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Based on interview with facility staff and review of documents the hospital failed to ensure the governing body was responsible for services furnished by a contracted provider had been evaluated to meet acceptable standards of practice.

Findings:


During an interview with the Director of Rehabilitation (Rehab) Operations (DRO) on 5/16/19 at 2:25 p.m., the DRO stated he runs a rehab services company which is contracted with the hospital to provide physical therapy, occupational therapy, and speech therapy services for the patients at the hospital. The DRO was asked how he determines the services provided by his company are effective and meet the needs of the patients in the hospital and was not able to provide a response. The DRO was asked what data he collects regarding measurable patient outcomes and submits to the hospital for inclusion in the hospital's quality assessment performance improvement (QAPI) program and stated he has not provided data or been asked to provide data to anyone at the hospital. The DRO stated he has not provided data for the purpose of evaluating his company's performance prior to his contract renewal. The DRO stated he is the one that signed the contract with the hospital.

Review of the contract between the rehab services company and the hospital indicated, "the contractor's on-going performance will be monitored to develop an oversight structure which ...addresses the relevant patient care and safety issues ...Under this agreement the contractor's performance will be reviewed to determine whether the services are being provided in a high quality manner ...on an ongoing basis, the performance data will be reviewed ...."

Based on interview with facility staff and review of documents the hospital failed to ensure the governing body was responsible for services furnished by a contracted provider had been evaluated to meet acceptable standards of practice. This deficient practice had the potential for all patients requiring rehab services to receive ineffective therapy.

Findings:

During a concurrent interview and record review with the Director of Rehabilitation (Rehab) Operations (DRO) on 5/16/19 at 2:25 p.m., the DRO stated he runs a rehab services company which is contracted with the hospital to provide physical therapy, occupational therapy, and speech therapy services for the patients at the hospital. The DRO was asked how he determines the services provided by his company are effective and meet the needs of the patients in the hospital and was not able to provide a response. The DRO was asked what data he collects regarding measurable patient outcomes and submits to the hospital for inclusion in the hospital's quality assessment performance improvement (QAPI) program and stated he has not provided data or been asked to provide data to anyone at the hospital. The DRO stated he has not provided data for the purpose of evaluating his company's performance prior to his contract renewal. The DRO stated he is the one that signed the contract with the hospital.

Review of the contract between the rehab services company and the hospital indicated, "the contractor's on-going performance will be monitored to develop an oversight structure which ...addresses the relevant patient care and safety issues ...Under this agreement the contractor's performance will be reviewed to determine whether the services are being provided in a high quality manner ...on an ongoing basis, the performance data will be reviewed ...."

Based on interview and record review, the hospital failed to ensure restraint orders were renewed according to the hospital policy and procedure for one of 31 sampled patients (Patient 17) when the use of soft mitten restraints was continued after the physician's order expired.

This failure resulted in the use of restraints without a physician's order and had the potential to result in physical injury.

Findings:

During a concurrent interview and record review, on 5/17/19 at 1:30 p.m., the Associate Chief Nursing Officer (ACNO) assisted with review of Patient 17's clinical record. The ACNO stated Patient 17 was admitted to the hospital on 5/8/19 with diagnoses of Subarachnoid hemorrhage (bleeding in the brain), hypoxia (lack of oxygen), and ventilator (a machine that blows air into and out of lungs) dependence. The ACNO stated soft mitten restraints (large gloves used to involuntarily restrict movement of hands) were used to keep Patient 17 from pulling her tracheostomy tube (plastic tube in the neck for breathing).

During a review of Physician Orders for Patient 17, dated 5/12/19 at 9:02 a.m., orders indicated soft mitten restraints were ordered for Patient 17 for a duration of 24 hours, expiring on 5/13/19 at 8:30 a.m. A renewal order was not obtained until 5/15/19 at 8:35 a.m.
During a review of the electronic Restraint Monitoring Flow for Patient 17, the record indicated usage of bilateral (both sides) soft mitten restraints were continued daily until present.

During a concurrent interview and record review, on 5/17/19 at 1:40 p.m., the ACNO stated no physician order was obtained for the use of restraints on Patient 17 for 5/13/19 and 5/14/19, confirming the use of restraints continued for an additional 48 hours without a physician's order. The ACNO was unable to find clinical documentation indicating restraints were removed on 5/13/19 and 5/14/19. The ACNO stated if the nurse applied a restraint, an order for restraints was needed. The ACNO stated patients had to be assessed by a physician and restraint orders renewed every 24 hours. The ACNO stated it was a patient rights issue.

The hospital policy and procedure titled, "Restraints" dated 4/19, indicated, " ... Purpose: To ensure the patient's rights to be free from restraints of any form ... 3. Obtain a physician's order prior to the application of a restraint ... Orders for restraints must be renewed on a daily basis ..."

Based on interview and record review, the governing body failed to develop, implement, and maintain the hospital's quality assessment and performance improvement (QAPI) program. This failure had the potential to effect the health status of all patients receiving care at the hospital.

Findings:

During an interview on 5/15/19 at 9:15 a.m., the Quality Committee (QC) failed to respond to requests to provide any documentation of governing body involvement in the QAPI process.

During an interview on 5/16/19 at 1:45 p.m., the QC failed to respond to requests to provide any documentation of governing body involvement in the QAPI process.

The hospital's Quality Manual indicated the hospital management team was responsible for the development and implementation of the quality management and is accountable for the effectiveness of the management system.

Based on interview with hospital staff and review of documents the hospital failed to ensure the medical staff periodically conducted appraisals of its members. This failure had the potential for unqualified and incompetent medical staff providing care to patients.

Findings:

During an interview on 05/17/2019 at 10:10 a.m., Chief of the Medical Staff (DM) stated he was unaware of any documentation of peer review. The Quality Coordinator (QC) failed to respond to requests made in interviews on 5/15/2019 at 9:15 a.m. and 5/16/2019 at 1:45 p.m. to provide documentation of peer review.

The facility's Quality Manual indicated that "...the monitoring, assessment, and evaluation of the patient care and the clinical performance of all individuals with clinical privileges shall be performed."

Based on interview with hospital staff and review of documents the hospital failed to ensure that the criteria for determining the privileges to be granted to individual practitioners and the procedure for applying the criteria to individuals requesting privileges as described in the bylaws was followed. This failure had the potential for unqualified and incompetent practitioners providing patient care.

Findings:

Review of physician credential files revealed that privileges had been granted to physicians for computed tomography (CT) and endoscopy.

During an interview on 05/16/2019 at 2:35 p.m. the Governing Body/Owner (GBO) stated the facility did not provide CT or endoscopy services. The lack of the services prevents the physicians from performing them and therefore the services cannot be evaluated and should not be granted.

Based on observation, interview and record review, the hospital failed to have physician verbal and telephone orders authenticated (signed) in patient medical records within 48 hours of issuance as required by state regulations. This failure to have verbal and telephone orders signed by the physician carried a higher risk of miscommunication of details in orders, particularly for medications which must specify drug name, dosage, quantity, and timing of administration and jeopardized patient safety by missing an important step for verification of the physicians' orders and also created a potential for drug error and diversion.

For the month of April 2019, there were 2,414 unauthenticated verbal and telephone orders for inpatients and a total of 1,430 in January, 2019, tracked in the hospital electronic health record (E.H.R.) system. This was in a patient sampling averaging 60 to 70 inpatient discharges per month.

Findings:

During an observation on 5/13/19 at 1:55 p.m., use of the electronic health record was demonstrated by the Clinical Information Specialist (CIS). CIS showed how the Medication Administration Record (MAR) was printed on a daily basis at each nursing station, and a sample MAR was printed for each patient. The listing or orders on the MAR did not indicate which ones were generated by verbal order or telephone order (VO/TO).

During an interview on 5/14/19 at 9:15 a.m., the HIM Director (HIM Dir) was asked about medical staff verbal orders and telephone orders (VO/TO) not signed within 48 hours in the E.H.R. HIM Dir stated that a weekly report of the unsigned VO/TOs were provided to the chief of the medical staff.

During a record review on 5/14/19 at 10:30 a.m., of the printed report known as Outstanding Cosignature/Verbal Orders (MROSCSVO) from 1/01/19 to 5/12/19, indicated 475 unsigned orders. Of these unsigned orders, there were 33 orders for Schedule II controlled medications (drugs regulated by government, generally known narcotics likely to cause severe psychological or physical dependence) that require the prescribing physician's signature by state law.

Upon a 5/14/19 review of the hospital's list of unsigned orders from 1/1/19 to 3/31/19, there were a total of 1,430 verbal and telephone orders for January 2019, 664 for February and 283 for March 2019 that were not authenticated within 48 hours of being issued. Medical Staff members with unsigned orders in the three month period included:
Physician Pulmonology (medical specialty of the respiratory system, MD Pulm), with 131 unsigned orders;
Nurse Practitioner (NP) with 72 unsigned orders.

Additionally the reporting of unsigned orders from 10/9/18 through 11/24/18, indicated:
Physician Nephrology (medical specialty of the kidney/urinary tract system, MD Nephr), with 141 unsigned orders.

An additional reporting of the unsigned orders report for the month of April 2019 was requested on 5/14/19 at 10:10 a.m., the Telephone Orders unsigned within 48 hours report (TORB Deficiencies) for April 2019 indicated 2,414 orders not signed within 48 hours of issuance. Of these, 1,422 were given "Incorrect Physician Assignment (by nursing staff)."

During an interview on 5/14/19 at 10:15 a.m., HIM Dir stated that there was an error in the numbers reported of the unsigned orders list, caused by addition of physicians to the facility staff in April, 2019.

A review of the hospital policy and procedure for Physician Verbal and Telephone Orders was requested on 5/14/19 for the rules regarding authentication (verification) of orders within 48 hours of receipt, and was not provided.

The HIM Policy & Procedure manual, provided upon request on 5/14/19, was reviewed on 5/14/19 and in the policy titled, "Concurrent Audits on Medical Records" (MRA 04, dated reviewed on 01/2016) indicated, "the clinical team should ... flag unsigned orders to meet regulatory requirements."

Based on observation, interview, and record review, the hospital failed to ensure the Hospital Pharmacy sterile (germ-free) compounding (mixing medications) procedures were consistent with Federal requirements of United States Pharmacopoeia (USP) <797> (chapter). USP <797> is a standard of practice for sterile compounding in hospitals. This occurred when:

1. Environmental viable (capable of living) airborne particle testing did not meet USP <797> requirements. First, the sampling sites of the sampling plan did not include locations within the segregated compounding areas (separate space for restricted activities) at greatest risk of contamination. Second, for low-risk level (category of contamination risk) and medium-risk level (category of contamination risk) compounding, air sampling was not performed at locations that are prone to contamination during activities such as staging (preparation), labeling, gowning, and cleaning. For the time period (extent) from 7/19/18 to 5/15/19, a universe of 292 patients out of 612 admitted patients were prepared 6,484 compounded sterile preparations (CSPs) in the hospital's single Compounding Aseptic Isolator (CAI). A CAI is one type of Primary Engineering Controls (PECs) which is a compounding device that provides ISO (abbreviation for International Organization for Standardization- a standard setting body) 5 (category of air cleanliness and quality) conditions. This failure had the potential to expose these patients to an increased risk of infections due to unknown data about the environment CAI was placed in.

2. Twenty-five (25) cardboard boxes were observed in the Pharmacy stored in the area restricted to the garbing (gowning), hand-washing procedures, and wiping down of items to be placed into the CAI. This failure had the potential to expose a universe of 74 patients to contamination with particles generated by the cardboard boxes.

3. A sterile water plastic pour bottle was observed outside of the ISO 5 environment not in accordance with the manufacturer's instructions and USP <797>. This failure had the potential to expose a universe of 74 patients to increased risk of infection(s) from microbial [disease-causing] contamination if the water was used to clean the CAI.

Findings:

1. A review of USP <797> dated 2012 in the section titled "INTRODUCTION" indicated, "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility)."

A review of the USP <797> dated 2012 in the section titled "Viable and Nonviable [not capable of living] Environmental Sampling (ES) Testing" indicated "The compounding area includes the ISO Class 5 ...PEC ( ...CAIs ...) ...and segregated compounding areas. Environmental sampling shall occur as part a comprehensive quality management program and shall occur minimally under any of the following conditions ...as part of the re-certification of facilities and equipment (i.e., every 6 months) ..."

A review of USP <797> dated 2012 in the section titled "ENVIRONMENTAL VIABLE AIRBORNE PARTICLE TESTING PROGRAM [air sampling reports] ...indicated "Sampling Plan ...selected sampling sites shall include locations ...and in the segregated compounding areas at greatest risk of contamination (e.g., work areas near the ISO Class 5 ... environment, counters near doors, pass-through boxes [chamber between the compounding area and the outside environment]). The plan shall include sample location, method of collection, frequency of sampling, volume of air sampled, and time of day as related to activity in the compounding area" ..."Viable Air Sampling ...For low-, medium-, and high-risk level compounding, air sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning. Locations shall include ...other areas where air backwash [the entry of unfiltered room air into the work area and may be created when the user inserts a hand or materials into the work area] turbulence may enter the compounding area (doorways, in and around the ISO Class 5 ...PEC and environments). Consideration should be given to the overall effect the chosen sampling method will have on the unidirectional airflow within a compounding environment. For low-risk level CSPs with 12-hour or less BUD [abbreviation for beyond-use date - the date or time after which a CSP shall not be stored] prepared in a PEC ( ...CAIs) that maintains an ISO Class 5 ..., air sampling shall be performed at locations inside the ISO Class 5 environment and other areas that are in close proximity to the ISO Class 5 ...environment during the certification of the PEC."

During a review of the hospital's environmental viable airborne particle testing reports from Company B dated 7/18 and 1/19, the reports did not indicate selected sampling sites included locations in the segregated compounding areas at greatest risk of contamination and air sampling was performed at locations that are prone to contamination during other activities such as staging, labeling, gowning, and cleaning.

During an interview with the Lead Certified Pharmacy Technician (Lead CPhT) on 5/15/19 at 8:11 a.m., the Lead CPhT stated the hospital staff conducted their own environmental testing of the compounding area and the tests results were analyzed by Company C. She stated the reports did not indicate where the air was tested outside of the CAI.

During an interview with the Director of Pharmacy (DOP) on 5/15/19 at 9:22 a.m., the DOP stated the hospital followed USP <797> standards of practice for sterile compounding.

During an interview with the DOP on 5/15/19 at 2 p.m., the DOP stated the recertification testing by Company B occurred every six months. She acknowledged she did not currently have certified Clean Room (a room in which the amount of airborne particles is controlled to meet a specified cleanliness class).

During an interview with the DOP on 5/15/19 at 3:56 p.m., the DOP stated for the environmental viable airborne particle testing reports dated 7/18 and 1/19 from Company B, the environmental sampling was conducted only inside the CAI. She acknowledged no areas outside of the CAI were tested in 7/18 or 1/19.

During an interview with the DOP on 5/15/19 at 5 p.m., when asked how the areas at greatest risk of contamination were determined, the DOP stated she thought the hospital staff conducting environmental sampling analyzed by Company C and recertification reports every six months from Company B was sufficient. She stated the staging area (outside of the CAI) in the segregated compounding area was one of the areas at greatest risk of contamination.

During an interview with the DOP on 5/16/19 at 9:15 a.m., the DOP stated Company B tests only inside the CAI unless specifically requested to test outside.

During an interview with the DOP and Registered Pharmacist (RPh 2) on 5/16/19 at 1:21 p.m., they stated that 6,484 items were compounded in the Pharmacy and 612 unique patients were admitted between 7/19/18 and 5/15/19.

During an interview with RPh 2 on 5/20/19 at 8:15 a.m., he acknowledged that 292 patients out of the 612 admitted patients were prepared 6,484 CSPs in the Pharmacy between 7/19/18 and 5/15/19.

The hospital policy and procedure titled: "Intravenous [IV - into the patient's vein] Admixture [mixture] - Sterile Preparations" dated 7/18 indicated "REFERENCES...USP <797>."

2. During an observation on 5/14/19 at 2:05 p.m. in the area where activities related to compounding occurred inside Pharmacy Department, an inspection was conducted with RPh 2 and the Lead CPhT. Pharmacy Technician (PhT 4) was observed wiping down IV fluid solution bags with a sporicidal (kills spores that cause disease) agent on the counter workspace. Twenty-five cardboard boxes were observed located in close proximity to the counter workspace where PhT 4 was observed to be wiping down the IV fluid bags.

During an interview with RPh 2 on 5/14/19 at 2:42 p.m., RPh 2 stated there were 25 cardboard boxes in the area where PhT 4 was observed working and wiping down the IV fluid solution bags.

During an interview with the PhT 4 on 5/14/19 at 4:19 p.m., the PhT 4 acknowledged she was wiping down the IV fluid bags with a sporicidal agent on the counter workspace at the time of inspection on 5/14/19 at 2:05 p.m.

During an interview with the Lead CPhT on 5/15/19 at 9:04 a.m., the Lead CPhT stated that every item needs to be wiped down with a sporicidal agent prior to being placed in the CAI (clean environment).

During an interview with the DOP on 5/15/19 at 9:22 a.m., the DOP stated the hospital followed USP <797> standards of practice for sterile compounding.

During an interview with the DOP on 5/15/19 at 2:05 p.m., the DOP stated the area where the 25 cardboard boxes were observed stored on 5/14/19 was called the "garbing area". The DOP acknowledged hospital staff had to put on disposable shoe covers before crossing the line on the floor to enter the "garbing area" for handwashing and gowning procedures.

During an interview with the Director of Infection Control on 5/17/19 at 10:24 a.m., the Director of Infection Control stated dust particles could be generated with the 25 cardboard boxes. He stated the expectation regarding cardboard boxes was to follow applicable guidelines for sterile compounding, such as USP <797>.

Review of the USP <797> dated 2012 on page 5 indicted "PECs ( ...CAIs ...) shall be certified and maintain ISO Class 5 ...and shall be in a segregated compounding area restricted to sterile compounding activities that minimize the risk of CSP contamination ...The specifications [requirements] in Cleaning and Disinfecting the Sterile Compounding Areas ...shall be followed as described in the chapter. Compounding personnel must recognize that the absence of an ISO Class 7 [measurement of air cleanliness or quality] ...buffer area [preparation area] environment in a general uncontrolled environment increases the potential of microbial contamination ..."

Review of the USP <797> dated 2012 titled "Cleaning and Disinfecting the Compounding Area" indicated "Environmental contact is a major source of microbial contamination of CSPs ...No shipping or other external cartons may be taken into ...segregated compounding area."

The hospital policy and procedure titled "Intravenous Admixture - Sterile Preparations" dated 7/18 indicated "Object that shed particles, such as cardboard boxes, shall not be brought or stored ..." and "REFERENCES...USP <797>."

3. During an observation on 5/14/19 at 2:05 p.m. in the area where activities related to compounding occurred inside Pharmacy Department, an inspection was conducted with RPh 2 and the Lead CPhT. An opened, undated, and partially used "Sterile Water for Irrigation [continuous flow of liquid]" plastic pour bottle from Manufacturer A (MFG A) was observed stored on a metal shelf outside of the CAI. The product labeling on the opened pour bottle from MFG A indicated "Discard unused portion."

During an interview with RPh 2 and CPhT on 5/14/19 at 2:42 p.m., the RPh 2 and CPhT acknowledged the "Sterile Water for Irrigation" plastic pour bottle from MFG A product labeling indicated to "Discard unused portion." RPh 2 acknowledged the opened and partially used plastic pour bottle containing water was stored outside of the CAI.

During an interview with the CPhT and Pharmacy Technician 4 (PhT 4) on 5/14/19 at 4:19 p.m., PhT 4 stated she opened the "Sterile Water for Irrigation" plastic pour bottle from MFG A around 12 p.m. to clean the CAI and that it was opened for approximately 30 minutes (at the time of inspection when it was observed outside of the CAI, it was calculated to be approximately two hours since the opening of the pour bottle).

During an interview with the DOP on 5/15/19 at 9:22 a.m., the DOP stated the hospital followed USP <797> standards of practice for sterile compounding.

Review of the USP <797> dated 2012 on page 7 indicated, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 ... air quality ..., and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 ... or cleaner air may be used up to 6 hours after initial needle puncture."

Review of letter from MFG A to the hospital dated 5/16/19 indicated "irrigation solutions in plastic pour bottles are manufactured per United States Pharmacopeia (USP) guidelines and are intended as a single dose container ...Any unused portion of irrigating solutions should be discarded, since no antimicrobial agent has been added."

The hospital policy and procedure titled: "Intravenous Admixture - Sterile Preparations" dated 7/18 indicated "REFERENCES...USP <797>."

Based on observation, interview and document review, the hospital failed to ensure the Food and Nutrition Services was organized in a manner that met state requirements when the hospital failed to:

1. Immediately implement infection control standards and practices to ensure sewage waste during a flood in the kitchen was cleaned properly and food was not prepared during the flood.

2. Ensure the Food Service Manager (FSM) 1 was qualified to manage the day to day responsibilities of foodservice.

This failure put patients at risk of food borne illness and compromised medical status.

An Immediate Jeopardy (IJ) situation was identified on 5/13/19 at 4:00 p.m., related to findings in Food and Dietetic Services 42 CFR 482.28 (a) [A-0619] in the presence of the hospital Chief Nursing Officer. Serious issues were identified in the maintenance of a sanitary hospital environment and food service operation during a sewage spill and hospital staff made the inappropriate decision to continue preparing food in an unsanitary environment. The hospital submitted an acceptable Action Plan and implemented corrective actions to address the immediate situation and sanitized the kitchen per nationally recognized infection control standards. The county health department then authorized the continued use of the kitchen. The IJ was abated on 5/14/19 at 5:14 p.m., in the presence of the Chief Executive Officer and Chief Operating Officer.


Findings:

1. During an observation on 3/13/19 at 1:30 p.m., the kitchen had a sewage spill that backed up covering 2/3 of the kitchen floor. Housekeeping was in the process of cleaning up the sewage water.

During a concurrent tour of the kitchen and interview on 3/13/19 at 2 p.m., Registered Dietician (RD 1) stated the kitchen would be closed and not prepare food.

During a concurrent observation and interview on 5/13/2019 at 3:05 p.m., in the production kitchen, food service staff had prepared desserts for service at the dinner meal. House Keeper (HK 1) stated he was cleaning up the sewage spill and was going to mop the floor with a sanitizer. Food Service Manager (FSM 1) he stated he would plan to use paper plates to serve dinner. FSM 1 or RD 1 had not contacted administration or infection control or the County Health Department regarding the sewage spill that was observed at 1:30 p.m., and continued to prepare patient food in the contaminated area.

During an observation on 5/13/19 at 3:08 p.m., conducted with two (2 Dietary Consultants of the survey team) and the hospital Infection Control Analyst (ICA) in the kitchen, the following observations were made:

a.) A significant area of the kitchen was wet and a Housekeeping Lead Staff was in the process of mopping the area. The Housekeeping Lead stated approximately 2/3 of the kitchen had sewage water and stated, "I am sucking up the water and then I will mop it and clean it". He also stated he did not know if the cleaning detergents were hospital grade or if they were EPA (Environmental Protection Agency-an independent agency of the United States federal government for environmental protection) registered.

b.) An open container filled with strawberries was on the food prepping table.

c.) An open bag of bread was on the food prepping table.

d.) A kitchen staff was transporting a cart with food from an area that had not been flooded, across a contaminated wet area and into a refrigerator located in an area that was wet and contaminated with sewage water.

e.) There was thick, grey, fuzzy matter above the stove area and throughout high touch surface areas, including the light fixtures.

An Immediate Jeopardy (IJ) situation was identified on 5/13/19 at 4:00 p.m., related to findings in Food and Dietetic Services 42 CFR 482.28 (a) [A-0619] in the presence of the hospital Chief Nursing Officer. Serious issues were identified in the maintenance of a sanitary hospital environment and food service operation during a sewage spill and hospital staff made the inappropriate decision to continue preparing food in an unsanitary environment. The hospital submitted an acceptable Action Plan and implemented corrective actions to address the immediate situation and sanitized the kitchen per nationally recognized infection control standards. The county health department then authorized the continued use of the kitchen. The IJ was abated on 5/14/19 at 5:14 p.m., in the presence of the Chief Executive Officer and Chief Operating Officer.

During an interview on 5/13/19 at 4 p.m., the Chief Nurse Officer (CNO) stated kitchen staff had not informed her of the sewage flood in the kitchen and she first knew about it because the two Dietary Consultant Surveyors informed her of it.

During an interview on 5/13/19 at 4:15 p.m., the ICA stated kitchen staff should have not been preparing food during the flooding.

During an interview on 5/14/19 at 9 a.m., the Infection Control Preventionist (ICP) stated he had not given the Hospital any standard to manage the cleanup for the kitchen spill.

During an interview on 5/14/19 at 1:15 p.m., the ICP stated kitchen staff had not informed him of the sewage flood in the kitchen on 5/13/19 but that the expectation was that they inform Infection Control so guidance can be provided to staff and instructions on how to clean and disinfect of the sewage water could also be provided to staff.

2. On 5/13/19 at 1:30 p.m., FSM 1 stated he was taking classes toward the Certified Dietary Manager qualifications but was not a Certified Dietary Manager. Registered Dietician (RD 1) confirmed FSM 1 was responsible for the day-to-day management of the food service and she did not provide the frequently required oversight as required directly in the kitchen.

Requirements at California Health and Safety Code 1265.4 requires a licensed health care facility (hospital) Who employs a full time dietary services supervisor who is responsible for the day to day running of the kitchen meet one of seven pathways. The FSM 1 stated he did not meet any of the path ways.

A review of Health and Safety Code 1265.4, indicated,
(b) The dietetic services supervisor shall have completed at least one of the following educational requirements:

(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.

(2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.

(3) A graduate of a dietetic assistant training program approved by the American Dietetic Association.

(4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.

(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.

(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service supervision.

(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

Based on observation, interview, and record review, the hospital failed to have a written plan to be prepared for an emergency disaster requiring medical records to be accessible for evacuation with patients. There was only one single back-up access to patient clinical records from the hospital system's Electronic Health Record (E.H.R) for five nursing units of the hospital. In a catastrophic disaster possibly involving damage and destruction to the hospital, this failure of emergency preparedness would create patient harm by impeding the ability to retrieve care history, medication and treatment records needed to maintain the continuity of care for patients at the facility during transfer or evacuation.

Findings:

During an interview on 5/14/19 at 1:20 p.m., the Director of Information Technology (IT DIR) was asked about recent downtime events involving the E.H.R. system. A copy of the Downtime Log from 1/1/18 - 5/14/19 was requested for the facility and was provided on 5/14/19. IT DIR confirmed that there was one recent extended outage of the E.H.R. system in April 2019. A copy of the policy and procedure for Disaster Response and Emergency Recovery of the E.H.R. was requested and provided on 5/14/19.

During a review of the E.H.R. Downtime Log (DT Log) on 5/14/19 at 1:25 p.m., an E.H.R. outage was noted on 4/28/19 for approximately 3.5 hours with intermittent outages on the next few days on 4/30 and 5/1/19 for 2.5 hours each. Also an outage of 4.5 hours was documented to have taken place on 1/24/19.

During an interview 5/14/19 at 1:30 p.m., IT DIR also clarified that an intentional planned outage of 2.5 hours took place on 5/13/19. When asked who had been trained on the disaster response of the E.H.R. outage, IT DIR stated, "All hospital staff had been trained".

The Chief Nursing Officer (CNO) joined the interview on 5/14/19 at 1:30 p.m. and stated that disaster response training had been provided to Clinical Coordinators and Nursing Supervisor, and had occurred around March 2019. A copy of the attendance sheet for this training was requested but was not provided. The CNO stated that remote viewing of the E.H.R. was available in a disaster by facility administration, the CNO, the Compliance Officer (Comp Ofcr) and the HIM Director.

The interview on 5/14/19 expanded to include the nursing House Supervisor (H/S) on duty at 2:05 p.m., who was requested to provide the downtime back-up medical record forms requiring manual completion in an emergency disaster response for inpatients. By 2:30 p.m. the following forms had been gathered for a patient documentation packet:

Physician Order form:
Physician Progress Note form;
Medication Administration Record (MAR);
Treatment Record form;
24 Hour Nurse's Notes (8 pages);
H/S was requested to demonstrate completion of the MAR and nursing notes which was thorough for those with experience with paper medical records. H/S agreed that newer clinicians -- both nurses and physicians -- trained only with E.H.R documentation are unfamiliar with the manual forms and require training to document on paper.

During an observation on 5/14/19 at 2:20 p.m., the Nursing House Supervisor (H/S) was retrieving back-up clinical information on the single back-up "view only" terminal, located in supervisor's office in the first floor patient care area. The information that was accessible from the E.H.R. included progress notes and the Medication Administration Record (MAR) of current inpatients.

During an interview on 5/14/19 at 2:50 p.m., the Compliance Officer (Comp Ofcr) described the E.H.R. outage which started on the weekend of 4/27/19 (Saturday), over a 7 hour period, starting at 10:30 a.m.. Comp Ofcr described that on 4/27/19 during the outage, Pharmacy could not access medication and medical records until 7:40 p.m.. Comp Ofcr state all facility staff were required to manually document on paper medical records. Comp Ofcr stated that a root cause analysis of the outage was conducted later that determined that the E.H.R. outage was caused by human error.

A review on 5/14/19 of IT Policy titled "Data Center Protection and Emergency Recovery Plan" (IT 003), indicated "Staff ... shall be trained on downtime and recovery procedures for ... unscheduled interruptions of electronic information systems" and "clinicians shall be trained in use of the paper-based ordering and charting tools" with "train ... provided ... at the time of orientation, annually and as needed." No specific steps were provided as training of manual documentation or access to the "read-only backup E.H.R. system".

A review on 5/14/19 of the Medical Record Emergency Disaster Plan (MRA 19), last reviewed on 1/2016, stated its purpose to "provide a stable and orderly recovery of care and services when faced with a disastrous event" yet did not address the E.H.R. system. The Health Information Policy on "File System Security & Safeguards" (MRA 20), also reviewed 01/2016, stated its purpose to "implement safeguards to protect the confidentiality, integrity and availability of its resident health information" and did not address E.H.R. system back up procedures, nor manual use of "paper-based ordering and charting tools" referenced in the IT 003.