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2139 AUBURN AVENUE

CINCINNATI, OH 45219

MEDICAL STAFF RESPONSIBILITIES - UPDATE

Tag No.: A0359

Based on medical record review, staff interview, and Medical Bylaws review, the facility failed to ensure physicians adhered to current medical bylaws that require reporting of any unusual event in a progress note. This affected one of 30 patients whose medical records were reviewed. (Patient #8) The census was 362 patients.


Findings include:

The medical record of Patient #8 was reviewed on 03/18/14. The patient had a past medical history significant for metastatic breast cancer. Approximately seven weeks after the surgical removal of a mediastinal mass, staff noted drainage from the patient's sternal incision. A CAT, computed tomography x-ray, scan of the chest revealed a mediastinal infection. Patient #8 underwent a sternal wound debridement with wound vacuum closure on 01/28/14 at 6:31 PM. The record lacked documentation anywhere in the medical record of the surgical fire that occurred on 01/28/14.

Staff R was interviewed on 03/21/14 at 01:30 PM and asked if there was a requirement for physician's to document any sentinel events such as the surgical fire that occurred on 01/28/14 in a progress note. Staff R stated: "There is no requirement for documenting those events in the medical record."

The Medical Bylaws were reviewed on 03/21/14. On Pages 21 and 22 , in section 6.6, entitled Post-Operative Care Reports, Notes and Discharge, the following was noted: "The operative report should include the patient's vital signs, level of consciousness, medications, blood and blood components administered, and notes of any unusual events or complications.

Staff A confirmed upon interview 03/19/14 at 2:30 PM, that a surgical fire in which an ignited drape covering the patient was doused with normal saline to extinguish the fire, is an unusual event that should have been documented in the patient's medical record.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on medical record review, interview, observation and policy review the facility failed to ensure two of five medical records reviewedof patients with pressure sores on admission were measured within the first 24 hours according to the facility's policy and procedure. (Patient #19 and #30) There was a total of 22 patients with pressure sores reviewed. The census was 362 patients.


Findings include:

1. Review of the medical record for Patient #19 revealed the patient was admitted to the facility on 03/15/14 with a diagnosis including a Stage 2 pressure sore to the coccyx. Review of the nursing assessment on admission revealed the patient had a reddened area to the coccyx. There was no documented evidence of the pressure sore being measured on admission until 03/20/14 (five days after admission). Review of the nursing wound assessment dated 03/20/14 revealed the wound measurements were six centimeters by two centimeters by zero depth. The nursing notes revealed Patient #19 had been receiving moisture barrier to the coccyx area since admission on 03/15/14.

Observation of Patient #19's coccyx area on 03/20/14 at 9:45AM revealed the coccyx area was slightly pink with no open areas.

Interview with Staff M on 03/20/14 at 9:50AM revealed when a patient is admitted to the facility with a pressure sore, initially the pressure sore is measured within the first 24 hours and then weekly.

2. Review of the medical record for Patient #30 revealed the patient was admitted to the facility on 03/07/14 with a diagnosis including an unstageable area to the right heel that was necrotic. There was no documented evidence of measurements of the right heel until 03/14/14 (seven days later) and the measurement was (four centimeters by five centimeters by zero depth) documented on the wound assemement note dated 03/14/14. The nursing notes revealed the right heel was being treated with betadine and wrapped with kerlix since admission on 03/07/14.

Observation with Staff N of Patient #30's right heel on 03/20/14 at 11:50AM revealed the heel was necrotic with no open areas. No measurements were taken at this time.

Interview with Staff N on 03/20/14 at 10:00AM revealed either a nurse or ostomy wound nurse could measure the patient's pressure sore on admission within the first 24 hours.

Review of the policy and procedure titled "Pressure Ulcer Prediction and Treatment", Policy Number 1.4.109, page 1 of 6, and included patients with existing pressure ulcers will be identified upon admission. The policy also revealed for pressure ulcer assessment and documentation revealed to assess all pressure ulcers initially including stage, color location and exudate. All present on admission (POA) pressure ulcers are to be measured initially and then weekly using centimeters and method of vertical by horizontal by depth.

These findings were confirmed with Staff P on 03/20/14 at 10:00AM in regard to the pressure sores for Patients #19 and #30 not being measured within the first 24 hours of admission.

CONTROLLED DRUGS KEPT LOCKED

Tag No.: A0503

Based on observation, review of policy, and staff interview, the facility failed to ensure staff followed the current facility policy for the requirement of medications to be locked in a cart or under direct observation. This had the potential to affect all patients undergoing surgical procedures at the facility. The facility performed a total of 14,675 surgeries in 2013. The census was 362 patients.


Findings include:


1. Surgical Suite #1 was toured with Staff E on 03/17/14 at 4:00 PM. Observation of the anesthesia cart revealed the drawers were easily opened and vials of the drugs Propofol (3 vials), Rocuronium, and Succinylcholine (all commonly used during the induction and maintenance of general anesthesia) were observed in the unlocked anesthesia cart.

2. Surgical Suite #2 was entered next on tour. Observation of the anesthesia cart revealed the drawers were easily opened and vials of the drugs Propofol, Rocuronium, and Succinylcholine were observed in the unlocked anesthesia cart.

3. Observation of Surgical Suite #3 revealed the drawers of the anesthesia cart were easily opened and vials of the drugs Propofol, Rocuronium, and Succinylcholine were noted in the anesthesia cart.

4. Observation of Surgical Suite #4 revealed the drawers of the anesthesia cart were easily opened and vials of the drugs Propofol, Rocuronium, and Succinylcholine were noted in the anesthesia cart.

Staff E was asked during observation of Surgical Suite #1 at 4:05 PM if it was customary for anesthesia carts to be unlocked. Staff E reported that it is policy for all anesthesia carts to be locked and confirmed the above observation during tour.


The facility policy entitled Medication Storage Requirements was reviewed on 03/19/14 at 10:30 AM. According to the policy, medications must be stored in a locked cart or under direct observation and will be accessible to authorized individuals. The policy further defined authorized individuals as associates who, in the scope of their practice, need access to obtain such medications.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on observation, interview, and record review, the facility to follow its own fire response plan when a fire occurred, failed to maintain fire proofing to steel I-beams, failed to have smoke detectors in rooms that open onto corridors, ensure each door in a corridor closed properly, failed to maintain the stated rating for construction enclosing vertical openings, the rating assigned to each of its rated walls that formed a smoke compartment, failed to ensure each storage area with a rated wall maintained the rating to that wall and failed to ensure each of its stairways used as exits maintained their stated fire protection rating. In addition the facility failed to ensure each path of egress was free of impediments, maintain corridor widths to their minimum regulatory requirements, ensure the emergency lighting in stairwells was tested, ensure each path of egress had exit signage, activate audible alarms during fire drill, maintain its sprinkler system in accordance with NFPA 25 and 13, failed to keep patient care areas free of space heaters, failed to ensure trash collection receptacles with capacities greater than 32 gallons out of corridors and failed to provide paved access to public way. (A709) The cumulative effect of these sytemic practices resulted in the agency's inability to ensure the environment was safe from fire. This had the potential to affect all patients, staff and visitors.The census was 362 patients.


Findings include:

The facility failed to maintain fire proofing to steel I-beams. Please refer to K12.
The facility failed to have smoke detectors in rooms that open onto corridors (waiting areas) and ensure each corridor wall resisted the passage of smoke. Please refer to K17
The facility failed to ensure each door in a corridor remained closed. Please refer to K18.
The facility failed to maintain the stated rating for construction enclosing vertical openings. Please refer to K20.
The facility failed to maintain the rating assigned to each of its rated walls that formed a smoke compartment. Please refer to K25.
The facility failed to ensure doors in each smoke barrier closed. Please refer to K27
The facility failed to ensure each storage area with a rated wall maintained the rating to that wall. Please refer to K29.
The facility failed to ensure each of its stairways used as exits maintained their stated fire protection rating. Please refer to K34.
The facility failed to ensure each path of egress was free of impediments. Please refer to K38
The facility failed to maintain corridor widths to their minimum regulatory requirements. Please refer to K39.
The facility failed to ensure the emergency lighting in stairwells was tested. Please refer to K46
The facility failed to ensure each path of egress had exit signage. Please refer to K47.
The facility failed to have fire drills under varying conditions and failed to follow its own fire response plan. Please refer to K48.
The facility failed to activate audible alarms during fire drill. Please refer to K50.
The facility failed to maintain its sprinkler system in accordance with NFPA 25 and 13. Please refer to K62.
The facility failed to keep patient care areas free of space heaters. Please refer to K70.
The facility failed to ensure trash collection receptacles with capacities greater than 32 gallons were not found in corridors. Please refer to K75.
The facility failed to provide paved access to public way. Please refer to K130.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on observation, interview, and record review, the facility failed to meet requirements for life safety, specifically, the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association. This has the potential to affect all patients, staff, and visitors to the facility. The census was 362 patients.


Findings include:
The facility failed to maintain fire proofing to steel I-beams. Please refer to K12.
The facility failed to have smoke detectors in rooms that open onto corridors (waiting areas) and ensure each corridor wall resisted the passage of smoke. Please refer to K17
The facility failed to ensure each door in a corridor remainclosed. Please refer to K18.
The facility failed to maintain the stated rating for construction enclosing vertical openings.Please refer to K20.
The facility failed to maintain the rating assigned to each of its rated walls that formed a smoke compartment. Please refer to K25.
The facility failed to ensure doors in each smoke barrier closed. Please refer to K27
The facility failed to ensure each storage area with a rated wall maintained the rating to that wall. Please refer to K29.
The facility failed to ensure each of its stairways used as exits maintained their stated fire protection rating. Please refer to K34.
The facility failed to ensure each path of egress was free of impediments. Please refer to K38
The facility failed to maintain corridor widths to their minimum regulatory requirements. Please refer to K39.
The facility failed to ensure the emergency lighting in stairwells was tested. Please refer to K46
The facility failed to ensure each path of egress had exit signage. Please refer to K47.
The facility failed to have fire drills under varying conditions and failed to follow its own fire response plan. Please refer to K48.
The facility failed to activate audible alarms during fire drill. Please refer to K50.
The facility failed to maintain its sprinkler system in accordance with NFPA 25 and 13. Please refer to K62.
The facility failed to keep patient care areas free of space heaters.Please refer to K70.
The facility failed to ensure trash collection receptacles with capacities greater than 32 gallons were not found in corridors. Please refer to K75.
The facility failed to provide paved access to public way. Please refer to K130.

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on observation, review of policy, and staff interview, the facility failed to ensure staff followed the current facility policy for cleaning of the Special Care Nursery and Labor and Delivery areas. This had the potential to affect staff, visitors, and patients admitted to those specialized areas. The census of the special care nursery was 3 patients.



Findings include:


1. The 15 bed Special Care Nursery with a census of 3 patients was toured on 03/17/14 at 11:00 AM.

a. Large clumps of dust were observed to fall from the arm of a wall-mounted monitor as this surveyor wiped a hand along it's surface in Pod 11.
b. Dust was also noted on top of a built-in storage cabinet in Pod 9.
c. An intravenous pump (IV) pump in Pod 9 was also noted to have a thin layer of dust coating the surface.
d. The tray attachment to the infant warmer in Pod 8 was noted to have a layer of dust and when wiped, particles of dust fell to the ground.
e. While touring in Pod 2, an Environmental Services staff member was noted to be wiping equipment in Pod 1 under the direction of a staff nurse. Large particles of dust were observed to fall off the monitor when wiped in Pod 4.
f. Visible dust was noted on top of the clock in the Medication Preparation area.
g. A thick layer of dust was noted on top of an infant warmer in the negative air pressure room, used for ill newborns requiring this isolation technique to prevent cross-contamination from room to room.
h. Dust was also noted on top of a storage cabinet in Pod 12.

2. The Labor and Delivery Unit was also toured on 03/17/14.

a. Dust was observed on the arm of a wall-mounted monitor in room 9064.
b. A dried red substance with the outline of fingerprints was also noted on the fetal monitor in this room.
c. Dust was noted on top of an infant warmer in room 9066.
d. A red phone in the hallway leading to the Cesarean Delivery Rooms was noted to be coated with a thick layer of dust.
e. Cesarean Delivery Room #2 was noted to have a layer of dust on top of the outlet tower.

3. The facility policy entitled Cleaning Specifications was reviewed on 03/19/14 at 11:25 AM. According to the policy, Environmental Services staff are instructed to perform a standard 10-step cleaning procedure daily. The 10-step cleaning procedure includes dusting monitors, overhead lights and ledges. High dusting is performed weekly and the floors are dusted and mopped with a germicidal solution on a daily basis.

These facts were confirmed with Staff P on 03/17/14 at 5:30 PM.

SURGICAL SERVICES

Tag No.: A0940

Based on observation, staff interview, medical record review, review of the root cause analysis, and review of policies, the facility failed to ensure staff provided services within acceptable surgical standards of practice related to the correct use of an electrical cauterization tool in the presence of alcohol and observation of a minimal drying time of a flammable prep which resulted in a surgical fire on 01/28/14. (A951) The cumulative effect of these practices resulted in the facility's inability to ensure safe surgical services.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, medical record review, staff interview, review of a root cause analysis, and review of policies, the facility failed to ensure staff followed surgical standard manufacturer instructions for the safe and effective use of an electrical cauterization tool and failed to follow facility policy for use of a minimal amount of drying time when alcohol-based solutions are used. This affected Patient #8 and had the potential to affect all patients undergoing surgical procedures at the facility. A total of 30 medical records were reviewed. The facility performed a total of 14,675 surgeries in 2013.


Findings include:

The facility's 33 Surgical Suites were toured on 03/17/14 at 4:00 PM. Five suites were not entered due to cases being in progress. Staff E was interviewed at 4:00 PM and asked about details of a recent fire in a surgical suite. Staff E reported at the conclusion of a procedure, an alcohol soaked sponge was applied to the skin by the surgeon in preparation for a wound vacuum application. The surgeon noticed bleeding and made the decision to use an electrical cauterization tool to gain hemostasis. The lap sponge and the drape covering the patient ignited. The sponge was thrown onto the floor and stamped out by a surgical technician and sterile water was thrown on the drape to extinguish the fire. Staff denied any burn or any other injury to the patient resulting from this incident.

Bottles of 70% Isopropyl alcohol were observed in all surgical suites toured. Numerous bottles of alcohol were also noted on shelving units in the halls of the surgical suites. During interview at 03/17/14 at 4:00 PM, Staff E reported the original action plan following the surgical fire included removal of all bulk alcohol from the surgical area but the decision was made to gather evidence-based practice to present to the OR Governance Committee after surgeons expressed concern about the removal of alcohol.

The root cause analysis was reviewed on 03/18/14 at 9:30 AM. According to the root cause analysis, the Manager of Surgical Services and Administration were notified immediately and a debriefing with all staff present during the surgical fire occurred immediately after the incident. The root cause analysis also indicated the patient returned to the Intensive Care Unit and a thorough examination was performed which revealed no burns to the patient. The action plan outlined in the root cause analysis included policy changes to the facility policies entitled Aseptic Barrier Material (#5.1.187) and Perioperative Skin Preps (#5.1.306). The action plan also noted "all staff required to re-review Fire Safety Health Stream education module."

The education included in the Fire Safety Health Stream was reviewed on 03/18/14 at 10:00 AM. The education was in the form of a power point presentation entitled "Fire Safety and Prevention Knowing your Role." None of the slides included instruction on the safe and effective use of electrical cauterization tools in the presence of alcohol. The staff attendance form listed the staff required to review the education after the surgical fire. It was noted that none of the staff required to re-review education on fire safety in the OR included surgeons. No documentation of any education on fire safety in the OR completed by surgeons was noted.

Review of the facility policy entitled Aseptic Barrier Materials (#5.1.187) mentioned in the root cause analysis revealed staff are instructed that "flammable solutions, such as alcohol, should not be introduced into the sterile field while drapes are in place."

Review of the original Aseptic Barrier Materials policy made no mention of flammable solutions. The facility policy entitled Perioperative Skin Preps (#5.1.306) was also reviewed on 03/18/14. According to the policy, staff are given the same instructions outlined in the Aseptic Barrier Materials policy. "Flammable solutions, such as alcohol, should not be introduced into the sterile field while drapes are in place."

The original policy for Perioperative Skin Preps was also reviewed on 03/18/14. The original policy, reviewed on 12/2010, instructed staff to remove fabric or disposable pads containing prep agent before utilizing a heat source such as bovie. It was confirmed with Staff H on 03/18/14 at 11:45 AM that the facility policy in effect when the surgical fire occurred on 01/28/14 was not followed by staff.

The facility policy entitled Universal Protocol was reviewed on 03/18/14 at 10:00 AM. The policy was last reviewed on 08/2013. According to the policy when an alcohol-based solution is used, staff must allow sufficient time for fumes to dissipate before draping (minimum of three minutes). Staff H was interviewed on 03/18/14 at 11:45 AM. Staff H reported a minimum of three minutes must be allowed after prep with an alcohol-based solution not only before draping the patient but also before use of a cauterization tool. Staff H stated: "It is Surgery 101 that you must allow any alcohol-based prep to dry before introducing the bovie."

Staff H was asked to provide documentation that staff was educated on the original and/or revised Aseptic Barrier Materials, Perioperative Skin Preps, and Universal Protocol policies. Documentation that Surgical Services staff, including registered nurses, surgical technicians, and ancillary staff, reviewed the policies was provided. The documentation lacked evidence that the surgeons reviewed any of the policies before or after the surgical fire. Staff H stated: "We don't have a mechanism is place to educate surgeons." Staff H explained that it was the "hope" of management, with these policies in place, staff would "at least" question a surgeon that asked for alcohol during the performance of a surgery.

The manufacturer's instructions for the Bovie electrical cauterization tool were reviewed on 03/18/14 at 02:00 PM. Under the heading of Safety, the following was noted: "The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator. There is no substitute for a properly trained and vigilant medical staff. It is important that they read, understand, and follow the operating instructions supplied with this electrosurgical equipment." Under the heading "Warning," in bold black print, the instructions read: "This equipment is for use only by trained, licensed physicians." The manufacturer instructions further noted that flammable substances (such as alcohol based skin prepping agents) contribute to increased fire and explosion hazards in the operating room. The sparking and heating associated with electrosurgery can provide an ignition source. Lastly, the instructions warn users to "observe fire precautions at all times. When using electrosurgery in the same room with flammable substances, prevent their accumulation or pooling under surgical drapes, or within the area where elctrosurgery is performed." It was confirmed with Staff A on 03/19/14 at 09:00 AM that these manufacturer's instructions, a surgical standard of practice, had not been followed.

The medical record of Patient #8 was reviewed on 03/18/14. The patient had a past medical history significant for metastatic breast cancer. Approximately seven weeks after the surgical removal of a mediastinal mass, staff noted drainage from the patient's sternal incision. A CAT scan of the chest revealed a mediastinal infection. Patient #8 underwent a sternal wound debridement with wound vacuum closure on 01/28/14 at 6:31 PM. There was no documentation anywhere in this medical record of the surgical fire event.