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Based on observations, staff interview and review of documentation, the Hospital failed to have an effective governing body legally responsible for the conduct of the hospital as follows:

Failure to ensure that the hospital's building and equipment were repaired and maintained to ensure patient safety when concerns regarding the hospital's medical gas system were identified in Jan. 2010 and remain on-going, not corrected and lacked a system in place to monitor on an ongoing basis. (Please refer to A083, A700 and A724)

Failure to ensure patients' rights were met regarding consents for procedures. (Please refer to A131)

Failure to ensure patient's privacy was maintained during an examination by a physician. (Please refer to A142)

Failure to ensure patients received care in a safe setting. (Please refer to A144)

Failure to ensure the Facility's Maintenance services responsible for the hospital's building and equipment consistently collected and submitted QA data for measurement, analysis and tracking by the Hospital ' s QA program. (Please refer to A267)

Failure to ensure that a Registered Nurse was made immediately available for the supervision and immediate management of patients requiring cardiac monitoring (Please refer to A395)

Failure to ensure that staff consistently implemented infection prevention and control protocols (Please refer to A749)

Failure to ensure there was a designated requestor or an individual who has completed a course approved by the Organ Procurement Organization, for approaching potential donor families or patients and requesting organ or tissue donation and patient care staff, were trained on donation issues and that the training program is developed in cooperation with the Organ Procurement Organization. (Please refer to A889 and A891)

Based on observation, review of facility reports and staff interview, the facility failed to ensure the hospital's building was maintained to ensure the safety of the patients requiring suction for 9 sampled patients, (#2, 3, 5, 6, 10, 21, 24, 25, and 26) out of a total sample of 30 and 5 additional patients requiring suction. Findings include:

During the initial entrance conference, on 5/18/11 at 8:30 A.M., the Chief Clinical Officer explained that this hospital was a 50 bed facility with a current census of 35. One of the main services provided was pulmonary care to respiratory patients on ventilators. This included suctioning patients on an ongoing basis to maintain a clear airway.

Observations during initial tour in the morning of 5/18/11, revealed at each patient's bedside there were 3 wall outlets, 1 for air, 1 for oxygen and 1 for suction/vacuum. The medical gases and suctioning were supplied via this wall system. There were 14 patients in-house which required suctioning to maintain a clear airway.

Per the NFPA 1999 edition, 4-3.2.1.1 Multiple Pumps and 4-3.2.1.2 Backup Operations revealed, there needs to be 2 or more pumps installed and there needs to be a device provided to automatically activate the additional pump(s) if one pump in operation is incapable of adequately maintaining vacuum.

Interview with the Director of Plant Operations in the morning of 5/19/11 revealed that currently 2 out of the 3 vacuum pumps which control the in-wall suction units at each bedside were not working and have not been working since May 6, 2011. On May 12 the 2 non-functioning vacuum pumps were sent out of the facility for repair. The Director of Plant Operations revealed that the need to fix and or replace the vacuum pumps has been an on-going problem since Jan. 2010 when identified by a outside vendor company. (This company periodically is called to the hospital to provide maintenance work to the hospital's medical gas system).

In the event the last vacuum pump malfunctioned, no in-wall suctioning would be available. The plan was to have a portable suction machine accessible at the bedside of each patient who needs suctioning.

Interview with the Clinical Care Officer, (CCO) on 5/19/11 at 1:30 P.M. revealed that the CCO was not aware that the building was down to 1 working vacuum pump. The CCO stated that if the last vacuum pump went down, there would be no suction available from the wall outlets and therefore portable suction machines would be placed at the patient's bedside and a Code Purple would be called. Per Code Purple policy, the purpose of calling a code purple is to notify all staff members of the disruption of Oxygen, Vacuum and or Ventilation disruption.

Per the Code Purple signage, which is placed outside a patient's room during a Code Purple stated, "in the event of:

1. Oxygen Disruption, oxygen cylinders must be in place for use.
2. Vacuum Disruption, portable suction units must be placed in use.
3. Ventilation Disruption, all patients requiring mechanical ventilation must be manually ventilated".

Review of the documentation entitled "Vacuum Pump repair time line" given to the surveyor on 5/23/11 at 12:30 p.m. from the Director of Plant Operations revealed:

- in February 2011, 1 out of the 3 vacuum pumps failed to work.
- on April 21, 2011 another vacuum pump failed to work and the facility called a Code Purple at 9:05 A.M. (At this point only 1 pump was working).
- at the time "Code Purple" was called, the facility rented portable suction machines/pumps to insure there were enough suction machines for patients in case the 3rd pump went down.
- at some point one of the failed pumps was reset and started to work, thus the facility then had 2 functioning vacuum pumps.
- on April 26, 2011 the portable rented suction machines/pumps were returned.
- on May 6, 2011 one of the functioning vacuum pumps did not work again, thus leaving only 1 out of 3 vacuum pumps operational. Although no "Code Purple" was called at this time, on 5/6/11, the Respiratory Director called and had delivered additional rented portable suction machines as back-up to meet the needs of patients who may need suctioning.
- on May 12, 2011 the 2 non-operating pumps were removed from the hospital for repair.

On May 19, 2011 at 1:30 P.M., the surveyors brought to the administrative staff's attention that the hospital was down to their last working vacuum pump. The CCO implemented a Code Purple at that time, and the Respiratory Therapist Director proactively rented 5 additional portable suction machines.

Interview with the Director of Respiratory Therapy on 5/23/11 at 12:15 P.M., revealed that
on 5/19/11 14 patients required suctioning; on 5/20/11, 16 patients required suctioning. In order to fully implement a code purple, two additional portable suction machines were needed so that each patient who was being suctioned had backup portable suction available at the patient's bedside. On 5/22/11 6 additional portable suction machines arrived at the facility. On the same day, the 2 failed vacuum pumps were returned to the facility.

The facility failed to adequately repair and/or replace the medical gas/ vacuum system, to resolve the problems identified since January 2010. None of the repairs resulted in a reliably functioning system.


(Please refer to A 724).

Based on review of the Governing Body meeting minutes, review of contracted services and interview with staff, the governing body failed to ensure that services provided by an outside company to provide routine and preventive maintenance and testing of the hospital's medical gas and vacuum/ suctioning system comply with all applicable conditions of participation and standards for the contracted services.

Finding include:

1. Interview with the Director of Plant Operations, the morning of 5/19/11, revealed that currently 2 out of the 3 vacuum pumps which control the in-wall suction units at each bedside were not working and have not been working since May 6, 2011. The Director of Plant Operations revealed that the need to fix and or replace the vacuum pumps has been an on-going problem since Jan. 2010 when identified by a outside vendor company. This company periodically is called to the hospital to provide maintenance work to the hospital's pumps and medical gas system. The Director of Plant Operations revealed that the in-house maintenance department staff did not have the knowledge or training to provide routine testing of the hospital's medical gas/ in-wall suctioning system and would need to rely on outside help.

2. Review of the Governing Body meeting minutes for the last year lacked reference to how the medical gas system was managed. Interview with the Chief Executive Officer (CEO) on 5/26/11 at 8:15 A.M., confirmed there was no formal process in place to provide a formal preventative maintenance program.


(Please refer to accompanying CMS- Form 2567 Life Safety Findings of 05/25/2011)

Based on record review and review of facility policy the hospital failed to follow it's policy for informed consent for 2 of 3 applicable patients, (#7 and #26), requiring a peripherally inserted central catheter (PICC) line in a total sample of 30.

Findings include:

1. A PICC is an invasive intravenous procedure where a peripheral site is used to introduce a catheter that is advanced through increasingly larger veins, toward the heart. Per hospital policy the procedure requires informed consent. The hospital policy on informed consent (H-PC 04-004) specifically stated that the "RN obtaining the informed consent may not sign as a witness". The Special Procedure Nurse (RN #2 ) routinely placed PICC lines.

2. Record review on 5/19/11 at 10:00 A.M. for patient #26 who had a PICC line inserted on 4/2/11 and for patient # 7, who had a PICC line inserted on May 17, 2011, revealed the nurse, Special Procedure Nurse (RN #2), who inserted, the catheter witnessed the consent his/herself, despite the hospital policy.

Based on record review and staff interview one of one applicable (non-sampled #3) patient, was not provided with privacy during an examination by a Physician #1 in the Intensive Care Unit (ICU) in May 2011. Physician #1 examined the Patient in view of three visitors within the room and staff in the ICU.

The findings are as follow:

Observation by this Surveyor on 05/19/11 at 11:50 AM indicated Physician #1 entered a precaution room for the non-sampled #3 Patient, who had a chest tube. Physician #1 examined the non-sampled #3 Patient and listened to the lung sounds of non-sampled #3 Patient.

Registered Nurse #2 was approached by this Surveyor. Registered Nurse #2 was informed Physician #1 was in examining the non-sampled #3 Patient without wearing PPE's and examining the patient in full view of three visitors in the room. Registered Nurse #2 said Physician #1 was not following the Hospital's Policies and later approached Physician #1.

The non-sampled #3 Patient was not provided with personal privacy.

Refer to A-Tag 0749.

Based on observation, record review and staff interview, the Facility failed to ensure that patients received care in a safe setting for ten of ten applicable patients (#4, #5, #20, #21,#22,#23, #24, #25 and a non-sampled #2) requiring cardiac telemetry and a patient (#7) with a tracheostomy who required oxygen saturation level monitoring.

The findings are as follow:

1. On 05/18/11 at 8:00 AM the Chief Clinical Officer (CCO) said the Hospital had recently implemented a system change in the monitoring of patients requiring cardiac telemetry. The Chief Clinical Officer said all patients requiring cardiac telemetry were monitored by a central monitor located in the Intensive Care Unit (ICU) with a telemetry technician seated 24/7 at the telemetry central station. As observed throughout each day on 05/18/11 and 05/19/11, a vendor consultant/representative was observed instructing the telemetry technicians on the new equipment. As observed, the telemetry technicians would call the Central One Unit with changes to the patients cardiac rhythm, oxygen saturation levels, electrode disconnections and/or any other emergent alerts; as seen on the central telemetry monitors in the ICU. The slave/satellite cardiac monitors remained on the Central One Unit at the Nurses Station, there was no longer an assigned telemetry technician and/or licensed nurse to watch the monitors. All communication for the patients cardiac status and/or medical condition as interpreted by cardiac telemetry originated in the ICU and called to the staff assigned to the patients on the Central One Unit.

2. On 05/23/11 at 9:07 AM, two Surveyors observed that nine patients on the Central One unit were on cardiac telemetry monitors. At 9:12 AM, Telemetry Technician #1 came to the Central One Unit from the ICU, carrying a electrocardiogram (EKG) strip, looking for the registered nurse assigned to Patient #4. Surveyors were the only individuals at the nurse's station at that time. Telemetry Technician #1 informed surveyor that Patient #4 had a rapid heart rhythm. Patient #4 had a sinus tachycardia (rapid rate) of 140 beats per minute per rhythm strip. Patient #4 had a tracheostomy and was on a mechanical ventilator. Per interview, Telemetry Technician #1 had been calling on the telephone to contact the registered nurse assigned to Patient #4, but the telephone calls went unanswered. (The surveyors observed the phone ringing continuously prior to the arrival of Telemetry Technician #1). Telemetry Technician #1 informed Registered Nurse#1 that Patient #4 had the rapid tachycardia recorded as 140 beats per minute and left the rhythm strip at the Nurses Station.

Registered Nurse #1 said Patient #4 had been transferred out of bed by a physical therapy assistant and Patient #4's heart rate had increased. Registered Nurse #1 said the physical therapy assistant returned Patient #4 to bed. Registered Nurse #1 was not alerted to Patient #4' s heart rate until Telemetry Technician #1 arrived on the Central One Unit.

Nursing Supervisor #1 arrived on the Central One Unit at approximately 9:35 AM on 5/23/11. Nursing Supervisor #1 came to the Central One Unit, as a routine to rounding on the Central One Unit. As Nursing Supervisor #1 was leaving the Central One Unit, this Surveyor informed Nursing Supervisor #1 of the communication problem between the ICU Telemetry Technician and the staff on Central One Unit. Nursing Supervisor #1 said there were walkie-talkie communication devices available, but the devices/units had not been dispensed to the nursing staff on Central One. Nursing Supervisor #1 was informed that the telephone at the Nurses Station had been ringing, and there was no one there to answer the phone.

Interview with the CCO on 5/23/11 at 11:00 A.M. revealed that there was a plan in place to address communication which included issuing walkie-talkie communication devices for the nurse to carry with them at all times and have direct communication with the telemetry technicians. Those devices were not handed to the nurses on duty that morning. However,
the technicians were sufficiently trained when to notify the nurse and when to call a rapid response when there was an abnormal finding on the telemetry monitor or any other alert. Observation on subsequent days indicated that walkie talkies were dispensed appropriately, and the nurses station was staffed so that phone calls were answered.

3. On 05/23/11 at 10:00 AM, Respiratory Therapist #1 instructed Licensed Practical Nurse (LPN) #2 to turn off the alarms to Patient #7's pulse oximetry/oxygen saturation level detector because the alarm was too noisy. Patient #7 had a tracheostomy and required frequent suctioning to clear the airway. Interview with LPN #2 confirmed that s/he silenced the alarm per instructions from Respiratory Therapist #1 while providing care for Patient #7.

The Hospital failed to ensure the safety of ten of ten patients on cardiac telemetry monitoring and/or needing pulse oximetry on Central One Unit during the morning of 05/23/11.

Refer to A-tag 0395.

Based on record review and staff interview, the Facility failed to ensure that a Registered Nurse was made immediately available for the supervision and immediate management of nine of nine patients (#4, #5, #20, #21, #22,#23, #24, #25 and a non-sampled #2) requiring cardiac telemetry monitoring on Central One Unit in May 2011.

The findings are as follow:

1. On 05/18/11 at 8:00 AM the Chief Clinical Officer (CCO) said the Hospital had recently implemented a system change in the monitoring of patients requiring cardiac telemetry. The Chief Clinical Officer said all patients requiring cardiac telemetry were monitored by a central monitor located in the Intensive Care Unit (ICU) with a telemetry technician seated 24/7 at the telemetry central station. As observed throughout each day on 05/18/11 and 05/19/11, a vendor consultant/representative was observed instructing the telemetry technicians on the new equipment. As observed, the telemetry technicians would call the Central One Unit with changes to the patients cardiac rhythm, oxygen saturation levels, electrode disconnections and/or any other emergent alerts; as seen on the central telemetry monitors in the ICU. The slave/satellite cardiac monitors remained on Central One Unit at the Nurses Station, there was no longer an assigned telemetry technician and/or licensed nurse to watch the monitors. All communication for the patients cardiac status and/or medical condition as interpreted by cardiac telemetry originated in the ICU and called to the staff assigned to the patients on the Central One Unit.

2. On 05/23/11 at 9:07 AM, two Surveyors observed that nine patients on the Central One unit were on cardiac telemetry monitors. At 9:12 AM, Telemetry Technician #1 came to the Central One Unit from the ICU, carrying a electrocardiogram (EKG) strip, looking for the registered nurse assigned to Patient #4. Surveyors were the only individuals at the nurse's station at that time. Telemetry Technician #1 informed surveyor that Patient #4 had a rapid heart rhythm. Patient #4 had a sinus tachycardia (rapid rate) of 140 beats per minute per rhythm strip. Patient #4 had a tracheostomy and was on a mechanical ventilator. Per interview, Telemetry Technician #1 had been calling on the telephone to contact the registered nurse assigned to Patient #4 but the telephone calls went unanswered. (The surveyors observed the phone ringing continuously prior to the arrival of Telemetry Technician #1). Telemetry Technician #1 informed Registered Nurse#1 that Patient #4 had the rapid tachycardia recorded as 140 beats per minute and left the rhythm strip at the Nurses Station.

Registered Nurse #1 said Patient #4 had been transferred out of bed by a physical therapy assistant and Patient #4's heart rate had increased. Registered Nurse #1 said the physical therapy assistant returned Patient #4 to bed. Registered Nurse #1 was not alerted to Patient #4' s heart rate until Telemetry Technician #1 arrived on the Central One Unit.

Nursing Supervisor #1 arrived on the Central One Unit at approximately 9:35 AM on 5/23/11. Nursing Supervisor #1 came to the Central One Unit, as a routine to rounding on the Central One Unit. As Nursing Supervisor #1 was leaving the Central One Unit, this Surveyor informed Nursing Supervisor #1 of the communication problem between the ICU Telemetry Technician and the staff on Central One Unit. Nursing Supervisor #1 said there were walkie-talkie communication devices available, but the devices/units had not been dispensed to the nursing staff on Central One. Nursing Supervisor #1 was informed that the telephone at the Nurses Station had been ringing, and there was no one there to answer the phone.

Interview with the CCO on 5/23/11 at 11:00 A.M. revealed that there was a plan in place to address communication which included issuing walkie-talkie communication devices for the nurse to carry with them at all times and have direct communication with the telemetry technicians. Those devices were not handed to the nurses on duty that morning. However,
the technicians were sufficiently trained when to notify the nurse and when to call a rapid response when there was an abnormal finding on the telemetry monitor or any other alert.. Observation on subsequent days indicated that walkie talkies were dispensed appropriately and the nurses station was staffed so that phone calls were answered.

The Hospital failed to ensure the safety of ten of ten patients on cardiac telemetry monitoring and/or needing pulse oximetry on Central One Unit during the morning of 05/23/11.

(Refer to A-0144.)

Based on a review of the hospital's policies and procedures for "Blood Products Management - Look Back" and confirmed through interview with staff on 5/19/11, the Hospital did not have policies and procedures that conform to Federal, State, and local laws.
Findings revealed the following:

- Another Hospital supplies Kindred Hospital Boston North Shore with blood products.
According to interview with staff and a review of policies and procedures, the Kindred Hospital Boston North Shore refers to the "Blood Bank" (at the other Hospital) in reference to notification of the patient who was given infected blood products and policies and procedures for notification of the patient .

Kindred Hospital Boston North Shore did not have their own policies and procedures that included the following:

- Patient Notification.
- Time frame of Notification
- Content of Notification including testing and counseling.
- Notification to legal representative or relative.
- Requirements for documentation.
- Requirements for the confidentiality of medical records and other patient information.

Based on observation, record review and staff interview, the Hospital failed to ensure the facilities supplies and equipment were maintained to an adequate level of safety and quality. The findings are:

The Hospital provides care to multiple patients who require ongoing suctioning of respiratory secretions to maintain an adequate airway. The Hospital provides wall suction to meet these needs. An ongoing issue with the in house vacuum system was identified by the Hospital plant operation manager as far back as January 2010 . The pumps that power this wall suction began to have mechanical issues at that time. The Hospital sustains three pumps for this purpose. In the event that the Hospital has a disruption in vacuum pressure, a "code purple" status is called.

During the initial entrance conference, on 5/18/11 at 8:30 A.M., the Chief Clinical Officer explained that this hospital was a 50 bed facility with a current census of 35. One of the main services provided was pulmonary care to respiratory patients on ventilators. This included suctioning patients on an ongoing basis to maintain a clear airway.

Observations during initial tour in the morning of 5/18/11, revealed at each patient's bedside there were 3 wall outlets, 1 for air, 1 for oxygen and 1 for suction/vacuum. The medical gases and suctioning were supplied via this wall system. There were 14 patients in-house which required suctioning to maintain a clear airway.

Per the NFPA 1999 edition, 4-3.2.1.1 Multiple Pumps and 4-3.2.1.2 Backup Operations revealed, there needs to be 2 or more pumps installed and there needs to be a device provided to automatically activate the additional pump(s) if one pump in operation is incapable of adequately maintaining vacuum.

Interview with the Director of Plant Operations in the morning of 5/19/11 revealed that currently 2 out of the 3 vacuum pumps which control the in-wall suction units at each bedside were not working and have not been working since May 6, 2011. On May 12 the 2 non-functioning vacuum pumps were sent out of the facility for repair. The Director of Plant Operations revealed that the need to fix and or replace the vacuum pumps has been an on-going problem since Jan. 2010 when identified by a outside vendor company. (This company periodically is called to the hospital to provide maintenance work to the hospital's medical gas system).

In the event the last vacuum pump malfunctioned, no in-wall suctioning would be available. The plan was to have a portable suction machine accessible at the bedside of each patient who needs suctioning.

Interview with the Clinical Care Officer, (CCO) on 5/19/11 at 1:30 P.M. revealed that the CCO was not aware that the building was down to 1 working vacuum pump. The CCO stated that if the last vacuum pump went down, there would be no suction available from the wall outlets and therefore portable suction machines would be placed at the patient's bedside and a Code Purple would be called. Per Code Purple policy, the purpose of calling a code purple is to notify all staff members of the disruption of Oxygen, Vacuum and or Ventilation disruption.

Per the Code Purple signage, which is placed outside a patient's room during a Code Purple stated, "in the event of:

1. Oxygen Disruption, oxygen cylinders must be in place for use.
2. Vacuum Disruption, portable suction units must be placed in use.
3. Ventilation Disruption, all patients requiring mechanical ventilation must be manually ventilated".

Review of the documentation entitled "Vacuum Pump repair time line" given to the surveyor on 5/23/11 at 12:30 p.m. from the Director of Plant Operations revealed:

- in February 2011, 1 out of the 3 vacuum pumps failed to work.
- on April 21, 2011 another vacuum pump failed to work and the facility called a Code Purple at 9:05 A.M. (At this point only 1 pump was working).
- at the time "Code Purple" was called, the facility rented portable suction machines/pumps to insure there were enough suction machines for patients in case the 3rd pump went down.
- at some point one of the failed pumps was reset and started to work, thus the facility then had 2 functioning vacuum pumps.
- on April 26, 2011 the portable rented suction machines/pumps were returned.
- on May 6, 2011 one of the functioning vacuum pumps did not work again, thus leaving only 1 out of 3 vacuum pumps operational. Although no "Code Purple" was called at this time, on 5/6/11, the Respiratory Director called and had delivered additional rented portable suction machines as back-up to meet the needs of the residents who could require suctioning.
- on May 12, 2011 the 2 non-operating pumps were removed from the hospital for repair.

On May 19, 2011 at 1:30 P.M., the surveyors brought to the administrative staff's attention that the hospital was down to their last working vacuum pump. The CCO implemented a Code Purple at that time, and the Respiratory Therapist Director proactively rented 5 additional portable suction machines.

Interview with the Director of Respiratory Therapy on 5/23/11 at 12:15 P.M., revealed that
on 5/19/11 14 patients required suctioning; on 5/20/11, 16 patients required suctioning. In order to fully implement a code purple, two additional portable suction machines were needed. On 5/22/11 the 6 additional portable suction machines arrived at the facility.
On 5/22/11 the 2 failed vacuum pumps were returned to the facility.

Interview with the Director of Plant Operations in the morning of 5/19/11 revealed that currently 2 out of the 3 vacuum pumps which control the in-wall suction units at each bedside were not working and have not been working since May 6, 2011. The Director of Plant Operations reported to the surveyor that the 2 non-functioning vacuum pumps were sent out on 5/12/11 for repair. The Director of Plant Operations revealed that the need to fix and or replace the vacuum pumps has been an on-going problem since Jan. 2010 when identified by an outside vendor company. This company periodically is called to the hospital to provide maintenance work to the hospital's pumps and medical gas system. There was no oversite/monitoring to ensure this outside vendor and/or the maintenance staff were providing the appropriate services to maintain the building.

The facility failed to adequately repair and/or replace the medical gas/ vacuum system, to resolve the problems identified in the January 2010 report to insure a reliably functioning system was put in place.

(Please refer to accompanying CMS- Form 2567 Life Safety Findings of 05/25/2011)

2. On 05/18/11 in the afternoon, in the ICU, an Ultrasound Technician went into a precaution room for Patient #2 without sanitizing her/his hands or putting on gloves and dropped a towel on the floor. The Ultrasound Technician then picked up the soiled towel and placed the towel on the portable equipment and then continued to glove. The Ultrasound Technician did not follow proper personal protective equipment (PPE) procedures.

3. On 05/19/11 at 11:50 AM, Physician #1 was observed entering into a precaution room for the non-sampled #3 Patient in ICU, who had a chest tube, and examined the abdomen and listened to the lung sounds of non-sampled #3 Patient.

a.) Physician #1 entered the room without wearing Personal Protective Equipment (PPE), as posted which required a gown and gloves.

b.) Registered Nurse #2 was approached by this Surveyor and informed that Physician #1 was in examining the non-sampled #3 Patient in room #7 in ICU without wearing PPE's. Registered Nurse #2 was told Physician #1 examined the non-sampled #3 Patient in full view of three visitors in the room. Registered Nurse #2 said Physician #1 was not following the Hospital's Policies and later approached Physician #1.

4. On 05/19/11 at 10:10 AM, Certified Nursing Assistant #1 (CNA) was observed inside Patient #25's room on Central One Unit with the linen cart pulled to the open door. Patient #25 was on contact precautions requiring gown and gloves. CNA #1 was wearing PPE and retrieved linens from the cart; after giving care to Patient #25. CNA #1 returned again to the linen cart, lifted the dropped curtain to retrieve additional towels.

5. On 05/25/11 at 8:50 AM, Registered Nurse #3 went to room #8 in ICU, after the patients transfer to West 2, to retrieve an intravenous pump. The room had not been cleaned after the patient's transfer to another unit. Before leaving the room, RN #2 noticed RN #3 had not cleaned the equipment. RN #2 requested RN #3 wipe down the equipment with Sani-Cloth and RN #3 complied with the instructions. At 9 AM, RN #3 was called to the telephone at the Nurses Station. RN #3 removed contaminated gloves from the un-sampled #4 Patient, who was in room 5 in ICU. RN #3 did not sanitize her/his hands after removing the contaminated gloves. After the telephone call, RN #3 proceeded to prepare an intravenous bag and was about to add the medication Protonix to the intravenous bag labeled for un-sampled #4 Patient. This Surveyor interrupted RN #3 and informed RN #3 that her/his hands had not been sanitized.


00420


E. Kitchen Sanitation

The hospital failed to maintain the kitchen in a sanitary manner and failed to ensure that cooked food was not stored for longer than 3 days after it had been cooked.

1. During the tour of the main kitchen on 5/18/11 at approximately 10:00 AM, the following sanitary concerns were observed:

a) The pot storage rack was dirty with a build up of dust and dirt.
b) The top of the mixer was splattered with old food substances.
c) The containers holding the rice and pasta were dirty with dust and dirt.
e) There were 4 quarter size Poly - Cambro pans and approximately 1 dozen other size Poly - Cambro pans which were heavily laden with a build up of dirt. Interview with FSD (food service director) #1 revealed that despite the pans being routinely washed, they developed a dirt scum that could not be washed off.

2. Interview with FSD#1 revealed that all food items were to be dated and labeled when placed in the refrigerator. The food items were to be disposed of 3 days after being placed in the refrigerator. The following items were found in the refrigerator on 5/18/11 and should have been disposed of: pasta which was labeled 5/11/11, pasta which was labeled 5/11/11, rice which was labeled 5/12/11 and chicken and pasta which were undated. Additionally, there were 6 other food items stored in Styrofoam single serving containers which were undated and unlabeled.

Interview with FSD #1 confirmed that the above mentioned items were not properly cleaned and that the food items were not stored correctly.






















07338


6. Hospital staff failed to don Personal Protective Equipment (PPE) in accordance with the Contact Precaution signs posted outside of the rooms on the West 2 Unit.

Observations on West 2, (NSP #1), on May 23, 2011 at 11:45 AM, revealed a physician entered Room 219 -A to pronounce an expired patient who was on contact precautions. According to the precaution sign, staff were to wear a gown and gloves when they entered the contact precaution room. The physician was not wearing a gown. The physician directly examined the patient immediately upon entering the room. This was confirmed with the nurse who was caring for the patient during the morning on May 23, 2011.


15020


Based on observations, review of facility infection control policies and staff interviews, the Hospital failed to ensure that staff consistently implemented infection prevention and control standards, failed to maintain a sanitary environment in the kitchen, at various locations where sharps containers are maintained, and in the Pharmacy, and failed to ensure that cooked food was not stored for longer than 3 days.

Findings include:

A. The hospital failed to minimize the risk of cross contamination during the use of a glucometer to test for fingerstick blood sugar (FSBS):

On 8/26/2010, the Centers for Disease Control (CDC) issued requirements for Infection Prevention during Blood Glucose Monitoring and Insulin Administration, supported by the Food and Drug Administration (FDA), that state fingerstick devices should never be used for more than one person. Whenever possible, point of care (POC) blood testing devices, such as blood glucose meter and PT/INR anticoagulation meter, should be used only on one patient and not shared. If dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared.

1. Certified Nursing Assistant (CNA) #1 was observed doing FSBS on Central 1 unit at 11:45 A.M. on 5/23/11. CNA #1 pushed an over-the-bedside table (which contained the glucometer case holding the glucometer, test strips, finger lancets, alcohol swabs, gauze, and band-aids) directly outside the doorway of room 102. CNA #1 washed hands and donned a pair of gloves. The CNA removed the meter from the case, went into the room and scanned non-sampled patient #4's name band. CNA #1 returned to the table outside the patient's room, with the meter, removed a test strip from the vial of test strips and placed a test strip into the meter. The CNA brought the meter with the test strip, an alcohol swab and a lancet from the case back into Nonsampled patient #4 and placed all the equipment onto NS #4's over-the-bed table. After cleaning this patient's finger with an alcohol swab, pricking the finger with a lancet and obtaining a blood sample by using both gloved hands, CNA #1 brought the meter up to the patient's finger and placed a drop of blood onto the strip. Despite handling the glucometer with contaminated gloves, the CNA removed the glucometer from the patient's room and placed the contaminated glucometer back into the case. The CNA failed to clean the glucometer after use and before returning the glucometer to the storage case, increasing the risk of cross contamination between patients.

The CNA removed gloves, washed hands and proceeded to room 105. The CNA donned a pair of gloves and a gown. The CNA proceeded to follow the same procedure in obtaining a FSBS with patient #25 who was on contact precautions. At the end the CNA placed the glucometer into the case. The glucometer was not cleaned.

Interview at that time with CNA #1 revealed that CNA #1 does not clean the glucometer in between patient use.

2. LPN (#1) was observed performing a FSBS procedure on May 18, 2011 at 12:10 PM, for patient #14 on the West 2 unit.

The glucometer case (containing the meter, test strips, finger lancets, alcohol swabs, gauze, and band-aids) was placed on a table directly outside the patient's doorway. After obtaining a blood sample from the patient, the nurse (LPN #1) inserted the blood sample into the glucometer. Despite handling the glucometer with contaminated gloves, the LPN failed to clean the glucometer after use and before returning the glucometer to the storage case, increasing the risk of cross contamination between patients. Patient #14 was on Contact Precautions (enhanced precautions used with patients known or suspected to have organisms transmitted by direct or indirect contact) because of a multi-drug resistant pathogen.

B. The hospital failed to ensure patient care practices/procedures were followed

1. Observation on 5/19/11 at 10:15 A.M., revealed RN #4 suctioning patient #26 via the patient's tracheostomy tube. At the time, RN #4 was wearing a gown and a pair of gloves. While suctioning this patient, some sputum splash up towards RN #4's face. RN #4 quickly moved away from the patient and stated "I should have donned a mask and eye shield before suctioning this patient".


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7. Hospital staff failed to don Personal Protective Equipment (PPE) in accordance with the Contact Precaution signs posted outside of the rooms on the West 2 Unit, and as confirmed in interview with the Infection Preventionist on May 18, 2011 at 9:30 AM.

Observations on West 2, (Patient #14), on May 19, 2011 at 11 AM, revealed a CNA (#2) assisting a patient on contact precautions. According to the precaution sign, staff were to wear a gown and gloves when they entered the contact precaution room. CNA (#2) was not wearing a gown or gloves. Observations on West 2, (Patient # 29), on May 23, 2011 at 10 AM revealed an Occupational Therapist and a Dietitian in a contact precaution room without PPE.

C. The Hospital failed to facilitate staff safety as it relates to sharps disposal:

1. Observations in five of five patient rooms on West 2 (room #213, #222, #225, #227, #229) on May 18, 19, and 23, 2011 revealed sharps (e.g. hypodermic needles) were disposed of in sharps containers held within a wall mounted cabinet. The hospital policy required the sharps containers be emptied when they became two-thirds filled. Because the sharps cabinets were designed as solid cabinets, there was no means to view filled containers until the bio-hazardous waste reached the neck of the container, far exceeding the two-thirds full mark. Over filled sharps containers increase the risk of a sharps injury.

Observations of the hazardous waste storage room on May 23, 2011 at 8:50 AM, revealed six of six sealed sharps containers exceeded the two-thirds full policy.

D. The hospital failed to provide a sanitary medication prep area in the Pharmacy.

1. Observation in the Pharmacy and confirmed through interview with the Director of Pharmacy, on May 23, 2011 at 2PM, revealed a wooden table used as a work station for medication preparation was worn with visible scratches and grooves and lacked a smooth, washable surface to permit ease of cleaning and adequate sanitizing.

Based on record review and interview, the Hospital did not have a designated requestor or an individual who has completed a course approved by the Organ Procurement Organization (OPO), for approaching potential donor families or patients and requesting organ or tissue donation for 30 of 30 applicable inpatient records (#1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, #27, #28, #29 and #30) in a total sample of 30. Findings include:

1. Interview with CCO on 5/18/11 during the entrance conference revealed that the Education Coordinator was the person identified as responsible for the OPO program. However, it was learned that this person has been on an extended leave from the hospital. Further, no one had been appointed to replace this person, who was on leave. According to the CCO the program would default to him/her.

2. Review of the admission packet revealed that it contained a form titled "Anatomical Gift By a Living Donor" .
Interview on 5/25/2011 at 8:30am with the CCO revealed that the Admission Coordinator was responsible for going over all the materials in the admission packet.

3. According to the Hospital OPO policy, dated 11/2010, at the time of admission, "the individual initiating the request must be an organ procurement representative or a employee who has been designated as a requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO/designated third party."

4. Review of the Anatomical Gift By a Living Donor form, reveals the following inquires: it states the purpose is to identify your wishes regarding organ donation by checking the appropriate boxes. First question, "I .... give ( ) my body; ( ) and needed organs or parts; ( ) the following organs or parts:...........; to the following person (or institute): ( ) the following named physician, hospital, storage bank or other medical institution;.... etc. and then a signature. " Second ,"I do not consent to being an organ donor " Next, The patient cannot comprehend the organ donor inquiry. This is signed by the Hospital Representative.

5. On 5/26/11, at 8:30am, interview with the Admission Coordinator confirmed that s/he did not receive any training or education on donation issues. At the time of admission the staff does provide a pamphlet provided by the OPO Bank and the form. The Anatomical Gift by a Living Donor is filled out and becomes part of the medical record.

6. For all the Patients' above admitted to the hospital, record review revealed that this form was not in the medical record. Further interview on 5/26/11 at approximately 1:00 PM, with the Admission Coordinator, revealed that the form was in the patient's financial file which was kept in the business office. The staff was in the process of pulling all the forms and placing them in the medical record as per policy.

Based on record review and interview, the hospital failed to ensure that all patient care staff, were trained on donation issues and that the training program is developed in cooperation with the Organ Procurement Organization. Findings include:

Based on policies and procedures for organ procurement, and staff interview, the hospital did not have a designated individual to be a representative or a designated requestor to initiate the request to a family for organ procurement when appropriate.

Interview with the CCO on 5/18/11 during the entrance conference as to who was responsible for the OPO program revealed the Education Coordinator at the hospital . Further discussion with the CCO revealed that this Education Coordinator was on an extended leave from the hospital and the CCO had assumed his/her responsibilities.

Review of policies and procedures for organ procurement, the hospital at the time of survey did not have a trained designated individual to be a representative or designated requestor to initiate the request to a family for organ procurement when appropriate.

Interview with the CCO on 5/25/2011 at 8:30am, regarding the hospital's contract with the organ procurement organization and the hospital's policy confirmed the hospital failed to ensure that all patient care staff were educated on donation issues. S/he stated that s/he (the CCO) had just completed on 5/24/2011, a 15 minute on-line "Self guided education module" which was an overview of organ and tissue donation which "provides the basics of donation". S/he further stated that the plan will be for all staff to complete this module.

During review of personal records which included patient care staff, there was no documented evidence regarding education or training on donation issues.

On 5/26/2011 interviews with the following staff confirmed they had not received training or education on organ donation issues:

1. Interview with the night nurse supervisor # 3, on 5/26/11 at 7:30am who was employed in this position for 3 1/2 years and is responsible for calling the OPO when a patient expires, confirmed s/he was only oriented to the procedure of contacting the OPO when a patient expires . No training or education on organ and tissue donation issues had been provided.

2. At the time of admission, it is the responsibility of the admission staff to provide a pamphlet by the OPO Bank and a form The Anatomical Gift by a Living Donor which is completed and then becomes part of the medical record. At 8:30am, interview with the Admission Coordinator who has been in this position for 6 yrs., confirmed that neither s/he nor the receptionist who was identified as the person who does admissions in the afternoons and evening received any training or education on donation issues.

Based on documentation review and staff interviews, the Hospital failed to ensure the Facility's Maintenance services responsible for the hospital's building and equipment consistently collected and submitted Quality Assurance, (QA) data for measurement, analysis and tracking by the Hospital's QA program.

Findings included:

1. Interview with the Director of Plant Operations in the morning of 5/19/11 revealed that currently 2 out of the 3 vacuum pumps which control the in-wall suction units at each bedside were not working and have not been working since May 6, 2011. The Director of Plant Operations reported to the surveyor that the 2 non-functioning vacuum pumps were sent out on 5/12/11 for repair. The Director of Plant Operations revealed that the need to fix and or replace the vacuum pumps has been an on-going problem since Jan. 2010 when identified by an outside vendor company. This company periodically is called to the hospital to provide maintenance work to the hospital's pumps and medical gas system. There was no oversite/monitoring to ensure this outside vendor and/or the maintenance staff were providing the appropriate services to maintain the building.

2. Review of the hospital's quality assurance data from Jan. 2010 - May 2011 lacked data to ensure that services provided by an outside company to provide routine and preventive maintenance and testing of the hospital's medical gas system are being done and analyzed.

3. Interview with the Director of Quality Management (DQM) on 5/25/11 at 1:15 P.M. who had started working at this facility last week revealed that s/he could not find any data in the quality assurance information to address monitoring of the medical gas system, nor was there any reports to the Environmental Care Committee to address issues.

4. Further interview with the Director of Plant Operations on 5/26/11 at 11:50 A.M. confirmed that he/she did not filter this information to the quality assurance/improvement committee to ensure that these systems were correctly and completely repaired or replaced as needed. Without bringing this information to the quality assurance/improvement committee, the committee cannot address building issues and how lack of maintaining the building impacts patient care and safety.