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Based on record reviews and administrative interviews, it was determined the hospital does not have an effective governing body legally responsible for the conduct of the hospital as an institution as it relates to Condition of Participation at A0263 Quality Assurance Performance Improvement and A0747 Infection Control. The governing body is responsible for the conduct of the hospital as an institution.

These failures present a substantial probability to adversely affect all patients' physical health, safety, and well-being.

The findings include:

1. The Condition of Participation for Infection Control is not met based on observations, staff interviews, and a review of hospital policies, procedures, and hospital records. It was determined the hospital failed to identify, investigate and mitigate Infection Control interventions. The facility failed to meet the needs of patients, staff, and community visitors regarding the safe containment of contaminants during renovation and demolition on the first floor. The facility was unable to ensure the infection control program met the applicable Conditions of Participation.

Additionally, the facility failed to have a respiratory department which follows guidelines for cleaning ventilators and Continuous Positive Air Pressure (CPAP) device; Failed to monitor hazardous waste in the dialysis department; Failed to have staff appropriately wearing Personal Protective Equipment (PPE) while administering direct patient care in the dialysis unit; Failed to properly sanitize dialysis equipment; Failed to have appropriate hand washing in the surgical suite; Failed to have staff trained to appropriately clean/sanitize glucometers after patient use; and failed to have clean equipment in the kitchen.

This failure by the hospital placed current patients, staff, and community visitors at risk of immediate jeopardy for serious physical and/or psychological harm.

On 12/12/11, issues related to the above became known. After complete investigation, Immediate Jeopardy was declared at 3:30 p.m., on 12/13/11. On 12/14/11 at 9:45 a.m., the facility had made sufficient improvements to abate the Immediate Jeopardy.

2. The Condition of Participation for Quality Assessment Performance Improvement is not met based on the lack of knowledge and monitoring of areas of the hospital currently under construction/demolation leading to deficient practice related to Infection Control.
Please refer to A 0747 for additional information related to Infectin Control
Please refer to A-0263 for additional information related to Quality Assessment Performance Improvement.

Based on observations, staff interviews, and a review of hospital policies, procedures and hospital records, the facility failed to provide a safe environment for patients regarding infection control. It was determined the hospital failed to identify, investigate, and mitigate Infection Control issues/concerns. The facility failed to meet the needs of patients, staff, and community visitors regarding the safe containment of contaminants during renovation and demolition on the first floor. Additionally, the facility failed to have a respiratory department which follows guidelines for cleaning ventilators and Continuous Positive Air Pressure (CPAP) device; Failed to monitor hazardous waste in the dialysis department; Failed to have staff appropriately wearing Personal Protective Equipment (PPE) while administering direct patient care in the dialysis unit; Failed to properly sanitize dialysis equipment; Failed to have appropriate hand washing in the surgical suite; Failed to have staff trained to appropriately clean/sanitize glucometers after patient use; and failed to have clean equipment in the kitchen.

The findings include:

Please refer to A0747

The Condition of Participation for Quality Assurance and Performance improvement is not met based on observations, staff interviews, and a review of hospital policies, procedures, and hospital records. It was determined the hospital failed to identify, monitor, investigate, and mitigate Infection Control issues/concerns during demolition and renovation. The facility failed to meet the needs of patients, staff, and community visitors regarding the safe containment of contaminants during renovation and demolition on the first floor. The facility was unable to ensure the infection control program met the applicable Conditions of Participation.

The findings include:

1. The facility failed to provide quality and performance improvement communication during the department director meeting to insure multidisciplinary improvement opportunities for the performance improvement teams. The facility also failed to maintain adequate attendance records for the meetings, to insure appropriate attendance and optimal outcomes related to Quality Assurance and Performance improvement.

2. 12/14/11 review of the Administrative Policy Manual for Improving Organizational Performance for 2011 - 2012 noted under the section Medical Staff. The Department Directors (DD) are responsible for their department Performance Improvement Program that actualizes the performance improvement process, adequate resources, and fostering participation in performance improvement by staff at all levels. They are also responsible to select improvement within their department and identify multidisciplinary improvement opportunities for the performance improvement teams.

12/14/11 at 10:00 a.m., interview with Chief Medical Officer (CMO), Director Clinical Outcomes Management (DCOM) and Director Strategy and Operational Performance (DSOP) related to the facility's Quality Assessment and Performance Improvement (QAPI) program. They explained there are multiple levels related to this program. The Board Quality Committee (BQC) meets every 2 months and discusses all the main quality indicators data. They track the data and chart the process throughout the year. They also have presentations at the meetings of current Performance Improvement (PI) programs in progress. The BCQ members are made up of physicians and upper level management.

They also stated the Department Directors (DD) meet every two weeks and discuss what each department is tracking and trending and what PI programs are currently in progress. All department heads are required to attend each meeting in the meeting room or via video conference.

Review of the last DD bimonthly meeting minutes on 11/08/11 noted the topics listed were Conditions of Participation Survey, Benefits Update, Announcements, Innovation presentation by board member MF and CMS updates. Review of each section noted there was no mention of any QAPI programs. The minutes did not reflect the committee had discussed any data driven QAPI programs developed by the DD for their department. There was no sign-in sheet of who attended each meeting.

3. 12/14/11 at 1:00 p.m., final interview with DCOM confirmed after reviewing DD meetings minutes for 11/22/11, 11/08/11, 9/27/11, 9/13/11, 5/24/11, and 3/15/11 they have no data driven QAPI programs and/or decision by the DD of PI programs currently in progress. He stated almost all the DD attends the meetings but confirmed there are no sign-in sheets, documentation who attends each meeting, who had presented a data driven PI programs currently in progress at each meeting and the evaluation/results of programs that were just concluded.

Please refer to A 0747 for additional information related to Infection Control concerns.

Based on observation and interview, the hospital failed to ensure a narcotic medication was properly secured after being administered by a student nurse anesthetist.

The findings include:

1. Observation on 12/13/11 at 8:15 a.m., in the preoperative holding area of the North campus, revealed a student registered nurse anesthetist (SRNA) in the room of Patient #59. The plunger portion of the syringe was observed in the top pocket of his scrub top. At 8:30 a.m., the same syringe was observed in his top pocket. This nurse was now at the nurse's station and out of the patient's room. He was asked what was in his scrub pocket to which he replied, "it's Duramorph, 0.5/ml" and pulled a full syringe of the narcotic out of his pocket. The medication was not labeled with the patient's name.

The SRNA was asked why he was walking around with a narcotic filled syringe in his pocket and explained he had pulled the medication out of the locked medication cart earlier in the morning in "an effort to be ready for the anesthesiologist" as he would be assisting him with administration of spinal anesthesia.

He indicated Patient #59's procedure was delayed due to another patient and did not place it back inside the locked cart. Despite the questioning, the student was observed to walk in and out of Patient #59's room in and around the holding area with the narcotic filled syringe at 8:45 a.m., 8:50 a.m., 9:00 a.m., and 9:05 a.m.

At 9:07 a.m., the anesthesiologist entered the patient's room and while the student assisted, initiated the administration of spinal anesthesia. The student was observed to remove the syringe out of his pocket with his gloved hands and administer a portion of the medication into the patient. After recapping the needle, he placed the remaining contents of the medication inside the same pocket as observed earlier. After the administration of the spinal anesthesia, the anesthesiologist left the patient's room. The syringe remained in the student's pocket.

From 9:10 a.m. through 9:45 a.m., the syringe remained in the student's pocket. At 9:50 a.m., the patient was transferred from the holding room to the operating room. The SRNA accompanied the patient out of the room to the operating room with the syringe remaining in his pocket.

An interview was conducted on 12/14/11 at 2:00 p.m., with the co-director of anesthesiology, who was also the dean of the college from where the SRNA attended. The anesthesiologist stated after administering the medication (to Patient #59), the SRNA should have wasted the rest of the medication prior to leaving the preoperative area.

Based on observation and staff interview the facility had outdated medication available for patient use in the outpatient cardiac catheterization lab.

The findings include:

1. A tour of the outpatient cardiac catheterization lab on 12/14/11 at 9:15 a.m., revealed medications used during the procedure stored in a locked drawer in the procedure room. A review of he medication in the locked drawer found two bottles of 30 ml Heparin Sodium with an expiration of "9/11;" indicating the medication expired the end of September 2011. These were the last two bottles in a case of the medication. The catheterization lab manager stated a lot of Heparin is used in the lab and he has recently been requesting these larger bottles. The manager stated pharmacy brought this batch up to the lab last week. A new case of Heparin was retrieved from storage. The expiration date for the new case was in 2012.

In an interview on 12/14/11 at 3:00 p.m., the hospital pharmacy director stated the hospital pharmacy does not supply medications to the outpatient catheterization lab and did not provide the Heparin to the catheterization lab. The director stated the catheterization lab has a pharmacy license and orders medication directly from the manufacturer. A contracted consultant pharmacist, monthly, evaluates the control and handling of medications in the catheterization lab. A report from the consultant pharmacist documents outdated medications were checked for in September, October and November 2011.

Based on observation and interview, the hospital failed to maintain supplies and equipment at an acceptable level of safety and quality as evidenced by medication refrigerator/freezer gaskets with an accumulation of unidentifiable black substances; door without latching device in preoperative holding room; dust, dirt, and lint build up on air conditioning vents in the sterile supply room; OR doors, walls, ceiling lights, wall panels and equipment in need of repair; medication refrigerators in need of defrosting; central supply pyxis machine with dried spillage, dust, dirt, and lint build up; substerile rooms in poor housekeeping condition; and ice machine in open heart tower section of the hospital with a build up of yellow slimy residue inside of the machine.

The findings include:

1. Observation on 12/12/11 at 10:45 a.m., during the tour of the preoperative area of the hospital at the "north" campus in the presence of the Assistant Director of Surgical Services (ADSS), revealed the inside of the gasket of the IV (intravenous) refrigerator filled with black, unidentifiable substances. The top of the refrigerator was rusted.


Observation of this area also revealed a set of double doors near one of the preoperative holding rooms in which a patient was awaiting surgery. Adjacent to these doors was a "free floating" door which granted access to a room where unfinished construction had taken place. The door was without a latching device in order to secure entry and exit out of the area.

Observation revealed a large accumulation of dust, dirt, lint, and "particulate matter" in this room. Because the door did not latched, observation revealed each time the electronic double doors opened into the holding area, the "floating" door moved back and forth, which could potentially allow for the particulate matter to leave the construction site and enter the area where patients where observed awaiting surgery.

Interview at this time with the ADSS confirmed renovation was taking place and she was not sure when it would be completed.

2. Observation on 12/14/11 at 8:50 a.m., during the tour of the operating room areas in the presence of the Assistant Director of Surgical Services (ADSS) at the "main" campus of the hospital revealed the following:

*front of the anesthesia carts in OR's (Operating Room) #5, #6, #9, and #10 slightly rusted.

*cracked chipped dry wall inside OR #7 near the double doors.

*large yellowish brown staining on the light cover above the operating table in OR #8.

*two of 3 wall panels behind surgical preparation area with large amount of rust in OR #10.

*batteries for the "hoods" worn by orthopedic surgeons located in the substerile room near OR #10 with an inspection sticker dated "8/2009."

Interview with the ADSS at this time confirmed they were "outdated."

*outside of OR door #10 revealed a large amount of "chipping."

*outside of OR door #4 revealed a large amount of "splintering."

*front of the bottom cupboards located in substerile rooms #2 and #3 revealed an accumulation of black marred residue. Brown unidentifiable substances were observed on the front of the freezer in this room. Inside of this freezer revealed gaskets filled with black particles. The countertops and front of the top cupboards were coated with a gray residue.

*ceiling panels directly above the operating table in OR #2 revealed beige and gray matter lining the sides of the panels. Reddish brown residue was observed on the wall directly above and behind the sharps container.

*air conditioning vents in the sterile supply room were filled with dust, dirt and lint. The ceiling tile surrounding one of the two of the vents was coated with dust and lint. Packaged sterile supplies could be observed directly underneath these areas.

*yellow slimy residue was observed on the plastic casing inside of the ice machine (ice not used for human consumption, rather, to chill human body parts) in substerile room #12 of the open hear tower. Water was observed running over this slime and into the ice resting inside the machine.

Interview with the maintenance representative during this observation revealed he never knew the machine was in this area and would have it removed and cleaned immediately. The top of the sink next to this ice machine was coated with a build up of dust, dirt, and lint and the caulking behind the sink was peeling away from the wall. The cupboards above and below the sink were observed to have white dried residue as well as black marred areas on the front of them.

Interview with the ADSS on 12/14/11 at 11:00 a.m., revealed he had turned work orders in for the repairs of the doors and dry wall but did could not confirm when the repairs would be completed. He stated environmental services was responsible for the cleanliness of the OR's and substerile rooms and would notify them immediately to come and clean the areas properly.

3. Observation on 12/14/11 between 8:42 a.m., and 9:30 a.m. during the tour of the medication rooms at the main hospital campus in the presence of the Pharmacy Director revealed the following:

*large amount of ice accumulation in the medication refrigerators in the medication rooms on 4 Northeast, 4 South, 3 Northwest, 2nd Northwest and 2 Northeast; though, all refrigerators maintained internal temperatures between 38 and 41 degrees F. Interview with the Pharmacist during these observations stated they would have the pharmacy technicians change out the refrigerators.

*air conditioning vent with black staining in the ICU (Intensive Care Unit).

*broken and cracked blood tube bins exposing sharp pieces of plastic on the wall of third floor, northwest, medication room.

*accumulation of clear crusted residue resting on the tops and sides of sterile supplies inside #7 and #8 sections of the central supply pyxis on 3 North west. The outside and inside cabinet door to this pyxis presented with a dried clear residue as well as reddish brown residue. The bottom shelf of the pyxis was filled with dust, dirt and lint. Interview with the Pharmacist during this observation revealed they do not have any oversight of this pyxis, it was central supply.

*dried white residue was observed on the sterile water bottles along with a buildup of dust dirt and lint inside the bins they were resting in on 3rd floor east.

An interview was conducted with the representative from supply services on 12/15/11 at 2:30 p.m., which revealed there was no policy and procedure in place delineating who was responsible for maintaining the condition of the inside or outside of the central supply pyxis machines.

The Condition of Participation for Infection Control is not met based on observations, staff interviews, and a review of hospital policies, procedures, and hospital records. It was determined the hospital failed to identify, investigate and mitigate Infection Control issues/concerns. The facility failed to meet the needs of patients, staff, and community visitors regarding the safe containment of contaminants during renovation and demolition on the first floor. The facility was unable to ensure the infection control program met the applicable Conditions of Participation.

Additionally, the facility failed to have a respiratory department which follows guidelines for cleaning ventilators and Continuous Positive Air Pressure (CPAP) device; Failed to monitor hazardous waste in the dialysis department; Failed to have staff appropriately wearing Personal Protective Equipment (PPE) while administering direct patient care in the dialysis unit; Failed to properly sanitize dialysis equipment; Failed to have appropriate hand washing in the surgical suite; Failed to have staff trained to appropriately clean/sanitize glucometers after patient use; Failed to have clean and sanitary equipment in the kitchen.

This failure by the hospital placed current patients, staff, and community visitors at risk of immediate jeopardy for serious physical and/or psychological harm.

On 12/12/11, issues related to the above became known. After complete investigation, Immediate Jeopardy was declared at 3:30 p.m. on 12/13/11. On 12/14/11 at 9:45 a.m., the facility had made sufficient improvements to abate the Immediate Jeopardy. A tour of the areas of concern revealed the areas had been terminally cleaned, all Infection Control Barriers had been constructed; the negative pressure machines were in place and functioning. All staff previously working in the area offices had been relocated out of the construction/demolition areas.


The findings include:

1. During the tour of the facility with the Fire Life Safety (FLS) surveyor and the director of maintenance on 12/13/11 at 8:35 a.m. The FLS surveyor observed a vapor barrier in place in the old pediatric suite. Upon further review it was noted the facility was remodeling the area.

During this tour two construction workers were noted in the area. This project included 6 rooms. Observation revealed the negative air pressure machines with HEPA (High-Efficiency Particulate Air) Filtration systems were not in use. In all but three rooms the ceiling tiles had been removed. In the other three rooms it was noted to have hard ceilings. In this area some of the drywall had been removed. The door that leads into this area is located down the corridor from the automatic double doors leading into the operating rooms suites. This door was not sealed nor had a dust mat at the entrance. When the door was opened it was observed that this area was positive pressure, air could be felt entering the corridor. The facility had placed blue filters on all the return vents for the air conditioner unit in this area. When questioned, the facility staff stated that the contractor started this remodel without the staff knowledge. The Infection Control Construction Permit for this area shows the start date as TBA (To be announced). It indicates this project is a Type C. Activity generates moderate to high levels of dust.

a.) On 12/13/11 at 8:45 a.m., a nurse surveyor tour of the first floor demolition/construction area was conducted. The tour included the Assistant Chief Nursing Officer (ACNO) for the North Hospital Campus and the Agency's Fire Life Safety surveyor joined the tour at 8:50 a.m. The area included the demolition area taking place in rooms 1300 and 1301. Staff was observed entering through the double doors adjacent to the demolition area.

An examination of the double doors revealed the doors opened to a hallway with access to the hospital property. One sticky mat (used for collecting debris and contaminants from foot wear) was observed on the hallway side of the double doors. The mat was placed at the one door closest to the south. The mat was observed with a tan/white residue. The other double door (north) was without a mat. The ACNO commented another mat should be placed in front of the other door.

An observation of the double doors inside the demolition area revealed there were no sticky mats in the area adjacent to rooms 1300 1nd 1301. The sticky mats in front of rooms 1300 and 1301 were covered with debris and particulate material. The ACNO commented new sticky mats would be placed.
At 8:50 a.m., the Fire Life Safety surveyor noted in the same area (rooms 1300 & 1301); two construction workers were removing drywall. This area had blue dust mats in place, however these two doors were not sealed; nor a negative air machine in place. This situation allowed dust to travel outside the room into the corridor. In the same area it was observed several offices in use. One was the Bio Medical equipment room and this door was open. It was also noted two other rooms in use known as employee health offices. These two offices had employees working in them with the doors opened. Other offices were noted in this area however these doors were closed.

b.) Approximately 12 foot away from rooms 1300 & 1301 was a nurses' station. This area was being used as storage for the operating room supplies.

At 8:52 a.m., a facility staff member was working in this area and when questioned stated he was getting supplies to be delivered to the operating rooms for today's cases. When question further he stated that this storage area was created about seven days for OR supplies. Directly behind the nurse's station was a supply room with additional OR supplies. In both areas neither was being protected from air borne dust. The supplies included (not limited to) blood tubes, bulb syringes, syringes, and cardboard boxes containing medical supplies.

The FLS surveyor noted the counter at the nurse's station had a light film of white/tan material. At 9:00 a.m., a decorative plastic plant was observed by the surveyors across from the nursing station. The plant was observed with a white/tan film covering the plastic plant leaves. The ACNO confirmed the plant was covered with the white /tan film stating it was a "dust barometer."

c.) It was further noted that the carpet in the construction area had visible foot prints from dirty shoes. The ACNO and the plant maintenance staff member commented to the surveyors the "dust" would be "taken care of immediately."

At 9:02 a.m., a worker was observed using a mop on the carpet to clean the "dust."

d.) It was also noted that this area had two sets of double doors leading in and out of the construction area. The double door near room 1300 & 1301 was closed; however, the double doors leading into the corridor near the OR suites, was open. Neither of the two sets of double doors had been sealed nor the single door, near the employee health offices. An observation by the survey team included an open door to a patient holding area. The ACNO stated this room was used for patients as a holding area prior to entering the Catheterization procedure room.

e.) At 9:01 additional facility staff members and contractor arrived in this area and shut down all construction work until the proper ICRA measures were in place before construction can continue.

f.) At 9:04 a.m., a staff member, wearing a bunny suit (protective gear worn to cover street clothes when entering the OR) was observed entering the closed double doors and pushing a medical device (on wheels). The staff member proceeded through the demolition area and later was observed exiting the area through the open double doors in the hallway close to the OR. The ACNO confirmed the staff member was part of the biomedical team.

g.) At 9:10 a.m., the ACNO was observed asking the environment/plant maintenance staff to remove the used sticky pads and place new sticky pads where they were needed.

h.) At 9:40 a.m., an interview with the Infection Control Director and Infection Control staff was conducted on 12/13/11. The facility infection control staff commented the Infection Control Risk Assessment (ICRA) was completed for the area. The ICRA document is dated 12/6/11. The facility documented the demolition/construction area as a "Type C" Construction Project Activity.

"Type C Project Activity Step 1" is documented as the following (not limited to):"Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or fixed assemblies."

Step 2 is identified as low risk according to a table grid identifying the Risk Groups affected. The Infection Control Department identified this project as "Low Risk" and as an office area, concluding this project was a Step 3 - "Type C- Low Risk."

Step 4 of the ICCRA identified the "Lateral, Behind and Front" areas adjacent locations as High Risk.

Step 5 - Identified the site as "North Naples Hospital Campus rooms 1300, 1301 -room renovations to occur. Room 1300 to be divided with duct work and electrical work to be performed and partial removal of cabinetry to occur. Room 1301 -door to room 1300 to be cut."

Step 6- Identified issues relating to ventilation, plumbing, electrical in terms of occurrence for probable outage creating risk relative to Infection Prevention and Control as "Electrical work and duct work being performed."

Step 7- Identified Containment measures, types of barriers, HEPA filtration, Negative pressures as "Egress doors will be kept closed when construction work is performed. Adhesive walk off mats will be placed at the entrance and exit of the construction work area and replaced when soiled."

Step 8- Identifies the risk for water damage as "N/A (not applicable)>

Step 9- Identifies Work Hours as "Weekdays/weekends-day/evening shifts.

Steps 10, 11, 12, and 13 are identified as "N/A"

Step 14 -Identifies the plan for containment issues including traffic flow, housekeeping, and debris removal as "Only authorized personnel will be permitted to access the construction area. All construction waste will be brought to the outside of the building in covered containers through exterior doors to the nearest exit. Work area to be kept clean. EVS (Environmental Services) to clean area prior to the office spaces being occupied.

The interview included a review of the Infection Control Construction Permit for the: Pre-admission Renovation and Rooms 1300 and 1301 Renovation. The infection control team was asked to explain the monitoring of the renovation sites. The Director of Infection Control commented that her team members monitored the site. The Director presented an Infection Prevention and Control Checklist: Construction/Renovation document used as the facility monitoring tool. The checklist included (not limited to) barrier, air handling trash and debris, and traffic control thresholds. The checklist also contains the project location, time, and dates the monitoring was completed. The Project Location for 1300 and 1301 dated 12/12/11 and 12/13/11 included the Inspector name. The 12/12/11 time was documented as 0720 (7:20 a.m.) and the 12/13/11 time was documented as 0715 (7:15 a.m.). The comment for 12/12/11 was documented as "12/12 Contractor has installed a hard surface flooring over carpet to protect carpet."

The 12/13/11 comment entry documented "12/13 Advised ____ (insert worker name) that ICRA needs to be posted."

The 12/12 and 12/13/11 checklist indicated the following (not limited to): Barriers: ICRA Posted - Blank no entryDoors Properly Closed and sealed -CheckedHoles, pipes conduits punctures, etc. sealed- Blank - no entry

Dust barriers intact and sealed-Includes containment cubes, partitions, etc.Ceiling tiles outside of containment area free of moisture and in place-Checked

Air Handling: All windows behind barrier closed - If using trash chute area around chute is sealed-CheckedNegative air pressure at barrier entrance, if appropriate- Blank-no entryPortable air flow units to maintain negative pressure running- Blank no entry
Trash & Debris:No visible evidence of insects or vermin- CheckedTrash in appropriate containers (all carts covered) Hand written entry- Blank- no entryAppearance of are (area) indicates routine cleaning performed- Blank -no entry"Sticky" due mats appropriately placed and clean- CheckedFloor and horizontal surfaces outside of containment area is free of dust, dirt and debris

Debris is removed in covered containers (all carets covered) - Blank - no entry

Traffic Control:

Doors and exits are free from debris- CheckedArea restricted to construction workers and essential staff such as plant engineering. -Checked. In response to the review of the checklist the infection control director commented, the inspector is a member of her staff and is "The inspector is part of her team and is capable to make the appropriate assessment of the area." The director stated "The construction just started yesterday, and the ICRA was correct according to the information the department was supplied." The director and the nurse who completed the ICRA denied visiting the site this morning or at the start of the demolition construction. The director commented she had seen the site on Friday prior to construction.

The director continued by commenting the major concern was not for the staff located and working in the site but the infection control concern was regarding the staff walking through the area and then travelling through the hospital.

i.) At 9:50 a.m., during the tour of the facility with the director of maintenance and the nurse surveyor, it was noted a door near the surgical waiting room did not have a door knob. Upon further investigation three construction workers were observed in this 6 foot wide corridor. Demolition was in progress which was creating a high level of dust. This area had not been sealed off nor was a negative air machine in this area. Further investigation of this area it was noted a door leading into a small room being used as a Pre-Operation evaluation for patients. When opened it was observed a staff member and a patient in this room. This area was not sealed off from the construction area. The surveyor instructed the workers to stop work immediately and have their supervisor come to this area. The construction superintendent arrived on site a couple of minutes later and was informed to stop work until further notice. The facility was unable to produce documentation for the infection control construction permit during this survey. The work being performed is a Type C project, activity that generates moderate to high levels of dust.

j.) A telephone conference was held with hospital administration at 10:30 a.m. The infection control concerns of the morning tour of the renovation sites were outlined. The facility administration responded by commenting the areas would have appropriate barriers, filters, signage, and infection control provisions to contain the sites and prevent infection.

k.) At 12:45 p.m., on 12/13/11, it was observed in the pre-op suite area a door missing the door knob. Upon investigation it was observed this area had done some demolition and/or added a wall. The new metal stud wall only had drywall on the outside wall. This area did not have a drop ceiling. It was also noted that holes in the wall in what appeared were created to access pipes in the wall. At the end of this area it was noted that openings above the drop ceiling point that would allow air-borne contaminates to travel into the interstitial space above the pre-op area. The health surveyor who first observed this condition stated that when the automatic double doors open and close, this allows this door leading into another area to open and close because the door was not equipped with a door knob for positive latch. During this survey it was noted that no work was being performed in this area.
l.) At 8:45 a.m., on 12/14/11 a meeting with nurse surveyor, the FLS surveyor, the CNO (Chief Nursing Officer) and other facility administration was conducted. A document entitled "NCH Immediate Action to Correct OR Construction Deficiencies" was provided. At 8:50 a.m., a tour of the facility was initiated. The FLS surveyor noted three additional provision requests including additional Infection Control rounds (Three per day- morning afternoon and prior to end of day), monitoring of construction materials (covered) and daily smoke checks with immediate correction if any issues are noted with the smoke test. At 10:00 a.m., the updated correction list was received.
m.) An additional tour of the facility was conducted at 8:30 a.m., on 12/15/11, with facility management staff. All necessary corrections to allow resumption of construction had been observed. At 9:45 a.m., on 12/15/11 the Immediate Jeopardy was abated and construction/demolition resumed.

2. During a tour of the facility's Hemo-Dialysis room with the Director of Critical Care (DCC) on 12/12/11 at 2:02 p.m., the following was observed. The unit was equipped with an isolation room. Observation of the room revealed it contained a mobile Dialysis machine, and attached to the machine was a mobile Reverse Osmosis unit (RO, this machine is used process water for dialysis), a sink, and a hospital bed.

Further observation of the room, revealed the bed protruded past the door, and prevented the door from closing, which would prevent full seclusion of a contaminated patient if place in the room. Further observation also revealed it would be very difficult to for staff to maneuver around the room, as the equipment and the bed were blocking adequate egress in and out of the room.

During the visit to the Dialysis unit, the Nurse in charge of the unit was questioned on how the dialysis machines would be terminally cleaned. The nurse explained that the machines are terminally cleaned after every patient use. When asked how the machines are cleaned, he said with the PDI sheets. The nurse was then questioned as to the wet contact time was with the PDI sheets, and replied 5 minutes, maybe 3 minutes.

Follow-up visit to the Dialysis unit isolation room on 12/13/11 at 10:00 a.m., with the Fire Life Safety Survey (FLS), and the DCC confirmed the door was not able to be closed with the bed blocking the door.

a. The initial tour of the North Campus kitchen on 12/12/11 at 11:00 a.m. revealed the column located on a wall near the food preparation area. The base of the column had numerous areas where the wall was gauged out, with chipping paint, and paint missing from the wall surface exposing the raw material underneath the column. Further observation revealed the hand washing sink was dirty, and underneath the sink was a waste paper basket, with trash overflowing, and exposed to the environment.

The tour continued to the free standing ice cream freezer, which was observed to have a thick layer of ice on the interior walls. The surveyor requested the staff member to demonstrate where the internal thermometer was. The staff member located the thermometer, which was covered over with a layer of ice, and the ice had to be scrapped off, before the thermometer cold was read.

Tour continued to the cafeteria area. Observed on 4 of the reach in cooler and warming units was an accumulation of grease and dirt on the exterior metal doors. The exterior door handles to the coolers and warmers had a buildup of dirt, grease, and an accumulation of dirt in the plastic rims surrounding the doors. Further observation of the reach in coolers revealed numerous shelves holding food items that had visible rust on them.

A tour of the Labor and Delivery unit on 12/12/11 at 11:30 a.m. revealed the nourishment room contained a microwave oven. On inspection of the microwave oven, the interior of the unit had a significant amount of rust, and the unit was visibly dirty with caked on dried up food spills. Further observation of the units refrigerator revealed the interior was dirty, to include the shelving and the interior walls.

A tour of the Pediatric nourishment room on 12/12/11 at 12:00 p.m. revealed the refrigerator had an accumulation of a black substance on the rubber gasket of the door.

The Director of Housekeeping was questioned on 12/15/11 at 2:15 p.m., in regards to who was responsible for cleaning the equipment in the nourishment rooms, and replied this is House keeping's job.

A follow-up visit was conducted on 12/14/11 at 10:10 a.m., of the cafeteria area. There were 2 plastic flatware dispenser machines set up for customer use. The plastic bins of the dispensers were observed to have food debris in the dispensing bens, and the plastic surface had a greasy appearing film on them. The area where the salad bar was set up had a metal interior rim that had black unidentified substance adhered to it. Further observation revealed the lettuce leafs were discolored noting a red and brown color. The area where fast food is prepared revealed the freezer exterior door had accumulation of dirt on the metal surface. The counter where food is prepared was dirty; the shelf underneath the counter had a significant accumulation of food spills and food debris on it. The wall located next to the serving area was soiled, and had food spills splattered on the wall.

On the same day at the same time a follow-up tour of the kitchen revealed the wall behind the hot food preparation area was observed to have an accumulation of dust, dirt, and food debris. Observation of the pot rack located over the hot food production area had an accumulation of dust and dirt.

An interview was conducted with the Food Service Director (FSD) on 12/14/11 at 10:35 a.m., in regards to area of concerns in the kitchen. The FSD confirmed this was a problem, and would deal with it immediately.

b. On 12/14/11 at 2:00 p.m., a tour of the main campus kitchen was conducted with the FSD. The walk in cooler revealed cooler #2, which contained dairy products, was observed to have numerous areas with visible rust on the interior walls, the 2 fans, and the piping in the unit. Cooler #3 and #4 also had a significant amount of rust on the walls and the fans. The exterior of the cooler doors were observed to be painted white, and the door surface, and frames had significant areas were paint had chipped off exposing the metal surface. The large freezer located inside the dry storeroom revealed the floor surface, had a black coating over the metal. The black coating was intended to prevent the floor from being slippery. The coating was observed to be worn, and exposing the metal surface underneath.

The tour continued into the cafeteria, where a Chief was observed with a full beard, the chief was observed preparing food, but did not have a protective cover over his facial hair.

The FSD was interviewed on 12/14/11 at 3:00 p.m. in regards to her role as a FSD. When questioned about the condition of the coolers as it pertained to the rust, the FSD said that in the past there had been problems with moisture in the coolers, and there had been previous repairs done on the coolers, specifically the condition of the flooring.

3. An interview with the Director of Respiratory Services on 12/14/11 at 2:00 p.m. revealed that respiratory equipment (ventilators, CPAP, etc.) are cleaned, after patient use, by the respiratory therapist assigned to the patient.

A facility policy (04-4.04), dated 1/1/08 states "The following are infection control guidelines for the Respiratory Care Services. A. Equipment Processing. 1. Cleaning and disinfection of all equipment will be done by the Respiratory Department. Washing and disinfecting will be done in accordance with procedure for each individual item. 2. All ventilators, CPAP/Bipaps, Pulse oximeters, heaters, O2 analyzers and other hardware will be wiped down using hospital approved disinfectant. 3. Equipment which has been processed, but is not used, is maintained with appropriate dust covers and packaging. Large pieces of equipment, which cannot be sterilized by Cidex OPA, will be sprayed with the hospital approved disinfectant and wiped down.

A Respiratory Therapist was observed in a soiled utility room at 12:05 p.m. on 12/15/11. The Director of Respiratory Services was present at this time. The therapist was observed cleaning and disinfecting a ventilator using PDI Germicidal Disposable Wipes. Directions for use of this product, were clearly visible on the label of the container; and stated that equipment should be "visibly wet for 2 full minutes" for disinfecting. Upon observation and questioning of the therapist cleaning the ventilator, and the Director of Respiratory Services, it was confirmed and acknowledged that the ventilator surfaces were dry within 60 seconds after being wiped with the PDI Germicidal Disposable Wipes. The Director of Respiratory Services stated "We used to use a spray disinfectant," as stated in the department Equipment Processing policy.

a. An interview of the Director of Respiratory Services on 12/14/11 at 2:00 p.m. revealed that respiratory equipment (ventilators, CPAP, etc.) are cleaned, after patient use, by the Respiratory Therapist assigned to the patient.

A facility policy (04-4.04), dated 1/1/08, states "The following are infection control guidelines for the Respiratory Care Services. A. Equipment Processing. 1. Cleaning and disinfection of all equipment will be done by the Respiratory Department. Washing and disinfecting will be done in accordance with procedure for each individual item. 2. All ventilators, CPAP/BiPAP, Pulse oximeters, heaters, O2 analyzers and other hardware will be wiped down using hospital approved disinfectant. 3. Equipment which has been processed, but is not used, is maintained with appropriate dust covers and packaging. Large pieces of equipment, which cannot be sterilized by Cidex OPA, will be sprayed with the hospital approved disinfectant and wiped down."

A Respiratory Therapist was observed in a soiled utility room, the respiratory therapy department, at 12:05 p.m. on 12/15/11. The Director of Respiratory Services was present at this time. The therapist was observed cleaning and disinfecting a ventilator using PDI Germicidal Disposable Wipes. Directions for use of this product were clearly visible on the label of the container; and stated that equipment should be "visibly wet for 2 full minutes" for disinfecting.

Upon observation and questioning of the therapist cleaning the ventilator, and the Director of Respiratory Services, it was confirmed and acknowledged that the ventilator surfaces were dry within 60 seconds after being wiped with the PDI Germicidal Disposable Wipes. The Director of Respiratory Services stated "We used to have a spray disinfectant," as stated in the department Equipment Processing policy.

b. A tour of the dialysis unit, Main Campus, on 12/15/11 at 10:00 a.m. revealed an open trash container lined with a red bag. There was no cover for the trash container which was observed being used for disposal of dressings and disposable equipment contaminated with blood.

c. A tour of the dialysis unit, Main Campus, on 12/15/11 at 10:00 a.m. revealed a Registered Nurse examining two patients and setting up their dialysis machines. During this procedure a technician, clothed in personal protective equipment (including gown, mask, eye shield and gloves), was accessing a left arm fistula for one patient and a right arm fistula for another patient. The Registered Nurse was wearing gloves, but no other personal protective equipment. The nurse was working very closely next to the technician and was at risk for contamination with blood borne pathogens. Failure to wear personal protective equipment, during the part of the dialysis treatment, placed the nurse, staff, and other patients at risk.

4. Observation in the preoperative area of the North Campus of the Hospital on 12/13/11 at 9:06 a.m. revealed Patient #59 awaiting spinal anesthesia. A nurse was observed to enter the room, walk over to the sink, wash her hands less than 10 seconds, turn the faucet off with her wet hand and then dry her hands with a paper towel. She was observed to toss the paper towel into the trash can and exit the room.

Further observation at 9:15 a.m. revealed Patient #59 assisted to a sitting position on the side of the stretcher. The anesthesiologist (MD) and SRNA (Student Registered Nurse Anesthetist) administered the spinal anesthesia. After administration of the medication, the MD walked over to the sink, washed his hands, turned the spigot off with the back of his hand, dried his hands off with a paper towel, and exited the room. The SRNA removed his gloves, walked over to the heart monitor, adjusted the controls, and walked over to the sink. He washed his hands less than 10 seconds, turned both spigots off with his wet hands, and then dried his hands with a paper towel.

At 9:19 a.m., an autotransfusionist entered the room, introduced herself, walked over to the sink, washed her hands, and turned the spigot off with her wet hands. She dried her hands with a paper towel and walked over to Patient #59 to draw blood. At 9:31 a.m. and after withdrawing blood from the patient's right hand, she removed her gloves, walked over to the sink, and washed her hands less than 10 seconds. She was observed drying her hands with a paper towel and used the same paper towel to wipe her mouth. She discarded the paper towel into a trash can, gathered her supplies, and exited the room.

Interview with the infection control nurse on 12/13/11 at 1:30 p.m. revealed staff are to wash their hands in accordance with CDC (Center for Disease Control) guidelines. She stated that after washing their hands, they are to turn the spigot off with a paper towel.

Interview on 12/14/11 at 2:00 p.m. with the Director of Anesthesia, who is also the Dean of the Anesthesia school from where the SRNA receives his teaching, confirmed after washing hands, the spigot should be turned off with a wet paper towel.

Review of the hospital infection control policies and procedures for hand hygiene includes, but is not limited to, the following: "Hand hygiene is known to be the single most important means of preventing the transmission of pathogens in healthcare facilities ...Perform hand hygiene after contact with a patient ...removing gloves." Under "Hand washing Technique with Soap and Water," the procedure includes the following: "Rinse hands with water ...dry thoroughly with a single use towel ...use towel to turn off faucet/tap ...and your hands are safe ...the duration of the entire procedure: 40-60 sec."

The clinical staff failed to utilize proper hand hygiene techniques before, during, and after care of the patient.

5. During the initial tour conducted on 12/12/11 at 10:55 a.m. the glucometers (Blood glucose test device) on the nursing and specialty units at the North Campus were observed and inspected.The 5th floor east nursing station glucometer was observed with red colored droplets. The Assistant Chief nursing Officer (ACNO) was shown the droplets and stated "That should not be there." The ACNO notified the nurse unit manager and the glucometer was removed from the area. On the 4th floor at 12:05 p.m. a glucometer was observed with red/rust colored debris. The Unit nurse manager wiped the glucometer with a sani-wipe and returned the wet glucometer to the docking/charging station. The unit manager continued by commenting the unit would dry in the station. On the 3rd floor the glucometer (#UJ85001677) was observed. The glucometer had a crack at the base of the unit and was noted to have red/rust colored debris in the crevasse inside the crack. On the 2nd floor, 2 of the 4 glucometers were also cracked with discolored debris observed in the crevasse. The docking stations at the north campus were noted with debris/dust like/dirt in the base of the units.
An observation of the glucometers at the main campus on 12/14/11 at 2:00 p.m. on the nursing and specialty units were also cracked or with debris noted on the devices.

Observation on 12/13/11 at 11:46 a.m. in the recovery room on the North Campus of the hospital revealed a nurse obtained an accucheck from a patient who had just returned to the recovery room from surgery. After obtaining the accucheck, the nurse immediately placed the glucometer inside of the holding device. Observation revealed an accumulation of d

The Condition of Participation for Infection Control is not met based on observations, staff interviews, and a review of hospital policies, procedures, and hospital records. It was determined the hospital failed to identify, investigate and mitigate Infection Control issues/concerns. The facility failed to meet the needs of patients, staff, and community visitors regarding the safe containment of contaminants during renovation and demolition on the first floor. The facility was unable to ensure the infection control program met the applicable Conditions of Participation.

Additionally, the facility failed to have a respiratory department which follows guidelines for cleaning ventilators and Continuous Positive Air Pressure (CPAP) device; Failed to monitor hazardous waste in the dialysis department; Failed to have staff appropriately wearing Personal Protective Equipment (PPE) while administering direct patient care in the dialysis unit; Failed to properly sanitize dialysis equipment; Failed to have appropriate hand washing in the surgical suite; Failed to have staff trained to appropriately clean/sanitize glucometers after patient use; Failed to have clean and sanitary equipment in the kitchen.

This failure by the hospital placed current patients, staff, and community visitors at risk of immediate jeopardy for serious physical and/or psychological harm.

On 12/12/11, issues related to the above became known. After complete investigation, Immediate Jeopardy was declared at 3:30 p.m. on 12/13/11. On 12/14/11 at 9:45 a.m., the facility had made sufficient improvements to abate the Immediate Jeopardy. A tour of the areas of concern revealed the areas had been terminally cleaned, all Infection Control Barriers had been constructed; the negative pressure machines were in place and functioning. All staff previously working in the area offices had been relocated out of the construction/demolition areas.


The findings include:

1. During the tour of the facility with the Fire Life Safety (FLS) surveyor and the director of maintenance on 12/13/11 at 8:35 a.m. The FLS surveyor observed a vapor barrier in place in the old pediatric suite. Upon further review it was noted the facility was remodeling the area.

During this tour two construction workers were noted in the area. This project included 6 rooms. Observation revealed the negative air pressure machines with HEPA (High-Efficiency Particulate Air) Filtration systems were not in use. In all but three rooms the ceiling tiles had been removed. In the other three rooms it was noted to have hard ceilings. In this area some of the drywall had been removed. The door that leads into this area is located down the corridor from the automatic double doors leading into the operating rooms suites. This door was not sealed nor had a dust mat at the entrance. When the door was opened it was observed that this area was positive pressure, air could be felt entering the corridor. The facility had placed blue filters on all the return vents for the air conditioner unit in this area. When questioned, the facility staff stated that the contractor started this remodel without the staff knowledge. The Infection Control Construction Permit for this area shows the start date as TBA (To be announced). It indicates this project is a Type C. Activity generates moderate to high levels of dust.

a.) On 12/13/11 at 8:45 a.m., a nurse surveyor tour of the first floor demolition/construction area was conducted. The tour included the Assistant Chief Nursing Officer (ACNO) for the North Hospital Campus and the Agency's Fire Life Safety surveyor joined the tour at 8:50 a.m. The area included the demolition area taking place in rooms 1300 and 1301. Staff was observed entering through the double doors adjacent to the demolition area.

An examination of the double doors revealed the doors opened to a hallway with access to the hospital property. One sticky mat (used for collecting debris and contaminants from foot wear) was observed on the hallway side of the double doors. The mat was placed at the one door closest to the south. The mat was observed with a tan/white residue. The other double door (north) was without a mat. The ACNO commented another mat should be placed in front of the other door.

An observation of the double doors inside the demolition area revealed there were no sticky mats in the area adjacent to rooms 1300 1nd 1301. The sticky mats in front of rooms 1300 and 1301 were covered with debris and particulate material. The ACNO commented new sticky mats would be placed.
At 8:50 a.m., the Fire Life Safety surveyor noted in the same area (rooms 1300 & 1301); two construction workers were removing drywall. This area had blue dust mats in place, however these two doors were not sealed; nor a negative air machine in place. This situation allowed dust to travel outside the room into the corridor. In the same area it was observed several offices in use. One was the Bio Medical equipment room and this door was open. It was also noted two other rooms in use known as employee health offices. These two offices had employees working in them with the doors opened. Other offices were noted in this area however these doors were closed.

b.) Approximately 12 foot away from rooms 1300 & 1301 was a nurses' station. This area was being used as storage for the operating room supplies.

At 8:52 a.m., a facility staff member was working in this area and when questioned stated he was getting supplies to be delivered to the operating rooms for today's cases. When question further he stated that this storage area was created about seven days for OR supplies. Directly behind the nurse's station was a supply room with additional OR supplies. In both areas neither was being protected from air borne dust. The supplies included (not limited to) blood tubes, bulb syringes, syringes, and cardboard boxes containing medical supplies.

The FLS surveyor noted the counter at the nurse's station had a light film of white/tan material. At 9:00 a.m., a decorative plastic plant was observed by the surveyors across from the nursing station. The plant was observed with a white/tan film covering the plastic plant leaves. The ACNO confirmed the plant was covered with the white /tan film stating it was a "dust barometer."

c.) It was further noted that the carpet in the construction area had visible foot prints from dirty shoes. The ACNO and the plant maintenance staff member commented to the surveyors the "dust" would be "taken care of immediately."

At 9:02 a.m., a worker was observed using a mop on the carpet to clean the "dust."

d.) It was also noted that this area had two sets of double doors leading in and out of the construction area. The double door near room 1300 & 1301 was closed; however, the double doors leading into the corridor near the OR suites, was open. Neither of the two sets of double doors had been sealed nor the single door, near the employee health offices. An observation by the survey team included an open door to a patient holding area. The ACNO stated this room was used for patients as a holding area prior to entering the Catheterization procedure room.

e.) At 9:01 additional facility staff members and contractor arrived in this area and shut down all construction work until the proper ICRA measures were in place before construction can continue.

f.) At 9:04 a.m., a staff member, wearing a bunny suit (protective gear worn to cover street clothes when entering the OR) was observed entering the closed double doors and pushing a medical device (on wheels). The staff member proceeded through the demolition area and later was observed exiting the area through the open double doors in the hallway close to the OR. The ACNO confirmed the staff member was part of the biomedical team.

g.) At 9:10 a.m., the ACNO was observed asking the environment/plant maintenance staff to remove the used sticky pads and place new sticky pads where they were needed.

h.) At 9:40 a.m., an interview with the Infection Control Director and Infection Control staff was conducted on 12