligram (mg)/milliliter (mL) and not marked with an expiration date.

Interview at the above time with the BHC pharmacy manager and the ECT supervisor revealed:
*Treatments were done for the day.
*The next date for treatments would have been 11/4/11.
*The Brevital syringes should have been returned to the refrigerator.
*The lidocaine syringes had not been prepared by the pharmacy.
*The lidocaine syringes were considered to have been for immediate use and should have been discarded.

Review of the provider's pharmacy services policy for product storage approved June 2003 revealed:
*The purpose of the policy was to comply with drug storage requirements established by the United States Pharmacopeia (USP) or individual drug monographs.
*IV solutions prepared by the pharmacy should have been stored in the refrigerator unless the stability of the medication was better at room temperature.
*Any expired, damaged, or contaminated medications should have been removed from the stock and segregated or immediately destroyed.

Review of the provider's pharmacy services policy for multiple/single-use vials approved January 2006 revealed multiple-dose vials should have been:
*Used up to 28 days after initially opened.
*Discarded when the vial reached its 28 day expiration date.
*Discarded when the date of vial opening was unknown.

Review of the Revision Bulletin <797>, Pharmaceutical Compounding-Sterile Preparations, USP, revealed:
*A sterile product transferred from one container to another was considered to be a compounded sterile preparation (CSP).
*Immediate use CSPs were exempted from sterile compounding requirements when simple aseptic measuring and transfer was needed, only non-hazardous products or diagnostic
radiopharmaceutical products were used, and aseptic technique was followed during preparation.
*Immediate use CSPs should have been used within one hour following preparation and must not have been stored for later use.
*Unless immediately and completely administered by the person who prepared it any CSP should have been labeled with patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact 1-hour beyond-use date.



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2. Observation on 11/3/11 at 9:00 a.m. at the physical therapy outpatient clinic at 6100 West 41st Street revealed four containers in a cabinet of dexamethasone sodium phosphate that had expired August 2011. Interview with employee H at the time of the observation confirmed the above medications had expired on August 2011. She stated she had not noticed the medications had expired.



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3. Observation on 11/1/11 at 1:00 p.m. in the gynecologic oncology clinic supply room revealed:
*One vial of methylene blue with the expiration date of July 2002.
*Three vials of methylene blue with the expiration date of January 2011.
*One vial of methylene blue with the expiration date of July 2011. That vial was opened and was not marked with a date of opening.

Observation on 11/1/11 at 1:30 p.m. in the gynecologic oncology clinic examination (exam) rooms revealed:
*Exam room 2 - Two opened vials of sterile sodium chloride and one opened vial of sterile water. The vials were not marked with a date of opening.
*Exam room 4 - One opened bottle of sterile gauze packing which compromised the sterility of that product.
*Exam room 6:
-One opened bottle of hydrogen peroxide with the expiration date of June 2000.
-One bottle of hydrogen peroxide with the expiration date of June 2000.
*Exam room 7 - One opened vial of sterile water with no date of opening.

Interview on 11/1/11 at 1:30 p.m. with registered nurse (RN) I confirmed the vials had not been dated when opened and those expired medications were available for use. The nurse revealed she was not aware how long an opened vial should have been used before discarding.



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4. Observation on 11/1/11 at 2:20 p.m. of storage room 3 located in the infusion area of the Hematology and Bone Marrow Transplant Clinic revealed:
*Two, ten mL vials of heparin with an expiration date of September 2011.
*One, ten mL vial of heparin with an expiration date of December 2010.

Interview on 11/1/11 at 2:30 p.m. with infusion center manager E confirmed the three vials of heparin were outdated.



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5. Observation on 11/1/11 at 10:30 a.m. of the manually locked medication storage cupboard next to the automated medication dispensing system on pod A of the 1 East floor revealed:
*A Cardizem intravenous (IV) drip bag labeled with patient 91's information was in the un-refrigerated medication storage cupboard.
*A partially used 10 milligram vial of Cardizem was located next to the above noted Cardizem IV drip.
*Both were in a plastic bag that was labeled "refrigerate."

Interview on 11/1/11 at 10:35 a.m. with the 1 East nurse manager and pharmacy technician L revealed:
*Pharmacy technician L had placed both the Cardizem IV drip and the Cardizem vial into the automated medication dispensing system refrigerator early that day. She was uncertain who had removed them from that refrigerator and placed them into the un-refrigerated medication storage cupboard.
*Both agreed the above medications should have been refrigerated as labeled until dispensed to the patient.



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6. Observation on 11/1/11 from 10:30 a.m. until 10:50 a.m. of the postpartum unit
medication storage areas revealed:
*Pod B - Four 30 milliliter (ml) vials of sterile sodium chloride with expiration dates of September 2011. One of those vials was also opened and not dated with an opening and/or expiration date.
*Pod C - Three 30 ml vials of sterile sodium chloride with expiration dates of September 2011. One of those vials was also opened and not dated with an opened and/or expiration date.
*Pod D - One 30 ml vial of sterile sodium chloride with an expiration date of September 2011.

Interview at the time of the above observation with the postpartum nurse manager revealed:
*The above vials of sterile sodium chloride had expired and were available for use.
*All opened vials of sterile sodium chloride or other multi-use vials should have been dated when opened with an expiration date of 30 days from opening.

Interview with the postpartum nurse manager on 11/3/11 at 9:50 a.m. revealed the pharmacy was responsible for stocking the postpartum unit with medication and other supplies and for checking for outdates.

Review of the nursing medication administration policy revised August 2011 revealed all multi-dose vials should have been discarded:
*Within twenty-eight days of opening. The vial should have been marked with the expiration date.
*When the product was otherwise unusable.

Based on observation, testing, interview, policy review, manufacturer's recommendations, and perioperative standards, the provider failed to ensure the proper warming of intravenous (IV) fluids and irrigation fluids in two of three (main and obstetrical (OB)) surgical areas. Findings include:

1. Observation on 11/1/11 at 10:30 a.m. of the obstetrical operating suite revealed a two-compartment warmer. The bottom half of the warmer contained blankets. The temperature of the top half of the warmer was 124 degrees Fahrenheit (F) and contained:
*One 1000 milliliter (ml) IV bag of Lactated Ringers (LR) solution enclosed in an overpouch.
*Eighteen 1500 ml bottles of sterile water for irrigation.
*Twelve 1000 ml bottles of 0.9 percent sodium chloride (NaCl) for irrigation.
There were no dates on any of the above solutions.

Interview on 11/1/11 at 10:45 a.m. with licensed practical nurse/OB scrub nurse B rand the OB resource nurse revealed:
*They were not aware of how long the LR IV solution had been in the warmer.
*They were not aware of what the temperature of the warmer should have been for IV solutions or irrigation solutions.
*They did not monitor the temperature of the warmer or the solutions it contained.

Review of the provider's revised April 2011 fluid warming guidelines policy revealed:
*Any fluid intended to be warmed must have an expiration date on it.
*1500 ml sterile water would have not been warmed except in room 6. It would out-date after 30 days.
*1000 ml NaCl would be warmed. It would out-date after 30 days.
*Any bag of solution must have an overpouch. Each bag would out-date after 14 days.

Review of the provider's revised September 2009 warming cabinets policy revealed:
*IV solutions could remain in the warmer for a period of not longer then 14 days at a temperature not to exceed 104 degrees F.
*Semi-rigid pour bottles could remain in the warming cabinet for up to 60 days at a temperature up to 104 degrees F.
*What felt safe to a clinician's brief touch could be dangerous over prolonged contact.

Review of a letter from the manufacturer for IV solutions and irrigation fluids dated 12/19/08 revealed:
*Solutions of large volume IVs could have been warmed in their plastic overpouches to temperatures not to exceed 104 degrees F and maintained for a period no longer then 14 days.
*Irrigation solutions could have been warmed to temperatures not to exceed 150 degrees F and maintained for a period no longer then 72 hours or to temperatures not to exceed 113 degrees F and maintained for a period of 14 days.
*The IV and irrigation solutions could have been removed from the warmer once the maximum number of days was reached and used until the manufacturer's expiration date. The solutions could not be warmed more than once.
*After removal from the warming cabinet the IV and irrigation solutions should have been identified as having been placed in the warming cabinet.

Review of the Association of periOperative Registered Nurses 2010 Perioperative Standards and Recommended Practices, 2010 Edition, Denver, CO., pp. 224 and pp. 225, revealed:
*A warming units temperature was checked at regular intervals according to the provider's policy and documented on a temperature log or recorded electronically.
*Setting, maintaining, and monitoring a warmer should have been assigned to specific personnel.
*Warming units with fluids in them should have been labeled with the safe temperatures of operation as per the manufacturer's instructions
*Fluids and blankets maintained in the warmer were used on a first-in, first-out basis.
*Fluids kept in a warming device would be maintained according to the manufacturer's recommendations.
*Solutions warmed to a temperature above normal body temperature should not exceed 98.6 degrees F at the time they were placed inside the body. That temperature should have been verified per sterile thermometer.



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2. Observation, testing, and interview on 11/1/11 at 4:00 p.m. with OR nurse manager A in OR 12 revealed:
*The warmer located in OR 12 contained multiple blankets and a bag of fluid.
*There was no thermometer located in the warmer.
*The nurse manager did not know how hot the items in the warmer were. The temperature control for the warmer was set in the green zone but not to any specific temperature. Once the warmer was set the temperature control was not to be adjusted.
*There were 14 operating rooms and each had a warmer with blankets and fluids. None of the warmers in the 14 operating rooms were monitored for temperatures. The nurse manager would rely on staff touching the items in the warmers too determine if the items were to hot to use.
*Testing of the ambient air temperature in the warmer of OR 12 revealed it was 91.7 degrees Fahrenheit.



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3. Observation on 11/2/11 at 10:40 a.m. of the labor and delivery (LD) area medication room revealed a warmer with several blankets and four 1500 ml bottles of sterile water for irrigation. Those bottles had an expiration date of 12/2/11 written on them. The warmer was set at 120 degrees F. The warmer's temperature gauge registered 126 degrees F. There was no thermometer inside the warmer.

Interview on 11/3/11 at 9:30 a.m. with the LD nurse manager revealed there was no policy and procedure specific to the warmer in the LD area. The policy and procedure for that warmer would be the same as the perioperative policies and procedures for the warmers.

A. Based on observation, interview, manufacturer's instructions, perioperative standards, and policy review, the provider failed to ensure all patient care instruments sterilized in one of three tabletop sterilizers (gynecologic and oncology clinic) was operated in accordance with the manufacturer's instructions and acceptable standards of practice. Findings include:

1. Observation on 11/1/11 at 1:30 p.m. in the soiled utility room located in the gynecologic and oncology clinic revealed an UltraClave tabletop steam sterilizer. The UltraClave sterilizer door was opened, and several small instruments in pouches were cooling on the inside.

Interview on 11/1/11 at 1:30 p.m. with technician I revealed:
*Procedures performed at the clinic included endometrial biopsies, cervical biopsies, and Loop Electrosurgical Excision Procedures.
*The clinic did not maintain a log of what instruments were sterilized.
*The clinic did not run daily or weekly biological indicators to ensure sterilization parameters were being met.
*The autoclave had been repaired (door gasket replaced) in June 2011, and no biological monitoring had been conducted prior to putting the unit back into service. She was not aware that was a requirement.
*The clinic did not have the manufacturer's operation manual on the premises. The company that last repaired the autoclave had the manual. The clinic had called for the manual, but the repair company had not returned it.
*There was no provider policy for operating the UltraClave tabletop steam sterilizer.
*The technician was asked about temperature and pressure settings of the autoclave. She was not sure of the temperature settings and stated she did not know about pressure settings.
*When asked how the clinic would recall instruments if there was a sterilizer failure the technician did not know what process should have been followed.
*There was no cleaning of the autoclave, and she was not aware that was a requirement.
*The clinic had contacted the hospital director of central processing for an in-service on the tabletop autoclave. That had been conducted in May 2011, but they had not been informed of any required monitoring parameters. There was no documentation of that in-service.

Interview on 11/2/11 at 9:00 a.m. with the director of central processing revealed she had been contacted by the gynecology and oncology clinic for information on the tabletop sterilizer. She had informed the staff she was not familiar with tabletop sterilizers. She had recommended they contact the manufacturer for the operating instructions for that unit. She was not aware the clinic had contacted the manufacturer but had not received the manufacturer operating instructions.

Interview on 11/3/11 at 8:30 a.m. with the infection control nurse confirmed:
*She was aware there was a tabletop sterilizer in the gynecology and oncology clinic.
*All sterilizers required monitoring to ensure sterilization parameters were being met.
*She had instructed the gynecology and oncology clinic to contact the manufacturer for operating instructions. She was not aware the clinic had not done that. She had not checked to ensure the recommendation had been followed-up on by the clinic.
*She was not aware the clinic was not monitoring the sterilization loads with a biological indicator.
*Autoclave processing for the steam sterilizer used in the gynecology and oncology clinic was not part of infection control monitoring or quality assurance monitoring. She confirmed the comprehensive dashboard monitoring report for that clinic indicated "N/A" for "Sterilization/autoclave positive biological monitors/response" from August 2010 through July 2011.

On 11/2/11 at 9:40 a.m. this surveyor was provided a copy of the M11 UltraClave Steam Sterilizer installation and operation manual that had been downloaded from the Internet.

Review of the M11 UltraClave Steam Sterilizer installation and operation manual revealed:
*Prior to installation and operating the unit the manual should have been read and understood.
*The provider should have ensured the manual was located near the sterilizer or permanently affixed to the sterilizer.
*The consumer had an option of buying the printer that would have provided a permanent record of actual exposure times and temperatures.
*The use of physical monitors (temperature and pressure measuring devices) helped detect failures in the sterilizer function. The sterilizer would notify the user if sterilization conditions fell outside of established limits. The printer accessory could create a record of each load's actual cycle time, temperature, and pressure.
*Process monitors (biological indicators and chemical indicators) should have been included in each sterilization cycle. "Process monitors detect whether the cycle parameters were delivered."
*Operator maintenance included daily cleaning of external surfaces, weekly cleaning of the chamber and trays, monthly flushing of the system with speed clean sterilizer cleaner, and quarterly removal and cleaning of the door gasket.

Review of the Association of periOperative Registered Nurses 2010 Perioperative Standards and Recommended Practices, Sterilization and Disinfection, 2010 Edition, Denver, Co., revealed:
*Page 461 - "Process challenge devices (PCDs) should be used with routine process monitoring devices (ie, chemical indicators, biological indicators, physical monitoring devices). Process challenge and process monitoring devices provide information to demonstrate that conditions for sterilization have been met."
*Page 462 - "Biological (BI) and chemical indicators should be used to monitor sterilizer efficacy and assess compliance of monitoring standards established for gravity-displacement and dynamic air-removal sterilizers."
*Page 471:
*"Accurate and complete records are required for process verification and used in sterilizer malfunction analyses. Documentation establishes accountability."
*Every sterilization cycle and modality, including steam (e.g. wrapped and unwrapped), should have been documented. "Documentation should include the assigned lot number; contents of each load; and results of physical, chemical, and biological monitors."

B. Based on observation, interview, and policy review, the provider failed:
*To maintain a sanitary environment in seven of seven patient care areas (gastroenterology clinic, intensive care unit, main operating area, ambulatory care area, obstetrical operating room, labor and delivery department, and acute dialysis.
*To ensure ices machines throughout the hospital were free of mineral build-up.
Findings include:

1. Observation on 11/1/11 from 9:45 a.m. to 10:30 a.m. in the gastroenterology clinic revealed:
*The enzymatic detergent solution was not mixed in accordance with the manufacturer's instructions.
*Flexible endoscopic scopes were stored in a cabinet contaminated with dust and dried water stains on the bottom of the cabinet.
*The flexible endoscopic scope cabinet was not on a cleaning schedule.
*A cardboard box with dried water stains was stored on the bottom shelf below the endoscopes.
*Flexible endoscopic scopes were not stored in a vented cabinet to allow for air circulation.
*A system was not in place to ensure flexible endoscopic scopes were processed in a timely manner.
*Test strips used to verify efficacy of high-level disinfectants were not dated with an expiration date 90 days after opening.
*Patient care supplies were exposed to potential contamination during endoscopic procedures.

Refer to A749, finding A 1-8.

2. Observation of the intensive care unit (ICU) on 10/31/11 and 11/1/11 revealed:
*Patient care supplies and equipment were not stored and maintained in a hygenic manner.
*The staff did not follow contact isolation precautions when caring for ICU patients 18 and 93.
*Three of four observed physicians in the ICU did not perform appropriate hand hygiene after patient care.
*Medications were administered hygienically to one of three observed ICU patients (92).
*Construction waste was hygienically removed from one of one ICU.

Refer to A749, finding B 1-6.

3. Random observation and testing on 11/1/11 revealed the provider failed to maintain a sanitary environment in six of six patient care areas (main operating room outer corridor, inner sterile supply core, the ambulatory care area, labor and deliver area, and obstetrical operating room.

Refer to A749, findings C1, C2, C3, C4, and C5.

A. Based on observation, interview, and record review, the provider failed to ensure:
*Endoscopic scopes were reprocessed in accordance with acceptable standards of practice for one of two gastroenterologist departments.
*Patient care supplies opened during an endoscopic procedure were not used during subsequent procedures for all patients in one of two gastroenterology laboratories (GI lab).
*The floor in the GI lab procedure room did not have duct tape covering computer cables. Findings include:

1. Observation on 11/1/11 at 9:45 a.m. in the scope processing room revealed the technician partially filled the sink with water and put two squirts of an enzymatic cleaner into the water. The endoscopic scope was placed in that solution for cleaning. The technician was observed as she worked to add additional enzymatic cleaner and water into the solution already in the sink when subsequent scopes were cleaned. The technician was did not measure the amount of water in the sink prior to adding the enzymatic cleaner and did not measure the amount of enzymatic cleaner squirted into the water.

Review of the manufacturer's label for the enzymatic cleaner revealed dilute 1/8 to 1/2 fluid ounce of cleanser to 1-2 gallons of water.

Interview on 11/1/11 at the time of the observation with technician W confirmed she had not measured the water or the enzymatic cleaner put in the sink.

Interview on 11/1/11 at 10:00 a.m. with clinic manager V confirmed the sink was not marked with a water line, and the enzymatic cleanser should have been measured. Clinic manager V revealed the enzymatic cleanser sales representative had provided them with a method to mark the water line in the sink. However the clinic had not marked the sink's water line or instructed the staff to measure the enzymatic cleaner used.

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., revealed:
*Page 406 - The manufacturer's written instructions should have been followed for the concentration of cleaning solution, disinfectant, or sterilant required for adequate cleaning, disinfecting, and sterilizing.
*Page 407 - The enzymatic detergent solution should have been discarded after each use. It did not possess bactericidal activity and might support growth of organisms if stored, and there were no tests to verify the strength of the solution prior to use. "Washing the external surfaces of the endoscope and flushing the internal channels with enzymatic solution helps to soften, moisten dilute, and remove organic soils (eg, blood, feces, respiratory secretions)."

2. Observation on 11/1/11 at 10:00 a.m. in the scope processing room revealed several scopes hanging on a metal rack. Clinic manager V was asked what process was in place to evaluate how long any given scope could hang in that cabinet before it needed to be reprocessed. Clinic manager V stated there was no formal system in place to determine when the scopes had been last processed. Clinic manager V stated the staff would have to look at the process printout from the automatic endoscopic processor to find that information. Clinic manager V stated if the physician using those scopes went on vacation there was the potential for a scope to be in that cabinet for a week. She stated she was confident the number of procedures performed in the clinic eliminated any chance a scope would not be used in a timely manner.

One random scope was selected and clinic manager V was asked when that scope had last been processed. After looking through a plastic bag with numerous rolls of printout tape a roll was selected. The clinic manager unraveled most of that roll before the scope processing date could be found. That random scope selected was last processed on 10/27/11, five days ago.

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., page 411, revealed flexible endoscopes should be reprocessed before use if unused for more than five days. Flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets had been shown to grow organisms after five days of no use.

3. Observation on 11/1/11 at 10:00 a.m. in the scope processing room revealed twelve containers of high-level disinfectant sitting on the floor. Interview at the time of the observation with clinic manager V confirmed to ensure the entire floor was cleaned at the end of the day the containers should not have been stored on the floor.

4. Observation on 11/1/11 at 10:25 a.m. of the scope cabinet revealed several scopes were hanging on a metal ring. The metal on the ring was coated with a layer of dust, that was wiped cleaned when touched. The bottom of the scope cabinet had a layer of dust and there was a cardboard box with dried brown stains on the top and the floor of the storage cabinet. Interview at the time of the observation with the clinic manager confirmed the scope cabinet needed cleaning and should have been cleaned daily. Clinic manager V revealed scopes hanging in a dirty closet needed reprocessing prior to using them in a procedure. Further observation of the scope cabinet revealed the cabinet was not vented to allow free air flow.

Interview on 11/3/11 at 9:30 a.m. with clinic manager V confirmed the scope cabinet was not vented. She stated at the end of the day that cabinet was left slightly opened to provide air circulation to the hanging scopes.

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., revealed:
*Page 411 - Flexible endoscopes should be stored in a closed cabinet with venting that allowed air circulation around the flexible endoscopes, and the surfaces were composed of cleanable materials.
*Page 413 - "Flexible endoscopes should have been reprocessed before use if evidence of improper drying exist (eg, evidence of discoloration, wet spots, or stains, or soil in the storage cabinet) when the scope is removed from storage."
*Page 413 - "Evidence of improper drying may include wet spots or stains on the bottom of the cabinet where the flexible endoscopes have been hanging. Improper drying creates an environment conducive to growth of microorganisms."
*Page 413 - Storage cabinets should have been cleaned and disinfected with an Environmental Protection Agency (EPA)-registered disinfectant when visibly soiled and on a weekly or monthly schedule."

5. Observation on 11/1/11 at 10:25 a.m. in the scope processing room revealed two bottles of test strips for the high-level disinfectant used in the automatic endoscopic reprocessing units. Both of the test strip bottles were opened. Interview at the time of the observation with technician W and clinic manager V confirmed both bottles were being used, one bottle did not have the date opened, and the other bottle was dated 1/25/11. At the time of the observation technician W stated she had opened both bottles that morning, had written the wrong date on one of the bottles, and had failed to put an open date on the second bottle.

A review of the manufacturer's instructions on the bottle of test strips revealed the test strips were good for 90 days after opening.

6. Observation on 11/1/11 at 8:50 a.m. in procedure room 1 revealed the computer cable on the floor was covered with gray duct tape. In large areas the duct tape was missing on the top of the cable and black debris was noted on the floor around the cable. Interview on 11/1/11 at 9:30 a.m. with surgical technician X confirmed the above observation. Technician X revealed the duct tape had been there for a long time, and they had requested the tape be removed. The tape become frayed and missing in areas because of equipment being rolled over it.

Interview on 11/1/11 at 10:33 a.m. with the clinic manager V confirmed duct tape was frayed in large areas, and black debris was noted along the cable. Those frayed areas were uncleanable surfaces. Clinic manager V revealed the hospital computer department had not completed all required construction for the computers to allow removal of the duct tape from the computer cables.

7. Observation on 11/1/11 at 8:50 a.m. during patient 16's surgical procedure revealed a metal three tiered cart with endoscopic supplies, an opened bag of clean gauze, clean blue towels, and Chux protective pads on the third tier (bottom) of the cart. The surgical technician used the top tier for supplies and the specimen container during the surgical procedure.

Interview on 11/1/11 at 10:33 a.m. with clinic manager V confirmed the above listed supplies were on a three tiered cart used during endoscopic procedures for all patients. Clinic manager V agreed there was a potential for those supplies to become contaminated during the procedures.

8. Random observation and interview on 11/1/11 at 10:33 a.m. with clinic manager V of the three rolling intravenous start trays in the gastroenterology clinic revealed they were dusty, and some of the bins had hair in them. Clinic manager V revealed staff should have been cleaning those bins daily, and that had not been done.




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B. Based on observation, interview, and policy review, the provider failed to ensure:
*Supplies and equipment in one of one intensive care unit (ICU) were stored and maintained in a hygenic manner.
*Contact isolation precautions were properly followed for two of two sampled ICU patients (18 and 93).
*Three of four observed physicians in the ICU performed appropriate hand hygiene.
*Medications were administered hygienically to one of three sampled ICU patients (92).
*Construction waste was hygienically removed from one of one ICU.
Findings include:

1. Tour of the ICU on 10/31/11 from 2:45 p.m. through 4:10 p.m. revealed:
*Two nasogastric feeding bags and attached tubing were found lying un-packaged in a cupboard next to the sink in the ICU kitchenette.
*Multiple partially used rolls of adhesive tape were found intermingled with the clean tape supply in the clean supply room.
*Eight Wet Task disinfectant wipes containers were found stored on the floor of the supply room. Four of the containers were opened with wipes protruding from them. Two of the four opened containers had no means to close the container leaving the wipes to dry out.
*One nasogastric tube was found open and stored with the clean supply of nasogastric tubes in the supply room.
*Three of three of the code carts located throughout the ICU were found to have had portable suction units attached to the lower right side of the code cart. Each of the suction units and their storage bins were found to have had a large amount of brown dust and other debris on them and in them.

Interview on 10/31/11 at 4:20 p.m. with the ICU nurse manager revealed:
*Once the above nasogastric supplies were removed from their packaging they should not have been returned to there clean storage areas.
*Rolls of tape were single-use items and used rolls should not have been returned to the clean storage area.
*Supplies of any kind were not to be stored on the floor.
*Wet Task containers should have been able to be sealed to prevent the disinfectant in them from drying out.
*Cleaning of the code carts was the ICU unlicensed staffs responsibility. She agreed the code carts noted above were dirty and in need of cleaning and disinfecting.

Interview on 11/3/11 at 8:50 a.m. with the director of infection control revealed she agreed the above findings were breaches in infection control practices.

2. Random observations on 11/1/11 from 9:00 a.m. through 10:00 a.m. of physician hand hygiene in the ICU revealed:
*Physician M entered room 2609 without washing his hands, examined the patient, and then exited the room without performing hand hygiene. The physician was noted to cross-contaminate multiple surfaces while he was outside of the room. After completion of that patient's visit he proceeded to room 2612 were the same process occurred. Physician M was observed leaving the ICU without performing any hand hygiene.
*Resident physician O was observed entering and examining the patient in room 2613 and then exiting that room multiple times without performing any hand hygiene. The physician was noted to cross-contaminate multiple surfaces while he was outside of the room. Resident physician O was also observed leaving the ICU without performing any hand hygiene.

Interview on 11/1/11 at 10:00 a.m. with the ICU nurse manager revealed she agreed the above observed lack of hand hygiene was an infection control breach.

Review of the provider's revised November 2010 hand hygiene policy revealed hand hygiene should had been performed prior to and after each patient examination/contact.

3. Observation on 11/1/11 at 10:45 a.m. of the construction area in the ICU revealed an unknown person was observed taking down and disposing of construction barriers/waste. That person was observed transporting the construction waste up and down the ICUs main corridor in his arms uncovered with construction dust falling from it.

Interview on 11/2/11 at 9:47 a.m. with facility engineer R revealed the above noted construction waste should had been placed in plastic bags, sealed, then placed in a covered trash transport container prior to its removal.

Interview on 11/3/11 at 8:50 a.m. with the director of infection control revealed she agreed the above finding was an infection control breach.

4. Observation on 11/1/11 at 11:18 a.m. of certified registered nurse anesthetist (CRNA) P revealed:
*The CRNA prepared and administered unknown medications into patient 92's IV access ports without cleaning those ports.
*After examining and touching patient 92 the CRNA used his contaminated gloved hands to rummage though three of the draws of medical supplies cart located in the patient's room.

Interview on 11/1/11 at 11:30 a.m. with the ICU manager revealed:
*Patient 92's IV access ports should have been cleaned with 70 percent alcohol prior to access per the provider's IV policies.
*She agreed CRNA P had cross-contaminated the medical supplies in patients 92's medical supply cart. Those supplies were removed from that cart, and the cart was disinfected per the nurse managers direction.
*She agreed the above observations were infection control breaches.

Interview on 11/3/11 at 8:50 a.m. with the director of infection control revealed she agreed the above findings were breaches in infection control practices.

5. Observation on 11/1/11 at 11:20 a.m. of RN Q revealed as patient 92 was being prepared by CRNA P to go to surgery RN Q emptied the urine from the patient's urinary catheter into an uncovered container. RN Q then proceeded to walk with that uncovered container of urine down the ICUs main hallway to the dirty utility room where its contents were disposed of.

Interview on 11/1/11 at 11:30 a.m. with the ICU manager revealed:
*Body fluids of any kind should have always been transported in a covered container to help prevent cross-contamination of surfaces and personnel.
*She agreed the above observation was an infection control breach.

Interview on 11/3/11 at 8:50 a.m. with the director of infection control revealed she agreed the above finding was an infection control breach.

6. Random observations on 11/1/11 from 8:00 a.m. through 4:00 p.m. of the isolation practices in the ICU revealed:
*Patients 18 and 93 in the ICU were currently in contact isolation precautions related to active infectious disease processes.
*Multiple observations were made of staff cross-contaminating the privacy curtains of the above two rooms via direct contact with contaminated gloves and gowns. Staff were observed grasping the outside of the privacy curtain with contaminated gloves, then wrapping that privacy curtain around their contaminated gowned body so they could call for assistance or supplies. Several other staff were then observed touching those curtains un-gloved and then cross-contaminating multiple other surfaces prior to performing any type of hand hygiene.
*On 11/1/11 at 9:30 a.m. of physician N revealed the physician entered ICU room 2608 that was posted with contact isolation precaution without putting on any personal protective equipment. The physician was noted to touch the contaminated privacy curtain as noted above. No hand hygiene was noted after that observation.
*On 11/1/11 at 3:43 p.m. RN Q was observed exiting contact isolation room 2606 with contaminated gloves and gown on and cross-contaminating multiple surfaces outside the isolation room.
*On 11/1/11 at 3:45 a.m. CRNA S was observed entering and then exiting contact isolation room 2606 in surgical scrubs without wearing any personal protective equipment.

Interview on 11/1/11 at 4:04 p.m. with the director of infection control and ICU nurse educator T revealed:
*Staff should have used the call light in the patient's rooms to call for assistance or supplies rather than contaminating the patient's privacy curtains.
*They both agreed the above observations constituted breaches in isolation

Review of the provider's revised February 2011 transmission based precautions (isolation) policy revealed:
*The purpose of isolation was to interrupt the transmission of infectious diseases between patients, personnel, and visitors.
*Isolation personal protective equipment was to have been worn upon entering an isolation room and was to be removed prior to leaving an isolation room.



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C. Based on observation, testing, interview, and policy review, the provider failed:
*To maintain a sanitary environment for five of five patient care areas (main operating room (OR) area, ambulatory surgery center (ASC), obstetrical OR, labor and delivery, and acute dialysis.
*To ensure ice machines throughout the hospital were free of mineral build-up.
Findings include:

1. Observation and testing on 11/1/11 from 8:29 a.m. through 10:30 a.m. of the main OR outer corridor, inner sterile supply core, and ambulatory care area revealed:
*Three Bev hip positioners with a paper type film over the rigid plastic piece. That paper film had numerous small tears in it and was porous making it an uncleanable surface (photo 3).
*One leg holder with a torn padded covering. That covering also had layers of discolored cloth tape making it an uncleanable surface (photo 4).
*Three tables with cracked and missing laminate on the top and corners. The missing laminate exposed particle board which was an uncleanable surface (photos 5 and 6).
*Twelve of twelve door frames that lead from the inner sterile supply core into the operating rooms had large amounts of chipped and missing paint. The chipped areas were rough to the touch making them an uncleanable surface (photo 7).
*All the plastic small case pull containers used in the main OR and the ASC had tape residue on the edges. That tape residue was sticky to the touch and an uncleanable surface.
*A curved wall at the north end of the ambulatory care area was gouged into the sheet rock making that an uncleanable surface (photo 10).
*The wall by the west double-door entrance in the ambulatory care area had paint that had been partially scraped off. The remaining paint could easily be flaked off with a fingernail making that an uncleanable surface (photo 9).
*The lower area of a cupboard by the west end of the nurses station was broken and revealed the inner particle board making it an uncleanable surface (photo 8).

Interview on 11/1/11 at 10:30 a.m. and again on 11/3/11 at 9:00 a.m. with the assistant vice president of perioperative services and registered nurse A revealed:
*They agreed the above items had uncleanable surfaces.
*There was no preventative maintenance program for the door frames.
*A maintenance request had been submitted for the walls in the ambulatory care area about one month ago.
*They had not realized the small case pull containers were uncleanable due to the tape residue. They stated the residue was from the needed procedure items and patient names having been taped to the edges.

Review of the provider's revised June 2011 environmental sanitation/housekeeping procedures policy revealed damaged or worn coverings would be replaced. There was no mention of other surfaces that could become damaged or uncleanable.



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2. Observation on 11/1/11 at 1:20 p.m. of the labor and delivery (LD) department medication room and of a pediatrics cart on that unit revealed:
*Twenty rolls of Transpore tape in a plastic bin on a supply cart in the medication room. Two of those rolls of tape were smaller than the others and appeared to have been previously used. They had been placed back in the bin with the clean rolls of tape.
*Six adhesive tape rolls were stored in a pediatrics cart. One of those rolls of tape was smaller than the others and appeared to have been previously used. It had been placed back in the cart with the clean rolls of tape.

Interview at that time with the LD nurse manager confirmed the two rolls of Transpore tape and the roll of adhesive tape had been used and placed back in the plastic bin and in the pediatric cart with the rolls of clean tape. She stated those used rolls of tape should have remained in the patient's rooms or have been discarded after use.

3. Observation on 11/2/11 at 1:50 p.m. in the obstetrical operating room 1 revealed a stainless steel Mayo table. That table had Transpore tape wrapped around the pole used to adjust the height of the table. The Transpore tape had an approximately one-inch gap where it had been torn apart. There was dirt, dust, and debris adhered to the sticky areas of the torn tape. That taped area of the Mayo table pole created an uncleanable surface.

Interview at that time with registered nurse/obstetrical scrub nurse (RN) F and certified registered nurse anesthetist (CRNA) G revealed that Mayo table was used for the CRNA's supplies and medications during surgery. They also confirmed:
*The Mayo table was broken and would not stay at the height it was adjusted to.
*The pole had been taped with Transpore tape to keep the table from falling down.
*The Transpore tape on the pole was torn and dirt, dust, and debris was adhered to the torn edges of the tape.
*The taped pole of the CRNA's Mayo table created an uncleanable surface.

Interview on 11/3/11 at 9:40 a.m. with RN F and the labor and delivery (LD) nurse manager again confirmed the above findings. The LD nurse manager stated the broken Mayo table would be replaced.



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4. Observation at 8:40 a.m. on 11/1/11 in the acute dialysis revealed the handsink and eyewash station countertop was pitted and rough and not cleanable (photo 01). Interview at 8:41 a.m. on 11/1/11 with the supervisor of facility services revealed she was not sure how the countertop got in that condition but would have the countertop replaced.

5. Random observations revealed a mineral buildup on the ice and water machines and the walls next to the machines throughout the hospital. Observation at 9:10 a.m. on 11/1/11 in B pod 3 east revealed mineral buildup and splash was on the exterior of the machine and adjacent wall (photo 02). Other ice and water machines were located throughout the patient care areas in the hospital and many had mineral buildup on the exterior of the machine and wall. Interview at 11:25 a.m. on 11/1/11 with the supervisor of facility services revealed she was aware of the mineral buildup on the machines and was in the process of trying to find something to remove it.

Based on interview, record review, and policy review, the provider failed to ensure for one of one sampled patient (34) that received a bone marrow biopsy:
*The physician verified the American Society of Anesthesiology (ASA) risk score.
*The nursing staff did not date and time the signature line for the physician's signature on the moderate sedation flow sheet.
*There was a physician's order to discharge the patient after post-operative monitoring had been completed.
Findings include:

1. Review of patient 34's moderate sedation flow sheet revealed the patient's ASA Risk Score was documented as class "III Significant medical problems, well controlled." The registered nurse had signed the form and indicated "Yes" the patient had been reassessed, was appropriate to undergo the procedure, and/or sedation. The physician had not signed the moderate sedation flow sheet, but there was a date and time documented on the signature line for his signature.

A review of patient 34's physician's orders from 8/17/11 through 11/1/11 did not reveal a physician order for discharge. A review of the patient's medical record did not reveal orders to discharge the patient when post-operative monitoring criteria had been met.

A review of patient 34's physician orders for a bone marrow biopsy and aspirate with moderate sedation signed 10/28/11 revealed no orders for discharge criteria. Those orders indicated the patient should have been monitored per the moderate sedation policy.

Interview on 11/1/11 at 2:30 p.m. with registered nurse J revealed:
*Post-procedure physicians did not write discharge orders or orders to discharge when criteria (Aldrete Score) was met.
*Patients were discharged by the nurse after the Aldrete Score was 8 or above or the patients' vital signs returned to pre-procedure baseline.
*The registered nurse providing patient care made the decision when patients could be discharged. There was no physician involvement with patient discharge.

Interview on 11/2/11 at 8:35 a.m. with the outpatient cancer director revealed:
*The sedation by non-anesthesia providers during diagnostic and therapeutic procedures policy was not specific as to who was responsible for discharging the patient after the Aldrete Score was 8 or above. The discharge process should have been clarified to indicate how the patient discharge occurred.
*As long as the Aldrete Score was 8 or above the patients were discharged in the company of a responsible adult.

Review of the provider's revised March 2009 policy sedation by non-anesthesia providers during diagnostic and therapeutic procedures revealed:
*The purpose of the policy was to provide a guideline for patient management for procedures requiring sedation by non-anesthesia personnel.
*Moderate/deep sedation pre-procedure: "The ASA is the evaluation of the patient's physical status pre-operatively or pre-procedurally. The patient will be classified by the physician or by a Registered Nurse counter-signed by the physician."
*Class III was described as "Patient with severe systemic disease (i.e. diabetes-well controlled with insulin whose restoration of normal diet will aid in diabetic control, immunosuppressed, moderate degree of pulmonary insufficiency, stable coronary artery disease, asthma under treatment-less than well controlled, extreme obesity)."
*"The Licensed Independent Practitioner will review pre-procedure assessment immediately prior to sedation and determine whether patient is an appropriate candidate for planned sedation.
*Moderate/deep sedation monitoring intra-procedure: "All patients receiving sedation/analgesia by non-intravenous routes should have a venous access (either a running infusion or IV lock) prior to sedation. The venous access is to be maintained until discharge criteria are met."
*Moderate/deep sedation post-procedure:
-"A. The patient is to be assessed for physiological, mental, and pain status. Vital signs are monitored every 15 minutes until the patient demonstrates a post procedure Aldrete score of at least 8 or return to pre-procedure baseline level of consciousness." Vital signs were then obtained within 30-60 minutes and if the patient was stable, the peri-operative registered nurse could have transferred the patient care to an accepting registered nurse.
-"B. Patients who have received moderate or deep sedation in the outpatient setting will be discharged in the company of a responsible adult."

Review of the Association of periOperative Registered Nurses (AORN) 2010 Perioperative Standards and Recommended Practices, Denver, CO., p. 622, revealed "The discharge policy should clearly specify who is responsible for discharging the patient from PACU phase I, II, and extended observation.