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Based on observation, interview, and record review, the facility failed to ensure life saving medications, Ambu bags and masks (items to help with breathing) and other equipment and supplies, for use in an emergency, were readily available, for one of 23 sampled patients (Patient 8), when a pediatric (for infants and children) crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations[reviving someone from death or unconsciousness]) was not present on the medical-surgical (med-surg) floor. This had the potential to result in a delay in the initiation of life saving efforts in case of a life threatening emergency.

Findings:

A review of Patient 8's record indicated he had been born in the Emergency Department (ED) on 4/30/17 at 7:07 pm, then along with his mother, admitted to the med-surg floor later that evening.

During a tour of the med-surg unit and observation of the crash cart, on 5/1/17 at 10:15 am, the Director of Nurses (DON) was interviewed and stated that there were no pediatric or infant medications, Ambu bags and masks, and other supplies on the crash cart. The DON stated the pediatric crash cart contained all the necessary medications and other supplies, but was located in the ED. The DON stated Patient 8 was the first baby admitted since the hospital had stopped providing Obstetrical (childbirth) services as of 10/2016.

During an observation on 5/1/17 at 1 pm, Maintenance Personnel 1 used a measuring wheel device and measured the length from the outside of Patient 8's room to the ED as 192-feet.

During an interview on 5/1/17 at 1:50 pm, Respiratory Therapist (RT) 1 stated the facility had infant Ambu bags and masks available. RT 1 stated the Ambu bags and masks had been permanently left in the room where Patient 8 was admitted, but had been removed when the hospital stopped providing Obstetrical services.

During an interview on 5/1/17 at 1:50 pm, the DON confirmed they should have the same emergency medicines and supplies available for any infants who were patients as they do for adult patients on the med-surg floor.

During an interview on 5/1/17 at 4 pm, the Chief Executive Officer, agreed that 192-feet was too far to have to go to get the pediatric crash cart in case of an emergency.

During a concurrent interview and observation on 5/3/17 at 8:15 am, the DON confirmed the Broselow Tape (a color coded tape measure that is commonly used for pediatric emergencies to provide a rapid means of determining the doses of medications and sizes of equipment that should be used in pediatric resuscitations) on the med-surg cart was the 2007 edition. She stated they were made aware of this in 1/2017 and were told the most current 2011 issue was on back order. DON said she did not know the status of the back order, but would call to check on it. The Broselow Tape in the ED pediatric crash cart was the 2011 edition.

Based on observation, interview, and record review, the facility failed to ensure the premises were kept clean when;

1. The dwell time (amount of time a surface must remain wet to allow the disinfectant to effectively kill germs and bacteria) for the disinfectant used during a room and bed cleaning, was insufficient and not in accordance with manufacturer's instructions.

2. The Malignant Hyperthermia (MH: a rare but potentially lethal side effect of certain medication used in the practice of anesthesiology) cart (which contains equipment and medications used to manage an MH crisis) was stored within three to four feet of a hopper (large toilet like device used to discard human waste and fluids) that was actively used to dispose of human waste in the surgery department.

These failures had the potential to spread germs and result in hospital acquired infections.

Findings:

1. On 5/2/17 at 1:50 pm, a room and bed cleaning was observed following a patient's discharge from that room. Environmental Staff (EVS) 1 and 2 cleaned the room and used an Eco E23 disinfectant. Some surfaces remained wet for five-minutes and the bed remained wet from two to three-minutes.

During an interview on 5/3/17 at 3:15 pm, EVS 2 was asked how long the dwell time should be for the disinfectant used in room cleaning. EVS 2 said, five to ten-minutes. EVS Supervisor (EVSS) who was present said the dwell time for ECO was ten-minutes. EVSS said they just started using the ECO about one week ago and before had used another disinfectant, Cavi, with a shorter dwell time of three-minutes.

The Chief Quality Officer provided a copy of the safety data sheet for the ECO disinfectant which was reviewed and indicated the dwell time to be ten-minutes.

The facility's policy titled, "Housekeeping Principles," dated 11/19/15, was reviewed and read, "Hospital grade disposable disinfectant/cleaner towelettes are used for cleaning throughout the facility. The quantity or towelettes used to clean and disinfectant each area is determined by the amount needed to completely pre-clean surfaces of gross debris and then to keep the surfaces thoroughly wet for disinfection



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2. On 5/4/17 at 11:53 am, an inspection of the MH Kit revealed that it was contained in a large orange tackle box and was located within 3 to 4 feet of a hopper in a cleaning room (where surgical instruments were cleaned) of the Surgery Department. During an interview of Scrub Tech 1 at that time she stated the hopper was currently used to dispose of human waste. This observation was verified at that time during a concurrent interview of the Director of Pharmacy (DOP).

The DOP confirmed that aerosols generated when the hopper was flushed could carry potentially pathogenic microbes over to the MH Kit where they could be deposited on the MH Kit container. Staff members carrying and opening the box could contaminate their hands and serve as a source of infection when using this potentially contaminated kit to manage an MH crisis especially if the crisis occurred in a surgical operating theater. It was a standard of practice to store medications in a clean area.

Based on interview and record review, the facility failed to develop and implement policies to direct what actions staff should take if monitoring devices in the Operating Room (OR) indicated the humidity, temperature, or air exchanges were not within normal parameters. Temperature, humidity, and airflow must be maintained within acceptable standards to inhibit bacterial growth and prevent infections. This failure had the potential to result in an unsafe surgical environment that could lead to contamination of equipment and surgical site infections.

Findings:

During a concurrent interview and record review on 5/3/17 at 10:20 am, Scrub Technician (ST) 1 provided a handwritten OR log for 1/2017 through 4/2017. The normal humidity indicated on the log was from 20 to 60 percent (%). For some days, the humidity fell below 20%. ST 1 said the temperature and humidity were monitored electronically, and if outside the acceptable parameters, an alert was sent to someone else in the hospital, although she did not know who or what department. ST 1 stated she could adjust the thermostat if the temperature was outside the acceptable temperature but there was nothing she could do if the humidity was too low or too high and she was unaware of to whom she should report it.

During an interview on 5/3/17 at 1:45 pm, the OR temperature and humidity log was discussed with the Chief Executive Officer (CEO). He said the log was monitored electronically and a text should go to the Registered Nurse (RN) supervisor who should notify maintenance, but does not know if that's always done.

During an interview on 5/3/17 at 2:15 pm, the Maintenance Supervisor (MS) said the nursing OR supervisor was notified via text for temperatures or humidity outside the acceptable parameters, then she should call maintenance. MS confirmed he has not received any calls regarding this.

In a subsequent interview on 5/2/17 at 2:30 pm, the Chief Operating Officer confirmed the Emergency Room Supervisor not the OR supervisor was notified via text of any abnormal temperatures or humidity levels.

A review of the electronic log for the past six months was reviewed. It showed short periods of time (two to four hours)when the humidity was 19 to 19.9%, except from 1/5/17 at 5:53 pm until 1/7/17 at 5:07 pm, the humidity ranged from 11.2 to 18.3%, at which time the OR was closed.

A copy of the air exchanges and pressure inside the OR and adjacent rooms performed on 4/27/17 was provided for review.

During an interview on 5/3/17 at 3 pm, MS stated other than adjusting the thermostat, he doesn't know what he can do to change the humidity and if the air exchange was inadequate, he could change the filter but was unaware of what other actions should be taken. MS said he did not know what the acceptable air exchanges and pressure ranges were at the time the facility's OR was built in 1983.

During an interview on 5/4/17 at 9:50 am, the CEO stated that Administration had not made sure they had a policy and procedure regarding actions the staff should take if the temperature, humidity, or exchanges were not within the acceptable parameters.

Based on observation, interview and record/document review, the facility failed to have an effective system in place to provide an environment that was safe, and met the needs of all patients as evidenced by:

1. Dietary services were not provided in accordance with recognized dietary practices (Refer to C-279, Findings 1-4).

2. The storage, production and distribution of medications were not in accordance with accepted professional principles (Refer to C-225, Finding 2 and C-276, Findings 2, 4 and 6).

3. No development of a written policy that would direct staff to take action if the current temperatures or humidity levels in the operating room failed out accepted parameters (See C-241).

4. The nursing units were lacking essential emergency supplies (Refer to C-202 and C-276, Findings 1, 7-11.)

5. Rooms were not cleaned in accordance with accepted professional principles (Refer to C-225, Finding 1).

6. The nursing staff did not meet the assessment needs of all patients (Refer to C-279, Findings 5-6, C-294, Finding 1, C-302, Finding 4 and C-297).

7. The facility's transfer forms contained incorrect and inaccurate information (Refer to C-302, Findings 1 and 2).

8. The facility's staff lacked certain competencies and emergency training which are essential in order to perform their duties. (Refer to C 276, Finding 5 and C-294, Findings 2-3.)

The cumulative effects of these systemic failures resulted in the hospital's inability to provide patient services in a safe and effective manner in accordance with the statutorily-mandated Condition of Participation- Provision of Services which had the potential for a worsening of the patient's condition including the possibility of death.

Based on inspection of one out of one pediatric (infants, children, and adolescents) crash cart (contains medications and equipment used to manage pediatric medical emergencies), located in the Emergency Department (ED), review of the approved medication content list for this emergency supply and staff interview, the hospital failed to ensure that a change in the medication content was approved by the organized medical staff through the Pharmacy and Therapeutics (P&T) Committee. As a result, the organized medical staff did not have the opportunity to formally weigh in on this process which has a direct impact on emergency patient care.

Findings:

On 5/4/17 at 9:24 AM, an inspection of the pediatric crash cart in the ED revealed that it contained one 500 milliliter (ml) intravenous bag of 10% dextrose (used to treat low blood sugar levels) in water. The approved medication content list for this emergency supply indicated it should contained one 50 ml pre-filled syringe of 50% dextrose.

This observation was verified by the Director of Pharmacy (DOP) during a concurrent interview conducted at that time. The DOP had removed the pre-filled syringe of 50% dextrose from the medication supply and replaced it with an intravenous bag of 10% dextrose in water without the approval of the Pharmacy and Therapeutics (P&T) Committee. The DOP stated the current Pediatric Advanced Life Support (PALs) guidelines indicated 10% dextrose should be used rather than 50% dextrose, but he stated he had made the change without getting the approval of the P&T Committee. The DOP stated this was the committee that would approve the change.

Based on observation, staff interview, and document review:

1. The hospital failed to ensure one of one pediatric (infants, children, and adolescents) crash cart (contains medications and equipment used to manage pediatric medical emergencies), located in the Emergency Department (ED) contained all the medications needed to manage a pediatric emergency as documented in the standard, the Broselow Tape guidelines (a tape that is used to estimate the weight of a child based on the height as measured on the tape and which provides weight based guidelines for medication doses required to manage pediatric medical emergencies), identified by the hospital as the guidelines it followed to manage a pediatric emergency. The hospital also failed to supply enough emergency medication to treat all weight ranges (from 3 kilograms [kg] to 36 kg) of children documented on the tape. The cart contained 1 milligram/milliliter (mg/ml) vials of atropine (medication used to speed up the heart rate when the heart is beating too slowly) that could be used to deliver a dose by the endotracheal route (ET: down the windpipe, a last resort route of medication administration used when other routes are not available in an emergency situation) however this was 2.5 times the concentration documented on the Broselow Tape which could result in administration of 2.5 times the dose if staff just followed the volume of administration published on the tape for this drug for the weight classes of children covered by the tape guidelines. The Pediatric Crash Cart did not contain any amiodarone (medication used to treat serious abnormal heart rhythms) even though dosing guidelines were provided on the Broselow Tape for all weight groups published on the tape. Finally, there was not enough sodium bicarbonate (medication that lowers the acid levels of blood that can rise during a medical emergency) to treat all weight classes (from 15 kg through 36 kg) of children documented on the Broselow Tape. These issues had the potential to delay the effective management of a pediatric medical emergency with the possible result of death to the patient.

2. a. The hospital failed to label one unit-of-use package for Patient 11 with the drug strength and clear auxiliary labels as stipulated by hospital policy. The unit of use package containing one 0.5 mg tablet of pramipexole (medication used to treat Parkinson's disease which manifests initially as a tremor of one hand, and progresses to stiffness, slow movement, and loss of balance) for the evening dose had no strength printed after the drug name and had a handwritten auxiliary label which indicated staff were to discard one-half of the tablet when, in fact, the patient was to receive the whole tablet. As a result of this mislabeled medication container, the nurse administering the dose to the patient cut the tablet in half and administered it to Patient 11 who, therefore, only received one-half the intended dose with the potential Patient 11 may have experienced a decreased effect of the drug and possible worsening of the patient's condition.

b. The hospital also failed to ensure the strength of digoxin (medication that is used to treat heart failure and heart rhythm problems) appeared correctly on the approved content list for the adult crash carts (contains medications and equipment for management of medical emergencies in adults). The approved content list indicated it contained two 2 ml ampules of digoxin 5 mg/2 ml when this drug is not available at this strength. It is available as 2 ml ampules of digoxin 0.5 mg/2 ml and this is what was found during inspection of one out of one Adult Crash Cart on the Medical Surgical (Med/Surg) Unit. The content list serves as a label for the contents of the cart and mislabeling it in this fashion could result in confusion in dose calculation during the management of a medical emergency with the possibilty of harm or death to the patient.

3. The hospital failed to ensure staff informed Patient 11's physician of the medication error with regard to pramipexole as required by hospital policy.

4. The hospital Pharmacy Department failed to act on viable sampling reports done in March of 2016 by a contracted certification service (contracted to ensure the sterile compounding area is maintained within established standards) that indicated that colony formoming units (CFUs individual colonies of bacteria, yeast or mold), from air samples obtained in the compounding area of the pharmacy, grew out organisms described as highly pathogenic (disease causing) in chapter 797 of the United States Pharmacopeia (USP 797: sets standards for drugs and compounding drugs that are enforceable by the Food and Drug Administration and hence are considered standards of practice). These organisms are documented in USP 797 to be coagulase positive Staphylococcus, gram negative rods, and molds and yeasts (fungi). A review of results from the March 2016 certification report indicated air samples obtained in the compounding room at that time grew out CFUs of coagulase positive Staphylococcus and fungi. The Pharmacy Department did not have a record of the results of viable sampling done in October of 2016 or results from viable sampling done in April 2017 by the contracted certification service. A review of results obtained from the contracted certification service during the survey by the Pharmacy Department for the October 2016 and April 2017 certification visits indicated highly pathogenic organisms (various genera of fungi) were identified from CFUs that grew out from air samples taken in the compounding room both in October 2016 and April 2017. No evidence was provided the Pharmacy Department ever acted on these reports to eliminate these organisms from the compounding environment as described in USP 797.

5. The hospital Pharmacy Department failed to ensure all staff members who compounded sterile products were assessed for correct technique by performing a sterile media fill test (compounding done using microbial growth media that is subject to various manipulations designed to mimic the most complex compounding staff performs and which is subsequently incubated at defined temperatures to see if anything grows out) as required by USP 797. One of two pharmacists, Pharmacist 1, who compounded sterile products, had not been tested by performing a media fill test. As a result, it had not been determined if the pharmacist, Pharmacist 1, who had not been tested could safely compound sterile products without contaminating them.

6. The hospital failed to ensure controlled drugs in Schedule II (drugs most likely to be abused such as morphine) and Scheduled IV (drug less likely to be abused: includes medications such as Valium) were locked up as required by hospital policy. Staff left one partially used cartridge of morphine sulfate (medication used to treat pain) and one open vial of lorazepam (medication used to treat seizures and as an anxiety relieving sedative) on top of an automated drug dispensing system cabinet in the ED located in the unattended nursing station. This had the potential to provide an opportunity for diversion (a medical and legal concept involving the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illegal use) of these medications.

7. The hospital failed to ensure that five out of five adult crash carts (contains medications and equipment used to manage an adult medical emergency) had up-to-date medication content lists posted outside of these emergency supplies. All five carts (located on the Med/Surg floor, in the ED, in the Wound Care area, in the Outpatient Surgery Department, and the Surgery Department) had vasopressin (medication used to help establish the return of spontaneous circulation) listed on their externally posted content lists but the updated content list available from the pharmacy did not list this medication and inspection of the Med/Surg Adult Crash Cart indicated it did not contain this medication. This could potentially delay therapy of a medical emergency, a worsening of a patient's condition, and possibly death if a physician called for the use of vasopressin based on its appearance on the external content list while staff searched the cart for this medication which had not been available, per the Director of Pharmacy's (DOP) report, for two years.

8. The hospital failed to ensure one out of one adult crash cart located on the Med/Surg floor was stocked as documented on the approved content list. The crash cart had less sterile water for injection (SWI: used to reconstitute powdered medication for injection prior to administration), and a dosage form of naloxone (medication used to reverse opiate based medication [such as morphine] overdoses) that was different in packaging (vial versus pre-filled syringes [PFSs]) and at a different concentration (0.4 mg/ml versus 1 mg/ml) than what was listed on the content list. the crash cart was also was missing a pre-mixed bag of lidocaine 2 grams in 500 ml of 5 percent (%) dextrose in water (medicated solution used to treat dangerous abnormal heart rhythms). There was no clear identified use for the SWI and inadvertent intravenous (IV - into a vein) administration could lead to destruction of red blood cells. Availability of a different concentration of naloxone other than as listed on the content list could result in dosing errors and the lack of availability of the pre-mixed bag of lidocaine could delay the treatment of a dangerous abnormal heart rhythm which could lead to a worsening of the patient's condition or death.

9. The hospital failed to ensure one out of one pediatric crash cart located in the ED was stocked as documented on the approved content list. The medication drawer contained one container extra for each of calcium gluconate (medication used to help stimulate the heart in pediatric emergencies) and naloxone. It was short one PFS of lidocaine for injection. The shortage of lidocaine, used to manage dangerous abnormal heart rhythms, could delay the treatment of a pediatric medical emergency leading to a worsening of the patient's condition or possible death.

10. The hospital failed to ensure all dosage forms that appeared on the approved content list for the Adult Crash Carts in the hospital were clearly delineated as to the size of the dosage unit when more than one size was commercially available. The content list indicated the cart was to contain SWI, furosemide for injection (medication that increases urination in order to rid the body of excess fluid), and lidocaine viscous (medication used to numb mucous membranes such as the mouth or throat), but did not specify the volume of the container. Failure to decide on the proper size of a dosage unit of medication to be stored in an emergency medication supply could result in less than desired amounts of medication being available during an emergency if it is left to staff discretion as to how to supply the cart. Inconsistentcies betwen the approved contents list and what was actually in the crash cart had the potenial to delay treatment in an emegency situation, a worsening of hte patien's condition, and possible death.

11. The hospital failed to ensure the date of the first drug to expire within the Adult Crash Cart located on the Med/Surg Unit and the Pediatric Crash Cart located in the ED was posted outside of these carts as required by California Code of Regulations, Title 22, Section 70263(f)(2). As a result, staff may not know when to replace expired medications contained within the emergency supply and expired medications would be available for patient use.

Findings:

1. On 5/4/17 at 9:42 am, an inspection of the pediatric crash cart located in the ED indicated the top drawer contained two sealed trays containing advanced cardiac (heart) life support drugs used to manage pediatric medical emergencies. The top drawer also contained a 2011 Edition A Broselow Tape. During a concurrent interview of Licensed Nurse (LN) 3 at that time, she stated the hospital used the Broselow guidelines to manage pediatric medical emergencies in the hospital. She stated the cart was equipped to treat children up to 36 kilograms (kg) in weight (the top weight category listed on the Broselow tape contained in the top drawer of the cart).

A review of the tape indicated it recommended that the cart contain atropine 0.4 milligrams/milliliter (mg/ml) for administration via the endotracheal route (ET: down the windpipe, a last resort route of medication administration used when other routes are not available in an emergency situation). The tape indicated a dose of atropine as well as the volume needed to deliver the dose for each weight class of children documented on the tape from 3 kg infants through 36 kg children, however, the volume documented on the tape was based on a concentration of 0.4 mg/ml of atropine. Inspection of the tray indicated it contained four 1 ml vials of atropine 1 mg/ml. This concentration was 2.5 times the concentration of atropine as listed on the Broselow Tape. The difference in the concentration of atropine in the tray opposed to the concentration of atropine indicated on the Broselow Tape had the potential for an administration error of 2.5 times the intended dose of atropine.

The Broselow Tape provided doses of amiodarone for all weight classes of children on the tape, yet the medication trays in the top draw of the Pediatric Crash Cart did not contain any amiodarone and amiodarone was not listed on the approved content list for the Pediatric Crash Cart.

Inspection of the pediatric crash cart indicated it contained three 5 milliequivalents (mEq) PFS of sodium bicarbonate 4.2% for infants. The total dose that these syringes could provide was 15 mEq. A concomitant review of the Broselow Tape indicated the 4.2% concentration was only specified for infants (the 3 kg, 4 kg, and 5 kg weight class on the tape) as after that only the drug name, sodium bicarbonate, appeared on the tape (sodium bicarbonate is available in 10 ml PFS at a 4.2% concentration for infants, and then 10 ml and 50 ml PFSs at a concentration of 8.4% for older children and adults). Further review of the tape indicated up to 33 mEq of sodium bicarbonate could be needed to manage medical emergencies for larger children (16.5 mEq for 15 to 18 kg weight group, 21 mEq for the 19 to 22 kg weight group, 27 mEq for the 24 to 28 kg weight group, and 33 mEq for the 30 to 36 kg weight group).

These observations were verified during concurrent interviews with the Director of Pharmacy (DOP).

2. a. On 5/2/17 at 9:15 AM, LN 1 prepared medications to give to Patient 11 one of which was pramipexole. The pramipexole doses were contained in plastic re-sealable plastic bags labeled for the patient and with the drug name, time of administration, and directions for use. There was no drug strength after the drug name. Both bags had handwritten instructions on the bottom of their labels to "Discard ½ tablet!" (exclamation point was in the handwritten directions).

One bag had printed directions on the label to give 0.25 mg orally in the morning with "1 (0.5 X 0.5 mg per dose)" printed beneath the directions which indicated staff were to give the patient one-half tablet. The label also had a printed barcode on it which staff would scan into a mobile computer station prior to administration to the patient (to ensure the right dose was administered to the right patient). The bag contained a whole tablet.

The second bag had printed directions on the label to give 0.5 mg orally each night at bedtime with "1 (1 X 0.5 mg per dose)" printed beneath the directions which indicated staff was to give the patient a whole tablet. The label also had a barcode printed on it. The bag contained one-half of a tablet. LN 1 took that one-half tablet out of the bag and administered it to Patient 11 at 9:33 a.m. A review of the patient's clinical record on 5/2/17 indicated the physician had prescribed a daily morning dose of 0.25 mg of pramipexole for Patient 11 (as well as a nightly dose of 0.5 mg).

On 5/2/17 at 11:11 AM, during an interview of Pharmacist 1 he stated he had initialed the bags (after checking them). He stated he had not cut the tablet in half (in the morning dose bag).

On 5/2/17 at 10:48 AM, during an interview of the DOP he reviewed the labels on both bags and stated the bag for the evening dose should not have had the handwritten "Discard ½ tablet!" labeling on it. He stated that he felt Patient 11 had received one-half tablet of pramipexole the previous night (instead of one whole tablet as ordered by the physician). He checked the computerized patient records and stated LN 2 had administered the pramipexole evening dose the previous evening.

On 5/2/17 at 11:23 AM, during an interview of the DON she checked the electronic medication administration record (eMAR: an electronically formatted document used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) and stated it indicated that one 0.5 mg tablet had been administered to the patient the prior night. She stated this message was generated when staff scanned the barcode on the label which indicated it contained one 0.5 mg tablet.

On 5/2/17 at 4:44 PM, during an interview of LN 2 she stated she had administered one-half of the pramipexole tablet in the evening dose bag to Patient 11 the prior evening because the bag had the handwritten message to "Discard ½ tablet!" written on it. She said as one scans the bar code on the label the computer did not pick up the error.

On 5/2/17 a review of the policy and procedure titled "LABELING STANDARDS, MEDICATION" (Originating Date 7/01, Revision Date: 6/2012), indicated it documented the policy was as follows: "All drug containers shall be labeled and drug labels must be clear, consistent, legible and in compliance with state and federal standards ...." It documented that "repackaged unit-of-use medication labels shall include at a minimum: generic drug name ... strength ... special notes (e.g., refrigerate) ...."

b. On 5/3/17 at 2:23 PM, an inspection the adult crash cart located on the Med/Surg floor indicated it contained two ampules of digoxin 0.5 mg/2 ml. The approved content list documented it contained two ampules of digoxin 5 mg/2 ml (10 times the concentration of the actual product). During a concurrent interview of the DOP at that time, he stated the entry on the content list was a "typo". He stated it should read 0.5 mg/2 ml.

3. On 5/3/17 a review of the policy and procedure titled, "MEDICATION ERRORS" (Approved 6/16/16 by Quality, approved 10/13/16 by Medication/Pharmacy and Therapeutics (Committee), indicated it documented staff was to notify a patient's physician if the patient had been subjected to a medication error.

On 5/4/17 at 1:41 PM, during a concurrent review of Patient 11's clinical record and interview of the DON, the DON stated she could find no evidence in Patient 11's clinical record that the physician had been informed of the pramipexole medication error that had occurred on the evening of 5/1/17.

4. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. The USP drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF). The USP revised general chapter <797> (USP 797) entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from ... microbial contamination ... (and) excessive bacterial endotoxins ..." among other things. If a hospital puts all the environmental controls as well as all the personnel training, certification, and compounding practices into place as described in USP 797, the hospital can assign beyond use dates (BUDs: date or time beyond which an IV product cannot be stored or transported) to compounded IV products as described in USP 797.

USP 797 defines a compounding aseptic isolator (CAI) as: "A form of isolator specifically designed for compounding pharmaceutical ingredients or preparations ...." It is a self-contained unit into which compounding ingredients and supplies are introduced to the cabinet via an ante chamber. The door to the ante chamber is closed and the individual performing the compounding inserts his or her arms into a sleeve/glove assembly built into the front wall of the CAI and which is used to access components in the main compounding area. An inner door between the ante chamber and the main compounding chamber is opened and the supplies are brought into the main chamber at which point the inner door is closed. Compounding can then proceed and the finished product is brought out by reversing the above process. This unit is commonly called a "glove box" and is also described as a "Primary Engineering Control" (PEC) in USP 797 as it creates a very clean environment by filtering air and maintaining positive pressure differentials relative to the outside environment to reduce the chance of contamination of CSPs to extremely low levels.

Under "Environmental Viable Airborne Particle Testing Program" USP 797 stipulates that defined volumes of air (400 liters to 1000 liters) and surface samples will be taken in all areas of a clean room including the PECs will be tested for microbial burden by looking for colony forming units that might grow out on culture medium in culture plates exposed to the air samples collected by sampling devices or by applying the plate to the surface being tested. USP 797 defines thresholds for the colony forming units (CFUs) depending on the cleanliness of the area tested (PEC is the most clean, then the buffer area, and then the ante-area) with less CFUs allowed for cleaner areas relative to the less clean areas. USP 797 defines coagulase positive Staphylococcus, gram negative rods, and molds and yeasts as highly pathogenic species. If even one CFU grows a "highly pathogenic" organism, USP 797 documents the situation must be remedied. It also documents that unclassified areas in which compounding occurs must be so assessed.

On 5/2/17 at 3:11 PM, during an interview of the DOP he stated the hospital followed the USP 797 standards to assure the quality of compounded sterile products produced in the hospital. He stated the hospital followed the Board of Pharmacy compounding regulations if they were stricter than the USP 797 standard.

On 5/1/17 a review of the Quality Assurance (QA) binder indicated it contained documentation that viable particle counts had been done by a contracted service on 10/19/16 but the results were not available in the binder. This was verified on 5/2/17 at 2:15 PM by the DOP during a concurrent review of the QA binder and interview of the DOP. The DOP did not recall if he had discussed the results with the contracted service. He stated that viable particle testing had been conducted this past month of April 2017 but the results were not available. He did produce a report of viable particle testing that had been done over a year ago on 3/15/16.

A review of the 3/15/16 report at 2:29 PM, indicated it found no microbes in the CAI but a 1000 liter (L) sample of room air had grown out 2 CFUs of coagulase positive staphylococcus and 8 CFUs of fungi: 2 CFUs of Cladosporium, 2 CFUs of non-sporulating colonies, 1 CFU of Penicillium species, and 3 CFUs of yeasts. During a concurrent interview of the DOP at that time he stated the results did not cause him concern as the CAI had been designed to be located in an unclassified space. He provided a report from the manufacturer of the CAI at that time that documented it could be located in an unclassified space and yet maintain ultra-clean environment in the compounding chamber.

On 5/3/17 at 11:39 AM, review of the "Biological Sampling Report" dated 10/19/16 which the DOP had obtained from the contracted certification service indicated that no viable organisms grew out from air samples taken inside of the CAI but a 1000 L sample of room air had grown out 10 CFUs of fungi: 1 CFU of Alternaria sp, 1 CFU of Aureobasidium sp, 4 CFUs of Cladosporium sp, 1 CFU of non-sporulating colonies, and 3 CFUs of yeasts. The report documented in "Footnotes and Additional Report Information" that "Regardless of ISO class, any fungal identification on an air or surface sample will cause the sample to be Out of Compliance" (with USP 797 standards). It also identified gram negative rods, coagulase positive staphylococcus, and yeasts/molds as "pathogenic organisms" that, "Regardless of the number of CFU identified" required "further corrective actions". Further review indicated these same footnotes were available in the 3/15/16 report.

On 5/3/17 at 11:52 AM, a review of a "USP <797> Viable Sample Report" dated 4/19/17 provided by the DOP (which he had obtained from the contracted certification service during the survey) indicated no CFUs had grown out from air sampling done in the CAI but 3 CFUs of fungi grew out of air samples taken in the room in which the CAI was located: 1 CFU of Aspergillus sp. and 2 CFUs of Penicillium sp. It also documented a surface sample taken from a counter in the compounding room grew out 1 CFU of a non-sporulating colony.

These record reviews were verified by the DOP at the time of the review during a concurrent interview.

5. USP 797 stipulates that all staff who compound sterile products will be assessed prior to starting compounding and annually thereafter by performing a sterile media fill under conditions that mimic the most difficult compounding situation under which they will compound.

On 5/2/17 at 3:50 PM, during an interview of the DOP, he stated the pharmacy technicians did no compounding of sterile products in the department. He stated that only he and Pharmacist 1 compounded sterile products in the pharmacy. He produced a report dated 8/16/16 that indicated he had successfully completed a sterile media fill test. He stated that Pharmacist 1 had not been assessed by performing a sterile media fill test.

6. On 5/3/16 at 4:23 PM, during an inspection of the ED, one cartridge of morphine sulfate 10 mg/ml containing 0.5 ml of morphine (5 mg morphine) and one open vial of lorazepam 2 mg/ml containing a small amount of lorazepam was observed on top of the automated drug dispensing system cabinet located in the ED nursing station. No staff was in the nursing station at that time. This observation was verified at that time by the Directoe of Nursing (DON). A review of the policy and procedure titled, "CONTROLLED DRUG DISTRIBUTION" (Originating Date: unknown, Revised 1/14/09), indicated, "all controlled drugs in schedule II, III and IV are stored in double locked security."

7. On 5/3/17 at 2:18 PM, the DOP provided a copy of the approved adult crash cart medication content list.

On 5/3/17 at 2:23 PM, an inspection of one out of one adult crash cart on the Medical/Surgical (Med/Surg) floor indicated it had a medication content list posted outside of the cart. A review of this content list and comparison with the approved content list provided in the pharmacy indicated the Med/Surg Crash Cart content list included vasopressin while the approved list did not include this drug.

This recoerd review was verified at the time of the inspection during a concurrent interview with the DOP. He stated that vasopressin for storage at room temperature had been on backorder for two years and therefore had been removed from the approved content list. He stated it had not been on the approved content list for about one year.

On 5/3/17 at 4:23 PM, a review of the externally posted medication content list posted outside of the adult crash cart located in the ED indicated it listed vasopressin as one of the medications available in the cart.

On 5/3/17 at 4:30 PM, a review of the externally posted medication content list posted outside of the adult crash cart located by the Outpatient Wound Care area indicated it listed vasopressin as one of the medications available in the cart.

On 5/3/17 at 4:35 PM, a review of the externally posted medication content list posted outside of the adult crash cart located in the Outpatient Surgery Department indicated it listed vasopressin as one of the medications available in the cart.

On 5/3/17 at 4:38 PM, a review of the externally posted medication content list posted outside of the adult crash cart located in the Surgery Department indicated it listed vasopressin as one of the medications available in the cart.

These last four observations in ED, Outpatient Wound Care area, the Outpatient Surgery Department, and the Surgery Department were verified at those times by a concurrent interview of the DON.

8. On 5/3/17 at 2:23 PM, an inspection of one out of one adult crash carts on the Medical/Surgical (Med/Surg) floor indicated the second drawer contained one 10 ml vial of SWI and one 50 ml vial of SWI in the medication drawer. An externally posted content list indicated the drawer contained four vials (volume not specified) of SWI. This observation was verified by the DOP during a concurrent interview at that time during which he stated, when questioned, that he did not know the reason SWI was included in the cart.

Further inspection of the crash cart indicated Drawer 3 contained one 10 ml vial of naloxone 0.4 mg/ml while the approved medication content list indicated the drawer was to contain two 2 ml PFSs of naloxone at a concentration of 1 mg/ml (2 mg total in the PFS). This observation was verified by the DOP during a concurrent interview at that time during which he stated he did not know why it contained a 10 ml vial of naloxone instead of the PFSs as listed on the content list.

Inspection of Drawer 5 indicated it did not contain a premixed bag of 2 gm lidocaine in 500 ml of 5% dextrose in water even though it appeared on the approved content list. This observation was verified by the DOP during a concurrent interview at that time during which he stated he did not know why it was not in the emergency supply as it was supposed to be in the cart.

9. On 5/4/17 at 9:42 AM, an inspection of the pediatric crash cart indicated the top drawer contained two sealed trays containing advanced life support drugs used to manage pediatric medical emergencies. Tray 1 contained two 10 ml vials of calcium gluconate 10% while the approved medication content list indicated it should have contained one such vial. Tray 1 also contained two 2 ml PFSs of naloxone 1 mg/ml while the approved content list indicated is should have contained one such dosage unit.

Inspection of Tray 2 in the top drawer of the pediatric crash cart indicated it contained one 5 ml PFS of lidocaine 20 mg/ml while the approved content list indicated it was to contain two such dosage units.

These observations were verified at the time of the inspection during a concurrent interview with the DOP.

10. On 5/3/17 at 2:23 PM, an inspection of one out of one adult crash carts on the Med/Surg floor indicated the following:

It contained one 10 ml and one 50 ml vials of SWI. The approved content list indicated it contained four vials of SWI but no volumes of the vials were specified on the list. The manufacturer's product labeling indicated it was available in 10 ml, 20 ml and 50 ml vials.
It contained one 4 ml vial of furosemide 10 mg/ml. The approved content list indicated it contained one vial of furosemide but no volumes for the vial was specified on the list. The manufacturer's product labeling indicates this medication is available in 2 ml, 4 ml, and 10 ml vials.

It contained one 15 ml unit dose cup of viscous lidocaine 2%. The approved content list indicated it contained one container of viscous lidocaine 2% but no volumes for the container was specified on the list. The manufacturer's labeling indicated it was available in 20 ml unit dose cups, 20 ml squeeze bottles and 100 ml squeeze bottles.

These observations were verified at the time of the inspection during a concurrent interview with the DOP.

11. On 5/3/17 at 2:23 PM, an inspection of one out of one adult crash carts on the Med/Surg floor indicated the date of the first medication to expire with the cart was not posted outside of the cart as required by Title 22,

Based on observation, interview and record review the hospital failed to ensure the in-patient dietary services were provided in accordance with recognized dietary practices, when the food and dietetic services was not organized, directed, and implemented in such a manner to ensure the nutritional needs of the patient were met as evidenced by:

1. Lack of a comprehensive nutritional analysis of the patient menus for the regular and therapeutic diets,

2. Lack of safe food handling practices when potentially hazardous foods (foods capable of supporting microbial growth) were not consistently cooled down for food safety.

3. Lack of handwashing by a dietary employee during food preparation.

4. Lack of knowledge on how to date a juice product to ensure it was used within ten days once thawed in accordance with the manufacturer's specifications.

5. Lack of a physician diet order and lack of an order for an oral nutrition supplement that was communicated to the kitchen to provide to the patient. (Patient 23)

6. Lack of an order for free water flush for a patient on tube feeding (receiving nutrition through a tube) in which time 600 milliliter's of free water flush was provided to the patient. (Patient 17)


These failures placed patients at risk for developing food borne illness, not meeting their nutritional needs, and implementing patient care without orders from the practitioner responsible for the care of the patient could adversely affect a patients health and safety.

Findings:

1. On 5/1/17 at 11:30 AM, a review of the patient's menu and therapeutic spreadsheet indicated the hospital had the following diets available; regular diet, regular NAS (no added salt), mechanical soft diet, puree diet, low cholesterol/low fat diet, 2 gram sodium diet and diabetic diets with calorie restrictions that included 1,200 calories (kcal), 1,500 kcal, 1,800 kcal and 2,000 kcal.

On 5/1/17 at 2:55 PM, the Registered Dietitian (RD) stated that she was unable to demonstrate whether the hospital's regular and therapeutic diet menus met the physician's order for the diets, "because we do not have a nutrient analysis for the patient menus." The RD acknowledged that she was unable to determine whether the patient menus met the nutritional needs of the patients due to lack of a nutritive analysis as related to the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences.

On 5/1/17 at 3:30 PM, the Dietary Manager (DM) verified that the hospital had not conducted a nutrient analysis for the patient menus that were currently in use.

Concurrently, the DM stated that the hospital purchased a new diet manual with corresponding nutrition software to include patient menus and nutritive analysis, but they have not been implemented. The DM stated, "We plan to implement the new patient menus in three weeks." The DM stated that she had not known if the new diet manual, patient menus and nutrition analysis had been reviewed and approved by the hospital's Medical Executive Committee yet.

On 5/2/17 at 9:40 AM, the Chief Executive Officer (CEO) stated the hospital purchased a new diet manual and patient menus that was accompanied with a nutritional analysis of the patient menus. The CEO was not aware that the new diet manual and patient menus had not been implemented.

The CEO provided meeting minutes from a Medical Executive Committee, dated 1/11/17, that included "Dietary - Diet Manual, committee approved the two new dietary manuals (1 for Acute and 1 for LTC [long term care]) with the changes noted..., [the RD] will implement the diet manuals..."

The hospital's job description for "Dietary Consultant [Registered Dietitian]" (last approved 4/19/16] indicated, "... Develops, coordinates, implements and evaluates the facility menus for nutritional adequacy... "

This is a repeat finding from a recertification survey conducted by the Department in 2012.

2. On 5/1/17 at 11:30 AM, Cook 1 pulled a large pan of turkey out of the oven. Cook 1 stated that the turkey was cooked yesterday and that she was re-heating it for the patient's main entrée for lunch.

On 5/1/17 at 1:05 PM, Cook 1 was asked to review the cool down log for the turkey. Cook 1 reviewed the cool down log and stated that the turkey was not documented on the log. Cook 1 stated that the turkey was cooked yesterday by a different cook. Cook 1 stated that she retrieved the turkey from the refrigerator this morning, and stated, "It was already cooked."

Concurrently, the Dietary Manager (DM) reviewed the cool down log, and stated, "It's not on the log. It was missed." The DM verified that approximately fifteen pounds of turkey had been cooked the day before and was not on the log to indicate it had been cooled down safely. The DM stated that another cook (Cook 2) had cooked the turkey the day before. Cook 2 was not working on 5/1/17, and thus unable to be interviewed.

Concurrently, a review of the hospital's Cooling Food Log Sheet for the month of April 2017, indicated that turkey and roast beef had not cooled down to 70-degrees or below within two hours, on 4/10/17 and 4/24/17, respectively. The DM stated, "Cool down was not done right on those days."

A review of the Cooling Food Log Sheet logs for the months of December 2016 through March 2017, indicated that four of the five months reviewed had incorrect cool downs noted on the log. The DM acknowledged there were some days in which the cool down process was not followed in accordance with safe food handling as related to the initial two hour cooling process, and stated, "I need to review the logs more often."

Concurrently, the DM stated that the Registered Dietitian (RD) conducted a "cleaning inspection," on a monthly basis. The DM went to her office and provided the last copy of the "cleaning inspection."

On 5/1/17 at 2:15 PM, the RD acknowledged that the cool down process was not part of the, "Dietary Sanitation Check List," that she had conducted on a monthly basis. The RD acknowledged that she was unaware that the cool down process for food safety had not been consistently implemented.

The hospital's policy and procedure titled, "Food Preparation," approved on 4/19/16, indicated employee's will "prepare food in a clean and safe manner to protect residents and staff from food borne illness .... Food preparation should be routinely supervised by the dietary services supervisor and consultant dietitian to ensure policies and standards are maintained .... Precooked food to be served on another day must be refrigerated promptly or kept frozen until service. Food must cool to 70-degrees within 2 hours then to 41-degrees F [Fahrenheit] within the next 4-hours ..., HACCP [hazard analysis critical control point] Temperature Control Log ...."

The hospital's Cooling Food Log Sheet included the following direction; "Product must be 70-degrees or below within 2-hours .... If does not make proper temperature, must reheat to 165 [degrees F] and begin process again."

"Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness ..., The Food Code provision for cooling provides for cooling from 135°F to 41°F within 6 hours, with cooling from 135°F to 70°F in 2 hours ..., The initial 2 hour cool is a critical element of this cooling process ...." (FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 3, Food 3-501.14 Cooling)

This is a repeat finding from a recertification survey conducted by the Department in 2012.

3. On 5/1/17 at 11:30 AM, Dietary Aide (DA 1) had gloves on when she was observed picking up an item that had fallen on the kitchen floor. DA 1 then proceeded to rinse a head of lettuce under running water without changing those same gloves.

Concurrently, DA 1 verified that she had picked garbage up off the floor, and stated, "I should've changed gloves." DA 1 proceeded to remove her gloves and then donned a new pair of gloves, without washing her hands.

Concurrently, DA 1 was asked if she was trained to wash her hands after removing dirty gloves and before placing on new gloves, and she stated, "Yes, I should have washed my hands."

On 5/1/17 at 1:15 PM, the above observation was discussed with the Dietary Manager (DM). The DM acknowledged that the employee should have washed her hands after removing soiled gloves prior to donning new gloves in order to prevent the potential for cross-contamination.

The hospital's policy and procedure titled Sanitation and Infection Control; Handwashing (last approved on 4/19/16), indicated, that handwashing will be performed after handling any waste or waste products.

4. On 5/1/17 at 11:37 AM, it was observed inside a reach-in refrigerator that there were three trays of four ounce cartons of Sun Cup juices. The Assistant Dietary Manager (ADM) was asked how long the juices could be stored in the refrigerator. The ADM stated the juices were received from the vendor frozen and placed in the freezer. Dietary staff would remove the juices from the freezer and place them in the refrigerator. The ADM stated, "They can be stored in the refrigerator for thirty days." A date indicating when the juices were placed in the refrigerator was not observed. The ADM was asked how long the juices had been in the refrigerator, and the ADM stated, "Oh, I see what you mean." The ADM was unable to state how long the juices had been stored in the refrigerator.

On 5/1/17 at 1:10 PM, the DM observed the Sun Cup juices in the refrigerator, and noted there were three trays of Sun Cup Juices "with about 24 four ounce juice cartons on each tray". The DM stated, "We thaw them in the refrigerator for five days, but they are good for thirty days."

Concurrently, the DM was asked to read the manufacturer's directions that were located on each individual carton of juice, and verified that the juices had to be used within ten days once thawed. The DM acknowledged that there was not a dating system for the thawed juices to ensure they were used in accordance with manufacturer's guidelines.

On 5/1/17 at 2:15 PM, the Registered Dietitian (RD) acknowledged that there should have been a system to ensure the Sun Cup juices would be used within ten days of thawing per the manufacturer's recommendations.

5. On 5/2/17 at 8:38 AM, Patient 23's medical record was reviewed. Patient 23 was admitted to the hospital on 5/1/17, with an admitting diagnosis of dehydration and altered level of consciousness (ALOC) per the admission orders.

On 5/1/17, there was a physician order that read, "Diet: As tolerated."

On 5/2/17 at 8:45 AM, the DM stated, "We do not recognize diet as tolerated as a diet order. We [the kitchen] received a communication slip clarifying the diet to be regular grind, and to give chocolate Ensure [an oral nutrition supplement] on 5/1/17."

Concurrently, the DM provided a copy of the "Change of Diet," communication form that indicated "Regular grind as tolerated, chocolate Ensure." The DM acknowledged that the communication slip had not specified the quantity of Ensure and provided a copy of Patient 23's meal tray card that indicated the kitchen planned to provide the Ensure "TID" (three times a day).

Concurrently, the ward clerk on duty (WC 1) reviewed Patient 23's paper medical record and electronic medical record, and stated, "There is no order for the Ensure."

On 5/2/17 at 10:10 AM, the Director of Nurses (DON) reviewed Patient 23's medical record and confirmed that there was not an order for the Ensure, in any quantity, and acknowledged that there was communication to the kitchen to send Patient 23 Ensure without a physician's order. The DON stated that it was the ward clerk's responsibility to clarify. At that time, the ward clerk that had completed the dietary communication slip was not working that day, therefore unable to interview.

On 5/2/17 at 2:20 PM, the DON reviewed the physician's diet order of "Diet: As tolerated.", dated 5/1/17, that was located in the paper medical record. The DON acknowledged that "diet as tolerated" was not a recognized diet order, and was not in the hospital's approved diet manual. The DON then reviewed a diet order that was entered in the electronic medical record (EMR) that indicated regular diet with "grind" texture on 5/1/17 at 6:32 PM The DON stated, "The diet order should be NPO (nothing by mouth), the patient is not alert, he still has ALOC." The DON stated she planned to have the diet order clarified with the physician for an NPO diet order.

Record review of Patient 23's Admission Assessment Inquiry completed on 5/1/17 at 12:35 PM included, "LOC [level of consciousness] Unresponsive, ...Feeding; Other, Feeding Note; Unable to assess..., chewing difficulty; Other, Chewing difficulty note; unable to assess..."

On 5/3/17 at 11:17 AM, the DON stated that there was not a physician order for a regular grind diet, and therefore that should not have been communicated to the kitchen on 5/1/17. The DON stated that a ward clerk (WC 2) had entered the information for regular grind diet into the EMR for Patient 23 on 5/1/17. The DON stated that she was not able to determine where the diet clarification came from which prompted WC 2 to enter "regular grind" diet in the EMR. The DON verified there was no physician's order for regular grind diet, nor nursing progress notes that would have noted a conversation with the practitioner responsible for the care of the patient related to the diet order.

The hospital's policy and procedure titled, "Nutrition Care," dated 4/19/16, indicated that all residents will have a written diet order on admission which has been prescribed by the physician. The facility will serve diets as ordered by the physician and in accordance with the approved diet manual... Unclear or questionable diet orders should be clarified by the registered dietitian, dietary supervisor and physician as soon as possible ...."

6. On 5/2/17 at 2:20 PM, Patient 17's medical record was reviewed. Patient 17 had a diagnosis of urosepsis (bacteria in the blood from urinary tract infection) per a physician's plan of care, dated 5/2/17.

Patient 17 had a physician's order from the long term care facility to transfer to the acute care hospital on 4/28/17 at 4 PM.

On 5/2/17 at 2:20 PM, the Director of Nurses (DON) reviewed a physician's order that indicated "VO [verbal order]: Jevity 1.2 [a nutrition formula designed to be fed through a tube] 1.5 Liter daily. Run at 100 cc [cubic centimeter]/hour." The DON acknowledged the order was not dated and timed and had not matched the MAR (medication administration record) which indicated to start the tube feeding at 2300 (11 PM) and run for fifteen hours at 100 ml [milliliter]/hour. The DON stated that she would need to get the tube feeding order clarified. Concurrently, the DON was asked to review Patient 17's medical record for free water flushes via the feeding tube.

On 5/2/17 at 3:06 PM, the DON stated, "There was no physician's order for the water flush and there should've been. I spoke with the nurse caring for the patient today and found out that the nurse's are giving 600 cc of free water flush daily. They went by the skilled nursing facility order and the RD [Registered Dietitian] assessment which are not acute care orders. The nurse's need to be trained more on what is an acute care order."

On 5/3/17 at 2:08 PM, the Registered Dietitian (RD) stated that she had completed a nutrition assessment for Patient 17 after admission to the acute care on 5/01/17. The RD stated that her nutrition assessment determined the recommendation to continue with the same tube feeding order and water flush recommendations of 600 mls per day that the patient had been receiving at the skilled nursing facility.

Concurrently, the RD reviewed the above tube feeding order that was not dated and timed and acknowledged that it was not a complete and accurate order, as the patient had been receiving the formula over a period of 15 hours starting at 11 PM. The RD reviewed Patient 17's medical record and acknowledged that there was not a physician's order for fluid flush at that time. The RD stated she completed the nutrition assessment remotely that day (not on the premises of the hospital), and thus was unaware of the incomplete tube feeding order, and of lack of a physician's order for water flush. The RD stated that if she had completed the nutrition assessment on the premises that she would have completed an internal communication form between the RD and nursing to alert nursing to obtain a complete order for the tube feeding, and to obtain an order for her water flush recommendations. The RD stated that she would expect the nurse's to read her nutrition assessment when she completed them remotely to become aware that she had left nutrition recommendations for a patient. Concurrently, the DON acknowledged that there was not an alert system in place in which nursing would have become aware that an RD had just completed a nutrition assessment remotely.

The hospital's undated policy and procedure titled, "Physician's Orders indicated," that physician orders in the Critical Access Hospital portion of Mayers are to be processed electronically through the CPOE (computer prescriber order entry) system.

Based on interview and record review, the facility failed to provide care in accordance with the needs of its patients when:

1. Nursing assessments were not done as ordered by the physician for one of 23 sampled patients (Patient 7). This had the potential to result in an unrecognized decline in the health of the patient.

2. Two Registered Nurses (RNs) working in the Emergency Department (ED) did not have the qualifications as required by the facility policy. This had the potential to result in inadequate care given to patients in an emergency situation.

3. One Scrub Technician (ST 1) working in the Surgery Department did not have annual competency checks of instrument processing as required by the facility policy. This had the potential to result in inadequate instrument cleaning and disinfection, unrecognized by facility administrative staff.

Findings:

1. A review of Patient 7's medical record indicated she presented to the ED on 4/30/17 in active labor and delivered a full term infant at 7:07 pm. Patient 7 and her new born baby were admitted to the medical surgical floor. Patient 7's physician wrote admission orders that included fundus (top portion of the uterus) and lochia (discharge from the uterus after childbirth) checks every 15-minutes times 4 then every 4-hours if stable; notify physician for excessive bleeding. The initial fundus and lochia checks were done every 15-minutes for the first four times and documented in the record, but documentation for the next two checks, to be done every four hours, could not be located in the medical record.

During a concurrent interview and record review on 5/2/17 at 3 pm, the Director of Nurses (DON) confirmed the above two assessments of the fundus and lochia were missing and not done as ordered by the physician.

2. A review of the most current job description for Emergency Department (ED) Registered Nurses (RNs), provided by the DON, indicated Pediatric Advanced Life Support (PALS) and Advanced Cardiac Life Support (ACLS) certification was mandatory to work in the ED.

On 5/3/17 at 11:30 am, employee files from five RNs who worked in the ED were reviewed with the Human Resources Director (HRD).

a. A review of Licensed Nurse (LN) 5's file indicated there was no current PALS certification in his file. During a subsequent interview, on 5/4/17 at 9 am, HRD confirmed she was unable to find any prior PALS certification for LN 5.

During an interview on 5/4/17 at 7:35 am, DON said she wasn't aware LN 5's PALS had expired until the prior day. The ED schedule was reviewed with the DON who confirmed LN 5 had worked as the only ED RN, on the night shift, on 4/30/17 and 5/1/17. DON confirmed LN 5's date of hire was 10/1/15.

b. A review of LN 6's file indicated there was no ACLS certification in his file. During a subsequent interview on 5/3/17 at 4:30 pm, HRD confirmed LN 6's ACLS certification had expired in 3/2015.

During an interview on 5/4/17 at 7:35 am, DON said she wasn't aware LN 6's ACLS had expired until the prior day.

3. A review of the facility's policy, "Cleaning, Disinfection, and Sterilization," dated 3/14/17, indicated, "Personnel must have proper training on processing instruments (through either Sterilization or High Level Disinfection) with competency testing upon hire, annually and periodically as needed."

During a concurrent interview and review of ST 1's employee training file, DON confirmed the last competency and evaluation for ST 1, whose job responsibilities included routine processing and sterilization of instruments, was completed on 5/20/15.

Based on closed record review and staff interview, the hospital failed to ensure that one of one patients (Patient 12), who received insulin by infusion per the hospital approved insulin infusion protocol had labs done and received the insulin according to the hospital approved protocol. A phosphorous level was not obtained prior to the start of the insulin infusion as required by the protocol. A venous blood sugar level was not ordered for one finger stick blood sugar (FSBS) result greater than 400 milligrams/deciliter (mg/dl) as required by the hospital protocol. Out of 28 recorded measurements where the results of both the FSBS result and the insulin infusion rates associated with those FSBS results were available for review, there were 15 instances (from 12:43 PM on 12/2/16 through 9 AM on 12/3/16) the insulin rate was higher than required by the hospital approved insulin infusion protocol. This had the potential to lower blood sugar lower than intended. Severely low blood sugars can result in coma, brain damage, or death. There were two instances (8:39 AM and 9:28 AM on 12/2/16) where the insulin rate was lower than required by the hospital protocol. Infusion of insulin at a rate lower than ordered could result in failure to achieve therapeutic lowering of the blood sugar levels to desired target levels.

Findings:

On 5/3/17, a review of the policy and procedure titled, "INSULIN INFUSION, CONTINUOUS" (Original Date 9/94, Revised 4/5/01), indicated it was the policy of the hospital to follow the procedures documented in the policy unless otherwise indicated by the prescribing physician.

The policy and procedure documented that staff was to obtain a baseline phosphorus level (along with other electrolyte -mineral - levels) prior to starting an insulin infusion.

The policy and procedure provided the following schedule for the insulin infusion rate based on the blood sugar level obtained from venous blood or from a "finger stick" blood sugar (FSBS) level:

Less than or equal to 140 mg/dl 0 units/hr
141 to 180 mg/dl 1.5 units/hr
181 to 220 mg/dl 2 units/hr
221 to 260 mg/dl 2.5 units/hr
261 to 300 mg/dl 3 units/hr
301 to 340 mg/dl 4 units/hr
Greater than 340 mg/dl 5 units/hr

The policy and procedure indicated that if the blood sugar result was greater than 400 mg/dl the result was to be verified by obtaining a blood sample by "venipuncture" and sending it to the lab for analysis.

A review of Patient 12's electronic clinical record on 5/3/17 and 5/4/17 indicated the following:

On 12/1/17 at 5:20 PM, a physician ordered insulin 100 units of 100 ml of 0.9% sodium chloride to be administered "PER PROTOCOL". It was discontinued at 10:50 AM. on 12/3/16. There were no other orders for insulin infusion in the clinical record. This observation was verified by the DON during an interview on 5/4/17 during a concurrent review of the record which started at 8:30 AM.

Staff did not obtain a phosphorous level when orders for blood chemistries were carried out per protocol prior to the start of the insulin infusion. This record review was verified by the Director of Nurses (DON) during an interview on 5/4/17 at 9:24 AM. during a concurrent review of the record which started at 8:30 AM.

On 12/2/16 at 10:30 AM. Patient 12's FSBS result was recorded to be 408 mg/dl. There was no evidence in the clinical record that a venous blood sample was obtained as required by the protocol. This record review was verified by the DON during an interview on 5/3/17 during a concurrent review of the record which started at 9:41 AM.

A review, on 5/3/17 and 5/4/17, of the FSBS results and the concurrent rate of the insulin infusion recorded in Patient 12's electronic clinical record with comparison to the insulin rate per protocol indicated the following:

On 12/2/16 at 8:39 AM, the FSBS was measured at 326 mg/dl and the insulin infusion rate was recorded to have been increased to 3.5 units/hr. The protocol indicated the insulin infusion rate should have been administered at 4 units/hr.

On 12/2/16 at 9:28 AM, the FSBS was measured at 343 mg/dl and the insulin infusion rate was recorded to have been increased to 4 units/hr. The protocol indicated the insulin infusion rate should have been 5 units/hr.

On 12/2/16 at 12:43 PM, the FSBS was measured at 300 mg/dl and the insulin infusion rate was recorded to have been decreased to 4 units/hr. The protocol indicated the insulin infusion rate should have been 3 units/hr.

On 12/2/16 at 3:37 PM, the FSBS was measured at 259 mg/dl and the insulin infusion rate was recorded to be 3 units/hr. The protocol indicated the insulin infusion rate should have been 2.5 units/hr.

On 12/2/16 at 9 PM, the FSBS was measured at 259 mg/dl and the insulin infusion rate was recorded to be 4 units/hr. The protocol indicated the insulin infusion rate should have been 2.5 units/hr.

On 12/2/16 at 10 PM, the FSBS was measured at 250 mg/dl and the insulin infusion rate was recorded to be 4 units/hr. The protocol indicated the insulin infusion rate should have been 2.5 units/hr.

On 12/2/16 at 11 PM, the FSBS was measured at 271 mg/dl and the insulin infusion rate was recorded to have been increased to 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 3 units/hr.

On 12/3/16 at midnight the FSBS was measured at 314 mg/dl and then rechecked at 261 mg/dl and the insulin infusion rate was recorded to be 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 4 units/hr for the first FSBS result and 3 units/hr for the second FSBS result.

On 12/3/16 at 1 AM, the FSBS was measured at 251 mg/dl and the insulin infusion rate was recorded to be 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 2.5 units/hr.

On 12/3/16 at 2 AM, the FSBS was measured at 254 mg/dl and the insulin infusion rate was recorded to be 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 2.5 units/hr.

On 12/3/16 at 3 AM, the FSBS was measured at 213 mg/dl and the insulin infusion rate was recorded to be 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 2 units/hr.

On 12/3/16 at 4 AM, the FSBS was measured at 219 mg/dl and the insulin infusion rate was recorded to be 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 2 units/hr.

On 12/3/16 at 5 AM, the FSBS was measured at 312 mg/dl and the insulin infusion rate was recorded to be 4.5 units/hr. The protocol indicated the insulin infusion rate should have been 4 units/hr.

On 12/3/16 at 6 AM, the FSBS was measured at 187 mg/dl and the insulin infusion rate was recorded to be 3.5 units/hr. The protocol indicated the insulin infusion rate should have been 2 units/hr.

On 12/3/16 at 7 AM, the FSBS was measured at 206 mg/dl and the insulin infusion rate was recorded to be 2.5 units/hr. The protocol indicated the insulin infusion rate should have been 2 units/hr.

On 12/3/16 at 8 AM, the FSBS was measured at 219 mg/dl and the insulin infusion rate was recorded to be 3 units/hr. The protocol indicated the insulin infusion rate should have been 2 units/hr.

On 12/3/16 at 9 AM, the FSBS was measured at 277 mg/dl and the insulin infusion rate was recorded to be 4 units/hr. The protocol indicated the insulin infusion rate should have been 3 units/hr.

These record review were verified at that time by the DON during a concurrent record review and interview.

Based on interview and record review, the hospital failed to ensure that a nursing care plan was developed for one of 23 sampled patients (Patient 17). This failure had the potential for care needs of the patient whom required tube feeding to not be met.

Findings:

On 5/2/17 at 2:20 PM, Patient 17's medical record was reviewed. Patient 17 had a diagnosis of urosepsis (bacteria in the blood from urinary tract infection) per a physician's plan of care, dated 5/2/17.

Patient 17 had a physician's order from the long term care facility to transfer to the acute care hospital on 4/28/17 at 4 PM.

On 5/2/17 at 2:20 PM, the Director of Nurses (DON) reviewed a physician's order that read, "VO [verbal order]: Jevity 1.2 [a nutrition formula designed to be fed through a tube] 1.5 Liter daily. Run at 100 cc [cubic centimeter]/hr." The DON was concurrently interviewed and acknowledged the order was not dated and timed and had not matched the MAR (medication administration record) which indicated to start the tube feeding at 2300 (11 PM) and run for fifteen hours at 100 ml [milliliter]/hour. The DON stated that she would need to get the tube feeding order clarified. Concurrently, the DON was asked to review Patient 17's medical record for free water flushes via the feeding tube.

During an interview on 5/2/17 at 3:06 PM, the DON stated, "There was no physician's order for the water flush and there should've been. I spoke with the nurse caring for the patient today and found out that the nurse's are giving 600 cc of free water flush daily. They went by the skilled nursing facility order and the RD [Registered Dietitian] assessment which are not acute care orders. The nurse's need to be trained more on what is an acute care order."

During an interview on 5/3/17 at 11:49 AM, the DON stated that nursing had not developed a care plan related to tube feeding for Patient 17, "and should have."

The hospital's undated policy and procedure titled, "Charting And Documentation," was reviewed and indicated that the admitting licensed nurse will complete the patient care plan within 6-hours of admit.

Based on interview and record review, the facility failed to ensure that 4 of 23 sampled patients' (Patients 2, 3, 4 and 18), records were complete and contained accurate information. These failures created an incomplete and inaccurate medical record, which could lead to potential negative clinical outcomes in terms of coordination of care.

Findings:

The facility's policy titled, "Charting and Documentation," dated 10/05, was reviewed and indicated the patient's clinical record was a concise account of treatment, care, response to care, signs/symptoms, progress of the patient's condition, and patient and family education.

1. Patient 2's record was reviewed. Patient 2 presented to this facility's emergency department on 3/17/17, with complaints of frequent diarrhea, dehydration and vomiting. Due to Patient 2's age (3-years old), she was transferred to another facility for specialized pediatric care.

2. Patient 4's record was reviewed. Patient 4 presented to this facility's emergency department in active labor on 4/15/17, where she delivered a female infant precipitously (extremely rapid labor and delivery) and in stable condition. Patient 4 and her new born baby girl were transferred to another area hospital.

Both Patient 2 and 4's records contained a document titled, "Patient Transfer Acknowledgement." This document indicated that the patient and/or patient's parent understood that they had the right to receive a medical screening, examination and evaluation by a physician or other appropriate personnel, without regard to their ability to pay, prior to any transfer from this hospital. This form indicated that they had the right to be informed as to the reason for any transfer from this hospital. This document further indicated that the patient and/or their parent understood that they had received a medical screening, examination and evaluation by a physician or other appropriate personnel and that they had been informed as to the reason for their transfer from this hospital, which included the risks and benefits of the transfer itself. This document indicated that should anyone have any complaints concerning the services that they had received at this hospital, then they could contact the: Department of Health Services, Licensing and Certification. 1367 East Lassen Avenue., Suite B-1. Chico, CA 95926.

The California Department of Public Health (CDPH), formerly known as the Department of Health Services (DHS), changed it's name in 2008. CDPH is the Department that provides state and federal oversight to this hospital and is an outside agency that an individual may contact to voice a complaint regarding care or services provided by this hospital. CDPH, Licensing and Certification moved locations on 5/9/09, and is now located at 126 Mission Ranch Blvd. Chico, CA 95926. All facilities were notified of the name change and change in location. This new information was noted to be posted in this facility's front lobby.

During a concurrent interview and record review, on 5/2/17 at 3:10 pm, with the Director of Nursing (DON), she acknowledged that Patient 2's and 4's Patient Transfer Acknowledgement form contained incorrect and out of date information. The DON confirmed that the currently used transfer form contained incorrect and out of date information and needed to be revised.

3. Patient 3's record was reviewed. Patient 3 presented to this facility's emergency department on 4/11/17, with complaints of asthma (a condition in which a person's airways becomes inflamed, narrow and swells, and produces extra mucus, which makes it difficult to breathe) in stable condition.

Patient 3 record contained a physician progress note dated 4/12/17, which indicated that Patient 3's mother had decided to take the patient home AMA (against medical advice) and had refused to sign the AMA paperwork.

The facility's undated policy titled, "AMA: Leaving Against Medical Advice," was reviewed and indicated whenever possible, the signature on the Leaving the Hospital Against Medical Advice form, should be the same as the Condition of Admission agreement. If the patient and/or patient's legal guardian refuses to sign, the notation, "patient refuses to sign," should be made in the space provided for the patient's signature. The witness should sign the form, note the exact time and date and enter a brief note concerning the circumstances of refusal.

During a concurrent interview and record review, on 5/2/17 at 3:10 pm, with the Director of Nurses (DON), she acknowledged that Patient 3's record contained a brief note concerning the circumstances of the refusal to sign the AMA form, but did not include the actual form with the notation as directed by the facility's policy and procedure.



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4. Patient 18's medical record was reviewed. Patient 18 was admitted to the hospital on 4/13/17, with diagnosis that included diabetes.

On 4/14/17, there was a physician's order that read, "Glucerna (an oral nutrition supplement) for snacks".

On 4/27/17, there was a physician's order that read, "800 cc (cubic centimeter) restriction [limit fluid]."

The dietary manager (DM) provided for review a "Change of Diet," communication slip, dated 4/28/17, that was provided to the kitchen staff by nursing that indicated, "NCS [no concentrated sweets], Glucerna for snacks, 800 cc fluid restriction." The DM acknowledged the physician's order had not specified quantity of Glucerna to provide per day, and stated, "We are providing Glucerna three times a day with snacks. We give the Glucerna to nursing, so nursing can determine when and how much to give to the patient due to the fluid restriction."

During a concurrent record review and interview on 5/2/17 at 10 AM, the Director of Nursing (DON), reviewed the order and reviewed the patient's flow sheets in the electronic medical record, and stated, "I can't tell from the flow sheet and input and output record if Glucerna was given." The DON stated that nursing would, at times, document consumption of the Glucerna in the care plan or nursing progress notes, but that there was not a formal system developed by the hospital for consistently documenting a physician's order for an oral nutrition supplement and percent consumption, and therefore was an incomplete medical record.

A review of a nutrition assessment completed by the Registered Dietitian (RD), dated 4/14/17, included "Diet Order: NCS, TID (three times a day) glucerna between meals ...."

An RD note, dated 4/25/17, for Patient 18 was reviewed and indicated, "Glucerna was encouraged to eat with foods ...."

According to Patient 18's care plan titled, "Alteration in Nutritional Status," initiated on 4/20/17, "continue to offer glucerna with requested food ... and document the consumption of these [noted by the RD] ... 5/1/17 ... Assessment: Recommend: Document liquid formula consumed [noted by the RD] .... "

Based on interview and record review, the facility failed to ensure that one of 23 sampled patients (Patient 4), had a properly executed informed consent form in regards to their transfer to another facility, when this form did not indicate that it had been witnessed by a staff member. This failure created an incomplete medical record and might indicate, the potential that this patient did not fully understand the transfer form that she had signed.

Findings:

Patient 4's record was reviewed. Patient 4 presented to this facility's emergency department in active labor on 4/15/17, where she delivered a female infant precipitously (extremely rapid labor and delivery) and in stable condition. Patient 4 and her new born baby girl were transferred to another area hospital.

Patient 4's record contained a document titled, "Patient Transfer Acknowledgement," which was signed by Patient 4 on 4/15/17. This document indicated that Patient 4 understood that she had the right to receive a medical screening, examination and evaluation by a physician or other appropriate personnel, without regard to her ability to pay, prior to any transfer from this hospital. This form indicated that Patient 4 had the right to be informed as to the reason for any transfer from this hospital. This document further indicated that Patient 4 understood that she had received a medical screening, examination and evaluation by a physician or other appropriate personnel and that she had been informed as to the reason for her transfer from this hospital, which included the risks and benefits of the transfer itself.

It was noted that although this document had been signed by Patient 4 (indicating her understanding), it was not witnessed by a facility's staff member.

The facility's policy titled, "Transfer of Patients ...," dated 5/16, was reviewed and indicated that the facility would obtain and witness all necessary patient signatures on the appropriate transfer forms as needed to facilitate a rapid and safe transfer from one facility to another.

The facility's undated policy titled, "Informed Patient Consent," was reviewed and indicated that after there has been validation of informed consent understanding, the licensed personnel will then obtain the signature of the patient consent on the appropriate consent form, which is then witnessed by facility staff.

During a concurrent interview and record review, on 5/2/17 at 3:10 pm, with the Director of Nurses, she acknowledged that Patient 4's Patient Transfer Acknowledgement form, had not been witnessed by a facility staff member and needed to have been.