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Based on a review of hospital documentation, contractor reports, policies, observations and interviews, it was determined that the hospital failed to meet the Condition of Participation for Governing Body as evidenced by:


1. The Governing body did not ensure that services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance included Patient Rights (Refer to A-144, A-162, A-167 and A-179), Quality Assurance Performance Improvement (refer to A-263 and A-283), Pharmaceutical Services (refer to A-490 and A-492) and Physical Environment (refer to A-701, A710 and A-723).


2. The Governing body failed to function effectively to ensure reports received from contractors were comprehensive to ensure compliance with USP 797 (refer to A-83).


a. On 7/1/14, USP 797 requirements were enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested. Review of the certification report dated 6/3/15 completed by Company #1 failed to identify that non-viable particle counts required for ISO classification was performed. In addition, viable sampling (cultures surface and air) were not obtained and/or failed to perform pressure testing and/or ceiling hepafilter leak testing. Further, the report failed to specify if the room was tested under dynamic conditions. Interview with the Director of Pharmacy and the hospital's infection control nurse on 9/22/15 stated that they attended training in April 2015 for the new USP 797 requirements, however, were not aware of all the criteria and/or elements required to ensure compliance with the new law. Subsequent to the identification of a non-certified compounding room, the hospital submitted an action plan that included in part, one hour beyond use dating (BUD) for all low risk compounding with the exception of Intravenous Immunoglobulin (IVIG) which was granted a three hour BUD, the discontinuation of high risk bladder irrigation, certification of the room with environmental sampling, and the establishment of a USP 797 committee.


b. The hospital failed to ensure that certification of the IV compounding room was completed every 6 months as required. Documentation reflected a report dated May 2014 then not again until June 2015.


c. Tour of the IV compounding room on 9/22/15 identified the BSC and LAFW were located in the same room. Interview with the Director of Pharmacy on 9/22/15 at 11:35 AM indicated the LAFW had not been in use for years due to inconvenience. Subsequent to the surveyors inquiry the hospital contracted with Company #2 who performed mechanical and environmental testing in the compounding room on 9/24/15 and identified a HEPA filter leak in the LAFW, therefore compounding in this hood was not permissible.


d. Tour of the IV compounding room on 9/22/15 identified that the pharmacist was observed compounding medication. It was identified that the facility failed to have a thermostat in the compounding room with a log that included a maximum and minimum range to ensure the temperature of the room was within an acceptable range for medications to be compounded/stored.


e. Tour of the IV compounding room on 9/22/15, it was observed that the facility failed to monitor pressures in the IV compounding room.


f. Tour of the IV compounding room on 9/22/15, it was observed that the facility failed to monitor humidity levels in the IV compounding room.


g. The facility failed to provide documentation that indicated air balancing had been conducted in the IV compounding room. Interview with the Director of Facilities on 9/29/15 at 11:30 AM identified air balancing was not conducted.


h. Tour of the IV compounding room on 9/22/15, the facility failed to ensure a line of demarcation in the ante-room that differentiated dirty from clean.


i. Tour of the IV compounding room on 9/22/15 identified abrasions and integrity breaches to the wall and flooring within the IV buffer room rendering an inability to effectively disinfect the surfaces.


Interview with the Director of Pharmacy on 9/23/15 at 1:15 PM stated other issues were identified in the Pharmacy that required a great deal of time therefore compliance with USP 797 was detained. The Director of Pharmacy indicated although she consulted with Company #3 on 4/24/14 to assist with USP 797 compliance she did not follow through with the implementation of USP 797 timely.


Review of the Governing Body meeting minutes from 7/1/14 through 9/29/15 failed to identify IV compounding was discussed.


Interview with the Chief Medical Officer (CMO) on 9/29/15 at 9:30 AM identified he was aware of the USP 797 law for IV compounding however was unaware that the hospital had not implemented all of the elements required to be compliant with the law effective 7/1/14.


Interview with the Chief Executive Officer (CEO) on 9/23/15 at 3:00 PM identified he was aware of the USP 797 law effective 7/1/14, and was knowledgeable of the USP 797 staff training that occurred in April of 2015. Further interview with the CEO indicated that on 4/24/14 consultation with Company #3 was acquired to assist with USP 797 compliance however identified that the company failed to assist the hospital in an effective manner. The CEO further stated he was responsible to ensure that the hospital was in compliance with USP 797 requirements.


The role of the Board of Trustees in part includes the accountability for quality of care and systems and processes to support care provided by the staff at the hospital. The Board of Trustees approves the organizational plan for Performance Improvement and is accountable to assure that the plan supports the mission, strategic plan and addresses the community and population being served. The Board of Trustees monitors the effectiveness and efficiency of the organization-wide quality process, assures compliance with statutes, regulations and accreditation standards for having an effective performance improvement process, and assesses the effectiveness of strategies to improve care, treatment and services. The Board of Trustees was responsible to assess effectiveness in leading the organization's patient safety and quality efforts.

Based on a review of facility documentation, contracted service reports, and interviews, the Governing body failed to ensure the hospital's Quality program assessed services provided by contractors' to identify quality and performance issues. The findings included:


On 7/1/14, USP 797 requirements was enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested. Review of the certification report dated 6/3/15 completed by Company #1 failed to identify that non-viable particle counts required for ISO classification was performed. In addition, viable sampling (cultures surface and air) were not obtained and/or failed to perform pressure testing and/or ceiling hepafilter leak testing. Further, the report failed to specify if the room was tested under dynamic conditions. Interview with the Director of Pharmacy stated the certification reports come to her for review, however, was unaware that the certification reports had missing elements that were required and would expect the contracted company to inform the hospital of such requirements. The Director of Pharmacy further identified that she and the hospital's infection control nurse attended training in April 2015 for the new USP 797 requirements.

Based on observation, review of clinical records, hospital policies and procedures, and staff interviews related to care and services of the behavioral health patients, it was determined that the hospital failed to meet the Condition of Participation for Patient Rights as evidenced by:

The hospital failed to ensure that patients received care in a safe setting free from ligature points; that the use of seclusion was documented according to hospital standard; that physical restraint use for patient's exhibiting violent and/or non-violent behaviors was implemented and/or documented according to hospital standard.

(Refer to A-144, A-162, A-167 and A-179)

Based on observation, review of hospital policies and procedures, and staff interviews related to care and services provided on the in-patient behavioral health unit, the hospital failed to ensure that patients received care in a safe setting when multiple points of ligature were observed on the behavioral health unit. The findings include:

Tour of the in-patient behavioral health unit on 09/21/15 at 10:00 AM with RN #4 identified a current census of 14. Observation of each patient bed room identified that there were one or two eight foot tall wooden armoires with unlockable double doors on the top half of each one. When opened, the doors protruded into the room approximately eight inches at a height of approximately 7.5 feet creating multiple points of ligature. Windows in each patient room were observed with circular metal locking devices that projected from the window approximately one half inch creating a point of ligature. Additional observations identified two medical beds with manual cranks projecting approximately 8 inches above the floor creating a point of ligature.

Interview with Clinical Director #3 on 09/28/15 at 1:45 PM identified that safety issues were identified and reported during completion of safety checks. However, review of the fifteen minute safety checklist and observation of staff performing safety checks on 09/21/15 identified that documentation was limited to patient location and did not identify that any safety concerns related to the environment were monitored or documented. Clinical Director #3 also identified that environmental safety issues were also evaluated in the biannual Environmental of Care Rounds conducted by the Infection Control Nurse, Director #5 (facilities), Director #3, and other staff. Review of Environment of Care Rounds dated 12/02/14 and 06/02/15 did not include safety issues specific to the in-patient behavioral health unit such as ligature points or access to potential objects for self-harm or harm of others.

Subsequent to surveyor inquiry, all patients were assessed for suicide risk, staff initiated environmental safety rounds every 15 minutes, doors on armoires and bed cranks were removed, and in the process of modifying projection grommet to eliminate point of ligature on windows.

Review of the policy for Patient Observational Status System identified that all patients are on every 15 minute checks and are to be observed every 15 minutes to ensure patient safety. Hospital policies failed to include safety assessments specific to psychiatric environmental hazards.

Based on observation, hospital policy and procedure and staff interviews for three of three behavioral health rooms in the Emergency Department (ED), rooms #13, #14, and #15, the hospital did not ensure that patients were free from involuntary seclusion. The findings include:

Observation of the specialized, behavioral health rooms in the ED with Director #2 on 09/23/15 identified that each of the behavioral health rooms had a button outside the room that could be pushed to activate a magnetic locking device inside the door. The door could be locked and remain locked, as long as pressure was maintained on the button. When pressure was released, the magnetic lock would disengage and the door could be opened. According to Director #2, the door lock could be activated if the staff needed assistance with management of a violent patient that presented a danger to self or others. By locking the door, while still observing the patient, safety could be maintained until assistance arrived. Director #2 identified that there were no policies or procedures in place to direct staff on the use of the locking device or for documenting an episode of seclusion when the locking device was used.

Interview with the Chief of Psychiatry on 09/25/15 at 10:30 AM identified that he/she was unaware of the magnetic locking devices in the behavioral health ED rooms. On 09/28/15 at 1:00 PM the Chief of Psychiatry identified that the use of the locking devices were considered seclusion and staff had been directed to disable the locks.

A hospital policy for restraint and seclusion identified seclusion as the involuntary confinement of a patient alone in a room or area from which the patient was physically prevented from leaving at will, and that seclusion may only be used for the management of violent or self-destructive behavior.

Based on review of clinical records, hospital restraint documentation, manufacturer ' s recommendations for use, policies and procedures, and staff interviews for one of five patients who required physical restraints (Patient #16) the hospital failed to ensure that a safety enclosure bed was used in accordance with hospital policy and/or that a comprehensive assessment including rationale was conducted and documented for each restraint ordered. The findings include:

Patient #16 was admitted to the hospital on 09/05/15 with diagnoses that included community acquired pneumonia. An initial triage note identified that Patient #16 was alert and oriented to person, place, and time with a fall risk score of 2 (high risk score equals five or greater). An order dated 09/07/15 at 8:25 AM directed to provide a sitter as the patient attempted to ambulate, was agitated, and wanted to leave against medical advice (AMA). A physician ' s order dated 09/07/15 at 12:15 PM directed to administer Olanzapine 2.5 mg twice a day for agitation, hallucinations, and irritability. The sitter remained in place through discharge 09/10/15.

According to the clinical record, on 09/09/15 Patient #16 was assessed as a high fall risk and at 7:32 AM the patient was placed in soft, bilateral, upper and lower extremity restraints due to threatening others. At 7:34 AM in addition to the bilateral limb restraints, the patient was placed in a safety enclosure bed due to threatening others. At 7:48 AM the soft limb restraints were changed to hard bilateral upper and lower extremity restraints due to threatening others. The hard restraints were discontinued at 9:47 AM. At 9:50 AM. For 2 hours and 3 minutes, Patient #16 was restrained with 2 types of restraints without an assessment for appropriateness. The safety enclosure bed was discontinued at 10:06 AM.

Review of the clinical record with Director #4 on 09/28/15 at 2:00 PM identified that ongoing threatening behaviors was the rationale for the use of the safety enclosure bed as well as soft and hard four point restraints. In addition, the clinical record lacked comprehensive assessments regarding the decision to change the types of restraints used.

A safety enclosure bed policy identified specific criteria for use that included: a patient at high risk for falls via nursing assessment; when less restrictive interventions are determined to be ineffective; when patient exhibits signs of confusion, dementia, forgetfulness, agitation or restlessness; when there is frequent need for redirection to comply with ADL's; to assist with mobility; or aid the patient in getting out of bed. Policy review failed to identify threatening and/or combative behavior as criteria for use of the safety enclosure bed.

Review of manufacturer's recommendations for the use of soft wrist/ankle restraints (secure-all limb holder) identified that the device was intended for patients at risk for disturbing medical treatments by pulling lines, catheters, or prone to injury and was contraindicated for use in combative or agitated patients.

Based on review of clinical records, hospital restraint documentation, policies and procedures, and staff interviews for one of five patients who required physical restraints (Patient #16) the hospital failed to ensure that the patient was evaluated face-to-face by a qualified practitioner within one hour of initiation of restraints including physical and behavioral assessment accordance with hospital policy. The findings include:

Patient #16 was admitted to the hospital on 09/05/15 with diagnoses that included community acquired pneumonia. An initial triage note identified that Patient #16 was alert and oriented to person, place, and time with a fall risk score of 2 (high risk score equals five or greater). An order dated 09/07/15 at 8:25 AM directed to provide a sitter as the patient attempted to ambulate, was agitated, and wanted to leave against medical advice (AMA). A physician ' s order dated 09/07/15 at 12:15 PM directed to administer Olanzapine 2.5 mg twice a day for agitation, hallucinations, and irritability. The sitter remained in place through discharge 09/10/15.

According to the clinical record, on 09/09/15 Patient #16 was assessed as a high fall risk and at 7:32 AM the patient was placed in soft, bilateral, upper and lower extremity restraints due to threatening others. At 7:34 AM in addition to the bilateral limb restraints, the patient was placed in a safety enclosure bed due to threatening others. At 7:48 AM the soft limb restraints were changed to hard bilateral upper and lower extremity restraints due to threatening others. The hard restraints were discontinued at 9:47 AM. At 9:50 AM. For 2 hours and 3 minutes, Patient #16 was restrained with 2 types of restraints without an assessment for appropriateness. The safety enclosure bed was discontinued at 10:06 AM.

Review of the clinical record with Director #4 on 09/28/15 at 2:00 PM identified that although multiple restraints were ordered by MD #8, a face-to-face was not thoroughly documented. A physician progress note entered on 09/09/15 at 7:15 AM (prior to the restraint episodes) by MD #8 identified that an emergency code had been called that morning as Patient #16 wanted to leave the hospital. The patient was temporarily put in restraints which had been discontinued as the patient was calm. Additionally, MD #8 identified that he/she had encouraged the patient to take his/her medications. Documentation did not address the patient ' s immediate situation, reaction to the multiple interventions, medical and behavioral condition, and/or need to continue or terminate the restraint.

A hospital Restraint Policy identified, in part, that when a restraint is used for the management of violent or self-destructive behavior that patient must be seen within 1 hour face-to-face by an LIP and an evaluation must be conducted and documented that includes the patient ' s immediate situation, response to intervention, medical and behavioral condition, and need to continue or terminate restraints

Based on a review of hospital documentation, contracted services, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement as evidenced by:


1. The hospital failed to integrate its departmental Quality Assessment and Performance Improvement (QAPI) program, specifically contracted services, and Pharmaceutical Services into the hospital wide program to ensure compliance with USP 797 effective 7/1/14. (Refer to A-283).


Cross reference A-43, A-83, and A-490.

Based on a review of hospital documentation, contractors' reports, interviews, and policies, the hospital failed to develop quality performance improvement activities regarding high risk area's including the IV compounding rooms in the Pharmacy and/or when new USP 797 requirements were enforced on 7/1/14. The findings included:

Cross reference A- 83 and A-492

1. On 7/1/14, USP 797 requirements were enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested.

a. Review of the certification report dated 6/3/15 completed by Company #1 failed to identify that non-viable particle counts required for ISO classification was performed. In addition, viable sampling (cultures surface and air) were not obtained and/or failed to perform pressure testing and/or ceiling hepafilter leak testing. Further, the report failed to specify if the room was tested under dynamic conditions. Interview with the Director of Pharmacy and the hospital's infection control nurse on 9/22/15 stated that they attended training in April 2015 for the new USP 797 requirements, however, were not aware of all the criteria and/or elements required to ensure compliance with the new law.

b. The hospital failed to ensure that certification of the IV compounding room was completed every 6 months as required. Documentation reflected a report dated May 2014 then not again until June 2015.

c. Tour of the IV compounding room on 9/22/15 identified the BSC and LAFW were located in the same room. Interview with the Director of Pharmacy on 9/22/15 at 11:35 AM indicated the LAFW had not been in use for years due to inconvenience. Subsequent to the surveyors inquiry the hospital contracted with Company #2 who performed mechanical and environmental testing in the compounding room on 9/24/15 and identified a HEPA filter leak in the LAFW, therefore compounding in this hood was not permissible.

d. Tour of the IV compounding room on 9/22/15 identified that the pharmacist was observed compounding medication. It was identified that the facility failed to have a thermostat in the compounding room with a log that included a maximum and minimum range to ensure the temperature of the room was within an acceptable range for medications to be compounded/stored.

e. Tour of the IV compounding room on 9/22/15, it was observed that the facility failed to monitor pressures in the IV compounding room.

f. Tour of the IV compounding room on 9/22/15, it was observed that the facility failed to monitor humidity levels in the IV compounding room.

g. The facility failed to provide documentation that indicated air balancing had been conducted in the IV compounding room. Interview with the Director of Facilities on 9/29/15 at 11:30 AM identified air balancing was not conducted.

h. Tour of the IV compounding room on 9/22/15, the facility failed to ensure a line of demarcation in the ante-room that differentiated dirty from clean.

i. Tour of the IV compounding room on 9/22/15 identified abrasions and integrity breaches to the wall and flooring within the IV buffer room rendering an inability to effectively disinfect the surfaces.

Review of the hospital's Pharmacy the Therapeutics Committee (P&T) minutes dated July of 2014 through September 29, 2015 failed to identify IV compounding was discussed.

Interview with the Director of Pharmacy on 9/22/15 indicated that although forum to discuss USP 797 was conducted at the Patient Safety Committee and Quality Improvement Committee review of the minutes failed to reflect discussion on this topic until 4/15/15.

Review of the P&T Committee functions directed in part that the committee would be responsible for the development and surveillance of all drug utilization policies and practices within the hospital in order to ensure optimum clinical results and a minimum potential for hazard. It shall assist in the formulation of broad professional policies regarding the evaluation, appraisal, selection , procurement, storage, distribution , use safety procedures, and all other matters related to drugs in the hospital

2. Review of infection control minutes from 7/1/14 through 9/29/15 failed to identify IV compounding was discussed. Interview with the Infection Control Nurse on 9/28/15 at 1:20 PM indicated she attended the training for USP 797 in the Spring of 2015 and was unaware that all of the requirements including culture testing needed to be implemented by 7/1/14. Review of the latest environmental rounds dated 2/2/15 indicated in part that CSP was performed in an ISO class 5 environment, pressure testing was conducted, personnel were wearing hair nets, shoe covers, gowns and gloves. The report further identified the LAFW was on for a specified amount of time before processing all IV add mixtures, irrigating solutions were prepared under the LAFW using aseptic technique (LAFW hood had not been in use for years), LAFW filters were changed every six months and were certified yearly by an independent contractor (USP 797 identifies certification needs to be conducted every six months), all IV fluid containers are to be checked for visible turbidity, leaks, cracks, particulate matter and discoloration. Further interview with the Infection Control Nurse indicated although she checked all of the indicators as completed she did not make observations of the pharmacists aseptic techniques and did not review the certification reports herself. The infection control nurse identified she interviewed the Director of Pharmacy and that is how the information was documented on the environmental rounds log.

The infection control policy and plan identified the committee was responsible to investigate, control and prevent infections within the hospital. The infection control plan directed a risk assessment and prioritization of goals related to preventing the acquisition and transmission of potentially infectious agents would be conducted. This assessment would be completed at least annually, re-assessed and changed as frequently as needed. Based on the risk assessment the infection control program would set goals for preventing the development of health care-associated infections within the hospital.

3. Interview with the Director of Facilities on 9/29/15 at 10:00 AM identified he was not aware of the facilities requirements for the compounding room in accordance with USP 797 that included in part air balancing, the HVAC system, and pressures within the room. Further interview with the Director of Facilities indicated he was scheduled to receive USP 797 education in April of 2015 but did not attend.

4. Review of the Patient Safety and Care Improvement meeting minutes from 7/1/14 through 4/14/15 failed to identify IV compounding was discussed. Review of the minutes dated 4/15/15 identified off site training had been conducted regarding USP 797. The Director of Pharmacy, the Infection Control Nurse, and a Quality staff employee had attended. The next step was to establish a work group that included infection control and engineering. On 6/17/15 the minutes indicated a plan would be developed that included the development of room design renovations to include ventilation. Staff training would also be implemented. On 8/19/15 the minutes reflected the purchase of software that would assist in tracking required documents and training activities. The minutes also reflected agar plates would be obtained from the hospital laboratory for gloved finger, surface and air sampling. On 9/16/15 the minutes indicated the pharmacy would be going live with the new software program.

Interview with the Vice President of Patient Safety/Quality on 9/28/15 at 2:00 PM who was in attendance of the Patient Safety and Care Improvement meetings identified she was aware of the USP 797 law and ensured that essential staff attended training however, was unaware that all of the elements and/or the requirements for USP 797 were necessary for implementation by 7/1/14. Further interview with the Vice President of Patient Safety was unaware that the Director of Facilities did not attend the USP 797 training.

The Patient Safety and Quality Assessment Performance Improvement plan in part was organized and designed to support the mission, vision, values and strategic goals of the organization through monitoring and improving the quality and safety of patient care delivered throughout the hospital. Quality was defined as care that was patient centered, safe, evidenced based, and which was delivered in a manner that was equitable, efficient and timely to provide optimal outcomes for each individual patient.

Based on a review of hospital documentation, contractor reports, policies, and interviews, it was determined that the hospital failed to meet the Condition of Participation for Pharmaceutical Services as evidenced by:


1. The hospital failed to ensure the Pharmacy Department was in compliance with federal and state laws (USP-797) and/or that the Director recognized questionable performance standards provided by the contracted service who provided environmental monitoring/testing/certification of the hospital's IV compounding room. (refer to A-492)

Cross reference A-43 and A-83.

Based on observation, review of facility documentation, contractor reports, interviews, and policy review, the hospital failed to provide the necessary supervision of Pharmacy services to ensure that the IV compounding room was tested/certified in accordance with federal and state laws (USP-797) and/or failed to ensure that quality services were performed by a contracted service. The findings include:


a. On 7/1/14, USP 797 requirements were enforceable for Connecticut hospitals. Subsequent to that date, a copy of the certification reports for the IV compounding room was requested. Review of the certification report dated 6/3/15 completed by Company #1 failed to identify that non-viable particle counts required for ISO classification was performed. In addition, viable sampling (cultures surface and air) were not obtained and/or failed to perform pressure testing and/or ceiling hepafilter leak testing. Further, the report failed to specify if the room was tested under dynamic conditions.


Interview with the Director of Pharmacy and the hospital's Infection Control Nurse on 9/22/15 stated that they attended training in April 2015 for the new USP 797 requirements, however, were not aware of all the criteria and/or elements required to ensure compliance with the new law, hence a failure to recognize that contractor reports were not comprehensive. The Director further identified that other issues were identified in the Pharmacy that required a great deal of time therefore compliance with USP 797 was detained and although she consulted with Company #3 on 4/24/14 to assist with USP 797 compliance, she did not follow through with the implementation of USP 797 timely.




Subsequent to the identification of a non-certified compounding room, the hospital submitted an action plan on 9/21/15 that included in part, one hour beyond use dating (BUD) for all low risk compounding with the exception of Intravenous Immunoglobulin (IVIG) which was granted a three hour BUD, the discontinuation of high risk bladder irrigation, certification of the room with environmental sampling, and the establishment of a USP 797 committee.


b. The hospital failed to ensure that certification of the IV compounding room was completed every 6 months as required. Documentation reflected a report dated May 2014 then not again until June 2015.


c. Tour of the IV compounding room on 9/22/15 identified the BSC and LAFW were located in the same room. Interview with the Director of Pharmacy on 9/22/15 at 11:35 AM indicated the LAFW had not been in use for years due to inconvenience. Subsequent to the surveyors inquiry the hospital contracted with Company #2 who performed mechanical and environmental testing in the compounding room on 9/24/15 and identified a HEPA filter leak in the LAFW, therefore compounding in this hood was not permissible.


d. Tour of the IV compounding room on 9/22/15 identified that the pharmacist was observed compounding medication. It was identified that the facility failed to have a thermostat in the compounding room with a log that included a maximum and minimum range to ensure the temperature of the room was within an acceptable range for medications to be compounded/stored.


e. Tour of the IV compounding room on 9/22/15, it was observed that the facility failed to monitor pressures in the IV compounding room.


f. Tour of the IV compounding room on 9/22/15, it was observed that the facility failed to monitor humidity levels in the IV compounding room.


g. The facility failed to provide documentation that indicated air balancing had been conducted in the IV compounding room. Interview with the Director of Facilities on 9/29/15 at 11:30 AM identified air balancing was not conducted.


h. Tour of the IV compounding room on 9/22/15, the facility failed to ensure a line of demarcation in the ante-room that differentiated dirty from clean.


i. Tour of the IV compounding room on 9/22/15 identified abrasions and integrity breaches to the wall and flooring within the IV buffer room rendering an inability to effectively disinfect the surfaces.


j. Interview with the Director of Pharmacy on 9/22/15 at 11:00 AM indicated compounded sterile preparations (CSP) were couriered over from the main hospital campus to the infusion center however, a the standard operating procedure for the transport and transfer of the CSP's was not comprehensive.


k. Interview with the Director of Pharmacy indicated glove fingertip testing had not been initiated to date of the survey. The hospital failed to provide documentation that the pharmacy staff had initial and annual competency assessments of aseptic compounding and/or that surveillance of aseptic technique was conducted.


l. Interview with the Director of Pharmacy on 9/22/15 at 12:00 PM identified although terminal cleaning was conducted monthly by the hospital staff the facility failed to document the terminal cleaning and/or failed to ensure the staff was trained and/or failed to provide surveillance to ensure quality services were provided.


Review of the job description for the Director of Pharmacy included in part the implementation of policies and procedures to ensure the pharmacy department provided optimal pharmaceutical services that meets all legal, accreditation, and certification requirements. The Director of Pharmacy would keep current with state regulations regarding the practice of pharmacy and implementation of changes as necessary to maintain compliance. The job description further directed the Pharmacy Director would demonstrate knowledge related to compounding sterile products and infection control.

1. Based on observation, review of hospital policies and procedures, and staff interviews related to care and services provided on the in-patient behavioral health unit, the hospital failed to ensure that therapeutic facilities including rooms or areas specifically designed for the purpose intended was evaluated, assessed and/or modified to ensure a safe setting for the psychiatric patient when multiple points of ligature were observed on the behavioral health unit.

2. The Hospital failed to ensure that the physical environment was designed and constructed to maintain the safety of patients with suicidal tendencies and/or tendencies to cause harm to themselves or others and failed to implement immediate safety interventions to correct the environmental safety issues.
(Refer to A-701, A-710 and A-723)

Based on tour, interviews and policy reviews the Hospital failed to maintain the overall hospital environment in such a manner that the safety and well-being of patients are assured. The findings include:

1. Based on observation on 09/22/15 during tours of the Behavioral Health Unit on the basement level of the facility from 11:00AM till 11:55 AM and from 1:15 PM till 1:45 PM, the surveyor accompanied by Engineering Department Staff, the Director of Facilities and Security and Supervisory Staff of the Behavioral Health Unit observed the following:

a. Within the right-side shower room there were numerous broken ceramic tile at the cove base of the shower walls that were loose and sharp and not repaired and/or removed to prevent a patient from utilizing the sharp edged broken tiles to harm themselves and/or other patients.

b. Within the three (3) shower rooms there were three (3) hard molded plastic soap dispensers and three (3) metal paper towel dispensers which could be broken and the sharp edges could be utilized by patients to harm themselves and/or other patients.

c. Within the right-side shower room there was an accumulation of black mold on the ceramic floor tiles, ceramic wall tiles and the drywall ceiling; the shower room lacked a functioning ventilation system.

2. Based on observation on 09/23/15 during the tour of the Pharmacy Ante Room and Clean Room Mixing Area, the surveyor accompanied by Engineering Department Staff and Pharmacy Staff observed the following:

a. There was not a structural separation between the Ante Room and Clean Room and there was no humidity, temperature or positive/negative pressure monitoring in place as required;

b. The ceiling tiles within the rooms were not secured in place and caulked with a bonding agent to resist the passage of contamination;

c. There was a large hole in the ceiling behind the BSC which was open to the plenum space above;

d. The BSC had duct tape around the metal duct where it meets the ceiling area,

e. The vinyl flooring throughout the room had cracks and separations at seams not allowing for a sanitary environment and cleanable surface to resist mold impact;

f. The return air duct vent in the ante room was blocked by shelving not allowing the HVAC to efficiently remove air as required;

g. The walls and seams were not caulked with a bonding agent to provide a cleanable and sanitary surface as required;

h. The BSC and LAFW hoods were showing rusty and dirty surfaces not providing a clean and sanitary environment;

i. The walls throughout the rooms had wall marring and appeared to not have a coating of epoxy type paint as required for cleaning to maintain a sanitary environment.

j. On 09/22/15 at 10:10 am the surveyor, accompanied by the Director of Engineering, observed the fire protection devices in the construction area of the IR Suite have been removed, not meeting the requirements of section 4.6.10.1 of NFPA 101. i.e; the existing fire sprinkler system has been removed by facility staff in the area under construction.

k. On 09/22/15 at 10:30 am the surveyor, accompanied by the Director of Engineering, observed the smoke detectors mounted in the PACU corridor do not meet the minimum location and spacing requirements set forth by section 5.7.3.2.1 of NFPA 72.

l. On 09/22/15 at 10:40 am the surveyor, accompanied by the Director of Engineering, observed the egress signage in the PACU corridor does not meet the minimum standard set forth by section 7.10.1.4 of NFPA 101.

m. On 09/23/15 at 09:50 am the surveyor, accompanied by the Director of Engineering, observed the exit access corridor within the Emergency Department was not free of all obstructions and/or impediments as specified in section 7.1.10.1 of NFPA 101. i.e; patient care bed is permanently located in corridor.

n. On 09/23/15 at 09:10 am the surveyor, accompanied by the Director of Engineering, observed the exit discharge door for the East Stairwell #3 located in the Emergency Department lacks signage indicating the use of a delayed egress lock on the door, not meeting the requirements set forth by section 7.2.1.6.1 (d) of NFPA 101.

o. On 09/23/15 at 11:10 am the surveyor was not provided with documentation and/or information from facility staff that would indicate that the interior finish of the ceiling in the boiler room of the Cancer Center was compliant with the standards set forth by section 10.2.3.1 of NFPA 101.

p. On 09/23/15 at 1:10 pm the surveyor, accompanied by the Director of Engineering, observed the Medical Gas headwall within Behavioral Health Unit #13 lacked tamper proof hardware as required by Psychiatric Design Guidelines edition 3.0 Level 4a (8).

q. On 09/22/15 at 09:30 am facility staff could not provide the surveyor with documentation from the State of Connecticut Department of Public Health approving the construction work being conducted in the IR Suite, not meeting the requirement of Connecticut General Statute 19a-491 (f).

The hospital did not ensure that applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA LSC 101, 2000 edition) were met; based on tours of the facilities on 09/22/15 and 09/23/15, staff interviews on 09/22/15 and 09/23/15, and documentation review on 09/23/15.

1. The facility did not ensure that fire drills were held at unexpected times under varying conditions at least quarterly on each shift as required by the referenced LSC. On 09/23/15 at10: 55 AM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that a fire drill was conducted on the second shift during the fourth quarter of 2014;


2. The facility did not ensure that a fire alarm system required for life safety is installed, tested, and maintained in accordance with NFPA 70 National Electrical Code and NFPA 72. The system has an approved maintenance and testing program complying with applicable requirements of NFPA 70 and NFPA 72 section 9.6.1.4. On 09/23/15 at10: 15 AM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that all fire alarm devices were tested annually as required; i.e., last documented functional test of all devices was conducted between 06/01/15 and 06/12/15 by Simplex Grinnell indicated that eighteen (18) door hold open devices were not tested and fixed temperature heat detectors located in pits of the elevators located in the North Building are to be relocated for testing, devices are obstructed and cannot be tested where located;


3. The facility did not ensure that all required smoke detectors, including those activating door hold open devices, were approved, maintained, inspected and tested in accordance with the manufacturer's specifications as require by the referenced LSC and NFPA 72. On 09/23/15 at 10:20 AM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that the three (3) smoke detections that failed testing between 06/01/15 and 06/12/15 had been repaired/replaced as required in NFPA 72 and as part of the facility's preventive maintenance program;


4. The facility did not ensure that the required automatic sprinkler system was continuously maintained in reliable operating condition and was inspected and tested periodically as required by the referenced LSC and NFPA 25. On 09/23/15 at 10:25 AM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that the necessary maintenance items identified on the sprinkler test report provided by simplex Grinnell dated 11/17/14 had been completed; i.e., two (2) underground Fire Department Connections need hydrostatic testing (one (1) done but failed), flow tests needed on standpipes, water motor gong on 6 " Star B 1963 was inoperable, Fire Department Connections signs needed throughout the property, flow switches need to be installed throughout the penthouse areas and waterflow alarms in panel did not match description of what they feed;


5. The facility did not ensure that the design, installation and use of its commercial cooking equipment were in accordance with NFPA 96: Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations as required by the referenced LSC. On 09/23/15 at 11:55 AM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that deficiencies identified by Innovative Environmental LLC on 02/03/15 had been corrected; i.e., the Dietary Department Cooking Exhaust systems were not constructed and cleaned to NFPA 96 standards; i.e., sufficient access panels not provided, access panels lack proper signage, suspect leaking at collar connection, diminished flow at main kitchen cooking line, exhaust fans not cleaned due to no access, horizontal and vertical ducts not cleaned due to no access, there was a heavy contamination level of grease, debris and oily sludge in the interior of the exhaust system and other grease removal and collection components, excessive amounts of grease dripping down walls, screws damaged welds and non-welded collar connections, failed caulking, etc;


6. The facility did not ensure that piped in medical gas systems are in compliance with NFPA 99, 4.1, 4.1.1, NFPA 70. On 09/23/15 at 1:20 PM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that deficiencies identified on the annual report for the Oxygen Medical Gas, Medical Air Compress and Vacuum System dated 03/06/15 by Airgas Medical Services had been corrected; i.e., required N2, N2O and Medical Air CO alarms not provided, valves for oxygen, air and vacuum were not tested in room W350 due to valves being obstructed;


7. The facility did not ensure that one or more specific responses of the emergency preparedness plan were held at least semi-annually as required by the referenced LSC and NFPA 99 " Health Care Facilities " Section 11-5.3.9. On 09/23/15 at 10:45 AM, The surveyor was not provided with documentation by the Director of Facilities and Security to indicate that semi-annual emergency preparedness drills were conducted; i.e., last documented disaster drill was conducted on 11/2914, required drills for 2015 had not been conducted as of the date of the survey;


8. The facility did not ensure that all employees, medical students and contractors are periodically instructed as to their duties during a fire emergency as required by NFPA 101 " Life Safety Code " 19.7.1 and annually as required in NFPA 99 " Health Care Facilities " 11-5.3.8. On 09/23/15 at 10:55 AM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that all employees, medical students and contractors received annual, fire safety education that was site specific, non-generic or otherwise reflected/supported the facilities ' written plan of protection for all persons in the event of a fire. Such in-service training shall be conducted for all, new employees, medical students and contractors and annually for all others per NFPA 99 " Health Care Facilities " 11-5.3.8; i.e., documentation reviewed indicated 71.9% completion by staff; documentation was not available for training and tracking of medical students and contractors;


9. The facility did not ensure that Emergency and Standby Power Systems were being inspected and maintained as required in NFPA 110 " Standard for Emergency and Standby Power Systems " . On 09/23/15 at 1:55 PM, the surveyor was not provided with documentation by the Director of Facilities and Security to indicate that the following deficiencies noted on the H.O. Penn Major PM Inspection dated 08/05/15 for the Caterpillar generator (serial number 024Z05289) had been corrected and/or repaired as required. The unit lacks a mechanical fuel pressure gauge and the right side turbocharger has a failed cartridge oil seal allowing oil to leak out of the compressor side of housing, RECOMMEND REPLACING ASAP.


10. The surveyor was not provided with documentation by the Director of Facilities and Security to indicated that the Air Conditioning, Heating and Ventilating Systems met the required temperature and humidity levels, General Pressure Relationships and Ventilation of Patient Surgical Areas, treatment areas, Dietary, Laboratories, Pharmacy and other required areas, and Filter Efficiencies for Central Ventilation and Air Conditioning Systems in the facility; i.e., the facility lacks a policy for testing and documentation of temperature, relative humidity, air changes per hour for required rooms and filter efficiencies and tests conducted by a qualified contractor were not available;


11. The surveyor was not provided with documentation by the Director of Facilities and Security to indicated that that the facility had developed a detailed plan to address the fifty-eight (58) deficiencies at two hundred and fifty-two (252) locations within the facility that were identified in the Plan for Improvement report completed by Russell Phillips & Associates, LLC on 02/13/15; i.e., areas identified included but not limited to listed fire stopping materials, door ratings, door latching, building separation (two hour walls, one hour walls and smoke barriers), sealing of penetrations in listed walls, sprinklered areas, location of smoke detectors, separation of hazardous areas, exit signs not visible, and scattered areas throughout the facility lack sprinkler coverage.

Based on observation, review of hospital policies and procedures, and staff interviews related to care and services provided on the in-patient behavioral health unit, the hospital failed to ensure that therapeutic facilities including rooms or areas specifically designed for the purpose intended when multiple points of ligature were observed on the behavioral health unit. The findings include:

Tour of the in-patient behavioral health unit on 09/21/15 at 10:00 AM with RN #4 identified a current census of 14. Observation of each patient bed room identified that there were one or two eight foot tall wooden armoires with unlockable double doors on the top half of each one. When opened, the doors protruded into the room approximately eight inches at a height of approximately 7.5 feet creating multiple points of ligature. Windows in each patient room were observed with circular metal locking devices that projected from the window approximately one half inch creating a point of ligature. Additional observations identified two medical beds with manual cranks projecting approximately 8 inches above the floor creating a point of ligature.

Interview with Clinical Director #3 on 09/28/15 at 1:45 PM identified that safety issues were identified and reported during completion of safety checks. However, review of the fifteen minute safety checklist and observation of staff performing safety checks on 09/21/15 identified that documentation was limited to patient location and did not identify that any safety concerns related to the environment were monitored or documented. Clinical Director #3 also identified that environmental safety issues were also evaluated in the biannual Environmental of Care Rounds conducted by the Infection Control Nurse, Director #5 (facilities), Director #3, and other staff. Review of Environment of Care Rounds dated 12/02/14 and 06/02/15 did not include safety issues specific to the in-patient behavioral health unit such as ligature points or access to potential objects for self-harm or harm of others.

Subsequent to surveyor inquiry, all patients were assessed for suicide risk, staff initiated environmental safety rounds every 15 minutes, doors on armoires and bed cranks were removed, and in the process of modifying projection grommet to eliminate point of ligature on windows.

Review of the policy for patient observational status system identified that all patients are on every 15 minute checks and are to be observed every 15 minutes to ensure patient safety. Hospital policies failed to include safety assessments specific to psychiatric environmental hazards.