The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

RIDEOUT MEMORIAL HOSPITAL 726 4TH ST MARYSVILLE, CA 95901 April 20, 2017
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure two of 49 sampled patients' records (Patients 25 and 31) included documentation that they were informed of their right to formulate an advanced directive (written instructions for provision of health care when an individual is incapacitated).

This had the potential for the resident to receive unwanted end of life care.

Findings:

Upon request of the hospital's current Advanced Directive policy, the hospital provided a "Not Approved Yet" policy and procedure. The hospital's Advance Directives-Hospitalwide policy, date created 12/91, showed that the hospital would provide patients with written information about their rights to formulate an advanced directive at the time of admission. "The hospital shall document in the individual's medical record whether or not the individual has executed an advance directive." The policy and procedure indicated, "The following procedures are carried out by the Patient Access Clerk when the patient is admitted /registered:...As part of the hospital admission process, the Patient Access Clerk shall provide the patient with information concerning health care. Such information which will address advance directives, surrogate decision making, and the forgoing of life-sustaining procedures,...Admissions Under Special Circumstances: When a patient is admitted to the hospital in such condition that it is not practical to provide information regarding advance directives at the time of admission, such information will be provided as soon as reasonable feasible for admission..."

1. Patient 25 was admitted on [DATE] with diagnoses that included sepsis and pyelonephritis. (Sepsis is a potentially life-threatening complication of an infection. It can trigger a cascade of changes that can damage multiple organ systems, causing them to fail.
If sepsis progresses to septic shock, blood pressure drops dramatically, it may lead to death.) (Pyelonephritis is severe kidney infection.)

On 4/19/17, Patient 25's record included a Conditions of Admission form, dated 4/16/17, that was checked that he did not have an advanced directive. The next box below was left unchecked to show that Patient 25 had been informed about his rights to formulate an advanced directive.

On 4/19/17 at 10 am, Quality Specialist (QS) was interviewed and confirmed that there was no evidence in Patient 25's record to show he had been informed of his right to formulate an advanced directive. QS stated that the omission was made by new admitting staff that required more training.





2. The clinical record was reviewed for Patient 31 on 4/17/17. Patient 31 was admitted on [DATE] with diagnoses that included traumatic subarachonoid hemorrhage (brain injury that might be sustained in an accident or a fall), diabetes, high blood pressure, and Bipolar disorder (a group of brain disorders that cause unusual shifts in mood, energy, and ability to function).

During a concurrent interview and record review with the Patient Access Lead (PAL) on 4/18/17 at 3:43 pm, she confirmed the hospital Conditions of Admission (COA) included an Advance Directive section to be completed during the admission process. The PAL confirmed the Advance Directive section for Patient 31 was incomplete. The PAL confirmed page 3 of 3 of the Conditions of Admission indicated Patient 31 was "altered" or unable to understand what he was signing. The PAL stated the registration department was responsible for checking on the patient status daily, to see if the patient was able to answer questions regarding the Advance Directive questions. The questions listed on the COA indicate if the patient has a current Advance Directive, if not, would they like information regarding Advance Directives. The PAL stated an information pamphlet regarding how to access information for Advance Directives is handed to patient's and/or family representative upon admission. The PAL confirmed in the registration visit notes, there had not been an updated patient status regarding Patient 31's ability to answer the Advance Directive questions posted to the note since admission on 4/9/17.

During a concurrent interview and record review with the ICU Nurse Manager (NM) H on 4/20/17 at 10:50 am, she confirmed Patient 31 received the Patient Services Guide, which included Advance Directive information, on 4/9/17 at 7:31 pm. The NM H confirmed there was no documentation in the record regarding updated Advance Directive status or communication regarding Advance Directive information with the family member. The NM H confirmed there was no physician or case management updates to the medical record. The NH H confirmed there was no referral to the physician or case management for Advance Directive information/communication initiated with the family member.

During a concurrent interview and record review with Registered Nurse (RN) Case Manager (CM) G on 4/20/17 at 10:55 am, she stated if a patient is admitted with an altered mental status, nursing makes a referral to case management to ensure family or the responsible party is assisted in completing the necessary Advance Directive forms as needed. The CM G confirmed there was no case management referral made for Patient 31.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on administrative staff interview and Food and Nutrition Services departmental performance improvement review, the hospital failed to develop a program that 1) developed an action plan for 1 of 4 key performance indications that was below hospital specified parameters, 2) continued to measure and report 3 of 4 key performance indicators that did not demonstrate meaningful opportunities for improvement and 3) failed to include the full depth and scope of departmental activities by lack of performance indicators for food services.

These failures had the potential for opportunities to improve the quality of nutritional services and support for patients to go unrecognized
which could affect the patient's physical and psychological well-being.

Findings:

On 4/19/17 beginning at 8:30 a.m., the performance improvement program for Food and Nutrition Services was reviewed with the Director of Food and Nutrition Services. It was noted for 2015 the hospital conducted four activities. They included evaluation of timely initiation of enteral support (a way to provide food through a tube placed in the nose, the stomach, or the small intestine) for trauma patients; improvement of diet order compliance; patient tray accuracy to improve meal satisfaction; and completion of nutrition assessment for wound patients. It was noted that cumulatively the compliance rate for three of the four parameters was greater than 98%. The exception was the initiation of enteral support. The analysis of enteral support for 4 of 5 patients revealed they were either not medically stable for enteral feeding or were given alternate nutritional support. The remaining patient did not receive timely nutrition assessment. There was no evaluation of whether the lack of timely nutrition assessment was an isolated instance or whether it would have qualified as a key performance indicator.

In April 2015, the hospital identified an issue with tube feeding (a flexible tube passed into the stomach for introducing fluids and liquid food into the stomach) infusion in relationship to the volume goal of the feeding noting compliance rates between 6 and 66 percent, with a goal of 100%. It was also noted in September 2015/ the action was to include approval of pre-selected Registered Dietitian (RD) consults on the surgical sets in the intensive and cardiac intensive care units. While an action was implemented, based on the ensuing performance improvement evaluations, the issue continued to be below the hospital specified parameters of 100 percent. There was no documented updated analysis or additional actions to improve the performance improvement indicator. Additionally there were no performance improvement indicators related to effectiveness of food production activities.

Departmental document titled, "Nutritional Services Quality Improvement Plan", dated 6/28/15, noted that "Quality improvement activities involve identifying high risk, high volume and/or problem prone areas. Action plans are developed to improve the care and/or services provided. Specific goals are set to evaluate the identified process and/or services in which opportunities for improvement are identified. All results not meeting the established goals are acted upon and corrective actions are initiated by the department's program Director."
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on observation, interview and record review, the nursing staff who cared for five randomly sampled patients of the possible 60 patients, (Patients 11, 12, 13, 14, and 15) within the 3 East, 2 East and 2 Central units, failed to fully implement and follow their facility's vascular access policy and procedures.

This failed practice had the potential for the needs of these patients to be unmet (Patients 11-15).

Findings:

During a tour of the 3 East, 2 East and 2 Central units with Nurse Manager (NM) B, starting at 10:28 am on 4/17/17, the following was observed:

Patient 11 (3 East) had a peripheral intravenous (PIV, a flexible tube that is inserted into a vein that is used to give medications or fluids through) line that had been converted to a saline lock (when the line is no longer connected fluids, but remains in the vein) in his left forearm that was not dated.

Patient 12 (3 East) had a PIV that had been converted to a saline lock in her right antecubital (near the bend of the arm) that was not dated.

Patient 13 (2 East) had a running PIV, located in his right forearm that was not dated.

Patient 14 (2 Central) had PIV that had been converted to a saline lock located in her right forearm that was not dated.

Patient 15 (2 Central) had a PIV that had been converted to a saline lock located in her right forearm that was soiled and dated 4/10/17.

During an interview on 4/17/17 at 11:50 am, NM B acknowledged the above findings and stated that it was the facility's policy to label PIV sites when they are placed, and to remove and restart an existing PIV when it is clinically indicated.

The facility's policy titled, "Vascular Access- Hospitalwide," dated 1/31/17, indicated that vascular access devices at this facility will be inserted and clinically managed using accepted standards of practice aimed at minimizing the risk of complications and infections. Peripheral catheters (PIVs) sites for adult inpatients, will only be changed when clinically indicated for example; phlebitis (redness or swelling), bleeding, or infiltration (when the tube becomes dislodged from the vein). The exterior dressing shall be changed every seven-days and as needed if loose or soiled. All insertion sites will be dated and timed on the label provided.
VIOLATION: USE OF VERBAL ORDERS Tag No: A0407
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and record review, the facility failed to use verbal orders in a manner that would not promote frequent use and for convenience for 1 of 49 sampled patients (Patient 26) when a verbal order for a tube feeding was discussed during a physician's visit to a patient and started without a written physician order.

This failure had the potential for increased risk of physician order miscommunication and therapeutic diet order error. (Cross-reference A-630)

Findings:

A record review showed that Patient 26 was admitted on [DATE] with chest pain and renal (kidney) failure. A physician order was noted for Glucerna (the brand name of a family of tube feeding nutritional formulas) 1.2 Cal (calories), start @ 20 ml (milliliters/hr (hour), adv (advance) 15 ml every 8 hours to a goal of 45 ml/hr to start on 4/15/2017 at 2:02 p.m. and stop on 4/18/2017 at 2:57 p.m.

An observation of Patient 26 in the Intensive Care Unit on 4/18/17 at 3:10 p.m. and concurrent interview with the Charge Nurse (CN E) and Registered Nurse A (RN A), showed a 1000 cc (cubic centimeters) bottle of Glucerna 1.2 connected to a pump that was running at 50 ml/h. RN A stated that she, the dietitian, and the physician were in the patient's room earlier that day and discussed a tube feeding change. The physician verbally stated to increase the tube feeding rate to 50 ml/hr based on the dietitian's recommendation. CN E showed the order was entered into the computer as a verbal order, but he was not able to tell who entered the verbal order. He could not show there was a written doctor's order for Glucerna 1.2 at 50 ml/hr.

A review of the policy provided by the facility, titled "Prescriber Order Processing - Hospitalwide" dated 3/9/2016, read "I. Policy: This policy is to provide a safe and efficient method for processing all patient orders submitted by prescribers. Ineffective communication is the most frequently cited root cause for sentinel events (any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a patient or patients, not related to the natural course of the patient's illness). Effective communication that is timely, accurate, complete, unambiguous, and understood by the recipient reduces error and result in improved patient safety. II. Purpose: The purpose of this policy is to establish a clear and concise workflow for the management of provider orders. Only prescribers who have been granted privileges ... may submit computerized, written, verbal, or telephone orders for patients. Acceptance of verbal or telephone orders should adhere to ... guidelines including but not limited to emergent events or when a provider is unable to access a computer (driving, code blue)."
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on inspection of one out of three Pediatric Crash Carts (contains equipment and medications used to manage pediatric medical emergencies) located in the Emergency Department (ED), inspection of two out of two laminar airflow workbenches (LAFW: provides an ultra-clean environment in which compounded sterile products [CSPs] such as intravenous solutions [IVs] are compounded by pharmacy staff ) located in the buffer area (a clean area created by filtering air entering the room) of the pharmacy IV compounding room, and one out of one [DIAGNOSES REDACTED] carts (MH Cart: contains equipment and medications used to manage [DIAGNOSES REDACTED], a rare but potentially lethal complication of the use of certain medications used in the practice of anesthesiology), staff interview, and document review:

1. The hospital failed to ensure it had enough sodium bicarbonate for the IV route, epinephrine for administration by the endotracheal route (ET route: instilled in the airway when other routes cannot be used to give an emergency drug), lidocaine via the ET route, and atropine via the ET route available in the Pediatric Crash Cart medication supply to treat all weight classes per the guidelines the hospital had identified to guide the management of pediatric medical emergencies.

This had the potential to delay the effective management of a pediatric medical emergency.

2. The hospital failed to ensure all inner surfaces of one out of two of the LAFWs were smooth and easily cleanable when they allowed a certification technician (a person working for a contracted service who makes environmental measurements of the clean compounding area of the pharmacy every six months) to affix a certification sticker (documents that the service had been performed on a given date and identifies the contracting agency which did the certification) to the upper left outer (closest to the front of the LAFW) corner inside this LAFW. The edges of the sticker could trap dirt and contaminants inside this ultra-clean environment so staff would not be able to completely clean the LAFW to meet specification of the standard identified by the hospital to ensure the quality of its CSPs.

This had the potential to allow the introduction of contaminants into the ultra-clean compounding environment of the LAFW which may result in contamination of the CSPs compounded in the LAFW.

3. The hospital failed to ensure that the organized medical staff had approved the inclusion of one 3000 milliliter (ml) irrigation bag of 0.9 sodium chloride for use in the MH emergency supply. It was stored in a labeled bag in the Post Anesthesia Care Unit (PACU: surgical cases are recovered here and then transferred to a regular hospital floor when stable) refrigerator and would be used to cool a patient undergoing an MH crisis (patients undergoing this crisis can have rapid temperature elevations up to 110 degrees Fahrenheit). As it did not appear on the approved content list staff may not always stock it, if that was the intent of the organized medical staff, so it was immediately available to manage an MH crisis.

This had the potential for emergency supplies to not be immediately available during a [DIAGNOSES REDACTED] crisis which could adversely affect a patient's outcome.

Findings:

1. On 4/20/17 at 10:30 a.m. during a concurrent interview of the Director of Emergency Department (DED) and an inspection of the Pediatric Crash Cart located in the Emergency Department (ED) "Rapids Area" she stated the hospital followed the Broselow Tape and Pediatric Advanced Life Support (PALS) guidelines to guide dosing emergency medications during a medical emergency although the physician present ultimately oversaw the management of the emergency. She stated the cart was intended for use on children up to 36 kilograms (kg) in weight. The Broselow Tape is used to measure children to estimate their weight and contains weight based doses of various drugs that staff could refer to during an emergency to properly medicate a pediatric patient. PALS guidelines are published by the American Heart Association and provide guidelines to manage a pediatric medical emergency including the proper use of medications in this population.

On 4/20/17 at 10:30 a.m., an inspection of the Pediatric Crash Cart located in the ED "Rapids Area" indicated the following:

The cart contained two 10 ml pre-filled syringe (PFS) of sodium bicarbonate (an emergency medication) 8.4% and one 10 ml PFS of sodium bicarbonate 4.2%. One 10 ml PFS of 8.4% sodium bicarbonate would deliver 10 milliequivalents (mEq) of sodium bicarbonate and the 10ml PFS of 4.2% sodium bicarbonate would deliver 5 mEq of sodium bicarbonate. Thus, the cart contained enough sodium bicarbonate to deliver a 25 mEq dose of sodium bicarbonate.

A concomitant review of the 2011 Edition A Broselow Tape stored on the cart indicated that children weighing 24 to 28 kilograms (kg) would require 27 mEq of sodium bicarbonate if called for during a medical emergency and children weighing 30 to 36 kg would require 33 mEq of sodium bicarbonate if called for during a medical emergency. Hence the cart was short 2 mEq for the children in the first group and 6 mEq for children in the second group. Using two different concentrations of a medication during a medical emergency could also result in a medication error.

The cart contained three 1 ml vials of epinephrine 1:1000 which the content list posted on the cart indicated was for use via the ET route.

A concomitant review of the 2011 Edition A Broselow Tape stored on the cart indicated that children weighing 30 to 36 kg would require 3.3 ml of epinephrine (an emergency medication) via the ET route if called for administration by this route by a physician during a medical emergency. Hence the cart was short 0.3 ml of epinephrine for the children this weight group.

The cart contained one 5 ml PFS of lidocaine 1% at (10 milligrams [mg]/ml).

A concomitant review of the 2011 Edition A Broselow Tape stored on the cart indicated that children weighing 19 to 22 kg would require 40 to 60 mg of lidocaine (an emergency medication) via the ET route, children weighing 24 to 28 kg would require 54 to 80 mg via the ET route, and children weighing 30 to 36 kg would require 66 to 100 mg of lidocaine via the ET route. Hence the cart was short lidocaine for the children within these weight groups if called for administration by this route of administration by a physician during a medical emergency.

A concomitant review of the 2011 Edition A Broselow Tape stored on the cart indicated that children could receive atropine (an emergency medication) via the ET route at a concentration of 0.4mg/ml if called for by a physician during a medical emergency. Inspection of the cart indicated it did not contain any atropine 0.4 mg/ml. Hence no atropine would be available for use during a medical emergency if called for administration by the ET route by a physician during a medical emergency.

On 4/20/17 a review of Policy and Procedure entitled PEDIATRIC/NEONATE CRASH CART - STOCKING AND MAINTENANCE - HOSPITALWIDE (Created 9/27/16, Reviewed 10/27/16) indicated it documented, under "POLICY": "It is the policy ... that appropriate hospital personnel have immediate access to supplies and medications needed in response to pediatric/neonate patient emergency situations. This shall be ensured via appropriate management of pediatric/neonate crash carts with regards to the ... availability ... of all the medications ... contained within the pediatric/neonate crash cart."

These observations regarding sodium bicarbonate, epinephrine, and atropine were verified with the DED and the Director of Pharmacy (DOP) during concomitant interviews conducted at that time with the DOP a second time at 12:17 p.m. on 4/20/17 with respect to the lidocaine.

2. 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.

Under "Facility Design and Environmental Controls" USP 797 documents: "The surfaces of ... cabinets in the buffer area (cleanest part of the compounding area) shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate."

On 4/17/17 at 10:56 a.m., during an interview the DOP stated the hospital followed USP 797 with regard to compounding Compounding Sterile Preparations (CSP)s.

On 4/17/17 at 2:12 p.m., an inspection of two of two LAFWs located in the buffer area of the pharmacy IV compounding area indicated that a certification sticker was placed on the left wall of one of the two LAFWs in the upper left corner at the front of the LAFW. The edges of the sticker as well as any adhesive on the sticker edge provided a potential site to collect contaminants when staff cleaned the LAFW.

3. [DIAGNOSES REDACTED] (MH) is a rare, but potentially lethal, adverse effect of certain medications, the anesthetic gases and succinylcholine (a muscle relaxant used during surgery), used in anesthesia and surgery. It is characterized by a rapid rise in a patient's temperature up to 110 degrees Fahrenheit or more. If not treated immediately it can result in injury to or death of a patient. The [DIAGNOSES REDACTED] Association of the United States has published guidelines for the treatment of this condition and is a nationally recognized organization that has published recommendations regarding the medical management of this potential adverse medical outcome. The [DIAGNOSES REDACTED] Association of the United States recommends facilities maintain a cart containing equipment and medications to manage an MH crisis. This includes refrigerated IV saline which would be used to cool a patient by direct IV administration or by irrigation of body cavities.

On 4/18/17 at 1:23 p.m., an inspection of the MH Cart located in the PACU indicated it had a content list which indicated three 1000 ml containers of 0.9% sodium chloride were available in the (PACU) refrigerator.

Inspection of the refrigerator indicated it contained a large plastic self-sealing plastic bag labeled "[DIAGNOSES REDACTED] Bag". It indicated the contents of the bag included one 3000 ml bag of 0.9% sodium chloride for irrigation, an item that did not appear on the content list of approved medications posted outside of the cart. Inspection of the contents of the bag indicated it contained one 3000 ml irrigation bag of 0.9% sodium chloride. This observation was verified by the DOP during a concurrent interview during the inspection on 4/18/17 at 1:23 p.m.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on inspection of one out of one warmer (a medical device used in healthcare facilities for warming fluids used in surgery) in the substerile core between operating room (OR) 1 and OR 2 (contained supplies used to help manage surgical cases) and staff interview, the hospital failed to ensure that nine out of fifteen intravenous solution (IV) bags stored in the warmer had been assigned accurate expiration dates by the staff. These bags were labeled to expire 4/1/17 (17 days prior to the survey) when they should have been labeled 5/1/17 (13 days after the survey). The expiration dates are part of the labeling of medications and these IV bags were mislabeled.

This failure put the patient at risk for exposure to intravenous solutions that had been stored at higher temperatures for a prolonged period that may affect the concentration and chemical composition of the fluids.

Findings:

On 4/18/17 at 2:24 p.m. an inspection of the substerile core between OR 1 and OR 2 indicated it contained a warmer containing two compartments, the top one of which contained sterile irrigation and IV solutions. An inspection of the contents of the top compartment indicated staff had placed printed labels on each irrigation bottle and each IV bag on which appeared a printed date. During a concurrent interview conducted at that time with RN R she stated the printed dates were expiration dates placed on the bags by surgical technicians.

The inspection indicated that the warmer contained seven 1000 milliliter (ml) IV bags of Lactated Ringers (contains minerals and is used to replace body fluid) four of which had applied labels with printed expiration dates indicating they had expired 4/1/17. The warmer contained eight 1000 ml IV bags of 0.9% sodium chloride five of which had labels indicating they had expired 4/1/17.

During an interview with Anesthesia Aide S at 2:39 p.m. she stated she had labeled the IV bags and put them in the warmer that day and that the bags should have been dated 5/1/17.
VIOLATION: POTENTIALLY INFECTIOUS BLOOD/BLOOD PRODUCTS Tag No: A0592
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure they had developed notification and documentation policies and procedures for one of 49 sampled patients (Patient 21) that had received potentially infected blood and blood products (blood products consist of specific processed components such as red blood cells, blood plasma, or platelets), that conformed to federal, state, and local laws.

This had the potential for the patients and providers to not be aware of their possibly infectious status.

Findings:

On 4/17/17, Patient 21's record was reviewed and showed he was admitted on [DATE], following a traumatic accident. Patient 21 received two units of packed cells, two units of fresh frozen plasma and two units of platelets (blood products) while being treated and stabilized in the emergency room .

On 4/18/17, Patient 21's Blood Component Lookback Form, dated 11/3/16, showed that one of the plasma units infused on 8/6/16 (during his trauma treatment) showed the physician was notified on 11/4/16 by letter. The letter included item 9 that read, "A Cover Letter and Original Blood Source letter of notification will be sent to the Physician of record, scanned into the EMR (electronic medical record), and copies retained by the Transfusion Services Supervisor." There was no confirmation by the physician that he received the notice.

The Original Blood Source letter, dated 10/24/16, that referred to the Patient 21's plasma units showed they were collected on 7/3/16. Subsequent donations collected from the same donor on 9/25/16 initially tested positive for the Zika Virus (a virus transmitted by mosquitoes which typically causes mild infection (fever and rash) in humans, it may be associated with an increased incidence of incomplete brain development in babies born to mothers infected during pregnancy). The FDA (United States Federal Drug Administration) issued guidance revised on 8/26/16 for blood centers to screen for ZIKA (just after Patient 21's transfusion collected on 7/3/16).

On 4/18/17 at 11 am, Quality Control Lab (QCL) and Lab Tech Supervisor (LTS) were concurrently interviewed. Patient 21's transfusions and the subsequent donor's potential ZIKA infection described in Patient 21's Blood Component Look Back Form, dated 11/3/16, were concurrently reviewed. QCL and LTS confirmed there was no documentation in Patient 21's record of the potentially infected transfusion or that he had been notified of the potential for ZIKA contamination in the plasma. QCL and LTS confirmed that there was no way to know if the physician was actually aware that Patient 21 had potentially received infectious blood products.

The hospital's Look-Back Policy for Transfusion Transmitted Diseases, dated 3/14/16, was concurrently reviewed with QCL and LTS on 4/18/17 at 11 am. They confirmed that the hospital's policy had not been updated for the ZIKA virus to conform with the FDA recommendations revised on 8/26/16. QCL and LTS also confirmed that the required notifications were not found in Patient 21's EMR as required by the hospital's policy. They stated that they were going to update their processes and policies to include the ZIKA virus.
VIOLATION: GENERAL BLOOD SAFETY ISSUES Tag No: A0593
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure they notified one of 49 sampled patients (Patient 21) that they had potentially received infectious blood products from a transfusion (packed cells, plasma, platelets ) as required by the FDA (United States Federal Drug Administration).

This had the potential for patients to be unaware of their risks of blood borne pathogens and possibly transfer the potential infection.

Findings:

On 4/17/17, Patient 21's record was reviewed and showed he was admitted on [DATE], following a traumatic accident. Patient 21 received two units of packed cells, two units of fresh frozen plasma and two units of platelets (all blood product components) while being treated and stabilized in the emergency room .

On 4/18/17, Patient 21's Blood Component Lookback Form, dated 11/3/16, showed that one of the plasma units infused on 8/6/16 (during his trauma treatment) showed the physician was notified on 11/4/16 by letter. Their was no indication that Patient 21 was notified or confirmation that the physician was aware.

The Original Blood Source letter, dated 10/24/16, that referred to the Patient 21's plasma units showed they were collected on 7/3/16. Subsequent donations collected from the same donor on 9/25/16 initially tested positive for the Zika Virus (can cause birth defects, transmitted through sperm and potentially transmitted through plasma transfusions). The FDA issued guidance revised on 8/26/16 for blood centers to screen for ZIKA (just after Patient 21's transfusion collected on 7/3/16).

On 4/18/17 at 11 am, Quality Control Lab (QCL) and Lab Tech Supervisor (LTS) were concurrently interviewed. Patient 21's transfusions and the subsequent donor's potential ZIKA infection described in Patient 21's Blood Component Look Back Form, dated 11/3/16, were concurrently reviewed. QCL and LTS confirmed there was no documentation in Patient 21's record that he had been notified of the potential for ZIKA contamination in the plasma.
VIOLATION: DIRECTOR OF DIETARY SERVICES Tag No: A0620
Based in dishwashing observations, dietary staff interview and dietary document review the hospital failed to ensure comprehensive monitoring and training of the Dishmachine in accordance with manufacturers' guidance.

Failure to ensure staff are fully trained in equipment functionality may result in practices that put patients at risk for cross contamination and foodborne illness.

Findings:

On 4/17/17 beginning at 2:15 p.m., dishwashing procedures were reviewed with Dietary Staff 28. The surveyor asked him to describe the process for ensuring the Dishmachine was working properly. He stated that he would evaluate the temperature on each of the gauges on the machine. Each of three gauges depicted water temperatures for the wash and 2 separate rinse cycles. He further stated that the values were documented on a Dishmachine log. He also stated that he utilized the guidance printed on the log as a reference.

Concurrent review of the departmental document titled "Dishwashing/Warewashing Machine Temperature and Sanitizer Log" dated March and April 2017 respectively revealed that the reference parameters on the log were intended for a low temperature dish machine which utilizes chlorine as a sanitizing agent, rather than parameters for a high temperature machine, the one utilized by the facility. The documented parameters on the log indicated the minimum temperatures for both the wash and rinse cycles were 140F (degrees Fahrenheit). Manufacturer's specifications, posted on the side of the Dishmachine revealed the following minimum temperatures: wash-150F; rinse-160F and final rinse-180F. It was also noted that while the documented temperatures for the wash cycle met manufacturers' guidance, the rinse temperatures did not rather were consistently below 180F.

Review of hospital training titled "Dishwasher" dated 9/22/16, was consistent with manufacturers' guidance; however Dietary Staff 28 was not present.
VIOLATION: QUALIFIED DIETITIAN Tag No: A0621
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the facility failed to make adequate provisions to perform and document nutritional assessments at a frequency to meet the needs of the patients when 1 of 49 sampled patients (Patient 45) did not have a consult with a dietitian in accordance with the hospital's policy.

This failure had the potential to result in nutrition related medical complications and illness for this patient who was at moderate nutrition risk.

Findings:

A review of the record for Patient 45 showed she was [AGE] years old and admitted with a fracture of the femur (thigh bone) on 4/13/17. Upon admission she was placed on a regular diet. Her diet was changed to nothing by mouth for one day due to a surgical procedure for her fracture and was advanced gradually back to a regular diet. The daily Assessment Inquiry indicated that Patient 45 ate 0 to 75 percent of her meals, of the meals that were recorded on the "Daily Assessment Inquiry."

A review of the policy provided by the facility titled "Initial Nutrition Screening, Consults, Nutrition Risk Criteria, Assessment, Follow-up & Risk Levels - FNS [Food and Nutrition Services]" dated 12/20/2016, read "C. Criteria for Nutrition Risk Level Procedures: 1. All patients shall be prioritized for nutrition assessment by an Registered Dietitian ( RD) according to the Criteria for Nutrition Risk Levels for Adults ... Refer to Adult Clinical Nutrition Priority Criteria, (Attachment A) ..."

A review of the document provided by the facility titled "Attachment A Adult Clinical Nutrition Priority Criteria" dated 12/20/16, showed a patient with a fracture and surgery and a patient greater than [AGE] years old is a Priority 2 and is at moderate nutrition risk and the initial RD assessment is to be within 3 days.

In an interview on 4/18/17 at 1 p.m., the General Manager of Nutrition Services (GMNS) stated Patient 45 did not have an initial assessment, which would include an analysis of nutrition needs, by an Registered Dietitian RD. According to the Adult Clinical Nutrition Priority Criteria, Patient 45 should have had an RD assessment within 3 days by 4/16/17 because the patient had a fracture, had surgery, and was greater than [AGE] years old. She said Patient 45 was not assessed by day 3 because higher priority patients needed to be assessed and there was not enough RD staff to meet the priority criteria list because the facility was short 1 RD position. She said the list of patients that RDs were to assess was re-prioritized daily. Higher priority patients were assessed before lower priority patients and the patients on the list that were not seen by the end of the work day would be re-prioritized the next day.

A review of the facility's contract amendment for nutrition services dated October 1, 2015, indicated the contracted Registered Dietitians were to complete patient care for nutrition services and patient acuity levels will affect the amount of time it takes to complete the clinical care work. Also, the Multi-Service GMNS shall perform with the facility's written policies and procedures.
VIOLATION: THERAPEUTIC DIETS Tag No: A0629
Based on meal plating observations, departmental administrative staff interview and dietary document review the hospital failed to ensure nutritional needs of one of 49 sampled patients (Patient 46) were met in accordance with the departmental approved menus when 1 random patient did not receive a meal tray in accordance with physicians' orders.

Failure to ensure meals are plated in accordance with hospital approved menus may result in further compromise of medical status.

Findings:

During meal distribution observation on 4/17/17 beginning at 11:30 a.m., it was noted that Patient 46 had a physician ordered Renal (kidney), Consistent Carbohydrate diet. Concurrent review of the standardized patient menu for this diet included a 4 ounce portion of fat free milk. Observations of additional meal trays revealed all of the milk glasses were full and there was little discernable difference in the milk portion between renal and regular diets.

In an interview on 4/17/17 at 11:50 a.m., the Director of Food and Nutrition Services (DFNS), requested staff to fill a glass with milk to the clear rim The clear rim measured approximately 3/8 inch around the top of the glass. It was noted that once the glass was filled to the clear rim it contained 8 ounces of fluid. The demonstration noted all patients, irrespective of physician ordered diet, received approximately 6 ounces of milk. The DFNS stated that the hospital had 4-ounce glasses that should have been used for the renal diet and the 8-ounce glasses should have been filled to the rim.

Review of the hospital's current "Diet Manual" revealed that the Renal diet was limited in dairy products due to its phosphorus content. Similarly offering 8 ounces of milk for each meal of the remaining diets significantly contributed to meeting the Calcium and Vitamin D requirement of patients.
VIOLATION: DIETS Tag No: A0630
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview, and record review the facility failed to provide a therapeutic diet in accordance with the physician order for 1 of 49 sampled patients (Patient 26).

This failure had the potential to provide inadequate nutrition as well as over-feeding for Patient 26 and result in nutritional related medical complications.

Findings:

A record review showed that Patient 26 was admitted on [DATE] with chest pain and renal failure. According to the "CPOE [Computerized Physician Order Entry] Orders Report" a tube feeding for Glucerna (is the brand name of a family of tube feeding formulas) 1.2 Cal (calories) at a rate of 10 ml (milliliters (ml)/hour (hr) was ordered to start on 4/15/2017. Later the same day, there was a follow-up order for Glucerna 1.2 Cal, Start @ 20 ml/hr, adv (advance) 15 ml every 8 hours to a goal of 45 ml/hr to start on 4/15/17.

A review of the document provided by the facility titled "Daily Assessment Inquiry" for Patient 26 showed the tube feeding for Glucerna was started at 10 ml/hr on 4/14/17 at 9:00 p.m. and was continued until 4/16/17 at 3 a.m. which was the day before the physician's order indicated to start the tube feeding. The documentation then showed the patient received Glucerna at 10 ml/ hr until it was increased to a rate of 45 ml/hr at 7 p.m. on 4/16/17. According to the documentation, there was not a gradual increase for Glucerna from 20 ml/hr to 45 ml/hr started on 4/15/17, as ordered by the physician.

An observation on 4/18/17 at 3:10 p.m., showed a bag of Glucerna 1.2 connected to a pump that was running at 50 ml/h. In a consecutive interview with Charge Nurse E (CN E), he stated there was not a written physician's order for the increased rate of the feeding.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on inspection of one out of one lab carts located in Emergency Department (ED) Room B and staff interview, the hospital failed to secure dangerous medical devices (syringes and hypodermic needles) according to hospital policy and failed to ensure expired bacterial culture vials were not available for use for testing patient blood samples.

This had the potential to allow diversion of the syringes and hypodermic needles by the general public and the potential to yield a false negative test for infected blood when placed into an expired culture vial to grow any bacteria that may be present in the blood sample added to the vial. A false negative test could result in less that optimal treatment of a patient with a blood infection.

Findings:

On 4/20/17 at 10:12 a.m., an inspection of ED Room B in the ED indicated the room was not occupied. It contained an unlocked cart with several drawers. Inspection of the one of the drawers indicated it contained 6 milliliter (ml) syringes, 3 ml syringes with an attached hypodermic needle and labeled for use in arterial blood draws, and 23 gauge 1 inch hypodermic needles. Such equipment is defined as dangerous medical devices and should not be easily available to the general public.

Further inspection indicated the bottom drawer contained ten BD Bactec Lytic/10 Anaerobic Culture Vials which had expiration dates printed on the manufacturer's label applied to the culture vials. Blood samples are added to the vials which are then sent to the lab to see if bacteria grow out which would indicate the patient from whom the sample was taken had a blood infection. One of the ten vials had expired 1/31/2017. Anaerobic Culture Vials are used to culture bacteria that normally can grow in an oxygen deficient environment.

During a concomitant interview of Lab Support Supervisor T (LSS T) conducted at that time she verified these observations. She stated it was hospital policy to lock the cart when it was unattended. She stated the use of an expired culture bottle may result in the failure to grow bacteria out (if present in a blood sample) which would be a false negative result.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations, when:

1. One of 38 sterilized (a process that eliminates, removes, kills, or deactivates all forms of life and other biological agents such as fungi, bacteria, viruses, and spores), surgical instruments contained visible debris on the surface and could not be verified as sterile; identification tape on the instrument handles was brittle and easily broken off.

2. Employee health files did not have documentation to verify immunization status for vaccine preventable diseases.

3. Surgical instruments were not sterilized within the standard timeframe.

4. Clean dishware and cooking utensils were stored next to handwashing sinks that did not have a splash guard.

5. A container filled with sanitizer used to clean food surface contact areas was stored on the floor.

6. Cool down temperatures for a cooked turkey were not taken. (Improper cooling and reheating are major causes of foodborne illness).

7. Holding temperatures for prepared food in the caf were not monitored. (Holding temperatures are the temperatures required to prevent foodborne illness. The temperature danger zone for food is between 41F to 140F)

These failed practices had the potential to expose patients, staff, and visitors to disease causing organisms that could lead to illness.

Findings:

1. On April 17, 2017 at 9:40 a.m., during an interview with Infection Prevention Nurse (IPN), he stated that the facility utilizes the Association of peri-Operative Registered Nurses (AORN), Centers for Disease Prevention and Control (CDC), Association for Professionals in Infection Prevention and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) standards as their nationally accepted infection control guidelines.

On April 17, 2017 at 10:30 a.m., during a tour of the sterile supply, a minor instrument tray was opened and inspected. One of 38 instruments was found to have visible debris on the surface. This was validated by Director of Perioperative Services (DPOS) and IPN.

On April 18, 2017 at 9:03 a.m. during a tour of the sterile supply room of the obstetrics (the branch of medicine that specializes in care of women before, during and after childbirth) facility, a Cesarean instrument tray was opened and inspected. One of 40 instruments was found to be soiled and three of 40 instruments were found to have identification tape on the handle. The tape was in a state of disrepair and could easily be broken off with a fingertip. These findings were validated by IPN, DPD and ORT Q.

According to the Association for the Advancement of Medical Instrumentation (AAMI TIR30, Section 5.4.):
Medical device manufacturers should be familiar with cleaning, disinfection, and sterilization technologies used in health care facilities and with the kinds of soil and microbial contamination encountered as a result of patient use.
Organic soil such as blood, serum, lipids, tissue fragments, and inorganic salts can impede the disinfection or
sterilization process if it is not removed during cleaning. Most of these soil components are substrates for the
sterilants used for disinfection or sterilization; that is, they are competitors for sterilant action. If these soil
components are insufficiently removed, they can also protect microorganisms from inactivation by limiting the
diffusion of the sterilant to the microorganisms' location on the medical device.

According to AORN Instruments may be marked using many techniques, such as instrument tape at the time of purchase. Repeated sterilization cycles can cause the tape to shift or become brittle. The shifting may expose sticky tape residue on the instrument, which is difficult to remove. When the tape becomes brittle, it may break or flake off, so the tape may be retained as a foreign object in the patient. The tape may not be permeable to all types of sterilants, which may restrict the method of sterilization that may be used on the taped instrument. If the tape is not permeable to the sterilants used as determined by the manufacturer's instructions for use and it flakes off, the area beneath the tape would not be considered sterile ... The instrument tape should be inspected and replaced if shifting or flaking has occurred.

2. On April 17, 2017 at 9:40 a.m., during an interview with IPN, he stated that the facility utilizes the Association of peri-Operative Registered Nurses (AORN), Centers for Disease Prevention and Control (CDC), Association for Professionals in Infection Prevention and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) standards as their nationally accepted infection control guidelines.

On April 18, 2017 at 1:00 p.m., nine employee health records were reviewed (EVS I, EVS J, IPN 2, Tech K, MD 9, DA M, DA N, DA O, DA P ). One (MD 9) out of nine files had no documentation of current influenza status. Two (Tech K, DA O) out of nine files did not have documentation of current mumps (a viral infection that primarily affects the parotid glands) status. Two (DA M, DA N) out of nine files did not have evidence of current Hepatitis B (a viral infection of the liver) status. One (DA N) out of nine files did not have evidence of current measles (or rubeola, a highly contagious viral infection that is characterized by fever, runny nose, cough, red eyes, and sore throat followed by a rash that spreads over the body) status. These findings were validated by HR L.

According to the facility policy Health Immunization-Hospital wide(1) dated 10/27/2016, all five vaccines MMR (Measles, Mumps, Rubella), Varicella, Hepatitis B, Tdap (Tetanus, Diphtheria and Pertussis), and Influenza will be offered to its personnel. All personnel will be asked to present proof of vaccination or immunity during pre-employment. Those who cannot provide proof will be submitted to testing of immunity status. Those whose immunity status indicates the absence of immunity will be offered the vaccine. Personnel may choose to decline the vaccination and will be asked to sign a declination form.

The CDC states that those who work directly with patients or handle material that could spread infection should get appropriate vaccines to reduce the chance that they will get or spread vaccine-preventable diseases. The CDC further states that healthcare workers include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff.

a. Employee health policies and procedures titled, " Health Immunization-Hospitalwide", dated 10/27/2016, did not follow the facility adopted, nationally recognized CDC guidelines for immunizations of health care workers that state:
i. ( ...recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace (i.e. hepatitis B, seasonal influenza, measles, mumps, rubella, pertussis, and varicella)
ii. Healthcare personnel should receive a single dose of Tdap (a vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, that prevents the diseases of Diphtheria, Tetanus and Whooping Cough) as soon as feasible upon hire if they have not been vaccinated previously.
iii. Healthcare organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter.





3. During a concurrent soiled utility room tour, observation, and interview on 4/18/17 at 11:10 am, with the Director of the Perinatal Department (DPD) and Perinatal Nurse Manager (NM) F, the DPD stated all instruments are placed in the hard, red plastic containers after use and sent to the Surgery Center for reprocessing and sterilization. The DPD stated all hinged instruments are opened and all instruments are sprayed with Pre-Klenz (A chemical spray used to initiate pre-cleaning without handling surgical instruments. Designed to keep the instruments moist to prevent the drying of soils on the instruments during transport to the sterile processing department) Four of 4 bins were full with instruments. The DPD stated the instruments were from three Cesarean Sections 4/17/17, one early morning 4/18/17 (four total), and any other delivery trays used during for vaginal deliveries (three total) between 4/17/17 and 4/18/17 at 11:00 am. Upon observation, none of the instruments appeared to be wet or moist.

During an interview with the Sterile Processing Technician (SPD) at the Surgery Center on 4/19/17 at 8:15 am, the SPD stated he picks up the instruments from the soiled utility room at the hospital between 7:00 am and 10:00 am Monday through Friday. The SPD stated if more instruments are needed after he has gone home, then the on-call SPD technician can pick up the bins and process them as soon as possible to ensure necessary instrumentation is available. The SPD stated instruments are usually not picked up more than once a day and the instruments can sit for a time greater than 16 hours.

According to the Association for the Advancement of Medical Instrumentation (AAMI ST79, Section 6.3 Care and handling of contaminated reusable items at point of use).

"To prevent the formation of biofilm, definitive cleaning should occur as soon as possible. Prior to transport, instruments should be prepared in such a way as to prevent organic soils from drying...or using an instrument spray designed for pretreatment. If processing is delayed, attention should be given to minimizing bacterial proliferation, including the use of precleaning disinfectants. Even with this step, extremely long delays in processing, such as might occur over a weekend, can result in the formation of tenacious and difficult-to-remove biofilm that will shield microorganisms from routine cleaning procedures and possibly interfere with disinfection or sterilization.

Biofilm consists of an accumulated biomass of bacteria and extracellular material that is tightly adhered to a surface and cannot be removed easily. Biofilm has the effect of protecting microorganisms from attempts to remove them by ordinary cleaning methods used in the sterile processing department. Biofilm can form on many surfaces but is particularly problematic in devices with lumens. Once biofilm forms, direct friction and/or oxidizing chemicals are needed to remove it. Prompt cleaning reduces or eliminates the population of biofilm-forming microorganisms and thus prevents the formation of biofilm. Precleaning disinfectants are appropriate for use in the event of processing delays; however, some disinfectants (e.g., aldehyde-based products) will act as fixatives for debris and make cleaning more of a problem (Merritt, et al., 2000)."

The facility policy and procedure titled Transporting Container System for Contaminated Instruments - Sterile Processing, dated 10/27/16, indicated "Cleaning instruments as soon as possible after use can help prevent formation of biofilm and dried blood. When blood or other bioburden is allowed to dry on instruments, it can become more difficult to remove. The effectiveness of disinfection or sterilization is dependent upon appropriate handling, cleaning, and decontamination of instrumentation."




4. On 4/17/17 at 10:20 a.m., a concurrent observation and interview was conducted with the General Manager of Nutrition Services (GMNS) in the kitchen. The handwashing sink was located next to a four tiered metal rack. The rack held cooking utensils including mixing bowls, pots, and pans. The rack was less than 15 inches from the hand washing sink. When the surveyor washed her hands, she had great difficulty not splashing water on to the cooking tools stored on the rack. The GMNS confirmed the cooking utensils stored on the rack near the handwashing sink were clean.

An observation on 4/17/17 at 2:00 p.m. and a concurrent interview with GMNS and DFNS, showed a rack that held 4 stacks of dishes stored less than 5 inches from a handwashing sink in the dish machine area. When the surveyor washed her hands, she had great difficulty not splashing water on the dishes. After the surveyor washed her hands, a food service worker washed his hands in the sink. GMNS stated the dishes in the rack were clean. DFNS stated the rack with clean dishes should not be stored near the handwashing sink. Other handwashing sinks located in the kitchen had splash guards to prevent water splashing beyond the sink but the sink located in the dish machine area and the sink located near the four tiered metal rack did not have splash guards.

The facility was asked to provide a policy for storage of clean dishware, but no such policy was provided.

5. During an observation on 4/17/17 at 10:35 a.m. and concurrent interview with Cook 1 and GMNS, Cook 1 was observed placing mixing bowls on top of a food preparation table. She stated she was getting ready to prepare food and the table she was about to use was where vegetables, fruit, and cold items were prepared. When the surveyor asked about the green and a red bucket filled with liquid stored on the floor under a food preparation table, Cook 1 stated the green bucket contained a wash solution and the red bucket contained a sanitizer solution used to sanitize the food preparation table. When the surveyor asked Cook 1 to test the strength of the sanitizer solution, she picked up the red bucket containing the solution off the floor and placed it on the food preparation sink where she was about to prepare food. She stated she always stored the solution bucket on the floor because she did not have another place to store it. GMNS stated the solution buckets should not be stored on the floor.

A review of the policy and procedures provided by the facility titled "Food Preparation and Kitchen Cleaning - FNS [Food and Nutrition Services]" dated 8/26/15 read "Purpose: A. To prevent the growth of bacteria by keeping the equipment clean and sanitary ... Procedure: 3. Work Stations - Tables ...: a. All work stations are provided with sanitizing buckets. B. All work tables are cleaned and sanitized before and after each shift."

The facility was asked to, but did not provide a policy for storage of sanitizing buckets.

6. An observation inside the walk-in refrigerator on 4/17/17 at 10:50 a.m. and showed a container in the walk-in refrigerator labeled cream of vegetable soup and dated 4/17/17 - 4/19/17. The container of soup was warm to the touch. The temperature of the soup, measured with the surveyor's calibrated thermometer, was 104 degrees Fahrenheit (F).

A review of the "Production and Culinary Service Record" provided by the facility showed the temperature cream of vegetable soup was documented at 180 degrees F at 8 a.m. on 4/17/17. The temperature documented 2 hours later (10 a.m.) was 67 degrees F. The documented temperature of the soup was 37 degrees F lower than the surveyor's temperature of the soup which was measured 50 minutes later than the documented temperature.

Continuing the observation inside the walk-in refrigerator on 4/17/17 at 10:50 a.m., a container labeled "turkey" contained cubed pieces of cooked meat. In a concurrent interview on, Cook 1 stated she cut the cooked turkey into cubes at 10:20 a.m. that morning and it was cooked a prior day.

In an interview on 4/17/17 at 1:50 p.m. with the Contract Operations Manager of Nutrition Services (OMNS) and Cook 2, OMNS stated the turkey was heated to serve patients on Friday 4/14/17. Then Cook 2 cooled the left-over turkey on the countertop and did not take temperatures during the cooling process. Cook 2 confirmed she did not take temperatures of the turkey while it cooled at ambient temperature on 4/14/17. OMNS also stated in regard to the cream of vegetable soup, the soup was used on trayline that morning for breakfast and the left-over was placed in the refrigerator to cool. He stated he could not explain why the documented temperature of the soup was 37 degrees F lower than the surveyor's temperature measured 50 minutes later.

A review of the "Production & [and] Culinary Service Record" provided by the facility, read "(4) Cooling Temperature Requirements ... Cool foods to 70 degrees F (21 degrees C [Celsius]) within 2 hours, then to 40 degrees F (4 degrees C) within 4 more hours. List steps taken on back of form." Documentation on the form showed Roasted Turkey was cooked to 165 degrees F on 4/14/17 and the temperature at 8 a.m. on 4/14/17 was 142 degrees F. There were no other documented temperatures for the turkey.

7. An observation in the facility caf on 4/17/17 at 2:13 p.m., showed two eggs in a plastic container, in the "grab-and-go" cooler, that had temperatures of 46.2 degrees F. and 48 degrees F. when measured with the surveyor's calibrated thermometer. The date on the egg container read April 21, 2017. The thermometer on the grab-and-go cooler was set to 43.2 degrees F.

In a concurrent interview, the Operations Manager for Retail Nutrition Services (OMRNS) confirmed the grab-and-go cooler was set to 43.2 degrees F. He stated the date on the egg container was the use-by-date but there was no way to tell how long the eggs had been stored above 41 degrees F.

Continuing the observation of the facility caf, the temperature of cut melon in the salad bar area read 49.3 degrees F.

A review of the document titled "Caf Cold Bar Temperature Log" dated 4/17/17 read "Required: Check all temperatures every 2 hours. All food items must be 40 degrees or lower. Record temperatures next to item checked ... if out of compliance notify supervisor or manager immediately." The log showed the "assorted fruit" was 44 degrees F at 12 p.m. The prior temperature of the fruit was 4 hours earlier at 8 a.m.

In a concurrent interview, OMRNS stated he was not aware the fruit temperature was above 40 degrees F. GMNS stated when the fruit was low it was refilled and there could be cut melon on the salad bar since 8 a.m. She stated there should be another temperature taken at 10 a.m. however, the form they used did not indicate to take a temperature at 10 a.m. She stated the melon temperature was out of compliance.

A review of the document provided by the facility titled "Holding Hot and Cold Food" dated 11/2002, read "Cold holding equipment (i.e., refrigerator, serving station, salad bar, deli bar) must keep food temperature at 40 degrees F (F degrees C) or lower."
VIOLATION: DISCHARGE PLANNING NEEDS ASSESSMENT Tag No: A0806
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to recognize a prior Emergency Department (ED) visit and hospital inpatient admission relating to the same diagnosis (abnormal blood sugar), within 30 days, and develop an action plan to prevent another readmission following discharge for one of 49 patients (Patient 8).

This had the potential to result in another readmission(s) for the same diagnosis.

Findings:

The facility's policy "Discharge Planning- Case Management," dated 1/4/17 was reviewed. It read, "B. Case management staff evaluate the patient's post-discharge within one business day . . .. C. Primary criteria used for prioritizing discharge planning needs of patients include, but may not be limited to the following: 4. Multi-hospitalization s / readmissions." The facility's "Utilization Management Plan - Hospitalwide," dated 1/31/17, defined readmission as: identifying patients who have been readmitted into the hospital within a 30 day time frame. Identifying the reason for readmission, then developing an action plan to address the readmission.

A review of Patient 8's records indicated she was an insulin dependent diabetic. She had a ED visit on 3/30/17 for confusion and abnormally low blood sugar. Upon discharge she was told to follow up with her personal physician on 4/3/17.

Patient 8 was admitted on [DATE] with confusion and abnormally low blood sugar. She was discharged on [DATE] and told to follow up with her clinic in five days.

Patient 8 was admitted again on 4/14/17 with diagnoses that included confusion and abnormally high blood sugar. Patient 8 was discharged on [DATE] and told to follow up with her clinic in seven days.

During an interview on 4/18/17 at 3:35 pm, Patient 8 said the physician had discussed her discharge but no nursing staff had done so.

During a concurrent record review and interview on 4/20/17 at 10:30 am, Case Manager (CM) A confirmed Patient 8's ED visit on 3/30/17, hospitalization from ,d+[DATE] to 4/11/17, and hospitalization from ,d+[DATE] to 4/19/17 were related to abnormal blood sugars. CM A stated there is an icon that pops up in the system that shows if the patient was readmitted in the last 30 days. If the visits are related then they try to come up with a plan to prevent a readmission and would ask the physician for something such as home health or whatever the patient might need.

During a concurrent interview and record review on 4/20/17 at 10:15 am, the Vice President of Revenue Cycle (VPRC, oversees the case management department) confirmed Patient 8's visits as noted above. Specific notes or discharge plans relating to prevention of readmission were requested but there were none. VPRC confirmed there have been issues with follow up and identification of needs and a care coordinator has just been hired to help with this issue.
VIOLATION: SURGICAL PRIVILEGES Tag No: A0945
Based on interview and record review, the hospital failed to ensure, in accordance with medical staff governance documents, that surgical privileges (the authority to perform procedures and patient care tasks) were delineated (specifically documented) in accordance with the qualifications and current competencies of each practitioner for certain high risk or complex procedures when:

1. Four of four critical care nurse practitioners (NP's 19, NP 20, NP 21, and NP 22) routinely performed insertion of breathing tubes into the large airway (tracheal intubations henceforth intubations) and insertion of plastic catheter tubes into large arteries and veins (central line catheters) into critically ill patients in the intensive care unit (ICU) without documented formal training in accordance with standards of practice, and without documented authority on the privilege lists of each of the files for NP 19, NP 20, NP 21, and NP 22.

2. Authority to perform complex ultrasound examination and interpretation of multiple body systems was granted to 1 of 1 emergency department (ED) physician assistants (PA 9) without documented formal training and current competence.

3. Protocols for ED physician assistants (PA's) and standardized procedures (SP's) for ED nurse practitioners (NP's) to correspond with the core surgical privileges filed for each were not clearly identified to accurately reflect the scope of work that PA's and NP's actually performed in the Emergency Department for 10 of 10 PA's (PA 9, PA 10, PA 11, PA 12, PA 13, PA 14, PA 15, PA 16, PA 17, and PA 18) and 5 of 5 NP's (NP 23, NP 24, NP 25, NP 26, and NP 27). Instead, medical textbooks that described hundreds of procedures performed by emergency medicine providers served as a reference for the scope of work that PA's and NP's may perform, without evidence (for those hundreds of procedures) of qualifications and current competence in the files PA 9, PA 10, PA 11, PA 12, PA 13, PA 14, PA 15, PA 16, PA 17, PA 18, NP 23, NP 24, NP 25, NP 26, and NP 27.

4. Family Medicine core privileges included surgical procedures without specifying a minimum volume to maintain competence for each renewal cycle, or criteria to determine current competence, for one of one medical doctor (MD 3) reviewed.

The hospital's practices did not conform with the expectations for high patient quality and safety set by the medical staff bylaws and rules/regulations.

These failures placed surgical patients at risk of medical errors or adverse events from procedures performed by unqualified practitioners.

Findings:

Review of the 11/28/16 Medical Staff Bylaws (MSB) documented under Article IV Membership, "no person shall exercise clinical privileges in the hospital unless and until that person applies for and obtains membership on the Medical Staff and is granted privileges as set forth in these Bylaws or, with respect to Allied Health Practitioners (AHP's such as NP's and PA's), has been granted a service authorization or privileges under applicable Medical Staff policies."

MSB Section 8.1 defined AHP as a licensed/certified health care professional, other than a physician, who was granted service authorization. Service authorization was defined as the permission granted to a AHP to provide specified patient care services within the AHP's qualifications and scope of practice.

MSB Section 8.2 documented the qualifications for service authorization to include the AHP's training, current competence, and ability "to demonstrate that any patient treated by the practitioner will receive care of the generally recognized professional level of quality established by the Medical Staff."

MSB Section 8.4-4 held AHPs to the applicable standards of medical staff members described in Article II.

MSB Article II, section 2.2-1-a noted basic qualifications for membership to include "adequate experience, education, and training" and "current professional competence."

1. Review of the April monthly schedule for provider coverage of ICU patients listed 2 physicians on 30 of 30 days, and one "Mid Level" (nurse practitioner NP) on 24 of the 30 days in April.

Review of the non-physician practitioner roster indicated that four NP's were authorized to provide care to critical patients of the ICU (NP 19, NP 20, NP 21, and NP 22).

In an interview on 4/18/17 at 3 p.m., medical doctor (MD) 1 stated that he supervised NP's in the ICU. In addition to sharing the workload as a team, NP's sometimes performed intubations and inserted central lines (with ultrasound guidance) for critical patients. For such procedures, a medical doctor was always "at the bedside" with the NP, though the doctor may be performing other procedures concurrently. MD 1 personally trained the NP's to do these procedures over the first few months of their tenure at the hospital. He trained them in the manner in which he learned to perform them, during his years of accredited medical school, accredited residency, and accredited fell owships in pulmonology and critical care medicine. MD 1 acknowledged that the curriculum for NP training may not have matched his training to perform the procedures. MD 1 did not know whether the NP's had actual experience performing the procedures in their nursing or NP training. MD 1 acknowledged that the critical care NP's did not have documented formal training or experience in performing the procedures prior to starting work in the ICU in this capacity. The critical care doctors and NP's together created a "standardized procedure" (SP, a state-required document describing the steps and manner to perform a task for which doctors are qualified by training but which can be delegated to a nurse with additional training, supervision, and test for competence) for the central line insertions of arteries and veins. A standardized procedure for intubations was not created.

Review of the file for NP 19 with the Director of Medical Staff Services (DMSS) on 4/18/17 beginning at 2 p.m. indicated that NP 19 completed a Family Nurse Practitioner masters in nursing degree in 2014. NP 19 started working as a critical care NP in the hospital ICU in 2015, and was granted core critical care NP privileges that did not include insertion of central lines nor intubation. The file contained no evidence of formal training or experience for intubations and ultrasound-guided insertion of central lines prior to starting work as a critical care NP. Standardized procedures for performing Arterial Line Placement and Central Venous Catheter Placement were in the file. However the standardized procedures did not require a doctor to directly supervise the NP at the bedside for central line insertions. "Supervising physicians are available ... in person or by telephone." Elsewhere the SP's documented, "Supervision: Indirect with immediate availability of supervising physician." The SP's did not describe the steps for using ultrasound. The SP's did not require formal training to perform central line insertions, only to be observed by an ICU doctor for 5 initial attempts and reviewed annually thereafter. The General Policy portion of the SP noted that training "may be waived if the NP has prior experience and/or demonstrated proficiency in each listed procedure protocol." A minimum number of procedures performed annually to maintain competence was not documented.

In a further interview on 4/19/17 at 11:30 a.m., MD 1 indicated that doctors who performed ultrasound guided central line insertions and intubations received formal training from accredited medical programs. MD 1 acknowledged the value of formal certifications that create a standardized method and baseline of expertise for all providers. MD 1 indicated that national organizations like the American College of Critical Care Medicine, the American College of Chest Physicians and the American Thoracic Society have established guidelines and standards for these types of procedures, but did not specifically serve as the basis for determining the qualifications and competence of the critical care NP's to perform high-risk invasive procedures.

2. Review of the file for PA 9 with DMSS on 4/18/17 at 3:30 p.m. indicated that privileges were granted for PA 9 to perform ultrasound examination and interpretation for trauma, pregnancy, abdominal large artery, heart, liver, kidney, bladder, leg blood clots, chest, skin and muscle, eye, and to guide invasive procedures (examples might be central lines and draining fluid from lungs), in the emergency department (ED) setting. However, the file contained no evidence of formal training, experience or competence for ultrasound tasks as described in the privilege. The emergency bedside ultrasound privilege required training of 25 to 50 cases, and competency achieved after 150-250 cases. To maintain competence one must perform 25 cases per year.

In an interview on 4/19/17 at 4 p.m., MD 4 (who served as Chief of Emergency Medicine) stated that PA 9 and other AHP's who worked in the Emergency Department did not use ultrasound for all the body systems described in the privilege that was granted to PA 9. PA's and NP's might use bedside ultrasound to determine the depth and extent of a skin abscess prior to draining it. But if more complex examinations were needed, they would be performed by a specialized technician or an emergency department physician. MD 4 did not expect PA 9 possessed the qualifications to meet the privilege requirements, or could achieve the volumes needed to maintain competence.

Review of the August 2016 Medical Staff Rules and Regulations documented under item N-2, "An ED Physician or designee shall be responsible for evaluating all patients presenting to the ED, either directly or indirectly by being responsible for appropriately trained and monitored Physician extenders (Physician Assistants or Nurse Practitioners) following specified protocols."

3. Review of the file for PA 9 with DMSS on 4/18/17 at 3:30 p.m. indicated that privileges were granted for core procedures in the emergency department setting for PA 9. The core procedures included cutting open skin abscesses, placing a device into a bone to administer fluids, suturing skin cuts, draining fluid from joints, injecting medicine into joints and soft tissue, removing finger or toe nails, and setting bone fractures/dislocations. These tasks would fall within the training and scope of a PA, but would require protocols and supervision by a qualified physician sponsor typically documented in a delegation of services agreement. DMSS referred to a binder owned by the emergency department contracted physician group to verify that delegation of services agreements were signed for each PA who worked in the ED. The binder similarly contained standardized procedures (SP's) for the NP's who worked in the ED, signed by ED physician sponsors.

Review of the ED binder described above with DMSS indicated that protocols for the PA's and SP's for the NP's were not specific to the invasive procedure items on the Core Procedure List for PA 9 and the other PA's and NP's. The binder contained the Table of Contents for several medical textbooks that listed numerous body system headings. That portion of the binder suggested that treatments for medical conditions related to the headings would be explained in the related chapters of the books. The chapters were not flagged to correspond with PA 9's core procedures, and contained hundreds of conditions and procedures that PA 9's training did not prepare him for. The binder did not contain specific detailed protocols and SP's for cutting open skin abscesses, placing a device into a bone to administer fluids, suturing skin cuts, draining fluid from joints, injecting medicine into joints and soft tissue, and setting bone fractures/dislocations. The DMSS knew of no medical staff policy that framed the limits of scope for the ED PA's and NP's by linking the core privileges to protocols and SP's, whether contained in the binder or elsewhere.

The DMSS indicated that 10 PA's (PA 9, PA 10, PA 11, PA 12, PA 13, PA 14, PA 15, PA 16, PA 17, and PA 18) and 5 NP's (NP 23, NP 24, NP 25, NP 26, and NP 27) were granted emergency department core privileges as described above for PA 9. None of their files contained protocols/SP's to correspond to the invasive procedures on the privilege list.

In an interview on 4/19/17 at 4 p.m., MD 4 stated that he knew of no specific written protocols/SP's that corresponded to the invasive procedures granted to ED PA's and NP's. MD 4 acknowledged that the ED physician group's binder table of contents section, if it was intended to serve as protocols and SP's that authorized the PA's and NP's to care for ED patients, far exceeded the scope of practice for these practitioners. MD 4 confirmed that ED PA's and NP's were not routinely exceeding their scope, and did generally limit their work to what was described on the core privilege list, despite this confusion. MD 4 acknowledged that the relationship between privileges and protocols/SP's was unclear and "could be cleaned up." That is, the privilege lists for ED PA's and NP's did not document an expectation that the privileges would only be permitted if corresponding protocols and SP's were created by the supervising physicians and followed by the PA's/NP's.

Review of the August 2016 Medical Staff Rules and Regulations documented under item N-2, "An ED Physician or designee shall be responsible for evaluating all patients presenting to the ED, either directly or indirectly by being responsible for appropriately trained and monitored Physician extenders (Physician Assistants or Nurse Practitioners) following specified protocols."

4. Review of the file for MD 3 with DMSS on 4/19/17 beginning at 10 a.m., indicated that MD 3 was granted Family Medicine (FM) core privileges at reappointment to the medical staff on 12/31/15. The description of FM core privileges was a sweeping statement that reflected the general training of a physician who completed a FM residency program, whether aspects of that content was applied at the hospital currently or not. The list of MD 3's FM core procedure list included a range of invasive activities for adults, children, and female genital care. The range was consistent with MD 3's medical training prior to his initial appointment to the medical staff in 2001. Examples included Assist at Surgery, removal of fluid from the abdomen, draining fluid from joint and injecting joints, injecting anesthetic to the nerves of a limb, draining skin abscess, and biopsy of the cervix or uterus. To renew approval of the core procedures every two years, there was no requirement for current experience and competence such as a minimum number of encounters over a period of time. An activity list for MD 3 at the renewal cycle in 2015 listed 36 procedures (which were not specified for type) and zero for assisting in procedures.

In an interview on 4/19/17 at 12:45 p.m., MD 3 explained that the activities he now performed at the hospital had changed from the time he began in 2001. It had been several years since he assisted in surgery. Some of the tasks on the core procedure list he may still perform in his office, but not usually in the hospital setting. And some he did not perform at all. MD 3 indicated that nowadays many family medicine doctors don't routinely perform specialty work in the hospital (such as surgical assisting, delivering babies, newborn care, biopsies, and women's genital care). But he had continued some of that work through his office practice outside of the hospital. MD 3 acknowledged that the renewal of procedure privileges did not require performing the procedures recently with a minimum volume, or demonstrating competence in hospital patients for whom the procedures were performed, unless an adverse outcome ensued.

MD 3 (who served as Chief of Staff and responsible for oversight of physician practice for all departments) stated that efforts in FM and other departments were underway but not yet completed to make the privileging system precise and appropriate for the work actually performed in the hospital. MD 3 acknowledged that inconsistencies in how each department approached privileging created variances for establishing clear expectations of the medical staff leaders for safe surgery and high quality practice in general.
VIOLATION: QUALIFIED EMERGENCY SERVICES PERSONNEL Tag No: A1112
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure reassessments were done according to its policy and procedure for one of seven Emergency Department (ED) patients (Patient 3).

This had the potential to result in a decline in Patient 3's condition and a delay in recognizing the change in condition.

Findings:

The facility's policy titled, "Standards for Assessment and Reassessment - Hospitalwide," dated 2/11/14, was reviewed. It required vital signs be taken with each triage assessment, within 30 minutes prior to discharge (excluding those that leave against medical advice or without being seen), every two hours and as needed as the patient's condition changes.

A review of Patient 3's record indicated she (MDS) dated [DATE] at 6:01 pm, with a complaint of chest pain for five days. Vital signs (blood pressure, pulse, respirations) were taken at 6:03 pm and repeated at 7:04 pm. Patient 3 was called to come in from the waiting room into a room in the ED at 11:05 pm and there was no answer. Patient 3 was noted to have left the ED without completing treatment. No vital signs were done after 7:04 pm.

During a concurrent interview and record review on 4/18/17 at 10:45 am, the Director of the Emergency Department (DED) stated labs had been done and an acute heart attack had been ruled out. Patient 3 had been left in the waiting room until a bed in the ED became available. When Patient 3 was called she had already left the ED. DED confirmed, according to their policy, Patient 3's vital signs should have been repeated every two hours and this was not done.