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Based on document review, observation and interview, the facility failed to furnish one (1) of six (6) patient care services reviewed in accordance with applicable State laws.

Findings include:

1. Review of the Indiana food code, 410 IAC 7-24, "Sanitary Standards for the Operation of Retail Food Establishments," section 179 read: "Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling, or washing by the consumer before consumption, food on display shall be protected from contamination by the use of: (1) packaging; (2) counter, service line, or salad bar food guards; (3) display cases; or(4) other effective means."

2. An observation on 7-24-2018 at approximately 12:30 pm and again on the same date at approximately 1:15 pm, a serving platter containing cut tomatoes and cut lettuce was observed on a counter top, to the left of the serving line, and a container of "shake shack sauce" was observed next to the serving platter. Neither the serving platter, nor container of sauce were covered, placed in a display case, nor had a food guard to protect them from contamination.

3. In interview on 7-24-2017 at approximately 1:15 pm with staff person L5 (Dietary Director), acknowledged the cut tomatoes, cut lettuce, and container of sauce were not protected from contamination.

4. Review of policy/procedure titled "Orientation / Annual In-services," policy number "HR503, "last approved by the Vice President of Human Resources on 4-10-18 read: "All employees will complete an initial orientation session with the VP of Human Resources / designee; the Employee Health Nurse / designee and the IT Staff ..." and "The orientation agenda will include ...fire ...infection control ...".

5. Review of personnel records indicated staff person L9 had not received an orientation to include infection control and fire safety training.

6. Documentation of orientation to include infection control and fire safety training for staff member L9 was requested on 7-23-2018 at 11:25 am during the entrance conference, on 7-25-2018 at 2:05 pm from staff person L3, and on 7-26-2018 at 11:00 am from staff person L3. The documentation was not provided prior to concluding the survey.
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Community Hospital of Bremen was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR 485.623(d). Life Safety from Fire and the 2012 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC).

The Community Hospital of Bremen was built in 2006 and is a single-story fully sprinklered building of Type II (111) construction with a fire alarm system with smoke detection in the corridors and spaces open to the corridors. The facility was surveyed with Chapter 19, Existing Health Care Occupancies of the Life Safety Code. The hospital provides overnight care, surgical services, and maintains an Emergency Department.

The facility has 24 certified beds. At the time of the survey, the census was 6.

Based on observation, record review, and interview, the facility failed to ensure 2 of 12 of smoke barrier doors would restrict the movement of smoke for at least 20 minutes (see tag K223), the facility failed to maintain 3 of 3 operating or procedure room's battery operated emergency lights in accordance with NFPA 99, 2012 Edition, Section 6.3.2.2.11 (see tag K291), the facility failed to ensure 1 of 1 hazardous areas such as rooms with collected trash in volume exceeding 64 gallons were protected in accordance with LSC Section 19.3.2.1 (see tag K321), the facility failed to ensure the humidity in 2 of 4 anesthetizing locations were maintained between 20% and 60% (see tag K323), the facility failed to provide ceiling construction in 1 of 1 MRI mechanical room in accordance with NFPA 13 (see tag K351), the facility failed to document sprinkler system inspections in accordance with NFPA 25 (see tag K353), the facility failed to provide written documentation or other evidence the sprinkler system components had been inspected and tested for 1 of 4 quarters (see tag K353), the facility failed to ensure the penetrations caused by the passage of wire and/or conduit through 1 of 3 smoke barrier walls were protected to maintain the smoke resistance of each smoke barrier (see tag K372), the facility failed to ensure 1 of 1 emergency generator was protected in accordance with NFPA 110 (see tag K918).

The cumulative effect of these systemic problems resulted in the hospital's 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.

Based on observation and interview, the facility failed to ensure 2 of 12 of smoke barrier doors would restrict the movement of smoke for at least 20 minutes. LSC 19.2.1 requires healthcare occupancies to comply with LSC Chapter 7. Doors in smoke barriers are self-closing and kept in the closed position unless held open by a release device complying with 7.2.1.8.2. LSC 7.2.1.8.2 states that automatic releasing mechanism is activated by the operation of approved smoke detectors. CMS requires corridor doors to be positively latching and that if the door-set has an astragal attached, a coordinating device must be installed to ensure the appropriate door closes first. This deficient practice could affect all building occupant, the facility failed to provide ceiling construction in 1 of 1 MRI mechanical room in accordance with NFPA 13. The ceiling tiles trap hot air and gases around the sprinkler and cause the sprinkler to operate at a specified temperature. NFPA 13, 2010 edition, 8.5.4.11 states the distance between the sprinkler deflector and the ceiling above shall be selected based on the type of sprinkler and the type of construction. This deficient practice could affect up to 10 patients and staff in the MRI Center and adjacent smoke compartment,

Findings include:

1. During a tour of the facility with the Director of Plant Operations on 08/20/18, the following were observed:
a) The Kitchen delivery double-doors, which is part of the A/B smoke barrier did not have a self-closing device or coordinator to ensure the proper door closed first.
b) The Kitchen delivery double-doors did not positively latch into the frame when closed.
c) The Laboratory Lounge Room, which is part of the B/C smoke barrier was propped open by a chair.
Based on interview at the time of observations, the Director of Plant Operations agreed that the kitchen door did not self-close, and that the door to the Laboratory lounge was propped open.

2. During a facility tour with the Director of Plant Operations on 08/20/18 at 3:45 p.m. it was discovered that the MRI Machine Room was missing 6 of 50 ceiling tiles due to the arrangement of conduit and cables. During interview at the time of observation, the Director of Plant Operations acknowledged the missing ceiling tiles.

Based on observation, record review, and interview, the facility failed to maintain 3 of 3 operating or procedure room's battery operated emergency lights in accordance with NFPA 99, 2012 Edition, Section 6.3.2.2.11. Section 6.3.2.2.11.1 requires that locations where deep sedation and general anesthesia is administered be protected by one or more battery operated emergency lights. Section 6.3.2.2.11.5 requires that such units shall be tested monthly for 30 seconds and annually for 30 minutes. This deficient practice could affect staff and up to 3 patients, the facility failed to document sprinkler system inspections in accordance with NFPA 25. NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 2011 Edition, Section 5.2.4.1 states gauges on wet pipe sprinkler systems shall be inspected monthly to ensure that they are in good condition and that normal water supply pressure is being maintained. Section 5.2.4.2 states gauges on dry pipe sprinkler systems shall be inspected weekly to ensure that normal air and water pressures are being maintained. Section 5.1.2 states valves and fire department connections shall be inspected, tested, and maintained in accordance with Chapter 13. Section 13.1.1.2 states Table 13.1.1.2 shall be utilized for inspection, testing and maintenance of valves, valve components and trim. Section 4.3.1 states records shall be made for all inspections, tests, and maintenance of the system and its components and shall be made available to the authority having jurisdiction upon request. This deficient practice could affect all patients, staff, and visitors, the facility failed to provide written documentation or other evidence the sprinkler system components had been inspected and tested for 1 of 4 quarters. LSC 4.6.12.1 requires any device, equipment or system required for compliance with this Code be maintained in accordance with applicable NFPA requirements. Sprinkler systems shall be properly maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems. NFPA 25, 4.3.1 requires records shall be made for all inspections, tests, and maintenance of the system components and shall be made available to the authority having jurisdiction upon request. 4.3.2 requires that records shall indicate the procedure performed (e.g., inspection, test, or maintenance), the organization that performed the work, the results, and the date. NFPA 25, 5.2.5 requires that waterflow alarm devices shall be inspected quarterly to verify they are free of physical damage. NFPA 25, 5.3.3.1 requires the mechanical waterflow alarm devices including, but not limited to, water motor gongs, shall be tested quarterly. 5.3.3.2 requires vane-type and pressure switch-type waterflow alarm devices shall be tested semiannually. This deficient practice could affect all patients, staff, and visitors in the facility, the facility failed to ensure 1 of 1 emergency generator was protected in accordance with NFPA 110. NFPA 110, 2010 Edition defines an Emergency Power Supply (EPS) at Section 3.3.4, as the source of electric power of the required capacity and quality for an emergency power supply system (EPSS). Section 3.3.5 defines an EPSS as a complete functioning EPS system coupled to a system of conductors, disconnecting means and overcurrent protective devices, transfer switches, and all control, supervisory, and support devices up to and including the load terminals of the transfer equipment needed for the system to operate as a safe and reliable source of electric power. Section 7.3.1 requires that Level 1 or Level 2 EPS equipment location(s) shall be provided with battery-powered emergency lighting. This requirement shall not apply to units located outdoors in enclosures that do not include walk-in access. This deficient practice could affect all patients and staff in the facility.

Findings include:

1. During record review with the Director of Plant Operations on 08/20/18 from 8:30 a.m. to 1:30 p.m., no documentation could be found regarding monthly or annual testing of the emergency lighting in the operating or procedure rooms. Based on a review of the building electrical prints, battery operated emergency lights were in both operating rooms and the procedure room. Based on observation with the Director of Surgery on the same date between 1:30 p.m. and 4:30 p.m. battery operated emergency lighting was found in the operating and procedure rooms. Based on interview at the time of record review, the Director of Plant Operations confirmed the presence of battery operated emergency lighting in the ORs, and that no monthly or annual testing was conducted.

2. During record review with the Director of Plant Operations from 8:30 a.m. to 1:30 p.m. on 08/20/18, weekly Pre-Action (dry) sprinkler system gauge inspection documentation for 52 weeks of the most recent 52 week period was not available for review. Monthly wet sprinkler system gauge inspection documentation for 12 months of the most recent 12 month period was also not available for review. In addition, monthly inspection documentation for all sprinkler system control valves for 12 months of the most recent 12 month period was not available for review. Based on interview at the time of record review, the Director of Plant Operations acknowledged sprinkler system gauge and control valve inspection documentation for the aforementioned weekly and monthly periods was not available for review.

3. During record review of the quarterly sprinkler system inspection records on 08/20/18 at 11:39 a.m. with the Director of Plant Operations present, there was no quarterly sprinkler system inspection report available for the second quarter (April, May, June) of 2018. During an interview at the time of record review, the Director of Plant Operations acknowledged there was no written documentation available to show the sprinkler system had been inspected during the second quarter of 2018.

4. Based on observation with the Director of Plant Operations on 08/20/18 at 3:19 p.m., battery powered emergency lighting was not provided at the automatic transfer switch location. Based on interview at the time of observation, the Director of Plant Operations confirmed the facility had a Level 1 EPS and agreed that the automatic transfer switch location did not include battery powered emergency lighting.

Based on observation and interview, the facility failed to ensure 1 of 1 hazardous areas such as rooms with collected trash in volume exceeding 64 gallons were protected in accordance with LSC Section 19.3.2.1. Section 19.3.2. states that any hazardous areas shall be safe-guarded by a fire barrier having a 1-hour fire-resistive rating or shall be provided with an automatic extinguishing system in accordance with Section 8.7.1. Where protected by sprinklers, the areas shall be separated from other spaces by smoke partitions in accordance with Section 8.4. This deficient practice could affect staff in the kitchen, and visitors in the dining area and adjacent smoke compartment.

Findings include:

1) During a tour of the facility with the Director of Plant Operations on 08/20/18 at 2:24 p.m. the door to the dishwashing area of the kitchen was found to be propped open with a wooden block and did not have a self-closing device. Furthermore, the double-doors to the serving area, which was open to the kitchen, did not have self-closing devices, and were blocked from closing by an Alcohol-Based Hand Rub dispenser stand and garbage container. Additionally, the double-doors did not positively latch into the frame when closed. Further investigation found trash in excess of 64 gallons in the serving area and kitchen. The dishwashing door and the serving-area double-doors lead from the dining area, which was open to the corridor. Based on interview at the time of observation, the Director of Plant Operations agreed that the hazardous area was not properly protected with self-closing doors.

Based on observation, document review, and interview, the food services failed to ensure proper cold food holding temperatures for four of six food items observed in the cafeteria, the facility failed to ensure the humidity in 2 of 4 anesthetizing locations were maintained between 20% and 60%. 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. CMS requires Operating Rooms not to exceed 60% humidity per S&C 13-25-LSC. This deficient practice could affect staff and up to 2 patients.

Findings include:

1. On 7-24-2018 at 12:30 PM; and at 1:15 PM, the following were observed to be held at room temperature in the cafeteria:
a. A serving platter containing cut tomatoes and cut lettuce located on a counter top to the left of the serving line. The serving platter was not refrigerated, nor was it placed on a container of ice.
b. An opened 20 ounce (oz.) bottle of "Hellman's Mayonnaise made with cage free eggs" located on a counter top next to the self-serve tray of cut tomatoes and lettuce. The mayonnaise was not refrigerated, nor was it placed on ice.
c. An opened 20 oz. bottle of "Hellman's Mayonnaise made with cage free eggs" located on a counter top next to the cash register. The mayonnaise was not refrigerated, nor was it placed on ice.

2. On 7-25-2018 at 12:30 PM and again on 7-26-2018 at 10:40 AM, an opened, 34 oz. container of "Hidden Valley Ranch Dressing" and an opened, 16 oz. bottle of "Marzetti Poppyseed Dressing" were observed on a counter top next to the self-serve salad bar. Neither bottle was refrigerated or placed on ice. Both bottles had the following statement printed on the bottle: "Refrigerate after opening." The poppyseed dressing was warm to the touch on 7-25-2018 at 12:30 PM.

3. Review of "FDA Model Food Code 2017" 3-501.16(A) read: "Except during preparation, cooking, cooling, or when time is used as a public health control...time/temperature control for safety of food shall be maintained...(2) at 5°C (41°F) or less."

4. Review of the Indiana Food Code, 410 IAC 7-24, "Sanitary Standards for the Operation of Retail Food Establishments" at section 187 read: "Except during preparation, cooking, or cooling, or when time is used as a public health control of section 193 of this rule, potentially hazardous food shall be maintained as follows...at 41 degrees Fahrenheit or less."

5. Review of facilities policies and procedures indicated the following:
a. A policy/procedure titled: "Food Temperature Guidelines," policy number "NS021," last reviewed by staff person L5, Dietary Director, on 5-23-16, read: "Foods must be stored at 41 degrees Fahrenheit or colder..."
b. A policy/procedure titled: "Test Temperatures," policy number "NS032," last reviewed by staff person L5, Dietary Director, on 5-23-16, read: "Recommended guidelines: 1. To serve all cold foods below 40 degrees."

6. In interview on 7-24-2018 at 1:15 PM, staff person L5, Dietary Director, acknowledged the cut tomatoes, cut lettuce, and two bottles of mayonnaise were held at room temperature during lunch service on 7-24-2018.

7. In interview on 7-26-2018 at 10:40 AM, staff person L5, Dietary Director, acknowledged the ranch and poppyseed dressings were held at room temperature when the salad bar is open.

8. Based on record review with the Director of Plant Operations and Director of Surgery on 08/20/18 a.m., the operating room humidity was found out of the appropriate range on 144 of 253 daily recordings taken during the most recent twelve month period. Internal policy "Surg. 119" states that Operating Room humidity levels will be maintained at 20% - 60% in regard to infection control standards. No documentation could be located or provided indicating a response was performed when the humidity levels were out of range. No other further documentation was available to show what response was performed. Based on interview at the time of record review, the Director of Surgery stated that humidity is recorded only when procedures are planned, not on a daily basis. During interview, the Director of Plant Engineering acknowledged the aforementioned condition and stated when humidity is out of range, a work order should be generated, however he could provide no work orders regarding humidity levels during the same timeframe.

Based on observation and interview, the facility failed to ensure the penetrations caused by the passage of wire and/or conduit through 1 of 3 smoke barrier walls were protected to maintain the smoke resistance of each smoke barrier. LSC Section 19.3.7.5 requires smoke barriers to be constructed in accordance with LSC Section 8.5 and shall have a minimum ½ hour fire resistive rating. This deficient practice could affect staff and up to 20 patients in the adjacent "B and C" smoke compartments.

Findings include:

During a tour of the facility with the Maintenance Assistant #1 and Maintenance Assistant #2 on 08/21/18 at 8:47 a.m. two penetrations were found on the B/C Smoke barrier above the ceiling tiles between the Laboratory and Surgery Staff Lounge door. Specifically, a 2 inch stubbed conduit was not properly sealed, nor a 1/2 inch annular gap around conduit. At the time of observation, Maintenance Assistant #1 confirmed the two penetrations and agreed with the measurements.

Based on document review, observation and interview, the facility failed to follow policy and procedure to ensure that the blood glucose meters were cleaned/disinfected according to the manufacturers recommendation for four (4) of four (4) glucometer kits; failed to ensure nursing staff followed the facility policy and procedure related to dating, when opened, the glucometer quality control solution bottles according to the manufacturers recommendation on two (2) of the four (4) units toured; as well as following the infection control policy for obtaining/documenting immunization status for two (2) of three (3) contracted staff members. (L8 & L9)

Findings include:

A: Glucometer:
1. Review of the hospital policy titled, "Whole Blood Glucose by ACCU-CHEK Inform II Systems", policy number, LABPOC001, date initiated 04/2000, indicated the meter "is cleaned after each use with the hospital's approved disinfectant". The "solutions are stable 3 months after opening or until expiration date", whichever comes first. This policy was last reviewed on 05/11/2017.

2. Review of the hospital policy titled, "Approved List of Cleaners & Disinfectants", policy number IC040, date initiated 07/13, indicated to refer to Appendix A for a list of "approved Cleaning and Disinfection" chemicals. The approved disinfectant cleaner description was "Sani Cloth AF3" for nursing units to use as a cleaner/disinfectant. This policy was last revised on 05/2017.

3. Review of the hospital policy titled, "Cleaning/Disinfection/Sterilization of Reusable Patient Care Equipment", policy number IC004, date initiated 09/2004, indicated reusable patient care equipment should be "cleaned, disinfected or sterilized based on their intended use to prevent the spread of infection". Choose an appropriate "hospital approved" registered cleaner/disinfectant, and to "follow the manufacturer's directions" for all cleaner/disinfectants. "Supervisors are responsible to ensure employees are in compliance with departmental cleaning policies." This policy was last revised on 05/2015.

4. Review of the hospital policy titled, "Reagent and Control Handling", policy number LAB-031, date initiated 11/1997, indicated "all reagents are to be labeled with...open date and expiration date". This policy was last revised on 01/2016.

5. Review of the "ACCU-CHEK Inform II" manufacturers recommendations, indicated that the acceptable active ingredients and products for cleaning and disinfecting the meter were "Clorox Germicidal Wipes" or "Super Sani-Cloth Germicidal Disposable Wipes". A note indicated to "always" use one of the two to clean and disinfect the meter. "Do not use any other cleaning or disinfecting solution." Using solutions other than the Clorox or Super Sani-Cloth "could result in damage to the system components".

6. Review of the "ACCU-CHEK Inform II Controls" manufacturers recommendations, noted "write the date the bottle was opened on the bottle label". The quality control solution "is stable for 3 months from that date", or until the use by date on the bottle label, whichever comes first.

7. Review of the "Glucose Patient Results" by location logs, indicated greater than five hundred (500) "ACCU-CHEK Inform II" glucose tests had been performed on patients since the Indiana State Licensure Survey exit date of 04/11/2018.

8. Review of the "INFECTION CONTROL PROGRAM", signed and dated by A # 1 (Infection Control Registered Nurse), indicated "the purpose of the Infection Control Program is to develop, implement and evaluate effective measures to prevent infection".

9. During the facility tour on 07/26/2018 at approximately 3:00 pm, with administrative staff member A # 2 (Vice President of Nursing), the glucometer kits on two (2) of the four (4) units (medical-surgical & obstetrics) were observed to have quality control solution bottles (HI/LO) that were previously opened, but lacked documented open dates.

10. In interview on 07/24/2018 at approximately 9:50 am with administrative staff member A # 1, confirmed the facilities glucometers were being cleaned with Sani-Cloth disposable wipes.

11. In interview on 07/25/2018 at approximately 3:15 pm with administrative staff member A # 2, confirmed the facility was using the "incorrect disinfectant to clean their meters" according to the "manufacturers recommendations". The facility had a total of four (4) meters that were located in "surgery, obstetrics, medical-surgery, and the emergency department".

12. In interview on 07/26/2018 at approximately 10:10 am with administrative staff member A # 2, confirmed that the ACCU-CHEK Inform II "control solutions bottles should have been dated when opened".

13. In interview on 07/26/2018 at approximately 2:15 pm with LB # 1 (Laboratory Assistant Director), confirmed the "control solution bottles should be dated when opened".

B. Contracted Personnel:
1. Review of the hospital policy titled "Employee Health Services," last approved by the Infection Control Chairperson on 7-13-18 and the Vice President of Nursing on 6-21-18 read: "The Employee Health Nurse (EHN) will schedule the following examinations for all new employees ...laboratory titers on the following ...Rubella ...Rubeola (if born after 1957) ...Varicella ...".

2. Review of personnel records indicated there was no documentation of rubella, rubeola, and varicella titers for contracted staff persons L8 and L9, polysomnography technicians.

3. In interview on 7-26-2018 at approximately 2:20 pm with administrative staff member A # 2, confirmed the facility lacked documentation of rubella, rubeola, or varicella titers for contracted staff persons L8 and L9.