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24 JOLIET ST

DYER, IN 46311

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on document review, observation, and staff interview, the hospital failed to ensure one of one blanket warmers located in the diagnostic imaging department maintained a safe temperature.

Findings include:

1. Review of policy / procedure titled: "Blanket and Fluid Warming Devices Policy," PolicyStat ID "1274455," last approved on "03/2015" read: "Blanket warmers are not to exceed 130 (degrees) F (54.4 C)."

2. Review of "Blanket Warmer Temperature Log" for the "Radiology - CT" department indicated the blanket warmer exceeded 130 degrees Fahrenheit (F) on the following dates: 10-4-2016 (131 F); 10-5-2016 (132 F); 10-7-2016 (132 F); 10-9-2015 (132 F); 10-10-2016 (132 F); 10-12-2016 (132 F); 10-13-2016 (132 F); 11-8-2016 (134 F); 11-12-2016 (138 F); 11-13-2016 (135 F); 11-15-2016 (135 F); 11-16-2016 (133 F); 11-17-2016 (134 F); 11-18-2-16 (133 F); 12-4-2016 (133 F); 12-5-2016 (134 F); 12-6-2016 (134 F); 12-7-2016 (133 F); 12-8-2016 (133 F); 12-10-2016 (134 F); 12-11-2016 (134 F); 12-12-2016 (134 F); 12-13-2016 (134 F); 12-14-2016 (135 F); 12-15-2016 (134 F); 12-16-2016 (135 F); 12-17-2016 (135 F); 12-18-2016 (134 F); and 12-20-2016 (135 F).

2. On 12-19-2016 at 3:00 PM, a blanket warmer was observed across the hall from Interventional Radiology. The temperature ("Setpoint") was set at 135 F for both the upper and lower chambers. The temperature reading for the upper chamber was "134" F and the temperature reading for the lower chamber was "135" F.

3. In interview on 12-19-2016 at 3:00 PM, Staff Member #28, Director of Imaging, acknowledged the blanket warmer temperatures were higher than 130 F.

PHYSICAL ENVIRONMENT

Tag No.: A0700

At this Life Safety Code survey, Franciscan Health Dyer was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 482.41(b), Life Safety from Fire and the 2012 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC).

Franciscan Health Dyer is comprised of the main hospital in Dyer, In (Building 01), and Franciscan Health Hammond Rehabilitation (Building 02), and Rehabilitation Services (Building 03).

Franciscan Health Dyer main building, Building 01, an multiple story fully sprinklered building of Type II (000) construction had a fire alarm system with smoke detection in the corridors and spaces open to the corridors was surveyed with Chapter 19, Existing Health Care occupancies. Building 01 provides overnight care. Building 01 has a capacity of 198 and had a census of 153 at the time of this survey.

The Franciscan Health Hammond Rehabilitation wing, Building 02, is part of an eight story fully sprinklered building of Type II (222) construction had a fire alarm system with smoke detection in the corridors and spaces open to the corridors was surveyed with Chapter 19, Existing Health Care Occupancies.

The Rehabilitation Services wing, Building 03, is a one story fully sprinklered building of Type II (000) construction had a fire alarm system with smoke detection in the corridors and spaces open to the corridors was surveyed with Chapter 19, Existing Health Care Occupancies.

Based on record review and interview, the facility failed to build the facility to health care construction limitations in accordance with Table 19.1.6.1 (see tag K161), failed to ensure 1 of 12 stairway exit exterior discharges was arranged to be accessible in respect to changes in elevation (see tag K271), failed to ensure 1 of 1 exit and directional sign was displayed in accordance with LSC 7.10, (see tag K293), failed to maintain protection of 1 of 1 stairway in accordance of 19.3.1, (see tag K311), failed to ensure the humidity in 8 of 8 Operating Rooms were greater than 20 percent (see tag K323), failed to ensure written fire safety plans that addressed preparation of floors for evacuation were not in conflict with each other or the LSC, (see tag K711), failed to ensure its policy regarding the use of space heaters was followed (see tag K781) and failed to ensure there were battery-powered lighting for 8 of 8 Operating Rooms using general anesthesia (see tag K911).

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure that all locations from which it provides services are constructed, arranged and maintained to ensure the provision of quality health care in a safe environment.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on record review and interview, the facility failed to build the facility to health care construction limitations in accordance with Table 19.1.6.1, failed to ensure 1 of 12 stairway exit exterior discharges was arranged to be accessible in respect to changes in elevation, failed to ensure 1 of 1 exit and directional sign was displayed in accordance with LSC 7.10. LSC 7.10.1.2.1 states, exits shall be marked by an approved sign that is readily visible from any direction of exit access, failed to maintain protection of 1 of 1 stairway in accordance of 19.3.1. LSC 19.3.1 requires vertical opening shall be enclosed or protected in accordance with Section 8.6. LSC 8.6.1 requires every floor that separates stories in a building shall be constructed as a smoke barrier. LSC 8.7.1.3 requires doors in barriers required to have a fire resistive rating shall have a minimum ¾ hour fire protection rating and be self-closing or automatic closing, failed to ensure the humidity in 8 of 8 Operating Rooms were greater than 20 percent. NFPA 99 9.3.1.1 requires heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities. ASHRAE 170, requires mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 20 percent or greater, and failed to ensure its policy regarding the use of space heaters was followed.

Findings include:

1. Based on record review with the Director of Engineering and Facility Management on 12/20/16 between 8:35 a.m. and 10:29 a.m., the facility has three different sections with three different construction types. The "MotherBaby" is on the fourth story with a construction rating of II (000). The "Physical Therapy" is part of the four story building with a construction rating of II (111). No documentation was available for the floor/assembly construction ratings. Based on an interview at the time of record review, the Director of Engineering and Facility Management acknowledged the aforementioned condition.

2. Based on record review, observation and interview; the facility failed to maintain the limited noncombustible rating in accordance with Table 19.1.6.1. This deficient practice could affect all occupants.

3. Based on record review with the Director of Engineering and Facility Management on 12/21/16 between 10:29 a.m. and 6:30 p.m., the cite plans indicated the 2nd floor "Interstitial Space" was constructed to II (222) rating. Based on observation, the 2nd floor "Interstitial Space" steel support beams had multiple spots measuring four inches by four inches where the protective coating was removed. Based on an interview at the time of record review, the Director of Engineering and Facility Management acknowledged the aforementioned condition and confirmed that bare metal was exposed.

4. Based on an observation with the Lead Mechanic on 12/21/16 at 3:15 p.m., the B1 stairway exit discharge to the public way extended up a slope for at least 50 feet, then continued over a section of the facility to the opposite side and then onto the public way. Based on interview at the time of observation, the Lead Mechanic acknowledged the sloped walkway was not provided with handrails.

a) Based on observation with the Manager of Engineering, on 12/20/16 at 4:40 p.m., there was an exit sign mounted perpendicularly on the ceiling above the 4th floor D building (D3) stairway door that was blank on the east side of the sign. Based on interview at the time of the observations, the Manager of Engineering acknowledged exit marking was not visible to staff or visitors east in the 4th floor D building corridor.
b) Based on an observation with the Lead Mechanic on 12/21/16 at 3:15 p.m., the B1 stairway exit discharge to the public way extended up a slope for at least 50 feet, then continued over a section of the facility to the opposite side and then onto the public way. Based on interview at the time of observation, the Lead Mechanic acknowledged the B1 exterior exit discharge was not provided with exit signage.

5. Based on observation with the Director of Engineering and Facility Management on 12/20/16 between 2:56 p.m. and 6:00 p.m., the following was discovered:
a) the 4th floor E-Stair-C3 middle stairwell contained three separate half inch penetrations around support beams.
b) the 4th floor SW-Stair-D2 door did not have a fire resistive rating tag installed
c) the 3rd floor South Stairwell door did not have a fire resistive rating tag installed
d) the 3rd floor S-Stair-D3 door did not have a fire resistive rating tag installed
e) the 3rd floor W-Stair-B2 door did not have a fire resistive rating tag installed

6. Based on interview at the time of observations, the Director of Engineering and Facility Management acknowledged the aforementioned condition and confirmed all the stairwells are rated two hours construction.

7. Based on record review with the Director of Engineering and Facility Management on 12/20/16 between 10:19 a.m. and 4:49 p.m., no humidity documentation was available to review. Based on interview at the time of record review, the Director of Engineering and Facility Management acknowledged the aforementioned condition.

8. Based on observation and interview, the facility failed to maintain 1 of 1 IMCU and 1 of 1 "Med/Surg" local alarms in accordance with 5.1.9.3. NFPA 99 5.1.9.5 requires local alarms shall be installed to function of the air compressor system(s), medical-surgical vacuum pump system(s), WAGD systems, instrument air systems and proportioning systems. This deficient practice could affect staff and up to 36 patients.

9. Based on observation with the Director of Engineering and Facility Management on 12/20/16 between 12:30 p.m. and 6:00 p.m., the test button for the oxygen/air/vacuum local alarm outside patient room 7533 was pressed. When the button was pressed, the panel did not illuminate all lights nor sound the alarm. Furthermore, the test button for the oxygen/air/vacuum local alarm outside patient room 6533 was pressed. When the button was pressed, the panel did not illuminate all lights nor sound the alarm. Based on interview at the time of each observation, the Director of Engineering and Facility Management acknowledged each aforementioned condition.

10. Based on observations with the Manager of Engineering, the following was noted:
a) On 12/20/16 at 2:53 p.m., in the 4th floor "Ortho" room, there was a space heater plugged into an electrical outlet with a label stating "Equipment checked-11/29/11".
b) On 12/20/16 at 4:20 p.m., in the 4th floor D building Revenue Management Director's office, there was a space heater plugged into an electrical outlet under the desk.
c) On 12/20/16 at 4:25 p.m., in the 4th floor D building RMD Pricer/CBR Analyst office, there was a space heater plugged into an electrical outlet under the desk near the window.
d) On 12/20/16 at 4:35 p.m., in the 4th floor D building Employee Assistance Program office, there was a space heater plugged into an electrical outlet.
e) On 12/21/16 at 11:05 a.m., in the 3rd floor Franciscan Physician Network Human Services office, there was a space heater plugged into an electrical outlet under the desk.
11.Based on observation with the Director Engineering and Facility Management, the following was noted:
f) On 12/21/16 at 10:55 a.m., in the 3rd floor Fire Room 1, there was a space heater
12. Based on interview at the time of the first observation, the Manager of Engineering and Director Engineering and Facility Management acknowledged the discovered space heaters and indicated it is the hospital's policy not to allow space heaters in employee areas. The subsequent discoveries of the additional space heaters were also acknowledged at the times of observation.

EMERGENCY POWER AND LIGHTING

Tag No.: A0702

Based on observation and interview, the facility failed to ensure there were battery-powered lighting for 8 of 8 Operating Rooms using general anesthesia. NFPA 99 2012 edition 6.3.2.2.11.1 states one or more battery-powered lights shall be provide within locations where deep sedation and general anesthesia is administered. 6.3.2.2.11.2 states the lighting level of each unit shall be sufficient to terminate procedures intended to be performed within the operating room.

Findings include:

Based on observation with the Director of Engineering and Facility Management on 12/20/16 at 3:22 p.m., two operating rooms in the "MotherBaby" area did not have battery operated emergency lighting. Based on interview at the time of observation, the Director of Engineering and Facility Management acknowledged the aforementioned condition and confirmed that of all eight operating rooms use general anesthesia and no battery operated emergency light is installed.

LIFE SAFETY FROM FIRE

Tag No.: A0710

Based on record review and interview, the facility failed to build the facility to health care construction limitations in accordance with Table 19.1.6.1, failed to ensure 1 of 12 stairway exit exterior discharges was arranged to be accessible in respect to changes in elevation, failed to ensure 1 of 1 exit and directional sign was displayed in accordance with LSC 7.10. LSC 7.10.1.2.1 states, exits shall be marked by an approved sign that is readily visible from any direction of exit access, failed to maintain protection of 1 of 1 stairway in accordance of 19.3.1. LSC 19.3.1 requires vertical opening shall be enclosed or protected in accordance with Section 8.6. LSC 8.6.1 requires every floor that separates stories in a building shall be constructed as a smoke barrier. LSC 8.7.1.3 requires doors in barriers required to have a fire resistive rating shall have a minimum ¾ hour fire protection rating and be self-closing or automatic closing, failed to ensure the humidity in 8 of 8 Operating Rooms were greater than 20 percent. NFPA 99 9.3.1.1 requires heating, cooling, ventilating, and process systems serving spaces or providing health care functions covered by this code or listed within ASHRAE 170, Ventilation of Health Care Facilities. ASHRAE 170, requires mechanical ventilation system supplying anesthetizing locations shall have the capability of controlling the relative humidity at a level of 20 percent or greater, failed to ensure its policy regarding the use of space heaters was followed, failed to ensure there were battery-powered lighting for 8 of 8 Operating Rooms using general anesthesia. NFPA 99 2012 edition 6.3.2.2.11.1 states one or more battery-powered lights shall be provide within locations where deep sedation and general anesthesia is administered. 6.3.2.2.11.2 states the lighting level of each unit shall be sufficient to terminate procedures intended to be performed within the operating room and failed to ensure written fire safety plans that addressed preparation of floors for evacuation were not in conflict with each other or the LSC. LSC 7.14.1.2 states the provisions of 7.14, Elevators for Occupant-Controlled Evacuation Prior to Phase 1 Emergency Recall Operations shall not apply where the limited or supervised use of elevators for evacuation is part of a formal or informal evacuation strategy, including the relocation of patients in healthcare occupancies and the relocation or evacuation of occupants with disabilities in other occupancies.

Findings include:

1. Based on record review with the Director of Engineering and Facility Management on 12/20/16 between 8:35 a.m. and 10:29 a.m., the facility has three different sections with three different construction types. The "MotherBaby" is on the fourth story with a construction rating of II (000). The "Physical Therapy" is part of the four story building with a construction rating of II (111). No documentation was available for the floor/assembly construction ratings. Based on an interview at the time of record review, the Director of Engineering and Facility Management acknowledged the aforementioned condition.

2. Based on record review, observation and interview; the facility failed to maintain the limited noncombustible rating in accordance with Table 19.1.6.1. This deficient practice could affect all occupants.

3. Based on record review with the Director of Engineering and Facility Management on 12/21/16 between 10:29 a.m. and 6:30 p.m., the cite plans indicated the 2nd floor "Interstitial Space" was constructed to II (222) rating. Based on observation, the 2nd floor "Interstitial Space" steel support beams had multiple spots measuring four inches by four inches where the protective coating was removed. Based on an interview at the time of record review, the Director of Engineering and Facility Management acknowledged the aforementioned condition and confirmed that bare metal was exposed.

4. Based on an observation with the Lead Mechanic on 12/21/16 at 3:15 p.m., the B1 stairway exit discharge to the public way extended up a slope for at least 50 feet, then continued over a section of the facility to the opposite side and then onto the public way. Based on interview at the time of observation, the Lead Mechanic acknowledged the sloped walkway was not provided with handrails.

a) Based on observation with the Manager of Engineering, on 12/20/16 at 4:40 p.m., there was an exit sign mounted perpendicularly on the ceiling above the 4th floor D building (D3) stairway door that was blank on the east side of the sign. Based on interview at the time of the observations, the Manager of Engineering acknowledged exit marking was not visible to staff or visitors east in the 4th floor D building corridor.
b) Based on an observation with the Lead Mechanic on 12/21/16 at 3:15 p.m., the B1 stairway exit discharge to the public way extended up a slope for at least 50 feet, then continued over a section of the facility to the opposite side and then onto the public way. Based on interview at the time of observation, the Lead Mechanic acknowledged the B1 exterior exit discharge was not provided with exit signage.

5. Based on observation with the Director of Engineering and Facility Management on 12/20/16 between 2:56 p.m. and 6:00 p.m., the following was discovered:
a) the 4th floor E-Stair-C3 middle stairwell contained three separate half inch penetrations around support beams.
b) the 4th floor SW-Stair-D2 door did not have a fire resistive rating tag installed
c) the 3rd floor South Stairwell door did not have a fire resistive rating tag installed
d) the 3rd floor S-Stair-D3 door did not have a fire resistive rating tag installed
e) the 3rd floor W-Stair-B2 door did not have a fire resistive rating tag installed

6. Based on interview at the time of observations, the Director of Engineering and Facility Management acknowledged the aforementioned condition and confirmed all the stairwells are rated two hours construction.

7. Based on record review with the Director of Engineering and Facility Management on 12/20/16 between 10:19 a.m. and 4:49 p.m., no humidity documentation was available to review. Based on interview at the time of record review, the Director of Engineering and Facility Management acknowledged the aforementioned condition.

8. Based on observation and interview, the facility failed to maintain 1 of 1 IMCU and 1 of 1 "Med/Surg" local alarms in accordance with 5.1.9.3. NFPA 99 5.1.9.5 requires local alarms shall be installed to function of the air compressor system(s), medical-surgical vacuum pump system(s), WAGD systems, instrument air systems and proportioning systems. This deficient practice could affect staff and up to 36 patients.

9. Based on observation with the Director of Engineering and Facility Management on 12/20/16 between 12:30 p.m. and 6:00 p.m., the test button for the oxygen/air/vacuum local alarm outside patient room 7533 was pressed. When the button was pressed, the panel did not illuminate all lights nor sound the alarm. Furthermore, the test button for the oxygen/air/vacuum local alarm outside patient room 6533 was pressed. When the button was pressed, the panel did not illuminate all lights nor sound the alarm. Based on interview at the time of each observation, the Director of Engineering and Facility Management acknowledged each aforementioned condition.

10. Based on observations with the Manager of Engineering, the following was noted:
a) On 12/20/16 at 2:53 p.m., in the 4th floor "Ortho" room, there was a space heater plugged into an electrical outlet with a label stating "Equipment checked-11/29/11".
b) On 12/20/16 at 4:20 p.m., in the 4th floor D building Revenue Management Director's office, there was a space heater plugged into an electrical outlet under the desk.
c) On 12/20/16 at 4:25 p.m., in the 4th floor D building RMD Pricer/CBR Analyst office, there was a space heater plugged into an electrical outlet under the desk near the window.
d) On 12/20/16 at 4:35 p.m., in the 4th floor D building Employee Assistance Program office, there was a space heater plugged into an electrical outlet.
e) On 12/21/16 at 11:05 a.m., in the 3rd floor Franciscan Physician Network Human Services office, there was a space heater plugged into an electrical outlet under the desk.
11.Based on observation with the Director Engineering and Facility Management, the following was noted: On 12/21/16 at 10:55 a.m., in the 3rd floor Fire Room 1, there was a space heater
12. Based on interview at the time of the first observation, the Manager of Engineering and Director Engineering and Facility Management acknowledged the discovered space heaters and indicated it is the hospital's policy not to allow space heaters in employee areas. The subsequent discoveries of the additional space heaters were also acknowledged at the times of observation.
13. Based on observation with the Director of Engineering and Facility Management on 12/20/16 at 3:22 p.m., two operating rooms in the "MotherBaby" area did not have battery operated emergency lighting. Based on interview at the time of observation, the Director of Engineering and Facility Management acknowledged the aforementioned condition and confirmed that of all eight operating rooms use general anesthesia and no battery operated emergency light is installed.
14. Based on a review of several plans on 12/21/16 at 9:30 a.m. with the Manager of Engineering and Director, Engineering Facilities, the "2016 Fire Safety Control Management Plan-Hammond/Dyer" stated, under the Fire Plan Elements section, "If a relocation or evacuation is deemed necessary, staff should, (4) If patients must be moved vertically, elevators provided with emergency power and with the permission of the Fire Department are used to move patients to lower floors." The "Fire Safety and Evacuation" plan with a PolicyStatID of 1502848 which was last revised on 04/30/15 and set to expire on 4/29/17 stated at G(4), "Elevators shall not be used except the Dyer Fire Department." Based on interview at the time review, the Manager of Engineering and Director, Engineering Facilities, acknowledged further review of the evacuation from upper floors was needed.

15. Based on record review and interview, the facility failed to provide a written plan that addressed all components of LSC 19.7.2.2. LSC 19.7.2.2 requires a written health care occupancy fire safety plan that shall provide for the following:
(1) Use of alarms
(2) Transmission of alarm to fire department
(3) Emergency phone call to fire department
(4) Response to alarms
(5) Isolation of fire
(6) Evacuation of immediate area
(7) Evacuation of smoke compartment
(8) Preparation of floors and building for evacuation
(9) Extinguishment of fire
16. Based on a review of the "Fire Safety and Evacuation" plan with a PolicyStatID of 1502848 which was last revised on 04/30/15 and set to expire on 4/29/17 on 12/21/16 at 9:30 a.m. with the Manager of Engineering and Director, Engineering Facilities, the plan in sections E and F did not address the K class fire extinguisher, its purpose or use in conjunction with the kitchen hood extinguishing system. The plan addressed only the use of fire extinguishers using the acronym "PASS", Class A, B, C and D fires and types of fire extinguishers used in the Lab such as ABC and Halon. Based on interview at the time review, the Manager of Engineering and Director, Engineering Facilities, acknowledged the use of the K class fire extinguisher was not addressed.

FIRE CONTROL PLANS

Tag No.: A0714

Based on record review and interview, the facility failed to ensure written fire safety plans that addressed preparation of floors for evacuation were not in conflict with each other or the LSC. LSC 7.14.1.2 states the provisions of 7.14, Elevators for Occupant-Controlled Evacuation Prior to Phase 1 Emergency Recall Operations shall not apply where the limited or supervised use of elevators for evacuation is part of a formal or informal evacuation strategy, including the relocation of patients in healthcare occupancies and the relocation or evacuation of occupants with disabilities in other occupancies.

Findings include:

1. Based on a review of several plans on 12/21/16 at 9:30 a.m. with the Manager of Engineering and Director, Engineering Facilities, the "2016 Fire Safety Control Management Plan-Hammond/Dyer" stated, under the Fire Plan Elements section, "If a relocation or evacuation is deemed necessary, staff should, (4) If patients must be moved vertically, elevators provided with emergency power and with the permission of the Fire Department are used to move patients to lower floors." The "Fire Safety and Evacuation" plan with a PolicyStatID of 1502848 which was last revised on 04/30/15 and set to expire on 4/29/17 stated at G(4), "Elevators shall not be used except the Dyer Fire Department." Based on interview at the time review, the Manager of Engineering and Director, Engineering Facilities, acknowledged further review of the evacuation from upper floors was needed.

2. Based on record review and interview, the facility failed to provide a written plan that addressed all components of LSC 19.7.2.2. LSC 19.7.2.2 requires a written health care occupancy fire safety plan that shall provide for the following:
(1) Use of alarms
(2) Transmission of alarm to fire department
(3) Emergency phone call to fire department
(4) Response to alarms
(5) Isolation of fire
(6) Evacuation of immediate area
(7) Evacuation of smoke compartment
(8) Preparation of floors and building for evacuation
(9) Extinguishment of fire
3. Based on a review of the "Fire Safety and Evacuation" plan with a PolicyStatID of 1502848 which was last revised on 04/30/15 and set to expire on 4/29/17 on 12/21/16 at 9:30 a.m. with the Manager of Engineering and Director, Engineering Facilities, the plan in sections E and F did not address the K class fire extinguisher, its purpose or use in conjunction with the kitchen hood extinguishing system. The plan addressed only the use of fire extinguishers using the acronym "PASS", Class A, B, C and D fires and types of fire extinguishers used in the Lab such as ABC and Halon. Based on interview at the time review, the Manager of Engineering and Director, Engineering Facilities, acknowledged the use of the K class fire extinguisher was not addressed.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on document review, observation and interview, the infection control (IC) program failed to ensure cleaning and disinfecting was performed in a safe and effective manner, failed to ensure documentation of surgery-specific training and competency for cleaning and disinfecting in the OR (operating room) environment, failed to ensure surfaces and equipment were maintained in a clean and sanitary manner for 10 of 10 observations, and failed to develop/implement a policy related to soiled linen management (see tag A749).

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure a sanitary environment was maintained and an active/effective infection control program was in place.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on document review, observation and interview, the infection control (IC) program failed to ensure cleaning and disinfecting was performed in a safe and effective manner using approved disinfecting products, ensure documentation of surgery-specific training and competency for cleaning and disinfecting in the OR (operating room) environment was maintained for 4 of 4 environmental services (EVS) personnel files reviewed (staff N45, N47, N48 & N49), and ensure surfaces and equipment were maintained in a clean and sanitary manner for 10 of 10 observations, and failed to develop/implement a policy related to soiled linen management.

Findings include:

1. Review of manufacturer's instructions for "Metricide (glutaraldehyde 2.6 %) 14-Day Sterilizing & Disinfecting Solution", read: "Immerse medical equipment / divide completely in Metricide solution for a minimum of 45 minutes at 25 (degrees) C..." and "Following immersion in Metricide...thoroughly rinse the equipment or medical device by immersing it completely in three separate copious volumes of water. Each rinse should be a a minimum of one minute in duration..." and "During the usage of Metricide solution as a high-level disinfectant and / or sterilant, it is recommended that a thermometer and timer be utilized to ensure that the optimum usage conditions are met. In addition, it is recommended that the Metricide solution be tested with a 1.5% glutaraldehyde concentration indicator prior to each usage." and "Use fresh portions of water for each rinse." and "The use period for activated Metricide solution is for no longer than 14 days following activation or as indicated by a 1.5% glutaraldehyde concentration indicator..."

2. Review of policy / procedure titled: "Infection Control - Cleaning & Disinfection of Transducers Policy," PolicyStat ID "2429290," last reviewed "5/19/2016" read: "The performing ultrasonographer will soak the transducer in a hospital approved disinfectant solution per manufacturer recommendations." and "The performing ultrasonographer will remove the transducer from the disinfectant solution and immerse it completely in three separate copious volumes of water. Each rinse should be a minimum of one minute in duration. Use fresh portions of water for each rinse."

3. Review of policy / procedure titled: "Glutaraldehyde Disinfectant Solution Policy," PolicyStat ID "1539386," last reviewed "6/24/2015" read: "Glutaraldehyde 2.6 %: a high level disinfectant when used or reused at full strength for a maximum of 14 days or 28 days at 25 (degrees) C with an immersion time of at least 45 minutes." and "Ultrasound body cavity transducers should be placed in a glutaraldehyde 2.5% solution after every case for at least 45 minutes...The brand glutaraldehyde 2.5 % solution currently used is Metricide...Metricide solution can be reused for 14 or 28 days maximum...The Metricide needs to be tested with a glutaraldehyde monitor prior to immersing the transducer in to the solution..." and "Following immersion on Metricide solution, thoroughly rinse the transducer by immersing it in three separate copious volumes of water. Each rinse should be a minimum of one minute. Use fresh portions of water for each rinse." and "Documentation of glutaraldehyde efficacy is necessary."

4. Review of "Glutaraldehyde Solution Log Sheet" for the outpatient ultrasound equipment indicated the following:
a. The time transducers were immersed in the glutaraldehyde solution was not documented. It was unable to be determined if transducers were immersed for a minimum of 45 minutes, as required by manufacturer instructions and hospital policy, from 10-12-2016 to 12-20-2016.
b. The glutaraldehyde solution concentration monitor was not documented on 10-12-2016
c. The glutaraldehyde solution was last activated on 10-17-2016 and expired on 10-31-2016. There was no documentation a fresh solution of glutaraldehyde was activated and placed in use from 10-31-2016 to 12-20-2016.
d. Temperature documentation indicated the "disinfectant temperature" was "22.8" on 10-12-2016 and "21.8" on 11-25-2016.

5. Review of "Glutaraldehyde Solution Log Sheet" for the inpatient ultrasound equipment indicated the following:
a. The time transducers were immersed in the glutaraldehyde solution was not documented. It was unable to be determined if transducers were immersed for a minimum of 45 minutes, as required by manufacturers instructions and hospital policy from 9-29-2016 to 12-20-2016.
b. The glutaraldehyde solution concentration monitor was not documented between 12-12-2016 and 12-20-2016.
c. The glutaraldehyde solution was activated on 9-14-2016 and expired on 9-28-2016. There was no documentation a fresh solution of glutaraldehyde was activated and placed in use from 9-28-2016 to 10-16-2016. Another glutaraldehyde solution was activated on 11-16-2016 and expired 14 days later (11-30-2016). There was no documentation a fresh solution of glutaraldehyde was activated and placed in use from 11-31-2016 to 12-9-2016.
d. The "disinfectant temperature" was not documented on 9-29-2016. The temperature documentation indicated the "disinfectant temperature" was "19.8" on 10-7-2016; "22.0" on 12-1-2016; and "20.1" on 12-19-2016.

6. Review of patient records indicated the following patients had ultrasounds, using transducers, as indicated below:
a. Patient #L13 (outpatient) on 10-12-2016
b. Patient #L14 (outpatient) on 11-25-2016
c. Patient #L15 (inpatient) on 9-29-2016
d. Patient #L16 (inpatient) on 10-7-2016
e. Patient #L17 (inpatient) on 12-1-2016
f. Patient #L18 (inpatient) on 12-19-2016

7. Staff interviews:
a. On 12-19-2016 at 3:15 PM, Staff Member #31, ultrasound technologist, indicated transducers are soaked in Metricide solution for one hour, then soaked in water for one hour. After soaking in water for an hour, the transducers are soaked in the water a second time for one hour. The staff member did not indicate the water was changed between each soaking or that they are rinsed three (3) times.
b. On 12-22-2016 at 11:40 AM, Staff Member #37, lead ultrasonographer, indicated transducers are placed in Metricide for 45 minutes, then rinsed under running water in the sink for at least a minute. The transducers are then immersed in a water basin for at least one minute, dried, and placed into use. Staff Member #37 further indicated the Metricide solution must be at least 1.5 %, as indicated by a daily test strip, for it to be used. The staff member indicated the ultrasound rooms do not have a stopwatch or timer to time the immersion of the transducers in the Metricide, but they take a mental note of the time on the clock to ensure the transducers are in the Metricide solution for a minimum of 45 minutes. The staff member acknowledged the time the transducers are placed in the Metricide and the time they are removed from the Metricide is not documented.
c. On 12-22-2016 at 1:00 PM, Staff Member #28, Director of Imaging, acknowledged there was no documentation of transducer immersion time in the Metricide and the Metricide solution temperatures were below 25 degrees Celsius (C), as required by manufacturer. The staff member further acknowledged there was no documentation a fresh solution was activated and placed into use between 9-28-2016 and 10-16-2016 and between 11-31-2016 and 12-9-2016 in the inpatient department and between 10-31-2016 and 12-20-2016 in the outpatient department.


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8. During an observation on 12-21-16 at 1410 hours of terminal OR cleaning in OR#1, in the company of the director of surgical services, staff A10 and the director of environmental services, staff A12, the EVS staff N45 was observed to be applying a bleach solution directly overhead to high wall surfaces in the OR (operating room) without the use of goggles or other eye protection to prevent serious injury in the event of splashing or dripping until directed to put on a surgical mask with an attached eye shield by the director of surgical services, staff A10.

9. During an observation on 12-21-16 at 1415 hours of terminal OR cleaning in OR#1, in the company of the director of surgical services, staff A10 and the director of environmental services, staff A12, the EVS staff N51 indicated they were using a quaternary ammonium disinfecting solution with a 10 minute wet contact time for disinfecting the overhead OR lights. The OR boom lights appeared to be completely dry after 8 minutes.

10. The deficient practice was confirmed by the director of surgical services, staff A10 at the time of observation.

11. Review of the list of IC committee cleaning products (approved 4-16) failed to indicate a diluted bleach (sodium hypochlorite) solution was approved for use for cleaning surfaces and/or equipment in the surgical environment.

12. During an observation on 12-21-16 at 1410 hours of terminal OR cleaning in OR#1, in the company of the director of surgical services, staff A10 and the director of environmental services, staff A12, the EVS staff N45 indicated they were using a diluted bleach solution described as ½ cup of bleach (sodium hypochlorite) added to 1 gallon of water for disinfecting the tile walls of the OR.

13. On 12-21-16 at 1410 hours, the director of surgical services, staff A10 and the director of environmental services, staff A12 confirmed the diluted bleach solution was not approved for cleaning and disinfecting surfaces in the OR.

14. Review of the policy/procedure Environmental Cleaning of the Surgical Setting (approved 10-16) indicated the following: "Nursing personnel... will assure that appropriate cleaning methods and procedures are achieved... References: The Association of Operating Room Nurses (sic), 2016 Standards, Recommended Practices and Guidelines: Environmental Cleaning of the Surgical Setting."

15. Review of the Housekeeping Employee Orientation Policy (approved 3-15) indicated the following: "To better help the employee understand the specific tasks required of the position and job assignments... A check-off list is completed by the training supervisor as the responsibilities and functions are reviewed... Attached are the orientation guide checklists (3)." Review of the New Hire Training checklist indicated the following: "...[a space for] date completed... 3 days training in Surgery... [a space for] Employee Sign Off..." and no other documentation indicating the OR-specific training content provided to EVS staff working in the restricted surgical environment was identified.

16. Review of the personnel file for EVS OR staff N45 indicated an Environmental Services Surgery Training Checklist was completed on 6-25-13 and signed by staff N45 and no personnel file documentation for EVS OR staff N45, N47, N48 or N49 indicated an EVS supervisor or OR educator instructed the EVS staff on OR-specific training content and observed each staff 's compliance with specific written performance standards while cleaning and disinfecting surfaces and equipment to validate staff competency for cleaning in the surgical environment.

17. On 12-20-16 at 1335 hours, the director of environmental services, staff A12 confirmed an EVS staff currently working in OR usually conducts the new employee orientation and confirmed no additional documentation outlining the OR-specific training content or indicating the minimum performance standards necessary to validate OR cleaning competency for EVS staff was available.

18. The Association of periOperative Registered Nurses (AORN) Recommended Practices for Environmental Cleaning (2015) indicated the following: "Disinfectants should be applied and reapplied as needed, per manufacturers' instructions, for the dwell time required to kill the targeted organism...Cleaning should progress from clean to dirty areas. Cleaning should progress from top to bottom areas... All work surfaces and high touch objects should be cleaned... Perioperative and environmental services personnel must receive education and complete competency verification activities that address specialized knowledge and skills related to the principles and processes of environmental cleaning... Policies and procedures must include processes for initial education, training, [and] ongoing competency verification... Process monitoring must be a part of every perioperative setting ...[and]... should include... cleaning procedures [and] monitoring cleaning and disinfection practices... Cleaning practices should be measured with qualitative measures (eg., visual observation of the cleaning process...) and quantitative measures (eg., culture, adenosine triphosphate [ATP] monitoring)."

19. On 12-19-16 and 12-20-16, the retiring director of surgical services, staff A14, the new director of surgical services, staff A10, the director of environmental services, staff A12, and the infection control nurse, staff A19 were requested to provide documentation of visual observations of EVS personnel (by staff A14, A10, A12, A19 or another qualified observer) while performing terminal OR cleaning to validate competency of the services performed and no documentation was provided prior to exit.

20. On 12-20-16 at 1010 hours and 1340 hours and on 12-21-16 at 1050 hours, the retiring director of surgical services, staff A14, the new director of surgical services, staff A10, the director of environmental services, staff A12, and the infection control nurse, staff A19 confirmed that no documentation of visual observations to validate EVS staff competency for terminal OR cleaning was available.

21. Review of the Surgery and PACU (post anesthesia care unit) Policy (approved 9-16) indicated the following: "Routine cleaning is established for warmers, refrigerators, cabinets, storage areas, etc. A complete schedule of project work is attached to this policy." and the attached Surgery Daily Worksheet failed to indicate a provision for cleaning blanket warmers on a daily or periodic basis.

22. Review of the Environmental Services Surgery Training Checklist for EVS OR staff N45 failed to indicate training on cleaning blanket warmers was provided on 6-25-13 or other date to the staff.

23. During a tour on 12-20-16 at 1207 hours and 1220 hours of the central surgical corridor, in the company of the director of surgical services, staff A10, the presence of accumulated dust was observed in two blanket warmers [asset 447500 and asset 447400] under the plenum in the upper compartment and on the upper edge of the magnetic door seal.

24. The deficient practices were confirmed by staff A10 at the time of the observation.

25. During a tour on 12-20-16 at 1207 hours of the central surgical corridor, in the company of the director of surgical services, staff A10, the presence of accumulated dust was observed on the upper surfaces of a Lifepak 12 defibrillator on the emergency cart.

26. The deficient practice was confirmed by staff A10 at the time of the observations.

27. During a surgical patient tracer observation on 12-20-16 at 1116 hours in OR#3, in the company of the director of surgical services, staff A10, a surgical instrument console was observed with a 3" x 3" cardboard sign taped to the faceplate panel.

28. The director, staff A10 confirmed during observation the instrument panel could not be properly disinfected between use with patients due to the porous nature of the cardboard material attached to the equipment and confirmed the cardboard would be immediately removed and discarded and the instrument surface disinfected before use with the patient.

29. During a tour on 12-20-16 at 1047 hours of the surgical services area adjacent to the surgery scheduling desk, in the company of the director of surgical services, staff A10, the presence of accumulated dust was observed on a 12" x 12" ceiling ventilation air grille and on the upper surface of an X-ray film viewing box.

30. The deficient practices were confirmed by staff A10 at time of observation.

31. During a tour on 12-20-16 at 1244 hours of the 1st floor SPD (sterile processing and distribution) department, in the company of the director of surgical services, staff A10 and the surgical services SPD nurse, staff A13, the presence of accumulated dust was observed on the upper surface of the automatic door opener leading into the SPD area.

32. The deficient practice was confirmed by staff A10 and A13 at the time of the observation.

33. During a tour on 12-20-16 at 1254 hours of the SPD department, in the company of the director of surgical services, staff A10 and the surgical services SPD nurse, staff A13, the presence of accumulated dust was observed on two 6" x 12" ceiling ventilation air grilles located directly over the area for loading and unloading two large wall-mounted instrument sterilizers in the clean SPD area.

34. The deficient practice was confirmed by staff A10 and A13 at the time of the observation.

35. On 12-20-16 at 1300 hours, the SPD supervisor, staff A15 indicated the EVS staff assigned to the SPD department had recently been changed on multiple occasions and indicated the SPD department has not been receiving cleaning and disinfecting services by a designated EVS personnel on a consistent basis.

36. During a tour on 12-20-16 at 1310 hours of the SPD department, in the company of the director of surgical services, staff A10 and the surgical services SPD nurse, staff A13, the presence of accumulated dust and debris was observed under an instrument wrapping table in the clean SPD area.

37. The deficient practice was confirmed by staff A10 and A13 at the time of observation.

38. During a tour on 12-21-16 at 1520 hours of the 3rd floor surgical services in the soiled utility room, in the company of the director of surgical services, staff A10, a cart containing red-bagged surgical waste and clear bags containing contaminated laundry was observed next to a cart elevator awaiting transfer to the 1st floor decontamination receiving room of the facility. The director, staff A10 and the surveyor proceeded to the 1st floor decontamination receiving room and observed a laundry cart containing only clear bags of contaminated laundry awaiting transport to a soiled laundry holding room or suitable containment until transport to an offsite commercial laundry provider. The director, staff A10 and the surveyor proceeded on to the receiving department and loading dock where two laundry carts containing contaminated laundry were observed (and photographed) in the dock area immediately adjacent to a large roll-up door.

39. A receiving department staff present in the area indicated the soiled laundry carts were brought to the receiving department and stored until picked up in the morning for delivery to a commercial laundry. No segregation of the contaminated laundry was identified and no handwashing facilities or personnel protective equipment were observed to be immediately available if needed.

40. The deficient practice was confirmed by staff A10 at the time of the observation.

41. On 12-21-16 at 0950 hours, the director of environmental services, staff A12 confirmed that no policy/procedure for soiled linen management indicating an approved process for handling and transporting contaminated linen from nursing, surgery, endoscopy, and/or cardiac catheterization units to an appropriate storage location until loaded on a truck for delivery to an offsite laundry was available.