HospitalInspections.org

Based on observations, review of records, review of the Hospital Bylaws, review of other facility documentation, and staff interviews, it was determined that the hospital failed to meet the Conditions of Participation for Governing Body as evidenced by:

The Governing Body did not ensure that all services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified included: Physical Environment, Infection Control, Quality Assessment and Improvement Programs, and Patient Rights.


The hospital failed to protect and promote the rights of each patient. (Cross refer to A115, A144),

1. Failure to ensure Family Center surgical suite ceiling tiles were maintained, and staff infection control practices were followed. (Cross refer to A701)

2. Failure to ensure all areas were identified and investigated related to Hepatitis C related adverse patient event. (Cross refer to A263)

3. Failure to keep drugs and biologicals secure and lack of full knowledge relating to the security of their drug access system. (Cross refer to A502)

4. Failure to maintain secure access to the Emergency Department environment. (Cross refer to A701)


The hospital failed to ensure that the hospital's buildings and equipment were arranged and maintained to ensure the safety and well being of patients. (Cross refer to A701).
1. The Hospital failed to maintain an environment to ensure the safety and well being of patients in the emergency department. The facility also failed to replace non- scrubbable ceiling tiles as outlined in the hospital Plan of Correction.

The hospital failed to have a hospital wide infection control program to control the transmission of infections and communicable diseases. (Cross refer A747, A 748 and A 749).
1. The hospital failed to ensure that all infection control practices were followed on three out of four units, which were toured during a follow-up survey on September 17 and 18, 2012.


The hospital failed to have an effective Quality Assessment and Improvement Program (Cross refer to A 263).

1. The hospital failed to ensure their quality program included all applicable departments and department personnel, that the data collected for quality assurance was proactive in nature and that the focus of the quality drivers were wide enough in scope to address all possible areas to determine the effectiveness of the overall practice in the entire facility operation. The hospitals Governing Body is responsible for the hospital wide quality assessment and performance improvement efforts for the enhancement of quality care.

During an interview on 9/18/12 with the hospital's VP of System Quality and the Director of Quality confirmed that the governing body is responsible for the overall conduct and operation of the hospital.

Based on observation, interview and document review, the hospital failed to protect and promote each patient's rights as evidenced by failing to ensure all patients receive care in a safe setting.

The findings include:

1. Failure to ensure Family Center surgical suite ceiling tiles were maintained, and staff infection control practices were followed. (Cross refer to A701)

2. Failure to ensure all areas were identified and investigated related to the Hepatitis C outbreak.(Cross refer to A263)

3. Failure to keep biologicals secure and lack of a secure drug access system. (Cross refer to A502)

4. Failure to maintain secure access to the Emergency Department environment. (Cross refer to A701)

Cross Refer to A144

Based on observation, interview and document review, the hospital failed to ensure all patients were able to receive care in a safe setting.

Findings include:

1. Failure to ensure Family Center surgical suite ceiling tiles were maintained, and staff infection control practices were followed.

2. Failure to ensure all areas were identified and investigated related to the Hepatitis C outbreak.

3. Failure to keep biologicals secure and lack of a secure drug access system.

4. Failure to maintain secure access to the Emergency Department environment.

1. Interview on 9/17/12 at approximately 10:00 a.m., with Staff A (Director of Maintenance), confirmed the ceiling tiles in the Family Center operating room suite had not been replaced as outlined in the hospital Plan of Correction. (Refer to A701)


Additionally, observations conducted on 9/17/12 at approximately 10:00 a.m. to 2:00 p.m., on patient care units, identified staff were not compliant with infection control practices. During observations of one of the four units toured it was noted that a member of the housekeeping staff was in a room that was identified by signage as being a "Contact Precaution" room. The staff member was gowned and gloved as they proceeded to clean the room. When the room was cleaned the staff member removed their gown, keeping their gloves on while outside of the room. Staff was observed placing their hands, which were still gloved after cleaning the contact precaution room, on the handrail outside the room.

The same staff person then returned inside the room and removed the garbage bag from the receptacle and tied off the bag. The staff person was then observed walking out of the room, around the nurse's station and down the hall to the dirty utility room. During this time the staff person was observed to drag the garbage bag on the floor and use their still gloved hands to open the door handle on the dirty utility room to enter.

During tour of the ICU (Intensive Care Unit) on 9/17/12, at approximately 11:30 a.m., two staff were observed cleaning a room identified by signage as a "Precaution Room". The gown on one of the staff had become loosened in the back and over the course of cleaning the room after approximately five minutes the gown had slipped down the front of their torso and was protecting only around one third of their uniform. Further observation identified this staff person exiting the precaution room and removing their gown in the middle of the hallway. At this time the staff member still had the same gloves on and had not removed them. After disposing of the gown in the trash receptacle the staff person reached into their pocket and took out a key to open a lock on the housekeeping cart and then replaced the key into their pocket at all times still wearing the same gloves they had on from when the precaution room had been cleaned.

On the same unit on 9/17/12 at approximately 12:00 p.m., when the housekeeping staff and Staff B (Housekeeping Director) were questioned what product they would use to clean a room where a patient had C-difficile, the housekeeper identified a product called "Virex 256" . This product was later identified by the director of housekeeping to not be effective against this bacterium.

During tour on the third of four units on 9/17/12 at approximately 1:00 p.m., an interview with a member of the nursing staff revealed that when asked for what type of infection would you use the "Gold topped cleaning wipes"? The nurse answered "for Noro virus". When questioned if they would use the gold topped wipes for a patient room with a C-difficile infection they answered "no just Noro virus". The gold topped wipes contain a bleach solution to disinfect the environmental surfaces in a patient room who has a diagnosis of Noro virus or C-difficile. Subsequent interview with Staff H (Infection Control Practitioner) confirmed the gold topped wipes were used for both C-difficile rooms as well as Noro virus rooms. This practice was not verbalized by the the aforementioned member of the nursing staff.

During interview with Staff B (Director of Housekeeping) on 9/17/12 at approximately 1:00 p.m., in the ICU Staff B stated that it was the housekeeping department that provides the training for the cleaning and infection control issues as they pertain to the housekeeping staff. Interview on 9/18/12, with Staff B and Staff H (Infection Control Practitioner) identified that the infection control aspects of the training are provided by Staff H. Staff B was not aware that Staff H provided initial infection control training on orientation.

2. During the follow up survey on 9/17/12 and 9/18/12 it was identified through interview with members of senior management and the quality control management team that an analysis of the alleged adverse events involving the hiring of a cardiac Cath Lab technician and the existence of 32 identified individuals who had been diagnosed with Hepatitis C was still in progress. Review of this analysis by the survey team during the facility's presentation identified that the main drivers of the analysis were the findings of the recent complaint and recertification surveys conducted by the State Agency, as well as findings by the N.H. Department of Public Health.

The analysis did not contain the necessary scope to address all causal factors. Although the analysis looked at infection control and medication security, it did so with a very narrow focus. Based on the findings, a much wider scope for both was necessary to establish a true root cause, providing the ability to analyze and evaluate the quality of their existing programs pertaining to infection control and medication security. This would allow the hospital to identify other potential areas for performance improvement.

3. During tour of the cardiac catheterization procedure room on 9/17/12 at 11:50 a.m. medications were found in an unlocked refrigerator. Interview with Staff C (Cath Lab RN) confirmed that medications were not locked even during off hours. The medications that were found in this refrigerator are as follows:
1) Aspirin 300 mg suppository quantity (4)
2) Eptifibatide 20 mg/10ml vial quantity (6)
3) Diltiazem 25 mg/5 ml vial quantity (9)
4) Eptifibatide 75 mg/100 ml bottle quantity (6)
5) Alteplase 2 mg/2 ml vial quantity (2)
6) Famotidine 20 mg/2 ml vial quantity (6)
7) Vancomycin 1000 mg/200 ml quantity (2)
8) Diltiazem 125 mg/125 ml quantity (2)

Interview with Staff D (The Director of Pharmacy) on 9/18/12 at approximately 2:00 p.m., revealed new employees receive a password for the use of the Pyxis system (automated medication dispensing system) which is located in the Cath Lab and other areas in the hospital. Once the password is established, the employee sets a pin number and their biometric (fingerprint). Staff D indicated the staff can change their biometrics at any Pyxis machine and the Pharmacy would not be aware. When asked if the Pharmacy tracks the biometric changes by employees, Staff D indicated that they did not know if the Pyxis system was capable of that task.

4. Staff E (Director of Emergency Department) stated that the ambulance services have remote access buttons (hand held devices) to enter the hospital during off hours. On 9/17/12 at approximately 12:30 p.m., Staff E was asked how many devices the hospital has, how many have you handed out, and who has these devices. Staff E was unable to answer any of the questions asked and does not know who has been issued the devices or how many devices there are.

The double doors off of the main lobby of the Emergency Room have card swiped access. Once the doors are opened the doors remain open for an extended period of time and if the motion sensor is activated the doors will continue to stay open allowing unauthorized access to the Emergency Department.

On 9/17/2012 at approximately 12:30 p.m., Staff E (Director of the Emergency Department) was asked during all hours of the day along with evening hours, who has card access into your department, Staff E did not know and does not have a list of employees who have access into the department nor does Staff E monitor who has accessed the Emergency Department.

Cross Refer to A502

Based on documentation review and interview the facility failed to ensure their quality program included all applicable departments and department personnel, that the data collected for quality assurance was proactive in nature and that the focus of the quality drivers were wide enough in scope to address all possible areas to determine the effectiveness of the overall practice in the entire facility operation.

Findings include:

During the follow up survey on 9/17/12 and 9/18/12 it was identified through interview with members of senior management and the quality control management team that an analysis of the alleged adverse events involving the hiring of a cardiac Cath Lab technician and the existence of 32 identified individuals who had been diagnosed with Hepatitis C was still in progress. Review of this analysis by the survey team during the facility's presentation identified that the main drivers of the analysis were the findings of the recent complaint and recertification surveys conducted by the State Agency, as well as findings by the N.H Department of Public Health.

The analysis did not contain the necessary scope to address all possible causal factors. Although the analysis looked at infection control and medication security, it did so with a very narrow focus. Based on the survey findings, a much wider scope for both was necessary to establish a true root cause, providing the ability to analyze and evaluate the quality of their existing programs pertaining to infection control and medication security. This would allow the hospital to identify other potential areas for performance improvement.

A more complete analysis as part of an effective QAPI (Quality Assurance Performance Improvement) program would have allowed the facility to examine other potential areas not directly related to infection control or medication security which needed to be examined to identify whether these areas also contributed to this adverse outcome.

During the QAPI interview with Staff F (Director of Quality) on 9/18/12 at approximately 2:00 p.m., it was identified that not all areas and departments were included in the data driven accumulation of relevant information to assess the wide scope analysis that was necessary to fully implement an effective program. This accumulation of data would be essential to monitor the effectiveness of interventions and the overall safety of services. The facility QA program adopted a much more narrow approach.

During the QAPI interview on 9/18/12 at approximately 2:00 p.m., it was identified that although many administrative meetings were held relating to the Hepatitis-C outbreak and associated infection control issues, the infection control practitioner was not included or required to attend these meetings.

The lack of scope, the required all inclusive nature and relevant information gathering as part of an effective QAPI program, coupled with an absence of oversight in the completion of a plan of correction contributed to the findings identified during the follow up survey.

Based on observation and interview it was found that the facility has failed to keep biologicals locked and secure.

Findings include:

During tour of the cardiac catheterization procedure room on 9/17/12 at 11:50 a.m. medications were found in an unlocked refrigerator. Interview with Staff C (Cath Lab RN) confirmed that medications were not locked even during off hours. The medications that were found in this refrigerator are as follows:
1) Aspirin 300 mg suppository quantity (4)
2) Eptifibatide 20 mg/10ml vial quantity (6)
3) Diltiazem 25 mg/5 ml vial quantity (9)
4) Eptifibatide 75 mg/100 ml bottle quantity (6)
5) Alteplase 2 mg/2 ml vial quantity (2)
6) Famotidine 20 mg/2 ml vial quantity (6)
7) Vancomycin 1000 mg/200 ml quantity (2)
8) Diltiazem 125 mg/125 ml quantity (2)

Interview with Staff D (The Director of Pharmacy) on 9/18/12 at approximately 2:00 p.m., revealed new employees receive a password for the use of the Pyxis system (automated medication dispensing system) which is located in the Cath Lab and other areas in the hospital. Once the password is established, the employee sets a pin number and their biometric (fingerprint). Staff D indicated the staff can change their biometrics at any Pyxis machine and the Pharmacy would not be aware. When asked if the Pharmacy tracks the biometric changes by employees, Staff D indicated that they did not know if the Pyxis system was capable of that task.

AIA, (American Institute of Architects) Guidelines for Design and Construction of Health Care Facilities 2.1 General Hospitals 8.2 General Standards for Details and Finishes 8.2.3.4 Ceilings

(3) Semirestricted areas

(a) Ceiling finishes in semirestricted areas such as airborne infection isolation rooms, protective environment rooms, clean corridors, central sterile supply spaces, specialized radiographic rooms, and minor surgical procedure rooms shall be smooth, scrubbable, nonabsorptive, non perforated, capable of withstanding cleaning with chemicals, and without crevices that can harbor mold and bacterial growth.

(b) If lay-in ceiling is provided, it shall be gasketed or clipped down to prevent the passage of particles from the cavity above the ceiling plane into the semirestricted environment. Perforated, tegular, serrated, or highly textured tiles shall not be used.

Based on tour of the hospital during follow up on 9/17/12 at approximately 12:30 p.m., it was found through observation and interview that the facility failed to maintain an environment to ensure the safety and well being of patients in the emergency department. The facility also failed to replace non scrubbable ceiling tiles.


Findings include:

The initial finding is as follows, during tour of the surgical suites located within the Family Center on 7/12/12 it was observed and shown to Staff I (Clinical Leader of the Family Center) that the ceiling tiles located in the semi-restricted corridors were perforated ceiling tiles. These tiles were not scrubbable and capable of withstanding cleaning and/or disinfecting chemicals. Also these tiles failed to be clipped down or gasketed, both concerns were told to Staff I at time of finding on 7/12/12.

During interview with Staff A (Director of Maintenance) during the follow up survey on 9/17/12 at approximately 10:00 a.m., it was revealed that the surgical suites ceiling tiles had not been replaced to provide an environment to meet surgical services.


During follow up at the facility on 9/17/12 it was found through interview and observation that the security and safety of patients and staff failed to be met due to several findings. The findings are as follows:

Staff E (Director of Emergency Department) stated that the ambulance services have remote access buttons (hand held devices) to enter the hospital during off hours. On 9/17/12 at approximately 12:30 p.m., Staff E was asked how many devices the hospital has, how many have you handed out, and who has these devices. Staff E was unable to answer any of the questions asked and does not know who or how many devices there are.

The double doors off of the main lobby of the Emergency Room have card swiped access. Once the doors are opened the doors remain open for an extended period of time and if the motion sensor is activated the doors will continue to stay open allowing unauthorized access to the Emergency Department.

On 9/17/2012 at approximately 12:30 p.m., Staff E (Director of the Emergency Department) was asked during all hours of the day along with evening hours, who has card access into your department, Staff E did not know and does not have a list of employees who have access into the department nor does Staff E monitor who has accessed the Emergency Department.

Based on observation and interview the facility failed to ensure that all infection control practices were followed and /or understood on 3 out of four units which were toured during a follow-up survey on September 17 and 18, 2012.

Findings include:

During the follow up survey on 9/17/12 at 2:00 p.m., of one of the four units toured it was observed that a member of the housekeeping staff was in a room that was identified by signage as being a "Contact Precaution" room. The staff member was gowned and gloved as they proceeded to clean the room. When the room was cleaned the staff member removed their gown and while outside of the room was observed to place their gloved hands on the handrail. The same staff person then returned inside the room and removed the garbage bag from the receptacle and tied off the bag. The staff person was then observed walking out of the room, around the nurse's station and down the hall to the dirty utility room. During this time the staff person was observed to drag the garbage bag on the floor and use their still gloved hands to open the door handle on the utility room to enter.

During tour on 9/17/2012 in the Intensive Care Unit staff were observed cleaning a room identified by signage as a "Precaution Room". The gown on one of the staff had become loosened in the back and while cleaning the room (after approximately five minutes) the gown had slipped around the front of their torso and was protecting around one third of their uniform. Further observation identified this staff person exiting the precaution room and removing their gown in the middle of the hallway. After disposing of the gown in the trash receptacle the staff person reached into their pocket and took out a key to open a lock on the housekeeping cart. The housekeeper then replaced the key into their pocket at all times wearing the same gloves they had on from when the precaution room had been cleaned.

On the same unit on 9/17/12 at approximately 12:00 p.m., when the housekeeping staff and Staff B (Housekeeping Director) were questioned what product they would use to clean a room where a patient had C-difficile, the housekeeper identified a product called "Virex 256" . This product was later identified by the director of housekeeping to not be effective against this bacterium.

During tour on the third of four units on 9/17/12 at approximately 1:00 p.m., an interview with a member of the nursing staff revealed that when asked for what type of infection would you use the "Gold topped cleaning wipes". The nurse answered "for Noro virus". When questioned if they would use the gold topped wipes for a patient room with a C-difficile infection they answered "no just Noro virus". The gold topped wipes contain a bleach solution to disinfect the environmental surfaces in a patient room who has a diagnosis of Noro virus or C-difficile. Subsequent interview with Staff H (Infection Control Practitioner) confirmed the gold topped wipes were used for both C-difficile rooms as well as Noro virus rooms. This practice was not verbalized by the the aforementioned member of the nursing staff.

During interview with Staff B (Director of Housekeeping) on 9/17/12 at approximately 1:00 p.m., in the ICU Staff B stated that it was the housekeeping department that provides the training for the cleaning and infection control issues as they pertain to the housekeeping staff. Interview on 9/18/12, with the Staff B and Staff H (Infection Control Practitioner) identified that the infection control aspects of the training are provided by Staff H. Staff B was not aware that Staff H provided initial infection control training on orientation.

Cross Refer to A748, A749

Based on policy review and observation the facility failed to implement policies governing control of infections and communicable diseases.

Findings include:

Review of the facility's policy and procedures dated 3/2011 Title Contract Precautions policy no.:IC-ISOL.005 revealed:
Purpose: "To provide guidelines for reducing the risk of transmission of epidemiologically important microorganisms that can be transmitted by direct contact with the patient (hand or skin-to-skin contact) or indirect contact with environmental surfaces or patient-care items in the patient's environment".


STEPS IN PROCEDURE:...
#3. Gowns (clean non sterile) and gloves are required when entering the patient's room. Remove the gown and gloves before leaving the patient's environment and discard, being careful that clothing does not contact potentially contaminated surfaces. Gowns are not used again even for repeated contact with the same patient.

During tour of the Intensive Care Unit on 9/17/12 between 10:00 a.m. and 2:00 p.m., staff were observed cleaning a room identified by signage as a "Precaution Room". The gown on one of the staff had become loosened in the back and while cleaning the room (after approximately five minutes) the gown had slipped around the front of their torso and was protecting around one third of their uniform. Further observation identified this staff person exiting the precaution room and removing their gown in the middle of the hallway. After disposing of the gown in the trash receptacle the staff person reached into their pocket and took out a key to open a lock on the housekeeping cart. The housekeeper then replaced the key into their pocket at all times wearing the same gloves they had on from when the precaution room had been cleaned.

Based on observation during follow up survey on 9/17/12 and 9/18/12 it was determined that the facility failed to ensure that policies concerning the wearing of appropriate personal protective equipment were implemented in contact precaution rooms.

Findings include:

On review of the facility's policy:

Review of the facility's policy and procedures dated 3/2011 Title Contract Precautions policy no.:IC-ISOL.005 revealed:
Purpose: "To provide guidelines for reducing the risk of transmission of epidemiologically important microorganisms that can be transmitted by direct contact with the patient (hand or skin-to-skin contact) or indirect contact with environmental surfaces or patient-care items in the patient's environment".

STEPS IN PROCEDURE:...
#3. Gowns (clean non sterile) and gloves are required when entering the patient's room. Remove the gown and gloves before leaving the patient's environment and discard, being careful that clothing does not contact potentially contaminated surfaces. Gowns are not used again even for repeated contact with the same patient.

During tour of the Intensive Care Unit on 9/17/12 between 10:00 a.m. and 2:00 p.m., staff were observed cleaning a room identified by signage as a "Precaution Room". The gown on one of the staff had become loosened in the back and while cleaning the room (after approximately five minutes) the gown had slipped around the front of their torso and was protecting around one third of their uniform. Further observation identified this staff person exiting the precaution room and removing their gown in the middle of the hallway. After disposing of the gown in the trash receptacle the staff person reached into their pocket and took out a key to open a lock on the housekeeping cart. The housekeeper then replaced the key into their pocket at all times wearing the same gloves they had on from when the precaution room had been cleaned.