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Based on observation, interview and record review, the hospital failed to ensure there was availability of adequate basic food supplies located at the hospital in order to implement the hospital's planned disaster menu to meet the nutritional needs for the hospital's licensed bed capacity to ensure patients, staff and potential visitors health and safety needs would be met, in the event of disaster, in accordance with state Title 22 70741(b)(1).

On March 1, 2016, at 3:12 p.m., the hospital's Chief Executive Office and Chief Nursing Officer were notified Immediate Jeopardy was declared in response to inadequate provisions on how to meet the nutritional needs of patients, staff and potential visitors in the event of an external disaster that would require persons to shelter in place. The hospital had not maintained adequate basic food supplies to meet the licensed bed capacity, staff and potential visitors in the event of an imminent external disaster. On March 3, 2016, at 4 p.m., the hospital was able to demonstrate adequate emergency food supplies had been replenished at the hospital to meet licensed bed capacity, staff and potential visitors in the event of a disaster.

Findings:

On March 1, 2016, at 11:20 a.m., a registered dietitian (RD 1) provided a copy of the hospital's approved disaster menu to be implemented to feed patients in the event of a disaster in which there was no gas, electricity or city water available. RD 1 stated, "The seven day disaster menu was approved by the governing body but we do not have all the food to implement yet."

Concurrently, RD 1 and a hospital staff employee (HS 1) stated the hospital had not planned to have enough emergency power from generators, directted to the foodservice equipment, therefore, would not be able to implement the daily operations menu for patients. RD 1 and HS 1 verified that the hospital's disaster menu was planned to anticipate unavailability of gas, electricity or city water.

A review of the hospital's undated "Seven Day Disaster Menu," indicated the plan was to serve ham for lunch on day 2, and pulled chicken for lunch on day 3. RD 1 stated the ham and chicken was located in the freezer and it was anticipated that the ready to eat chicken and ready to eat ham would thaw (without a refrigerator running on power) and still remain within safe temperatures to consume on day 2 and day 3. RD 1 was asked how she knew that the food would remain out of the temperature danger zone without refrigeration in the event of loss of power, and she stated, "I don't have a guarantee. I don't know for sure." In the presence of RD 1, a cook (Cook 1) stated there was two five pounds chicken breasts in the freezer (the chicken was purchased as a fully cooked chicken breasts), and two cases of ready to eat ham, which totaled twenty pounds of ham.

RD 1 reviewed the quantity of disaster food supply that was located at the hospital and stated, "We don't have enough food here for three days." RD 1 was asked what the hospital's plan was in terms of how many people were anticipated to feed daily in order to maintain the hospitals expected par level of disaster food supply in order to implement the hospital ' s disaster menu, and RD 1 stated, "Let me review the policy."

Concurrently, the hospital's policy and procedure (with an effective date of 12/2015) titled Emergency Meal Plan indicated, "Purpose; To define Food and Nutrition Services policy on Emergency Meal Plan in utilizing available foods on hand at the time of a disaster. Policy; It is the policy of GRHMC [abbreviations for the name of the hospital] to institute alternate menus enabling continued operations during emergency/disaster. Procedure; 1. Utilize first all foods which would perish with out held under refrigeration and do not require cooking for service as applicable, 2. After perishable foods are depleted, food items from the freezer which can be served when defrosted such as cooked meats, cold cuts and frozen vegetables will be used. It is critical that temperature of these foods be checked to ensure that they are with in the safety zone. 3. Canned and dry food items will be used last. 4. Meals are to be served on disposable wares until the ability to wash and sanitize dishes is restored. 5. Memorandum of Agreement (MOA) from food purveyors/vendors is recommended that they shall make emergency deliveries if needed in a disaster situation."

RD 1 stated, "The policy doesn't say how many people per day to plan for, in terms of expected par levels of disaster food to have on hand at all times."

On March 1, 2016, at 11:23 a.m., HS 1 stated the hospital was licensed to serve the needs for 137 potential in-patients. HS 1 stated the average patient census was around thirty five patients per day. RD 1 and HS 1 acknowledged the hospital was licensed for a 137 bed capacity and that in the event of a disaster the hospital should have anticipated a surge of patients to arrive at the hospital up to the licensed bed capacity, plus staff to care for the patients, and potential family visitors.

RD 1 stated, "We do not have enough food at the hospital to meet the nutritional needs of 137 patients a day, and we were never directed on a quantity of staff or family that we would need to feed in order to assure adequate food supply." RD 1 and HS 1 confirmed the hospital would be unable to meet the nutritional needs of inpatients up to licensed bed capacity, staff and family/visitors who may be present in the event of an imminent external disaster.

RD 1 was asked if the approved Seven Day Disaster Menu included adequate provisions on how to meet the needs for the patients who required a renal diet (diet for kidney disease) when Day 1 included crackers with lunch and dinner, potato chips, vegetable/tomato juice, Day 2 included peanut butter, ham, tortilla chips, baked beans, canned potatoes, vegetable/tomato juice, beef chili, crackers. RD 1 reviewed the seven day disaster menu plan and stated, "There are not adequate provisions for therapeutic diets." According to a current diet order list there were two patients, in the facility, who required a renal diet.

RD 1 listed the following food items from the disaster food supply located in the kitchen; 4 boxes of apple juice, 4 boxes of cranberry juice, and 4 boxes of cranberry blend juice with each box containing 12 containers at 46 ounces each in one box, 4 boxes of chicken Gerber baby food (12 jars at 12.5 ounces each in each box), 6 boxes of jars of Gerber baby food of peas (with 8/2 packs in each box), six boxes of Gerber baby food of peaches (8/2 packs per box), two boxes of green beans (2 box 8/2 pks), one box of tuna (6 containers at 66.5 ounce each), two boxes of Oreo cookies (120 - 1.2 ounce per box), one box of honey maid crackers (150 crackers in one box), one box of saltine crackers (500 crackers in the box), one instant two pound dry milk powder, one box of low fat granola with raisin cereal boxes at 70 boxes per the case, two boxes of cornflakes at 70 individualized sized boxes per case, 5 boxes of fiber one bars (16 bars at 1.4 ounce each per box), 4 boxes of nature valley oats/honey at 144 individualized sized bars per box, 4 boxes of Nutrigrain bars at 16 individual sized bars per box, and twenty pounds of ham and ten pounds of chicken that was ready to eat and stored in the freezer.

On March 1, 2016, at 11:45 a.m., RD 1 and HS 1 stated they identified that the hospital had not had an adequate supply of disaster food on the premises and notified the hospital's previous management company. RD 1 and HS 1 stated a few options were presented to the hospital staff at that time, at least four months earlier, and they were told there were not enough financial resources to ensure an adequate supply of disaster foods would be maintained at the hospital, at all times.

Based on observation, interview, and record review, the hospital's governing body and Chief Executive Officer (CEO) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by failing to ensure:

1. The disaster menu stipulated a par level that included the licensed bed capacity and staff required to provide care; and maintained an adequate amount of disaster food supplies, to meet the nutritional needs of the patients and staff, in the event of an disaster. The facility failed to have adequate provisions for meeting the nutritional needs of their licensed bed capacity and required staff, in accordance with Title 22 70741 (b)(1). (Refer to A 020);

2. Patients rights were promoted and patients were kept safe, when an allegation of abuse was made, and the alleged perpetrator was allowed to continue patient care; fire alert systems in the operating room were ineffective in alerting staff to external emergency; and the grievance process was not followed for five of seventeen grievances filed in the last year. (Refer to A 0115)

3. To develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured the program reflected the different department/services; and the program focused on indicators in improving health outcomes and the prevention of medical errors (Refer to A 263);

4. The provision of safe and sanitary dietary services was implemented, resulting in the potential for patient harm (Refer to A 0619); and

5. An active, system wide, infection surveillance control program for prevention, control, and investigation of infections and communicable diseases in a universe of 29 patients was implemented to meet the needs of the patients and staff (Refer to A 0749).

The cumulative effect of these systemic problems resulted in failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview, and record review, the facility failed to ensure:

1. Oversight of the grievance process by the Governing Board. (A119)

2. Acknowledgement of a grievance was completed within seven days of receipt for five of 17 patients (Patient 20, 21, 22, 23, and 24). (A122)

3. A written notice of its decision to the patient's grievance was provided for five of 17 patients (Patient 20, 21, 22, 23, and 24). (A123)

4. The alleged perpetrator of abuse was removed from providing patient care. (A144)

5. A safe environment that was free from abuse. (A145)

The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on observation, interview, and record review, the facility failed to develop, implement, and maintain an effective, data driven, quality assessment and performance improvement (QAPI) program by failing to:

1. Ensure compliance with the Condition of Participation for Federal, State, and Local Laws, by the identification of the deficient practices, or by ensuring projects were in place to improve them (A0020);

2. Ensure compliance with the Condition of Participation for Governing Body, by the identification of the deficient practices, or by ensuring projects were place to improve them (A043);

3. Ensure compliance with the Condition of Participation for Patient's Rights, by the identification of the deficient practices, or by ensuring projects were place to improve them (A115);

4. Ensure grievances were analyzed for trends and opportunities for improvement when no grievance data had been reported to or reviewed by the Quality Assessment Performance Improvement (QAPI) Committee for the previous eight months (A273);

5. Develop quality indicators and implement corrective action to ensure the discharge planning process was meeting the needs of the patients, by failing to measure, analyze, and track readmissions to determine if they were potentially due to problems with discharge planning, or the implementation of discharge plans (A273);

6. Develop new indicators for the food and nutrition department, related to sanitation and safe food handling, when 100% compliance had been attained for several months with the current data being collected (A273);

7. Eight of ten members of the Medical Staff reviewed (MDs 1,2,3,5,6,7,8, and 10), had documented evidence of current ongoing professional practice evaluation (OPPE) being completed (A341);

8. Ensure compliance with the Condition of Participation for Food and Dietetic Services, with no identification of the deficient practices, or projects in place to improve them (A618); and,

9. Ensure compliance with the Condition of Participation for Infection Control, by the identification of the deficient practices, or by ensuring projects were place to improve them (A747).

The cumulative effect of these systemic problems resulted in existing problems throughout the facility to go unrecognized and uncorrected, and the inability to ensure quality healthcare was being provided in a safe environment and a safe and effective manner.

Based on observation, interview and record review the hospital failed to ensure the condition of participation for food and dietetic services was met as evidenced by the following regulations not in compliance (Cross-Reference); A -0619, A- 0620, A-0622, A-0629. In addition, the hospital was not compliant for regulation A-0020.

1. The hospital failed to ensure the food and dietetic services was sufficiently integrated into the hospital-wide QAPI (Quality Assurance and Program Improvement) program (Cross-Reference A-0273).


On March 2, 2016, at 10:05 a.m., the hospital's designated infection preventionist (IP 1) stated, "I do go into the kitchen at times. Once in a while I find a food not dated, or a food item that should have been thrown out." IP 1 stated that there was not an identified concern related to infection control issues in the kitchen in which the infection control program and the food and dietetics department had been actively working to improve on. The hospital failed to sufficiently integrate the food and dietetic services into the hospital-wide infection control programs. (Cross-Reference A-0620, A-0749).

As a result, the above cited system failures placed the highly susceptible patients at a potential for immediate risk of developing a food borne illness and/or not having their nutritional needs met, in the event of a disaster.

On March 1, 2016, at 3:12 p.m., the hospital's Chief Executive Office and Chief Nursing Officer were notified Immediate Jeopardy was declared in response to the potential of foodborne illness, and due to inadequate provisions on how to meet the nutritional needs of patients, staff and potential visitors in the event of an external disaster that would require persons to shelter in place. (Cross-Reference A-0620 and A-0622).

The cited system failures within the food and dietetic services department had not maintained sanitary and safe food handling conditions and practices which placed the patients at risk for developing a food borne illness.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases in a universe of 28 patients. The infection control program failed to meet the needs of all patients and staff as evidenced by:

1. The hospital failed to provide documentation to show the qualifications of their Infection Control Officer (Refer to A074);

2. The hospital did not designate in writing who was the designated Infection Control Officer responsible for their infection control program. (Refer to A0748);

3. The hospital's peel packs were not properly utilized for the sterilization of instruments (Refer to A0749);

4. Instruments were not properly positioned in sterilization trays and in preparation for sterilization (Refer to A0749);

5. Terminal cleaning of the hospital's decontamination and sterile processing areas were not performed daily (Refer to A0749);

6. The flooring in the hospital's decontamination, sterile processing and ICU areas were torn, cracked and unable to be disinfected (Refer to A0749);

7. Hospital staff did not perform hand hygiene after removal of gloves (Refer to A0749);

8. Hospital staff did not wear proper surgical attire in the operating room (Refer to A0749);

9. Disinfection of the hospital's operating room was not performed properly and disinfectants were not used according to the manufacturer's instructions (Refer to A0749);

10. Secondary containers of cleaning products were not labeled (Refer to A0749);

11. Employees did not follow their local Health Officer's order which instructed staff to wear masks after declination of influenza vaccine (Refer to A0749);

12. Healthcare workers were not vaccinated according to policy or nationally recommended guidelines (Refer to A0749);

13. TB screening of healthcare personnel was not performed (Refer to A0749);

14. Fit testing and fit testing competency was not performed (Refer to A0749);

15. Active surveillance for Methicillian Resistant Staph aureus was not performed according to policy (Refer to A0749);

14. Testing of Cidex solution used for high level disinfection was not performing according to AORN recommendations (Refer to A0749); and

15. Internal cleaning and sanitization of the facility's three ice machines was not conducted per facility policy and manufacturer's guidelines.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services.

Based on interview and record review, the Governing Board failed to ensure oversight of the grievance process when the responsibility was delegated to the Quality Assessment/Risk Management Department. This failed practice resulted in the potential for unsafe practices to go unidentified and uncorrected.

Findings:

During an interview conducted with the Director of Quality/ Risk Manger (DQRM) on March 2, 2016, at 8:30 a.m., she stated, "I started in July 2015 and I have not followed up with the grievances. None of the grievances have been reported to Quality Assessment Performance Improvement (QAPI)."

On March 2, 2015, at 2 p.m., the facility's Board of Director's Committee meeting minutes were reviewed with a member of the Board. The minutes indicated, grievances were submitted for review for January through June 2015. There was no indication grievances were submitted since June 2015 (8 months).

The facility policy and procedure titled "Complaints & Grievance-Patients" revised October 2015, indicated, "The purpose of this policy is to :... 3. Provide a process to determine the effectiveness of the complaint and/or grievance process through performance Improvement monitoring to help identify, investigate and resolve any deeper, systemic problems indicated by the grievance analysis...The Governing Board has delegated the Grievance Process to the Risk Manager or designee. Procedure...10. Grievance shall be tracked for the purpose of trending, improving the processes, and ensuring customer satisfaction with follow-through...Procedure For Using The Patient And Family Complaint/Grievance Form...8. The complaint/grievance log shall be summarized and presented to the Quality Council. Medical Executive Committee and the Governing Board at least quarterly for review and recommendations."

Based on interview and record review, the facility failed to ensure acknowledgement of a grievance was completed within seven days of receipt for five of 17 patients (Patient 20, 21, 22, 23, and 24)). This had the potential to result in a delay in the investigation of the grievances.

Findings:

On February 29, 2016, the facility's grievance log was reviewed.

On March 1, 2016, at 8:30 a.m., the following grievance files were reviewed with the Director of Quality and Risk Management (DQRM):

1. Patient 20's grievance file indicated, "On July 16, 2015, Patient 20's mother called the nurse to check on Patient 20 since he had just had a seizure. The nurse came in and asked Patient 20 if he wanted some water. The supervisor apologized, said it wouldn't happen again, and would do an investigation."

There was no indication the facility had conducted an investigation or sent a letter to Patient 20 with the facility's conclusion of the investigation (163 days after Patient 20 had filed a grievance).

2. Patient 21's grievance file indicated, "On August 6, 2015, the Radiology technician told Patient 21 his CT of the head result showed bleeding and MRI had been ordered. Upset because she got results from the technician and not the provider. She wanted to speak with the physician. Physician never returned calls to the patient."

There was no indication the facility had conducted an investigation or sent a letter to Patient 21 with the facility's conclusion of the investigation (148 days after Patient 21 had filed a grievance).

3. Patient 22's grievance file indicated, " On September 12, 2015, Patient 22 made a note saying the night shift Registered Nurses are mean to her and being ignored of her needs of when she calls. Happens every night and particularly last night."

There was no indication the facility had conducted an investigation or sent a letter to Patient 22 with the facility's conclusion of the investigation (122 days after Patient 22 had filed a grievance).

4. Patient 23's grievance file indicated, "On September 12, 2015, patient like to report two incidents for a.m. blood draws. She has a portacath and MD okayed it. Patient stated she has been asking nurse to get blood draw from port and registered nurse (RN) refused."

There was no indication the facility had conducted an investigation or sent a letter to Patient 23 with the facility's conclusion of the investigation (122 days after Patient 23 had filed a grievance).

5. Patient 24's grievance file indicated, "On October 1, 2015, certified nursing assistant (CNA) 1 took patients call light and phone because "you are calling too much". Nurse reassured patient and family, not have CNA assigned to her and this type of treatment not tolerated."

There was no indication the facility had conducted an investigation or sent a letter to Patient 23 with the facility's conclusion of the investigation (99 days after Patient 24 had filed a grievance).

During a concurrent interview with the DQRM, she stated, "I started in July 2015 and I have not followed up with the grievances. None of the grievances have been reported to Quality Assessment performance Improvement (QAPI)."

On March 2, 2015, at 2 p.m., the facility's Board of Director's Committee meeting minutes were reviewed with a member of the Board. The minutes indicated, grievances were submitted for review for January through June 2015. There was no indication grievances were submitted since June 2015 (8 months).

The facility policy and procedure titled "Complaints & Grievance-Patients" revised October 2015, indicated, "The purpose of this policy is to :...2. Provide a process to review, investigate, and resolve a patient's complaint/grievance within a reasonable time frame...Procedure: The Risk Manager will be responsible for investigation of the complaint/grievance, auditing, aggregating, and analyzing data to present to the QA/PI committee and to the Governing Board for review and recommendation...2. Timeframe for response to the patient's grievance is within 7 days if it requires extensive investigation...6. Written resolution of the grievance should be provided in a language and manner the patient and responsible person understands. 7. Grievance may not always be resolved within the timeframe but the Risk Manager should address to the patient and/or responsible person that the hospital is still working on resolving the problem. 8. The Risk Manager should inform the patient and /or responsible person that another follow-up response will be sent within 14 days...10. Grievances shall be tracked for the purpose of trending, improving the processes, and ensuring customer satisfaction with follow-through...Procedure For Using The Patient And Family Complaint/Grievance Form...8. The complaint/grievance log shall be summarized and presented to the Quality Council, medical Executive Committee and the Governing Board at least quarterly for review and recommendations."

Based on interview and record review, the facility failed to ensure a written notice of its decision regarding the patient's grievance was provided for five of 17 patients (Patient 20, 21, 22, 23, and 24). This resulted in Patient 20, 21, 22, 23, and 24 not receiving a resolution of the grievances submitted.

Findings:

On February 29, 2016, the facility's grievance log was reviewed.

On March 1, 2016, at 8:30 a.m., the following grievance files were reviewed with the Director of Quality and Risk Management (DQRM):

1. Patient 20's grievance file indicated, "On July 16, 2015, Patient 20's mother called the nurse to check on Patient 20 since he had just had a seizure. The nurse came in and asked Patient 20 if he wanted some water. The supervisor apologized, said it wouldn't happen again, and would do an investigation."

There was no indication the facility had conducted an investigation or sent a letter to Patient 20 with the facility's conclusion of the investigation (163 days after Patient 20 had filed a grievance).

2. Patient 21's grievance file indicated, "On August 6, 2015, the Radiology technician told Patient 21 his CT of the head result showed bleeding and MRI had been ordered. Upset because she got results from the technician and not the provider. She wanted to speak with the physician. Physician never returned calls to the patient."

There was no indication the facility had conducted an investigation or sent a letter to Patient 21 with the facility's conclusion of the investigation (148 days after Patient 21 had filed a grievance).

3. Patient 22's grievance file indicated, " On September 12, 2015, Patient 22 made a note saying the night shift Registered Nurses are mean to her and being ignored of her needs of when she calls. Happens every night and particularly last night."

There was no indication the facility had conducted an investigation or sent a letter to Patient 22 with the facility's conclusion of the investigation (122 days after Patient 22 had filed a grievance).

4. Patient 23's grievance file indicated, "On September 12, 2015, patient like to report two incidents for a.m. blood draws. She has a portacath and MD okayed it. Patient stated she has been asking nurse to get blood draw from port and registered nurse (RN) refused."

There was no indication the facility had conducted an investigation or sent a letter to Patient 23 with the facility's conclusion of the investigation (122 days after Patient 23 had filed a grievance).

5. Patient 24's grievance file indicated, "On October 1, 2015, certified nursing assistant (CNA) 1 took patients call light and phone because "you are calling too much". Nurse reassured patient and family, not have CNA assigned to her and this type of treatment not tolerated."

There was no indication the facility had conducted an investigation or sent a letter to Patient 23 with the facility's conclusion of the investigation (99 days after Patient 24 had filed a grievance).

During a concurrent interview with the DQRM, she stated, "I started in July 2015 and I have not followed up with the grievances. None of the grievances have been reported to Quality Assessment Performance Improvement (QAPI)."

On March 2, 2015, the facility's Board of Director's Committee meeting minutes were reviewed. The minutes indicated, grievances were submitted for review for January through June 2015. There was no indication grievances were submitted since June 2015 (8 months).

The facility policy and procedure titled "Complaints & Grievance-Patients" revised October 2015, indicated, "The purpose of this policy is to :... Written resolution of the grievance should be provided in a language and manner the patient and responsible person understands. The written notice should contain the following: a. Hospital's decision b. Name of the Hospital contact person c. Steps taken on behalf of the patient to investigate the grievance d. date of grievance investigation completion 7. Grievance may not always be resolved within the timeframe but the Risk Manager should address to the patient and/or responsible person that the hospital is still working on resolving the problem. 8. The Risk Manager should inform the patient and /or responsible person that another follow-up response will be sent within 14 days."

Based on interview and record review, the facility failed to ensure informed consents were signed by the patient's physician regarding the administration of blood and/or blood components, for two patients', (Patients 8 and 17). These failures may affect the patient's rights to make an informed decision regarding their health care.

Findings:

A review of the facility policy, "Blood and Blood Components, Transfusion (Approval Date 11/14)," was conducted. The first step of the procedure, prior to administration of the blood or blood product reflected, "Consent/Physician Responsibilities: Blood Transfusion Consent for Blood and Blood Products Transfusion is required...The physician must obtain this consent from the patient or legal representative... The physician must explain the risks and benefits of blood and blood products transfusion...Paul-Gann Transfusion Information Form must be signed by the physician."

(Paul Gann Act-Indicates the patient must be provided with the California Department of Health Services pamphlet titled, A Patient's Guide to Blood transfusion, which informs the patient of the risks and benefits of receiving autologous blood and blood from designated or community blood donors and that the patient must be informed of the risks and benefits of receiving blood by the physician).

1a. A review of Patient 8's record was conducted. Patient 8 was admitted to the facility on February 24, 2016, with a diagnosis of severe anemia. The patient had a colonoscopy, and was found to have bleeding from the colon. Patient 8 received multiple blood transfusions during her inpatient hospitalization.

A review of Patient 8's Consent For Blood, Blood Products, and Blood Derivatives Transfusion was conducted. The physicians statement which indicated the possible risks, complications, benefits, and alternatives of blood transfusions, including non treatment, was not signed by the physician. A copy of the Transfusion Information Form (per the Paul Gann Act, was not observed in the patient's records.

An interview was conducted with Patient 8's family member on February 29, 2016, at 11:30 a.m. The family member stated he was the patient's responsible party and was not given a copy of a pamphlet about blood transfusion.

b. A review of Patient 17's record was conducted. Patient 17 was admitted to the facility on February 26, 2016, with a diagnosis of chronic osteomyelitis (infection of a bone) of the lumbar spine. The patient had surgical debridment (removal of the infected tissue) on March 2, 2016.

A review of Patient 17's Consent For Blood, Blood Products, and Blood Derivatives Transfusion was conducted. The consent was not signed by the physician. The Transfusion Information Form was also not signed by the physician, which indicated the patient was not provided with a copy of the pamphlet, A Patient's Guide to Blood Transfusions.

An interview was conducted on March 3, 2016, at 11 a.m., with the Registered Nurse (RN) 4, in the intensive care unit. RN 4 stated the physician did not sign the Physicians Statement regarding the blood transfusion and the Transfusion Information Form for Patient 17. RN 4 further stated both documents should have been signed.

Based on observation, interview, and record review the facility failed to ensure:

1. The operating room had an audible and visual fire alarm system, or a process to alert operating room personnel, to emergency situations throughout the facility; and,

2. Patients were kept safe when an allegation of abuse was made, the alleged perpetrator (Certified Nursing Assistant 1) was allowed to continue patient care and had the potential to result in harm to the patients cared for by the Certified Nursing Assistant (CNA) 1.

Findings:

1. On March 3, 2016, at 11 a.m., a tour of the operating room area was conducted. The operating room (OR) and post anesthesia care unit (PACU) were located beyond locked doors, off a hall way in the back of the facility. The restricted area of the OR was located beyond an automatic sliding glass door. The department had four operating rooms, a smaller room currently used for storage, and two small storage areas.

During the tour, a surgery was underway in OR 1. The door to the operating room was closed. There were no speakers connected to the overhead paging system in any of the operating rooms. There were no phones in the operating rooms.

During a concurrent interview with the Interim Chief Nursing Officer (ICNO), the OR Supervisor, and Scrub Tech 1, the Scrub Tech was asked if he could hear "Code Reds (overhead page for fire)," when they were called. Scrub Tech 1 stated they (OR staff) could not hear the intercom system, or the fire alarms, in the operating rooms. In addition, Scrub Tech 1 stated there was no visible system like "a red indicator light that many ORs have." Scrub Tech 1 and the OR Supervisor both stated they were in the operating room until 10 p.m., last night assisting with a surgical procedure. Both staff stated if the fire alarm system was working last night, they would not have heard it, "but the PACU nurse would hear it and let us know."

On March 3, 2016, at 11:10 a.m., while standing in an empty OR, with the door open, the overhead paging system was tested. The ICNO and Scrub Tech stated they were unable to hear the page on the overhead system.

On March 3, 2016, at 11:15 a.m., the PACU was observed. The PACU was next to the OR, and could be accessed through a door in the OR non restricted area. There was no visible speaker system in the PACU. The overhead page system was tested again, but could not be heard in the PACU.

During an interview with PACU Registered Nurse (RN) 3, on March 3, 2016, at 11:15 a.m., the RN stated she did not hear the overhead page today. The RN stated she could hear an overhead page from the speakers in the hallway. PACU RN 3 stated if she was working after hours and heard an overhead page for "Code Red," she would let everyone in the OR know.

The facility policy titled "PBX Call Received Fire Procedures," with a governing board approval date of November 2015, was reviewed. The policy indicated "Code Red," would be paged over the hospital intercom system, five times at 15 second intervals.

The facility policy for "Code Red Duties - Surgery," with a governing body approval date of November 2015, was reviewed. The policy indicated, if the fire was outside of the department, staff was to close the door, department head was to report status of the department to the Control Center, and "report to the front of the hospital for further assignments."

The facility policy and procedure titled "Fire Safety Management Plan," with a governing board approval date of November 2015, was reviewed. The policy indicated its purpose was to "construct, maintain, and operate the facility in a manner that minimizes the possibility of a fire emergency. To ensure safety and protection of occupants, the plan addresses operating and maintenance procedures, and adequate training of personnel. The policy indicated the facility would satisfy all Life Safety Codes and requirements, including state, local, or federal requirements that are stricter than Life Safety Codes.



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2. On February 29, 2016, the facility's grievance log was reviewed.

On March 1, 2016, at 8:30 a.m., grievance files were reviewed with the Director of Quality and Risk Management (DQRM):

Patient 24's grievance file indicated, "On October 1, 2015, certified nursing assistant (CNA) 1 took patients call light and phone because "you are calling too much". Nurse reassured patient and family, not have CNA 1 assigned to her and this type of treatment not tolerated."

During a concurrent interview with the DQRM, she stated, "I started in July 2015 and I have not followed up with the grievances. None of the grievances have been reported to Quality Assessment Performance Improvement (QAPI)."

During a concurrent interview with the DQRM and the Nursing Supervisor (NS), the NS stated, the CNA 1 continues to work for us. The CNA 1 personnel file was reviewed with the NS. The NS acknowledged there was no counseling memo or disciplinary action related to the alleged abuse in CNA 1 personnel file.

An interview was conducted with the Chief Nursing Officer (CNO) on March 1, 2016, at 11 a.m. The CNO stated she was not aware of this grievance and it happened prior to her start date. She stated she was never updated on this allegation of abuse. She stated, the CNA 1 should have been suspended pending further investigation.

An interview was conducted with the Chief Human Resources Officer (CHRO) on March 2, 2016, at 3:30 p.m. CHRO stated he was unaware of this alleged abuse by CNA 1.

On March 2, 2016, the record for Patient 24 was reviewed. Patient 24 was admitted to the facility on September 29, 2015, with the diagnosis of shortness of breath.

There was no indication in the record of Patient 24's concerns/allegations.

There was no indication in the record of Social Services being notified of Patient 24's concerns or Patient 24 being evaluated by a Social Worker.

There was no indication in the record Patient 24's physician was notified of her concerns/allegations.

There was no indication the facility notified Adult Protective Services of the allegation.

The facility's policy titled, "Abuse, Adult and Elder," approved by the Governing Board on November 2014, indicated, "The Risk Management and/or social Services Department will investigate thoroughly each alleged violation and report the result to the Hospital Administration...6. Investigation Procedure: ...b. Social Worker will call Adult Protective Services and report the case. Social worker/Unit manager or designee initiates an investigation immediately...Reporting procedure:...c. Notify the patient attending physician or his/her designee regarding the alleged incident and assessment of findings...Corrective Action:...2. If incident involves a staff member, corrective action is taken in coordination with the Human Resources Director and Risk Manager. 3. Notification is made to the appropriate licensing agency if the incident involves a licensed employee or to the State Nursing Assistant Registry, if the incident involves a nursing assistant...Result of Investigation: The results of all investigations must be reported to the appropriate state agencies and to the department of Health Services, Licensing and Certification within five (5) working days of the incident or as required by law."

There was no indication in the facility's policy and procedure that the accused individual would be removed from patient care, was to leave the facility premises and was to be placed on administrative leave pending the results of the facility's investigation of the allegation of abuse.

Based on interview and record review, the facility failed to ensure patients were kept safe when an allegation of abuse was made, the alleged perpetrator (Certified Nursing Assistant 1) was allowed to continue patient care and the facility policy and procedure was not followed, to include notification of the facility Social Worker and Adult Protective Services for one patient (Patient 24). This resulted in a delay in the investigation by the facility of the abuse allegation, and had the potential to result in harm to the patients cared for by the Certified Nursing Assistant (CNA) 1.

Findings:

On February 29, 2016, the facility's grievance log was reviewed.

On March 1, 2016, at 8:30 a.m., grievance files were reviewed with the Director of Quality and Risk Management (DQRM):

Patient 24's grievance file indicated, "On October 1, 2015, certified nursing assistant (CNA) 1 took patients call light and phone because "you are calling too much". Nurse reassured patient and family, not have CNA 1 assigned to her and this type of treatment not tolerated."

During a concurrent interview with the DQRM, she stated, "I started in July 2015 and I have not followed up with the grievances. None of the grievances have been reported to Quality Assessment performent Improvement (QAPI)."

During a concurrent interview with the DQRM and the Nursing Supervisor (NS), the NS stated, the CNA 1 continues to work for us. The CNA 1 personnel file was reviewed with the NS. The NS acknowledged there was no counseling memo or disciplinary action related to the alleged abuse in CNA 1 personnel file.

An interview was conducted with the Chief Nursing Officer (CNO) on March 1, 2016, at 11 am. The CNO stated she was not aware of this grievance and it happened prior to her start date. She stated she was never updated on this alleged abuse. She stated, the CNA 1 should have been suspended pending further investigation.

An interview was conducted with the Chief Human Resources Officer (CHRO) on March 2, 2016, at 3:30 p.m. CHRO stated he was unaware of this alleged abuse by CNA 1.

On March 2, 2016, the record for Patient 24 was reviewed. Patient 24 was admitted to the facility on September 29, 2015, with the diagnosis of shortness of breath.

There was no indication in the record of Patient 24's concerns/allegations.

There was no indication in the record of Social Services being notified of Patient 24's concerns or Patient 24 being evaluated by a Social Worker.

There was no indication the facility informed Adult Protective Services of the allegation

There was no indication in the record Patient 24's physician was notified of her concerns/allegations.

The facility's policy titled, "Abuse, Adult and Elder," approved by the Governing Board on November 2014, indicated, "The Risk Management and/or social Services Department will investigate thoroughly each alleged violation and report the result to the Hospital Administration...6. Investigation Procedure: ...b. Social Worker will call Adult Protective Services and report the case. Social worker/Unit manager or designee initiates an investigation immediately...Reporting procedure:...c. Notify the patient attending physician or his/her designee regarding the alleged incident and assessment of findings...Corrective Action:...2. If incident involves a staff member, corrective action is taken in coordination with the Human Resources Director and Risk Manager. 3. Notification is made to the appropriate licensing agency if the incident involves a licensed employee or to the State Nursing Assistant Registry, if the incident involves a nursing assistant...Result of Investigation: The results of all investigations must be reported to the appropriate state agencies and to the department of Health Services, Licensing and Certification within five (5) working days of the incident or as required by law."

There was no indication in the facility's policy and procedure that the accused individual would be removed from patient care, was to leave the facility premises and was to be placed on administrative leave pending the results of the facility's investigation of the allegation of abuse.

Based on interview and record review the facility failed to ensure employee files for two registered nurses (RN 10 and RN 11) contained documentation that the nurses underwent annual restraint training to include completed competency per facility policy. The facility policy indicated the patient had the right to safe implementation of restraints by trained staff and training must occur during "Annual reorientation." This failure placed patients at risk for the application of restraints by untrained staff members.

Findings:

During a tour of the intensive care unit (ICU), on February 29, 2016, at 11:50 a.m., RN 10 was interviewed. RN 10 stated she did not currently have any patients with restraints (physical device that immobilizes or reduces the patient's ability to move their arms or legs), but she does occasionally restrain patients who were on ventilators (mechanical breathing machine), to protect their airway.

On March 2, 2016, personnel files for RN 10, and RN 11 were reviewed and the following noted:

a. RN 10 was a full time ICU RN, with a hire date in June 2013. There was no evidence in RN 10's file that she had completed initial or annual restraint orientation. There was no evidence in RN 10's personnel file that restraint training and/or competencies were initiated during orientation or annually in 2014, and 2015.

b. RN 11 was a full time ICU RN, with a hire date in November 2013. RN 11's file contained a copy of documentation that indicated he had completed initial restraint orientation, but did not contain evidence of restraint training for 2014, and 2015.

During an interview with the Chief Human Resources Officer (CHRO), on March 2, at 4 p.m., the CHRO stated there was no documentation in RN 10's personnel file that restraint training and demonstration of competency were successfully completed. In addition, CHRO stated there was no documentation in either RN 10 or RN 11 had completed annual restraint training.

The facility's policy and procedure titled "Restraint and Seclusion," with a governing board approval date of November 2014, indicated the purpose of the policy was to provide guidelines when restraints could be applied to patients. The policy indicated the following:

"1... support the limited use of restraints through the promotion of preventive strategies and the use of safe and effective alternatives that prevents injury to the patients and others;

2...establish guidelines for the use of the least restrictive and most protective measures which limit the use of restraints to those situation with appropriate and adequate clinical justification; and

3...provide guidelines to ensure that the patient's rights, dignity and will-being are maintained should restraints be necessary."

The policy indicated the facility must train staff and assess their competency to safely implement the use of restraint or seclusion, at new hire orientation, on periodic basis, during annual reorientation, and before participating in the use of restraint or seclusion.

The policy indicated "There must be documentation of the staff training and competency in the employee file."

2. An interview was conducted with Case Manager (CM) 1, on February 29, 2016, at 2:30 p.m. CM 1 stated Patient 12's record failed to show a completed discharge plan, which she said was, "unusual," because on February 26, 2016, Patient 12's record was audited internally, and it was determined at that time the discharge plan was incomplete. According to CM 1, the assigned CM had been instructed to complete the discharge plan, and had not done so.

A review of the facility policy titled, "Discharge Planning (Effective Date: 11/2015)," was conducted. The policy indicated, "The hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning..."

An interview was conducted with the Manager of Quality Services (MQS) on March 3, 2016, at 10 a.m.

The MQS stated the facility did not assess readmissions to determine whether the readmissions were potentially due to problems in discharge planning, or with the implementation of the discharge process.

3. On March 12, 2016, at 10:05 a.m., the MQS was unable to state current performance improvement (PI) projects that were in process in an interdepartmental, integrated manner with the food and nutrition department. The MQS stated, "Not really, I have been working on other areas of the hospital."

A review of the PI data related to the food and nutrition department indicated the information had been reported by a previous food service director that had not been employed by the hospital for four months, per the Human Resource director.

The PI data was titled, "Performance Improvement Report 2015," and included the following;

a. Hair covered inside the department and while serving food;

b. Raw meats are stored separately from cooked food;

c. All food is covered and labeled with expiration date;

d. All food is discarded prior to expiration date;

e. Storage room temperature (50-70 F [degrees Fahrenheit]; and,

f. Storage room humidity (50-60%).

The data collection remained the same for the year of 2015, with the majority of the year reflecting 100% compliance for each month of 2015. There was no system to assist the food and nutrition department in identifying new quality indicators that would identify and improve new problems with sanitary conditions to prevent a negative impact on the health and safety of the patients.



32201

Based on interview and record review, the facility failed to:

1. Ensure grievances were analyzed for trends and opportunities for improvement when no grievance data had been reported to or reviewed by the Quality Assessment Performance Improvement (QAPI) Committee for the previous eight months;

2. Develop quality indicators and implement corrective action to ensure the discharge planning process met the needs of the patients, by failing to measure, analyze, and track readmissions to determine if they were potentially due to problems with discharge planning; and,

3. Develop new indicators for the food and nutrition department, related to sanitation and safe food handling, when 100% compliance had been attained for several months with the current data being collected.
These failed practices resulted in the potential for unsafe patient care practices, unsafe discharges, and unsafe sanitation and food handling practices to go unidentified and uncorrected.

Findings:

1. During an interview conducted with the Director of Quality/ Risk Manger (DQRM) on March 2, 2016, at 8:30 a.m., she stated, "I started in July 2015 and I have not followed up with the grievances. None of the grievances have been reported to Quality Assessment Performance Improvement (QAPI)."

The facility policy and procedure titled "Complaints & Grievance-Patients" revised October 2015, indicated, "The purpose of this policy is to :... 3. Provide a process to determine the effectiveness of the complaint and/or grievance process through performance Improvement monitoring to help identify, investigate and resolve any deeper, systemic problems indicated by the grievance analysis...The Governing Board has delegated the Grievance Process to the Risk Manager or designee. Procedure...10. Grievance shall be tracked for the purpose of trending, improving the processes, and ensuring customer satisfaction with follow-through...Procedure For Using The Patient And Family Complaint/Grievance Form...8. The complaint/grievance log shall be summarized and presented to the Quality Council. Medical Executive Committee and the Governing Board at least quarterly for review and recommendations."

Based on interview and record review, for eight out of ten members of the Medical Staff reviewed (MDs 1,2,3,5,6,7,8, and 10), there was no documented evidence of current ongoing professional practice evaluation (OPPE) being completed. This failed practice had the potential for the risk of substandard healthcare for patients receiving services from these physicians.

Ongoing Professional Practice Evaluations were documented summaries of ongoing data collection for the purpose of assessing a practitioner ' s clinical competence.

Findings:

On March 1, 2016, at 9:15 a.m., a review of the credentialing files for eight physicians did not contain evidence of ongoing professional practice evaluations.

The facility does not have a policy for Ongoing Professional Practice Evaluation. However, the Medical Staff Bylaws had a section on evaluation and corrective action for the physician.

The Medial Staff Bylaws, Article VI section 6.2- Ongoing Peer Review, was reviewed on March 2, 2016. The bylaws indicated " All members are subject to evaluation based on medical staff peer review criteria, adopted consistent with these bylaws. Evaluations results are used in privileging, system improvement, and warranted, corrective action. "

The criteria listed included, " review of operative and other clinical procedures performed and their outcomes, pattern of blood and pharmaceutical usage, requests for tests and procedures, and patterns of length of stay. "

During an interview with the Director of Medical Staff, on March 3, 2016, at 9:15 a.m., she stated OPPE had not been done due to the lack of resources.

Based on observation, interview and record review, the facility failed to ensure:

1. Physician orders and facility wound care policy were followed for two patients (Patient 1 and 2) ;

2. Methicillin Resistant Staph Aureus (MRSA) screening was conducted per facility policy when facility nursing staff failed to obtain cultures on two intensive care unit patients;

3. Medications were administered according to standards of practice and facility policy; and

4. Healthcare personnel were protecting patients from nosocomial (hospital acquired) influenza, by failing to wear masks according to policy and procedure and a county health care directive.

Findings:

1. The facility policy and procedure titled "Decubitus Ulcer (Pressure Ulcer), Assessment, Prevention, Treatment, Management," with a governing board approval date of November 2014, was reviewed. The policy indicated its purpose was to provide guidelines for assessment, staging, interventions and documentation of patients actual skin breakdown. The policy indicated "Timely application of preventive measures and prompt institution of a therapeutic regimen are essential of an interdisciplinary approach to prevention and care of decubitus ulcer."

The policy indicated a pressure ulcer/decubitus ulcer was a localized injury to the skin usually over a bony prominence. Procedures included:

-An initial head to toe assessment and identification of risk;

-Braden scale score of 15 or less was considered as "at risk for developing pressure ulcers;

-The licensed nurse should follow the Pre-printed Physician orders for wound decubitus/pressure ulcer treatment; and

-Treatments (dressing changes) were documented in the "Wound Treatment Record."

a. On February 29, 2016, at 11:50 a.m., a tour of the facility's Intensive Care Unit (ICU) was conducted. Patient 1 was observed in Bed 2. Patient 1 was lying on a regular hospital bed mattress. There was no evidence of additional pressure reduction devices on Patient 2's bed.

During a concurrent interview with ICU registered nurse (RN) 10, the nurse stated Patient 1 was transferred to the facility from a local skilled nursing facility due to an elevated white blood count (indicative of infection) and a urinary tract infection. RN 10 stated Patient 1 had a stage III (full thickness tissue loss) pressure ulcer on his coccyx (bottom). RN 10 confirmed Patient 1's bed did not have an additional pressure reduction device.

Patient 1's record was reviewed with RN 10, on February 29, 2016. Patient 1 was admitted to the facility on February 25, 2016, for treatment of sepsis (infection in the blood). Patient 1's record contained a form titled "Pre-Printed Physician Orders for Wound/Decubitus Treatment," dated February 25, 2016. The form indicated "Checked items were automatically implemented unless crossed out and initialed by the physician." Orders included:

Use waffle air mattress if Braden score 15 and below or with skin breakdown up to stage III;

Change dressing every 3 days and PRN (as needed).

During a concurrent interview with RN 10, the nurse stated she was not sure why the orders for the mattress were not implemented.

Further review of Patient 1's record revealed a "Wound Treatment Record," that contained documentation on February 25, 2016, but did not contain evidence of additional dressing changes since. During a concurrent interview with RN 10 on February 29, 2016, at 2:20 p.m., the nurse was unable to find documentation of dressing changes since the patient's initial dressing change on February 25, 2016, (four days prior). The nurse indicated she had not performed dressing change "yet," today.

b. On February 29, 2016, at 2:15 p.m., a tour of the facility's Intensive Care Unit (ICU) was conducted. Patient 2 was observed in Bed 6. Patient 2 was mechanically ventilated (mechanical assist for respiration) and had a tracheostomy (surgically made opening that provides opening for a tube placed into the trachea). Patient 2 was lying on a regular hospital bed mattress. There was no evidence of additional pressure reduction devices on Patient 2's bed.

During an interview with ICU RN 11, on February 29, 2016, at 2:20 p.m., RN 11 stated Patient 2 was a transfer from a long term acute care facility.

Patient 2's record was reviewed with RN 11, on February 29, 2016. Patient 2 was admitted to the facility on February 25, 2016, for treatment of severe anemia (low blood count) and abdominal pain. Patient 2's record contained a form titled "Pre-Printed Physician Orders for Wound/Decubitus Treatment," dated February 25, 2016. The form indicated "Checked items were automatically implemented unless crossed out and initialed by the physician." Orders included:

Use waffle air mattress if Braden score 15 and below or with skin breakdown up to stage III;

Change dressing every 3 days and PRN (as needed).

Patient 2 was identified as having a stage II (partial thickness skin loss) to the buttocks bilaterally and a Braden score less than 15.

During an interview with RN 11, on February 29, 2016, at 2:45 p.m., RN 11 stated Patient 2 was not on a speciality mattress. RN 11 stated the patient's Braden Scale score was "4," and a waffle mattress should be in place.

Further review of Patient 2's record revealed a "Wound Treatment Record," that contained documentation on February 25, 2016, but did not contain evidence of additional dressing changes since.

During a concurrent interview with RN 11, on February 29, 2016, at 3 p.m., the nurse was unable to find documentation of dressing changes since the patient's initial dressing change on February 25, 2016, (four days prior).

2. The facility policy and procedure titled "MRSA (Methicillin Resistant Staph aureus-a type of infection that is resistant to antibiotics) Active Surveillance," was reviewed. The policy indicated its purpose was:

-To identity, as soon as possible after admission/transfer, patients in designated high risk groups who may be colonized with MRSA;

-To isolate those patients whose surveillance were positive for MRSA or other Multi-drug resistant organisms; and

-To prevent healthcare associated transmission of MRSA from one patient to another.

The policy indicated Active Surveillance Cultures (ASC) for MRSA would be obtained for "High Risk," patients. High risk patients included patients admitted to or transferred to the intensive care unit (ICU), and patients transferred from a Nursing Home or other Healthcare Facility. The policy indicated cultures "should be done on admission or transfer or within 24 hours of admission or transfer of the designated high risk patient.

a. On February 29, 2016, at 11:50 a.m., a tour of the facility's Intensive Care Unit (ICU) was conducted. Patient 1 was observed in Bed 2.

During a concurrent interview with ICU registered nurse (RN) 1, the nurse stated Patient 1 was transferred to the facility from a local skilled nursing facility due to an elevated white blood count (indicative of infection) and a urinary tract infection.

Patient 1's record was reviewed with RN 10, on February 29, 2016. Patient 1 was admitted to the facility on February 25, 2016, for treatment of sepsis (infection in the blood). There was no evidence MRSA ASC was collected since his admission to the ICU. According to Patient 1's record, five days have past since his admission, and no MRSA ASC was obtained.

During a concurrent interview, RN 10 stated the Emergency Department nurse collected the ASC on all patients prior to their transfer to a room. RN 10 was unable to find evidence of MRSA screening for Patient 1, prior to February 29, 2016.

b. On February 29, 2016, at 2:15 p.m., a tour of the facility's Intensive Care Unit (ICU) was conducted. Patient 2 was observed in Bed 6. Patient 2 was mechanically ventilated (mechanical assist for respiration) and had a tracheostomy (surgically made opening that provides opening for a tube placed into the trachea).

During an interview with ICU RN 11, on February 29, 2016, at 2:20 p.m., RN 11 stated Patient 2 was a transfer from a long term acute care facility.

Patient 2's record was reviewed with RN 11, on February 29, 2016. Patient 2 was admitted to the facility on February 25, 2016, for treatment of severe anemia (low blood count) and abdominal pain. Patient 2's "History and Physical," indicated Patient 2 resides in a subacute unit (other Healthcare Facility). There was no evidence MRSA ASC was collected since Patient 2's admission to the ICU.

There was no evidence in Patient 2's record that MRSA ASC was collected since admission, five days ago.

During an interview with Infection Control Consultant (ICC) A, on March 1, 2016, at 11 a.m., ICC A stated there was a breakdown in communication, as facility staff believed a physician's order was required for MRSA screening.

The facility's policy titled "Provision of Patient Care," with a governing board approval date of November 2014, was reviewed. The policy indicated patient care was accomplished through organized and systematic processes designed to ensure delivery of safe, effective and timely care and treatment. The policy indicated "Each patient is assessed upon admission and reassessed throughout his/her hospital stay to identify the individual patient care needs."

3. During observations in the facility between February 29, and March 1, 2016, several employees were observed to be wearing masks improperly below the nose, staff in patient care areas.

On March 1, 2016, at 9:20 am, RN 11 and RN 3 were observed to be wearing masks below their noses in the patient care area on unit 2. RN 11 stated she had the mask on because she had not taken the influenza vaccine. She placed the mask in the proper position, covering the nose, during the interview.

During an concurrent interview, RN 3 stated that she was allergic to eggs and did not receive the influenza vaccination. During the interview she placed the mask in the proper position covering the nose.

In a letter dated October 1, 2015, to all licensed Acute Care Facilities in Los Angeles County, the Interim Health Officer for Los Angeles County, issued an order for all licensed facilities to require influenza vaccination for their Health Care Personnel (HCP). The letter indicated during the annual influenza season (October through March), employees who decline the vaccination, must wear a mask when they are in contact with patients, or in patient care areas.

4. According to the California Nursing Practice Act § 2725.1, "...Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon if the nurse is functioning within a licensed clinic..."

According to the California Code of Regulations, Title 22, Division 5, § 70263(g), "No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish..."

On February 29, 2016, at 11:50 a.m., Patient 1, was observed in the Intensive Care Unit (ICU). Patient 1 had an intravenous infusion of Levophed (Norepinephrine Bitartrate a concentrated, potent drug used to increase the blood pressure when it is dangerously low), infusing via an automated pump at 8 cc (milliliters) per hour.

During a concurrent interview, ICU RN 1 stated Patient 1 was currently receiving 4.25 micrograms (mics) of Levophed per hour. RN 10 stated she adjusted the medication based on the patient's systolic (top number) blood pressure (not the MAP as ordered). RN 10 stated if the patient's systolic blood pressure was greater than 100 mm/Hg (millimiters of mercury), the medication could be titrated down.

A review of Patient 1's orders included a physician's order dated February 26, 2016, at 6:30 p.m., that indicated: "Norepinephrine concentrate equal to 32 micrograms per milliter, start 8-12 mcg/min (micrograms per minute). Change rate 2-10 mcg/min every 10 minutes, titration parameter keep MAP (Mean Arterial Pressure) >65 as tolerated with HR (heart rate) < 125."

According to the order, the nurse could choose from a range of doses to start the infusion (8, 9, 10, 11, or 12 mcg/min). Then the nurse could choose how much to adjust the the rate up or down ( 2, 3, 4, 5, 6, 7, 8, 9, or 10 mcg/min) every 10 minutes.

On March 1, 2016, at 9 a.m., the facility's Director of Pharmacy (DP) was interviewed. The DP was unable to find a policy or protocol for the administration of Norepinephrine. The DP stated the order for Patient 1's Norepinephrine did include a range for the starting dose and for the titrating dose. The DP stated the order was standardized before her arrival. The DP was unaware the staff used systolic blood pressure to titrate Norepinephrine.

The facility policy titled "Medication Administration," with a governing board approval date of November 2014, was reviewed. The policy indicated its purpose was to provide a mechanism for safe medication administration and review and to provide guidelines for the safe and legal administration of patient medications. The policy indicated "administration of drugs shall be in accordance with all the laws of this state, federal laws, rules and regulations that govern such acts, and medical staff rules and regulations." According to the policy "ranges are not allowed."



25281

Based on observation, interview, and record review, the facility failed to ensure:

1. Medications were administered through a gastrostomy tube (G-tube - a tube inserted directly into the stomach/intestine to aid in feeding and medication administration) in accordance with the facility policy and accepted standards of practice for one sampled patient (Patient 500) with a G-tube when the nurse crushed medications that were not safe to crush, mixed liquid and solid medications together prior to administering, and did not flush the tube before and after administering medications, resulting in the potential for unsafe drug interactions, ineffective medications, and blockage of the G-tube;

2. Medications were administered according to the manufacturer's recommendations for one patient (Patient 500) when the nurse administered a medication to be given one half to one hour before meals within a half hour of the patient eating, resulting in the potential for the medication to be ineffective;

3. Prevention of infection due to cross contamination when the anesthesia staff routinely used single dose vials of narcotic medication for two patients, resulting in the potential for infections and diseases to spread between patients; and,

4. Intravenous medications (infusing directly into the vein) were administered in accordance with standards of practice, state laws, and regulations when when they failed to clarify an order that did not include a starting dose or specific instructions for titration (adjusting the infusion rate up and down) for one sampled patient (Patient 1), resulting in Registered Nurses (RNs) determining infusion rates, and the potential for medication errors leading to patient harm or death.

Findings:

1. During a medication pass observation on March 1, 2016, at 8:25 a.m., with RN 500, for Patient 500, the following was observed:

a. RN 500 opened the unit dose packaging of 11 different solid, oral medications, placed all of them together in a plastic pouch, and crushed them all together;

b. RN 500 crushed one delayed-release omeprazole (a medication for acid reflux) 20 milligram (mg) capsule and one extended-release memantine (a medication for Alzheimer's disease) 14 mg tablet, which should not have been crushed due to special formulations;

c. RN 500 mixed the crushed medications with other oral liquid medications, and administered them together;

d. RN 500 did not flush the G-tube with water before and after the administration of the medications; and,

e. RN 500 gathered medications from the medication cart and the Pyxis MedStation (an automated dispensing cabinet for medications) for two different patients, and placed them inside of plastic bags, one for each patient.

During an interview on March 1, 2016, at 10:15 a.m., RN 501, a Charge Nurse for the Medical/Surgical Unit, stated the medications should have been crushed and administered individually, and the G-tube flushed should have been flushed with water before, in between, and after the medication administration. RN 501 also stated medication pass should be done one patient at a time, and RN 500 should not have prepared medications for the next patient until the first patient's medications had been administered.

In a concurrent interview, the Director of Pharmacy (DP) agreed the medications should not have been pulled out of the medication carts for multiple patients at the same time.

The facility policy titled, "Administration Practice, General Medication," with an effective date of "06/06," was reviewed. The policy indicated, "Drugs shall be prepared and administered in accordance with the orders of the prescriber or practitioner responsible for the patient's care and accepted standards of practice..."

The hospital provided a document from the Institute for Safe Medication Practices (ISMP - a nationally recognized organization devoted entirely to medication error prevention and safe medication use) titled, "Oral Dosage Forms That should Not Be Crushed 2015." The document included memantine XR and omeprazole as medications not to be crushed.

The facility policy titled, "Medication Administration Through a Feeding Tube," with an effective date of, "01/15/11," was reviewed. The policy indicatedthe following:

"...Prepare each dose of medication. Do not mix incompatible medications;

Crush medications, if allowable (See list of Medications Which Should Not Be Crushed)...; and,

Flush the tube with approximately 50 (milliliters) ml of water using a catheter-tipped syringe. Allow medications to flow by gravity through the enteral tube...Flush tube with a minimum of 50 ml of water..."

According to the ISMP May 6, 2010, Medication Safety Alert, on the topic of "Preventing errors when administering drugs via an enteral feeding tube;"

Problem: Did you know administering drugs through a feeding tube can be prone to errors? Medication errors related to this route of administration happen more often than reported or recognized. These errors are often the result of administering medications that are incompatible with administration via a tube, preparing the medications improperly, and/or administering a drug using improper administration techniques, which can lead to an occluded feeding tube, reduced drug effect, or drug toxicity. These potential adverse outcomes can lead to patient harm or even death...

Establish drug and dosage form suitability. Practitioners should ensure that the drug and formulation are appropriate for enteral administration. Use only immediate-release solid dosage forms or liquid dosage forms. For solid dosage forms, refer to the up-to-date Do Not Crush list...to help determine suitability. Nurses should consult with the pharmacist if they have questions or to see if liquid dosage forms are available and appropriate. The pharmacist can also contact the prescriber to switch to a different product more suitable for enteral tube administration when necessary...

Prepare separately. Each medication should be prepared individually so it can be administered separately...

Flush. The feeding should be stopped and the tube flushed with at least 15 mL of purified water before and after administering each medication.

Administer separately. Each medication should be administered separately through the feeding tube using a clean 30 mL or larger oral (non-luer tip) syringe.

Flush again. The tube should be flushed again with at least 15 mL of purified water to ensure drug delivery and clear the tube..."

2. During a medication pass observation on March 1, 2016, at 8:25 a.m., with RN 500, for Patient 500, a dose of Synthroid (thyroid supplement) 75 micrograms (mcg) was administered and documented on the electronic Medication Administration Record (eMAR) in the hospital computer system.

Review of the patient's electronic Medical Record (eMR) showed there was a physician order on February 29, 2016, for Synthroid 75 mcg by mouth once a day.

Review of the detailed pharmacist-verified order for Synthroid showed the direction, take one 75 mcg tablet once a day before meals.

Review of the patient's eMAR showed the scheduled time for Synthroid was 7:30 in the morning.

Review of the patient eMR also showed documentation the patient consumed 75 percent of her breakfast at 8 a.m., on March 1, 2016.

During an interview, the DP acknowledged the dose of Synthroid should have given before the meal was given to the patient.

According to the Manufacturer's Package Insert for Synthroid,

"...Synthroid is administered as a single daily dose, preferably one-half to one-hour before breakfast. Synthroid should be taken at least 4 hours apart from drugs that are known to interfere with its absorption...

Consumption of certain foods may affect levothyroxine (generic name for Synthroid) absorption thereby necessitating adjustments in dosing. Soybean flour (infant formula), cotton seed meal, walnuts, and dietary fiber may bind and decrease the absorption of levothyroxine sodium from the GI tract..."

3. On February 29, 2016, at 12:20 p.m., the anesthesia Controlled Substance Administration Record (CSAR) forms were reviewed. The form dated November 11, 2015, indicated each midazolam (an injectable controlled substance used for sedation) 2 mg/2 ml vial was being used for two different patients.

Observation of the midazolam 2 mg/2 ml injectable vials revealed they were labeled as single dose vials, meaning they should be used for one patient only.

During a concurrent interview, the DP acknowledged the single dose vials of midazolam should not have been divided in half to make two doses for two patients.

The Association for Professionals in Infection Control and Epidemiology (APIC) is the leading professional association for infection preventionists (IPs) with more than 15,000 members with a mission to create a safer world through the prevention of infection.

According to the, "APIC Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, ...Discard single-dose vials after use. Never use them again for another patient..."

Based on observation, interview, and record review, the facility failed to ensure accounting procedures for controlled substances in the Surgical Department were performed in accordance with the facility policy when documentation of use, wastage, and reconciliation by the medical, nursing, and pharmacy staff was incomplete and inconstistent. This failed practice resulted in the potential for medication errors to go unrecognized and narcotic medications to be diverted away from patients who needed them, leading to the potential for patient harm or death.

Findings:

During an inspection of the Pharmacy on February 29, 2016, at 12:20 p.m., the Anesthesia Controlled Substance Administration Record (CSAR) forms were reviewed. The forms were located inside the Anesthesia Narcotic Boxes (ANBs), for the anesthesiologists to use during surgical procedures, and completed after the procedures were completed to account for the amount of controlled substances used and wasted. This reconciling process was to be completed before the ANBs were returned to the Pharmacy by the anesthesiologists and nurses in the Surgical Department. A second reconciling process was to be completed by a nurse and a pharmacist when the ANBs were returned to the Pharmacy.

The CSAR forms, some of which were undated, contained missing signatures from anesthesiologists and nurses for wastage of controlled substances, doses used, and inventory count. There was also lack of documentation by the pharmacists verifying remaining end quantities of controlled substances inside of the ANBs when they were returned to the Pharmacy.

In a concurrent interview, the DP stated the signatures were required on all CSAR forms and acknowledged the signatures of anesthesiologists, nurses, and pharmacists were missing on the forms.

Review of the facility policy titled, "Controlled Drugs: Anesthesia" with an effective date of, "10/12," indicated, "The use, wastage, or disposal of all C-II through C-V drugs in anesthesia shall be documented fully...A controlled substance administration record (CSAR) shall be supplied with each container. The record shall be completed at the end of each case...Signature and title of person who administered, the drug-OR-adjusted the stock. Signature and title of witness to destruction of wasted portion-OR-adjustment to stock..."

Based on observation, interview, and document review, the hospital failed to control and distribute to ensure patient safety in accordance with the policy and procedure consistent with the current standards of practice by failing to:

1. Conduct prospective pharmacist review of all new non-urgent medication orders from physicians prior to dispensing and administration of medications:
2. Control potentially unauthorized access to Pyxis MedStations (automated dispensing cabinets for medications) by terminated employees for approximately 2 months: and ,
3. Conduct IV (intravenous) sterility testing of compounded sterile preparations (CSPs) that included samples of all CSPs made in the Pharmacy IV Room in accordance with the policy and procedure quarterly.

Findings:

1. In an interview on February 29, 2016, at 11 a.m., the DOP stated there was a Pharmacy Night Locker (a locked area for storage of medications), which night nurse supervisors could access to obtain necessary medications for administration to patients after the Pharmacy was closed until it reopened the next morning.

The Pharmacy Night Locker was observed on March 1, 2016, at 2:30 p.m., and it was noted a small amount of each of the numerous urgent (conditions that cause suffering and serious harm) and non-urgent maintenance medications (blood pressure, cholesterol, prostate, etc.) was stocked.

Review of the hospital policy and procedure titled, "Night Locker, Acquisition of Medications by Nursing Personnel From the Pharmacy" with the effective date of "06/06" showed,

"...Night Locker: The pharmacy maintains a limited supply of commonly used drugs, located adjacent to the pharmacy, that may be utilized for distribution to patients during pharmacy closure hours based the order of a qualified physician...

Entrance into the pharmacy night locker by authorized nursing supervisors...shall be limited to those times when the procurement of medication is needed to meet the immediate needs of the patient...

Only those Nursing Supervisors who are authorized to enter the night locker may do so...The patient profile must be checked for allergies and other related information...Nursing Supervisor is to ensure that all medication removed from the pharmacy is signed out to the appropriate patient using the designated log...

The Pharmacist will audit the log for accuracy upon arrival...

Each physician's order will be reviewed by a pharmacist as soon as is feasible during the subsequent work period to ensure that appropriate medications were distributed..."

Review of the hospital policy and procedure titled, "Medication Orders, Review by Pharmacist" with the effective date of "02/06" showed,

"To proactively identify prescribing errors, potential drug/drug and drug/food interactions, and other patient risks through a pharmacist's review of medication orders prior to dispensing and administration of medications...A pharmacist's review of medication orders prior to dispensing is a recognized safety procedure in the medication management process...In the case of an urgent situation, where delaying administration of the medication could harm the patient as often occurs in the Emergency Room, Surgery, PACU (Post Anesthesia Care Unit), ICU (Intensive Care Unit), and Radiology...it cannot be assumed that every medication administered in these areas is urgent and therefor a pharmacist's review is not needed..."

On March 2, 2016, the "Night Locker Drug Removal Log" for February 2016, was reviewed and it showed removal of medications for new admissions and new physician orders that would not be considered urgent or emergent for which a pharmacist review would cause delay in treatment and prolonged suffering or harm.

In an interview on March 2, 2016, at 3 p.m., the DOP stated during pharmacy off-hours, a pharmacist would be on-call to respond only to questions about the medications and medications not available in the Night Locker.

The DOP also stated the "Night Locker Drug Removal Log" which contained information of accessed medications from the Night Locker by the nurse supervisors was reviewed the following morning and the pharmacist review of new medication orders by the physicians were not prospective, acknowledging the duty should be the responsibility of the pharmacist.

The American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacy organization, develops official professional policies, in the form of policy positions and guidance documents and according to "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals,"

"...Review of Medication Orders. All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in
which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order. There shall be a procedure for retrospective review of these orders..."

2. Review of the hospital policy and procedure titled, "Automated Dispensing Machine (Pyxis)" with the effective date of "4/09" showed,

"Deleting employees from the system: The Human Resources Department will provide the Pharmacy Manager with reports of nursing personnel terminations. The Pharmacy Manager will then terminate the employee's access to the CareFusion Pyxis System..."

Review of the report showing currently active employees having access to the Pyxis MedStations (automated dispensing cabinets for medications) included two direct care staff who were terminated on January 7, 2016 and January 4, 2016. These terminated employees could have entered into the Pyxis MedStations and had unauthorized access to medications including controlled substances.

In an interview on March 1, 2016 at 4 p.m., the DOP acknowledged the receipt of the report and stated she did not get to the task of terminating the employees from access to the Pyxis immediately upon receipt of the report.

3. Review of "Performance Improvement Report 2015" on February 29, 2016 showed the IV end product sterility testing, a process validation to ensure the compounded sterile IV preparations made by the Pharmacy is free off microbial contamination, for the fourth quarter was not done.

In an interview on February 29, 2016, at 3:35 p.m., the DOP acknowledged the sterility testing was not done during the fourth quarter of 2015 because no large volume parenterals (LVPs) with additives such as potassium (electrolyte supplement) prepared by the Pharmacy came back from the unit unused.

The DOP stated the LVFs were tested only if they came back from the nursing unit unused and the small volume IVPB (IV piggyback) bags were not tested for sterility.

Review of the hospital policy and procedure titled, "Intravenous Admixture Service: I.V. Solution Preparation" with the effective date of "4/2014" showed,

"The pharmacy department will follow USP (United States Pharmacopeia) 797 standards and requirements along with the California Code of Regulations for sterile product preparations...Process Validation...At least one large volume parenteral (LVPs) shall be tested at least quarterly, on a random basis, for microbial contamination..."

Based on observation and interview, the facility failed to ensure the CT (Computerized Tomography- a specialized diagnostic x-ray) room was available and safe for use, by failing to ensure roof leaks were fixed. This failed practice placed the facility at risk for the loss of the CT function and patients at risk for delayed diagnostic testing.

Findings:

During a tour of the radiology department on March 2, 2016, at 9:15 a.m., the CT scanner room was observed. A large room, the CT scanner was located in the middle of the room. The ceiling of the room had obvious water damage, peeling paint and water stains.

During a concurrent interview with the Director of Ancillary Services and Radiology Technician 1, they reported the roof was leaking and when it rained, plastic was applied to the ceiling and containers were used to catch the water.

During an interview with the Director of Plant Operations, on March 2, 2016, 10:45 a.m., the Director stated they were aware of the leaking roof, had received estimates for repair, but due to the cost the leak had not been fixed.

Based on observation, interview and record review, the hospital failed to maintain an organized food and dietetic services department as it had not ensured a full-time qualified food service director was available to operate the daily management of the food service department (Cross-Reference A-0620). In addition, the hospital had not ensured the therapeutic diet menus were in accordance with the physician's diet order (Cross- Reference A-0629).F

Findings:

1. On February 29, 2016, at 11:15 a.m., a hospital staff employee (HS 1) stated that he had administrative oversight over the food and nutrition department. HS 1 stated that a registered dietitian (RD 1) was responsible for the food service operation from the time the food was delivered to the hospital to the time the food was served to the patient.

On February 29, 2016, at 11:50 a.m., RD 1 was asked who had the delegated responsibility from governing body to ensure safe food handling and sanitation within the foodservice operation, and she stated, " The lead cook [name of Cook 1]. "

On February 29, 2016, at 12:23 p.m., RD 1 and HS 1 acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks rotate as being in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."

On February 29, 2016, at 2:40 p.m., leftover chicken that was to be used for the patients for dinner that evening for puree and mechanical soft diets remained in the reach-in refrigerator, after RD 1 verified earlier that day that proper cooling of the potentially hazardous food had not occurred. In the presence of the Chief Executive Officer (CEO), RD 1 was asked if the chicken was safe to serve to patients, and RD 1 stated, "Yes, I believe so based on what they [the cooks] said, it was cooked yesterday." At that time, it was requested for HS 1 to come in the kitchen as he was present for the earlier interviews from the cooks as listed above. RD 1 and HS 1 were asked if they could assure the chicken was safe to serve to patients, and HS 1 stated, "No." Concurrently, RD 1 stated, "We don't know it's safe." HS 1 discarded the chicken.

On March 1, 2016, at 8:30 a.m., RD 1 stated that the hospital had not developed a policy and procedure that would have guided dietary staff on how to cool down potentially hazardous food (PHF) that needed time/temperature control for food safety (TCS). RD 1 stated, "I started helping/assisting [name of Cook 1] as of January 2016. I'm still learning food service. Clinical nutrition is my area."

According to RD 1's current signed job description (signed on 10/26/11), "Position Description; Job Title: Clinical Dietitian ...Position Summary: The Clinical Dietitian is responsible and accountable, to provide and specialize in medical nutrition therapy to patients, clients and the community. To communicate among food production personnel, patient, and hospital staff to ensure accurate, appropriate cost effective, and high quality nutritional care is delivered in accordance with Food and Nutritional Department standards, policies and procedures ..., Ability; Ability to perform accurate nutritional assessments ..., completes nutrition initial assessment within the timeframe based on hospital policy. Ability to formulate an accurate assessment based on age-specific health care data ..., ability to interview patients to assess patient ' nutritional needs, ability to plan and monitor nutrition support activities, ability to establish and evaluate interventions that describe specifically what type of diet should be given for each problem identified, ability to maintain accountability and responsibility for the effective oversight and coordination of care for patients with the multidisciplinary team, ability to prioritize patient problems and establish appropriate nutritional care process, ability to evaluate and/or modifies the plan of care when there are changes in the status and/or condition of the patients, ability to recognize and interprets age-specific health data, ability to effectively give diet instructions based on age-specific ..." Further review of RD 1's job description under the category of "Knowledge" indicated that knowledge of food service operations related to sanitation and safe food handling was not listed.

The job description for the previous food service director that was full-time to the position approximately four months earlier, according to the Human Resources director, indicated, "Position Description; Job Title: Food Service Director, Position Summary: The Director of Food Services is responsible and accountable for the efficient operation and coordination of food services. He/she provides for the safe, satisfying and nutritionally adequate food for patients through the appropriation allocation of staff, space, equipment and supplies. Job duties include the oversight of food storage, processing and handling in a manner that minimizes the potential for infection or food intoxication for patients and/or employees ..."

On February 29, 2016, at 12:23 p.m., RD 1 and HS 1 acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks rotate as being in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."

A review of two of two cooks (Cook 1 and Cook 2) that were identified by RD 1 and HS 1 as had a "lead" cook role to operate the daily food service operation was reviewed. Cook 2 had a performance evaluation completed on 2/24/15 completed by the hospital's previous food service director (FSD). Cook 2 had received a score of "2" which was defined as "Usually met but occasionally fell below expectations" for the following areas; Demonstrates the ability to put perishable items within 15 minutes, Ensures food safety by taking food temperatures and log appropriately before tray line begins, Maintain work area and all equipment in a clean and sanitary condition, Follows procedure for damaged goods, Follows daily and weekly cleaning as assigned, Keeps work area organized, clean and uncluttered, Ensures food safety by monitoring and discarding outdated food items in a timely manner. Attached to Cook 1 ' s performance evaluation was a "Core Competency "check list that entailed " Tries to accommodate any requests based on preferences/dislikes or recommended by RD ..., Provides food portions based on modified diet.., accommodates cultural or religious preferences or special diet needs ... " The attached competency check list was marked as "me " in all areas, and had not addressed the "2" markings in which the employee received. Concurrently, the HR [human resources] director verified that the above documents were the hospital's current method for evaluating competency of the cook.

Cook 2's performance evaluation was completed on June 11, 2015, by the previous FSD. The evaluation indicated that Cook 2 was given a score of "2" in 22 out of 57 areas that were possible to mark, which consisted primarily of unsanitary and unsafe food handling concerns. Cook 2's attached "Core Competency" list, dated 6/5/15, had "Met" checked in all areas possible that were listed on the form.

The hospital failed to ensure there was a clearly delineated full-time director of the food and dietetic services who had been granted the authority and delegated responsibility by the hospital ' s governing body and medical staff for the operation of the dietary services. Lack of a competent full-time food service director to provide daily oversight over safe food handling and sanitation contributed to the system failures that posed an immediate threat to the health and safety of the highly susceptible patients by placing the patients at high risk of developing a food borne illness, and compromising their medical status.

2. On March 1, 2016, at 9:41 a.m., a registered dietitian (RD 1) reviewed Patient 9 s physician diet order, and stated, "He was prescribed a 2 gram sodium diet on 2/26/16." RD 1 was asked to demonstrate that the hospital's food service was providing Patient 9 a 2 gram sodium diet in accordance with the physician's diet order. RD 1 provided a copy of a menu that was labeled as 2 gram sodium diet.

On March 1, 2016, at 10:00 a.m., RD 1 was asked if a nutrient analysis was conducted on the 2 gram sodium diet non-select menus for breakfast, lunch and dinner to ensure 2 grams of sodium was not exceeded in a day. RD 1 stated another RD that no longer worked at the hospital had conducted nutrient analysis for the menu for the regular diet. RD 1 stated, " We have not conducted a nutrient analysis on the hospital's menus for the 2 gram sodium diet. RD 1 acknowledged that she was unable to verify whether the hospital's 2 gram sodium non-select menu was in accordance with the physician's diet order "because a nutrient analysis on the food items offered for that menu in a day has not been done."

Concurrently, RD 1 stated that the hospital has not conducted any nutrient analysis of the menus for any of the therapeutic diet orders. According to the hospital's current diet census list the following patient ' s had these physician prescribed diet orders; 2 gram sodium diet; 1,800 calorie carbohydrate controlled (diabetic diet) with 2 gram sodium restriction diet; 1,800 calorie carbohydrate controlled diet, low fat low cholesterol 1,800 calorie carbohydrate controlled diet; renal (diet for kidney disease) 1, 800 calorie carbohydrate controlled diet, and a renal diet.

RD 1 acknowledged that the hospital failed to conduct a nutrient analysis for the hospital's therapeutic menus to ensure the menus were in accordance with the physician's therapeutic diet order, as defined in the hospital's approved diet manual.

Based on observation, interview and record review the hospital failed to ensure;

1. There was a full-time food service director who would be responsible for daily management of dietary services to assure safe food handling and sanitation occurred within the food service operation;

2. Failed to ensure there was a sufficient emergency food supplies on the premise in order to implement the hospital's planned disaster menu to meet the nutritional needs of patients, staff and potential visitors;

3. The hospital failed to ensure dietary staff were knowledgeable on cooling down of potentially hazardous foods (PHF - food capable of supporting microbial growth) that required time/temperature monitoring for food safety, and to ensure a cook was competent on proper internal cooking temperature for poultry;

4. Failed to ensure an effective system in order for consistent effective sanitizing of food contact surfaces;

5. Failed to ensure dietary staff were trained on expected sanitary practices when preparing pureed foods;

6. Failed to ensure dietary staff consistently dated and labeled food in accordance with the hospital's policy and procedure, and/or manufacturer's guidelines;

7. Failed to ensure the kitchen was maintained in a sanitary manner; and

8. Failed to ensure the ice-machine located in the kitchen was handled in a sanitary manner, and was sanitized in accordance with the ice-machine's manufacturer's guidelines.

As a result, the above cited system failures placed the highly susceptible patien population at a potential immediate risk of developing a food borne illness and/or not having their nutritional needs met, in the event of a disaster.

("Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; preschool age children, or older adults; and (2) Obtaining FOOD at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center. FDA Food Code 2013)

On March 1, 2016, at 3:12 p.m., the hospital's Chief Executive Office (CEO) and Interim Chief Nursing Officer (ICNO) were notified Immediate Jeopardy was declared in response to the potential of foodborne illness, and due to inadequate provisions on how to meet the nutritional needs of patients, staff and potential visitors in the event of an external disaster that would require persons to shelter in place.

On March 3, 2016,at 4:00 p.m., the hospital was able to demonstrate adequate emergency food supplies had been replenished at the hospital, and the hospital hired a full-time qualified registered dietitian who had specialized in foodservice operations to provide the direct oversight over daily operations of the foodservice operation.

Findings:

1. On February 29, 2016, at 11:15 a.m., a hospital staff employee (HS 1) stated that he had administrative oversight over the food and nutrition department. HS 1 stated that a registered dietitian (RD 1) was responsible for the food service operation from the time the food was delivered to the hospital to the time the food was served to the patient.

On February 29, 2016, at 11:50 a.m., RD 1 was asked who had the delegated responsibility from governing body to ensure safe food handling and sanitation within the foodservice operation, and she stated, "The lead cook [name of Cook 1]."

On February 29, 2016, at 12:23 p.m., RD 1 and HS 1 acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks rotate as being in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."

On February 29, 2016, at 2:40 p.m., leftover chicken that was to be used for the patients for dinner that evening for puree and mechanical soft diets remained in the reach-in refrigerator, after RD 1 verified earlier that day that proper cooling of the potentially hazardous food had not occurred. In the presence of the Chief Executive Officer (CEO), RD 1 was asked if the chicken was safe to serve to patients, and RD 1 stated, "Yes, I believe so based on what they [the cooks] said, it was cooked yesterday." At that time, it was requested for HS 1 to come in the kitchen as he was present for the earlier interviews from the cooks as listed above. RD 1 and HS 1 were asked if they could assure the chicken was safe to serve to patients, and HS 1 stated, "No." Concurrently, RD 1 stated, "We don't know it's safe." HS 1 discarded the chicken.

On March 1, 2016,at 8:30 a.m., RD 1 stated that the hospital had not developed a policy and procedure that would have guided dietary staff on how to cool down potentially hazardous food (PHF) that needed time/temperature control for food safety (TCS). RD 1 stated, "I started helping/assisting [name of Cook 1] as of January 2016. I'm still learning food service. Clinical nutrition is my area."

According to RD 1's current signed job description (signed on 10/26/11), "Position Description; Job Title: Clinical Dietitian...Position Summary: The Clinical Dietitian is responsible and accountable, to provide and specialize in medical nutrition therapy to patients, clients and the community. To communicate among food production personnel, patient, and hospital staff to ensure accurate, appropriate cost effective, and high quality nutritional care is delivered in accordance with Food and Nutritional Department standards, policies and procedures..., Ability; Ability to perform accurate nutritional assessments..., completes nutrition initial assessment within the timeframe based on hospital policy. Ability to formulate an accurate assessment based on age-specific health care data..., ability to interview patients to assess patient' nutritional needs, ability to plan and monitor nutrition support activities, ability to establish and evaluate interventions that describe specifically what type of diet should be given for each problem identified, ability to maintain accountability and responsibility for the effective oversight and coordination of care for patients with the multidisciplinary team, ability to prioritize patient problems and establish appropriate nutritional care process, ability to evaluate and/or modifies the plan of care when there are changes in the status and/or condition of the patients, ability to recognize and interprets age-specific health data, ability to effectively give diet instructions based on age-specific..." Further review of RD 1's job description under the category of "Knowledge" indicated that knowledge of food service operations related to sanitation and safe food handling was not listed.

The job description for the previous food service director that was full-time to the position approximately four months earlier, according to the Human Resources director, indicated, "Position Description; Job Title: Food Service Director, Position Summary: The Director of Food Services is responsible and accountable for the efficient operation and coordination of food services. He/she provides for the safe, satisfying and nutritionally adequate food for patients through the appropriation allocation of staff, space, equipment and supplies. Job duties include the oversight of food storage, processing and handling in a manner that minimizes the potential for infection or food intoxication for patients and/or employees..."

On February 29, 2016, at 12:23 p.m., RD 1 and HS 1 acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks rotate as being in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."

A review of two of two cooks (Cook 1 and Cook 2) that were identified by RD 1 and HS 1 as had a "lead" cook role to operate the daily food service operation was reviewed. Cook 2 had a performance evaluation completed on 2/24/15 completed by the hospital's previous food service director (FSD). Cook 2 had received a score of "2" which was defined as "Usually met but occasionally fell below expectations" for the following areas; Demonstrates the ability to put perishable items within 15 minutes, Ensures food safety by taking food temperatures and log appropriately before tray line begins, Maintain work area and all equipment in a clean and sanitary condition, Follows procedure for damaged goods, Follows daily and weekly cleaning as assigned, Keeps work area organized, clean and uncluttered, Ensures food safety by monitoring and discarding outdated food items in a timely manner. Attached to Cook 1's performance evaluation was a "Core Competency" check list that entailed "Tries to accommodate any requests based on preferences/dislikes or recommended by RD..., Provides food portions based on modified diet.., accommodates cultural or religious preferences or special diet needs..." The attached competency check list was marked as "met" in all areas, and had not addressed the "2" markings in which the employee received. Concurrently, the HR [human resources] director verified that the above documents were the hospital's current method for evaluating competency of the cook.

Cook 2's performance evaluation was completed on 6/11/15 by the previous FSD. The evaluation indicated that Cook 2 was given a score of "2" in 22 out of 57 areas that were possible to mark, which consisted primarily of unsanitary and unsafe food handling concerns. Cook 2's attached "Core Competency" list, dated 6/5/15, had "Met" checked in all areas possible that were listed on the form.

The hospital failed to ensure there was a clearly delineated full-time director of the food and dietetic services who had been granted the authority and delegated responsibility by the hospital's governing body and medical staff for the operation of the dietary services. Lack of a competent full-time food service director to provide daily oversight over safe food handling and sanitation contributed to the system failures that posed an immediate threat to the health and safety of the highly susceptible patients by placing the patients at high risk of developing a food borne illness, and compromising their medical status.

2. On March 1, 2016, at 11:20 a.m., a registered dietitian (RD 1) provided a copy of the hospital's approved disaster menu to be implemented to feed patients in the event of a disaster in which there was no gas, electricity or city water available. RD 1 stated, "The seven day disaster menu was approved by the governing body but we do not have all the food to implement yet."


Concurrently, RD 1 and a hospital staff employee (HS 1) stated that the hospital had not planned to have enough energy from generators for any of the foodservice equipment, therefore, would not be able to implement the daily operations menu for patients. RD 1 and HS 1 verified that the hospital's disaster menu was planned to anticipate unavailability of gas, electricity or city water.

A review of the hospital's undated "Seven Day Disaster Menu" indicated the plan was to serve ham for lunch on day 2, and pulled chicken for lunch on day 3. RD 1 stated the ham and chicken was located in the freezer and it was anticipated that the ready to eat chicken and ready to eat ham would thaw (without a refrigerator running on power) and still remain within safe temperatures to consume on day 2 and day 3. RD 1 was asked how she knew that the food would remain out of the temperature danger zone without refrigeration in the event of loss of power, and she stated, "I don't have a guarantee. I don't know for sure." In the presence of RD 1, a cook (Cook 1) stated there was two five pounds chicken breasts in the freezer (the chicken was purchased as a fully cooked chicken breasts), and two cases of ready to eat ham, which totaled twenty pounds of ham.

RD 1 reviewed the quantity of disaster food supply that was located at the hospital and stated, "We don't have enough food here for three days." RD 1 was asked what the hospital's plan was in terms of how many people were anticipated to feed daily in order to maintain the hospitals expected par level of disaster food supply in order to implement the hospital's disaster menu, and RD 1 stated, "Let me review the policy."

Concurrently, the hospital's policy and procedure (with an effective date of 12/2015) titled Emergency Meal Plan indicated, "Purpose; To define Food and Nutrition Services policy on Emergency Meal Plan in utilizing available foods on hand at the time of a disaster. Policy; It is the policy of GRHMC [abbreviations for the name of the hospital] to institute alternate menus enabling continued operations during emergency/disaster. Procedure; 1. Utilize first all foods which would perish with out held under refrigeration and do not require cooking for service as applicable, 2. After perishable foods are depleted, food items from the freezer which can be served when defrosted such as cooked meats, cold cuts and frozen vegetables will be used. It is critical that temperature of these foods be checked to ensure that they are with in the safety zone. 3. Canned and dry food items will be used last. 4. Meals are to be served on disposable wares until the ability to wash and sanitize dishes is restored. 5. Memorandum of Agreement (MOA) from food purveyors/vendors is recommended that they shall make emergency deliveries if needed in a disaster situation." RD 1 stated, "The policy doesn't say how many people per day to plan for in terms of expected par levels of disaster food to have on hand at all times."

RD 1 was asked if the approved Seven Day Disaster Menu included adequate provisions on how to meet the needs for the patients who required a renal diet (diet for kidney disease) when Day 1 included crackers with lunch and dinner, potato chips, vegetable/tomato juice, day 2 included peanut butter, ham, tortilla chips, baked beans, canned potatoes, vegetable/tomato juice, beef chili, crackers... RD 1 reviewed the seven day disaster menu plan and stated, "There are not adequate provisions for therapeutic diets." According to a current diet order list there were two patients who required a renal diet.

RD 1 listed the following food items from the disaster food supply located in the kitchen; 4 boxes of apple juice, 4 boxes of cranberry juice, and 4 boxes of cranberry blend juice with each box containing 12 containers at 46 ounces each in one box, 4 boxes of chicken Gerber baby food (12 jars at 12.5 ounces each in each box), 6 boxes of jars of Gerber baby food of peas (with 8/2 packs in each box), six boxes of Gerber baby food of peaches (8/2 packs per box), two boxes of green beans (2 box 8/2 pks), one box of tuna (6 containers at 66.5 ounce each), two boxes of Oreo cookies (120 - 1.2 ounce per box), one box of honey maid crackers (150 crackers in one box), one box of saltine crackers (500 crackers in the box), one instant two pound dry milk powder, one box of low fat granola with raisin cereal boxes at 70 boxes per the case, two boxes of cornflakes at 70 individualized sized boxes per case, 5 boxes of fiber one bars (16 bars at 1.4 ounce each per box), 4 boxes of nature valley oats/honey at 144 individualized sized bars per box, 4 boxes of nutrigrain bars at 16 individual sized bars per box, and twenty pounds of ham and ten pounds of chicken that was ready to eat and stored in the freezer.

On March 1, 2016, at 11:45 a.m., RD 1 and HS 1 stated they identified that the hospital had not had an adequate supply of disaster food on the premises and notified the hospital's previous management company. RD 1 and HS 1 stated that a few options were presented to the hospital staff at that time, at least four months earlier, and they were told there were not enough financial resources to ensure an adequate supply of disaster foods would be maintained at the hospital, at all times.

The hospital failed to ensure adequate emergency food supplies were maintained on the premises in order to implement the hospital's planned "Seven Day Disaster Menu". This failure placed the patients at risk for not having their nutritional needs met in case of an immediate external disaster that may have required patients, staff and visitors to shelter in place.

3. On February 29, 2016, at 11:25 a.m., inside the kitchen in a reach-in refrigerator was a pan that contained cooked chicken. In the presence of hospital staff (HS 1), and the registered dietitian (RD 1), a Cook (Cook 1) stated, "The chicken will be used for patients with a puree and mechanical soft diet order for dinner tonight." Cook 1 acknowledged the chicken was not dated, and stated, "It was cooked yesterday." Cook 1 was asked if the chicken was on a cool down log, and stated, "I don't have a cool down log."

On February 29, 2016at 11:25 a.m., another Cook (Cook 2) observed the chicken in the reach-in refrigerator and was asked when the chicken was cooked. Cook 2 stated, "It was cooked this morning by [name of Cook 1]." Cook 2 was asked if the cooks utilized a cool down log, and Cook 2 stated, "No."

Concurrently, in a joint interview with Cook 1 and Cook 2 both cooks acknowledged that they were unable to state the day the chicken was cooked.

On February 29, 2016, at 11:32 a.m., the registered dietitian (RD 1) identified Cook 1 as the person the hospital had designated to be responsible for daily operations to ensure safe food handling and sanitation. Cook 1 verified that the chicken to be used for dinner that night for patients with a puree or mechanical soft chopped diet order had been cooked at the hospital on a previous day. Cook 1 was asked to explain the cooking and cooling process of chicken that was going to be served on another day, and/or would be stored as a leftover, and he stated, "I cook chicken until 160 or 165 degrees [Fahrenheit]. I cover, date and put it in the refrigerator." Cook 1 stated, "No, I don't check temperatures after that."

Concurrently, RD 1 was asked if Cook 2 stated the correct safe internal cooking temperature for chicken in order to confirm the chicken was cooked thoroughly, and she stated, "No. He should cook the temperature to 180 degrees F [Fahrenheit]."

On February 29, 2016, at 11:45 a.m., inside the walk-in freezer was an undated bag that was sealed with frozen meat. A dietary employee (DE 3) stated, "Those are leftover meatballs. Should've been dated. They were cooked here [in hospital kitchen] two days ago."

Consecutively, RD 1 acknowledged that the chicken and the meatballs were leftover potentially hazardous food, and stated, "I know they require a cooling process." RD 1 acknowledged that a proper cool down process had not occurred.

On February 29, 2016at 12:13 p.m., RD 1 stated, "If it were up to me, I wouldn't allow leftover foods to be used." RD 1 acknowledged that she was unable to verbalize proper cool down procedures in accordance with standards of practice for safe food handling.

On February 29, 2016, at 12:23 p.m., RD 1 and HS 1 acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks vary in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."

On February 29, 2016, at 2:40 p.m., the leftover chicken that was to be used for the patients for dinner that evening for puree and mechanical soft diets remained in the reach-in refrigerator, after RD 1 verified that proper cooling of the potentially hazardous food had not occurred. In the presence of the Chief Executive Officer (CEO), RD 1 was asked if the chicken was safe to serve to patients, and RD 1 stated, "Yes, I believe so based on what they [the cooks] said, it was cooked yesterday." At that time, it was requested for HS 1 to come in the kitchen as he was present for the earlier interviews from the cooks as listed above. RD 1 and HS 1 were asked if they could assure the chicken was safe to serve to patients, and HS 1 stated, "No." Concurrently, RD 1 stated, "We don't know it's safe." HS 1 discarded the chicken.

On March 1, 2016, at 8:30 a.m., RD 1 stated that the hospital had not developed a policy and procedure that would have guided dietary staff on how to cool down potentially hazardous food (PHF) that needed time/temperature control for food safety (TCS). RD 1 stated that the hospital had not developed a policy and procedure to be available to dietary staff on proper internal cooking temperatures for food, such as the chicken. According to the United States Department of Agriculture Food Safety Information the minimum internal temperature for poultry is 165 degrees F.

RD 1 stated, "I started helping/assisting [name of Cook 1] as of January of this year. I'm still learning food service. Clinical nutrition is my area."

According to standards of practice in the food service industry, safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, potentially hazardous foods (time/temperature control for safety foods) are subject to the growth of a variety of pathogenic microorganisms. The Food Code provision for cooling provides for cooling from 135°F to 41°F within 6 hours, with cooling from 135°F to 70°F in 2 hours.

4. On March 1, 2016, at 8:35 a.m., a dietary employee (DE 6) was asked how she sanitized her food contact surface at her food preparation area. DE 6 stated I used a spray bottle to clean the countertop. DE 6 walked to the janitorial closet that was located inside the kitchen and pointed to a spray bottle, and stated, "I used that one." A joint observation of the solution in the spray bottle was conducted with a hospital staff member (HS 1). HS 1 acknowledged the solution appeared light in color with a slight pinkish tint. DE 6 was asked how she knew the solution in the spray bottle was at an effective concentration to sanitize, and DE 6 stated, "Because of the label on the bottle." The bottle had a pre-printed manufacturer's label that indicated "Sanitech Butler".

Concurrently, a cook (Cook 1) who was identified by HS 1 as having had a lead role within the dietary department was shown the same spray bottle with the solution, and was asked how he knew the solution was at an effective concentration to sanitize. Cook 1 stated, "By the color of the solution and the label on the bottle." Cook 1 was asked if he was expected to test the solution with a chemistry strip to check the concentration of the sanitizer, and he stated, "No."

On March 1, 2016, at 8:50 a.m., the registered dietitian (RD 1) stated, "The chlorine strip is the only strip available to check the concentration of the chlorine for the dish machine. We do not have strips for the sanitizer used for food contact surfaces but it comes out pre-dispensed."

On March 1, 2016, at 8:55 a.m., in the presence of HS 1 and RD 1, DE 6 pointed to various spray bottles, located in the janitor's closet in the kitchen, that contained liquid solutions and acknowledged that there were dark pinkish red colored solution, a very light colored solution, and a bluish/purplish colored solution located in spray bottles that were labeled as "Sanitech Butler". DE 6 was asked to point to the spray bottles that were used to sanitize food contact surfaces. DE 6 took two spray bottles out of the closet and stated they were to sanitize food contact surfaces and verified they were readily available for further use.

On March 1, 2016, at 10:07 a.m., a representative from the Sanitech Butler company (RB) entered the kitchen with chemistry test strips to check the concentration of the sanitizer solution located in the spray bottles that DE 6 stated was used to sanitize the food contact surfaces.

Concurrently, in the presence of RD 1 and HS 1, RB immersed a chemistry test strip into the solution that was from one of the spray bottles, and compared the color change to a color coded graph on the vial of chemistry strips. The RB stated, "It's at 300 PPM [parts per million] and should be between 200 - 400 PPM's." The RB checked the solution from the other spray bottle which turned a bright blue color that had not resembled any of the color options on the color coded graph located on the vial of chemistry strips, and stated, "It's a chemical reaction to whatever is in there but it is not the sanitizing solution." RB added, "I know when [name of previous food service director; FSD] was here, they used to have the test strips to check the effectiveness of the concentration of the sanitizer." HS 1 confirmed that the previous FSD had not been employed at the hospital for four months.

Concurrently, RD 1 and HS 1 acknowledged that one of two spray bottles that dietary staff identified as a food contact surface sanitizer was not at an effective concentration to sanitize. RD 1 and HS 1 was unable to state the type of chemical that was located in the other bottle.

The hospital did not have a policy and procedure related to sanitizing of food contact surfaces available to guide dietary staff on expected procedures.

According to standards of practice in the food service industry, "A quaternary ammonium compound solution [the type of sanitizer the hospital chose to use] shall have a concentration...as indicated by the manufacturer's use directions..." (2013 FDA Food Code; 4-501.114(C). "A test kit or other device that accurately measures the concentration...of sanitizing solutions shall be provided." (FDA Food Code; 4-302.14)

5. On March 1, 2016, at 10:20 a.m., in the presence of a registered dietitian (RD 1) and a hospital staff employee (HS 1), a dietary employee (DE 5) used a food processor to puree green beans. After she pureed the green beans, DE 5 rinsed out the food processor under running water at a food preparation sink, and proceeded to place sirloin meat into the food processor to puree. After the sirloin meat had been pureed, DE 5 rinsed out the container with water and proceeded to puree the soup available for that day.

On March 1, 2016, at 10:30 a.m., RD 1 stated it was the hospital's expectations for dietary employees to wash and sanitize the food processor container between food items in order to avoid cross-contamination or cross-sensitivity in case a patient had a food allergy. In addition, RD 1 stated it was the hospital's expectations for a dietary employee to wash hands after completion of pureeing a food item and handling its food service equipment, such as utensils, prior to proceeding with the next food item to puree. RD 1 stated, "She should have washed her hands to prevent potential for cross-contamination."

On 3/2/16, at 1:30 p.m., RD 1 stated the hospital had not developed a policy and procedure in regard to preparing pureed food to guide staff on expected sanitary and safe food handling practices.

6. On February 29, 2016, at 11:40 a.m., inside a reach-in refrigerator, were individual sized cartons of mighty shakes and sun cup juices. The individualized boxes were dated with a date from a label gun. In the presence of the registered dietitian (RD 1), a dietary employee (DE 4) stated, "I label both the mighty shakes and the sun cup juices with a date 14 days out from the time I put them in this refrigerator." DE 4 stated, "We have 14 days to use them once thawed."

Concurrently, DE 4 read the manufacturer's directions located on the individual sized cartons of the sun cup juice which indicated the juices, once thawed the juices had a ten day shelf life under refrigeration. DE 4 acknowledged that she had not known to date them to be used within ten days, once thawed.

On February 29, 2016, at 11:45 a.m., inside the walk-in freezer was an undated bag that was sealed with frozen meat. A dietary employee (DE 3) stated, "Those are leftover meatballs. Should've been dated. They were cooked here [in hospital kitchen] two days ago."

On February 29, 2016, at 11:55 a.m., inside the walk-in refrigerator were multiple cases of the sun cup juices that were undated. A dietary employee (DE 3) stated, "They are not dated. They were pulled last Wednesday from the freezer. We don't date them when we move them in here. There about 12 cases of the sun cup juices here."

Concurrently, a cook (Cook 1) observed the undated cases of sun cup juices in the walk-in refrigerator, in the presence of hospital staff 1 (HS 1), and stated, "We date them when we put them out there [out in the kitchen food preparation area where there was a reach-in refrigerator]."

HS 1 acknowledged that the hospital had not developed an effective dating system to ensure the sun cup juices shelf life would be adhered to in accordance with the manufacturer's guidelines.

The hospital's policy and procedure titled Covering, Labeling and Dating of Prepared and Leftover Foods (Reviewed 11/15) indicated, "Purpose; To define policy on proper covering, labeling and dating of prepared and leftover food items. Policy; To insure patients and others safety all prepared and leftover foods that will be refrigerated and used for future use shall be properly covered, labeled and dated. ..Procedure; Frozen Items; ...2. Unused frozen leftovers shall be discarded within 60 days. 3. Frozen juices and health shakes shall be labeled when it was taken out from the freezer. If not used, they shall be discarded within 14 days from the date it was taken out from the freezer to the refrigerator."

On March 1, 2016,at 8:30 a.m., RD 1 stated, "The policy needs to be updated to reflect the correct manufacturer's guidelines for the Sun Cup juices."

7. On February 29, 2016at 12:13 p.m., during a joint observation with a registered dietitian (RD 1) and a hospital staff (HS 1) a meat slicer was observed on top of a silver colored tray. The tray had an extensive quantity of dried food debris. Cook 1 stated, "The meat slicer has not been used today."

RD 1 and HS 1 acknowledged the food preparation area had not been maintained in a sanitary manner.

Concurrently, Cook 1 was asked if the dietary department had a cleaning schedule, and Cook 1 stated "No, we clean as we go."

On March 1, 2016,at 10:17 a.m., multiple trays, pots and pans were observed on a shelf and were readily available for use. The foodservice equipment had extensive build- up of thick black substances. RD 1 and HS 1 acknowledged the food service equipment was not maintained in a sanitary manner.

On March 1, 2016,at 10:20 a.m., a joint observation with RD 1 and HS 1 was conducted. At that time, a dietary employee (DE 5) was using a food processor to prepare pureed consistency green beans and to puree beef sirloin tips for patient's lunch that day. Directly behind the same food contact surface used to prepare the puree food was missing parts of the countertop that exposed yellowish and brownish colored material. RD 1 and HS 1 acknowledged the food preparation area was not maintained in good repair and impeded the ability to effectively clean and sanitize the area.

During the same joint observation of the kitchen, RD 1 and HS 1 acknowledged the kitchen floors and base boards were not maintained in good condition and/or in a sanitary manner. RD 1 and HS 1 observed unidentifiable small round black debris underneath the two-compartment sink.

Concurrently, three dead insects which were identified as cockroaches by HS 1, and RD 1, were located underneath the dish machine.

Concurrently, RD 1 stated that she had recently developed a cleaning schedule and provided an in-service to dietary staff on the cleaning schedule on 1/25/16. The in-service education included the following, "...As a Food and Nutrition Services employee, you and the areas you work in must always be clean. Cleanliness is the best way to keep harmful bacteria from growing or spreading..., Insects, such as flies and roaches, carry bacteria in their mouth parts, intestinal tracts, and on their feet and legs...., In order to spread, bacteria must have a carrier... We must remember that hospital patients are ill and in a weakened condition and, therefore,

Based on observation, interview and record review, the hospital failed to maintain an effective system to ensure dietary staff were competent in their respective duties. (Cross Reference A-0620) As a result, unsafe food handling and unsanitary practices had the potential to result in patients developing a food borne illness.
Findings:
On February 29, 2016, at 11:50 a.m., a registered dietitian (RD 1) was asked who had the delegated responsibility from governing body to ensure safe food handling and sanitation within the foodservice operation, and she stated, "The lead cook [name of Cook 1]."
On February 29, 2016, at 12:23 p.m., RD 1 and a hospital staff employee (HS 1) acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks rotate as being in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."
On February 29, 2016, at 11:25 a.m., inside the kitchen in a reach-in refrigerator was a pan that contained cooked chicken. In the presence of hospital staff (HS 1), and the registered dietitian (RD 1), a Cook (Cook 1) stated, "The chicken will be used for patients with a puree and mechanical soft diet order for dinner tonight." Cook 1 acknowledged the chicken was not dated, and stated, "It was cooked yesterday." Cook 1 was asked if the chicken was on a cool down log, and stated, " don't have a cool down log."
On February 29, 2016, at 11:25 a.m., another Cook (Cook 2) observed the chicken in the reach-in refrigerator and was asked when the chicken was cooked. Cook 2 stated, "It was cooked this morning by [name of Cook 1]." Cook 2 was asked if the cooks utilized a cool down log, and Cook 2 stated, "No."
Concurrently, in a joint interview with Cook 1 and Cook 2 both cooks acknowledged that they were unable to state the day the chicken was cooked.
On February 29, 2016, at 11:32 a.m., the registered dietitian (RD 1) identified Cook 1 as the person the hospital had designated to be responsible for daily operations to ensure safe food handling and sanitation. Cook 1 verified that the chicken to be used for dinner that night for patients with a puree or mechanical soft chopped diet order had been cooked at the hospital on a previous day. Cook 1 was asked to explain the cooking and cooling process of chicken that was going to be served on another day, and/or would be stored as a leftover, and he stated, "I cook chicken until 160 or 165 degrees [Fahrenheit]. I cover, date and put it in the refrigerator." Cook 1 stated, "No, I don't check temperatures after that."
Concurrently, RD 1 was asked if Cook 2 stated the correct safe internal cooking temperature for chicken in order to confirm the chicken was cooked thoroughly, and she stated, "No. He should cook the temperature to 180 degrees F [Fahrenheit]."
On February 29, 2016, at 11:45 a.m., inside the walk-in freezer was an undated bag that was sealed with frozen meat. A dietary employee (DE 3) stated, "Those are leftover meatballs. Should've been dated. They were cooked here [in hospital kitchen] two days ago."
Consecutively, RD 1 acknowledged that the chicken and the meatballs were leftover potentially hazardous food, and stated, "I know they require a cooling process." RD 1 acknowledged that a proper cool down process had not occurred. RD 1 acknowledged the cooks were unable to state what cool down of leftover food was and that the hospital had not had a leftover cool down log in order to monitor for assurance the leftover chicken, or leftover meatballs was cooled down safely in accordance with safe food handling practices.
On February 29, 2016, at 12:13 p.m., RD 1 stated ,"If it were up to me, I wouldn't allow leftover foods to be used." RD 1 acknowledged that she was unable to verbalize proper cool down procedures in accordance with standards of practice for safe food handling.
On February 29, 2016, at 12:23 p.m., RD 1 and HS 1 acknowledged that the hospital had not had a full-time qualified food service director for "about four months." RD 1 stated, "The cooks vary in a lead cook role and they are responsible for the foodservice operation. I have some extra responsibility in terms of oversight over sanitation in a limited capacity."
On February 29, 2016, at 2:40 p.m., the leftover chicken that was to be used for the patients for dinner that evening for puree and mechanical soft diets remained in the reach-in refrigerator, after RD 1 verified that proper cooling of the potentially hazardous food had not occurred. In the presence of the Chief Executive Officer (CEO), RD 1 was asked if the chicken was safe to serve to patients, and RD 1 stated, "Yes, I believe so based on what they [the cooks] said, it was cooked yesterday." At that time, it was requested for HS 1 to come in the kitchen as he was present for the earlier interviews from the cooks as listed above. RD 1 and HS 1 were asked if they could assure the chicken was safe to serve to patients, and HS 1 stated "No." Concurrently, RD 1 stated, "We don't know it's safe." HS 1 discarded the chicken.
On March 1, 2016, at 8:30 a.m., RD 1 stated that the hospital had not developed a policy and procedure that would have guided dietary staff on how to cool down potentially hazardous food (PHF) that needed time/temperature control for food safety (TCS). RD 1 stated, " I started helping/assisting [name of Cook 1] as of January 2016. I'm still learning food service. Clinical nutrition is my area."
A review of two of two cooks (Cook 1 and Cook 2) that were identified by RD 1 and HS 1 as had a "lead" cook role to operate the daily food service operation was reviewed. Cook 2 had a performance evaluation completed on 2/24/15 completed by the hospital's previous food service director (FSD). Cook 2 had received a score of "2" which was defined as "Usually met but occasionally fell below expectations" for the following areas; Demonstrates the ability to put perishable items within 15 minutes, Ensures food safety by taking food temperatures and log appropriately before tray line begins, Maintain work area and all equipment in a clean and sanitary condition, Follows procedure for damaged goods, Follows daily and weekly cleaning as assigned, Keeps work area organized, clean and uncluttered, Ensures food safety by monitoring and discarding outdated food items in a timely manner. Attached to Cook 1's performance evaluation was a "Core Competency" check list that entailed "Tries to accommodate any requests based on preferences/dislikes or recommended by RD ..., Provides food portions based on modified diet.., accommodates cultural or religious preferences or special diet needs ..." The attached competency check list was marked as "met" in all areas, and had not addressed the "2" markings in which the employee received. Concurrently, the HR [human resources] director verified that the above documents were the hospital's current method for evaluating competency of the cook.
Cook 2's performance evaluation was completed on 6/11/15 by the previous FSD. The evaluation indicated that Cook 2 was given a score of "2" in 22 out of 57 areas that were possible to mark, which consisted primarily of unsanitary and unsafe food handling concerns. Cook 2's attached "Core Competency" list, dated 6/5/15, had "Met" checked in all areas possible that were listed on the form.

On March 3, 2016, at p.m., the hospital hired a new Food Service Director (NFSD) in response to an immediate plan of correction due to an immediate jeopardy situation (cross-reference A-0620 and A-0020). The NSFD reviewed the hospital's process for performance evaluation and core competency check list for the cooks, and stated, "That is not an adequate competency checklist to evaluate competency for the cooks' duties."
The hospital's undated job description for Lead Cook included, "...Responsible for the preparation, cooking and serving hot foods for patients, ...adheres to department and hospital standards for Infection Control and Sanitation, Is knowledgeable of the cleaning schedules duties assigned..., Ensures the safety of patients, customers, and physicians by serving food in the proper food temperatures ..."

On March 3, 2016, at 8:30 a.m., RD 1 stated that the hospital had not developed a policy and procedure that would have guided dietary staff on how to cool down potentially hazardous food (PHF) that needed time/temperature control for food safety (TCS). RD 1 stated that the hospital had not developed a policy and procedure to be available to dietary staff on proper internal cooking temperatures for food, such as the chicken. According to the United States Department of Agriculture Food Safety Information the minimum internal temperature for poultry is 165 degrees F.

RD 1 stated, "I started helping/assisting [name of Cook 1] as of January of this year. I'm still learning food service. Clinical nutrition is my area."

The hospital lacked an adequate competency check list system to evaluate competencies as to assigned duties when the clinical RD was given "extra responsibilities" to assist the lead cooks within the foodservice operation. A review of RD 1's signed job description (signed on 10/26/11), included the following "Position Description; Job Title: Clinical Dietitian ...Position Summary: The Clinical Dietitian is responsible and accountable, to provide and specialize in medical nutrition therapy to patients, clients and the community. To communicate among food production personnel, patient, and hospital staff to ensure accurate, appropriate cost effective, and high quality nutritional care is delivered in accordance with Food and Nutritional Department standards, policies and procedures ..., Ability; Ability to perform accurate nutritional assessments ..., completes nutrition initial assessment within the timeframe based on hospital policy. Ability to formulate an accurate assessment based on age-specific health care data ..., ability to interview patients to assess patient ' nutritional needs, ability to plan and monitor nutrition support activities, ability to establish and evaluate interventions that describe specifically what type of diet should be given for each problem identified, ability to maintain accountability and responsibility for the effective oversight and coordination of care for patients with the multidisciplinary team, ability to prioritize patient problems and establish appropriate nutritional care process, ability to evaluate and/or modifies the plan of care when there are changes in the status and/or condition of the patients, ability to recognize and interprets age-specific health data, ability to effectively give diet instructions based on age-specific ..." Further review of RD 1's job description under the category of "Knowledge" indicated that knowledge of food service operations related to sanitation and safe food handling was not listed.

Based on interview and record review, the hospital failed to ensure the menus for therapeutic diets were nutritionally analyzed, in accordance with recognized dietary practices, and to ensure therapeutic diet orders were met in order to meet the nutritional needs of the patients.

As a result, failure to conduct nutritional analysis of therapeutic diet menus had the potential to provide inadequate nutrition, and may not have been within the therapeutic diet order as determined necessary by the physician which could negatively impact a patient ' s medical status.

Findings:

On March 1, 2016, at 9:41 a.m., a registered dietitian (RD 1) reviewed Patient 9 ' s physician diet order, and stated, " He was prescribed a 2 gram sodium diet on 2/26/16. " RD 1 was asked to demonstrate the hospital ' s food service was providing Patient 9 a 2 gram sodium diet in accordance with the physician ' s diet order. RD 1 provided a copy of a menu that was labeled as 2 gram sodium diet.

On March 1, 2016, at 10 a.m., RD 1 was asked if a nutrient analysis was conducted on the 2 gram sodium diet, non-select menus for breakfast, lunch and dinner, to ensure 2 grams of sodium was not exceeded in a day. RD 1 stated another RD that no longer worked at the hospital had conducted nutrient analysis for the menu for the regular diet. RD 1 stated, " We have not conducted a nutrient analysis on the hospital ' s menus for the 2 gram sodium diet." RD 1 acknowledged that she was unable to verify whether the hospital ' s 2 gram sodium non-select menu was in accordance with the physician ' s diet order, " because a nutrient analysis on the food items offered for that menu in a day has not been done. "

Concurrently, RD 1 stated the hospital had not conducted any nutrient analysis of the menus for any of the therapeutic diet orders. According to the hospital ' s current diet census list the following patient ' s had these physician prescribed therapeutic diet orders:

-2 gram sodium diet;
-1,800 calorie carbohydrate controlled (diabetic diet) with 2 gram sodium restriction diet;
-1,800 calorie carbohydrate controlled diet, low fat low cholesterol;
-1,800 calorie carbohydrate controlled diet;
-renal (diet for kidney disease) 1,800 calorie carbohydrate controlled diet; and
-a renal diet.

RD 1 acknowledged the hospital failed to conduct a nutrient analysis for the hospital ' s therapeutic menus, to ensure the menus were in accordance with the physician ' s therapeutic diet order, as defined in the hospital ' s approved diet manual.

Based on observation, interview, and document review this standard was not met when:

Qualifications for the Infection Control Officer were not documented in facility job descriptions or in employee files; and

The facility did not designate, in writing, who was the infection control officer and was responsible for the infection control program.

Findings:

During an interview, with the Chief Excesutive Officer (CEO), on February 29, 2016, at 11 a.m., Infection Control Consultant (ICC) A and ICC B were identified as the infection control officers for the facility.

On March 1, 2016, at 3:30 pm, employee records and the contract for ICC A and ICC B were reviewed with the Quality Assurance (QA) Manager. When asked for a copy of a job description for ICC A or ICC B, QA stated that there were no job descriptions. In the employee file of ICCB, no documentation of licensure, education or experience was included to determine if ICCB was qualified for the job of infection control officer. This finding was verified with QA.

During an interview with the CEO on February 29, 2016, at 11 a.m., ICC A and ICC B were identified as the infection control officers for the facility.

On March 1, 2016, at 4:50 p.m., the document titled "Authority of the Infection Control Committee," found in the facility's Infection Control Manual, did not identify who was designated as the infection control coordinator and had no dates or signatures on two lines that were pre-printed for Administrator-CEO and Chief of Staff signatures.

Based on observation, interview, and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices, and guidelines and regulations, when:

1. Peel packs were not properly utilized for the sterilization of instruments;

2. Instruments were not properly positioned in trays in preparation for sterilization;

3. Terminal cleaning of decontamination and sterile processing areas was not performed daily;

4. Flooring in decontamination, sterile processing and Intensive Care Unit (ICU)was unable to be disinfected;

5. Hand hygiene was not performed after removal of gloves;

6. Proper surgical attire was not worn in the operating room;

7. Disinfection of operating room was not performed properly and disinfectants not being used according to manufacturer's instructions;

8. Secondary containers of cleaning products were not labeled;

9. Employees did not follow local health officer's order to wear masks after declination of influenza vaccine;

10. Healthcare workers were not vaccinated according to policy or nationally recommended guidelines;

11. TB screening of healthcare personnel was not performed;

12. Fit testing and fit testing competency were not performed;

13. Active surveillance for Methicillin Resistant Staph Aureus (MRSA) was not performed according to policy;

14. Testing of Cidex solution used for high level disinfection was not performing according to Association of periOperative Registered Nurses (AORN) recommendations; and

15. Oversight in regard to the hospital's cleaning and sanitizing procedures for three of three ice- machine's located in the hospital was not performed. As a result, ice-machine's that were not maintained in a sanitary manner, posed a risk to the health and safety of the patients.

These failures placed patients at an increased risk for developing a hospital acquired infection (HAI).

Findings:

1. On February 29, 2016, at 11:30 a.m., during a tour of the sterile processing area, several peel packs (see-through paper packages that contain sterilized surgical instruments) were observed to be placed on top of one another, compressing the packaging, within containers on the storage cart.

One peel pack examined, contained two Cobb Elevators (large surgical instrument that were approximately 8 inches long, and weighed approximately 5 ounces each), in a large peel pack. This was confirmed by Operating Room Technician (ORT) 2.

ORT 2 stated he sterilized surgical instruments (like the Cobb Elevators) and was not aware that large heavy instruments should be excluded from the peel pack packaging process.

During an interview with the Infection Control Consultant (ICC A), on February 29, 2016, at 11:30 a.m., the ICC stated the facility has adopted the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice as one of the facility's nationally recognized infection control standards.

According to AORN Guidelines for Perioperative Practice (2016), Selection and Use of Packaging Systems for Sterilization, Section VII.a:

"Peel pouches should be used only for small, lightweight, low-profile items (e.g., one or two claamps, scissors). Heavy devices ....should not be packaged in peel pouches."

2. On February 29, 2016, at 11:30 a.m., an arthroscopy tray (instruments used for knee surgery) was observed. The instruments were lying on a rolled towel to position them for sterilization. Five of the hinged instruments were not in the open position. ORT 2 stated that there were stringers (devices used to string instruments with handles to keep them open in surgical packs) in the department that could be used to hold the instruments apart and open during sterilization.

On March 1, 2016 at 8:45 a.m., in the sterile storage room within surgery, a sterilized arthroscopy tray was opened and examined. Instruments were lying on a rolled towel. Four of the instruments were not fully open.

During an interview with the Infection Control Consultant (ICC A), on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice as one of the facility's nationally recognized infection control standards.

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Selection and Use of Packaging Systems for Sterilization, Section V.:

"Items to be sterilized should be placed in the package or tray in an open or unlocked position. The open or unlocked position facilitates sterilant contact of all surfaces of the item. Racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position."

3. On February 29, 2016, at 12:20 p.m., in the Decontamination Room, the instrument washer was observed to be leaking a steady drip of water into an open drain on the floor. On the floor, in the vicinity of the drain, was a wet cloth covering a dead cricket. The floor was visibly soiled. The Chief Executive Officer (CEO) confirmed the situation and upon request provided a checklist for the daily terminal cleaning (thorough cleaning of all surfaces including the floor at the end of the day) of the perioperative areas performed by the housekeeping department. The decontamination room was not identified as an area on the checklist.

During an interview with the Infection Control Consultant (ICC A), on February 29, 2016, at 11:30 a.m., he stated the facility had adopted the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice as one of the facility's nationally recognized infection control standards.

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Environmental Cleaning, IV.e.:
"Sterile processing areas should be terminally cleaned. Terminal cleaning (physical cleaning followed by disinfection with an approved hospital disinfectant) and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used ...sterile processing areas where deconta.m. ination occurs have some of the highest risks for environmental contamination of all perioperative areas."

4. On February 29, 2016, at 11:30 a.m., during a tour of the Sterile Processing room, the flooring around the autoclave (sterilizing machine) was broken with the surface beneath the flooring exposed. This was validated by Operating Room Technician (ORT) 2 and the Chief Executive Officer (CEO).

On February 29, 2016, at 12:20 p.m., in the Decontamination Room, the flooring was cracked and broken around exposed plumbing. This was validated by ORT 2 and the CEO.

On February 29, 2016, at 3:25 p.m., in the intensive care unit, the flooring outside rooms 4 and 5 was observed to have 2 circular holes exposing the surface beneath.

During an interview with the Infection Control Consultant (ICC A), on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Association of periOperative Registered Nurses Guidelines for Perioperative Practice as one of the facility's nationally recognized infection control standards.

According to AORN Guidelines for Perioperative Practice (2016), Guideline for a Safe Environment of Care, Part 2, Recommendation V:

"The integrity of structural surfaces (e.g., doors, floors, walls, ceilings, cabinets) should be maintained, and surfaces should be repaired when damaged ...Damaged surfaces can lead to an inability to clean. Damaged structural surfaces may create a reservoir for the collection of dirt and debris that cannot be removed during cleaning."

5. On March 1, 2016, at 9:30 a.m., a surgical procedure was observed in operating room (OR) 3. Observation continued until 10:36 a.m. During the procedure, registered nurse (RN) 5 was observed appling and removing non-sterile gloves, five times without performing hand hygiene (hand washing with soap and water or using an alcohol based hand rub).

During this OR observation, on March 1, 2016, the following was noted:

Physician (MD) 1 removed his contaminated surgical gloves without performing hand hygiene;

MD 2 removed his non-sterile gloves without performing hand hygiene; and

Operating Room Technician (ORT) 3 removed contaminated surgical gloves without performing hand hygiene.

During an interview with Infection Control Consultant (ICC) A, on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Centers for Disease Prevention and Control (CDC) as one of the facility's nationally recognized infection control standards.

According to the CDC Guideline for Hand Hygiene in Health-Care Settings (2002), hand hygiene was to be performed after glove removal.

6. On March 1, 2016, at 9:30 a.m., a surgical procedure was observed in operating room (OR) 3. Observation continued until 10:36 a.m. . During the procedure Physician (MD) 1, MD 2 and Operating Room Technician (ORT) 3 were observed wearing surgical caps (head coverings). MD 1, MD 2 and ORT 3 all had visible, exposed hair at the nape of their necks.

During an interview with Infection Control Consultant (ICC) A, on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Association of periOperative Registered Nurses Guidelines (AORN) for Perioperative Practice as one of the facility's nationally recognized infection control standards.

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Surgical Attire, Recommendation III:

"Personnel entering the ...restricted areas (surgery) should cover the head, hair, ears, and facial hair. Hair and skin can harbor bacteria that can be dispersed into the environment. A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn."

7. On March 1, 2016, at 10:41 a.m., following an observation in operating room (OR) 3, at the conclusion of surgery, Environmental Services Staff (EVS) 2 cleaned several pieces of equipment with Super Sani-Cloth® wipes.

EVS 2 did not clean or disinfect a mayo stand (instrument stand) and the large stainless steel table used for instruments. When asked, EVS 2 was unable to recall the contact time (time product is to remain wet to achieve disinfection) for the Super Sani Cloth wipes, she used for disinfecting equipment.

During a concurrent interview, EVS 2 stated, "sometimes she does and sometimes she does not [clean the tables]."

EVS 2 mopped the floor with a solution in an unlabeled container. EVS 2 stated the product was Virux ® 256 II. When asked, EVS 2 was unable to recall the contact time (time product is to remain wet to achieve disinfection) for the Virux® 256 II that she used for disinfection of the floor.

According to facility policy titled Surgery Infection Control Guidelines, Cleaning the Environment, dated February 2014, the horizontal surfaces of furniture and equipment that have been involved in the surgical procedure should be cleaned with a germicidal (disinfectant) solution.

According to the manufacturer, Professional Disposables International, Inc., Super Sani-Cloth® was a pre-moistened non-woven durable wipe containing a quaternary (ammonium)/alcohol based solution for use on hard non-porous surfaces. "Some organisms are removed from the surface by thoroughly wiping the surface with the wipe. Most remaining organisms are killed within two (2) minutes by exposure to the liquid in the wipe."

According to the manufacturer, Diversey, Virux® 256 II was a quaternary (ammonium)/germicide that if used as directed, it was highly effective against a wide variety of pathogens. The directions for use indicated all surfaces must remain wet for ten minutes for disinfection.

During an interview with the Infection Control Consultant (ICC) A, on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice and the Centers for Disease Prevention and Control (CDC), as the facility's nationally recognized infection control standards.

According to the CDC / HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011), Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas:

"Select EPA-registered disinfectants ...and use them in accordance with the manufacturer's instructions."

According to the AORN Guidelines for Perioperative Practice (2016), Guideline for Environmental Cleaning, Recommendation II:

"Disinfectants should be applied and reapplied as needed, per manufacturers' instructions, for the dwell time (wet time) required to kill the targeted microorganism."

8. From February 29 until March 1, 2016, during intermittent observation of cleaning carts throughout the facility, three buckets containing liquid and mop heads and one bucket containing liquid and microfiche cloths, were not labeled with the chemical and the chemical's concentration.

During an interview with the Infection Control Consultant (ICC A), on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice as one of the facility's nationally recognized infection control standards.

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Environmental Cleaning, Recommendation II:

"If the cleaning chemical is removed from the original container, the secondary container should be labeled with the chemical name, concentration, and expiration date."

9. From February 29 until March 1, 2016, during intermittent observation of staff in patient care areas, several employees were observed to be wearing masks improperly below the nose.

On March 1, 2016, at 9:20 a.m., registered nurse (RN) 6 and RN 3 were observed to be wearing masks below their noses in the patient care area on Unit 2. RN 6 stated she had the mask on because she had declined the influenza vaccine. RN 6 placed the mask in the proper position, covering the nose, during the interview.

RN 3 stated she was allergic to eggs and did not receive the influenza vaccination. During the interview, she placed the mask in the proper position covering the nose.

In a letter dated October 1, 2015, to all licensed Acute Care Facilities in Los Angeles County, the Interim Health Officer for Los Angeles County, issued an order for all licensed facilities to require influenza vaccination for their Health Care Personnel (HCP), or that HCP who decline to be vaccinated, must wear a mask when they are in contact with patients or in patient care areas during the annual influenza season (October 1, 2015-March 31, 2016).

10. On March 1, 2016 at 3:30 PM, employee health records were reviewed with the Quailty Assurance Manager (QA).

Seven out of seven files did not have complete vaccination records. The following employee files did not contain evidence of complete vaccination records:
-Infection Control Consultant (ICC) A;
-ICC B;
-Operating Room Technician (ORT) 1;
-ORT 2;
-Environmental Services Staff (EVS) 1;
-EVS 2; and
-Registered Nurse (RN) 5.

The following employee files did not have documentation that tDap (Tetanus [a serious illness caused by bacteria that can enter the body through a deep cut] Diphtheria [a serious bacterial infection], and Pertussis [commonly known as Whooping Cough, an infectious bacterial disease that causes uncontrollable coughing];

-ICC A;
-ICC B;
-ORT 1;
-EVS 1;
-EVS 2; and
-RN 5

Two of seven employee files did have evidence of Hepatitis B (virus that affects the liver) status.

Two of seven employee files did not have evidence of influenza vaccination or delination, (ICC B, EVS 2).

Six of seven (ICC A, ICC B, ORT 1, EVS 1, EVS 2, RN) did not have MMR (measles, mumps, rubella) [measles a viral infection of the respiratory system characterized by a rash; mumps an acute viral infection characterized by infla.m. mation of the parotid gland; rubella a contagious viral infection that is characterized by a rash, short duration].

Six of seven (ICC A, ICC B, ORT 1, EVS 1, EVS 2, RN 5) did not have evidence of varicella (Chickenpox) vaccination or immunity.

These results were verified by the QA.

The facility policy titled "Immunizations for Healthcare Workers," dated February 2014, was reviewed on March 1, 2016, at 2:30 p.m. The policy indicated in Table 3, page 346, that the immunization schedule for health-care workers included Hepatitis B, Influenza, MMR, Rubella, Td (tetanus diphtheria) and varicella.

During an interview with ICC A, on February 29, 2016, at 11:30 a.m., he stated the facility had adopted the Centers for Disease Prevention and Control (CDC) as one of the facility's nationally recognized infection control standards.

The CDC recommends staff who work directly with patients or handle material that could spread infection, should get appropriate vaccines to reduce the chance that they will get or spread vaccine-preventable diseases.

The CDC further indicated healthcare workers included physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff.

a. Employee health policies and procedures did not follow the facility adopted, nationally recognized CDC guidelines for immunizations of health care workers that indicated:

i...recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace (i.e. hepatitis B, seasonal influenza, measles, mumps, rubella, pertussis, and varicella;

ii. Healthcare personnel should receive a single dose of Tdap (a vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, that prevents the diseases of Diphtheria, Tetanus and Whooping Cough) as soon as feasible upon hire if they have not been vaccinated previously; and

iii. Healthcare organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter.

11. On March 1, 2016, at 3:30 p.m., employee health records were reviewed with the Quality Assurance Manager (QA). In two (Infection Control Consultant A and B) out of seven files there was no documentation of current tuberculosis (TB) screening.

According to the facility policy titled "Employee Health TB Exposure Control Plan," dated, February 2014: all hospital employees shall be evaluated for TB as part of their pre-employment evaluation and annually thereafter. Employees with no history of positive PPD skin test reaction will be evaluated with a PPD skin test. Employee with documented positive PPD skin test reaction will be evaluated for symptoms related to TB using a questionnaire.

During an interview with the Infection Control Consultant (ICC) A on February 29, 2016 at 11:30 a.m. , he stated that the facility has adopted the Centers for Disease Prevention and Control (CDC) as one of the facility ' s nationally recognized infection control standards.

CDC guidelines for TB screening of health care workers state: All healthcare personnel should receive baseline TB (tuberculosis) screening upon hire. Follow-up screening/testing should be completed annually.

12. On March 1, 2016, at 3:30 p.m., employee records were reviewed with the Quality Assurance Manager (QA). In seven of seven files(Infection Control Consultant [ICC] A , ICCB, Operating Room Technician [ORT] 1, ORT 2, Environmental Services Staff [EVS] 1, EVS 2, and Registered Nurse [RN] 5) reviewed, there was no documented evidence that fit testing or fit testing competency was performed.

According to the facility policy titled "N 95 Particulate Respirator Fit Testing," dated November 2014, all nursing and EVS [environmental services] staff would have fit testing competency skills checklist completed. The completed competency skills checklist would be sent to Human Resources to be kept in the employee's file. (The fit test ensures that, when donned properly, the selected brand and size of respirator fits adequately to protect the wearer from excessive inward leakage of contaminant through the face seal).

During an interview with the Infection Control Consultant (ICC) A, on February 29, 2016, at 11:30 a.m. he stated the facility had adopted the Centers for Disease Prevention and Control (CDC) and the Association for per-Operative Registered Nurses (AORN) as two of the facility's nationally recognized infection control standards.

According to the CDC, if respirators were used in a health-care setting, the Occupational Safety and Health Administration (OSHA) required the development, implementation, administration, and periodic reevaluation of a respiratory protection program.

The most critical elements of a respiratory protection program included:

1) assignment of responsibility;

2) training; and

3) fit testing.

All HCWs who use respirators for protection against Mycobacterium tuberculosis (TB) infection should be included in the respiratory protection program. Fit testing [should be] performed during the initial respiratory protection program training and periodically thereafter, in accordance with federal, state, and local regulations.

According to AORN (2016), Guidelines for Perioperative Practice, Guideline for Prevention of Transmissible Infections, IV.i. :

Administrative controls should be established to reduce the risk of TB exposure to patients and personnel. Administrative controls should include: training and educating health care providers about TB prevention, transmission, and symptoms; establishing a TB screening progra.m. to screen and evaluate health care providers who are at risk for TB or who might be exposed to Mycobacterium tuberculosis; and implementing a respiratory protection progra.m. for personnel requiring fit testing and certification to use an N95 respirator (s a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles).

13. The facility policy and procedure titled "MRSA (Methicillin Resistant Staph Aureus-a type of infection that is resistant to antibiotics) Active Surveillance," was reviewed. The policy indicated its purpose was:

-To identity, as soon as possible after admission/transfer, patients in designated high risk groups who may be colonized with MRSA;

-To isolate those patients whose surveillance were positive for MRSA or other Multi-drug resistant organisms; and

-To prevent healthcare associated transmission of MRSA from one patient to another.

The policy indicated Active Surveillance Cultures (ASC) for MRSA would be obtained for "High Risk," patients. High risk patients included patients admitted to or transferred to the intensive care unit (ICU), and patients transferred from a Nursing Home or other Healthcare Facility. The policy indicated cultures "should be done on admission or transfer or within 24 hours of admission or transfer of the designated high risk patient.

a. On February 29, 2016, at 11:50 a.m., a tour of the facility's Intensive Care Unit (ICU) was conducted. Patient 1 was observed in Bed 2.

During a concurrent interview with ICU registered nurse (RN) 10, the nurse stated Patient 1 was transferred to the facility from a local skilled nursing facility due to an elevated white blood count (indicative of infection) and a urinary tract infection.

Patient 1's record was reviewed with RN 10, on February 29, 2016. Patient 1 was admitted to the facility on February 25, 2016, for treatment of sepsis (infection in the blood). There was no evidence MRSA ASC was collected since his admission to the ICU or within 24 hours of his admission to ICU. According to Patient 1's record, five days had past since his admission, and no MRSA ASC was obtained.

During a concurrent interview, RN 10 stated the Emergency Department collected the ASC on all patients prior to their transfer to a room. RN 5 was unable to find evidence of prior MRSA screening for Patient 1, on February 29, 2016.

b. On February 29, 2016, at 2:15 p.m., a tour of the facility's Intensive Care Unit (ICU) was conducted. Patient 2 was observed in Bed 6. Patient 2 was mechanically ventilated (mechanical assist for respiration) and had a tracheostomy (surgically made opening that provides opening for a tube placed into the trachea).

During an interview with ICU RN 11, on February 29, 2016, at 2:20 p.m., RN 11 stated Patient 2 was a transfer from a long term acute care facility.

Patient 2's record was reviewed with RN 6, on February 29, 2016. Patient 2 was admitted to the facility on February 25, 2016, for treatment of severe anemia (low blood count) and abdominal pain. Patient 2's "History and Physical," indicated Patient 2 resides in a subacute unit (other Healthcare Facility). There was no evidence MRSA ASC was collected since Patient 2's admission to the ICU or within 24 hours of his admission to ICU.

There was no evidence in Patient 2's record that MRSA ASC was collected since admission, five days ago.

During an interview with Infection Control Consultant (ICC) A, on March 1, 2016, at 11 a.m., ICC A stated there was a breakdown in communication, as facility staff believed a physician's order was required for MRSA screening.

14. During an interview with Infection Control Consultant (ICC) A, on February 28, 2016, at 11:30 a.m., the ICC stated the facility had adopted the Association of Operating Room Nurses (AORN) Guidelines for Perioperative Practice as one of their nationally recognized infection control standards.

During an observation of the Radiology Department, sonogra.m. room, on March 2, 2016, at 9:45 a.m., a wall mounted soak station was observed. The soak station was enclosed to provide protection from fumes, as one container held Cidex (a solution used for high level disinfection of vaginal probes). Three containers, two containing water for rinsing and one with the Cidex solution, were fully enclosed in the soak station. Taped to the outside of the soak station was the "Ultrasound Cidex OPA Log: EV (endovaginal) Probe," log.

During an interview with the Sonographer, on March 2, 2016, at 9:45 a.m., the Sonographer stated a transvaginal probe cover was placed on the probe prior to each use. The Sonographer stated following the use of the probe, the cover was removed, it was rinsed with water, placed (immersed) in the container of Cidex OPA (a high level disinfectant), for 12 minutes, rinsed and dried. The Sonographer stated the container of Cidex was tested daily for appropriate concentration of the solution.

The "Ultrasound Cidex OPA Log: EV (endovaginal) Probe," log was reviewed with the Director of Ancillary Services and the Sonographer on March 2, 2016, at 10:45 a.m. The form contained spaces to document:

a. the date the Cidex solution was changed;

b. the discard date;

c. information about the original bottle of Cidex (i.e. lot number, original open date and discard date);

d. date solution was tested, result, test strip expiration, temp of the area near the soak station, and initials of tester;

e. medical record of patient (if probe used and cleaned) soak in and out times.

There was no documentation on the log to indicate what time the test was completed. There was no documentation on the log that would provide evidence the solution was tested "prior," to the immersion of a vaginal probe.

During a concurrent interview, the Director and the Sonographer indicated the solution was tested daily and was not checked again prior to immersion of the probe.

The facility document titled "Maintaining CIDEX for EV Probe," indicated CIDEX was used for probe cleaning. The document indicated when probe was disinfected, the information was placed "next to the appropriate date." There were no instructions indicating solution was to be tested before probe insertion.

According to the Centers for Disease Control (CDC), transvaginal (endovaginal) probes were semi-critical devices and should undergo high level disinfection following each use. High level disinfection was a process for eliminating pathogenic microorganism on inanimate objects, with a liquid chemical.

The AORN "Guidelines for Perioperative Practice (2016), Guideline for High Level Disinfection (HLD)," were reviewed. Recommendation IX, indicated documentation should be completed to:

"...demonstrate compliance with regulatory and accrediting agency requirements."

According to the guidelines, documentation should be completed to enable the identification of trends and demonstrate compliance with regulatory and accrediting agency requirements. HLD processing records should be kept and include, test results before each load, indicating the solution used was at the proper concentration and within the expiration date.


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15. On March 1, 2016, at 9 a.m., an ice-machine was observed inside the kitchen. A registered dietitian (RD 1) stated the hospital maintenance staff was responsible for cleaning the internal components of the ice-making apparatus.

On March 1, 2016, at 9:10 a.m., in the presence of RD 1, a maintenance employee (ME 7) stated he would use a chemical called "Evap Foam No Rinse," to clean the coil located on the inside of the top part of the ice-machine. ME 7 stated before he sprayed the chemical on the coil, he would place a plastic liner over the ice located in the bin "because they [dietary staff] use it." ME 7 added, "Sometimes I would remove the ice, sometimes not."

ME 7 obtained the plastic cover from his maintenance room, located down the hospital corridor from the kitchen, to bring into the kitchen. Concurrently, ME 7 stated that hospital staff was not responsible for cleaning the internal components of the ice-machine, other than the coil as needed. ME 7 stated the internal cleaning of all three ice-machines located in the hospital was done one time a year by an outside vendor.

At that time, a copy of the last two invoices for each of the ice-machines, that addressed cleaning and sanitizing of the ice-machines, was requested.

Concurrently, RD 1 stated, "He needs to remove the ice before spraying chemicals in the machine. That is not safe or acceptable."

On March 1, 2016, at 5 p.m., RD 1 provided one invoice for the ice-machine located in the kitchen, dated 1/19/15, and stated,"[name of ME 7] stated that was all the invoices he had in regard to the ice machines."

The invoice was dated January 19, 2015, and indicated "troubleshooting ice machine and found ice machine had condenser coil dirty. Cleaned condenser coil ... " The invoice had no indication that the internal components of the ice-machine was cleaned and sanitized in accordance with the ice- machine's manufacturer's guidelines.

On March 2, 2016, at 8:50 a.m., the Director of Plant Operations (DPO) confirmed that the outside vendor was to clean and sanitize the ice-machines annually. The DPO read the invoice ME 7 had provided from the outside vendor and acknowledged that there was no documentation on the invoice that indicated the ice-machine was cleaned and sanitized in accordance with the manufacturer's guidelines. The DPO stated, "I will call the vendor and see if they have any further invoices for the ice machines."

On March 2, 2016, at 8:53 a.m., a joint observation of an ice-machine located next to a nursing station (nursing station 3), with the DPO and ME 7, was conducted The DPO acknowledged the external components of the ice-machine, that included the chute in which the ice made direct contact, was not maintained in a sanitary manner. There was build-up of white colored substance in and around the chute, with a small area of black substance, in which the ice was dispensed from. In addition the rack over the drain outlet was worn and torn and therefore impeded effective cleaning.

Concurrently, a joint observation with the DPO and ME 7 was conducted. A second ice machine, located next to a nursing station that was located down the hall from nursing station 3, was observed. The DPO and ME 7 acknowledged the chute in which the ice was dispersed from contained white and black colored substances in and around the chute.

ME 7 removed the top panel exposing the inside components of the ice-making apparatus. There was a cloth towel that was discolored with orange an

Based on interview and record review, the facility failed to ensure an initial discharge plan was completed for Patient 12, per the facility's procedure. This failure may result in a potentially unsafe situation upon discharge, and impact the continuity of the patient's care.

Findings:

A review of Patient 12's record was conducted on February 29, 2016, at 2 p.m., with Case Manager (CM) 1. Patient 12 was admitted to the facility on February 23, 2016, with an admitting diagnosis of partial obstruction of the small bowel. Patient 12 had exploratory surgery on February 24, 2016.

A review of the initial Case Managent assessment dated February 24, 2016, was conducted. The assessment failed to indicate where the patient would be discharge to, or equipment the patient may already have, or may need.

An interview was conducted with CM 1 on February 29, 2016, at 2:30 p.m. CM 1 stated Patient 12's record failed to show a completed discharge plan, which she said was "unusual" because on February 26, 2016, Patient 12's record had been audited and it was determined at that time that the discharge plan was incomplete. CM 1 stated when the chart was audited and the discharge plan was found to be incomplete, the assigned CM had been instructed to complete it, and had not done so.

A review of the facility policy, "Discharge Planning (Effective Date: 11/2015)," was conducted. The process indicated, "The hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning..."

Based on interview and record review, the facility failed to ensure, for three patients, (Patients 7,12, and 13), that the initial Case Management assessment included an assessment of the durable medical equipment the patients had, and potentially may need upon discharge. This failure could result in an unsafe discharge for Patients 7, 12, and 13.

Findings:

1a. A review of Patient 7's record was conducted. Patient 7 was admitted to the facility on February 17, 2016, with a diagnosis of seizures.

A review of Patient 7's Case Management assessment dated February 18, 2016, was conducted. The assessment reflected that Patient 7 was dependant for all activities of daily living (to include bathing, feeding oneself and dressing).

The Case Management assessment failed to reflect the durable medical equipment Patient 7 had, or would possibly require upon discharge.

b. A review of Patient 12's record was conducted on February 29, 2016, at 2 p.m., with Case Manager (CM) 1. Patient 12 was admitted to the facility on February 23, 2016, with a diagnosis of partial obstruction of the small bowel. Patient 12 had exploratory surgery on February 24, 2016.

A review of the initial Case Management assessment dated February 24, 2016, was conducted. The assessment failed to indicate where the patient would be discharged to, or equipment the patient may already have, or may need.

c. A review of Patient 13's record was conducted. Patient 13 was admitted to the facility on August 31, 2015, with diagnoses of bradycardia, (a slow heart rate) and syncope (dizziness).

A review of the Case Management initial assessment dated September 1, 2015, failed to indicate the durable medical equipment the patient may potentially require upon discharge due to her diagnosis of dizziness.

An interview was conducted with Case Manager (CM) 1 on February 29, 2016, at noon, who stated the Case Management computer program does not populate an area which reflected durable medical equipment the patient had or may need upon discharge.

CM 1 further stated a patient's need for durable medical equipment were to be assessed upon the patients admission and reassessed as needed.

Based on interview and record review, the facility failed to ensure its assessment of readmissions include an evaluation of whether the readmissions were potentially due to problems with discharge planning, or the implementation of discharge plans.

Findings:

An interview was conducted with the Manager of Quality Services (MQS) on March 3, 2016, at 10 a.m.

The MQS stated the facility does not assess readmissions to determine whether the readmissions were potentially due to problems in discharge planning or with the implementation of the discharge process.

Based on observation, interview and document review, the facility failed to ensure policies for hand washing, surgical attire, and operating room cleaning were followed. The facility failed to ensure operating room personnel:

1. Washed their hands, after removing gloves, according to policy and standards of practice;

2. Wore the appropriate head covering while in an operating room were surgery was in process; and

3. Cleaning of an operating room was conducted according to policy and the manufacture's directions for use.

These failures placed surgical patients at risk for hospital acquired infections.

Findings:

During an interview with Infection Control Consultant (ICC) A, on February 29, 2016, at 11:30 a.m., ICC A stated the facility had adopted the Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, and the Centers for Disease Prevention and Control (CDC), as the facility's nationally recognized infection control and operating room standards.

1. On March 1, 2016, at 9:30 a.m., a surgical procedure was observed in operating room (OR) 3. Observation continued until 10:36 a.m. During the procedure, Registered Nurse (RN) 1 was observed applying and removing non-sterile gloves five times, without performing hand hygiene (hand washing with soap and water or using an alcohol based hand rub).

During this OR observation, the following was noted:

Physician (MD) 1 removed his contaminated surgical gloves without performing hand hygiene;

MD 2 removed his non-sterile gloves without performing hand hygiene; and

Operating Room Technician (ORT) 3 removed contaminated surgical gloves without performing hand hygiene.

According to the "CDC Guideline for Hand Hygiene in Health-Care Settings (2002)," hand hygiene should be performed after glove removal.

2. On March 1, 2016, at 9:30 a.m., a surgical procedure was observed in operating room (OR) 3. Observation continued until 10:36 am.

During the procedure Physician (MD) 1, MD 2, and Operating Room Technician (ORT) 3 were observed to be wearing surgical caps (head coverings). MD 1, MD 2 and ORT 3 all had visible, exposed hair at the nape of their necks.

The facility policy and procedure titled "Attire-Surgical," with a governing board approval date of November 2012, was reviewed. The policy indicated the human body was a major source of microbial contamination in the restricted areas of the surgical environment; and surgical attire was worn to promote high level cleanliness and hygiene in the surgical environment. The policy indicated: "All possible head and facial hair, including sideburns and neckline shall be covered when in a surgical suite."

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Surgical Attire, Recommendation III:

"Personnel entering the ...restricted areas (surgery) should cover the head, hair, ears, and facial hair. Hair and skin can harbor bacteria that can be dispersed into the environment. A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn."

3. On March 1, 2016, at 10:41 a.m., in OR 3, at the conclusion of surgery, Environmental Services Staff (EVS) 2, was observed cleaning different pieces of equipment with Super Sani Cloth® wipes. EVS 2 did not clean or disinfect a mayo stand (instrument stand) and a large stainless steel table used for instruments.

During a concurrent interview with EVS 2, she stated "sometimes she does and sometimes she does not [clean the tables]." When asked, EVS 2 was unable to recall the contact time (time product is to remain wet to achieve disinfection) for the Super Sani Cloth wipes.

EVS 2 was observed mopping the floor with a solution in an unlabeled container. She stated the product was Virux ® 256 II. When asked, EVS 2 was unable to recall the contact time for the Virux® 256 II, that she used to disinfect the floor.

According to facility policy, titled "Surgery Infection Control Guidelines, Cleaning the Environment," dated February 2014, the horizontal surfaces of furniture and equipment that were involved in the surgical procedure should be cleaned with a germicidal (disinfectant) solution.

According to the manufacturer, Professional Disposables International, Inc., Super Sani-Cloth® was a pre-moistened non-woven durable wipe containing a quaternary (ammonium)/alcohol based solution for use on hard non-porous surfaces. The manufacturer indicated "Some organisms are removed from the surface by thoroughly wiping the surface with the wipe. Most remaining organisms are killed within two (2) minutes by exposure to the liquid in the wipe."

According to the manufacturer, Diversey, Virux® 256 II was a quaternary (ammonium)/germicide that if used as directed, was highly effective against a wide variety of pathogens. The directions for use indicated all surfaces must remain wet for ten minutes for disinfection.

According to the CDC / HICPAC, Guidelines for Environmental Infection Control in Health-Care Facilities (2011):

"Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas: Select EPA-registered disinfectants ...and use them in accordance with the manufacturer's instructions."

According to the AORN Guidelines for Perioperative Practice (2016), Guideline for Environmental Cleaning, Recommendation II:

"Disinfectants should be applied and reapplied as needed, per manufacturers ' instructions, for the dwell time (wet time) required to kill the targeted microorganism."

Based on observation, interview and record review, the facility failed to ensure the Emergency Department's (ED) Admitting Representative (AR), did not assess individuals when they presented to the ED seeking treatment. This failure could interfere with the provision of the overall medical care in the ED, and could potentially result in a death or serious disability.

Findings:

A tour and observation of the ED was conducted on March 1, 2016, at 10:30 a.m., with the Triage Nurse (TN).

An interview was conducted with the AR, on March 1, 2016, at 10:40 a.m. The AR stated when a patient came to the ED, the patient presented to the admitting area. The AR stated the admitting area was next to the ED lobby. The AR stated he obtained the patient's name and their chief complaint and placed their name on the tracking board located inside the ED, on the wall.

The AR then stated, when the patient told him their chief complaint, he determined if the patient's acuity level (severity of a patient's chief complaint) was "high." The AR further stated if the acuity level was high, he took the patient into the ED area and told the triage nurse. The AR stated if he determined the acuity level was not high, he told the patient to wait in the ED lobby. The AR was asked if he was a licensed nurse, he responded, "no."

An observation of the ED lobby was conducted, on March 1, 2016, at 10:40 a.m. The ED lobby could not be seen by licensed staff working in the ED. The ED lobby could only be seen by the admitting staff, through a window.

An interview was conducted with the TN, on March 1, 2016, at 10:50 a.m. The TN stated the licensed staff did not go into the ED lobby to observe the patients. The TN stated they rely on the tracking board to see the patient's chief complaint. The TN further stated they attempted to triage all patients within 15 minutes of their arrival time.

An interview was conducted with the TN on March 2, 2016, at 3 p.m. The TN was asked if the admitting representatives should determine a patient's acuity when the patient presented to the ED. The TN stated, "The admitting representatives should not be placed in a position to determine a patient's acuity, they could miss the symptoms of a silent myocardial infarction (heart attack) or miss other serious symptoms."

A review of the facility policy, "Triage, Initial Screening and Classification of the ER (emergency room) Patient," with a governing board approval date of November 2014, was conducted. The purpose of the policy indicated, "To define standards for the categorization and classification of a patient's condition when the patient presents for care in the emergency room."

The procedure indicated, "The RN (registered nurse) is responsible for assuring that initial evaluation is carried out on a timely basis and is performed to rule out life-threatening illnesses or injuries that can lead to deterioration in the patient's condition..." "Subsequent to the initial assessment and evaluation by the RN, the patient's priority status is classified as emergent, urgent, or non-urgent."