The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

STAMFORD HOSPITAL ONE HOSPITAL PLAZA STAMFORD, CT 06904 Dec. 19, 2016
VIOLATION: SURGICAL SERVICES Tag No: A0940
This Condition of Participation is not met. Based on record review, review of hospital policies, review of hospital documentation, and interviews for one of ten patients reviewed for surgical services (Patient #34) the hospital failed to develop comprehensive surgical policies and/or ensure that surgical policies/practices were followed to prevent a fire hazard during a surgical procedure.

Please see A951
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review, review of hospital policies, review of hospital documentation, and interviews for one of ten patients reviewed for surgical services (Patient #34) the hospital failed to develop comprehensive surgical policies and/or ensure that surgical policies/practices were followed to prevent a fire hazard during a surgical procedure. The finding includes:

Patient #34 was admitted on [DATE] for bilateral temporal artery biopsy by MD #3. The anesthesia record dated 12/2/16 identified that the patient received monitored anesthesia care, was not intubated and received oxygen (O2) via nasal cannula at 5 liters/minute throughout the procedure. The intraoperative nursing record dated 12/2/16 indicated that electrocautery was utilized. The anesthesia record by the certified CRNA #1 dated 12/2/16 noted that at approximately 12:10 PM a fire on the field was noted, O2 was stopped, O2 cannula, facial drapes and tape were removed from the patient as well as the oral airway. The ENT consult note dated 12/2/16 and/or 12/4/16 identified that Bovie (Force Triad) cautery was utilized during the procedure, a fire ignited at the tip of the O2 cannula, the patient sustained 1st, 2nd and 3rd degree burns to the face, blister to the tip of the tongue and other airway structures were without evidence of burn or thermal injury.

Interview with MD #3 on 12/14/16 at 11:45 AM indicated that although the Bovi (electrocautery device) was used on both the right and left temporal surgical sites, notification to the anesthesia provider was not given by the surgeon immediately prior to use. He/she further indicated that communication immediately prior to Bovi use was not routinely done.

The hospital policy for electrosurgical safety identified that anesthesia should use the lowest practical level of O2 to a patient during use of an electrosurgical device as an oxidizer control intervention. The policy lacked direction for communication of the Bovi use just prior to ignition. Subsequently, the hospital submitted an immediate action plan dated 12/14/16 that included education to surgical and anesthesia staff for the required communication before electrocautery device use.

In addition, the intraoperative nursing record dated 12/2/16 indicated that the MD #3 prepped the patient with chlorhexidine on the left temporal area and chlorhexidine diluted with normal saline on the right temporal area.

Interview with the Perioperative nurse Educator on 12/13/16 at 1:40 PM noted that the hospital follows the Association of periOperative Registered Nurses (AORN) guidelines in the surgical setting.

Interview with MD #3 on 12/14/16 at 11:45 AM noted that he/she prepped the patient's right temporal area with diluted chlorhexidine and waited at least 3 minutes before he/she applied the drape.

The facility policy for surgical skin preparation identified that antiseptic agents approved by the Food and Drug Administration and the infection control committee may be used following manufacturer's guidelines.

The material safety data sheet for Chlorhexidine 4% identified the product may be combustible at high temperatures. The facility did not have a specific policy and/or approval for Chlorhexidine 4% and/or diluted Chlorhexidine 4% use as a skin preparation.

The manufacturer's Chlorhexidine bottle label directed, in part, to swab the surgical site for 2 minutes, dry with a sterile towel and repeat the procedure. According to AORN 2016 Guidelines for Perioperative Practice, Collective evidence found following the antiseptic manufacturer's instructions for use is the safest way for handling, storing, and dispensing of skin antiseptics.

2. A tour of the OR was conducted on 12/13/16 with the Director and Educator of Perioperative Services. Observations on 12/13/16 at 9:50 AM and/or 9:55 AM identified that the Chief of Anesthesia in OR #1 and Scrub Technician in OR #6 with wisps of hair exposed at sides and/or top and/or back of the head during surgical procedures. Interview with the Perioperative Educator on 12/13/16 at 9:55 AM indicated that the policy for surgical attire addressed head hair coverage. The facility policy for surgical attire in the OR identified that head and facial hair including sideburns and neckline is covered when in the semi restricted and restricted areas (OR).
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on record review, review of hospital policies, review of hospital documentation, observations and interviews for one of ten patients reviewed for surgical services (Patient #34) the hospital lacked a mechanism for interdisciplinary communication in the operating room and/or follow facility policies and/or manufacturer's recommendations and/or hospital practices to ensure a safe environment resulting in a fire and a finding of Immediate Jeopardy.


Please see A144
VIOLATION: ANESTHESIA SERVICES Tag No: A1000
This Condition of Participation is not met. Based on record review, review of hospital policies, review of hospital documentation, observations and interviews for one of ten patients reviewed for surgical and/or anesthesia services (Patient #34) the hospital failed to ensure that anesthesia services were provided in accordance with hospital policies and practice to prevent a fire hazard during a surgical procedure.

Please see A1002
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review, review of hospital policies, review of hospital documentation, observations and interviews for one of ten patients reviewed for surgical services (Patient #34) the hospital failed to ensure that anesthesia services were provided in accordance with hospital policies and practice. The finding includes:

Patient #34 was admitted on [DATE] for bilateral temporal artery biopsy by MD #3. The anesthesia record dated 12/2/16 identified that the patient received monitored anesthesia care, was not intubated and received oxygen (O2) via nasal cannula at 5 liters/minute throughout the procedure. The intraoperative nursing record dated 12/2/16 indicated that MD #5 (Anesthesiologist) was relieved by CRNA #1 at 11:54 AM and electrocautery was utilized. The anesthesia record by the certified CRNA #1 dated 12/2/16 noted that at approximately 12:10 PM a fire on the field was noted, O2 was stopped, O2 cannula, facial drapes and tape were removed from the patient as well as the oral airway. The ENT consult note dated 12/2/16 and/or 12/4/16 identified that Bovie (Force Triad) cautery was utilized during the procedure, a fire ignited at the tip of the O2 cannula, the patient sustained 1st, 2nd and 3rd degree burns to the face, blister to the tip of the tongue and other airway structures were without evidence of burn or thermal injury.
Observations and interviews with Risk Manager #1 on 12/13/16 at 1:05 PM and/or Director #1 (Perioperative Services) at 1:13 PM noted a charred, partially melted biohazard specimen bag with tape attached that had been taped over the patient's bridge of the nose by MD #5 (Anesthesiologist). Further interview with Director #1 on 12/13/16 at 1:13 PM indicated that the biohazard bag was used as if it were a surgical mask and if the mask were used, the anesthesia provider would have to hold the mask in place with his/her hand.
Interview with MD #5 (Anesthesiologist) on 12/19/16 at 1:20 PM identified that he/she used the biohazard bag to reduce the frequency and depth of patient desaturations and that this was his/her usual practice. He/she also indicated that a rebreather mask could also have been used to reduce the frequency and depth of patient desaturations.
Interview with CRNA #1 on 12/19/16 at 1:47 PM identified that he/she was not aware of the biohazard bag placement prior to the fire due to the placement of the sterile drapes.
Interview with Director #1 on 12/13/16 at 1:40 PM and the Safety Officer on 12/14/16 at 10:10 AM noted that it was not facility practice to tape a biohazard bag over the patient's nose during surgery.
Interview with MD #7 (the Chief of Anesthesia) on 12/19/16 at 2:25 PM noted that he/she was not familiar with the manner in which the biohazard bag was used. MD #7 identified that MD #5 was the only Anesthesiologist that he/she knew of that had used the biohazard bag in this manner.
Interview with the Manager of Regulatory Affairs on 12/14/16 at 3:14PM indicated that the hospital did not have a policy for the use of a biohazard bag during operative procedures.
The hospital anesthesia contract identified that the Anesthesiology Group shall comply with all bylaws, rules, regulations, policies and procedures of the Hospital. Subsequently, on 12/13/16 the hospital submitted an immediate plan of action to include an email to be sent to all anesthesia providers indicating only hospital approved drapes may be utilized in the surgical field and use of biohazard bags for draping purposes will be prohibited in the OR.
VIOLATION: PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES Tag No: A0122
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on medical record reviews review of facility policies and interviews for one of three patients who had complaints regarding care and services (Patient #38), the facility failed to respond to the complaints timely. The finding includes:

Patient #38 was admitted on [DATE] and splenectomy on 12/23/15. An email by Patient #38 to the hospital dated 3/10/16 identified complaints regarding his/her care during these hospitalization s. A hospital response email dated 3/14/16 indicated that the hospital received the letter, would review the issues and let Patient #38 know the findings of the review within 30 business days. A subsequent email to the patient dated 4/21/16 (29business days after complaint receipt) noted that the hospital was in the process of reviewing the matter and as soon as the review was complete, would respond to Patient #38 ' s concerns. The hospital provided a final written response to the patient ' s concerns on 8/18/16. Although interview with the Director of Patient Relations on 12/21/16 at 10:35 AM indicated that the hospital had communicated with the patient during May, June and July 2016, the final written response was not set to Patient #38 for 161 days after the patient filed the care complaint. The hospital grievance policy identified, in part, that if the issue could not be resolved within 30 business days, status of the investigation will be sent to the patient in writing. The policy lacked a timeframe and/or required communication should the investigation exceed the 30 day timeframe.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, review of hospital policies, review of hospital documentation, observations and interviews for one of ten patients reviewed for surgical services (Patient #34) the hospital lacked a mechanism for interdisciplinary communication in the operating room and/or follow facility policies and/or manufacturer's recommendations and/or hospital practices to ensure a safe environment resulting in a finding of Immediate Jeopardy. The finding includes:


Patient #34 was admitted on [DATE] for bilateral temporal artery biopsy by MD #3. The anesthesia record dated 12/2/16 identified that the patient received monitored anesthesia care, was not intubated and received oxygen (O2) via nasal cannula at 5 liters/minute throughout the procedure and had an oral airway in place. The intraoperative nursing record dated 12/2/16 indicated that MD #5 (Anesthesiologist) was relieved by CRNA #1 at 11:54 AM, the right temporal artery was prepped by MD #3 using chlorhexidine diluted with normal saline and electrocautery was utilized with settings of monopolar and 25 for coagulation. The anesthesia record by CRNA #1 dated 12/2/16 noted that at approximately 12:10 PM a fire on the field was noted, O2 was stopped, O2 source was disconnected and facial drapes, tape and oral airway were removed from the patient. The ENT consult note dated 12/2/16 and/or 12/4/16 identified that Bovie (Force Triad) cautery was utilized during the procedure, a fire ignited at the tip of the O2 cannula, the patient sustained 1st, 2nd and 3rd degree burns to the face, blister to the tip of the tongue and other airway structures were without evidence of burn or thermal injury. The surgical procedure continued following evaluation by the ENT MD and the patient showed no signs of respiratory difficulty throughout hospitalization (discharged [DATE]).


Direct observation and/or observation of photographs and interviews with Risk Manager #1 on 12/13/16 at 1:05 PM and/or Director #1 (Perioperative Services) at 1:13 PM noted a charred, partially melted biohazard specimen bag with tape attached that had been taped over the patient's bridge of the nose by MD #5 (Anesthesiologist). Further interview with Director #1 on 12/13/16 at 1:13 PM indicated that the biohazard bag was used as if it were a surgical mask and if the mask were used, the anesthesia provider would have to hold the mask in place with his/her hand. Additional observations included a surgical towel with multiple burn holes and charring and a blackened tip of the oral airway.


Interview with Director #1 on 12/13/16 at 1:40 PM and the Safety Officer on 12/14/16 at 10:10 AM noted that it was not facility practice to tape a biohazard bag over the patient's nose during surgery.


Interview with MD #3 on 12/14/16 at 11:45 AM identified that although he/she saw the biohazard bag in place, he/she did not think to question its use.


Interview with MD #5 (Anesthesiologist) on 12/19/16 at 1:20 PM identified that he/she used the biohazard bag to reduce the frequency and depth of patient desaturations and that this was his/her usual practice. He/she also indicated that a rebreather mask could also have been used to reduce the frequency and depth of patient desaturations.

Interview with CRNA #1 on 12/19/16 at 1:47 PM identified that he/she was not aware of the biohazard bag placement prior to the fire due to the placement of the sterile drapes.

Interview with MD #7 (the Chief of Anesthesia) on 12/19/16 at 2:25 PM noted that he/she was not familiar with the manner in which the biohazard bag was used. MD #7 identified that MD #5 was the only Anesthesiologist that he/she knew of that had used the biohazard bag in this manner.


Interview with the Manager of Regulatory Affairs on 12/14/16 at 3:14 PM indicated that the hospital did not have a policy for the use of a biohazard bag during operative procedures.


In addition, interview with MD #3 on 12/14/16 at 11:45 AM indicated that although the Bovi was used on both the right and left temporal surgical sites, notification of activation to the anesthesia provider (to decrease the oxygen) was not given by the surgeon immediately prior to use. He/she further indicated that communication immediately prior to Bovi use was not routinely done.

The hospital policy for electrosurgical safety identified that anesthesia should use the lowest practical level of O2 to a patient during use of an electrosurgical device as an oxidizer control intervention. Hospital education provided from 1/1/16 to 11/3/16 identified to stop supplemental O2 or nitrous oxide for 1 minute before using ignition source (i.e. Bovi). The manufacturer's user guide for the ForceTriad (Bovie) directed to stop supplemental O2 for at least 1 minute before and during use of electrosurgery if possible.

The hospital lacked a mechanism that defined the practice of interdisciplinary communication during electrosurgery procedures in the OR.

In addition, interview with the Perioperative Nurse Educator on 12/13/16 at 1:40 PM noted that the hospital follows the Association of Peri Operative Registered Nurses (AORN) guidelines in the surgical setting.

Interview with MD #3 on 12/14/16 at 11:45 AM noted that he/she prepped the patient's right temporal area with diluted Chlorhexidine and waited at least 3 minutes before he/she applied the drape. The facility policy for surgical skin preparation identified that antiseptic agents approved by the Food and Drug Administration and the infection control committe may be used following manufacturer's guidelines. The material safety data sheet for Chlorhexidine 4% identified the product may be conbustible at high temperatures. The facility did not have a specific policy and/or approval for Chlorhexidine 4% and/or diluted Chlorhexidine 4% use as a skin preparation. The manufacturer's Chlorhexidine bottle label directed, in part, to swab the surgical site for 2 minutes, dry with a sterile towel and repeat the procedure.

According to AORN 2016 Guidelines for Perioperative Practice, Collective evidence found following the antiseptic manufacturer's instructions for use is the safest way for handling, storing, and dispensing of skin antiseptics.

Similar surgical procedures were not conducted by the hospital using O2 administered via nasal cannula from 12/3/16 through 12/14/16. The facility initiated formal staff education beginning 12/13/16 regarding surgical prep application and OR fire risk assessment. The facility submitted an immediate action plan dated 12/14/16 to include education for required communication during Bovie use above the Xiphoid, standardizing the required prep dry time to 10 minutes and the approved surgical drapes (biohazard bags not included).
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, review of hospital documentation, 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 conduct mechanical testing and/or environmental sampling every six months and/or when problems were identified to ensure the safety of compounded sterile preparations in accordance with hospital policies and or USP 797 regulations. Refer to A-492.

2. The hospital failed to maintain a sanitary environment in accordance with hospital policies and/or USP 797 regulations. Refer to A-501.
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on a review of facility documentation, interviews and policy review the hospital failed to timely perform the necessary mechanical and environmental sampling to ensure that the IV compounding rooms were tested /certified in accordance with federal and state laws (USP-797). The findings included:

a. Interview and review of hospital documentation with the Director of the Pharmacy on 12/13/16 at 10:00 AM identified mechanical testing in the main pharmacy was conducted on 2/3/16 by contracted service #1. The Hepa filter leak test failed. The remedial action plan included a Hepa filter adjustment that was completed from 2/3/16 -3/21/16 however, an exact date could not be provided by the hospital.

Subsequent to the adjustment of the Hepa filter, a leak test was conducted on 3/22/16 and continued to fail. The remedial action plan included moving the housing unit for the Hepa filter which was completed on 4/4/16. Subsequent to the remediation testing failed to be conducted until 6/1/16, fifty-eight days later, which continued to identify the failure of the Hepa Filter leak test.

Further interview with the Director of the Pharmacy indicated the housing filters were determined to be installed incorrectly by facilities therefore new Hepa filters were installed on 6/23/16. Hepa filter leak testing was conducted on the same day and failed. A recommendation to replace the housing for the Hepa filter was made by contracted service #1, however documentation of the testing and the recommendations from the contracted service was not provided by the hospital.

The Director of Pharmacy indicated a comprehensive mechanical testing was conducted three months later on 9/20/16 at which time the Hepa filter leak test continued to fail.

On 11/1/16 the entire housing unit was replaced by contracted service #2. A Hepa leak test was conducted thirty days later on 12/1/16 and passed. Further interview with the Director of the Pharmacy identified although the leak test failed on several occasions from February through December of 2016 he was reassured about the safety of intravenous compounding as the environmental testing had passed in the main pharmacy in February and September of 2016, high risk compounding had not been conducted and a twelve hour beyond use date (BUD) was in place. The Director of Pharmacy indicated he was not aware that mechanical certification needed to be performed whenever the device or room was relocated, altered or major service to the facility was performed in accordance with USP 797.

b. Review of the facility documentation identified environmental testing in the main pharmacy was conducted on 2/3/16 and 9/20/16. Environmental testing failed to be completed following the servicing of the Hepa filters on 3/22/16, 4/4/16, 6/23/16, and 11/1/16. According to USP 797 environmental sampling would occur following any servicing of facilities and equipment. Interview with the Pharmacy Director on 12/13/16 at 11:00 AM indicated he was not aware that environmental sampling needed to be performed following servicing of facilities and/or equipment.

c. Review of the environmental testing in the IV prep rooms in the main pharmacy identified environmental sampling was conducted on 2/3/16 and 9/20/16. Interview with the Pharmacy Director on 12/15/16 failed to identify that environmental sampling was conducted every six months. The Pharmacy Director indicated environmental sampling should have been conducted minimally every six months in accordance with the requirements for USP 797 and was not.

In accordance with USP 797, environmental sampling should occur as part of a comprehensive quality management program and should occur minimally as part of the recertification of facilities and equipment (i.e. every 6 months).

d. Interview and review of the certification reports from contracted service #1 with the Pharmacy Director on 12/13/16 failed to identify that mechanical testing was conducted every six months. A full certification of the IV preparation rooms in the main pharmacy was completed on 2/3/16 and on 9/20/16 and was forty-eight days late. The Director of the Pharmacy indicated certification was not performed timely in accordance with the requirements for USP 797 and should have been.

The hospital policy entitled Sterile Preparations: Sterile Compounding Area directed in part the sterile compounding facility shall be checked for operational efficiency by a qualified certifier at least once every six months.

e. Interview and review of the environmental testing from the IV prep rooms in the Cancer Center dated 2/3/16 conducted by contracted service #1 (contracted service who obtained environmental testing) with the Director of the Pharmacy on 12/13/16 at 2:00 PM identified 2 colony forming units (CFU's) of mold (cladosporium) in the air of the chemo room.

Interview with the Pharmacy Director identified an alternate company was utilized on 2/11/16, contracted service #3, to ensure the validity of the results. The Pharmacy Director indicated that mold was an issue surrounding the sterile suite with a high colony count of mold in the hallway, the hospital did not provide the documentation from contracted service #3.

On 2/16/16 an action plan was developed that included the removal of a blanket warmer that was in close proximity to a pass thru window to reduce air particles/dust from entering the anteroom and the removal of the carpet outside of the pharmacy suite which was replaced with laminate wood. These interventions were conducted on 4/8/16. Intravenous compounding ceased operation from 2/29/16 through 4/10/16 due to the identified mold. All IV compounding was conducted at the hospital's main pharmacy.

Interview with the Director of Pharmacy identified intravenous compounding resumed at the Cancer Center on 4/11/16 absent environmental testing, as the compounding hoods themselves did not reveal growth in February of 2016 with a one hour BUD implemented. Further interview with the Pharmacy Director indicated environmental testing in the Cancer Center was conducted on 9/19/16 seven (7) months after mold was identified in the air of the chemo room and in the hallway of the IV suite. On 9/19/16 one (1) CFU of mold (cladosporium) was identified in the air of the anteroom.

Interview with the Director of the Pharmacy identified the action plan consisted of reduced traffic into the compounding area that included medications delivered via the pass thru window. Staff education was provided.

Environmental testing was conducted on 11/3/16, forty-five (45) days after mold was identified in the anteroom (on 9/19/16). Twenty seven (27) colonies of bacterial growth (gram positive flora) was identified in the air of the anteroom. Remediation included instillation of an interlock door mechanism from the receiving room into the anteroom to reduce particles from entering the anteroom. Environmental sampling failed to be conducted as of 12/13/16.

Interview with the Director of the Pharmacy on 12/15/16 identified although he was aware when environmental sampling revealed identified problems a timely evaluation, investigation and implementation of an action plan was required however was unaware that prompt resampling of the environment was required in accordance with USP 797.

According to USP 797 a CFU count that exceeds its respective action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures and air filtration efficiency within the aseptic compounding location. An investigation into the source of the contamination shall be conducted, the source shall be eliminated and re-sampling performed.

f. Review of the environmental testing in the IV prep rooms at the cancer center identified air and surface sampling was obtained on 2/3/16 and 9/19/16. Interview with the Pharmacy Director on 12/15/16 failed to identify that environmental sampling was conducted every six months. The Pharmacy Director indicated certification was not performed timely in accordance with the requirements for USP 797 and should have been.

In accordance with USP 797 environmental sampling should occur as part of a comprehensive quality management program and should occur minimally as part of the recertification of facilities and equipment (i.e. every 6 months).

The job description for the Director of Pharmacy included the management of all drug dispensing and clinical operations of the pharmacy. The Director would facilitate safe medication use, and was responsible for all drug regulations related to the procurement, handling, dispensing and destruction of medications. The Director of Pharmacy would have current knowledge of pharmacy law, both federal and state and the ability to maintain standards related to USP 797 sterile product admixtures. The Director would provide strategic planning for the pharmacy department that includes goals with a direction aimed at improving department performance. The Director of Pharmacy would demonstrate the ability to address problems in a group setting using tools and techniques for identification and resolution of problems including updating operational procedures and policies, regulatory compliance and accreditation.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, a review of facility documentation, staff interview, and a review of hospital policies, the hospital who compounds sterile pharmaceuticals failed to maintain a sanitary environment in accordance with USP 797 requirements. The findings included:

1. During a tour of the main pharmacy and of the Cancer center pharmacy with the Pharmacy Director on 12/13/16 identified the following concerns:

a. Several areas of clutter were identified in the intravenous (IV) prep rooms in both areas. The ante rooms contained items that included files, multiple supplies and other paper products rendering the items unable to be properly cleaned and/or sanitized. Interview with the Director of the Pharmacy on 12/13/16 at 10:15 AM indicated he was unaware that paper items could not be stored in the IV prep rooms.

The hospital policy entitled Guide to Sterile preparations in the Pharmacy directed in part that papers shall not be stored in the intravenous (IV) prep rooms.

The hospital policy entitled Sterile Preparations: directed in part that Sterile Preparations must be compounded in areas that are clean, uncluttered and functionally separate to minimize the possibility of contamination of the preparations.

The hospital policy entitled Sterile Preparations: Compounding Procedures directed in part supplies that are required for back-up or general support of operations may be stored on designated shelving in the buffer area, but excessive amounts of supplies are to be avoided.

b. Continued tour of the main pharmacy on 12/13/16 identified two storage carts, each in both the positive pressure and the chemo room, contained multiple plastic bins with excessive products that included IV tubing, medications, multiple syringes and other pharmaceutical supplies. Interview with housekeeper #1 on 12/13/16 at 4:30 PM identified he took the bins off of the carts in the IV compounding rooms once a week to clean the surface, the bins, and their contents. Further interview with housekeeper #1 failed to identify he was aware that the carts in the IV compounding room needed to be cleaned daily and/or that excessive supplies should not be stored in these areas in accordance with the hospital policy and USP 797.

Interview and review of the cleaning logs with the Director of the Pharmacy on 12/14/16 indicated the logs failed to identify that the bins on the carts were cleaned daily and should have been.

c. Continued tour of the main pharmacy on 12/15/16 by the Building and Fire Safety Inspector (BFSI) observed that the doors to the Ante room, Clean Room & Hazardous Mixing Room were not interlocking, the pass through windows between the mixing rooms and the pharmacy were not fail safe and opened on both sides simultaneously; the gasketing material around the pass through doors was porous not maintaining a clean and sanitary surface. The light fixtures and ceiling tiles within the rooms were not sealed and caulked into place.

The low air return in the Ante Room was blocked by a large refrigerator. There was a large mount of dirt and debris behind the LAFW (Laminar-airflow Workbench).

d. A tour of the Cancer Center Pharmacy on 12/15/16 by BFSI identified that the pass through windows between the mixing room pharmacy work room were not fail safe and opened on both sides simultaneously; the gasketing material around the pass through doors was porous not maintaining a clean and sanitary surface. The light fixtures and ceiling tiles in the ante room were not sealed and caulked into place, the pipes under the sink in the ante room were not sealed and the cabinets within the room were wooden with holes for shelving not maintaining a clean and sanitary surface.

The Biological Safety Cabinet was blocking the low air return within the room and also had rust on the front of the cabinet.

The hospital policy entitled Sterile Preparations: Compliance Cleaning and Disinfecting the Sterile Compounding Area directed in part that daily cleaning included cleaning the carts, counters, hoods, shelves and floors with a disinfectant or sporicidal agent followed by 70% sterile isopropanol alcohol.

Further interview with the Pharmacy Director identified he was unaware that excessive amounts of supplies should be avoided in the IV compounding areas in accordance with USP 797.

USP 797 directed in part that supplies that are required frequently or otherwise needed close at hand but not necessarily needed for the scheduled operations of the shift are decontaminated and stored on shelving in the ante-room.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on direct observations of the behavioral health unit on 12/15/16, the hospital failed to ensure that the environment was maintained in a manner conducive to the safety and well-being of the behavioral health patients resulting in a finding of Immediate Jeopardy.


Unit capacity is 15.
Unit census on 12/15/16 was 13.
No patient's were identified as being at risk for self harm on 12/15/16.



Please see A701
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on direct observations of the behavioral health unit, the hospital failed to ensure that the environment was maintained in a manner conducive to the safety and well-being of the behavioral health patients resulting in a finding of Immediate Jeopardy. The findings include:



During a tour of the Behavioral Health Unit while accompanied by the Director of Safety and Security on 12/15/16, the following was observed:

a. Patient room #184 had a broken interior door handle that was hanging from the door which was a ligature point for patients;

b. The tracks attached to the ceiling for window blinds in all patient rooms were secured in a fashion in which was a ligature point for patients;

c. The sprinklers within the patient rooms were covered by metal escutcheon plates and the sprinkler heads were of non-institutional type which are not permissible for this type of location;

d. The shower rooms throughout the unit had plastic switch covers which were cracked and open electrical boxes were observed posing an electrical safety hazard;

e. Patient room #104 had wall damage covered by raw plywood attached to the wall by sheetrock screws which were not tamper proof as required for this area;

f. The light fixtures located in patient room bathrooms were easily removable allowing for a safety hazard and ligature point for patients;

g. Throughout the behavior health unit, observations identified wall marring and peeling paint not maintaining a clean, sanitary and safe environment.


Unit specific risk assessments were conducted monthly but did not include the physical environment. The hospital was unable to provide documentation of the annual physical environment audits at the time of the survey.


In response to the survey findings and identification of Immediate Jeopardy on 12/15/16, the hospital provided an action plan to mitigate the safety hazards and ensure patient safety during the mitigation process. Elements included the posting of security staff 24/7 to conduct continuous environmental safety rounds on the unit until identified safety hazards have been corrected. Between 12/15/16 and 12/19/16, the hospital repaired and/or replaced lighting fixtures, electrical outlets, removed curtain tracks, installed tamper-proof screws where necessary, repaired wall damage, and replaced sprinkler heads in bedrooms and bathrooms where able. The bedrooms and bathrooms where replacement of sprinkler heads had not yet occurred were closed and not in use. Bedroom door handles have been ordered and a plan is in place for installation once they are received.