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.

MONTCLAIR HOSPITAL MEDICAL CENTER 5000 SAN BERNARDINO ST MONTCLAIR, CA 91763 Aug. 12, 2015
VIOLATION: SURGICAL SERVICES Tag No: A0940
The hospital failed to ensure the Condition of Participation: CFR 482.51 Surgical Services was met by failing to:

1. Follow Association of periOperative Registered Nurses (AORN) standards in storing endoscopes in the gastrointestinal (GI) lab. (refer to A-0951)

2. Separate the decontamination area from the procedure room in the GI lab. (refer to A-0951)

3. Maintain the humidity and temperature ranges in OR 5 (operating room 5) within acceptable ranges according to AORN standards. (refer to A-0951)

4. Maintain a sanitary environment in OR 5, Caesarian Section Room (CSR), and Post
Anesthesia Care Unit (PACU). (refer to A-0951)

The cumulative effect of these deficient systemic problems resulted in the failure of the hospital to deliver quality health care in safe environment to deliver care in a safe setting in order to be compliant with the Condition of Participation for surgical services.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to implement the standards (AORN) used by the hospital to achieve and maintain standards of medical practice and patient care, in the operating room as evidenced by:

1. Improper storage of clean endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body) in cabinets inside the procedure area of the gastrointestinal (GI - stomach and intestines) Lab.

2. The decontamination room was in the same area as the procedure room, in the GI Lab.

3. Humidity (amount of moisture in the air) and temperature were out of range in operating room 1, 2, 3, and 5 (OR 1, 2, 3, and 5).

4. Multiple housekeeping problems found in OR 5, Caesarian Section Room, and Post Anesthesia Care Unit (PACU).

These failure had the potential to transmit infection and affect the health and well being of patients having a surgical procedure.

Findings:

1. During a tour of the GI lab procedure area, with the Operating Room Charge Nurse (ORCN), on August 7, 2015, at 4:46 PM, there were two (2) cabinets attached to the wall containing endoscopes cleaned, processed, and ready for use. In the cabinet near the entrance, three (3) scopes were hung on the bolted rack. Parts of each scope were curled and touching each other.

The second cabinet was placed on the far end of the room. Upon opening the cabinet doors, both scopes were observed to swing forward and backwards, and touching a handle on the inner side of the cabinet doors.

During a concurrent interview with the ORCN, she identified the scopes inside the cabinet near the entrance, as bronchoscopes (instrument used to visualize the inner cavity of the lungs). She confirmed the scopes were not stored hanging straight.

During an interview with the Director of Performance Improvement (DPI) on August 10, 2015, at 9:20 AM, he was asked what standard of practice did the facility use for surgical services, she stated "The AORN standards."

According to the Association of periOperative Registered Nurse (AORN) 2003 Standards, Recommended Practices and Guidelines, indicated under the section "Recommended Practices for Cleaning and Processing Endoscopes and Endoscopes Accessories, Recommended Practice V, ...2...After processing, hang endoscopes in a vertical position to facilitate drying. Store them in a manner that protects them from contamination."

2. During a tour of the gastrointestinal (GI) lab with the ORCN on August 7, 2015, at 9:05 AM, it was observed that upon entering the GI lab/OR 3 immediately on the right side of the room is a metal sink with faucets. This room continued to the procedure area of the GI lab without any doors separating both rooms.

During a concurrent interview with the ORCN, she confirmed that the sink was used for decontamination.

During an interview with the Director of Performance Improvement (DPI), on August 10, 2015, at 9:20 AM, he was asked what standard of practice did the facility use for surgical services, she stated "The AORN standards."

According to the Association of periOperative Registered Nurse (AORN) 2014 "Standards, Recommended Practices and Guidelines," indicated under "Defined Spaces for Clean vs. Dirty, AORN now recommends building enough spaces to properly complete instrument decontamination and immediately use steam sterilization based upon projected utilization (see Recommendation II). These spaces must be adequately designed with a barrier from dirty work and instruments."

3. During a tour in the Caesarean Section Room (a surgical procedure where a incision is made on the abdomen of a pregnant woman to deliver a baby) with the Environmental Services Director (ESD) on August 10, 2015 at 9:20 AM, the temperature in the Caesarean Section Room registered 66.6 degrees Fahrenheit (acceptable range=68 to 73 degrees Fahrenheit), and the humidity registered 68% (acceptable range = 20 to 60 percent). The ESD then increased the thermostat (device to regulate the temperature inside the room) and set it to 70 degrees Fahrenheit. Five minutes later, the temperature registered 67.5 degrees Fahrenheit, and the humidity at 68%.

During a concurrent interview with the DHE, he confirmed the room temperature and humidity readings were out of range. He added, the transporters responsibility is to monitor and document daily, the temperatures and humidity in the operating rooms. Then the transporter was to email engineering if the temperature and/or humidity were out of range.

Review of the facility document titled "Daily Temp/Humidity Log" indicated the following:

OR 1 - Temporarily closed from February 3, 2015 to July 31, 2015 due to renovation and construction work.

OR 2 - A review of the facility "Temperature and Humidity Log" indicated on "February 1, 2015 the Temperature (T) was out of range (T=64.0 degrees F), and the temp (temperature) was increased. Engineering notified, was blank (nothing documented). From February 3, 2015 to July 31, 2015, OR 2 temporarily closed due to renovation and construction."

OR 3 (GI lab) - February 7, 2015, Humidity (H) = 65.7% (out of range), documented out of range, no corrective action done, and notification to engineering blank.

February 8, 2015, T=66.6 F (out of range), documented as out of range, temperature was increased, engineering was notified, and it was corrected.

March 23, 2015, T=67.5 F (out of range), documented as not out of range, no corrective action done, notification to engineering blank.

March 24, 2015, T=66.2 F (out of range), documented as not out of range, no corrective action done, notification to engineering blank.

March 25, 2015, T=67.3 F (out of range), documented as not out of range, no corrective action done, notification to engineering blank.

April 2, 3, 6, 7, 8 .9 10. 13, 14, 15, 16, 17, 18, 22, 23, and 24, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

May 6, 7, 8, and 23, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

OR 5 - February 3, 2015, T=66.3 F (out of range), temperature was corrected, notification to engineering blank.

February 18, 19, 20, 22, 23, 24, 25, 26, and 27, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

March 1, 2, 3, 4, 5, 6, 9, 10, 11, 12, 13, 14, 16, 19, 20, 23, 24, 25, 26, and 31, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

April 2, 3, 4, 6, 7, 8, 9, 10, 15, 17, 20, 21, 22, 23, 24, 25, 27, and 28, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

May 6, 7, 8, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 25, 26, 27, 27, 30, and 31, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

June 2, 2015, temperature and humidity were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

June 28, 2015, temperature was out of range, documented as not out of range, no corrective action done, notification to engineering blank.

July 6, 8, 10, 12, 16, 19, 20, 22, and 27, 2015, temperatures or humidity were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

During a concurrent interview with the Director of Performance Improvement (DPI), she said the facility used 68 to 73 degrees F for temperature and 20 to 60% for humidity to be maintain in the operating rooms.

4. During initial tour of the Post Anesthesia Care Unit (PACU) on August 7, 2015, from 9:00 AM, until 9:25 AM, the following were observed:

1. A red biohazard bin was observed in the utility behind the PACU nurses station, positioned next to a [DIAGNOSES REDACTED] cart (used to store refrigerated cold packs and saline solutions). The staff required to reach over the biohazard bin when gathering, sterile supplies.

2. An electrocautery equipment (machine used to control bleeding during surgery using electricity) was located in the PACU. The electrocautery machine was positioned next to the janitor's sink which contained dirty items used to clean the floor.

3. A black powder substance was observed in the PACU air conditioning vents, the dirty utility room in the entry hallway to the PACU, and operating rooms (OR 1, 2, and 3).

During an interview with the Registered Nurse (RN 2) on August 7, 2015, at 9:08 AM, she stated the bin should not be stored next to the [DIAGNOSES REDACTED] cart, and below the sterile supply storage cabinets.

On August 7, 2015, the facility sent out samples of the black powder substances for culture, analysis by an independent laboratory for testing. Air samples were also tested and analyzed for the presence of airborne spores (mold in the air can be inhaled into the lungs causing respiratory breathing issues). The results taken from the PACU and ICU came out positive for Aspergillus mold (mold spores inhaled can cause difficulty breathing in individuals), Basidiospores mold (mold spores inhaled can cause asthmatic attacks in individuals), Alternaria Fungus mold (mold spores inhaled can cause pneumonitis when exposed to airborne particles in individuals), Ascospores mold (mold spores inhaled may trigger asthmatic attacks in individuals), Pithomyces mold (mold spores exposure can cause irritation to the skin and cause liver damage in excessive levels in individuals), and Cladosporium mold (mold spores that can cause difficulty in breathing in individuals).

During a tour of the OR 4/Caesarean Section Room, and OR 5 with the Plant Operation Director (POD) and Environmental Services Director (ESD) on August 10, 2015, from 9:30 AM to 10:22 AM, the following were observed:

1. There were black particles on the cushions of the OR table (specialized bed in the OR used during surgery).

2. The wallpaper on the wall across the entry door in OR 5 was peeling off.

3. The east wall of OR 5 had presence of cracks with the dry wall exposed.

4. The OR supply cabinet in the OR 5 had rust-like colored stains on the hinges.

5. The wall clock in the OR 5 had the metal frame covered with rust-like colored stain.

According to the Association of periOperative Registered Nurses (AORN) 2003 Standards, Recommended Practices, and Guidelines, indicated under Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, Recommended Practice 1, " Patients should be provided a safe, clean environment... "

.
AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization
Spotting, Staining, and Corrosion of Surgical Instruments
Surgical instrument Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today.
Retrieved from: <http://www.infectioncontroltoday.com/articles/2000/10/spotting-staining-and-corrosion-of-surgical-instr.aspx> spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview,and record review, the facility's Governing Body failed to ensure that the facility's daily operation was conducted in an effective, safe, and organized manner as evidenced by a failure to:

1) Develop, implement, and maintain an effective infection control program, to ensure a clean and sanitary environment, to prevent the spread of infectious diseases, in accordance with nationally recognized infection control standards. This failure resulted in a situation of immediate jeopardy to patient safety on August 7, 2015. (refer to A 0749).

2) Ensure surgical services were performed in accordance with the facility policies and procedures, and acceptable standards of practice (AORN). (refer to A0940).

3) Develop, implement, and maintain an effective quality assessment and performance improvement program, involving all hospital departments, and addressing the complexity of services provided, to prevent potential adverse events, and improve patient outcomes. (refer to A 0263).

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting and be in compliance with the Condition of Participation for Governing Body.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview,and record review, the facility's Governing Body failed to ensure the medical staff, as a group, is accountable to the Governing Body for the quality of care provided to patients, as evidenced by:

1) Develop, implement, and maintain an effective infection control program, to ensure a clean and sanitary environment, to prevent the spread of infectious diseases, in accordance with nationally recognized infection control standards. This failure resulted in a situation of immediate jeopardy to patient safety on August 7, 2015.

2) Ensure that surgical services were performed in accordance with the facility policies and procedures, and acceptable standards of practice.

3) Develop, implement, and maintain an effective quality assessment and performance improvement program, involving all hospital departments, to address the complexity of services provided in the prevention of potential adverse events, and improve patient outcomes.

These deficient practices had the potential to affect the health and safety of patients in a universe of 30 patients.

Findings:


1. During initial tour on August 7, 2015 at 9:00 AM, a red biohazard bin was observed in the PACU positioned next to a [DIAGNOSES REDACTED] cart (used to store refrigerated cold packs and saline solutions) which required staff to reach over the biohazard bin when gathering sterile supplies.

During an interview with the The Operating Room Charge Nurse (ORCN) on August 7, 2015 at 9:08 AM, she was asked should the red biohazard bin be stored next to the [DIAGNOSES REDACTED] cart, and below the sterile supply storage cabinets where staff gather sterile supplies on a daily basis, she stated "no."

During an interview with the Plant Operations Director (POD) on August 7, 2015 at 8:50
AM, he was asked how often do you inspect the hospital building, he stated, "I don't check
the entire building daily."

During initial tour on August 7, 2015 at 9:17 AM, it was observed that an electrocautery equipment (it provides quick cleaning of wound sites and the prevention of bacterial infection) was located in the PACU, positioned next to the janitor's sink which contained dirty items used to clean the floor.

During initial tour on August 7, 2015 at 9:25 AM, black powder substance was observed in the PACU vents and on the dirty utility room walls and floor. The dirty utility room is located inside the entry hallway within the PACU department.

During an interview with the ESD on August 7, 2015 at 9:30 AM, he was asked why there is so much black dust substance on the walls and floor of the PACU's dirty utility room, he replied "I don't know."

During an interview with the Registered Nurse (RN 1) on August 7, 2015 at 9:50 AM when informed the ESD had stated the operating room staff placed the electrocautery equipment next to the janitor's sink, she replied "yes, because there is not enough room in the PACU."

During an interview with the Infection Control Nurse (ICN) on August 11, 2015 at 11:06 AM she stated she does rounds with the ESD and POD on a monthly basis. She also does a walk thru of the hospital building on a daily basis; she opens every single cabinet and opens every drawer. She stated, " I did not see any black substance. There was not a lot of administration involvement. We need a new process and at this time our hospital is only eighty percent clean."

During an initial tour of the facility's Intensive Care Unit (ICU) on August 7, 2015, it was observed, two air-circulating inlet ducts had a black powder substance leading out of the ducts, leaving residual black markings on the wall. At the time of the observation, five (5) ICU patients were being cared for in the ICU Unit.

On August 7, 2015, samples of the black powder substance were cultured and sent to an independent laboratory for testing. Air samples were also tested and analyzed for the presence of airborne spores (mold in the air can be inhaled into the lungs causing respiratory breathing problems).

On August 7, 2015, the following culture results came back positive for the presence of mold growth (a fungus), including the air sample. The results taken from the Post Anesthesia Care Unit (PACU), and Intensive Care Unit (ICU), are as follows:

a. Aspergillus mold (mold spores inhaled can cause difficulty breathing in individuals).
b. Basidiospores mold (mold spores inhaled can cause asthmatic attacks in individuals).
c. Alternaria Fungus mold (mold spores inhaled can cause pneumonitis when exposed to airborne particles in individuals)
d. Aeciospores mold (mold spores inhaled may trigger asthmatic attacks in individuals)
e. Pithomyces mold (mold spores exposure can cause irritation to the skin and cause liver damage in excessive levels in individuals)
f. Cladosporium (mold spores that can cause difficulty in breathing in individuals).

Two of the requirements for mold growth are moisture and temperature. According to the University of Central Florida, Infection Control Literature, most mold require a "considerable" amount of moisture for growth."

Basidiospores are a form of fungus similar to mushrooms found in areas of high humidity (moisture). The known disease conditions caused by basidiospores are keratitis and pneumonia in immune compromised patients. It may also cause hay fever, asthma and mushroom sensitivity. Phoma/coelmycetes mold are known to cause hay fever and asthma.

Cladosporium is the most common indoor and outdoor mold. It is olive green to black in color. The airborne spores of Cladosporium species are significant allergens, and in large amounts they can severely affect asthmatics and people with respiratory diseases. Cladosporium produce volatile organic compounds (VOCs) associated with odors. It's presence indicate a strong environment of moisture.

2. 1. During a tour of the GI lab procedure area, with the Operating Room Charge Nurse (ORCN), on August 7, 2015 at 4:46 PM, there were two (2) cabinets attached to the wall containing endoscopes, cleaned, processed, and ready for use. In the cabinet near the entrance, three (3) scopes were hung on the bolted rack. Parts of each scope were curled and touching each other.

The second cabinet was placed at the far end of the room. Upon opening the cabinet doors, both scopes were observed to swing forward and backwards, and touching a handle on the inner side of the cabinet doors.

During a concurrent interview with the ORCN, she identified the scopes inside the cabinet near the entrance, as bronchoscopes (instrument used to visualize the inner cavity of the lungs). She confirmed the scopes were not stored hanging straight.

During an interview with the Director of Performance Improvement (DPI) on August 10, 2015 at 9:20 AM, she was asked, what standard of practice did the facility use for the surgical services, she stated "the AORN standards."

According to the Association of periOperative Registered Nurse (AORN) 2003 Standards, Recommended Practices and Guidelines, indicated under the section "Recommended Practices for Cleaning and Processing Endoscopes and Endoscopes Accessories, Recommended Practice V, ...2...After processing, hang endoscopes in a vertical position to facilitate drying. Store them in a manner that protects them from contamination."

2. During a tour of the gastrointestinal (GI) lab with the ORCN on August 7, 2015 at 9:05 AM, it was observed that upon entering the GI lab/OR 3 immediately on the right side of the room is metal sink with faucets. This room continued to the procedure area of the GI lab without any doors separating the rooms.

During a concurrent interview with the ORCN, she confirmed that the sink was used for decontamination.

During an interview with the Director of Performance Improvement (DPI) on August 10, 2015 at 9:20 AM, she was asked what standard of practice did the facility use for the surgical services, she stated "the AORN standards."

According to the Association of periOperative Registered Nurse (AORN) 2014 Standards, Recommended Practices and Guidelines, indicated under Defined Spaces for Clean vs. Dirty, "AORN now recommends building enough spaces to properly complete instrument decontamination and immediately use steam sterilization based upon projected utilization (see Recommendation II). These spaces must be adequately designed with a barrier from dirty work and instruments."

3. During a tour in the Caesarean Section Room (a surgical procedure where a incision is made on the abdomen of a pregnant woman to deliver a baby) with the Environmental Services Director (ESD) on August 10, 2015 at 9:20 AM, the temperature in the Caesarean Section Room registered 66.6 degrees Fahrenheit (acceptable range=68 to 73 degrees Fahrenheit), and the humidity registered 68 percent (%), (acceptable range = 20 to 60%). The ESD then increased the thermostat (device to regulate the temperature inside the room) and set it to 70 degrees Fahrenheit. Five minutes later, the temperature registered 67.5 degrees Fahrenheit, and the humidity at 68%.

During a concurrent interview with the DHE, he confirmed the room temperature and humidity readings were out of range. He added that the transporters are held responsible to monitor, and document daily, the temperatures and humidity in the operating rooms. He is to email the ESD, if the temperature and/or humidity is out of range.

Review of the facility document titled "Daily Temp/Humidity Log" indicated the following:

OR 1 - Temporarily closed from February 3, 2015 to July 31, 2015, due to renovation and construction work.

OR 2 - A review of the facility "Temperature and Humidity Log" indicated on "February 1, 2015, the Temperature (T) was out of range (T=64.0 degrees F), and the temp (temperature) was increased. Engineering notified, was blank (nothing documented). From February 3, 2015 to July 31, 2015, OR 2 temporarily closed due to renovation and construction."

OR 3 (GI lab) - February 7, 2015, Humidity (H) = 65.7% (out of range), documented out of range, no corrective action done, and notification to engineering was blank.

February 8, 2015, T=66.6 F (out of range), documented as out of range, temperature was increased, engineering was notified, and it was corrected.

March 23, 2015, T=67.5 F (out of range), documented as not out of range, no corrective action done, notification to engineering blank.

March 24, 2015, T=66.2 F (out of range), documented as not out of range, no corrective action done, notification to engineering blank.

March 25, 2015, T=67.3 F (out of range), documented as not out of range, no corrective action done, notification to engineering blank.

April 2, 3, 6, 7, 8 .9 10. 13, 14, 15, 16, 17, 18, 22, 23, and 24, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

May 6,7,8, and 23, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

OR 5 - February 3, 2015, T=66.3 F (out of range), temperature was corrected, notification to engineering blank.

February 18, 19, 20, 22, 23, 24, 25, 26, and 27, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

March 1, 2, 3, 4, 5, 6, 9, 10, 11, 12, 13, 14, 16, 19, 20, 23, 24, 25, 26, and 31, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

April 2, 3, 4, 6, 7, 8, 9, 10, 15, 17, 20, 21, 22, 23, 24, 25, 27, and 28, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

May 6, 7, 8, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 25, 26, 27, 27, 30, and 31, 2015, temperatures were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

June 2, 2015, temperature and humidity were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

June 28, 2015, temperature was out of range, documented as not out of range, no corrective action done, notification to engineering blank.

July 6, 8, 10, 12, 16, 19, 20, 22, and 27, 2015, temperatures and humidity were out of range, documented as not out of range, no corrective action done, notification to engineering blank.

During a concurrent interview with the Director of Performance Improvement (DPI), she said the facility used 68 to 73 degrees F for temperature, and 20 to 60% for humidity, to maintain the operating rooms.

3. In an interview with the Governing Body members, on August 10, 2015, at 12:35 PM, the members indicated the governing body provided oversight of hospital operations. The members acknowledged the Governing Body was ultimately responsible to ensure care and services provided to patients were safe, effective and of high quality.

A review of the facility document titled "Amended and Restated Bylaws of the [Hospital Name]" dated December 4, 2013, indicated..."under Article II Section 2.1 Hospital Management ... the Governing Board is to make decisions regarding Medical Staff appointment and Clinical Privileges, to oversee performance improvement, utilization review, risk management, patient safety, identification and reduction of medical errors and similar matters regarding the provision of quality patient care at the Hospital, and to establish policies regarding these matters."
VIOLATION: QAPI Tag No: A0263
Based on observation, and interview, the hospital failed to ensure the Condition of Participation: CFR 482.21 Quality Assurance and Performance Improvement (QAPI) were met by failing to ensure the following:

1. Develop, implement, and maintain, an effective infection control program, to ensure a sanitary environment, and to prevent, avoid, and minimize, sources of transmission of infectious and communicable diseases, in accordance with nationally recognized infection control standards, which resulted an Immediate Jeopardy (IJ) situation for patient safety, on August 7, 2015. (refer to A 0749).

2. Ensure that surgical services were organized in accordance with the facility policies and procedures, and acceptable standards of practice.(refer to A 0940)

3. Follow the Association of Operating Room Nurses (AORN) standards in storing endoscopes. (refer to A 0951)

4. Separate the decontamination area from the procedure room in the gastrointestinal (GI.) (refer to A 0951)

5. Maintain the humidity and temperature ranges in operating room 5 (OR 5), within the acceptable standards according to AORN. (refer to A 0951)

6. Multiple areas of unclean housekeeping conditions found in OR 5, the Caesarian Section Room (CSR), and the Post Anesthesia Care Unit (PACU). (refer to A 0951)

7. The Governing Body (GB) and Medical Staff failed to ensure quality oversight of the hospital's daily operations, and that they are conducted in an effective, safe, and organized manner, for the management of patient care. (Refer to A-0283).


The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting in order to be in compliance with the Condition of Participation for Quality Assurance and Performance Improvement.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview and record review, the facility failed to set priorities for its performance improvement actives which had the potential to affect patient safety,and quality of care delivered, as evidenced by:

1) In the Post Anesthesia Care Unit (PACU), there was a presence of a black dust substance observed in the inlet vents, and in the biohazard dirty utility room on the walls, and on the floor.

2) In the Intensive Care Unit (ICU) there was the presence of a black dust substance observed on the walls and in the air-conditioning vents (AC) .

3) The Governing Body (GB) and Medical Staff failed to ensure the facility's mode of operation was conducted in an effective, safe, and organized manner for the management of patient care.

These deficient practices had the potential to affect the health and safety of patients in a universe of 30 patients.

Findings:

1. During an interview with the Plant Operations Director (POD), on August 7, 2015, at 8:50 AM, to inquire how often the hospital building is inspected, he stated, "I don't check the entire building daily."

During the intial tour on August 7, 2015 at 9:00 AM, a red biohazard bin was observed in the PACU, positioned next to the [DIAGNOSES REDACTED] cart ( a cart used to store refrigerated cold packs and saline solution) which required staff to reach over the biohazard bin when gathering sterile supplies.

During an interview with the Operating Room Charge Nurse (ORCN) on August 7, 2015, at 9:08 AM, she was asked if the red biohazard bin should be stored next to the [DIAGNOSES REDACTED] cart, below the sterile supply storage cabinets, she stated "No."

During initial tour on August 7, 2015, at 9:17 AM, electrocautery equipment (a tool used during surgery to provide quick cleaning of wound sites and the prevention of bacterial infection) was observed in the PACU, located next to the janitor's sink.

During initial tour on August 7, 2015, at 9:25 AM, black dust substance was observed on two of the inlet air vents in the PACU, and on the walls and floor of the dirty utility room (located inside the entry hallway) of the PACU.

During an interview with the Environmental Services Director (ESD), on August 7, 2015, at 9:26 AM, was asked who placed the electrocautery equipment next to the janitor's sink he stated "the operating room staff."

During an interview with the ESD on August 7, 2015 at 9:30 AM, was asked why there is so much black dust substance on the walls and floor of the dirty utility room, he replied "I don't know."

During an interview with the Registered Nurse (RN 1), on August 7, 2015, at 9:50 AM, when told the ESD had stated the operating room staff placed the electrocautery equipment next to the janitor's sink, she replied "yes, because there is not enough room in the PACU."

During an interview with the Infection Control Nurse (ICN), on August 11, 2015, at 11:06 AM, she stated, "I do rounds with the ESD and POD on a monthly basis. I also walk through the hospital building on a daily basis and I open every single cabinet and drawer. I did not see any black substance. There was not a lot of administration involvement. We need a new process. At this time our hospital is only eighty percent clean."

2. During an initial tour of the facility's Intensive Care Unit (ICU) on August 7, 2015, it was observed that two air-circulating inlet ducts had a black powder substance leading out of the ducts, leaving residual black markings on the wall. At the time of the observation, five (5) ICU patients were being cared for in the Unit.

On August 7, 2015, a sample of the black powder substance was cultured and sent out to an independent laboratory for testing.

On August 7, 2015, the following culture results tested positive for the presence of mold growth (a fungus), including positive air samples taken in the PACU (Recovery Room) unit and Intensive Care Unit:
a. Aspergillus mold (mold spores inhaled can cause difficulty breathing in individuals).
b. Basidiospores mold (mold spores inhaled can cause asthmatic attacks in individuals).
c. Alternaria Fungus mold (mold spores inhaled can cause pneumonitis when exposed to airborne particles in individuals)
d. Ascospores mold (mold spores inhaled may trigger asthmatic attacks in individuals)
e. Pithomyces mold (mold spores exposure can cause irritation to the skin and cause liver damage in excessive levels in individuals)
f. Cladosporium mold (mold spores that can cause difficulty in breathing in individuals).

Two of the requirements for mold growth are moisture and temperature. According to the University of Central Florida, most mold require a "considerable" amount of moisture for growth " .

Basidiospores are a form of fungus similar to mushrooms found in areas of high humidity (moisture). The known disease conditions caused by basidiospores are keratitis and pneumonia in immune compromised patients. It may also cause hay fever, asthma and mushroom sensitivity. Phoma/coelmycetes mold are known to cause hay fever and asthma.

Cladosporium is the most common indoor and outdoor mold. It is olive green to black in color. The airborne spores of Cladosporium species are significant allergens, and in large amounts they can severely affect asthmatics and people with respiratory diseases. Cladosporium produce volatile organic compounds (VOCs) associated with odors. It's presence indicate a strong environment of moisture.

During an interview with the Plant Operations Director (POD) on August 7, 2015, at 8:50 AM, he was asked how often the hospital building is inspected, he stated "I don't check the entire building daily."

During an interview with the Performance Improvement Director (PID) on August 10, 2015, at 4:45 PM, she stated "...there is a process, but things fell into the cracks. We did not do our jobs. We don't know how this was missed."

During an interview with the Infection Control Nurse (ICN) on August 11, 2015, at 11:06 AM, she stated "I do rounds with the ESD and POD on a monthly basis and a walk through of the hospital building on a daily basis, opening every single cabinet and drawer." She also stated, "I did not see any black substance. There was not a lot of administration involvement. We need a new process. At this time our hospital is only eighty percent clean."

3. In an interview with the Governing Body members, on 8/10/15 at 12:35 PM, the members indicated the governing body provides oversight of hospital operations. The members acknowledged that the Governing Body is ultimately responsible to ensure the care, and services to patients are safe, effective and of high quality.

Review of the facility document titled "Amended and Restated Bylaws of the [Hospital Name]" dated 12/4/13, Article II, Section 2.1- Hospital Management, indicates "... the Governing Board is to make decisions regarding Medical Staff appointment and Clinical Privileges, to oversee performance improvement, utilization review, risk management, patient safety, identification and reduction of medical errors and similar matters regarding the provision of quality patient care at the Hospital, and to establish policies regarding these matters."
VIOLATION: INFECTION CONTROL Tag No: A0747
The hospital failed to ensure the Condition of Participation: Infection Control, was met by failing to:

1. Develop, implement, and maintain an effective infection control program to ensure a sanitary environment, and to prevent sources of infectious diseases, in accordance with nationally recognized infection control standards. This failure resulted in an Immediate Jeopardy situation of patient safety, on August 7, 2015. (refer to A-0749).

2. Ensure surgical services were organized in accordance with the facility policies and procedures, and acceptable standards of practice. (refer to A-0940).

3. Follow AORN standards in storing endoscopes. (refer to A-0951)

4. Separate the decontamination area, from the gastrointestinal (GI) procedure area. (refer to A-0951).

5. Maintain the humidity and temperature ranges in operating room 5 (OR 5) according to AORN standards. (Refer to A-0951)

6. Multiple housekeeping unsanitary conditions found in OR 5, Caesarian Section Room (CSR), and Post Anesthesia Care Unit (PACU). (refer to A-0951)

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting in order to be compliance with the Condition of Participation for Infection Control.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review the facility failed to maintain a clean and sanitary environment as evidenced by:

1. In the Post Anesthesia Care Unit (PACU), there was the presence of a black powder substance located in the inlet vents, and in the biohazard dirty utility room's walls and floor.

2. In the Intensive Care Unit (ICU), there was presence of black powder substance noted on the walls, shelves, and air-conditiong vents.

These failures had the potential to affect the health and safety of patients, staff, and visitors, by inhaling the black powder substance (mold), as confirmed by the facility's third party laboratory analysis consultant, in a universe of 30 patients.

An Immediate Jeopardy (IJ) situation was declared on August 7, 2015, at 11:30 AM, in the presence of the Facility Administrator, due to the facility's failure to ensure the ICU and PACU were clean and free of mold growth.

Findings:

1. During the initial tour on August 7, 2015, at 9:00 AM, a red biohazard bin was observed in the PACU positioned next to a malignant hyperthermia cart (used to store refrigerated cold packs and saline solutions to treat Malignant Hyperthermia-a medical emergency condition) which required staff to reach over the biohazard bin when gathering sterile supplies.

During an interview with the Registered Nurse (RN 2), on August 7, 2015, at 9:08 AM, she was asked if the red biohazard bin should be stored next to the malignant hyperthermia cart, below the sterile supply storage cabinets, where staff gather sterile supplies on a daily basis, she stated "no."

During an interview with the Plant Operations Director (POD), on August 7, 2015, at 8:50
AM, he was asked how often do you inspect the hospital building, he stated, "I don't check
the entire building daily."

During initial tour on August 7, 2015, at 9:17 AM, it was observed that an electrocautery equipment (it provides quick cleaning of wound sites and the prevention of bacterial infection) was located in the PACU, positioned next to the janitor's sink, which contained dirty items used to clean the floor.

During initial tour on August 7, 2015, at 9:25 AM, a black powder substance was observed in the PACU in-let air vents, and on the walls and floor, of the dirty utility room.

During an interview with the Environmental Services Director (ESD), on August 7, 2015, at 9:30 AM, he was asked why there is so much black powder substance on the walls and floor of the PACU's dirty utility room, he replied "I don't know."

During an interview with the Registered Nurse (RN 1), on August 7, 2015, at 9:50 AM, when informed the ESD had stated the operating room staff placed the electrocautery equipment next to the janitor's sink, she replied "yes, because there is not enough room in the PACU."

During an interview with the Infection Control Nurse (ICN), on August 11, 2015, at 11:06 AM, she stated she does rounds with the ESD and POD on a monthly basis. She also does a walk through of the hospital building on a daily basis; she opens every single cabinet and drawer. She stated, "I did not see any black substance. There was not a lot of administration involvement. We need a new process. At this time our hospital is only eighty percent clean.

2. During an initial tour of the facility's Intensive Care Unit (ICU), on August 7, 2015, it was observed that two air-circulating inlet ducts had a black powder substance leading out of the ducts, leaving residual black markings on the wall. At the time of the observation, five (5) ICU patients were being cared for in the ICU Unit.

On August 7, 2015, a sample of the black powder substances were cultured and sent to an independent laboratory for testing. Air samples were also tested and analyzed for the presence of airborne spores (mold in the air can be inhaled into the lungs causing respiratory breathing problems).

On August 7, 2015, the following culture results came back positive for the presence of mold growth (a fungus), including the air sample. The results taken from the PACU (Recovery Room) and Intensive Care Units are as follows:

a. Aspergillus mold (mold spores inhaled can cause difficulty breathing in individuals).

b. Basidiospores mold (mold spores inhaled can cause asthmatic attacks in individuals).

c. Alternaria Fungus mold (mold spores inhaled can cause pneumonitis when exposed to airborne particles in individuals)

d. Ascospores mold (mold spores inhaled may trigger asthmatic attacks in individuals)

e. Pithomyces mold (mold spores exposure can cause irritation to the skin and cause liver damage in excessive levels in individuals)

f. Cladosporium mold (mold spores that can cause difficulty in breathing in individuals).

Two of the requirements for mold growth are moisture and temperature. According to the University of Central Florida, Infection Control Literature, most mold require a "considerable"amount of moisture for growth.

Basidiospores are a form of fungus similar to mushrooms found in areas of high humidity (moisture). The known disease conditions caused by basidiospores are keratitis and pneumonia in immune compromised patients. It may also cause hay fever, asthma and mushroom sensitivity. Phoma/coelmycetes mold are known to cause hay fever and asthma.

Cladosporium is the most common indoor and outdoor mold. It is olive green to black in color. The airborne spores of Cladosporium species are significant allergens, and in large amounts they can severely affect asthmatics and people with respiratory diseases. Cladosporium produce volatile organic compounds (VOCs) associated with odors. It's presence indicate a strong environment of moisture.

On August 11, 2015, at 7:45 PM, the Immediate Jeopardy situation was lifted in the presence of the Chief Executive Officer (CEO), and Chief Nursing Officer (CNO), when the survey team approved the facility's Corrective Action Plan, after observation; interview and record review, confirmed the facility was clean and free from mold growth. The Corrective Action Plan included the following components:

1. Assessed and identify all potential causes of mold growth. The main air filter was replaced which was found installed backwards during routine maintenance of the filters in July 2015.

2. Perform general environmental terminal cleaning to all affected areas cultured as positive for mold growth.

3. Staff education and accountability.

4. Environmental surveillance and rounds in all clinical areas monthly, and quarterly in non-clinical areas.

5. Install new air-circulation system throughout the hospital including the PACU and ICU units.

6. Retesting of all surfaces in question for the presence of mold as indicated.

7. Continued monitoring of all patients potentially exposed to mold.

8. Daily rounds by the Infection Control Nurse of the facility to ensure it is 100 % safe for patient occupancy.





In a concurrent interview the ESD pointed out the tested areas of the highest air concentration of contaminates is on the outside R-19 exit where he noted this has been an issue for some time. Observed on the outside of this exit is a spiral staircase leading up to the rooftop. On the staircase, black fuzzy growth identified by staff as mold, was found to trail up to the roof. Once on the roof a HVAC (heating,ventilating,air conditioning) equipment was found and observed to have similar fuzzy growth covering the hood.

On 8/15/10 at 10:30 AM., In a subsequent interview, with the ESD and ICN, they reported a third party vender inspected the HVAC unit, They found a part was installed incorrectly, causing the equipment to pull the outside contaminates into the facility, spreading it throughout affected areas.

The ICN indicated she did not have prior knowledge of the air quality and vent contamination, or the cleanup work in the sub sterile area before it began. The ESD said he did not communicate with the ICN, nor did he have a policy to consult the ICN for such needs.