HospitalInspections.org

Based on observation, interview, and record review, the hospital did not have an effective governing body that carried out the functions required by a governing body when:

1. Hospital A failed to maintain a safe patient care environment for patients housed in room 312 in the Behavioral Health Unit (BHU) when signs of water damage and potential microbial growth, as evidenced by the observation of a black furry substance in the shower area of room 312, was not reported and repaired in a timely manner. (A-144 #1)

2. Hospital A failed to maintain a safe patient care environment for 3 patients. An electrical device used for the assessment of vital signs was left unattended and within the reach of a patient, who had been assessed at risk for self harm and a danger to others. Two patients who required direct monitoring for safety, were monitored by a Certified Nursing Assistant (CNA) who had not completed required training. (A-144 #2, 3)

3. The hospital failed to ensure the development of a Performance Improvement Program that fully reflected the depth and scope of clinical nutrition care and food services as evidenced by the department' inability to self-identify opportunities and complete comprehensive analysis of data that demonstrated an improvement in quality of patient care services.
(A-273 #2)

4. The hospital failed to ensure the analysis of pharmacy data collected on automated dispensing cabinet (ADC) medication overrides performed by charge nurses. Between 9/1/15 to 10/28/15 the pharmacy reviewed all ADC overrides. During this time, the pharmacy did not analyze the data to determine if the overrides were performed by authorized charge nurses.
(A-273 #1)

5. Hospital A failed to ensure that the Chief Nursing Officer had nursing oversight on medication overrides by charge nurses. There was no documented evidence to demonstrate that medication overrides by charge nurses were monitored and evaluated to ensure that patient and medication safety measures were in place. (A-386 #1)

6. Hospital A failed to ensure that the Chief Nursing Officer had oversight on the nurse staffing and organization of their Spine Unit. There was no documented evidence that a written staffing plan had been developed to address the staffing needs, nursing care and scope of service of the Spine Unit. (A-386 #2)

7. Hospital A failed to ensure comprehensive nursing admission assessments were performed on two patients. (A-395 #1, 2)

8. The hospital failed to ensure the development and implementation of a policy and procedure for automated dispensing cabinet medication override. The hospital authorized the nursing unit's assigned charge nurse to have automated dispensing cabinet override access security for the removal of medications. (A-491)

9. The hospital failed to ensure the development and implementation of a policy and procedure to limit access to medications before orders have been reviewed and approved by a pharmacist. The hospital authorized the nursing unit's assigned charge nurse to have automated dispensing cabinet override access security for the removal of medications. (A-500 #1)

10. Hospital A failed to ensure that their policy and procedure for labeling medications guided licensed staff related to labeling of floor stocked (supply located on the nursing unit) medications. The lack of labeling did not ensure the safe distribution of the medication. (A-500 #2)

11. The hospital failed to ensure medications stored in automated dispensing cabinets were secured from unauthorized override (access). The hospital authorized the nursing unit's assigned charge nurse to have ADC override access security for the removal of medications. (A-502)

12. The hospital failed to ensure that outdated injectable solutions and used biological supplies were not available for patient use in the Emergency Department. Date expired vials of injectable sterile saline solutions and opened, undated and partially used biological solutions were stored and available for use in the ED supply. (A-505)

13. The hospital failed to ensure that humidity, temperature and airflow were monitored in the interventional radiology suite. (A-535)

14. The hospital failed to ensure that food products were stored in accordance with manufacturers' recommendations. Manufacturers' recommendations for storage are designed to maintain food safety, freshness and palatability of products. (A-620 #1, 2)

15. The hospital failed to ensure staff competency related to thermometer calibration of 1 dietetic services staff member. (A-622)

16. The hospital failed to ensure the following: 1) the nutritional value of the menus in accordance with the hospital demographics and physician approved parameters for therapeutic diets. The hospital failed to ensure that substitutes were of equal nutritive value to the entrée items;
2) implement remedies when the hospitals' menu did not meet the nutritional needs of patients. The hospitals' menus were deficient in Vitamins D and E. Additionally the hospital menus did not consistently meet physician specified nutritional parameters for renal, post-dialysis and sodium restricted diets. There was no analysis of vegetarian or gluten free diets both of which were routinely ordered by physicians;
3) complete nutrition related assessment in accordance with hospital policy.
(A-629 #1, 2, 3)

17. The hospital failed to utilize a diet manual that was specific to the hospital, included diets routinely ordered, nor provided accurate guidance for ordering and preparing patient meals. (A-631)

18. The hospital failed to ensure adequate food supplies or a fully detailed plan that would provide all hospital staff guidance on the implementation of dietetic services in the event of a wide-spread disaster; and failed to ensure the dishwasher was maintained in accordance with manufacturers' parameters as evidenced by broken temperature measuring dials.
(A-701 #1, 2)

19. The hospital failed to ensure dietetic services were implemented in a safe/effective manner as evidenced by 1) lack of an comprehensive system that monitored the thawing of raw meats; 2) storage of foods at temperatures that could promote bacterial growth associated with foodborne illness; 3) lack of monitoring of cooldown of potentially hazardous foods; 4) lack of maintenance and cleanliness of hospital ice machines; 5) retention and use of food items that exposed to flying pests; 6) lack of effective hand hygiene during food production activities; 7) lack of effective sanitation of food delivery equipment; 8) lack of effective are gaps in food production equipment; 9) retention of food storage equipment whose surfaces were compromised and 10) multiple unclean kitchen areas/surfaces. (A-749 #s 2, 3, 4a, 4b, 5, 6, 7, 8, 9, 10, 11)

20. Failed to ensure that its performance improvement activities included the evaluation of high risk, problem prone areas. The hospital failed to monitor and evaluate the cleaning and disinfection procedures of surgical instruments when an enzymatic agent (chemical used to remove debris) was not utilized in accordance with the hospital's approved policies and procedures. (A-283 #1a, 1b, 2)

21. Failed to show documented evidence to demonstrate that the hospital's Quality Assessment and Performance Improvement (QAPI) program had complete oversight over the sterile processing of surgical instruments, hand hygiene and the use of personal protective equipment (PPE - equipment used to protect against exposure to infection) in the Sterile Processing Unit (SPU). The failure to have a QAPI program in place to ensure oversight of the hospital-wide infection control program led to an increased risk for the transmission of infections amongst patients undergoing procedures.
(A-283 #1a, 1b, 2)

22. The hospital and governing body in governance of the infection control officer and in accordance with hospital policy and nationally recognized infection control standards failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases. (A-748)

23. The hospital failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards. Surgical instruments were not processed to ensure sterility when job specific competencies were not demonstrated by staff. Proper hand hygiene, use of personal protective equipment and traffic patterns between sterile and contaminated areas to prevent transmission of infection and/or cross-contamination were not practiced. Cleanliness was not maintained in designated clean and decontamination areas.
(A-749 #1)

24. The hospital staff did not recognize and report potential environmental microbial growth in a patient care area. (A-749 #14)

25. The hospital failed to implement an infection control program with procedures which prevented potential patient exposure to communicable infectious disease. Shared use patient diagnostic medical equipment was not disinfected after patient contact in the Emergency Department (ED). A torn upholstered chair with exposed padding was available for patient use in an ED treatment room. (A-749 #12, 13)

26. The lack of proper transport of linen did not ensure that infection prevention techniques were maintained and practiced by staff to prevent the spread of infection throughout the hospital in accordance with their own policy and procedures.
(A-749 #15)

27. The hospital failed to ensure that an instructor (hospital visitor/contracted individual) was able to verbalize the correct contact time for the use of bleach wipes. (A-749 #16)

28. The Chairman of the Medical Staff Department of Surgery was not given responsibility for the medical care provided to surgical patients by not being aware of failures in the performance of surgical instrument processing and sterilization. In addition, he was not made aware by the Governing Body, that survey findings resulted in cancellation of surgeries and the institution of bypass for the Operating Rooms (ORs), the Emergency Department (ED), and Labor and Delivery (mother/baby unit). (A-353)

29. The hospital failed to ensure an effective, active system wide infection control program for prevention, control, and investigation of infections and communicable diseases in surgical services. The infection control program did not meet the needs of all patients receiving surgical care and supportive healthcare in the hospital.
(A-951 #1, 2)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Governing Body.

Based on observation, interview, record and document review, Hospital A failed to maintain a safe patient care environment for patients housed in room 312 in the Behavioral Health Unit (BHU) when signs of water damage and potential microbial growth, as evidenced by the observation of a black furry substance in the shower area of room 312, was not reported and repaired in a timely manner.

Failure to develop and implement a policy and procedure related to changes in environmental conditions. This failure did not ensure a safe and sanitary patient care environment was provided.

In addition, Hospital A failed to maintain a safe patient care environment for 3 of 33 sampled patients (11, 23, 24). An electrical device used for the assessment of vital signs (blood pressure/pulse) was left unattended and within the reach of Patient 11, who had been assessed at risk for self harm and a danger to others. The device included cords and tubing which potentially could have been used for harmful intentions. Patient 23 and Patient 24 who required direct monitoring for safety, were monitored by a Certified Nursing Assistant (CNA) 26 who had not completed required training.

Failure to provide care in a safe setting, impeded the staff from meeting the patient's required safety needs.

Findings:

1. On 10/29/15 at approximately 2:39 P.M., an observation, interview and document review was conducted during a tour of the 3rd floor locked psychiatric unit. In room 312, a black substance was viewed around the entrance to the bottom of the shower entrance. The exterior wall of the shower showed an approximately 2 feet high by approximately 6 inches wide of a black furry looking substance. The Infection Control Preventionist (ICP 1), Corporate Manager of Infection Prevention (ICP 2) and Director of Nursing/Performance Improvement Director (DON/PID) acknowledged the substance should have been reported and removed as it was now spreading to multiple spots throughout the room. The ICP 2 identified the substance as mold. The ICP 1 could not identify the facilities policy for dealing with the discovery of suspected mold. At time of exit, a policy and procedure for containment of suspected environmental infections substances was not provided.

During an interview on 10/30/15 at 8:15 A.M., Environmental Services staff (EVS) 1 stated that she worked in Hospital A's BHU. EVS 1 stated her job responsibilities included daily cleaning and servicing of the patient rooms and bathrooms on the BHU. EVS 1 recalled that she had noticed an area of "blackish" discoloration, in the bathroom shower stall of BHU room 312, "about a month ago". EVS 1 stated "I showed it to someone and they said the room shouldn't be used." EVS 1 was unable to state the name or role of the person to whom she spoke. EVS 1 stated "I thought that person had reported it." EVS 1 stated patients had continually occupied the room, for the past month, and that she had not reported the shower discoloration to her supervisor. EVS 1 stated "I usually tell the secretary at the nurses station if I see a problem." EVS 1 acknowledged that she had not reported the discoloration in the shower stall to the secretary at the nurses station.

During an interview on 10/30/15 at 8:30 A.M., the BHU Nurse Manager (NM) stated that he had not been made aware of the area of discoloration in the shower stall of room 312. The NM stated that the nursing staff conducted daily physical environment rounds of the BHU patient rooms, which included the bathroom areas. The NM stated identified repair needs were reported and submitted to engineering via an electronic work order form.

A review of the hospital form entitled Behavioral Health Services Unit Safety Check Monitor, listed a checklist of the environmental items for daily inspection and included "Sinks/Toilets/Showers out of order". The form also included an area to add comments. The daily checklists for the past month (October 2015) had not identified a problem with the shower area in room 312. In addition, a review of the previous month (October 2015), electronic Work Order Details forms, failed to document submission of a request for inspection or repairs to BHU room 312.

A review of the hospital policy entitled Utility Equipment and Systems Operation Assessment, dated "07/2015" included "All utility equipment systems problems and failures shall be reported to the Engineering Department via the following: Service calls...Work orders...Risk identification report...When problems are identified, they shall be evaluated and acted upon in a timely manner."

A review of the hospital policy entitled Infection Control Program, dated "February 2014" included "The Safety Officer shall be apprised of possible infectious issues that are potentially hazardous to patients and staff."

A review of the hospital policy entitled Patient Rights, dated "4/17", included "Patient rights will include..Receive care in a safe setting."

During an interview on 10/30/15 at 9:30 A.M., the Director of Behavioral Health Unit (DBHU) stated the 'blackish" discoloration, observed in room 312 of the BHU, should have been identified by the nursing staff during their daily rounds. In addition, the DBHU stated that EVS 1 should have reported her observation, at the time she had discovered the concern, to her supervisor or nurse station staff. The DBHU acknowledged that the hospital had not implemented measures to identify and control a potential infectious process in a timely manner.

During an interview on 11/3/15 at 8:30 A.M., the Director of Plan Operations (DPO) stated that he maintains oversight over work orders submitted to the engineering department. The DPO stated that a work order, regarding BHU room 312 shower stall, had not been submitted to engineering until 9/29/15, when the concern was identified by the survey team. In addition, the DPO stated the BHU had been scheduled for a routine "environment of care" (physical inspection) in the month of August 2015. The DPO stated that the inspection had not been conducted as planned and that the missed BHU inspection had not been added to the September 2015 schedule. The DPO acknowledged that the BHU had not had an environment of care physical inspection since February of 2015. The DPO acknowledged that the scheduled environment of care inspections were attended by the hospital Infection Control Preventionist (ICP) and were intended to identify potential problems which could affect patient outcome.





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2. Patient 11 was admitted to Hospital A's Emergency Department (ED) on 10/26/15. Patient 11 had been placed on a 72 hour hold/detention, by local law enforcement, after the patient had made harmful gestures towards others and threatening self harm statements.

During an observation on 10/27/15 at 10:10 A.M., Patient 11 was observed on a gurney in an ED treatment room. The treatment room had been designated for the use of patients that were in need of a 72 hour hold. A portable electronic device, used for the assessment of vitals signs, was positioned next to the patient's gurney. The device included an electrical cord and various equipment tubing. The device was not in use or attended by ED staff at the time of the observation.

During an interview on 10/27/15 at 10:10 A.M., Certified Nursing Assistant (CNA) 12 stated that the electronic device, observed in Patient 11's treatment room, had been left in the patient's treatment room "in order to keep it out of the hallway."

A review of the hospital policy entitled Involuntary Detention and Treatment, 72-Hour Hold, dated "September 2015", included "A patient meets the criteria for 72-hour Involuntary Detention...if he/she is considered to be, as a result of mental disorder: A danger to self...A danger to others."

A review of the hospital policy entitled Patient Rights, dated "4/17", included "Patient rights will include..Receive care in a safe setting."

A review of the hospital policy entitled Safety Precautions Emergency Services, dated "June 2013", included "Assure that safety practices are used on all patient on a 72-Hour Hold."

A review of the the hospital policy entitled Management of High Risk Behavior, dated "May 2014", included "High Risk Behaviors are those behaviors...that place a patient or others in danger of harm. These behaviors include, but are not limited to suicide/self harm...Cords, cord-like articles, sharps are to maintained away from this patient."

During an interview on 10/27/15 at 10:15 A.M., the Emergency Department Manager (EDM) stated that ED treatment rooms, designated for patients on a 72 hour hold, were to be free of items which could potentially be used to harm others or used for self inflicted harm. The EDM acknowledged that the hospital had not implemented policies which maintained Patient 11's care environment in a safe manner.



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3. On 10/27/15 at 11:40 A.M., a tour of the sixth floor medical surgical unit was conducted with the Nurse Director of Telemetry (NDOT) and the Director of Respiratory Services (DRS). CNA 26 was observed in the hallway, facing Patient 23 and 24 in their rooms.

On 10/27/15 at 11:45 A.M., an interview was conducted with CNA 27. CNA 27 stated she was assigned as the sitter for both patients 23 and 24 for safety precautions. In addition, she stated that she was aware that CNA 26 was a new employee under preceptorship by CNA 28, however; she asked CNA 26 to accept responsibility as the sitter for both patients.

On 10/27/15 at 11:55 A.M., an interview was conducted with CNA 28. CNA 28 stated that he was the preceptor for CNA 26 and she was not permitted to perform job duties independently until she completed her orientation.

On 10/27/15 at 1:00 P.M., a review of Patient 23 and 24's medical records were conducted.

Patient 23 was admitted to Hospital A on 10/25/15 according to the Admission Registration record dated 10/25/15.

A History and Physical (H&P) dated 10/27/15, indicated that Patient 23 was admitted for Physical Therapy status post fall with a fracture. In addition, the H&P indicated, that Patient 23 was a poor historian.

A nursing note entry dated 10/25/15 indicated, Patient 23 had a 2:1 sitter for safety.

Patient 24 was admitted to Hospital A on 10/25/15 according to the Admission Registration record dated 10/25/15.

A nursing note entry dated 10/23/15 indicated, Patient 24 had a 2:1 sitter for safety.

CNA 26's employee file was reviewed. Her file indicated her date of hire as a CNA was 10/11/15 and she was under preceptorship. Her initial competency for orientation completion due date was 1/11/16.

A review of the hospital policy entitled Patient Rights, dated "4/17", included "Patient rights will include..Receive care in a safe setting." This policy was not implemented when CNA 26 relieved CNA 27 of her sitter role without having authority to obtain sole responsibility.

Based on interview, record and document review the hospital did not ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when the hospital:


1. Failed to ensure the development of a Performance Improvement Program that fully reflected the depth and scope of clinical nutrition care and food services as evidenced by the department' inability to self-identify opportunities and complete comprehensive analysis of data that demonstrated an improvement in quality of patient care services.
(A-273 #2)

2. Failed to ensure the analysis of pharmacy data collected on automated dispensing cabinet (ADC) medication overrides performed by charge nurses. Between 9/1/15 to 10/28/15 the pharmacy reviewed all ADC overrides. During this time, the pharmacy did not analyze the data to determine if the overrides were performed by authorized charge nurses.
(A-273 #1)

3. Failed to ensure that its performance improvement activities included the evaluation of high risk, problem prone areas. The hospital failed to monitor and evaluate the cleaning and disinfection procedures of surgical instruments when an enzymatic agent (chemical used to remove debris) was not utilized in accordance with the hospital's approved policies and procedures. (A-283 #1a, 1b, 2)

4. Failed to show documented evidence to demonstrate that the hospital's Quality Assessment and Performance Improvement (QAPI) program had complete oversight over the sterile processing of surgical instruments, hand hygiene and the use of personal protective equipment (PPE - equipment used to protect against exposure to infection) in the Sterile Processing Unit (SPU). The failure to have a QAPI program in place to ensure oversight of the hospital-wide infection control program led to an increased risk for the transmission of infections amongst patients undergoing procedures.
(A-283 #1a, 1b, 2)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement (QAPI).

Based on observation, interview, and record review, the hospital failed to ensure the consistent analysis of collected quality data as evidenced by:

1. Based on interview and record review, the hospital failed to ensure the analysis of pharmacy data collected on automated dispensing cabinet (ADC) medication overrides performed by charge nurses. Between 9/1/15 to 10/28/15 the pharmacy reviewed all ADC overrides. During this time the pharmacy did not analyze the data to determine if the overrides were performed by authorized charge nurses. The hospital authorized the nursing unit's assigned charge nurse to have ADC override access security for the removal of medications. A sample 11 ADC overrides did not show six medications were removed by the authorized charge nurse. The pharmacy did not report the ADC data to the performance improvement committee (oversees the improvement activities in the hospital). The performance improvement committee did not analyze data and create a corrective action. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff.
2. Based on management staff interview and dietay document review, the hospital failed to ensure the development of a Performance Improvement Program that fully reflected the depth and scope of clinical nutrition care and food services as evidenced by the department' inability to self-identify opportunities and complete comprehensive analysis of data that demonstrated an improvement in quality of patient care services.

Findings:

1. During an interview, on 10/28/15 at 10:50 A.M., in the pharmacy, Director of Pharmacy (DPH 1) and Pharmacy Technician (Pharm Tech 51) were requested to describe Hospital A's pharmacy services (safe and appropriate use of medications (ordering, pharmacist review for appropriateness, distribution, and dispensing). DPH 1 stated that Hospital A's pharmacy was open (staffed with a pharmacist) 24 hours a day, seven days a week. Their description included the medication order was entered in Hospital A's Company 51's computer system (electronic record). The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's Company 52's (automated medication dispensing cabinet (ADC)). Then the nurse could login to the ADC and obtain the authorized medication for the patient. DPH 1 and Pharm Tech 51 described that select medications, needed in an emergency, were available to all nurses through the ADC override process. The override process permitted the nurse to remove a medication prior to a pharmacist review of the physician order. DPH 1 and Pharm Tech 51 stated all medications in the ADC were authorized to be available, using the override process, to the shift charge nurse on each nursing unit. Pharm Tech 51 stated that a list of charge nurses was maintained in the ADC. The ADC list was updated by pharmacy once a quarter.

During an interview, on 10/29/15 at 10:00 A.M., in the pharmacy, DPH 1 and Pharm Tech 51 were requested to describe the pharmacy review of the ADC overrides. DPH 1 and Pharm Tech 51 stated that pharmacy reviewed all ADC overrides. DPH 1 and Pharm Tech 51 were asked if the nurse who performed the override was compared against the authorized charge nurse, assigned to patient care unit, for the corresponding date and time. DPH 1 and Pharm Tech 51 stated that the nurses responsible for the overrides were not compared to the charge nurse staffing records. DPH 1 was asked if any irregularities were brought to his attention by Pharm Tech 51, for ADC overrides by unauthorized charge nurses. DPH 1 stated that no issues had been brought to his attention from 9/1-10/28/15.

During a concurrent interview and administrative record review, on 10/29/15 at 12:05 P.M., the hospital's Pharmacy and Therapeutics (P and T) committee minutes for 2015 were identified. Review of the minutes from 1/14/15, 4/8/15, and 7/8/15, did not show ADC overrides were discussed. DPH 1 identified the P and T minutes and acknowledged they did not show ADC overrides were discussed. DPH 1 stated the P and T committee did not provide direction for monitoring of the ADC override process.

During a concurrent interview and administrative record review, on 10/29/15 at 12:50 P.M., Registered Nurse (RN 1) identified Hospital A's 4 east RN schedule June 21-July 18, 2015 schedule (schedule of nursing assignments). RN 1 was requested to review the nursing schedule and identify the charge nurse on 6/28/15 at 12:46 P.M. and 7/1/15 7:17 P.M. RN 1 reviewed the document and stated the 4 east charge nurse responsibilities were not assigned on the schedule. RN 1 was requested to describe the charge nurse process for 4 east. RN 1 stated that she was the 4 east charge nurse 24 hours a day, seven days a week (all the time). RN 1 was requested to describe the quality assurance (measurement, analysis, and correction) process the hospital used to investigate the non-charge nurse overrides in the 4 east ADC. RN 1 stated that she had not been contacted to discuss overrides.

During a concurrent interview, on 10/29/15 at 2:45 P.M., Human Resource Manager (HRM) was asked if the hospital had a job description for the charge nurse. HRM stated the hospital had developed a charge nurse job description. HRM stated that the hospital's charge nurses were employed under the title of charge nurse.

During a concurrent interview and administrative record review, on 10/29/15 at 3:20 P.M., RN 1 identified Hospital A's Company 52 medication override report for 6/28-7/1/15. RN 1 acknowledged the report showed Staff 51 and Registered Nurse (RN 51) removed three medications from the ADC using the override process. RN 1 acknowledged neither person was the charge nurse assigned to 4 east at the documented override date and time. RN 1 was requested to describe the official hospital Company 52 ADC override process. RN 1 stated that she was not aware of an official ADC override process.

During a concurrent interview and administrative record review, on 10/29/15 at 2:45 P.M., HRM identified the current list of charge nurses in Company 52's ADC report (provided by pharmacy). The list identified individuals with the charge nurse security level that could override all medications in the ADC. HRM reviewed the list and identified 20, out of 136, individuals who were not charge nurses by job title.

During a concurrent interview and administrative record review, on 10/30/15 at 7:30 A.M., DPH 1 identified Hospital A's Company 52's Medication Order Override Report (9/1/15-10/28/15). Inspection of the report showed, from 9/1/15-10/28/15, 182 medications were removed from the ADC using the override process. Eight overrides were identified for review. DPH 1 inspected the overrides and identified three were performed by individuals who were not the assigned charge nurse. The overrides identified were 9/2/15 11:31 by Registered Nurse 52 on 4S, 9/8/15 3:16 by Registered Nurse 53 on 5S, and 10/15/15 12:55 by Registered Nurse 54 on 6N.

During a group interview, on 10/30/15 at 10:30 A.M., the hospital's pharmacy services were discussed. The group included Dir of Nursing/Performance Improvement Dir, Chief Nursing Officer (CNO), DPH 1, and Administrator (Admin). The discussion included the medication order was entered in Hospital A's Company 51 computer system. The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's ADC. Then the nurse could login to the ADC and obtain the authorized medication for the patient. The nurse scanned (computer reading of the bar code) the medication, prior to administration, at the patient bedside. The nurse administered the medication. CNO stated that a medication removed from the ADC, using an override, would not be scanned at the patient bedside. The group acknowledged a medication removed from the ADC, using an override, would not be verified by a pharmacist. The group acknowledged, pharmacist verification of a physician order and scanning of a medication at the patient bedside, were steps in the medication management process. These two steps helped to ensure medications were administered in a safe and effective manner. The group acknowledged administering medication without pharmacist verification theoretically increased the potential for a medication error. The group acknowledged administering medication without the nurse scanning the dose theoretically increased the potential for a medication error. The group acknowledged the hospital did not evaluate the override process to ensure only authorized charge nurses obtained medications from Hospital A's ADCs for administration to patients. The group was requested to describe the pharmacy department's reporting structure within the hospital. The group stated the pharmacy reported to Admin. The group stated that pharmacy submitted quality reports to the P and T and to the Performance Improvement committees.

An administrative record review, of the hospital's policy and procedure for automatic Drug Dispensing Cabinets, Company 51 (Last Reviewed: September 2014) did not show an override process for the removal of medication.

An administrative record review, of the hospital's policy and procedure for Performance Improvement Plan (Last Reviewed: July, 2015) showed, Goal and Objectives, "The primary goal is to provide a comprehensive Performance Improvement Program that will coordinate and integrate All performance improvement activities [Hospital Name]-wide to assure that the highest achievable safe and quality of care is delivered throughout [Hospital Name]...The intent of the plan is to increase the probability of desired patient outcomes,.." Continued review showed, Performance Improvement Priorities, "[Hospital Name] Leadership and Medical Staff will set performance improvement priorities for [Hospital Name] wide activities and patient health outcome, which is proportional to the scope and complexity of the [Hospital Name's] program. The program will include but not be limited to indicators for which there is evidence of improved health outcomes and the prevention and reduction of medical errors (medication errors)." Further review showed, A. Priorities are based on:, 5. High risk, high/low volume, or problem prone areas."

The American Society of Health System-Pharmacists (ASHP) is a professional organization composed of pharmacists. ASHP develops official professional policies, in the form of policy positions and guidance documents, in order to establish best practices and provide guidance to ASHP members and other audiences impacted by health-system pharmacy practice (including hospitals).

An administrative record review of the ASHP website at showed ASHP Guidelines on the Safe Use of Automated Dispensing Devices (ADC). Review of the document showed Override Access to Medications Through Automated Dispensing Devices, "All medication distribution systems have medication withdrawal functions that allow nurses and other caregivers limited access to certain medications before order review and approval by a pharmacist, especially in cases of patient emergencies. This function is typically referred to as an "override." Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacist, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error." Further review showed, Safety Checks, "The organization should have a written plan for ensuring the accuracy of (1) medications stored and accessed through an automated pharmacy system and (2) machine-readable identification on medication labels. This plan should provide...Policies and procedures designed to preclude errors, and, A quality-assurance program for reviewing override data and medication error data associated with the automated dispensing device and identifying opportunities for improvement, including a process for validating any medications that have been designated as high risk via machine-readable coding on removal."

An administrative record review, of the ASHP website at showed ASHP Statement on Bar-Code-Enabled Medication Administration Technology. Review of the document showed, Position, "The American Society of Health-System Pharmacists (ASHP) encourages health systems to adopt bar-code-enabled medication administration (BCMA) technology to improve patient safety and the accuracy of medication administration and documentation. Continued review showed, Role of the Pharmacist, "Pharmacist should take the lead in ensuring that the implementation of BCMA systems and the reengineering of the medication-use system address the complexities of the process and that the goal of improving patient safety is achieved. Poor design and inadequate planning can compromise the effectiveness of a BCMA system and may even introduce new sources of error into the medication-use process." Further review showed, "Implementation of a BCMA system must be accompanied by the development of policies and procedures that ensure the system's safety. These policies and procedures should be developed by an interdisciplinary team that includes pharmacist."

An administrative record review, of the hospital's List of Charge Nurses in Company 52 (Oct 29, 2015 10:29 A.M.) showed 137 staff had the security level to remove medications from the ADC using an override.

An administrative record review, of Hospital A's Company 52 Medication Order Override Report (Date Range: 9/1/2015-10/28/2015) showed 165 medications were removed from the ADCs using an override.

An administrative record review, of Hospital A's Admission Register by Account Number (For Date: 9/1/15-10/28/15) showed 1,927 patients were admitted to the hospital.




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2. On 10/29/15 beginning at 2:30 P.M., the dietary departments' performance improvement program was reviewed with Management Staff (MS 83). She described a program that monitored documentation of supplement consumption, water temperatures of the manual dishwashing sink at Hospital A as well as a review of unspecified diet orders. She also stated that she tabulated the data and forwarded it to performance improvement directors; however she had not analyzed the data to demonstrate whether or not the projects improved patient outcomes. She also stated that the selection topics to address came from previous State and/or Federal surveys.

Review of data beginning April through September 2015, the hospital identified issues with the necessity to clarify diet orders, the data was limited to a list of patients, the unspecified diet order, the physician who ordered the diet and the new diet order. There was no analysis of the data, nor was there a demonstration of how the clarification improved patient outcomes of hospital processes. MS 83 stated there were no performance improvement programs, with the exception of water temperatures, in relationship to food services at Hospital A. She also acknowledged there were no performance improvement activities in relationship to foodservices at Hospital B.

On 10/30/15 at 2:10 P.M., during a QAPI group interview, the Director of PI stated that he did not have a robust oversight (infection control surveillance/hospital wide QAPI). He was still building this program. He stated they have yearly meetings to discuss goals of each department but PI projects have been based on previous/identified deficiencies and required monitoring. He acknowledged that the QAPI program had not reached out to departments to establish individualized department QAPI goals.

Hospital policy titled "Performance Improvement Plan" dated July 2015 noted the goal of the hospitals' program was to "...reflect the complexity of the hospital's organization and services..."

Based on observation, interview and document review, the hospital failed to ensure that their performance improvement activities included the evaluation of high risk, problem prone areas. The hospital failed to monitor and evaluate the cleaning and disinfection procedures of surgical instruments, when an enzymatic agent (chemical used to remove debris), was not utilized in accordance with the hospital's approved policies and procedures.

There was no documented evidence to demonstrate that the hospital's Quality Assessment and Performance Improvement (QAPI) program had complete oversight over the sterile processing of surgical instruments, hand hygiene and the use of personal protective equipment (PPE - equipment used to protect against exposure to infection) in the Sterile Processing Unit (SPU). The failure to have a QAPI program in place to ensure oversight of the hospital-wide infection control program led to an increased risk for the transmission of infections amongst patients undergoing procedures.

Findings:

1 a. On 10/27/15 at approximately 1:00 P.M. to 3:50 P.M., an observation, interview and document review during a tour, with the Director of Nursing/Performance Improvement Director (DON/PID), Infection Control Preventionist (ICP 1) and Sterile Processing Technician (SP TECH 1), widespread deficient practice in the environment of care was observed throughout the Sterile Processing Unit decontamination room.

In a concurrent interview ICP 1 and DON/PID both stated, "Environmental Services is responsible for the general (environmental) cleaning". Neither staff members could provide specific information regarding the duties of environmental services (EVS) related to the decontamination room. EVS was not available for interview. DON/PID and ICP 1 acknowledged responsibility for the facility-wide infection control program that should include the SPU. The DON/PID stated the Nurse Director of Peri-Operative Services (NDOS) was responsible for the rounding in the SPU.

In a subsequent interview with NDOS at 5:00 P.M., The NDOS stated, "sometimes I can be through here (SPU) two times a week. Sometimes... not at all... It just depends on what is going on." ICP 1 acknowledged lack of formal communication regarding Infection Control (IC) surveillance in the SPU. ICP 1 stated "I have only had an orientation to the process of the SPU; we have not discussed surveillance".

1 b. On 10/27/15 on 1:00 P.M., and approximately 3:50 P.M., during a tour, interviews, observations and review of documentation of the SPU decontamination room, widespread pattern of potential ineffective cleaning, disinfection and lack of prevention of transference of infectious substance was revealed in the decontamination room of the SPU. The DON/PID, ICP 1, and SP TECH 1 acknowledged the deficient practice.

2. On 10/28/15 at 4:12 P.M., an Immediate Jeopardy (IJ) situation was determined related to the widespread pattern of potential ineffective cleaning, disinfection and lack of prevention of transference of infectious substances in the sterile processing unit. Sterility of surgical instruments could not be ensured due to the absence of an enzymatic product that must be used in the decontamination process per the hospital's own policy and procedures, titled "Sterilization and Disinfection, Sterile Processing Department" dated April 2015, pages 1-4, and a second policy and procedure titled, "Surgical Instruments, Care and Cleaning" dated June 2010.

In addition, the following standard practice deficiencies were found:
1) A substance was found around the edges of the decontamination sink and immediately above on the wall;
2) The sterile processing room was found with dust and debris throughout the unit and specifically, debris falling into the open container supplying detergent to the washer;
3) The STERIS washer was found not to be maintained per manufacture's instructions when a review of records revealed a lack of documentation;
4) The documentation of the washing cycle was not accurately recorded when the tape printed out erroneously that an enzymatic product was injected into the washer and lacked the documentation by the sterile processing
technician according to national recognized standards.

On 10/28/15 at approximately 8:30 A.M., during an observation and subsequent interviews, with ICP 1, Corporate Manager for Infection Prevention (ICP 2), DON/PID and NDOS, all reported that "others" were responsible for the oversight of maintaining the decontamination process.

The ICP 2 stated, she did not have prior knowledge of the sterile processing and decontamination area state of, "unacceptable practice in the environment of care services."

In addition, ICP 2 stated, and the NDOS nodded agreement, "this must change immediately." The ICP 1, ICP 2, DON/PID and NDOS acknowledged the instruments processed in this unit could not be ensured to be sterile. All verbalized acknowledgment that if sterility cannot be assured then the instruments must be reprocessed and re-sterilized.

On 10/28/15 at approximately 9:30 A.M., the NDOS acknowledged responsibility for the environmental cleaning of the sterile core, sub sterile unit, sterile processing and decontamination unit. She indicated, she did not communicate with the ICP nor did she have a practice or policy to consult the ICP regarding any on-going environmental issues other than an orientation of the ICP 1 to the SPU. Surveillance documentation on the above listed areas was requested. At the time of exit, the facility was unable to provide active surveillance documentation by the ICP and NDOS.

In a concurrent/ongoing interview, the NDOS revealed that she did not formally communicate issues with the environment of care in the sterile storage, sterile processing or decontamination areas with the ICP. NDOS acknowledged the need for improved cleaning. The NDOS indicated she does not have a specific mechanism for communication of the needs beyond calling in work orders and she did not know if this communication reached the ICP 1.

On 10/30/15 at approximately 9:30 A.M., in a record review, observation and interview, ICP 1 acknowledged that she did not have documentation from the rounds. ICP 1 stated that the surveillance is informal. ICP 1 stated that she was the responsible for the sterile processing and was not yet familiar with the policy and procedures for the units, if they exist. The ICP 1 acknowledged she was not familiar with the term "event related sterility", and the policy and procedure the facility follows as a standard of quality control for sterile surgical instruments and supplies. ICP 1 acknowledged she was not familiar with any job related infection control training provided to the staff.

In subsequent interview and record review at approximately 3:00 P.M., ICP 1, ICP 2 and the DON/PID, acknowledged a lack of coordination and oversight by infection control staff of the sterile processing unit and decontamination room. Each indicated the previous ICP, to their knowledge, did not actively conduct surveillance beyond the quarterly team facility rounds. Each acknowledged the lack of rounding in the SPU was not formally communicated.

On 10/30/15 at 9:50 A.M., a record review was conducted of the proposed schedule for the Environment of Care (EOC) rounds. Review of record titled, "EOC rounds" revealed the rounds in sterile processing were not completed in March 2015 or recently in September 2015, thus, ICP 2 acknowledged the broad sweep of the EOC rounds scheduled were not conducted to date for the SPU.

Based on interview, the Chairman of the Medical Staff Department of Surgery was not given responsibility for the medical care provided to surgical patients by not being aware of failures in the performance of surgical instrument processing and sterilization. In addition, he was not made aware by the Governing Body, that survey findings resulted in cancellation of surgeries and the institution of bypass for the Operating Rooms (ORs), the Emergency Department (ED), and Labor and Delivery (mother/baby unit). This resulted in the medical staff not having responsibility, knowledge or input into events ongoing during the survey.

Findings:

The Chairman of Surgery for the Medical Staff (a Physician) was interviewed on 10/30/15 at 9:40 A.M. He stated that he had been at the hospital and on-call for surgery for most of the preceding days. He had not been aware that the survey team had found issues with the sterile processing of surgical instruments. He had not been aware that the ORs, Mother-Baby unit (unable to provide caesarian deliveries) and the ED had been on bypass for several hours. He wondered why his on-call had been so quiet. He was informed shortly before meeting with surveyors on 10/30/15. The Administrator stated that an email had been sent out but he could not verify that any other communication was made with the Chairman of Surgery.

Based on interview, record and document review, Nursing Leadership did not provide adequate oversight, to establish and maintain safe and effective care of patients, when Nursing Leadership:


1. Failed to ensure that the Chief Nursing Officer had nursing oversight on medication overrides by charge nurses. There was no documented evidence to demonstrate that medication overrides by charge nurses were monitored and evaluated to ensure that patient and medication safety measures were in place. (A-386 #1)

2. Failed to ensure that the Chief Nursing Officer had oversight on the nurse staffing and organization of their Spine Unit. There was no documented evidence that a written staffing plan had been developed to address the staffing needs, nursing care and scope of service of the Spine Unit. (A-386 #2)

3. Failed to ensure comprehensive nursing admission assessments were completed. (A-395 #1, 2)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Nursing Services.

Based on observation, interview and document review, the hospital failed to ensure that the Chief Nursing Officer (CNO) had nursing oversight on medication overrides by charge nurses. There was no documented evidence to demonstrate that medication overrides by charge nurses were monitored and evaluated to ensure that patient and medication safety measures were in place. The CNO also failed to ensure that there was oversight on the nurse staffing and organization of their Spine Unit. There was no documented evidence that a written staffing plan had been developed to address the staffing needs, nursing care and scope of service of the Spine Unit, which was opened in May 2014 for patient care.

Failure to ensure nursing oversight for medication overrides by charge nurses posed a patient/medication safety concern, potential patient exposure to avoidable medication errors and increased risk of medication diversion.

The lack of a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care impeded the CNO from having nursing oversight and ensuring that the operation of services, staffing plan and nursing care was provided to meet the needs of the patients in the Spine Unit.

Findings:

1. During an interview, on 10/28/15 at 10:50 A.M., in the pharmacy, Director of Pharmacy (DPH 1) and Pharmacy Technician (Pharm Tech 51) were requested to describe Hospital A's pharmacy services (safe and appropriate use of medications (ordering, pharmacist review for appropriateness, distribution, and dispensing). DPH 1 stated that Hospital A's pharmacy was open (staffed with a pharmacist) 24 hours a day, seven days a week. Their description included that the medication order was entered in Hospital A's Company 51's computer system (electronic record). The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's Company 52's (automated medication dispensing cabinet (ADC)). Then the nurse could login to the ADC and obtain the authorized medication for the patient. DPH 1 and Pharm Tech 51 described that select medications, needed in an emergency, were available to all nurses through the ADC override process. The override process permitted the nurse to remove a medication prior to a pharmacist review of the physician order. DPH 1 and Pharm Tech 51 stated all medications in the ADC were authorized to be available, using the override process, to the shift charge nurse on each nursing unit. Pharm Tech 51 stated that a list of charge nurses was maintained in the ADC. The ADC list was updated by pharmacy once a quarter.

During a concurrent interview and administrative record review, on 10/29/15 at 12:50 P.M., Registered Nurse (RN 1) identified Hospital A's Spine Unit (4 east) RN schedule June 21-July 18, 2015 (schedule of nursing assignments). RN 1 was requested to review the nursing schedule and identify the charge nurse on 6/28/15 at 12:46 P.M. and 7/1/15 at 7:17 P.M. RN 1 reviewed the document and stated the 4 east charge nurse responsibilities were not assigned on the schedule. RN 1 was requested to describe the charge nurse process for 4 east. RN 1 stated that she was the 4 east charge nurse 24 hours a day, seven days a week (all the time). RN 1 was requested to describe the quality assurance (measurement, analysis, and correction) process the hospital used to investigate the non-charge nurse overrides in the 4 east ADC. RN 1 stated that she had not been contacted to discuss overrides.

During a concurrent interview, on 10/29/15 at 2:45 P.M., Human Resource Manager (HRM) was asked if the hospital had a job description for the charge nurse. HRM stated the hospital had developed a charge nurse job description. HRM stated that the hospital's charge nurses were employed under the title of charge nurse.

During a concurrent interview and administrative record review, on 10/29/15 at 3:20 P.M., RN 1 identified Hospital A's Company 52 medication override report for 6/28/15-7/1/15. RN 1 acknowledged the report showed Staff 51 and Registered Nurse (RN 51) removed three medications from the ADC using the override process. RN 1 acknowledged neither person was the charge nurse assigned to 4 east at the documented override date and time. RN 1 was requested to describe the official hospital Company 52 ADC override process. RN 1 stated that she was not aware of an official ADC override process.

During a concurrent interview and administrative record review, on 10/29/15 at 2:45 P.M., HRM identified the current list of charge nurses in Company 52's ADC report (provided by pharmacy). The list identified individuals with the charge nurse security level that could override all medications in the ADC. HRM reviewed the list and identified 20, out of 136, individuals who were not charge nurses by job title.

During a concurrent interview and administrative record review, on 10/30/15 at 7:30 A.M., DPH 1 identified Hospital A's Company 52's Medication Order Override Report (9/1/15-10/28/15). Inspection of the report showed, from 9/1/15-10/28/15, 182 medications were removed from the ADC using the override process. Eight overrides were identified for review. DPH 1 inspected the overrides and identified three were performed by individuals who were not the assigned charge nurse. The overrides identified were 9/2/15 11:31 by Registered Nurse 52 on 4S, 9/8/15 3:16 by Registered Nurse 53 on 5S, and 10/15/15 12:55 by Registered Nurse 54 on 6N.

An administrative record review, of the hospital's List of Charge Nurses in Company 52 (Oct 29, 2015 10:29 A.M.) showed 137 staff had the security level to remove medications from the ADC using an override.

An administrative record review of Hospital A's Company 52 Medication Order Override Report (Date Range: 9/1/2015-10/28/2015), showed 165 medications were removed from the ADCs using an override.

An administrative record review of Hospital A's Admission Register by Account Number (For Date: 9/1/15-10/28/15), showed 1,927 patients were admitted to the hospital.

During a group interview, on 10/30/15 at 10:30 A.M., the hospital's pharmacy services were discussed. The group included the Director of Nursing/Performance Improvement Director, Chief Nursing Officer (CNO), DPH 1, and Administrator (Admin). The discussion was about medication orders entered into Hospital A's Company 51 computer system. The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's ADC. Then the nurse could login to the ADC and obtain the authorized medication for the patient. The nurse scanned (computer reading of the bar code) the medication, prior to administration, at the patient bedside. The nurse administered the medication. CNO stated that a medication removed from the ADC, using an override, would not be scanned at the patient bedside. The group acknowledged a medication removed from the ADC, using an override, would not be verified by a pharmacist. The group acknowledged, pharmacist verification of a physician order and scanning of a medication at the patient bedside, were steps in the medication management process. These two steps helped to ensure medications were administered in a safe and effective manner. The group acknowledged administering medication without pharmacist verification theoretically increased the potential for a medication error. The group acknowledged administering medication without the nurse scanning the dose theoretically increased the potential for a medication error. The group acknowledged the hospital did not evaluate the override process to ensure only authorized charge nurses obtained medications from Hospital A's ADCs for administration to patients.

2. An interview with the CNO was conducted on 10/29/15 at 2:00 P.M. The CNO stated that the Spine Unit located on the 4th floor (4 East) was opened in May 2014. There was no documented staffing plan for the unit to address the nurse staffing needs and scope of service for patient care. The CNO stated that the hospital's Medical Surgical Scope of Service should have included the Spine Unit, as the unit was an extension of their medical-surgical services which was located on the 6th floor. The CNO stated that the 6th floor Medical Surgical charge nurse would cover both units.

On 10/29/15 at 3:24 P.M., a tour of the Spine Unit located on the 4th floor (4 East) was conducted with the CNO. General observations were conducted. There were 10 private room beds. There were no patients in the unit at the time of the tour and observations.

A review of the hospital's policy titled "Scope of Service, Medical/Surgical Services", dated 6/2014, was conducted. The policy's intent indicated that "Medical/Surgical Services is comprised of a nursing unit in which specialty-trained nurses and supportive personnel provide continuous medical/surgical nursing services. The majority of the patient population served are adults, 16 years of age and older." Per the policy, "Daily operations are under the direction of the director and the lead charge nurses. The charge nurse is typically without a patient care assignment." The policy contained a staffing plan, scope and complexity of patient care needs and type of patients served. The policy did not address or include the hospital's Spine Unit located in 4 East.

An interview with RN 3 (an RN who has floated to the Spine Unit) was conducted on 10/29/15 at 3:33 P.M. RN 3 stated that she had worked at the hospital for over 1 year and had floated to the Spine Unit a few times. RN 3 stated that there was 1 charge nurse and 1 floor nurse in the Spine Unit. Each nurse had a patient care assignment per RN 3. She recalled the last time she was on the Spine Unit, the charge nurse had a patient care assignment in addition to being the charge nurse of the unit.

An interview with the clinical coordinator of the Spine Unit (Registered Nurse - RN 1) was conducted on 10/29/15 at 3:46 P.M. RN 1 stated that since the Spine Unit opened in May 2014, on average, the unit had 1-3 patients. RN 1 stated that the unit was staffed with a minimum of 2 RNs for every 12 hour shift even if there was only 1 patient in the unit. She stated that the Spine Unit followed the staffing plan of the Medical Surgical unit because it was a sub-specialty of medical surgical services. RN 1 stated their nurse staffing ratio was 5 patients to 1 RN. RN 1 stated that from Monday to Friday 8:00 A.M. to 6:00 P.M., she was the assigned charge nurse for the Spine Unit. She stated that during the night shift, a nursing supervisor would be in charge. However, she acknowledged that the Spine Unit's Patient Care Assignment sheets from 9/1/15 to 10/27/15, did not contain documented evidence of an assigned charge nurse in the unit. The Patient Care Assignment sheets did not have a charge nurse listed (only blank entries), or in most instances, the "charge nurse" section of the form, a zero was entered.

An interview with RN 4 (charge nurse of the Medical Surgical unit/6th Floor) was conducted on 11/3/15 at 8:33 A.M. RN 4 had worked at the hospital as a full time RN for 26 years. From May 2014 to 11/3/15, RN 4 stated that she had not been the charge nurse for the Spine Unit. As a charge nurse on the medical surgical floor, RN 4 was not aware of any email, memo, meeting or discussion that had taken place regarding the charge nurse coverage in the Spine Unit.

A follow-up interview with the CNO was conducted on 11/3/15 at 8:50 A.M. The CNO did not know why RN 4 was not able to validate the hospital's staffing plan to include charge nurse coverage in the Spine Unit nor why RN 3's recollection of the Spine Unit charge nurse having a patient care assignment. The CNO acknowledged that there discrepancies in the information obtained from staff and what leadership had explained was the staffing plan to include charge nurse coverage in the Spine Unit. The CNO was also not able to provide documented evidence to demonstrate the planning and discussions that took place to address the Spine Unit staffing plan and scope of service.

Based on medical record review, nursing staff interview and document review, Hospital A failed to ensure comprehensive nursing admission assessment of 2 patients (81, 83) in a sample of 33. Failure to effectively assess patients at the time of admission may result in delayed care leading to poor patient outcomes, further compromising medical status. Patient 81 was not effectively assessed for history of substance abuse, wound screening, fluid assessment and necessity for potential bowel care. Patient 83 was not effectively assessed for risk of blood clots.

Findings:

1. Patient 81 was transferred to the general acute care unit from the hospitals' inpatient behavioral health unit with diagnoses including acute renal failure, cyclical vomiting (vomiting that has no apparent cause) and low sodium levels. Admission diet order, dated 10/26/15, was for a clear liquid diet. Admission orders, dated 10/26/15, also included administration of intravenous fluids and strict fluid intake/output documentation. Admission history and physical dated 10/23/15, noted the patient had a history of substance abuse issues. Medical record review was conducted on 10/28/15 beginning at 8:30 A.M. with Registered Nurse (RN) 82.

Nursing admission assessment dated 10/23/15, completed by an RN, failed to fully and/or accurately assess the patient at the time of admission to the unit. The assessment failed to identify the history of substance abuse; there was a decline in the level of independence and/or function but did not describe the extent of the decline. The assessment also noted that the last bowel movement was on 10/22/15.

The assessment also indicated that Patient 81 had a wound on his left upper arm that was present on admission. The electronic assessment guided nursing staff to complete the MRSA (methicillin-resistant Staphylococcus Aureus - an infection caused by a type of staph bacteria that's become resistant to many of the antibiotics used to treat). The MRSA screening was not completed. Hospital policy titled "Management of Patients with MRSA", dated 2/2013, guided staff that all patients with any open wounds "will be screened ...for MRSA within 24 hours of admission to the unit ..."

A comprehensive nutrition assessment dated 10/28/15, completed by the Registered Dietitian estimated Patient 81's fluid need as 2610-3045 milliliters (ml-a metric unit of measure) per day. It was also noted that his glomerular filtration rate was greater than 60 a value that is indicative of kidney damage with mild loss of kidney function (National Kidney Foundation). His potassium value was also noted to be 2.9 mmol/Liter (a metric unit of measure, normal 3.5-5.0 mmol/Liter). Low levels of potassium may affect the heart, nerves and kidneys (Mayo Clinic, 2005).

Review of fluid input/output records revealed that on 10/27 and 10/28/15 the patient received 4600 ml and 5140 ml of fluid respectively, a value that was significntly above his assessed fluid needs. Excessive fluids may also contribute to decreased levels of sodium in the blood. In a concurrent interview with RN 82 she acknowledged that there was no assessment of the intake and output records and that likely there was not strict recording in accordance with the physicians' orders. She also stated that it was likely the order should have been clarified with the physician with respect to parameters for fluid intake. Hospital policy titled "Intake and Output", dated 4/2012, noted it was the responsibility of "An RN or LVN [licensed vocational nurse] to determine adequacy of I[intake]/O[output] and notify physician when indicated." Hospital policy titled "Assessment-Inpatient Admission", dated 8/2015, relied on nursing staff to "...document and report significant findings...identify needs and problems, which will be the basis of the patient's plan of care..."

Concurrent review of medical record with RN 82 revealed that there was no documented evidence of a bowel movement for Patient 81 since 10/22/15 (6 days earlier). She acknowledged that it did not appear that nursing staff recognized nor validated the absence of a bowel movement. Hospital policy titled "Bowel Program, Adult", dated 1/2014, that upon "admission the RN will assess patient's normal pattern/frequency of bowel elimination ..." Hospital policy titled "Assessment-Inpatient Admission", dated 8/2015, relied on nursing staff to complete a "focused reassessment" focusing on newly identified abnormal findings.

2. Patient 83 was admitted with diagnosis including altered level of consciousness, septic shock (an infection on the bloodstream), pneumonia (an infection of the lungs) and congestive heart failure. Physician orders dated 10/18/15 included heparin injection (a medication used to treat blood clots) 5,000 units every 8 hours.

Comprehensive nursing admission assessment dated 10/18/15 and completed by the RN revealed that the patient was at risk for a venous thromboembolism (VTE-the formation of blood clots in the vein). While the patient was identified at risk, the risk assessment was not completed at the time of admission, rather was not completed until 10/25/15 (7 days later) at which time the patient was assessed with a score of 7. A Score of greater than 5 was designated as "highest risk." Hospital policy titled "Venous Thromboembolism Protocol", dated 9/2013, noted that patients with a VTE risk score of greater or equal to 5 will require mechanical and pharmacologic interventions. The policy also guided the RN to implement a physician critical call back sequence to notify of the high risk patient. The hospital did not identify the risk in accordance with hospital policy nor notified the physician of the "highest risk" score once the assessment was completed.

Based on observation, interview, and administrative record review, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. Hospital's failure to ensure the development and implementation of a policy and procedure for automated dispensing cabinet (ADC) medication override. The hospital authorized the nursing unit's assigned charge nurse to have automated dispensing cabinet (ADC) override access security for the removal of medications. A sample 11 ADC overrides did not show six medications were removed by the authorized charge nurse. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff (See A-0491).

2. Hospital's failure to ensure the development and implementation of a policy and procedure to limit access to medications before orders have been reviewed and approved by a pharmacist. The hospital authorized the nursing unit's assigned charge nurse to have automated dispensing cabinet (ADC) override access security for the removal of medications. A sample 11 ADC overrides did not show six medications were removed by the authorized charge nurse. These six medication orders were not reviewed and approved by a pharmacist before administration. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff (See A-0500 #1).

3. Hospital's failure to ensure medications stored in automated dispensing cabinets (ADC) were secured from unauthorized override. The hospital authorized the nursing unit's assigned charge nurse to have ADC override access security for the removal of medications. A sample 11 ADC overrides did not show showed six medications were removed by the authorized charge nurse. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff (See A-0502).

4. Hospital's failure to ensure that outdated injectable solutions and biological supplies were not available for patient use in the Emergency Department (ED). Expired date injectable saline solutions and opened, undated and partially used biological solutions were stored and available for use in the ED supply. (See A-0505)

5. Hospital A failed to ensure that their policy and procedure for labeling medications guided licensed staff related to labeling of floor stocked (supply located on the nursing unit) medications. The lack of labeling did not ensure the safe distribution of the medication. (See A-0500 #2)


The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on interview and record review, the hospital failed to ensure the development and implementation of a policy and procedure for automated dispensing cabinet (ADC) medication override. The hospital authorized the nursing unit's assigned charge nurse to have automated dispensing cabinet (ADC) override access security for the removal of medications. A sample 11 ADC overrides did not show six medications were removed by the authorized charge nurse. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff.

Findings:

During an interview, on 10/28/15 at 10:50 A.M., in the pharmacy, Director of Pharmacy (DPH 1) and Pharmacy Technician (Pharm Tech 51) were requested to describe Hospital A's pharmacy services (safe and appropriate use of medications (ordering, pharmacist review for appropriateness, distribution, and dispensing). DPH 1 stated that Hospital A's pharmacy was open (staffed with a pharmacist) 24 hours a day, seven days a week. Their description included the medication order was entered in Hospital A's Company 51's computer system (electronic record). The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's Company 52's (automated medication dispensing cabinet (ADC)). Then the nurse could login to the ADC and obtain the authorized medication for the patient. DPH 1 and Pharm Tech 51 described that select medications, needed in an emergency, were available to all nurses through the ADC override process. The override process permitted the nurse to remove a medication prior to a pharmacist review of the physician order. DPH 1 and Pharm Tech 51 stated all medications in the ADC were authorized to be available, using the override process, to the shift charge nurse on each nursing unit. Pharm Tech 51 stated that a list of charge nurses was maintained in the ADC. The ADC list was updated by pharmacy once a quarter.

During a concurrent interview and administrative record review, on 10/29/15 at 12:50 P.M., Registered Nurse (RN 1) identified Hospital A's 4 east RN schedule June 21-July 18, 2015 schedule (schedule of nursing assignments). RN 1 was requested to review the nursing schedule and identify the charge nurse on 6/28/15 at 12:46 P.M. and 7/1/15 at 7:17 P.M. RN 1 reviewed the document and stated the 4 east charge nurse responsibilities were not assigned on the schedule. RN 1 was requested to describe the charge nurse process for 4 east. RN 1 stated that she was the 4 east charge nurse 24 hours a day, seven days a week (all the time). RN 1 was requested to describe the quality assurance (measurement, analysis, and correction) process the hospital used to investigate the non-charge nurse overrides in the 4 east ADC. RN 1 stated that she had not been contacted to discuss overrides.

During a concurrent interview, on 10/29/15 at 2:45 P.M., Human Resource Manager (HRM) was asked if the hospital had a job description for the charge nurse. HRM stated the hospital had developed a charge nurse job description. HRM stated that the hospital's charge nurses were employed under the title of charge nurse.

During a concurrent interview and administrative record review, on 10/29/15 at 3:20 P.M., RN 1 identified Hospital A's Company 52 medication override report for 6/28-7/1/15. RN 1 acknowledged the report showed Staff 51 and Registered Nurse (RN 51) removed three medications from the ADC using the override process. RN 1 acknowledged neither person was the charge nurse assigned to 4 east at the documented override date and time. RN 1 was requested to describe the official hospital Company 52 ADC override process. RN 1 stated that she was not aware of an official ADC override process.

During a concurrent interview and administrative record review, on 10/29/15 at 2:45 P.M., HRM identified the current list of charge nurses in Company 52's ADC report (provided by pharmacy). The list identified individuals with the charge nurse security level that could override all medications in the ADC. HRM reviewed the list and identified 20, out of 136, individuals who were not charge nurses by job title.

During a concurrent interview and administrative record review, on 10/30/15 at 7:30 A.M., DPH 1 identified Hospital A's Company 52's Medication Order Override Report (9/1/15-10/28/15). Inspection of the report showed, from 9/1/15-10/28/15, 182 medications were removed from the ADC using the override process. Eight overrides were identified for review. DPH 1 inspected the overrides and identified three were performed by individuals who were not the assigned charge nurse. The overrides identified were 9/2/15 11:31 by Registered Nurse 52 on 4S, 9/8/15 3:16 by Registered Nurse 53 on 5S, and 10/15/15 12:55 by Registered Nurse 54 on 6N.

An administrative record review, of the hospital's policy and procedure for automatic Drug Dispensing Cabinets, Company 51 (Last Reviewed: September 2014) did not show an override process for the removal of medication.

The American Society of Health System-Pharmacists (ASHP) is a professional organization composed of pharmacists. ASHP develops official professional policies, in the form of policy positions and guidance documents, in order to establish best practices and provide guidance to ASHP members and other audiences impacted by health-system pharmacy practice (including hospitals).

An administrative record review of the ASHP website at showed ASHP Guidelines on the Safe Use of Automated Dispensing Devices (ADC). Review of the document showed Override Access to Medications Through Automated Dispensing Devices, "All medication distribution systems have medication withdrawal functions that allow nurses and other caregivers limited access to certain medications before order review and approval by a pharmacist, especially in cases of patient emergencies. This function is typically referred to as an "override." Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacist, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error." Further review showed, Safety Checks, "The organization should have a written plan for ensuring the accuracy of (1) medications stored and accessed through an automated pharmacy system and (2) machine-readable identification on medication labels. This plan should provide...Policies and procedures designed to preclude errors, and, A quality-assurance program for reviewing override data and medication error data associated with the automated dispensing device and identifying opportunities for improvement, including a process for validating any medications that have been designated as high risk via machine-readable coding on removal."

An administrative record review, of the hospital's List of Charge Nurses in Company 52 (Oct 29, 2015 10:29 A.M.) showed 137 staff had the security level to remove medications from the ADC using an override.

An administrative record review, of Hospital A's Company 52 Medication Order Override Report (Date Range: 9/1/2015-10/28/2015) showed 165 medications were removed from the ADCs using an override.

An administrative record review, of Hospital A's Admission Register by Account Number (For Date: 9/1/15-10/28/15) showed 1,927 patients were admitted to the hospital.

Based on observations, interview, record and document review, the hospital failed to ensure the development and implementation of a policy and procedure to limit access to medications before orders have been reviewed and approved by a pharmacist. The hospital authorized the nursing unit's assigned charge nurse to have automated dispensing cabinet (ADC) override access security for the removal of medications. A sample of 11 ADC overrides did not show six medications were removed by the authorized charge nurse. These six medication orders were not reviewed and approved by a pharmacist before administration. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff.

In addition, Hospital A failed to ensure that their policy and procedure for labeling medications guided licensed staff related to labeling of floor stocked (supply located on the nursing unit) medications, for 1 of 33 sampled patients (22). The lack of labeling did not ensure the safe distribution of the medication.

Findings:

1. During an interview, on 10/28/15 at 10:50 A.M., in the pharmacy, Director of Pharmacy (DPH 1) and Pharmacy Technician (Pharm Tech 51) were requested to describe Hospital A's pharmacy services (safe and appropriate use of medications (ordering, pharmacist review for appropriateness, distribution, and dispensing). DPH 1 stated that Hospital A's pharmacy was open (staffed with a pharmacist) 24 hours a day, seven days a week. Their description included the medication order was entered in Hospital A's Company 51's computer system (electronic record). The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's Company 52's (automated medication dispensing cabinet (ADC)). Then the nurse could login to the ADC and obtain the authorized medication for the patient. DPH 1 and Pharm Tech 51 described that select medications, needed in an emergency, were available to all nurses through the ADC override process. The override process permitted the nurse to remove a medication prior to a pharmacist review of the physician order. DPH 1 and Pharm Tech 51 stated all medications in the ADC were authorized to be available, using the override process, to the shift charge nurse on each nursing unit. Pharm Tech 51 stated that a list of charge nurses was maintained in the ADC. The ADC list was updated by pharmacy once a quarter.

During a concurrent interview and administrative record review, on 10/29/15 at 12:50 P.M., Registered Nurse (RN 1) identified Hospital A's 4 east RN schedule June 21-July 18, 2015 schedule (schedule of nursing assignments). RN 1 was requested to review the nursing schedule and identify the charge nurse on 6/28/15 at 12:46 P.M. and 7/1/15 7:17 P.M. RN 1 reviewed the document and stated the 4 east charge nurse responsibilities were not assigned on the schedule. RN 1 was requested to describe the charge nurse process for 4 east. RN 1 stated that she was the 4 east charge nurse 24 hours a day, seven days a week (all the time). RN 1 was requested to describe the quality assurance (measurement, analysis, and correction) process the hospital used to investigate the non-charge nurse overrides in the 4 east ADC. RN 1 stated that she had not been contacted to discuss overrides.

During a concurrent interview, on 10/29/15 at 2:45 P.M., Human Resource Manager (HRM) was asked if the hospital had a job description for the charge nurse. HRM stated the hospital had developed a charge nurse job description. HRM stated that the hospital's charge nurses were employed under the title of charge nurse.

During a concurrent interview and administrative record review, on 10/29/15 at 3:20 P.M., RN 1 identified Hospital A's Company 52 medication override report for 6/28-7/1/15. RN 1 acknowledged the report showed Staff 51 and Registered Nurse (RN 51) removed three medications from the ADC using the override process. RN 1 acknowledged neither person was the charge nurse assigned to 4 east at the documented override date and time. RN 1 was requested to describe the official hospital Company 52 ADC override process. RN 1 stated that she was not aware of an official ADC override process.

During a concurrent interview and administrative record review, on 10/29/15 at 2:45 P.M., HRM identified the current list of charge nurses in Company 52's ADC report (provided by pharmacy). The list identified individuals with the charge nurse security level that could override all medications in the ADC. HRM reviewed the list and identified 20, out of 136, individuals who were not charge nurses by job title.

During a concurrent interview and administrative record review, on 10/30/15 at 7:30 A.M., DPH 1 identified Hospital A's Company 52's Medication Order Override Report (9/1/15-10/28/15). Inspection of the report showed, from 9/1/15-10/28/15, 182 medications were removed from the ADC using the override process. Eight overrides were identified for review. DPH 1 inspected the overrides and identified three were performed by individuals who were not the assigned charge nurse. The overrides identified were 9/2/15 11:31 by Registered Nurse 52 on 4S, 9/8/15 3:16 by Registered Nurse 53 on 5S, and 10/15/15 12:55 by Registered Nurse 54 on 6N.

During a group interview, on 10/30/15 at 10:30 A.M., the hospital's pharmacy services were discussed. The group included Dir of Nursing/Performance Improvement Dir, Chief Nursing Officer (CNO), DPH 1, and Administrator (Admin). The discussion included the medication order was entered in Hospital A's Company 51 computer system. The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's ADC. Then the nurse could login to the ADC and obtain the authorized medication for the patient. The nurse scanned (computer reading of the bar code) the medication, prior to administration, at the patient bedside. The nurse administered the medication. CNO stated that a medication removed from the ADC, using an override, would not be scanned at the patient bedside. The group acknowledged a medication removed from the ADC, using an override, would not be verified by a pharmacist. The group acknowledged, pharmacist verification of a physician order and scanning of a medication at the patient bedside, were steps in the medication management process. These two steps helped to ensure medications were administered in a safe and effective manner. The group acknowledged administering medication without pharmacist verification theoretically increased the potential for a medication error. The group acknowledged administering medication without the nurse scanning the dose theoretically increased the potential for a medication error. The group acknowledged the hospital did not evaluate the override process to ensure only authorized charge nurses obtained medications from Hospital A's ADCs for administration to patients. The group was requested to describe the pharmacy department's reporting structure within the hospital. The group stated the pharmacy reported to Admin. The group stated that pharmacy submitted quality reports to the P and T and to the Performance Improvement committees.

An administrative record review, of the hospital's policy and procedure for automatic Drug Dispensing Cabinets, Company 51 (Last Reviewed: September 2014) did not show an override process for the removal of medication.

The American Society of Health System-Pharmacists (ASHP) is a professional organization composed of pharmacists. ASHP develops official professional policies, in the form of policy positions and guidance documents, in order to establish best practices and provide guidance to ASHP members and other audiences impacted by health-system pharmacy practice (including hospitals).

An administrative record review of the ASHP website at showed ASHP Guidelines on the Safe Use of Automated Dispensing Devices (ADC). Review of the document showed Override Access to Medications Through Automated Dispensing Devices, "All medication distribution systems have medication withdrawal functions that allow nurses and other caregivers limited access to certain medications before order review and approval by a pharmacist, especially in cases of patient emergencies. This function is typically referred to as an "override." Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacist, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error." Further review showed, Safety Checks, "The organization should have a written plan for ensuring the accuracy of (1) medications stored and accessed through an automated pharmacy system and (2) machine-readable identification on medication labels. This plan should provide...Policies and procedures designed to preclude errors, and, A quality-assurance program for reviewing override data and medication error data associated with the automated dispensing device and identifying opportunities for improvement, including a process for validating any medications that have been designated as high risk via machine-readable coding on removal."

An administrative record review, of the hospital's List of Charge Nurses in Company 52 (Oct 29, 2015 10:29 A.M.) showed 137 staff had the security level to remove medications from the ADC using an override.

An administrative record review, of Hospital A's Company 52 Medication Order Override Report (Date Range: 9/1/2015-10/28/2015) showed 165 medications were removed from the ADCs using an override.

An administrative record review, of Hospital A's Admission Register by Account Number (For Date: 9/1/15-10/28/15) showed 1,927 patients were admitted to the hospital.





29499


2. On 10/27/15 at 11:15 A.M., a tour of the fifth floor telemetry unit was conducted with the Nurse Director of Telemetry (NDOT) and the Director of Rehabilitation Services (DRS).

Patient 22 had an empty medication bag (floor stock) of potassium chloride hanging from an IV (intravenous - in the vein) pole. There was no documented evidence on the medication bag to indicate the patient's name, date, time and rate the medication was administered. In addition, there was no authentication by the Registered Nurse (RN) who had hung the IV bag for administration.

On 10/27/15 at 11:20 A.M., an interview was conducted with the NDOT, DRS and RN 25. RN 25 acknowledged that she hung Patient 22's potassium chloride medication bag but had not labeled it. RN 25 stated that she did not initial the medication bag with the required information which would include patient's name, date, time and rate of administration. The NDOT and DRS were not aware of a policy related to labeling floor stocked medications however, the NDOT stated the hospital's expectation was that all medications indicated patient's name, date, time and rate the medication was administered and initialed by the RN.

On 10/29/15 at 2:15 P.M., a review of Patient 22's medical record was conducted. Patient 22 was admitted to Hospital A on 10/23/15 per the Admission Registration record dated 10/27/15.

According to the physician's orders dated 10/27/15, Patient 22 had orders for 10 milliequivalent (meq) potassium chloride via IV route at 50 milliliters per hour (mls/hr).

An administrative record review of the hospital's policy and procedure titled "Labeling of Medications" dated 9/2014, did not show a procedure to label floor stock IV solutions with patient name, date and time the fluid was started, and the rate the fluid was administered.

During an interview on 10/29/15 at 4:30 P.M., the Chief Nursing Officer (CNO) acknowledged that the hospital did not have a policy and procedure directing the labeling of floor stock intravenous solutions. The CNO stated the hospital's minimum expectation was for labeling of a patient's IV solution to include the patient's name, date and time the IV fluid was started, and the rate the fluid was administered.

Based on interview and record review, the hospital failed to ensure medications stored in automated dispensing cabinets (ADC) were secured from unauthorized override (access). The hospital authorized the nursing unit's assigned charge nurse to have ADC override access security for the removal of medications. A sample 11 ADC overrides did not show six medications were removed by the authorized charge nurse. These failures resulted in the potential for 1,927 patients, from 9/1/15-10/28/15, to be exposed to avoidable medication errors from 165 ADC medication overrides by 137 staff.

Findings:

During an interview, on 10/28/15 at 10:50 A.M., in the pharmacy, Director of Pharmacy (DPH 1) and Pharmacy Technician (Pharm Tech 51) were requested to describe Hospital A's pharmacy services (safe and appropriate use of medications (ordering, pharmacist review for appropriateness, distribution, and dispensing). DPH 1 stated that Hospital A's pharmacy was open (staffed with a pharmacist) 24 hours a day, seven days a week. Their description included the medication order was entered in Hospital A's Company 51's computer system (electronic record). The medication order was then reviewed by a pharmacist for appropriateness. The pharmacist then verified (released in the computer system for nursing to act upon) the order. After the order was verified the patient's medication was authorized to be dispensed from Hospital A's Company 52's (automated medication dispensing cabinet (ADC)). Then the nurse could login to the ADC and obtain the authorized medication for the patient. DPH 1 and Pharm Tech 51 described that select medications, needed in an emergency, were available to all nurses through the ADC override process. The override process permitted the nurse to remove a medication prior to a pharmacist review of the physician order. DPH 1 and Pharm Tech 51 stated all medications in the ADC were authorized to be available, using the override process, to the shift charge nurse on each nursing unit. Pharm Tech 51 stated that a list of charge nurses was maintained in the ADC. The ADC list was updated by pharmacy once a quarter.

During a concurrent interview and administrative record review, on 10/29/15 at 12:50 P.M., Registered Nurse (RN 1) identified Hospital A's 4 east RN schedule June 21-July 18, 2015 schedule (schedule of nursing assignments). RN 1 was requested to review the nursing schedule and identify the charge nurse on 6/28/15 at 12:46 P.M. and 7/1/15 at 7:17 P.M. RN 1 reviewed the document and stated the 4 east charge nurse responsibilities were not assigned on the schedule. RN 1 was requested to describe the charge nurse process for 4 east. RN 1 stated that she was the 4 east charge nurse 24 hours a day, seven days a week (all the time). RN 1 was requested to describe the quality assurance (measurement, analysis, and correction) process the hospital used to investigate the non-charge nurse overrides in the 4 east ADC. RN 1 stated that she had not been contacted to discuss overrides.

During a concurrent interview, on 10/29/15 at 2:45 P.M., Human Resource Manager (HRM) was asked if the hospital had a job description for the charge nurse. HRM stated the hospital had developed a charge nurse job description. HRM stated that the hospital's charge nurses were employed under the title of charge nurse.

During a concurrent interview and administrative record review, on 10/29/15 at 3:20 P.M., RN 1 identified Hospital A's Company 52 medication override report for 6/28-7/1/15. RN 1 acknowledged the report showed Staff 51 and Registered Nurse (RN 51) removed three medications from the ADC using the override process. RN 1 acknowledged neither person was the charge nurse assigned to 4 east at the documented override date and time. RN 1 was requested to describe the official hospital Company 52 ADC override process. RN 1 stated that she was not aware of an official ADC override process.

During a concurrent interview and administrative record review, on 10/29/15 at 2:45 P.M., HRM identified the current list of charge nurses in Company 52's ADC report (provided by pharmacy). The list identified individuals with the charge nurse security level that could override all medications in the ADC. HRM reviewed the list and identified 20, out of 136, individuals who were not charge nurses by job title.

During a concurrent interview and administrative record review, on 10/30/15 at 7:30 A.M., DPH 1 identified Hospital A's Company 52's Medication Order Override Report (9/1/15-10/28/15). Inspection of the report showed, from 9/1/15-10/28/15, 182 medications were removed from the ADC using the override process. Eight overrides were identified for review. DPH 1 inspected the overrides and identified three were performed by individuals who were not the assigned charge nurse. The overrides identified were 9/2/15 11:31 by Registered Nurse 52 on 4S, 9/8/15 3:16 by Registered Nurse 53 on 5S, and 10/15/15 12:55 by Registered Nurse 54 on 6N.

An administrative record review, of the hospital's List of Charge Nurses in Company 52 (Oct 29, 2015 10:29 A.M.) showed 137 staff had the security level to remove medications from the ADC using an override.

An administrative record review, of Hospital A's Company 52 Medication Order Override Report (Date Range: 9/1/2015-10/28/2015) showed 165 medications were removed from the ADCs using an override.

An administrative record review, of Hospital A's Admission Register by Account Number (For Date: 9/1/15-10/28/15) showed 1,927 patients were admitted to the hospital.

Based on observation, interview and record review, the hospital failed to ensure that outdated injectable solutions and used biological supplies were not available for patient use in the Emergency Department (ED) of Hospital A. Date expired vials of injectable sterile saline solutions (medications generally used for intravenous injections) and opened, undated and partially used biological solutions (medicated solutions used on skin or tissue) were stored and available for use in the ED supply. The potential use of expired injectable and undated partially used biological solutions for patient care, increased the risk for adverse reactions.

Findings:

During a joint observation and interview on 10/27/15 at 10:35 A.M., the clean utility room of the ED was observed with the Emergency Department Manager (EDM). The clean utility area contained a portable white metal cart with drawers, which contained assorted supplies. One of the drawers contained several single use 10 ml (milliliters) vials of injectable saline solution. Six (6) vials of saline solution were observed labeled with past expiration dates. Two (2) vials had the expiration date of "March 1 2015" and Four (4) vials had the expiration date of "September 2015". In addition another drawer contained an opened, partially used, 4 ounce bottle of 10% povidone-iodine solution and an opened partially used 3 ounce bottle of hydrogen peroxide solution. The EDM stated that the observed expired injectable saline vials should have been removed from the available supply. In addition, the EDM stated the observed bottles of partially used biological solutions were intended for single use and were expected to be discarded and not stored for reuse. The EDM acknowledged that the hospital ED had not stored medication and biological supplies as expected.

A review of the hospital policy entitled Expiration Dates of Medications, dated "SEPT 2014", included "Expired medications shall be returned to the Pharmacy for proper disposition."

Based on observation and interview, the hospital failed to ensure that humidity, temperature and airflow were monitored in the Interventional Radiology (Angiography - an examination by X-ray of blood or lymph vessels) suite. This resulted in the potential for unobserved growth of mold and other microbes, and the spread of these organisms through the air. This caused an increased likelihood of the spread of infection among the staff and patients in the Angiography suite.

Findings:

The Interventional Radiology Suite (Angiography) was toured on 10/29/15 at 1:00 P.M. No temperature or humidity monitors or logs were present.

The manager of Radiology was interviewed on 10/29/15 at 1:00 P.M. He stated that the humidity, temperature and airflow of the Angiography suite were not monitored. He was unaware that this was necessary.

Based on dietetic services observations, dietary staff interview, and dietary and administrative document review, the hospital failed to ensure the provision of dietetic and nutrition services in a safe and effective manner as evidenced by:

1. Lack of development of an effective performance improvement program within dietetic services and clinical nutrition care (Cross Reference A-273 #2);
2. Lack of food storage practices in accordance with manufacturers' specifications (Cross Reference A-620);
3. Lack of effective time/temperature monitoring of Potentially Hazardous Foods (PHF's) which are defined as those which have the potential to grow bacteria associated with foodborne illness (Cross Reference A-749 #2, 3, 4a, 4b, 5, 6, 7, 8, 9, 10, 11);
4. Incomplete nutritional analysis of the hospital's regular and therapeutic menu (Cross Reference A-629);
5. Lack of training in thermometer calibration for a staff member, responsible for temperature monitoring activities (Cross Reference A-622);
6. Lack of a Clinical Diet manual that accurately reflected the hospitals' regular and therapeutic menus (Cross Reference A-631);
7. Lack of adequate food supplies to be implemented in the event of a widespread disaster and lack of equipment maintenance in accordance with manufacturers' specifications (Cross Reference A-701).


The cumulative effects of these systemic problems resulted in the hospitals' inability to provide clinical nutrition care and dietetic services in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Dietetic Services.

Based on food storage observations and management staff interview, the hospital failed to ensure that food products were stored in accordance with manufacturers' recommendations. Manufacturers' recommendations for storage are designed to maintain food safety, freshness and palatability of products.

Findings:

1. During food storage observations at Hospital A on 10/27/15 beginning at 1:40 P.M., it was noted that dietary staff was retaining expired and/or food items that were not stored in accordance with food storage practices. In the food production area dietary staff was storing scoops in containers of seasoned salt and vegetable broth base. In an effort to mitigate cross contamination the standard of practice would be to ensure that scoops are removed from products when not in use (Food Code, 2013).

During food storage observations at Hospital B on 10/29/15 beginning at 9:00 A.M., dietary staff was retaining a case of miniature mushrooms with and expiration date of 2013.

2. During initial tour on 10/27/15 of Hospital A, beginning at 10:00 A.M., it was noted that in the walk-in refrigerator there were multiple items that were not stored in accordance with manufacturers' recommendations. Facility staff was storing bread products such as bagels and tortillas that were labeled to "store in a cool dry place." Similarly there was a case of hot dogs with a manufacturers' label to "keep frozen." In a concurrent interview with Management Staff 1 he stated that bread type products should be stored in the dry storage area and that the hot dogs should have been in the freezer as they should be cooked from the frozen state.

Based on food storage observations and dietary staff interview, the hospital failed to ensure staff competency related to thermometer calibration of 1 dietetic services staff member. Incorrect calibration of thermometers may lead to inaccurate food holding/cooking temperatures and may put patients as risk for foodborne illness. Symptoms of foodborne illness include gastrointestinal distress in in severe instances may result in death.

Findings:

On 10/27/15 beginning at 2:50 P.M., food holding practices in Hospital A's café were reviewed. It was noted that the temperature of the Asian beef noodle salad was 46°F (degrees Fahrenheit) and cantaloupe was 54°F. In concurrent interview with Dietary Staff (DS) 67 she stated that food temperatures were recorded when the food was put out for service. DS 67 also stated she would calibrate the thermometer to ensure accuracy. She proceeded to get a small amount of ice from the ice machine, place it in a 12 ounce Styrofoam cup and add water until the cup was filled. Concurrent observation revealed that the ice filled no more than ¼ of the cup, the rest of the cup was filled with water. DS 67 stated this was her usual method of calibration. The standard of practice for accurate thermometer calibration would include filling a large glass with crushed ice. Add clean tap water to the top of the ice and stir well. Immerse the food thermometer stem a minimum of 2 inches into the mixture, touching neither the sides nor the bottom (United States Department of Agriculture, Food Safety and Inspection Service).

Based on meal distribution observation, dietary staff interview and dietary document review, the hospital failed to ensure
1) the nutritional value of the menus in accordance with the hospital demographics and physician approved parameters for therapeutic diets. The hospital failed to ensure that substitutes were of equal nutritive value to the entrée items;
2) implement remedies when the hospitals' menu did not meet the nutritional needs of patients. The hospitals' menus were deficient in Vitamins D and E. Additionally the hospital menus did not consistently meet physician specified nutritional parameters for renal, post-dialysis and sodium restricted diets. There was no analysis of vegetarian or gluten free diets both of which were routinely ordered by physicians;
3) complete nutrition related assessment in accordance with hospital policy.

Failure to ensure menus meet individual nutritional needs may result in protein deficiencies that may contribute to patient morbidity/mortality. Failure to meet nutritional needs and medical staff approved therapeutic diet limitations and failure to fully complete assessment may result in delayed nutritional care further compromising medical status.

Findings:

1. During meal distribution on 10/29/15 at Hospital B, it was noted that one patient had a physician ordered diet that included allergies/intolerances associated with dairy products, including eggs. It was noted that both of the hot entrees contained milk and/or cheese. Dietary staff was observed placing a peanut butter/jelly sandwich in place of the entrée. In an interview with MS 83 she was asked to describe how the hospital selected alternate entrees. She stated that the sandwich was one of the choices used as a substitute. Review of the lasagna entrée revealed that the protein content of the meal would be 27 grams of protein, there was no protein analysis of the alternate chicken philly pasta; however the analysis of the peanut butter was limited to 15 grams of protein/serving.

2. On 10/29/15 beginning at 10:35 A.M., the hospitals' nutritional analysis was reviewed with Management Staff 83. She stated that the hospital utilized the Dietary Reference Index as the standard by which the menus would be evaluated. She also stated that while the data entry was done at a local level the nutrition analysis program was uploaded at the corporate level. She also stated she was unsure of the demographic (i.e. age or gender) that was used as a baseline. MS 83 stated that the demographic for Hospital B was mostly male with an average age of 40-50. She was unsure of the demographics of Hospital A but thought it was mostly an elderly population. A sample review of the menus revealed that Vitamins D and E did not meet the nutritional needs of the baseline population. The Vitamin D content of the menus, through all regular and therapeutic diets averaged between 60-70% of dietary needs. Similarly Vitamin E content met between 30-50% of dietary requirements. MS 83 stated that while the data was put into the nutritional analysis program in July 2014 she had not evaluated whether the menu met nutritional needs.

Additional review of the analysis for renal diets revealed that for 2 of 7 days the nutritional content exceeded physician approved nutrient parameters. The protein content of the menu which was designated as 60 grams (a metric unit of measure) per day had 2 days that were 70 and 76 grams. Similarly the potassium content should have been limited to 2 grams, however 1 day was analyzed at 2,775 grams. The post-dialysis diet did not meet the protein requirements of 80 grams of protein for 3 of 7 days. One day was limited to 50 grams and two other days were listed as 96 and 93 grams of protein. The 2 gram sodium restriction also had similar issues as 4 of the 7 days had sodium contents in excess of 2 grams.

MS 83 stated that while the hospital offered a vegetarian and gluten free menu, there was no analysis of these menus. MS 83 acknowledged the menu was not consistently analyzed for nutritional reference ranges.

3. Patient 81 was transferred to the general acute care unit from the hospitals' inpatient behavioral health unit with diagnosis including acute renal failure, cyclical vomiting (vomiting that has no apparent cause) and low sodium levels. Admission diet order dated 10/26/15 was for a clear liquid diet.

A comprehensive nutrition assessment dated 10/26/15 which was completed by the Registered Dietitian noted that the patient had inadequate calorie and protein intake with overall inadequate intake. The assessment also documented a nutritionally related diagnosis of "non-severe protein-calorie malnutrition [PCM]." In a concurrent interview with Registered Dietitian 85 she stated that the hospital had specific criteria for charting this particular diagnosis. She also stated that in addition there patient would need to establish additional parameters that were indicative of PCM; however these parameters were not identified and/or documented. Review of hospital policy titled "Nutrition Assessment" last reviewed on 7/2013 failed to address diagnostic guidance related to protein-calorie malnutrition.

Based on interview and document review, the hospital failed to utilize a diet manual that was specific to the hospital, included diets routinely ordered, nor provided accurate guidance for ordering and preparing patient meals. This failure had the potential to result in a lack of consistency and communication concerning the diets served among the medical, nursing and dietary staff.

Findings:

On 10/29/15 beginning at 10:35 a.m., the diet manual for Hospitals' A and B was reviewed with Management Staff (MS) 83. She stated that the manual was purchased; and was not modified to reflect the routinely ordered diets of the hospital. As an example the hospital utilized a combination of calorie restricted and carbohydrate modified diets for patients with diabetes. Concurrent review of the diet manual for the section was limited to conceptual information and patient education of meal planning for patients with diabetes. Additionally it was noted that the hospital had a physician ordered "PVH mother diet," there was no detailed description of this diet. MS 83 also stated that the manual contained many diets that the hospital did not offer.

The purpose of a diet manual is to establish a common language and practice for physicians and other healthcare professionals to use when providing nutritional care to patients. The diet manual did not indicate the nutritional analysis of all of the types of diets provided at the hospital. A diet manual would include all relevant information including the purpose of the diet, description of the diet, nutritional adequacy, foods to use, foods to avoid and a sample meal plan in accordance with the hospital menu. While the presented document did have some elements of a diet manual it was not modified to give guidance specific to the hospitals' practices.

Based on food storage observations, dietary and administrative staff interview and dietary document review, the hospital failed to 1) ensure adequate food supplies or a fully detailed plan that would provide all hospital staff guidance on the implementation of dietetic services in the event of a wide-spread disaster and 2) ensure the dishwasher was maintained in accordance with manufacturers' parameters as evidenced by broken temperature measuring dials.

Failure to ensure adequate supplies and a comprehensive feeding plan as part of disaster preparedness may result in compromising the nutritional status of patients, further compromising medical conditions. Failue to maintain dishwashing equipment may result in unclean and/or unsanitized dishes.

Findings:

1. On 10/27/15 beginning at 2:25 P.M., review of disaster preparedness, in relationship to food supplies, at Hospital A with Management Staffs 61 and 63 was conducted. It was noted that the hospital planned to utilize a combination of perishable and canned food supplies. Concurrent review of the hospitals' menu revealed the perishable foods would be used for the first day; however there was no menu and/or guidance on which foods would be designated, nor were there any recipes that could be utilized by hospital staff for implementation of the plan. There was also no guidance to staff on steps to implement for the assurance of food safety of the perishable foods.

It was also noted that the hospitals' plan was based on the average daily census rather than the licensed bed count. On 10/27/15 beginning at 9:10 a.m., the food supplies were reviewed at Hospital B. It was noted that the feeding plan was for the average daily census, rather than the licensed bed count. Review of food supplies of Hospital B revealed a plan to offer sandwiches multiple times through the 4 day period. It was noted that the hospital did not have adequate bread supplies to implement the plan.

Review of the hospital document dated 10/28/15 that was provided by Management Staff 83 revealed that for Hospital A, a daily average staffing pattern was listed as 96 patients and 417 staff for Hospital A and 50 patients and 30 staff for Hospital B. Review of the hospitals' licensed revealed that Hospital A was licensed for 188 general acute care beds and 39 distinct part acute psychiatric beds. Hospital B was licensed for 64 acute psychiatric beds.

In an interview on 10/30/15 beginning at 9:10 A.M., with Management Staff (MS) 84, he acknowledged that the hospital had not planned for the full licensed bed count. He also stated that while he was aware that the hospital planned to utilize perishable foods for the first day of the disaster there was no evaluation of the available supplies or a detailed written plan of the implementation of dietetic services. Additionally, he confirmed that the county-wide disaster preparedness plan was for the hospital to ensure self-sufficiency for 96 hours (4 days). In an interview on 10/30/15 beginning at 9:30 A.M., with NDOT (Nursing Director of Telemetry), she stated that average daily staffing for the current average daily census was calculated as 399 for Hospital A and 94 for Hospital B. There was no analysis of required staffing patterns, in relationship to the provision of dietetic services, for the licensed bed count, in relationship to food supplies for disaster preparedness.

2. During review of dishwashing procedures on 10/27/15 at 1:25 P.M., it was noted that the dishwasher had a total of 4 temperature indicator gauges, two of which were associated with the wash cycles and the remaining two were associated with the rinse cycles. It was noted that only 1 of the two rinse cycle gauges were functioning. The auxiliary rinse dial read 170°F with an acceptable range of 165-170°F and the final rinse dial read 140°F with an acceptable range of 180-195°F. In a concurrent interview, Management Staff 61 stated that the machine was installed several years earlier and the dial never worked. He also stated that he monitors the effectiveness of the machine by reviewing facility logs, he did not conduct regular visual inspections of the machine gauges.

Based on observation and interview, Hospital A failed to ensure that call light devices were operational in the Rehabilitation Unit for all patients. One call light device in the Physical Therapy (PT) gym patient bathroom and two call light devices in a patient shower were tested and were not functioning. Failure to ensure that the call light devices were functioning impeded hospital staff's ability to alert or signal for help in case of an emergency.

Findings:

On 10/28/15 at 10:18 A.M., a tour of the Rehabilitation Unit was conducted with the rehabilitation lead nurse (Registered Nurse- RN 2), the Chief Nursing Officer (CNO) and the Nurse Director of Telemetry (NDOT). One call light device located in the Physical Therapy gym patient bathroom was tested. There was no audible or visible signal noted when pulled. Two call light devices located in a patient shower next to the Physical Therapy gym were tested. There was no audible or visible signal noted when pulled.

An interview with RN 2 was conducted on 10/28/15 at 10:23 A.M. RN 2 stated that both the PT gym bathroom and patient shower were used by patients and staff. She explained that patients were assisted by staff at all times whether in the PT gym bathroom or the patient shower (used for training purposes). She acknowledged that without functioning call light devices, hospital staff would not be able to alert or signal for help.

An interview with the Director of Rehabilitation (DOR) was conducted on 10/28/15 at 10:38 A.M. The DOR stated that the patient shower located by the PT gym was not in use and was used only for training purposes. He stated that patients were with staff at all times. He acknowledged that with broken call light devices, hospital staff would not have a mechanism to alert or signal for help in case of an emergency.

Based on observations, interviews, record and document review, the hospital failed to ensure that their infection control program was systematically and consistently implemented as evidenced by:


1. The hospital and governing body in governance of the infection control officer and in accordance with hospital policy and nationally recognized infection control standards failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases. (A-748)

2. The hospital failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards. Surgical instruments were not processed to ensure sterility when job specific competencies were not demonstrated by staff. Proper hand hygiene, use of personal protective equipment and traffic patterns between sterile and contaminated areas to prevent transmission of infection and/or cross-contamination were not practiced. Cleanliness was not maintained in designated clean and decontamination areas.
(A-749 #1)

3. The hospital staff did not recognize and report potential environmental microbial growth in a patient care area. (A-749 #14)

4. The hospital failed to ensure dietetic services were implemented in a safe/effective manner as evidenced by 1) lack of an comprehensive system that monitored the thawing of raw meats; 2) storage of foods at temperatures that could promote bacterial growth associated with foodborne illness; 3) lack of monitoring of cooldown of potentially hazardous foods; 4) lack of maintenance and cleanliness of hospital ice machines; 5) retention and use of food items that exposed to flying pests; 6) lack of effective hand hygiene during food production activities; 7) lack of effective sanitation of food delivery equipment; 8) lack of effective are gaps in food production equipment; 9) retention of food storage equipment whose surfaces were compromised and 10) multiple unclean kitchen areas/surfaces.
(A-749 #2, 3, 4a-4b, 5, 6, 7, 8, 9, 10, 11)

5. The hospital failed to implement an infection control program with procedures which prevented potential patient exposure to communicable infectious disease. Shared use patient diagnostic medical equipment was not disinfected after patient contact in the Emergency Department (ED). A torn upholstered chair with exposed padding was available for patient use in an ED treatment room. (A-749 #12, 13)

6. The lack of proper transport of linen did not ensure that infection prevention techniques were maintained and practiced by staff to prevent the spread of infection throughout the hospital in accordance with their own policy and procedures.
(A-749 #15)

7. The hospital failed to ensure that an instructor (hospital visitor/contracted individual) was able to verbalize the correct contact time for the use of bleach wipes. (A-749 #16)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Infection Control.

Based on observation, interview, and document review, the facility and governing body in governance of the infection control officer and in accordance with facility policy and nationally recognized infection control standards failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases, as evidenced by the hospital's failure to have effective systems in place to provide and ensure:

1. Active surveillance to identify policies and procedures that are not implemented correctly in an active infection control program.

a. Infection Control (IC) Program failed to provide surveillance to identify deficiency in the staff knowledge regarding Infection Control concepts and procedures.

b. Infection Control Program failed to provide surveillance to identify deficient staff practices that were inconsistent with facilities policy and procedures and/or national recognized standards.


2. Active surveillance to identify and correct environmental conditions to prevent the growth of infectious and communicable diseases.

a. Infection Control Program failed to ensure sanitary condition of the sub-sterile and sterile core environment through rounding, staff education and a chain of responsibility. Specifically, the IC Program failed to identify potential sources of cross-contamination from the decontamination room to the sterile processing room.

b. Infection Control Program failed to provide effective monitoring to ensure staff was trained and competent to effectively decontaminate all surgical instruments.

c. Infection Control Program failed to monitor the disinfecting and environmental cleaning of patient room and equipment (i.e. counters, patient care devices).

3. Failed to provide effective Infection Control monitoring and surveillance of areas designated as restricted and semi-restricted.

a. Failed to implement facility adopted Association of Preoperative Registered Nurses (AORN) standards and facility policy and procedures resulting in a failure to ensure safe and sanitary air handling systems maintained in the Interventional Radiology room.

b. Infection Control Program failed to provide training for staff to recognize and implement facility adopted AORN standards for restricted and semi-restricted (sterile and sub-sterile) areas.

c. Infection Control Program failed to ensure the sterility of all surgical instruments and sterile supplies, facility-wide.

d. Infection Control Program failed to provide effective monitoring and oversight of sterile supplies and all sterile surgical instruments.

e. Infection Control Program failed to provide staff surveillance for proper policy and procedure implementation, facility-wide. Additionally, the IC Program failed to provide effective training and competencies in the monitoring of staff to ensure sterile supplies were maintained in accordance with facility policy regarding event-related sterility standards.

4. Ensure integrated active system-wide infection prevention and control program into the facility QAPI program.

a. Failed to provide an effective system-wide infection control program that includes effective communications.

b. Failed to provide job/duty specific effective infection control training system-wide to ensure staff competency.


On 10/28/15 at 4:12 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 951, A Tag 748 and A Tag 749. The Administrator, the Chief Nursing Officer (CNO), and the Director of Nursing/Performance Improvement Director (DON/PID) were present. The Immediate Jeopardy was lifted on 10/30/15 at 1:05 P.M. after an acceptable corrective action plan was implemented.

Findings:

On 10/27/2015 at approximately 1:00 P.M. to 3:50 P.M., an observation, interview and document review during a tour, with the Director of Nursing (DON/PID), Infection Control Preventionist (ICP 1) and sterile processing technician (SP TECH 1), widespread deficient practice in the environment of care was observed throughout the Sterile Processing Unit (SPU) decontamination room. In a concurrent interview ICP and the DON/PID both stated, "Environmental Services is responsible for the general (environmental) cleaning". Neither staff members could provide specific information regarding the duties of environmental services (EVS) related to the decontamination room. EVS was not available for interview. The DON/PID and ICP 1 acknowledged responsibility for the facility-wide infection control program that should include the SPU. The DON/PID stated the Nurse Director of Peri-Operative Services (NDOS) was responsible for the rounding in the SPU.

In a subsequent interview with NDOS at 5:00 P.M., The NDOS stated, "sometimes I can be through here (SPU) two times a week. Sometime not at all. It just depends on what is going on."

On 10/28/15 in a follow up observation, review of documents and direct interview, the Infection Control Practitioner revealed:

· The ICP 1 could not answer general questions of surveillance in the areas indicating she had not been aware of the state of deficient practice in the above listed areas. "I have only quickly toured through this area after starting about 2 months ago."
· The ICP 1 could not identify the method of storage of sterile instruments and supplies adopted by the facility per the Corporate Manager for Infection Prevention (ICP 2) interview (10/29) and observation the facility follows the AORN standard of Event Related Sterility. Previously, acknowledged by the DON/PID during the tour.
· The ICP 1 indicated the outgoing infection control practitioner (released from her position 08/15) did not report off any issues of concern to her regarding the above stated areas. Surveillance documents for the last 6 months were requested. At the time of exit, the facility did not provide the targeted documentation.

On 10/28/15 at approximately 8:30 A.M., during an observation and subsequent interviews, with ICP 1, ICP 2, DON/PID and the NDOS, all reported that "others" were responsible for the oversight of maintaining the decontamination process.

The ICP 2 stated, she did not have prior knowledge of the sterile processing and decontamination area state of, "unacceptable practice in the environment of care services."

The ICP 2 stated, and the NDOS nodded agreement, "this must change immediately." The ICP 1, ICP 2, the DON/PID and the NDOS acknowledged the instruments processed in this unit could not be ensured to be sterile. All verbalized acknowledgment that if sterility cannot be assured then the instruments must be reprocessed and re-sterilized.

On 10/28/15 at approximately 9:30 A.M., the NDOS acknowledged responsibility for the environmental cleaning of the sterile core, sub-sterile unit, sterile processing and decontamination unit. She indicated, she did not communicate with the ICP nor did she have a practice or policy to consult the ICP regarding any on-going environmental issues other than an orientation of the ICP 1 to the SPU unit. Surveillance documentation on the above listed areas was requested. At the time of exit, the facility was unable to provide active surveillance documentation related to the specific areas conducted by the ICP or the NDOS.

In a concurrent/ongoing interview, the NDOS revealed that she did not formally communicate issues with the environment of care in the sterile storage, sterile processing or decontamination areas with the ICP 1. NDOS acknowledged the need for improved cleaning. The NDOS indicated she does not have a specific mechanism for communication of the needs beyond calling in work orders and she did not know if this communication reached the ICP 1.

On 10/30/15 at approximately 9:30 A.M., in a record review, observation and interview, the ICP 1 acknowledged that she did not have documentation of the rounds. ICP 1 indicated the surveillance was informal.

a. She indicated she was indeed the ICP 1 responsible for the sterile processing and is not yet familiar with the policy and procedures for the units if they exist.
b. The ICP 1 acknowledged she was not familiar with the term event related sterility and the policy and procedure the facility follows as a standard of quality control for sterile surgical instruments and supplies.
c. ICP 1 acknowledged she was not familiar with any job related infection control training provided to the staff.

In subsequent interview and record review at approximately 3:00 P.M., ICP 1, ICP 2 and the DON/PID, acknowledged a lack of coordination and oversight by infection control staff of the sterile processing unit and decontamination room. Each indicated the previous ICP to their knowledge, did not actively conduct surveillance beyond the quarterly team facility rounds.

On 10/30/15 at 9:50 A.M., a record review was conducted of the proposed schedule for the Environment of Care rounds (EOC). Review of record titled, "EOC rounds" revealed the rounds in sterile processing were not completed in March 2015 or recently in September 2015, thus, ICP 2, acknowledged the broad sweep of the EOC rounds scheduled were not conducted to date for the SPU.

On 10/30/15 at 10:00 A.M., during an interview with the Chairman of the Surgery Department, he revealed he was the surgeon on call for the Emergency Department. He indicated he was not aware of the Immediate Jeopardy the hospital was under or that emergencies were diverted and surgeries canceled or delayed. He indicated he was not aware of the issues or concerns related to surgical instrument sterility.

On 10/30/2015 at 3:15 P.M., in a continued review of records and the "infection control plan" during an interview with ICP 1. The plan acknowledged the need for support staff for infection control and an experienced ICP. The ICP 1 stated, "I need two years to learn." She further indicated she works directly under the DON/PID. She acknowledged she did not have the knowledge or the time to provide surveillance in the restricted and semi-restricted areas other than quarterly environment of care rounds (EOC). The ICP acknowledged the infection control program at the facility was more reactive (passive) than proactive.

Based on observation, interview and document review, the hospital failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards. Surgical instruments were not processed to ensure sterility when job specific competencies were not demonstrated by staff. Proper hand hygiene, use of personal protective equipment (PPE - equipment used to prevent exposure to infection) and traffic patterns between sterile and contaminated areas to prevent transmission of infection and/or cross-contamination were not practiced. Cleanliness was not maintained in designated clean and decontamination areas. In addition, hospital staff did not recognize and report potential environmental microbial growth in a patient care area.

The hospital failed to ensure dietetic services were implemented in a safe/effective manner as evidenced by 1) lack of an comprehensive system that monitored the thawing of raw meats; 2) storage of foods at temperatures that could promote bacterial growth associated with foodborne illness; 3) lack of monitoring of cooldown of potentially hazardous foods; 4) lack of maintenance and cleanliness of hospital ice machines; 5) retention and use of food items that exposed to flying pests; 6) lack of effective hand hygiene during food production activities; 7) lack of effective sanitation of food delivery equipment; 8) lack of effective are gaps in food production equipment; 9) retention of food storage equipment whose surfaces were compromised and 10) multiple unclean kitchen areas/surfaces.

Failure to ensure effective food production systems may result in practices associated with foodborne illness and cross contaminiation of food. Foodborne illness or contamination of food may result in gastrointestinal distress further compromising medical status and in severe instances may result in death.

The hospital failed to implement an infection control program with procedures which prevented potential patient exposure to communicable infectious disease. Shared use patient diagnostic medical equipment was not disinfected after patient contact in the Emergency Department (ED). A torn upholstered chair with exposed padding was available for patient use in an ED treatment room.

In addition, Hospital A failed to ensure that staff implemented proper infection control practices, for 1 of 33 sampled patients (21). A Certified Nursing Assistant (CNA) 24 exited Patient 21's room with a soiled towel placed in her gloved hands. She entered a public hallway and transported the towel into a soiled utility room. The lack of proper transport of linen did not ensure that infection prevention techniques were maintained and practiced by staff to prevent the spread of infection throughout the hospital in accordance with their own policy and procedures.

Lastly, Hospital A failed to ensure that an instructor (hospital visitor/contracted individual) was able to verbalize the correct contact time for the use of bleach wipes, for 1 of 33 sampled patients (1) who was admitted with C-Diff (Clostridium Difficile - a bacteria that causes loose stools). Hospital visitor (HV 1) verbalized that the contact time for bleach wipes was 2-4 minutes.

The hospital's failure to ensure that contracted hospital visitors were able to verbalize correct contact times when using hospital approved disinfectants could lead to an ineffective use of disinfectants.


On 10/28/15 at 4:12 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 951, A Tag 748 and A Tag 749. The Administrator, the Chief Nursing Officer (CNO), and the Director of Nursing/Performance Improvement Director (DON/PID) were present. The Immediate Jeopardy was lifted on 10/30/15 at 1:05 P.M. after an acceptable corrective action plan was implemented.

Findings:

1. On 10/27/15 during a tour at approximately 1:00 P.M. to 5:00 P.M., a tour of the restricted and semi-restricted areas conducted with the Infection Control Preventionist (ICP 1) and the Director of Nursing/Performance Improvement Director (DON/PID).

Observation 1: observation of staff passing back and forth to the restricted area of the decontamination room of the SPU (Sterile Processing Unit) over to the restricted sterile side of the SPU was made. Sterile processing technician (SP TECH 1) was observed to cross over from side to side of the units failing to practice hand hygiene per facility policy and Association of Preoperative Registered Nurses (AORN) standards. AORN is the national recognized standards identified by the DON as the standard adopted by the facility for the policy regarding attire in restricted and semi-restricted areas.

In a subsequent interview, SP TECH 1 indicated that she was wearing gloves and that were clean and therefore she was "ok".

Observation 2: SP TECH 1 did not utilize clean PPE and therefore wore the same scrubs back and forth between the decontamination room and the sterile storage room.

In a subsequent interview, SP TECH 1 verbalized that visitors in the decontamination room did not need to wear PPE.

In a concurrent interview, the ICP 1 and DON/PID indicated they did not know the standard or policy but stated they trusted the knowledge of SP TECH 1 to know, as she had worked in the unit for 27 years.

The tour passed into the restricted sterile side of the processing and storage of sterile surgical instruments. After prompting, the visitors were asked to put on hair and head cover then a light non-permeable yellow gown, that did not cover the legs or entire arms of the visitor. ICP 1 and DON/PID deferred to SP TECH 1 to know the policy.

In a record review, SP TECH 1 stated she knew they had policies somewhere but that she did not remember the last time she reviewed them. She again stated that she had worked here for approximately 27 years and knew the units well. SP TECH 1 indicated that she did not receive on-going job specific education.

Random opportunity for observation:
Wet time (amount of time a disinfectant must stay wet on the surface of the item being disinfected) in practice was observed: 3 out of 3 employees in the sterile and sub-sterile core area did not observe and/or verbalize the wet time per the manufacture's instructions. Observed were the ICP 1, SP TECH 1 and SP TECH 2.

On 10/29/15 at 8:45 A.M., in a subsequent interview with ICP 2, the ICP 2 indicated that staff in the above documented observation did not follow the AORN standards or facility policies. ICP 2 acknowledged the lack of understanding by the staff regarding "wet time", proper PPE and proper environmental care of the decontamination room.

A documentation review of The Perioperative Standards and Recommended Practices published by the AORN (Association of Perioperative Registered Nurses), 2014 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area."

On 10/27/15 during the concurrent tour and interviews, observations and review of documentation of the SPU decontamination room between 1:00 P.M. and approximately 4:30 P.M., and 10/28/15 between 8:45 A.M. and approximately 12:00 P.M., the DON/PID, ICP 1, and SP TECH 1 acknowledged the deficient practice of a widespread pattern of potential ineffective cleaning, disinfection and lack of prevention of transference of infectious substance in the decontamination room. The DON/PID, ICP 1, SP TECH 1 acknowledged the deficient practice.

As a result of this discovery, on 10/28/15 at 4:12 P.M., an Immediate Jeopardy (IJ) was declared for the widespread pattern of potential ineffective cleaning, disinfection and lack of prevention of transference of infectious substances when in the sterile processing unit. Sterility of surgical instruments could not be ensured due to the absence of an enzymatic product that must be used in the decontamination process per the hospitals own policy and procedures, titled "Sterilization and Disinfection, Sterile Processing Department" dated April 2015, pages 1-4, and a second policy and procedure titled, "Surgical Instruments, Care and Cleaning" dated June 2010.

In addition the following standard practice deficiencies were found:
1) A substance was found around the edges of the decontamination sink and immediately above on the wall.
2) The sterile processing room was found with dust and debris throughout the unit and specifically, debris falling into the open container supplying detergent to the washer.
3) The STERIS washer was found not to be maintained per manufactures instructions when a review of records revealed a lack of documentation.
4) The documentation of the washing cycle was not accurately recorded when the tape printed out erroneously that an enzymatic product was injected into the washer and lack of documentation by the sterile processing technician.

A review of the facility policy and procedures, titled "Surgical Instruments, Care and Cleaning" dated June 2010:
"Step 1. Enzymatic cleaner solution
Follow Hand Hygiene 8753-026
a. Don gloves face shield and impervious gown or apron.
Step 2, Soak Instruments in enzymatic cleaner solution for two to three minutes after washing and before placing into the sonic cleaner.
Step 7, Do not prolong soaking as it may damage the instrument surfaces. Step 10, Only clean, decontaminated instruments should be processed in an ultrasonic cleaner."

Ultrasonic cleaning is not a substitute for decontamination/sterilization. "Sterilization and Disinfection, Sterile Processing Department" dated April 2015, pages 1-4. Thoroughly cleaned and prepared to reduce bioburden (visible debris). An expiration date, determined according to the manufacturer's instructions, shall be marked on the container of the disinfectant currently in use. Adopted from the Center for Disease Control (CDC) guidelines, APIC (Association of Professional Infection Control Practitioners and ANSI (American National Standards Institute)/AAMI (Association for the Advancement of Medical Instrumentation) standards.

On 10/28/15 from 8:45 A.M. to 12:00 P.M., in an observation tour and interviews. The sub-sterile core known as the decontamination room was found to be non-compliant with facility policy for cleaning and disinfection of the surgical instruments in the first step of sterilization. The ICP 1 and ICP 2 indicated the staff should be following both the facilities environment of care policy and the national recognized standards such as APIC, AORN and CDC that the facilities adopted as the standards to base facility policy on.

Observation:

1. Sterile processing (SP) staff failed to recognize the instruments were not being processed per facility policies when only detergent was being used to clean instruments. Staff failed to recognize the detergent used for hand cleaning of the instruments was labeled to use in an automatic washer.

2. SP TECH 1, failed to fully submerge surgical instruments in enzymatic soak and decontaminate the instruments with a brush.

3. SP Staff failed to review the washer receipt and document the acceptance of the load as properly washed.

4. SP Staff failed to have prepared cleaner labeled with content, date and time.


(AORN) Recommendation IV (2009)
Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

· IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces.3 [3: Limited Evidence] Sterilant contact is necessary for sterilization to be achieved.
· IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer ' s written and validated IFU specifies that disassembly is not required.3 [3: Limited Evidence] Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.3
· IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.3,4 [1: Strong Evidence] Preventing water retention can help avoid the occurrence of wet packs and sterilization failure.
· IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. [3: Limited Evidence] Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction.
· IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. [3: Limited Evidence]

(AORN) Recommendation IV
Instruments should be kept free of gross soil during surgical procedures.

Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials.

· IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil.

Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved.





17065


2. During initial tour on 10/27/15 of Hospital A, beginning at 10:00 A.M., it was noted that in the walk-in refrigerator there were several shelves of multiple types of raw meat. The meat included frozen beef patties, partially thawed ground turkey, 3-1/2 cases of frozen chicken breast, 20 pounds each of frozen ground turkey and fully thawed ground beef. All of the items were listed as delivered on 10/21/15.

In a concurrent interview with Management Staff 1 he stated that all meats were delivered frozen and were to be logged once the thawing process began. Concurrent review of the document titled "Daily Meat Pull/Thaw Log" noted that the ground turkey was not recorded and that the ground beef was not recorded accurately. It was also noted that staff were guided to pull thawing meats "3 days prior to being needed." Review of the log revealed that items pulled on 10/21/15 included chicken that was not scheduled to be used until 10/28/15 (7 days) and pork loin that was not scheduled to be used until 10/26/15 (5 days).

To ensure food safety the United States Food and Drug Administration suggests that thawed chicken should not be stored for greater than 1-2 days. Facility policy titled "Food Labeling and Dating", reviewed 7/13, noted storage guidance for defrosted and/or raw meat not to exceed 3 days, timeframes that may not be consistent with federal food safety standards.

In a concurrent interview with Management Staff 1, he was asked to describe oversight of the facility thawing process. He stated that he reviewed the entry log of thawing meats. The surveyor asked if he compared the entries on the log with the items that were being thawed. He replied that he did not validate the entries.

3. During initial tour of Hospital A on 10/27/15 beginning at 10:00 A.M., it was noted that the refrigerator adjacent to the juice machine was not working effectively. Concurrent observation revealed the internal thermometer read 48°F (degrees Fahrenheit). Food temperatures were as follows: cottage cheese-50°F, cantaloupe-51°F and olives-47°F. In a concurrent interview with Dietary Staff 62, he stated that he recorded refrigerator temperatures at approximately 4:00 A.M. The temperature for 10/27/15 was listed as 30°F.
A follow up observation on 10/27/15 beginning at 3:20 P.M., noted that the external thermometer read 38°F, the internal thermometer read 44°F. The temperature of beets and cut melons ,all of which were in the refrigerator for greater than 4 hours, was 54°F and 52°F respectively. In a concurrent interview with Management Staff 2, she acknowledged that the holding temperature of refrigerated foods should be less than 41°F

4. Potentially hazardous foods (PHF's) are those that are capable of supporting bacterial growth associated with foodborne illness. PHF's require monitoring for time and/or temperature control during all phases of food production, storage and service. Hot foods that are prepared and/or foods prepared from room temperature ingredients and held for service at a later time must be monitored while cooling in accordance with preparation methods. Cold foods shall be held at temperatures less than 41°F (Food Code 2013).

a. On 10/27/15 beginning at 2:50 P.M., food holding practices in Hospital A's café were reviewed. It was noted that the temperature of the Asian beef noodle salad was 46°F (degrees Fahrenheit) and cantaloupe was 54°F. In concurrent interview with Dietary Staff (DS) 67, she stated that food temperatures were recorded when the food was put out for service. Intermittent temperatures were not recorded during holding. Hospital also had an area that contained prepackaged snacks and sandwiches. The temperature of a chicken salad sandwich was 44°F.

Follow up observation on 10/29/15 at 3:55 P.M., noted the temperature of chicken taco salad on the salad bar was 49°F. The temperature of a pre-packaged egg salad sandwich was 49°F. While the hospital had implemented a temperature monitoring system beginning 10/27/15 it was noted that the 1:00 P.M. temperature was recorded as 38 °F. Management Staff 1 was unable to explain the difference. Temperatures were taken with accurately calibrated hospital thermometers.

b. In an interview on 10/29/15 beginning at 4:00 P.M. with Dietary Staff (DS) 68, he was asked to describe how an item such as tuna salad was prepared. He stated that he obtained the tuna and mayonnaise from the dry storage area. He further described that he would add items such as celery and onions. Once the salad was mixed he would label/date the item and place it in the refrigerator. He also stated that the item would be prepared every 2-3 days, depending on usage. He confirmed that he did not take any temperatures once the item was prepared. In a concurrent interview with Management Staff 1, he stated that the only food that was monitored were those that were heated and held for service at a later date.
Review of hospital documents titled "HAACP Daily Temperature Log-For Cooking Raw Foods" from 8/24-10/27/14 noted 10 entries for cooked chicken. The entries listed final cooking temperatures ranging from 180-194F° the log also listed final temperatures ranging from 35-39F°; however there was no date or time recorded when the final temperature was taken. In a concurrent interview with MS 1, he was asked to describe the purpose of the final temperature. He replied that it was as a result of a previous survey but was unsure of the rational for taking the temperatures. Review of hospital document from 10/13-10/27/15 titled "HACCP Daily Temperature Log-For Cooling Cooked Potentially Hazardous Foods" noted that the documentation was limited to cooked chicken. There was no temperature monitoring for foods prepared at ambient room temperature.

5. On 10/29/15 beginning at 10:05 A.M., at Hospital B the preventive maintenance of the ice machine was reviewed with Engineering Staff (ES) 70. Concurrent observation of the ice production area revealed that there was a build up of a hard what calcified material on the internal components. Additionally there was a build up of a dark green, slimy material, resembling mold on the exterior surfaces of the hoses that supplied water to the ice producing mechanism. There was also a build up of a grey substance resembling dust on the air filter of the machine. ES 70 stated that the white clacified substance was likely minerals; however was unsure of what the slimy green substance was. ES 70 stated the maintenance process included the vacuuming of the coils and filters as well as the circulation of a cleaner through the ice producing components. He confirmed that the cleaner was the only chemical that was circulated through the machine.

Concurrent review of the cleaning instructions printed on the inside cover of the machine guided staff to utilize a 2-step process that included both a cleaner and a sanitizer. ES 70 acknowledged that the sanitation step was not part of regular preventive maintenance and he would have no way to know when the ice machine was last sanitized. He further stated that this was the same process that was utilized for all ice machines at Hospital B. Review of hospital document titled "Preventive Maintenane Work Order", dated 9/30/15, noted that the work order was limited to an inspection for abnormal conditions, check for unusual noise. There was no indication that preventive maintenance would include comprehensive cleaning/sanitation of the ice machine in accordance with manufacturers' specifications.

6. During food production observations at Hospital B on 10/29/15 beginning at 9:50 A.M., it was noted Dietary Staff 69 was preparing the noon entrée. It was noted that he had a partially cut onion on the counter. It was also noted the remaining onions were in a clear plastic container measuring approximately 24" (inches) x12" x10". There were greater than 20 small "fruit-type" flies nesting in the clear bin. In a concurrent interview with MS 63, she acknowledged that it was likely that some of the onions were used in the casserole that was being prepared for the noon meal and that the facility retained the infested product. In a concurrent interview with Management Staff 63, she stated that one of the onions was spoiled and the flies likely came in with the onions.

7. During general food production observations at Hospital B on 10/29/15 beginning at 9:55 A.M., it was noted that Dietary Staff (DS) 69 was producing the noon meal. He was observed handling soiled recipe binders with gloves then moving directly to food production activities without washing his hands or changing his gloves. Similarly he was observed obtaining supplies from the walk-in refrigerator and returning to food production without proper hand hygiene. Hand hygiene practices would dictate that employees "shall...clean their hands afer handling soiled utensils or equipment...to prevent cross contaminiation when changing tasks..." (Food Code, 2013).

8. On 10/27/15 beginning at 2:10 P.M., equipment sanitation practices were reviewed with Dietary Staff (DS) 64. He stated that once the meal carts were emptied he wiped them down with a sanitizer. The surveyor asked DS 64 to describe how he ensured the solution was effective. He demonstrated the use of a color changing strip that tested the chemical strength. It was noted that there was a negligible reaction of the strip after it was placed in the solution. In a concurrent interview, he stated that the sanitizer buckets were changed three times/day. He further stated that he changed the solution approximately 30 minutes earlier.

It was also noted that although the cart was rolled to the clean area of the kitchen there continued to be food particles on the interior areas of the cart. In a concurrent interview with Management Staff 61, he stated there was no policy for deep cleaning patient meal carts. He believed that the last time they were cleaned was approximately 2 months earlier. It would be the standard of practice to ensure that non-food contact surfaces of equipment remained free of food residue and other debris. Additionally equipment utilized in dietetic services should be washed and rinsed prior to sanitation (Food Code, 2013).

9. During initial tour on 10/27/15 of Hospital A, beginning at 10:00 A.M., it was noted that in the bakery area the food production sink was plumbed directly into the waste water system. It would be the standard of practice to ensure that waste piping discharged into the building drainage system through an air gap or air break. The required gap would measure twice the diameter of the discharge or a minimum of 1 inch (Food Code, 2013). In a follow up observation on 10/27/15 at 2:00 P.M., revealed that the food production sink in the cooks' area was also plumbed directly into the wastewater system. A concurrent observation revealed that the drain hose for the steamer was inserted below the rim level of the floor sink.

During initial tour on 10/29/15 beginning at 9:00 A.M., at Hospital B, it was noted that the wastewater discharge from the 2-compartment sink was placed below the rim level of the floor sink, eliminating the required air break.

10. During initial tour of Hospital A, on 10/27/15 beginning at 10:00 A.M., it was noted that in the bakery area there was a green refrigerator whose interior surface was compromised. There was a brown material resembling rust on the wire racks. It was also noted that the coating on the interior walls of the refrigerator had chipped off which resulted in a similar build up of the brown material. In a concurrent interview with Management Staff 61, he stated that "it looks like rust" and in the past the wire racks were replaced; however the interior walls had not been repaired. The standard of practice would be to ensure that the surfaces of food production equipment was finished to have a smooth, easily cleanable surface and was resistant to pitting, chipping and decomposition (Food Code, 2013).

11. During general dietetic services observations at Hospital A on 10/27/15 and 10/28/15 from at 10:00-11:30 A.M. and from 2:30-3:00 P.M., it was noted there were multiple pieces of equipment and areas that had a build-up of food residue. As an example there were food particles on the inside of patient meal transport carts, the grab and go unit in the café, café cooks refrigerators, drawers in the food production area that held cleaned/sanitized utensils, there were also dried on food particles on the outside of multiple refrigerator doors as well as dried on food particles on the tile walls of the kitchen, in particular in the food production areas. The recipe books that were routinely touched by food production staff were covered with dried on food particles and a clear sticky substance resembling grease. In an interview on 10/27/15 at 3:00 P.M., with Management Staff 63, she acknowledged that the kitchen areas could use deep cleaning.

During general dietetic services observations at Hospital B on 10/29/15 beginning at 9:55 A.M., similar areas of uncleanliness were noted. There was a build up of a clear grease-like substance on the shelf above the food production area. There was dried on food residue on multiple pieces of equipment including the stove, oven and in drawers that held cleaned/sanitized utensils.

Review of hospital document titled "Cleaning Schedule" for Hospital A dated 10/4-10/17/15 revealed that while cleaning tasks were divided among 12 different job tasks, depicting different areas of the kitchen, all were signed off as being clean and complete. Review of hospital document titled "Paradise Valley Hospital Food Safety Inspection-Infection Control & Prevention", dated 2/12/15, noted identification that the storage room "needs deep cleaning" there was no indication that a deep cleaning schedule was implemented. Review of hospital B's daily cleaning list dated October 2015 noted that all kitchen areas were documented as clean on 10/27/15. It was also noted there were multiple areas that were left blank throughout the month. In a concurrent interview with MS 63 she stated MS 61 was the position responsible for the day to day operations of the department; however he usually was at the site only weekly.

In an interview on ICP 1 (Infection Control Preventionist) she was asked to describe infection control oversight into dietetic services. She indicated that the previous ICP did occasional rounds in the department; however she had not completed any rounds since her transition into the ICP position. Review of the rounds titled "Food Safety Inspection-Infection Control & Prevention" dated 1/22, 2/12, 5/6 and 5/8/15 respectively revealed the review focused on personnel, food storage and food preparation with the exception of noting unclean kitchen areas the hospoital failed to recognize any other food safety issues.






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12. During a joint observation with the Director of Intensive Care Unit (DICU), on 10/27/15 at 9:55 A.M., a portable hand held electronic oral thermometer (device used to measure body temperature) was observed docked on a wall near Emergency Department (ED) treatment room 12. The same treatment room was occupied by Patient 13. Registered Nurse (RN) 11 was observed as he exited treatment room 12 and removed the electronic thermometer from the docking station and used the thermometer to assess Patient 13. RN 11 then returned the thermometer to the docking station. RN 11 did not cleanse the thermometer after it had been used for the patient's assessment and handled by RN 11, who had direct contact with the patient.

During an interview on 10/27/15 at 10:00 A.M., RN 11 stated that the observed thermometer was commonly used by ED staff and patients assigned to treatment rooms 12, 15, 16 and 17. RN 11 stated that commonly shared medical equipment was expected to be "wiped down with sanitizing cloths" after each use. RN 11 acknowledged that he had not cleansed the thermometer after it had been used to assess Patient 13 and returned to the docking station.

A review of Patient 13's medical record indicated that the patient had been admitted to the ED on 10/27/15 at 9:21 A.M. with complaints of abdominal pain and diarrhea (symptoms of a potential infectious illness caused by a microorganism). The patient's medical record indicated that laboratory tests were in progress and that a diagnosis was pending.

A review of the hospital policy and procedure entitled Cleaning and Disinfection, dated "OCTOBER 2013", included "Disinfection (low, intermediate, high level)...is the killing or inactivation of all microorganisms...Low Level Disinfection...medical equipment...Disinfect with Sani-Cloth...Disinfect with Sani-Cloth Bleach for c-diff infections (clostridium difficile, a transmittable infectious illness of the colon with symptoms which can include profuse diarrhea)".

During an interview on 10/28/15 at 11:30 A.M., the 10/27/15 observation in the ED was reviewed with the Director of Nursing/Performance Improvement Director DON/PID. The DON/PID stated the expectation that shared medical equipment was to be disinfected after each use. The DON/PID acknowledged that the facility staff had not implemented infection control practices that prevented potential exposure to a transmittable infectious disease.

13. During a joint observation of ED treatment room 3,with the Director of Intensive Care Unit (DICU), on 10/27/15 at 9:30 A.M., an upholstered chair was observed in ED treatment room 3. The seat portion of the chair was torn, which left 6 inches of rough edge and foam padding exposed. The DICU stated that the chair was intended for patient/visitor use and should not be accessible to patients or visitors in it's current condition. A second observation was conducted with the DICU

Based on observation, interview and document review, the hospital failed to maintain an organized surgical services that meets that needs of patients as evidenced by:


1. The Chairman of the Medical Staff Department of Surgery was not given responsibility for the medical care provided to surgical patients by not being aware of failures in the performance of surgical instrument processing and sterilization. In addition, he was not made aware by the Governing Body, that survey findings resulted in cancellation of surgeries and the institution of bypass for the Operating Rooms (ORs), the Emergency Department (ED), and Labor and Delivery (mother/baby unit). (A-353)

2. The hospital failed to ensure an effective, active system wide infection control program for prevention, control, and investigation of infections and communicable diseases in surgical services. The infection control program did not meet the needs of all patients receiving surgical care and supportive healthcare in the hospital.
(A-951 #1, 2)


The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation for Surgical Services and failure to provide care to their patients in a safe environment.

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection control program for prevention, control, and investigation of infections and communicable diseases in surgical services. The infection control program did not meet the needs of all patients receiving surgical care and supportive healthcare in the hospital as evidenced by the facility's failure to ensure:

1. Active surveillance to identify policies and procedures that are not implemented correctly in an active infection control program.

2. Active surveillance to identify and correct environmental conditions to prevent the growth of infectious and communicable diseases in surgical services and in the post-op surgical services environment.

3. The sterility of surgical instruments and sterile supplies.

a. Failed to provide effective monitoring of sterile supplies and sterile surgical instrument storage throughout the facility. Specifically, sterile processing department.

b. Failed to ensure sterile supplies and sterile surgical instruments were maintained in accordance with facility policy regarding event-related sterility according to the nationally recognized standard of the Association of Perioperative Registered Nurses (AORN). The ICP (infection control practitioner) identified AORN, as the standard the facility adopted and followed.

4. Sanitary condition of patient room environment.

a. Failed to provide effective monitoring to ensure staff was trained and competent to identify, prevent and control infectious environments in patient areas.

b. Failed to ensure policy and procedures in place and staff trained to report infectious or potentially infectious environments.


On 10/28/15 at 4:12 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 951, A Tag 748 and A Tag 749. The Administrator, the Chief Nursing Officer (CNO), and the Director of Nursing/Performance Improvement Director (DON/PID) were present. The Immediate Jeopardy was lifted on 10/30/15 at 1:05 P.M. after an acceptable corrective action plan was implemented.

Findings:

1. On 10/27/15 at 1:00 P.M., and approximately 3:50 P.M., during a tour, interviews, observations and review of documentation of the sterile processing unit (SPU) decontamination room, widespread pattern of potential ineffective cleaning, disinfection and lack of prevention of transference of infectious substance was revealed, in the decontamination room of the sterile processing department. The DON/PID, Infection Control Preventionist (ICP 1), sterile processing technician (SP TECH 1) acknowledged the deficient practice.

On 10/28/15 at approximately 8:30 A.M., during an observation and subsequent interviews, with ICP 1, Corporate Manager for Infection Prevention (ICP 2), DON/PID and NDOS, all reported that "others" were responsible for the oversight of maintaining the decontamination process.

The ICP 2 stated, she did not have prior knowledge of the sterile processing and decontamination area state of, "unacceptable practice in the environment of care services."

In addition, ICP 2 stated, and the NDOS nodded agreement, "this must change immediately." The ICP 1, ICP 2, DON/PID and NDOS acknowledged the instruments processed in this unit could not be ensured to be sterile. All verbalized acknowledgment that if sterility cannot be assured then the instruments must be reprocessed and re-sterilized.

On 10/28/15 at approximately 9:30 A.M., the NDOS acknowledged responsibility for the environmental cleaning of the sterile core, sub sterile unit, sterile processing and decontamination unit. She indicated, she did not communicate with the ICP nor did she have a practice or policy to consult the ICP regarding any on-going environmental issues other than an orientation of the ICP 1 to the SPU. Surveillance documentation on the above listed areas was requested. At the time of exit, the facility was unable to provide active surveillance documentation by the ICP and NDOS.

In a concurrent/ongoing interview, the NDOS revealed that she did not formally communicate issues with the environment of care in the sterile storage, sterile processing or decontamination areas with the ICP. NDOS acknowledged the need for improved cleaning. The NDOS indicated she does not have a specific mechanism for communication of the needs beyond calling in work orders and she did not know if this communication reached the ICP 1.

On 10/30/15 at approximately 9:30 A.M., in a record review, observation and interview, ICP 1 acknowledged that she did not have documentation from the rounds. ICP 1 stated that the surveillance is informal. ICP 1 stated that she was the responsible for the sterile processing and was not yet familiar with the policy and procedures for the units, if they exist. The ICP 1 acknowledged she was not familiar with the term "event related sterility", and the policy and procedure the facility follows as a standard of quality control for sterile surgical instruments and supplies. ICP 1 acknowledged she was not familiar with any job related infection control training provided to the staff.

In subsequent interview and record review at approximately 3:00 P.M., ICP 1, ICP 2 and the DON/PID, acknowledged a lack of coordination and oversight by infection control staff of the sterile processing unit and decontamination room. Each indicated the previous ICP, to their knowledge, did not actively conduct surveillance beyond the quarterly team facility rounds. Each acknowledged the lack of rounding in the SPU was not formally communicated.

On 10/30/15 at 9:50 A.M., a record review was conducted of the proposed schedule for the Environment of Care (EOC) rounds. Review of record titled, "EOC rounds" revealed the rounds in sterile processing were not completed in March 2015 or recently in September 2015, thus, ICP 2 acknowledged the broad sweep of the EOC rounds scheduled were not conducted to date for the SPU.

2. On 10/28/15 at 4:12 P.M., an Immediate Jeopardy (IJ) was determined for the widespread pattern of potential ineffective cleaning, disinfection and lack of prevention of transference of infectious substances in the sterile processing unit. Sterility of surgical instruments could not be ensured due to the absence of an enzymatic product that must be used in the decontamination process per the hospital's policy and procedures, titled "Sterilization and Disinfection, Sterile Processing Department" dated April 2015, pages 1-4, and a second policy and procedure titled, "Surgical Instruments, Care and Cleaning" dated June 2010.

In addition, the following standard practice deficiencies were found:
1) A substance was found around the edges of the decontamination sink and on the above wall.
2) The sterile processing room was found with dust and debris throughout the unit and specifically, debris falling into the open container supplying detergent to the washer.
3) The STERIS washer was found not to be maintained per manufacture's instructions when a review of records revealed a lack of documentation.
4) The documentation of the washing cycle was not accurately recorded when the tape printed out erroneously, that an enzymatic product was injected into the washer and lacked the documentation by the sterile processing technician, according to national recognized standards.