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Based on observation, staff interview, and review of contracted agreements for hospital services, the governing body failed to ensure all hospital services measured and reported quality indicators of patient health outcomes and strategies to reduce medical error. The governing body further failed to ensure surgical services were performed in a safe manner, promote and protect patient rights, and maintain an infection control program that sought to minimize infections and communicable diseases. The cumulative effect of these systemic failures resulted in the facility's inability to ensure the provision of quality care in a safe and sanitary environment. The findings were:

1. Refer to A115 for evidence of the facility's failure to promote and protect each patient's rights to care in a safe environment and freedom from physical restraints;
2. Refer to A263 for evidence of the facility's failure to effectively integrate contracted anesthesia services into a hospital-wide QAPI program;
3. Refer to A747 for evidence of the facility's failure to sustain infection control practices to minimize the risk of transmitting infections; and
4. Refer to A940 for evidence of the facility's failure to ensure surgical services were performed in a safe manner.

Based on staff interview and review of quality assessment and performance improvement (QAPI) records and contracted arrangements for patient care services, the governing body failed to require anesthesia services to provide substantive data to the hospital-wide QAPI program. The findings were:

On 1/7/10 at 10:35 AM, agreements for four contracted services were reviewed with the Directors for Accreditation and Data Management. One contract (anesthesia services) failed to require the contractor to measure and report indicators related to improved patient outcomes or the prevention of medical errors. The "quality requirements" described in the contract were related to the availability of on-call personnel for preoperative consultation, response time when requested by hospital staff, and availability for trauma/emergency responder. The contract did not specify demonstrable patient care outcomes or error reduction strategies for anesthesia services.

The accreditation director stated in an interview on 1/7/10 at 10:45 AM that she was not aware of any additional monitoring performed or reported by the anesthesia contractor. Neither of the two directors were aware if criteria cited in the contract, i.e., availability and response time, were measured and reported to the QAPI committee. Aside from reiterating the need for prompt response, the accreditation director was not able to identify any specific patient care data monitored and reported by anesthesia services for consideration by the hospital's quality committee.

Based on observation, medical record review, staff interview, review of policies and procedures, and review of employee education materials, the facility failed to meet the conditions of participation for patient rights, specific to the requirements for restraints and seclusion. The facility failed to meet the requirements related to restraint use for 4 of 5 sample patients (#7, #25, #26, #35) who were restrained. The facility further failed to provide required staff education and training regarding the use of restraints and seclusion. The combined cumulative effect of these systemic failures resulted in the facility's inability to protect and promote the rights of patients. The findings were:

1. Refer to A154 for evidence of the facility's failure to safely impose restraints for these patients.
2. Refer to A168, A175, A178, and A179 for evidence of the facility's failure to complete the one hour face-to-face requirement and obtain and follow physician orders for restraints.
4. Refer to A194, A199, A201, A202 and A204 for evidence of the facility's failure to provide staff education regarding restraint use.

Based on observation, medical record review, staff interview, and policy and procedure review, the facility failed to ensure the safe, necessary use of restraints were properly imposed for 4 of 5 sample patients (#25, #26, #7, #35) who were physical restrained. The findings were:

1. Review of medical records for patient #26 revealed s/he was admitted through the emergency department (ED) on 10/18/09. The patient had diagnoses that included suicidal ideation. Review of the ED nursing notes showed the patient was placed in four-point leather restraints (all extremities) on 10/18/09 for the one hour and thirty minutes. The following concerns were identified:
a. The nursing and physician documentation did not describe the behaviors/actions that warranted the use of four-point restraints. The nursing note dated 10/18/09 at 2:30 AM showed the patient "became violent (physical)." The note did not provide any specific behaviors. The physician did not make any note regarding the use of the restraint other than his order which showed, "4 pt [point] leather restraints per protocol."
b. Review of the documentation, including the restraint, flow record, failed to show a one hour face-to-face evaluation that included the patient's reaction to the intervention, the behavioral condition, and the need to continue or terminate the restraint. Review of the carepath showed the physician signed, dated, and timed a statement that referred to a one hour face-to-face assessment; however, there were no documented findings. Interview with the chief nursing officer (CNO) on 1/7/10 at 12:45 PM revealed she was unaware the evaluation did not cover the required areas.

2. Review of the medical record for patient #25 showed s/he was an inpatient on the behavioral health unit. On 12/2/09 at 5:45 PM the physician ordered four-point leather restraints due to "destructive disruption and danger to others." Review of the restraint flow record showed staff failed to evaluate the required elements for the one hour face-to-face evaluation.The documentation did not describe the patient's reactions to the intervention, behavioral condition or describe the need to continue or terminate the restraint. Review of the form identified by the CNO on 1/7/10 at 12:45 PM as the one hour face-to- face evaluation revealed this form also failed to evaluate these required areas.

3. Medical record review for patient #35 showed s/he was pysically restrained on 3/14/09 at 8:18 PM while an inpatient on the behavioral health unit. The patient was demonstrating self-injurious behaviors and attempting to pull out a suprapubic catheter. According to the physician's order, two-point leather restraints were to be applied to the upper extremities. However, the restraint flow record showed four-point leather restraints were actually used. Review of the record failed to show an order for the four-point leather restraints. In addition, the restraint observation form was not completed. The form did not have any signature of who filled it out or the time the restraint was initiated or discontinued. In addition, the area to record vital signs was blank, and the observation and care delivery section was blank after the first hour. According to a review of the carepath, the patient was released from the restraint at 12:15 AM, four hours and two minutes after initiation. Interview with the CNO on 1/7/10 at 12:45 PM confirmed the restraint flow record was not completed. Review of the facility's policy and procedure for behavioral restraints showed, "Vital signs should be attempted/obtained a minimum of every hour. All contacts, observations, offers of and use of toileting, fluids and ongoing assessment of the patient's behavior and condition shall be documented..."

4. Review of the1/4/10 nursing intensive care unit (ICU) patient information sheet showed patient #7 was admitted to the ICU from the ED on 1/3/10 at 10:34 AM with a ventilator and restraints. Review of the documentation in the nursing notes showed continuous ventilator use was discontinued at 8:34 AM on 1/4/10, and the soft wrist restraints were removed at 9 AM. Observation of the patient on 1/4/10 at 1:45 PM confirmed s/he no longer had a ventilator or restraints. The medical record lacked documented monitoring, assessment and rationale for restraint use. Additional medical record review revealed no physician's order for the restraint. During an interview on 1/4/10 at 3:40 PM, registered nurse (RN) #1 stated she "forgot" to obtain a physican's order.

5. Review of the facility's policies and procedures related to restraints and seclusion showed they did not correspond to required areas of the Federal regulations in the following ways:
a. Review of the policy and procedure for medical/surgical (non-behavioral health restraints) with an effective date of October 18, 2005 showed, if a restraint was initiated by an RN based on appropriate assessment, "The licensed independent practitioner [LIP] is to be notified within 12 hours of the initiation of the restraint. The physician will examine the patient and write an order for the restraint within 24 hours of the restraint being used." The Federal requirement for any restraint application is that the LIP or physician will order the restraint prior to the application of the restraint or seclusion. In an emergency case, the order must be obtained during the emergency application or immediately after the restraint or seclusion is applied.
b. Review of the policy and procedure for restraints used for behavioral management was last revised in March 2009. The policy and procedure failed to address the required elements needed for the one hour face-to-face evaluation.
c. Review of the facility's restraint policies for medical/surgical and seclusion, both dated October 18, 2005, showed they failed to adequately address the requirements for staff education. Review of the policy and procedure for medical/surgical restraints showed multiple references to qualified/trained staff. However, there was no detail as to how staff would be trained or the periodic basis for the training. The policy and procedure for seclusion did not reference any educational or training requirements.

Based on medical record review, staff interview and policy and procedure review, the facility failed to ensure physicians' orders for restraints were obtained and followed for 2 of 5 patients (#35, #7) who had been restrained. The findings were:

1. Medical record review for patient #35 showed s/he was physically restrained on 3/14/09, while an inpatient on the behavioral health unit. According to the physician's order dated 3/14/09 at 8:10 PM, two point leather restraints were to be applied to the patient's upper extremities. The patient was demonstrating self-injurious behaviors and attempting to pull out a suprapubic catheter. Review of the restraint flow record showed four-point leather restraints were used. Further review of the record showed no order for a four-point restraints. Interview with the chief nursing officer (CNO) on 1/7/10 at 12:45 PM confirmed the actual order was for two-point restraints.

2. Review of 1/4/10 nursing intensive care unit (ICU) patient information sheet showed patient #7 was admitted to the ICU from the emergency department (ED) on 1/3/10 at 10:34 AM with a ventilator and restraints. Review of the entire medical record showed no physician's order for the restraint. During an interview on 1/4/10 at 3:40 PM, registered nurse (RN) #1 stated she "forgot" to obtain a physician's order.

3. Review of the policy and procedure for medical/surgical (non-behavioral health restraints) with an effective date of October 18, 2005 showed, if a restraint was initiated by an RN based on appropriate assessment, "The licensed independent practitioner [LIP] is to be notified within 12 hours of the initiation of the restraint. The physician will examine the patient and write an order for the restraint within 24 hours of the restraint being used." The Federal requirement for any restraint application is that the LIP or physician will order the restraint prior to the application of the restraint or seclusion. In an emergency case, the order must be obtained during the emergency application or immediately after the restraint or seclusion is applied.

Based on staff interview, policy and procedure review, and review of the staff educational materials, the facility failed to ensure staff were adequately trained related to restraints and seclusion. The findings were:

Refer to A194 for evidence of the facility's failure to meet the training requirements for using restraints and seclusion.

Based on medical record review, policy and procedure review, and staff interview, the facility failed to ensure a one hour face-to-face evaluation was completed for 3 of 3 sample patients (#25, #26, #35) who were restrained for violent or self-destructive behavior. The findings were:

Refer to A179 for evidence of the facility's failure to complete the required 1-hour face-to- face evaluation.

Based on medical record review, staff interview, and review of the facility policy and procedures, the facility failed to include the required evaluation within one hour of the restraint initiation for 3 of 3 patients (#25, #26, #35) who were restrained for behavioral management. The findings were:

1. Review of medical records for patient #26 revealed s/he was admitted through the emergency department (ED) on 10/18/09. The patient's diagnoses included suicidal ideation. Review of the ED nursing notes showed the patient was placed in four-point leather restraints (all extremities) on 10/18/09 for the duration of one hour and thirty minutes. Review of the documentation including the "restraint flowsheet" failed to show a one hour face-to-face evaluation that included the patient's reaction to the intervention, the behavioral condition, and the need to continue or terminate the restraint. Review of the carepath showed the physician signed, dated, and timed a statement that referred to a one hour face-to-face assessment, however, there were no documented findings. Interview with the chief nursing officer (CNO) on 1/7/10 at 12:45 PM revealed she was unaware the evaluation did not cover the required areas.

2. Review of the medical record for patient #25 showed s/he was an inpatient on the behavioral health unit. On 12/2/09 at 5:45 PM the physician ordered four-point leather restraints due to "destructive disruption" and danger to others. Review of the "restraint flow record" showed staff failed to evaluate the required elements for the one hour face-to-face evaluation. The documentation did not describe the patient's reactions to the intervention, and review of the behavior form also failed to show an evaluation of these required areas.

3. Medical record review for patient #35 showed s/he was physical restrained on 3/14/09 at 8:18 PM while an inpatient on the behavioral health unit. The patient was demonstrating self-injurious behaviors and attempting to pull out a suprapubic catheter. According to the physician's order, two-point leather restraints were to be applied to the upper extremities. The restraint flow record showed four-point leather restraints were used. However, review of the medical record showed the one hour face-to-face evaluation was lacking. Interview with the CNO on 1/7/10 at 12:45 PM confirmed the restraint flow record was incomplete.

Based on medical record review, staff interview and review of training materials and employee education records, the facility failed to ensure staff were adequately trained for safe implementation of restraints and seclusion. The findings were:

1. Review of the medical record documentation for 4 of 5 patients reviewed for restraint use showed required information was lacking. Interview with the chief nursing officer (CNO) on 1/7/10 at 12:45 PM revealed all nursing staff received training related to restraint use. She stated the training was provided at orientation and annually thereafter. Review of the training materials, including an electronic training resource, and materials titled "Restraint Application and Documentation" showed the facility failed to train staff on the following Federal requirements:
a. "Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion."
b. "Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition."
c. "The safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress."
e. "Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary."

2. Review of the facility's policy and procedure for behavioral restraints, revised in March 2009, revealed "All persons involved in a physical escort/transport and restraint procedure should be aware of and use only those techniques that have been demonstrated in the Mandt training program for managing aggressive behavior." Review of the educational records for two employees who were involved in the application and monitoring of behavioral restraints showed the Mandt training was not completed. Although medical record reviews documented that staff applied four-point leather restraints and vest restraints, a review of the employee education files showed the only skills validation was related to the use of wrist restraints.

3. Review of the facility's restraint policies for medical /surgical and seclusion, both dated October 18, 2005, showed they failed to adequately address the requirements for staff education. Review of the policy and procedure for medical/surgical restraints showed multiple references to qualified/trained staff. However, there was no detail as to how staff would be trained or the periodic basis for the training. The policy and procedure for seclusion did not reference any educational or training requirements.

Based on medical record review, staff interview and review of training materials and employee education records, the facility failed to ensure staff were adequately trained for safe implementation of restraints and seclusion. The findings were:

Refer to A194 for evidence of the facility's failure to provide education and training regarding techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion.

Based on medical record review, staff interview and review of training materials and employee education records, the facility failed to assure staff were adequately trained for safe implementation of restraints and seclusion. The findings were:

Refer to A194 for evidence of the facility's failure to provide education and training regarding the least restrictive intervention based on an individualized assessment of the patient's medical or behavioral status or condition.

Based on medical record review, staff interview and review of training materials and employee education records, the facility failed to ensure staff were adequately trained for safe implementation of restraints and seclusion. The findings were:

Refer to A194 for evidence of the facility's failure to provide education and training regarding the safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress.

Based on medical record review, staff interview and review of training materials and employee education records, the facility failed to ensure staff were trained for safe implementation of restraints and seclusion. The findings were:

Refer to A194 for evidence of the facility's failure to provide education and training regarding clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.

Based on observation, staff interview and review of quality assessment and performance improvement (QAPI) records and contracts for selected hospital services, the facility failed to implement a hospital-wide QAPI program for all patient care services. The cumulative effect of this failure resulted in non-compliance with this condition. The findings were:

1. Review of the contracted agreement for anesthesia services on 1/7/10 at 10:40 AM failed to show evidence the contractor was required to measure or report on indicators showing patient care outcomes or strategies to reduce or prevent medical errors. Subsequent interview with the director of accreditation on 1/7/10 at 11:05 AM confirmed the absence of patient outcome indicators to assess the quality of anesthesia services. Refer to A1000 in regard to the failure to integrate anesthesia services into a hospital-wide QAPI program.

2. Observations in the facility during the dates of the survey revealed repeat deficiencies from previous surveys in the area of facility maintenance. On 1/05/10 at 11:49 AM the engineering manager reported the engineering department did not participate in the facility's quality assurance program. This lack of participation was confirmed by the facility director in an interview on 1/5/10.

Based on medical record review and staff interviews, nursing staff failed to provide appropriate supervision for 1 of 9 sample patients (#16) who were undergoing surgery. Due to this failure, laboratory (lab) tests were not completed as ordered prior to surgery. The findings were:

Review of the medical record showed patient #16 had preoperative surgical orders written on 12/31/09, which included lab tests for a complete blood count with differential and PT/INR and APTT (tests to ensure blood clotted in a timely fashion). These orders were noted by a registered nurse (RN) on 1/4/10 after the patient's admission for surgery that day. The orders also included instructions to "make sure the results of any ordered test are on the chart on call to OR[operating room]." Detailed review of the medical record with the nurse manager, RN #2, failed to reveal the lab test results. After checking with the lab on 1/5/10 at 11 AM, the nurse manager reported the lab had not received an order to perform the tests. Interview with the director of inpatient services on 1/6/10 at 1:20 PM confirmed the tests were not completed as ordered.

Based on observation, staff interviews, and review of policies and procedures, the facility failed to ensure medications were administered as ordered for 1 of 11 sample patients (#34) observed during medication passes. One error was observed out of 32 opportunities for error, resulting in an error rate of 3.1 percent. The findings were:

Observation on 1/5/10 at 8:55 AM showed registered nurse (RN) #3 prepared and administered medications, including the anti-seizure medication Dilantin, for patient #34. The RN had already poured liquid Dilantin into a medication cup, but instructions on the label of the bottle called for 100 milligrams (mg) per 4 milliliters (ml). The amount of medication in the cup could not be determined, as the cup was marked at 2.5 and 5 ml, and the liquid was above 2.5 ml but below the 5 ml mark. When asked how she determined the correct amount, the RN stated she poured liquid Dilantin into the medication cup and "estimated" the amount. After administering the medication, the RN stated she had "no reason" for not measuring the medication with a syringe and that she could have done so to ensure an accurate dose. Reconciliation of the medication with the physician's orders confirmed the order was Dilantin 100 mg per 4 ml.
Interview with the nurse manager, RN #4, at 8:58 AM that day revealed his expectation was that medication dosages be accurate and that syringes be used for accurate measurement when necessary. Review of the hospital's policy and procedure entitled "Medication Administration" Number: CLIN-MM-33, last reviewed and revised in August 2009, showed the "six rights" of medication administration included the "right dosage."

Based on observation, staff interview, and review of policies and procedures, the facility failed to ensure routine intravenous (IV) solutions were stored in a secure location. The findings were:

On 1/5/10 at 3:35 PM the director of pharmaceutical services stated routine IV solutions (those without additional medications) were stored in central supply as there was not room in the pharmacy. Observation on 1/7/10 at 7:45 AM showed IV solutions (such as Lactated Ringers, Normal Saline, Dextrose in Water) in various amounts were stored on multiple shelves in central supply. The door was open and staff did not immediately see the surveyor enter the area. Further observation revealed no signage limiting access to authorized personnel only. During the observation, the manager stated one of the doors to central supply was always unlocked. She confirmed the IV solutions were not stored securely.

Based on observation of 3 of 3 anesthesia carts, staff interview, and review of manufacturer's recommendations, the facility failed to ensure expired medications were discarded, that opened medications were labeled with the date opened, or that temperature-sensitive medications were properly stored. The findings were:

Observation with two peri-operative registered nurses and the medical director of peri-operative services on 1/5/10 from 1:25-1:35 PM showed medications in three anesthesia carts were stored and available for use in the following manner:
a. The first cart contained opened, but not dated, vials of glycopyrrolate, neostigmine, Esmolol, rocuronium, Xylocaine, Protamine, labetalol, and Anectine.
b. The second cart contained opened, but not dated, vials of glycopyrrolate, neostigmine, lidocaine, rocuronium bromide, sodium chloride and Anectine.
c. The third cart contained a vial of labetalol and a vial of Protamine, each labeled with a 10/09 opened date (more than two months prior to the observation).

According to the pharmaceutical manufacturer's recommendations: Opened multi-dose vials of Anectine lose potency after fourteen days at room temperature and opened vials of rocuronium bromide should be used within thirty days of being stored at room temperature. Review of the facility's policy and procedures for Storage of Medications, revised July 2009, showed, "Sterile multi-dose vials can be used for only 28 days after opening."

Based on observation, staff interview, review of the facility's work orders, and review of manufacturer equipment manuals, the facility failed to ensure appropriate daily management for food storage in the behavior health unit. In addition, they failed to monitor for routine sanitization of ice machine equipment throughout the facility that produced ice for patient consumption. The findings were:
According to the 2009 food code, 3-305.11 food storage, "(A) Except as specified in (B) and (C) of this section, food shall be protected from contamination by storing the food:
(1) In a clean, dry location;
(2) Where it is not exposed to splash, dust, or other contamination ..."

1. The following failures to follow practices specified in the Food Code for safe food storage was identified on 1/4/10 at 3:12 PM:
a. Observation of the dining area in the behavior health unit revealed food items were left unrefrigerated, uncovered, and unlabeled. The items included three slices of lemon meringue pie, a container of carrot and celery sticks, and a pastry with a fruit and creamy center. Interview with the unit charge nurse at that time revealed the items were leftovers from breakfast and lunch and were available for patient consumption. She stated the items would be discarded when the next meal arrived and she was unaware of the need to cover or refrigerate them.
b. Observation of the food storage area for the unit revealed a narrow enclosed hall-like area which housed the ice machine, bags of dry cereal, condiments, and bottles of soda pop. A stacked washer and dryer unit with an open container of washing detergent on the floor near the washer were also located in the same enclosed area. Interview with the charge nurse revealed she did not know when the washer was last used, but stated the dryer was used by staff to warm blankets. She identified the washer-dryer unit as a "back-up" for patient use.

2. Observation on 1/4/10 at 2:19 PM of the ice machine on the behavioral health unit revealed a water filter which was undated. Interview with the unit charge nurse on 1/4/10 at 3:15 PM revealed maintenance staff was responsible for changing the water filter. She stated she did not know who sanitized the ice machine. Further observations of ice machine filters throughout the facility, review of work order documentation related to "colored" ice on one unit, and staff interviews revealed the following concerns related to routine sanitization of ice machines:
a. On 1/5/10 at 8:23 AM, the surveyor requested a copy of the ice machine sanitization policy or procedure from the infection control nurse. At 11:05 AM, the policy was delivered to the survey team. At that time, the survey team was told the facility did not have a policy or procedure that addressed ice machine sanitization, and the current policy had been developed that day.
b. Review of facility work orders for ice machines dated from 6/8/09 to 6/16/09 showed, the Same Day Surgery unit ice machine had produced colored ice, ranging from pink to gray. The work orders showed maintenance tried to resolve the problem, but after six separate attempts, a new ice machine was installed on 6/17/09.
c. Interview with one of the maintenance staff (M )#1 on 1/6/10 at 10:17 AM revealed machine sanitization was the responsibility of the housekeeping staff.
d. Interview with two housekeeping staff (H#1 and H#2) on 1/6/10 at 10:30 AM revealed H#1 said she was unaware of the responsibility for disinfecting the machines. H#2 said the housekeeping staff did not know until the day before (1/5/10) that they were responsible for disinfecting the interior of ice machines on the patient care units.
e. On 1/6/10 at 10:30 AM interview with the assistant housekeeping manager revealed housekeeping staff were to disinfect/sanitize interiors of all of the ice machines weekly. She stated currently there was no monitoring system in place. The assistant manager provided the disinfection policy for the machines, which was the same policy identified on 1/5/10 at 11:05 AM as "just" having been developed.
f. Review of the manuals with the manufacturers' directions for the various machines throughout the facility showed all of the ice machines were to disinfected at least quarterly. Additional review of the manuals showed the specific disinfectant agents varied according to the manufacturer. One manufacturer permitted a household bleach solution as a disinfecting agent; however none of the manuals identified vinegar as a disinfecting agent as allowed by the facility's newly developed policy.

According to the 2009 Food Code, Chapter 4 - Equipment, Utensils, and Linen, 4-6 Cleaning of Equipment and Utensils, Frequency: 4-602.11 Equipment Food-Contact Surfaces and Utensils:
(E) 4. (4) In EQUIPMENT such as ice bins and BEVERAGE dispensing nozzles and enclosed components of EQUIPMENT such as ice makers, cooking oil storage tanks and distribution lines, BEVERAGE and syrup dispensing lines or tubes, coffee bean grinders, and water vending EQUIPMENT:
(a) At a frequency specified by the manufacturer, or
(b) Absent manufacturer specifications, at a frequency necessary to preclude accumulation of soil or mold.

Based on observation, staff interview, and review of facility documentation, the facility failed to ensure manufacturers' directions for routine maintenance of water filtration devices were followed. The findings were:

1. Observation of the ice machine on the behavioral health unit on 1/4/10 at 2:19 PM revealed an undated water filter. The brown filter was encased in clear plastic and had visible debris accumulated on its surface.

2. Interview with the unit charge nurse on 1/4/10 at 3:15 PM revealed the maintenance staff was responsible for changing the water filter. Observations of other ice machine filters throughout patient care areas in the facility on 1/6/10 revealed various filters in use. A total of five different types of filters were observed in patient care areas. Some were labeled with date last changed; some were not.

Interview with one of the maintenance staff (M #1) on 1/6/10 at 10:18 AM revealed he worked in the engineering department and was familiar with the water filters for the ice machines. He stated the facility's preventive maintenance system required work orders to be issued for when preventative maintenance, such as changing the water filters. He stated water filters were changed approximately every six months, but the facility did not have a systematic schedule for this task or a system for verifying the last filter change date. He confirmed that the date on a filter was the last change date.

Later that day at 10:44 AM, a maintenance staff person was able to provide the manufacturer's information for one of the five types of filters. He confirmed it to be the type of filter used in the facility's patient care tower units. The box label documented it as an "aqua-pure water filter #AP327" and listed the filter life for 1500 gallons of water. He stated there was no way to know how many gallons of water passed through the filter by the time it was changed. He stated it would vary on patient census and the amount of ice staff used. He confirmed no information was available for the other filters throughout the hospital. As a result, it was unclear whether a fixed six month filter change interval was appropriate.

3. Review of work orders for ice machines throughout the facility revealed issues with the discolored ice produced by the Same Day Surgery unit ice machine. A work order dated 6/8/09 documented, "Ice machine is still putting out pink ice. [C]hanged filter Friday, but it didn't help the problem..." On 1/6/10 at 11:15 AM, observation of this filter revealed a change date of "June 2009." Also, on 1/6/10, filter observations revealed un-dated filters in the post-anesthesia care unit and in the surgical procedure area.

Based on observation, staff interview, and review of infection control policies and procedures, the facility failed to ensure staff maintained a sanitary patient care environment and complied with practices to reduce the potential transmission of infections. Specifically, housekeeping staff did not obey signs identifying infection precautions during 4 of 5 observations of staff entering posted patient rooms. The facility further failed to ensure 17 of 32 (53%) containers of disinfectant wipes were properly stored to retain their antimicrobial properties. In addition, the facility failed to ensure staff minimized exposure risks from blood splatter, soiled laundry, and potentially contaminated ice machines. Due to the cumulative effect of the deficiencies and the unnecessary and preventable risk to patient and employee health, the condition of participation for infection control was not met. The findings were:

1. An infection control tour of the facility was performed on 1/5/10 with the infection control nurse (ICN). While on tour, five observations were made of housekeeping staff entering patient rooms posted with precautionary signage (i.e.,contact and droplet precautions related to an infection). Of these five observations, four consisted of breeches in appropriate infection control practices; these events were:
a. On 1/7/10 at 10:35 AM room 8202 was observed to be posted with a "Contact Precautions" sign and a caddy containing personnel protective equipment (PPE), such as gloves, mask, and gowns, was affixed to the door. The sign stated potential infectious conditions existed and directed staff and visitors to use PPEs before entering the room and to wash their hands upon exiting. An unidentified housekeeper was observed to exit room 8202, remove PPE in the hallway and sanitize his hands. He then reentered the room without any PPE and placed his hands on the patient's bedding, bedside table, cloth partition, and dresser top. He exited the room and did not wash or sanitize his hands until the ICN intervened and directed him to wash his hands.
b. On 1/7/10 at 10:55 AM a housekeeper was observed to enter room 7208 without gloves or other PPE; the room was posted with a "Contact Precautions" sign. The housekeeper removed trash from the patient's room, repositioned a bedside table, and exited the room without using any PPE. She handled several items on her cleaning cart and did not sanitize her hands until prompted by the ICN.
c. A used facial mask was found on top of the PPE caddy hanging from the door to room 7208. The ICN stated on 1/7/10 at 10:40 AM that infection control policies required all PPE items be disposed of immediately after use.
d. On 1/7/10 at 2:25 PM a housekeeper was observed exiting from intensive care unit (ICU) room 10, a room posted with "Contact Precaution" signage. She removed the disposable gown and mask donned when entering the room, but did not remove the disposable gloves she wore when cleaning inside room 10. The housekeeper used her gloved hands to move a cleaning cart, a trash can, and a linen cart all located in the hallway outside the room. The ICN intervened to prevent the housekeeper from entering another room without removing the gloves and washing her hands.
e. Interview with the ICN on 1/7/10 while on the infection control tour (10 AM to 11:55 AM and again from 2 PM to 4:15 PM) revealed the facility adopted the Centers for Disease Control and Prevention (CDC) Guideline for Isolation Precautions, published June 2007. The CDC Guidelines recommends that "Healthcare personnel caring for patients on Contact Precautions wear a gown and gloves for all interactions that may involve contact with the patient potentially contaminated areas in the patient's environment. Donning PPE upon room entry and discarding before exiting the patient room is done to contain pathogens..." The ICN acknowledged housekeeping staff were trained to use PPE as directed by the precautionary signage and used an alcohol-based hand rub after removing their gloves.

2. A tour of the hospital on 1/4/10 revealed disinfectant wipes were widely available and used by staff to clean durable items such as glucometers, blood pressure cuffs, stethoscopes, and high touch surfaces in patient rooms and common areas. Subsequent observations on 1/5/10 and 1/6/10 identified the following deficiencies:
a. Seventeen of 32 plastic containers (53%) of disposable wipes on the medical, surgical, oncology, pediatrics, and mother-baby units were left open after use. The manufacturer's label stated the containers were to be closed after use to preserve the antimicrobial activity of the disinfectant.
b. Of the wipes extending from the unsealed containers, 5 (29%) were dry to the touch, an indicator the alcohol-based disinfectant solution had evaporated and reduced the disinfectant properties of the wipe.
c. A telephone call to the manufactures' technical representative on 1/6/10 at 2:20 PM confirmed the disinfectant wipes were to be stored with the re-sealable container closed. The representative further stated the wipes should not be used to clean equipment or contact surfaces once they had dried because the disinfectant was "...not any good..." once the wipes were dehydrated.
d. The ICN stated on 1/6/10 at 3:20 PM staff were expected to follow the manufacturers' recommendations to close disinfectant wipes containers after use. She acknowledged the potential loss of disinfectant properties if the wipes were allowed to dry out.

3. a. The initial tour of hospital-based outpatient services was done on 1/4/10 from 3:25 to 4:30 PM. Two housekeeping carts were observed with pump dispensers containing an alcohol-based hand sanitizer. One of the sanitizing solutions was observed to have an expiration date of October 2008. The housekeeper was interviewed at the time of this observation and stated she did not know the product had expired. She acknowledged it was her responsibility to replace empty containers.
b. On 1/5/10 at 2:30 PM, observation in one of the bathrooms in the peri-operative area showed a container of alcohol-based hand sanitizer available for use that had expired in November 2008.

4. Observation in room 5125 on 1/6/10 at 4:25 PM showed a pair of shoes covered with red-brown material that resembled dried blood. A second pair of shoes were fitted with disposable blue shoe covers; closer observation showed the bottoms of the covers were worn from previous use (e.g., dirty, small holes in the disposable material). Registered nurse (RN) #5 was present for the observation and stated the room was used by the OB/GYN on-call physician. The RN further stated she thought the red-brown material was dried blood. Interview with the ICN on 1/7/10 at 9:45 AM revealed her expectation that all staff should remove clothing and shoes contaminated with blood or body fluids. She viewed room 5125 and confirmed her impression the red-brown material was dried blood. She further stated disposable shoe covers were to be discarded before leaving a procedure room or a patient's room; they were not to be worn around the unit.

5. Touring the East Campus building on 1/7/10 from 8 AM to 9:30 AM with the ICN revealed the following infection control deficiencies:
a. Observations in the mental health and acute recovery units showed 2 of 7 disinfectant wipe containers had been left open. The exposed wipes in each open container were dry to the touch.
b. A laundry cart was observed in the back hall of the mental health unit at 8:40 AM. The cart contained dirty linens from patient rooms. The linens were not bagged, nor was the cart covered. Patients and staff were seen walking in the hallway in the immediate vicinity of the uncovered dirty laundry.
c. A food storage room located off the main dining room in the behavioral health unit included a stacked washer/dryer unit in addition to prepackaged foods and an ice machine. A white powdery residue was observed in the detergent tray on the washer and lint was present in the dryer lint trap. She stated the washer/dryer in the food storage closet had been used in the past to wash patient laundry. She acknowledged patients would have to bring dirty clothing into the food storage area to use the washer/dryer.

6. On 1/5/10 a series of maintenance work orders initiated by the Same Day Surgery (SDS) service were reviewed. These documents showed the SDS experienced ongoing problems with their ice machine form 6/8/09 through 6/14/09. The complaints involved colored ice, from pink (8-9 June) to gray (10 June) and back to pink(14 June).

a. Interview with maintenance staff (M #1) on 1/6/10 at 10:18 AM revealed he worked in the engineering department and was familiar with the water filters for the ice machines. When asked if he was aware of issues with colored ice in the SDS unit, he stated he believed the off-color of the ice was due to bacteria. When asked how he knew it was bacteria, he responded, "What else could it be?"
b. A telephone interview with the ICN on 1/7/10 at 3:20 PM revealed she was unaware SDS had concerns about the quality of ice produced by their machine, nor the assumption by maintenance personnel that bacterial contamination was responsible for the colored ice. She added that hospital staff were supposed to report possible contamination of a water source or an ice machine to the infection control office for follow-up investigation.

Based on observation, review of the surgical policies, patient records, and interview with staff, the facility failed to develop policies and procedures and document measures to ensure patient safety for use of alcohol based skin preparations in anesthetizing locations for 9 of 9 sample patients (#4, #6, #8, #9, #11, #12, #16, #22, and #24). In addition, the facility failed to follow the pre-operative orders for 1 of 9 (#16) sample patients. The combined effects of these deficeincies resulted in the facility's failure to meet the conditons of participation for surgical services which requires that care be provided in a safe environment and according to acceptable standards of practice. The findings were:

Refer to A951 for evidence of the facility's failure to develop policies and procedures and document measures to ensure patient safety for the use of alcohol-based skin preparations in anesthetizing locations, and the facility's failure to follow pre-operative orders.

Based on observation, review of surgical services polices, patient records and interview with staff, the facility failed to develop policies and procedures for use of alcohol-based skin preparations in anesthetizing locations. In addition, the facility failed to document measures that were implemented to ensure patient safety during the use of alcohol-based skin preparations for 9 of 9 sample patients (#4, #6, #8, #9, #11, #12, #16, #22, and #24) who received care and services in anesthetizing locations. The facility further failed to follow the pre-operative laboratory orders for 1 of 9 (#16) sample patients. The findings were:

1. Review of 9 of 9 patients' (#4, #6, #8, #9, #11, #12, #16, #22, and #24) operative records revealed a lack of documentation regarding the implementation of safety measures during the use of alcohol based skin preparations. Review of the anesthesia and surgical policies and procedures revealed the facility did not have any policies and procedures for the use of alcohol-based skin preparations. Interview with the director of perioperative services on 1/6/10 at 2 PM revealed the facility routinely used alcohol-based skin preparations in anesthetizing locations, but the safety policy and procedures did not specifically address alcohol-based skin preparations. She also stated there was a lack of documentation and implementation because she was unaware of the regulatory requirements.

2. Review of the medical record showed patient #16 had preoperative surgical orders written on 12/31/09 that included laboratory (lab) tests for a complete blood count with differential and PT/ INR and APTT (tests to ensure blood clotted in a timely fashion). These orders were noted by a registered nurse on 1/4/10 after the patient's admission for surgery that day. The orders also included instructions to "make sure the results of any ordered test are on the chart on call to OR [operating room]." Review of the surgical checklist completed prior to the patient's transfer to surgery on 1/4/10 showed "LABS...labs drawn...results on chart" were included on the list, but all areas were blank. Review of the perioperative nursing record dated 1/4/10 showed the "pre-op checklist" was documented as complete. However, during the transfer, no one checked to ensure the ordered lab work was completed and on the record. According to the hospital's policy and procedure entitled "Care of the Pre-operative Patient in the Pre-op Hold Area in PACU" last revised September of 2004, the pre-op checklist will be "...completed by floor RN and on chart." Refer to A0395 for additional details related to failure to complete the ordered lab work.


27095

Based on observation, medical record review, staff and anesthesiologist interviews, and review of quality assessment and performance improvement (QAPI) records, the facility failed to integrate anesthesia services into a facility-wide QAPI program, therefore, the condition of particiaption for anesthesia services was not met. In addition, the facility failed to ensure postanesthesia evaluations were completed in accordance with standards of anesthesia care for 9 of 9 sample patients (#4, #6, #8, #9, #11, #12, #16, #22, and #24) who received an postanesthesia evaluations. The facility further failed to ensure two (#6, #16) patients were sufficiently recovered from the acute administration of the anesthesia to particiapte in the post anesthesia evaluation. Finally, the facility failed to appropriately retain medications for future use in 3 of 3 anesthesia carts. The cumulative effects of these systemic failures resulted in the facility's inability to identify and address quality of care and infection control issues. The findings were:

1. During an interview on 1/6/10 at 10:25 AM, the medical director of peri-operative services said his responsibilities included managing the facility's anesthesia services, but he was unable to provide information about integration of anesthesia services into the hospital-wide QAPI program.

2. On 1/7/10 at 10:35 AM, review of the contract for anesthesia services with the Directors for Accreditation and Data Management, revealed it did not require the service provider to assess improved patient outcomes or initiatives to prevent medical errors. The only QAPI requirements expressed in the contract were specifically related to the availability of on-call personnel for preoperative consultation, response time when requested by hospital staff, and availability for trauma/emergency. The agreement did not require the contractor to report on patient care outcomes or error reduction strategies for anesthesia services. The accreditation director stated in interview on 1/7/10 at 10:45 AM she was not aware of any additional monitoring performed or reported by anesthesia services. Neither was she aware if criteria cited in the contract, i.e., availability and response time, were measured and reported by the contractor for consideration by the hospital QAPI committee.

3. Refer to A505 for evidence of the facility's failure to ensure expired medications were discarded, opened medications were labeled with the date opened, or that temperature-sensitive medications were properly stored in the anesthesiology carts.

4. Refer to A1005 for evidence of the facility's failure to ensure postanesthesia evaluations were completed in accordance with standards of anesthesia care.

Based on medical record review, staff interview, and interview with an anesthesiologist, the facility failed to ensure two (#6, #16) patients were sufficiently recovered from the acute administration of the anesthesia to participate in the postanesthesia evaluation. In addition, the facility failed to ensure postanesthesia evaluations were completed in accordance with standards of anesthesia care for 9 of 9 sample patients (#4, #6, #8, #9, #11, #12, #16, #22, and #24) who received postanesthesia evaluations. The findings were:

Review of the Center for Medicare and Medicaid State Operations Manual for Hospital Surveys, revised 12/11/09, and The Practice Guidelines for Postanesthetic Care, developed by the American Society of Anesthesiologist, 2002, showed the patient should be sufficiently recovered from the acute administration of anesthesia in order to participate in the postanesthesia evaluation. In addition, review of both sources showed the elements of an adequate postanesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including respiratory function, cardiovascular function, mental status, temperature, pain, nausea and vomiting, and hydration. The following concerns were identified:

1. According to the medical record, patient #6 had open heart surgery on 12/28/09 under general anesthesia. Review of the anesthesia record showed anesthesia started at 7:32 AM and ended at 2:31 PM. During that time period, the patient was on the cardiopulmonary (heart-lung) bypass machine for 2 hours and 11 minutes. Review of the post-anesthesia evaluation showed it was done at 2:36 PM, 5 minutes after anesthesia ended, and that the patient remained intubated and was "not awake yet." There was no evidence that the patient was sufficiently recovered from anesthesia to participate in the evaluation, or that pain, nausea and vomiting, and postoperative hydration were addressed.

2. Review of the surgical record showed patient #16 had surgery on 1/4/10 for repair of a malaligned tibial fracture. Review of the anesthesia record showed the patient was intubated and anesthesia, which lasted 2 hours and 14 minutes, ended at 11:12 AM. Further review showed the post-anesthesia evaluation was completed at 11:14 AM. Although the evaluation documented the patient was "awake", there was no evidence s/he participated in the evaluation, or that the anesthesiologist addressed pain, nausea and vomiting, or postoperative hydration.

3. Review of postanesthesia evaluations for the following patients showed two or more of the required elements were lacking for the following patients: #4 on 1/2/10, #8 on 11/23/09, #11 on 1/4/10, #12 on 1/4/10, #6 on 12/28/09, #16 on 1/4/10, #22 on 1/5/10, #24 on 7/1/09, and #9 on 1/4/10.

4. Interview on 1/6/10 at 10:25 AM with the medical director of peri-operative services, who is also an anesthesiologist, said the anesthesiologist did not not consistently conducted postanesthesia evaluations according to the referenced standards because scheduled procedures did not allow time to do the evaluations at a later time. At that time he also verified the missing elements in the postanesthesia evaluations.

Based on staff interview and review of job descriptions and personnel files, the provider failed to assure the medical staff approved the qualifications, training, functions, and responsibilities of all nuclear medicine personnel. The findings were:

During an interview on 1/6/10 at 10:55 AM, the interim director of medical imaging stated the medical staff had not approved the qualifications, training, functions, and responsibilities of the nuclear medicine personnel, unless approval was included in the new job descriptions developed by human resources. Review of the job descriptions with the director showed medical staff approval was not included. Review of personnel files showed no evidence medical staff approval had been obtained. On 1/7/10 at 4:50 PM, the interim director stated she had been unable to locate any documentation providing evidence the medical staff approved the regulatory requirements for nuclear personnel.