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1441 FLORIDA AVENUE

MODESTO, CA 95350

GOVERNING BODY

Tag No.: A0043

Based on observation, interview and record review, the hospital failed to provide an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital failed to follow policy and procedure for informed consent (permission granted for treatment with full knowledge of possible risks and benefits) when "The Consent of Treatment/ Conditions of Services" (COT/COS) (form used for patient /legal guardian to sign indicating consent was given) form was not signed for one of 30 sampled patients (Pt) Patient 15. (Refer to A-131);

2. Crash carts (a cart stocked with emergency medical equipment, supplies, and drugs for use during a medical emergency) on nursing units were not checked by nursing staff every 24 hours. (Refer to A-386);

3. Sharps (medical device with sharp edge that can cut or puncture skin) and Pharmaceutical (drug) Waste containers in patient care areas were left opened. (Refer to A-386);

4. Patient (Pt) 1's blood sugar was not checked hourly as ordered by the physician and Patient (Pt) 1 was discharged without supporting documentation that his emergency medical condition had resolved which resulted in his subsequent death due to hypoglycemia (low blood sugar). (Refer to A-0392); and

5. Medication was not stored in accordance with accepted professional principles when an opened vial of insulin (medication used to lower the amount of sugar in an individual's blood) had no indication of when it was opened. (Refer to A-405);

6. The hospital failed to provide emergency services in accordance with the hospital's policies and procedures when Patient (Pt) 1's blood sugar was not checked hourly per physician's orders and physician did not follow up with the results of the blood sugars before discharging Pt 1. (Refer to A-1104).

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality health care in a safe environment.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review, the hospital failed to follow policy and procedure for informed consent (permission granted for treatment with full knowledge of possible risks and benefits) when "The Consent of Treatment/ Conditions of Services" (COT/COS) (form used for patient /legal guardian to sign indicating consent was given) form was not signed for one of 30 sampled patients (Pt) Patient 15.

This failure had the potential for Pt 15 or his legal guardian to be denied their right for information needed to make informed health care decisions.

Findings:

Review of Pt 15's clinical record indicated he was admitted to the hospital on 10/28/18 at 8:46 a.m. Pt 15's COS was requested for review but staff was unable to locate the form in Pt 15's clinical record.

On 11/28/18 at 1:50 p.m., during an interview, the Director of Patient Access (DPA) stated the Admissions Department staff were responsible for obtaining patients' COS on admission. The DPA stated Pt 15's COS was signed since it was not located in his hard chart (paper chart) nor scanned into his electronic medical record.

On 11/28/18 at 3:25 p.m., during an interview, the DPA stated the COS was an important form and should remain in the patients' hard charts for the entire length of their hospital stay. The DPA stated it was important to review and sign the COS with newly admitted patients because the COS advised patients of their rights and hospital practices. The DPA stated the COS form was evidence patients were informed of their rights and responsibilities, financial obligations, and consented to treatments provided by the hospital.

The hospital policy and procedure titled, "Registration Policy and Procedure" dated 5/11, indicated "... D. Forms ... It is the responsibility of Patient Access to ensure that all required standard and hospital specific forms are signed by the appropriate individuals. The Consent of Treatment/Condition of Services, Notice of Privacy Practices Acknowledgement, Directory of Opt Out, Important Message from Tricare, Important Message from Medicare and Medicare Off-Campus Co-Insurance Notification are required forms and its usage is outlined as the following: 1. Consent of Treatment/Conditions of Services: All patients presenting for and receiving treatment will receive one or both of these documents, based on State specific requirements. Consent is required on the document for each visit ..."

NURSING SERVICES

Tag No.: A0385

Based on observation, interview and record review, the hospital failed to provide nursing services that ensured patient safety when:

1. Crash carts (a cart stocked with emergency medical equipment, supplies, and drugs for use during a medical emergency) on nursing units were not checked by nursing staff every 24 hours. (Refer to A-386);

2. Sharps (medical device with sharp edge that can cut or puncture skin) and Pharmaceutical (drug) Waste containers in patient care areas were left opened. (Refer to A-386);

3. Patient (Pt) 1's blood sugar was not checked hourly as ordered by the physician and Patient (Pt) 1 was discharged without supporting documentation that his emergency medical condition had resolved which resulted in his subsequent death due to hypoglycemia (low blood sugar). (Refer to A-0392); and

4. Medication was not stored in accordance with accepted professional principles when an opened vial of insulin (medication used to lower the amount of sugar in an individual's blood) had no indication of when it was opened. (Refer to A-405).

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality health care in a safe environment.

ORGANIZATION OF NURSING SERVICES

Tag No.: A0386

Based on observation, interview, and record review, the hospital failed to follow their policies and procedures for "Crash Carts (a cart stocked with emergency medical equipment, supplies, and drugs for use during a medical emergency) - Cleaning, Checking, and Restocking Policy" and "Handling and Disposal of Regulated and Hazardous Waste" when:

1. The Crash cart check in the Interventional Radiology (IR-an area of radiology that use image-guided procedures to diagnose and treat disease) Department was not performed by nursing staff every 24 hours.

2. The Crash cart check in the Perioperative Services Department (an area where patients go before surgery) was not performed by nursing staff every 24 hours.

3. The crash cart check in the Telemetry Unit (a unit with continuous electronic monitoring of heart rate, heart rhythm, breathing), was not performed by nursing staff every 24 hours.

4. Sharps (medical device with sharp edge that can cut or puncture skin) and Pharmaceutical (drug) Waste containers in patient care areas were left opened.

These failures had the potential for crash carts to have malfunctioning equipment, missing and/or expired supplies in an emergency, and for patients and staff to have access to medications and to be exposed to needles or other sharp objects, and bloodborne illnesses.

Findings:

1. On 11/26/18 at 3 p.m., an initial tour of the IR Department was conducted. Two crash carts, one pediatric and one adult positioned side by side in IR- room 6 was observed. A review of the "Emergency Medications for Resuscitation Documentation Log" indicated a crash cart check had not been documented on the pediatric documentation log for 11/17/18, 11/18/18, and 11/23/18. A crash cart check had not been documented for 11/22/18 on the adult crash cart documentation log.

On 11/26/18 at 3:20 p.m., during an interview, Registered Nurse (RN) 6 stated it was his expectation the adult and pediatric crash carts were both checked and documented in the log at the same time. The documentation in both logs should be the same. RN 6 stated it is important to check both crash carts everyday because the carts may need to be used in an emergency.

On 11/26/18 at 3:25 p.m., during an interview, the IR Director (IRD) stated it was his expectation that both the adult and pediatric crash carts were checked daily per policy and procedure.

The hospital policy and procedure titled, "Crash Carts-Cleaning, Checking, and Restocking Policy" dated 10/17, indicated "Purpose: To ensure ... supplies required for immediate, emergency patient care are in place at all times an in usable condition. ... Frequency: Once every 24 hours ..."

2. On 11/26/18 at 2:17 p.m., an initial tour of the Perioperative Services Department was conducted. The crash cart in the cardinal (part of the unit) room was observed. A review of the "Emergency Medication for Resuscitation Documentation Log" indicated a crash cart check had not been documented for 11/16/18 and had an attached note that indicated, "This area was open Friday 11/16, crash cart not done."

On 11/26/18 at 2:33 p.m., during an interview, RN 4 stated it was her expectation that the crash carts were checked and signed off daily. RN 4 stated the documentation log was left blank on 11/16/17, an indication it was not checked and the log should not be blank. When asked about the attached note that stated, "The area was open Friday 11/16 crash cart not done," RN 4 stated the crash cart was not checked.

The Hospital policy and procedure titled "Crash Carts-Cleaning, Checking, and Restocking Policy" dated 10/17, indicated "Purpose: To ensure ... supplies required for immediate, emergency patient care are in place at all times and in usable condition. ... Frequency: Once every 24 hours..."

3. On 11/26/18 at 3:30 p.m., during a concurrent observation and interview in the Telemetry Unit, the crash cart on 3 South Telemetry was observed. A review of the "Emergency Medication for Resuscitation Documentation Log" indicated a crash cart check had not been documented for 11/24/18. RN 8 and RN 9 stated it was their expectation that the crash cart was checked and signed off daily. RN 8 stated the documentation log was blank on 11/24/18, an indication it was not checked. RN 9 stated the unit was open on 11/24/18 and the log should have been signed if the crash cart check was completed.

The hospital's policy and procedure titled "Crash Carts-Cleaning, Checking, and Restocking Policy" dated 10/17, indicated "Purpose: To ensure ... supplies required for immediate, emergency patient care are in place at all times an in usable condition. ... Frequency: Once every 24 hours..."

4. On 11/26/18 at 2:14 p.m., during a concurrent observation and interview in the Labor and Delivery Triage room, an opened pharmaceutical waste container was next to the nourishment refrigerator. The Labor and Delivery Director (LDD) stated used medications were discarded in the pharmaceutical waste container. The LDD confirmed the waste container was opened and stated, "As soon as they [nurses] dump it [used medication] it [pharmaceutical waste container] should be closed."

On 11/26/18 at 3:05 p.m., during a concurrent observation and interview in the IR department, opened sharps and pharmaceutical waste containers secured in metal framed hampers were on the entrance floor. The Director of Radiology (DOR) stated both containers should remain closed for patient safety. The DOR stated the open containers placed all patients in the area at risk for injury. The DOR stated the foot pedal used to open and close the container lids on the metal hampers were broken (causing the lids to remain open).

On 11/26/18 at 3:45 p.m., during a concurrent observation and interview in the Endoscopy (dedicated area in the hospital to examine patients' digestive system) department, an opened pharmaceutical waste container was in a metal framed hamper next to the medication cart in the hallway; easily accessible to patients and staff. RN 5 confirmed the pharmaceutical waste container was left open. RN 5 stated, "Frankly I don't want it [pharmaceutical waste container] clipped ... it's easier to work when it's open but it should be closed because meds [medications] are in it."

On 11/27/18 at 11:05 a.m., during an interview, the Hospital Safety Officer (HSO) stated the hospital followed Occupational Safety and Health Administration (OSHA - US government agency) standards for safety when handling drug waste or sharps. The HSO stated all waste containers including sharps and pharmaceutical waste containers should remain closed regardless of where the containers were stored. The HSO stated the contents of the containers were easily accessible if left opened. The HSO stated pharmaceutical waste containers held discarded medications including antibiotics (medicine to kill germs), narcotics (pain medicine), sedatives (medicine that causes sleep and relaxation), etc. and sharps containers held contaminated (unclean) needles and syringes (device used to inject liquid). The HSO stated closed waste containers protected visitors, children, and patients from possible injury.

The hospital policy and procedure titled, "Handling and Disposal of Regulated and Hazardous Waste" dated 2/17, indicated "... Policy: ... will comply with California Code of Regulations (CCR) Title 22 Division 4.5 Hazardous Waste Management Systems which also includes Hazardous Resource Conservation and Recovery Act (RCRA) waste. The facility will also comply with federal regulations- 40 Code of Federal Regulations (CFR) 261. Further the facility will comply with California Health and Safety Code Division 104, Part 14 Pharmaceutical Medical Waste and California Occupational Safety and Health Administration Occupational Exposure to Blood borne Pathogens- 8 CCR 5193 ... What can go in the container? ... Blue and white or all blue Pharm. [pharmaceutical] Container ... All partially used/ residual Pharmaceutical; IV bags and tubing that contains residual medication; Syringes (Needless Syringes or Oral syringes) with residual medication; Pharmaceutical medication ... Sharps container ... Contaminated broken glass, Disposable blades and scalpels; Lancets [small two edged blade with a sharp point]; Needles; Syringes; Pipettes [slender tube]; Emptied narcotic needles, syringes & ampoules [sealed glass bulb filled with solution for injection] ..."

A review of pages 1-11 of The California Occupational Safety and Health Standards 1910.1030 titled, "Bloodborne pathogens" indicated, "... Contaminated Sharps means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires ... 1910.1030(d)(4)(ii)(E) Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. ... 1910.1030(d)(4)(iii)(A)(1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: 1910.1030(d)(4)(iii)(A)(1)(i) Closable; ... 1910.1030(d)(4)(iii)(A)(2) During use, containers for contaminated sharps shall be ... 1910.1030(d)(4)(iii)(A)(3)(i) Closed immediately prior to the removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping..."

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on interview and record review, the hospital failed to provide nursing care in accordance with the hospital's policies and procedures when Patient (Pt) 1's blood sugar was not checked hourly per physician's orders.

This failure resulted in Pt 1 being discharged without supporting documentation that his emergency medical condition had resolved which resulted in his subsequent death due to hypoglycemia (low blood sugar).

Findings:

A review of Pt 1's clinical record titled, "Patient Summary Report" indicated Pt 1 arrived to the Acute Care Hospital (ACH) on 9/16/17 at 2:24 a.m.

A review of Pt 1's clinical record titled "Emergency Physician Note" dated 9/16/17 indicated Pt 1 was a 74 year old male that was brought into the Emergency Department (ED) from home by ambulance with chief complaint of altered level of consciousness (ALOC-measurement of a person's alertness and responsiveness to stimuli from the environment). Pt 1 was found at home on the floor by family. Emergency Medical Services (EMS) obtained a blood sugar reading of 32 mg/dl, administered 25 g (grams) (form of measurement) of dextrose (sugar), and obtained a recheck blood sugar reading of 207 mg/dl (form of measurement) prior to arrival to the ED. Pt 1's associated diagnoses during the course of hospital stay included ESRD (end stage renal disease) (when the kidney can no longer function), hypoglycemia (low blood sugar), and prostate cancer.

A review of Pt 1's clinical record titled, "ED Triage Form" dated 9/16/17, indicated "ESI (Emergency Severity Index) (a five-level ED triage algorithm that provides clinically relevant group of patients into five groups from 1 (most urgent) to 5 (least urgent) on the basis of acuity and resource needs) Level: ESI 2"

On 11/27/18 at 11:26 a.m., during an interview, Medical Doctor (MD) 2 (Nephrologist-physician that cares for diseases of the kidney) stated he received a call from a nurse at the outpatient dialysis center stating Pt 1 had died at the dialysis center. MD 2 stated he was informed Pt 1 was hypoglycemic on arrival to the dialysis center, Pt 1 experienced cardiac arrest, cardiopulmonary resuscitation (CPR) (emergency life-saving procedure that is done when someone's breathing or heartbeat has stopped) was started, but Pt 1 expired at the dialysis center shortly thereafter. MD 2 stated if he was the treating physician from the hospital, he would not have discharged Pt 1. MD 2 stated he would have expected the hospital staff to check Pt 1's blood sugar prior to discharge to ensure Pt 1 was stable (not deteriorating in health).

On 11/27/18 at 1:01 p.m., during a concurrent interview and record interview, the Emergency Department Director (EDD) stated the process for patients with a diagnosis of hypoglycemia is to perform a finger stick blood sugar (procedure that measures the amount of sugar, or glucose, in your blood), draw blood, check the patient's alertness, and continue to check a few supplemental blood sugars. The EDD stated a few supplemental blood sugars would mean two times if there were no changes and no further intervention was required. The EDD stated Pt 1's blood sugar was obtained at 2:37 a.m., shortly after arrival to the ED, and Pt 1's blood sugar was not rechecked during the entire ED stay. The EDD stated there was a physician's order for glucose monitoring every hour. The EDD stated her expectation was for the physician's orders to be followed. The EDD stated if blood sugars were checked, the staff would have seen Pt 1's blood sugars were low and Pt 1 would have been kept in the ED for additional testing or consultations.

On 11/27/18 at 1:31 p.m., during a concurrent interview and record review, Registered Nurse (RN) 1 stated she triaged Pt 1 on 9/16/17. RN 1 stated Pt 1 received an ampule (a sealed glass containing medication) of dextrose from EMS prior to arriving to the ACH. RN 1 stated Pt 1 arrived to the ED at 2:27 a.m. and a finger stick blood sugar was obtained at 2:37 a.m. with a result of 237 mg/dl. RN 1 stated blood was collected at 2:50 a.m., and the results were available at 3:39 a.m., with a reading of 143 mg/dl. RN 1 stated the normal process for patients with hypoglycemia is to perform a finger stick and do a blood test. RN 1 stated the results of the two tests would be compared. RN 1 stated if an ampule of dextrose was given, the results of the reading will give an initial high and then the blood sugar will drop. When RN 1 was asked about the finger stick blood sugar and serum (blood) glucose result, RN 1 stated 237 mg/dl and 143 mg/dl are significantly different and it should have been questioned. RN 1 stated at 2:41 a.m., there was a physician's order for hourly blood sugar checks. RN 1 stated hourly blood sugar checks were not performed. RN 1 stated the only results of blood sugar was the finger stick obtained shortly after arrival at 2:37 a.m. and the serum glucose at 2:50 a.m. RN 1 stated she would expect a blood sugar check to be completed prior to discharge. RN 1 stated, "...If a patient is hypoglycemic, you have to have a blood sugar recheck..." RN 1 stated hourly blood sugar checks should have been done.

On 11/27/18 at 2:01 p.m., during a concurrent interview and record review, the Emergency Department Educator (EDE) stated the normal process for patients with hypoglycemia is to obtain report from EMS about the patient's blood sugar, perform a finger stick blood sugar after arrival to the ED and recheck the blood sugar every 15 minutes if there were interventions or as ordered by the physician. The EDE stated Pt 1 had hourly blood sugars ordered and she would have expected staff to follow the physician's orders. The EDE stated she would have expected at least a blood sugar to be completed prior to discharge to ensure Pt 1 was stable for discharge.

On 11/27/18 at 2:21 p.m., during a concurrent interview and record review, RN 2 stated she was assigned to Pt 1 on 9/16/17. RN 2 stated Pt 1 was brought from home for ALOC and was found to have low blood sugar. RN 2 stated she did not check Pt 1's blood sugar hourly as ordered. RN 2 stated she was not aware Pt 1 had hourly blood sugar checks ordered. RN 2 stated Pt 1's blood sugar should have been checked prior to discharge.

On 11/27/18 at 3:19 p.m., during an interview, MD 1 stated the the process for patients with hypoglycemia is to either give dextrose or feed the patient and order blood sugar checks. MD 1 stated if blood sugar checks are ordered, his expectation is for the nursing staff to carry out the orders. MD 1 stated he would have expected the staff to recheck the blood sugar because it was ordered. MD 1 stated if the staff would have checked the blood sugar every hour, they would have caught Pt 1's blood sugar was dropping.

On 11/28/18 at 10:30 a.m., during a concurrent interview and record review, the Chief Nursing Officer (CNO) stated her expectation was for staff to follow the physician's orders. The CNO stated if staff would have checked the blood sugar as ordered, there would have been a blood sugar check completed close to discharge. The CNO validated Pt 1 had hourly blood sugar checks ordered at 2:41 a.m. and RN 2 had reviewed the order of hourly blood sugar checks at 4:37 a.m. The CNO stated if there was a delay in implementing the orders, the RN could have started checking the the blood sugars after the order was reviewed. The CNO stated there needed to be further assessment (of blood sugars). The CNO stated Pt 1's level of consciousness was assessed and documented, however the hypoglycemia was not assessed objectively with a blood sugar reading.

A review of Pt 1's orders titled, "Blood Glucose Monitoring" dated 9/16/18 at 2:41 a.m., indicated "...Priority: Stat (immediately)...Frequency: Q1H (every one hour)...Nurse Review...Nurse reviewed by (RN 2) on 9/16/2017 at 04:37 PDT (Pacific Daylight Time)..."

A review of Pt 1's clinical record titled "Results Detail" dated 9/16/17, indicated Pt 1 was discharged from the ACH at 6:25 a.m. to dialysis accompanied with EMT/paramedics (emergency medical services).

A review of Pt 1's clinical record from the dialysis center that received Pt 1, titled, "Progress Notes Report" dated 9/16/17, indicated "...Got report-[Pt 1] hypoglycemia during the night pt had went by ambulance to (name of ACH). RN stated that his glucose was now 250. pt didn't arrive to (name of dialysis center) until 7:05 [a.m.]...blood sugar checked and was 54...code called CPR initiated...pt pronounced dead..."

The hospital's policy and procedure titled, "Medical Screening Examination" dated 3/15, indicated "Purpose: To outline the policies regarding the provisions of a medical screening exam...Supportive Data...State and Federal regulations require the provision of a medical screening examination...The medical screening exam may include the provision of ancillary diagnosis services routinely available...to determine whether the individual has an emergency medical condition...Content...A. It is the policy of the Hospital...2. If it is determined that the individual has an emergency medical condition, to provide such further medical examination and treatment necessary to stabilize the medical condition...II. Definitions...C. 'Emergency Medical Condition' means: 1. A medical condition manifesting itself by acute (sudden onset) symptoms of sufficient severity...E. 'Medical Screening Examination' means the screening process required to determine, with reasonable clinical confidence, whether an Emergency Medical Condition does or does not exist...III. Procedure: B. medical Screening Exam (MSE)...2. The MSE will be based on the patient's condition and prior history and will include at least the following:...c. Initiation and documentation of any necessary testing, treatments...3...The MSE is an ongoing monitoring process, which continues until a medical emergency condition is found not to exist or until appropriate steps to stabilize the presenting emergency medical condition begin..."

The hospital's policy and procedure titled, "Triage Nurse Policy" dated 5/13, indicated "Purpose: To outline the responsibilities and function of the Triage Nurse in the Emergency Department...Content...5. If determined that the patient does not need immediate intervention or observation, complete an initial nursing history...and initiate appropriate order per protocol..."

The hospital's policy and procedure titled, "Standard of Care" dated 6/15, indicated "Purpose: These are the fundamental components of care that are to be applied to any patient presenting for treatment to the Emergency Department (ED)...Policy: 2. All patient conditions will be classified and prioritized utilizing the Emergency Severity Index (ESI) algorithm as follows...ESI Level 2: The patient is assessed as high risk. The patient presents with a condition that has the potential for major life and organ threat. The patient's condition may deteriorate if left unattended, and therefore should not wait..."

The hospital's policy and procedure titled, "Discharge of Patients Procedure" dated 6/15, indicated "Purpose: To assess continuing care needs and provide referrals as appropriate...Preparation for Discharge: 1. In preparation for discharge, continuing care needs are assessed on admission and throughout the patient's stay..."14. Documentation in addition to Discharge Summary/Instructions will include: a. Nursing Assessment of the patient prior to discharge to include any unresolved patient problems..."

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on observation, interview and record review, the hospital failed to ensure the storage of medication was in accordance with accepted professional principles when an opened vial of insulin (medication used to lower the amount of sugar in an individual's blood) had no indication of when it was opened.

This failure had the potential for patients to receive a medication that was expired, resulting in possible decreased potency.

Findings:

On 11/26/18 at 1:27 p.m., during a concurrent observation and interview on the Medical Telemetry unit (a unit with continuous electronic monitoring of heart rate, heart rhythm, breathing), located on the South side of the second floor, an opened vial of insulin was stored in the medication refrigerator. Registered Nurse (RN) 3 stated the medication was opened and there was no date on the vial indicating when it was opened. RN 3 stated the process is once medication vials are opened, they can only be used for 30 days. RN 3 stated without indication of when the medication vial was opened, if used, patients that receive the medication would not get the right dose because it can be expired. RN 3 stated her expectation was for the opened vial of insulin to be dated and timed when it was opened.

On 11/28/18 at 9:45 a.m., during an interview, the Director of Pharmacy (DP) stated long acting insulin vials are multi-dose (more than one use) and are stored in the medication refrigerators. The DP stated when the vial is opened, the nurse is supposed to place a date on the vial to indicate when it was opened. The DP stated it is the "manufacture's rule" to date the vial when it is opened because it is usually good for 28 days (after opening). The DP stated the importance of labeling the vial is possible expiration and contamination of the medication vial which will lower the usability of the drug. The DP stated his expectation is opened vials of medications to be dated.

The facility policy and procedure titled, "Medication Administration Policy and Procedure" dated 1/18, indicated "Purpose: Assure the safe and timely administration of medications throughout the organization...Basic Safe Medication Administration Practices...Multiple dose vials shall be dated upon initial use with the expiration date recommended by the manufacturer not to exceed 28 days..."

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation, interview, and record review, the facility failed to store food in accordance with professional standards for food safety service when:

1. The temperatures of nourishment refrigerators and freezers located in the Labor and Delivery Triage unit, the Cardinal Room (an additional treatment room in a unit), Radiology Department (a department that uses imaging used to diagnose or treat diseases), Endoscopy Department (a dedicated area where medical procedures are performed with cameras used to visualize structures within the body), and Infusion Room (room dedicated for administration of medications into the vein) were not checked daily.

2. The temperature of the nourishment refrigerator located on the neuro (neurological-relating to the anatomy, functions, and organic disorders of nerves and the nervous system) stepdown unit registered outside the hospital's set range of between 32 degrees Fahrenheit [F] and 40 degrees F.

These failures had the potential to cause foodborne illness for all patients that received nourishment stored in the refrigerator and/or freezer located in the listed departments.

Findings:

1. On 11/26/18 at 1:28 p.m., during a concurrent observation and interview in the labor and delivery's triage room, the expiration dates of foods stored in the patients' nourishment refrigerator were checked by the Labor and Delivery Director (LDD). The LDD stated the refrigerator was maintained and stocked by hospital dietary staff. The LDD stated dietary personnel recorded refrigerator temperatures on the temperature documentation log located on the refrigerator door.

A review of the facility document titled, "Temperature Documentation Log" dated 11/18, indicated a daily log of temperature readings for the Labor and Delivery Triage Room nourishment refrigerator. The log indicated omissions of recorded temperature checks for 11/25/18 and 11/26/18.

On 11/26/18 at 2:29 p.m., during a concurrent observation and interview in the Cardinal Room, Registered Nurse (RN) 4 stated dietary staff were responsible for the refrigerator temperature checks on the unit. RN 4 stated dietary staff stocked the refrigerator with snacks, checked expiration dates, and logged temperatures daily. RN 4 stated she did not expect nurses to check the refrigerator because it was done daily by dietary staff.

A review of the Cardinal Room nourishment refrigerator and freezer temperature logs dated 11/18 indicated omissions of recorded temperature checks for 11/4/18, 11/18/18, 11/24/18, 11/25/18, and 11/26/18.

On 11/26/18 at 2:40 p.m., during a concurrent observation and interview, the Retail Manager (RM) and Patient Services Manager for Food (PSMF) stated dietary personnel were assigned the task of stocking refrigerators, checking expiration dates, and logging refrigerator temperatures located on various units/departments. The RM stated daily temperature checks ensured food preservation (process to stop or slow down food spoilage, loss of quality, taste or nutritional value). The RM stated refrigerator temperatures above the recommended range (32 degrees F to 40 degrees F) could cause foods and drinks to spoil. The PSMF stated dietary staff were expected to document why temperatures were not checked on the refrigerator temperature logs. The PSMF stated refrigerator temperature logs were checked daily by her for completeness. The PSMF stated she was not aware of missed temperature checks in the Cardinal Room on 11/4/18, 11/18/18, 11/24/18, 11/25/18, and 11/26/18.

On 11/26/18 at 3:05 p.m., during a tour in the Radiology Department, a review of the nourishment refrigerator temperature log dated 11/18 indicated omissions of recorded temperature checks for 11/10/18, 11/17/18, 11/24/18, 11/25/18, and 11/26/18.

On 11/26/18 at 3:15 p.m., during an interview, the Utility Food Service Worker (UFW) stated UFWs were responsible for stocking and maintaining patients' refrigerators located on the units/departments. The UFW stated his process was to rotate foods based on their expiration dates then log refrigerator temperatures. The UFW stated it was important to check temperatures daily because food can spoil.

On 11/26/18 at 3:38 p.m., during a tour of the Endoscopy Department, a review of the nourishment refrigerator temperature log dated 11/18 indicated omissions of recorded temperature checks for 11/10/18, 11/18/18, 11/24/18, 11/25/18, and 11/26/18.

On 11/27/18 at 9:10 a.m., during a tour of the Infusion Room, a review of the nourishment refrigerator temperature log for the Infusion Room dated 11/18 indicated omissions of recorded temperature checks for 11/3/18.

2. On 11/26/18 at 3:30 p.m., during a concurrent observation and interview in the neuro stepdown unit a nourishment refrigerator temperature registered 48 degrees F. RN 10 stated the refrigerator temperature was out of range. RN 10 pointed to the temperature log on the refrigerator and indicated the safe range was between 32 degrees F and 40 degrees F. RN 10 stated a potential outcome would be people could get sick.

The hospital policy and procedure titled, "Food and Nutrition Manual Policy and Procedure F1- Floor Supplies" dated 4/17, indicated "... Purpose...To provide floor stock items for patient use according to a predetermined par level and to maintain food safety practices...Procedure...7. Temperatures of patient refrigerators are recorded daily by Food Service staff on the refrigerator log located on the front of the refrigerator...patient refrigerators are randomly monitored by management...for compliance with guidelines, including temperature and proper food storage..."

EMERGENCY SERVICES

Tag No.: A1100

Based on observation, interview and record review, the hospital failed to provide emergency services that met the needs of patients when Patient (Pt) 1's blood sugar was not checked hourly as ordered by the physician and Patient (Pt) 1 was discharged without supporting documentation that his emergency medical condition had resolved which resulted in his subsequent death due to hypoglycemia (low blood sugar). (Refer to A 1104).

The cumulative effect of this systemic failure resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on interview and record review, the hospital failed to provide emergency services in accordance with the hospital's policies and procedures when Patient (Pt) 1's blood sugar was not checked hourly per physician's orders and physician did not follow up with the results of the blood sugars before discharging Pt 1.

This failure resulted in Pt 1 being discharged without supporting documentation that his emergency medical condition had resolved and resulted in his subsequent death due to hypoglycemia (low blood sugar).

Findings:

A review of Pt 1's clinical record titled, "Patient Summary Report" indicated Pt 1 arrived to the Acute Care Hospital (ACH) on 9/16/17 at 2:24 a.m.

A review of Pt 1's clinical record titled "Emergency Physician Note" dated 9/16/17 indicated Pt 1 was a 74 year old male that was brought into the Emergency Department (ED) from home by ambulance with chief complaint of altered level of consciousness (ALOC-measurement of a person's alertness and responsiveness to stimuli from the environment). Pt 1 was found at home on the floor by family. Emergency Medical Services (EMS) obtained a blood sugar reading of 32 mg/dl, administered 25 g (grams) (form of measurement) of dextrose (sugar), and obtained a recheck blood sugar reading of 207 mg/dl (form of measurement) prior to arrival to the ED. Pt 1's associated diagnoses during the course of hospital stay included ESRD (end stage renal disease) (when the kidney can no longer function), hypoglycemia (low blood sugar), and prostate cancer.

A review of Pt 1's clinical record titled, "ED Triage Form" dated 9/16/17, indicated "ESI (Emergency Severity Index) (a five-level ED triage algorithm that provides clinically relevant group of patients into five groups from 1 [most urgent] to 5 [least urgent] on the basis of acuity and resource needs) Level: ESI 2"

On 11/27/18 at 11:26 a.m., during an interview, Medical Doctor (MD) 2 (Nephrologist-physician that cares for diseases of the kidney) stated he received a call from a nurse at the outpatient dialysis center stating Pt 1 had died at the dialysis center. MD 2 stated he was informed Pt 1 was hypoglycemic on arrival to the dialysis center, Pt 1 experienced cardiac arrest cardiopulmonary resuscitation (CPR) (emergency life-saving procedure that is done when someone's breathing or heartbeat has stopped) was started, but Pt 1 expired at the dialysis center shortly thereafter. MD 2 stated if he was the treating physician from the hospital, he would not have discharged Pt 1. MD 2 stated he would have expected the hospital staff to check Pt 1's blood sugar prior to discharge to ensure Pt 1 was stable (not deteriorating in health).

On 11/27/18 at 1:01 p.m., during a concurrent interview and record interview, the Emergency Department Director (EDD) stated the process for patients with a diagnosis of hypoglycemia is to perform a finger stick blood sugar (procedure that measures the amount of sugar, or glucose, in your blood), draw blood, check the patient's mentation, and continue to check a few supplemental blood sugars. The EDD stated a few supplemental blood sugars would mean two times if there were no changes and no further intervention was required. The EDD stated Pt 1's blood sugar was obtained at 2:37 a.m., shortly after arrival to the ED, and Pt 1's blood sugar was not rechecked during the entire ED stay. The EDD stated there was a physician's order for glucose monitoring every hour. The EDD stated her expectation was for the physician's orders to be followed. The EDD stated if blood sugars were checked, the staff would have seen Pt 1's blood sugars were low and Pt 1 would have been kept in the ED for additional testing or consultations.

On 11/27/18 at 1:31 p.m., during a concurrent interview and record review, Registered Nurse (RN) 1 stated she triaged Pt 1 on 9/16/17. RN 1 stated Pt 1 received an ampule (a sealed glass containing medication) of dextrose from EMS prior to arriving to the ACH. RN 1 stated Pt 1 arrived to the ED at 2:27 a.m., and a finger stick blood sugar was obtained at 2:37 a.m., with a result of 237 mg/dl. RN 1 stated blood was collected at 2:50 a.m. and the results came back at 3:39 a.m. with a reading of 143 mg/dl. RN 1 stated the normal process for patients with hypoglycemia is to perform a finger stick and do a blood test. RN 1 stated the results of the two tests would be compared. RN 1 stated if an ampule of dextrose was given, the results of the reading will give an initial high and then the blood sugar will drop. When RN 1 was asked about the finger stick blood sugar and serum (blood) glucose result, RN 1 stated 237 mg/dl and 143 mg/dl are significantly different and it should have been questioned. RN 1 stated at 2:41 a.m., there was a physician's order for hourly blood sugar checks. RN 1 stated hourly blood sugar checks were not performed. RN 1 stated the only results of blood sugar was the finger stick obtained shortly after arrival at 2:37 a.m., and the serum glucose at 2:50 a.m. RN 1 stated she would expect a blood sugar check to be completed prior to discharge. RN 1 stated, "...If a patient is hypoglycemic, you have to have a blood sugar recheck..." RN 1 stated hourly blood sugar checks should have been done.

On 11/27/18 at 2:01 p.m., during a concurrent interview and record review, the Emergency Department Educator (EDE) stated the normal process for patients with hypoglycemia is to obtain report from EMS about the patient's blood sugar, perform a finger stick blood sugar after arrival to the ED, and recheck the blood sugar every 15 minutes if there were interventions or as ordered by the physician. The EDE stated Pt 1 had hourly blood sugars ordered and she would have expected staff to follow the physician's orders. The EDE stated she would have expected at least a blood sugar to be completed prior to discharge to ensure Pt 1 was stable for discharge.

On 11/27/18 at 2:21 p.m., during a concurrent interview and record review, RN 2 stated she was assigned to Pt 1 on 9/16/17. RN 2 stated Pt 1 was brought from home for ALOC and was found to have low blood sugar. RN 2 stated she did not check Pt 1's blood sugar hourly as ordered. RN 2 stated she was not aware Pt 1 had hourly blood sugar checks ordered. RN 2 stated Pt 1's blood sugar should have been checked prior to discharge.

On 11/27/18 at 3:19 p.m., during an interview, MD 1 stated the the process for patients with hypoglycemia is to either give dextrose or feed the patient and order blood sugar checks. MD 1 stated if blood sugar checks are ordered, his expectation is for nursing staff to carry out the orders. MD 1 stated he would have expected staff to recheck the blood sugar because it was ordered. MD 1 stated if staff would have checked the blood sugar every hour, they would have identified Pt 1's blood sugar was dropping.

On 11/28/18 at 10:30 a.m., during a concurrent interview and record review, the Chief Nursing Officer (CNO) stated her expectation was for staff to follow physician's orders. The CNO stated if staff would have checked the blood sugar as ordered, there would have been a blood sugar check completed close to discharge. The CNO validated Pt 1 had hourly blood sugar checks ordered at 2:41 a.m. and RN 2 had reviewed the order of hourly blood sugar checks at 4:37 a.m. The CNO stated there needed to be further assessment (of blood sugars). The CNO stated Pt 1's level of consciousness was assessed and documented, however the hypoglycemia was not assessed objectively with a blood sugar reading.

A review of Pt 1's orders titled, "Blood Glucose Monitoring" dated 9/16/18 at 2:41 a.m., indicated "...Priority: Stat (immediately)...Frequency: Q1H (every one hour)...Nurse Review...Nurse reviewed by (RN 2) on 9/16/2017 at 04:37 PDT (Pacific Daylight Time)..."

A review of Pt 1's clinical record titled "Results Detail" dated 9/16/17, indicated Pt 1 was discharged from the ACH at 6:25 a.m. to dialysis accompanied with EMT/paramedics (emergency medical services).

A review of Pt 1's clinical record from the dialysis center that received Pt 1, titled, "Progress Notes Report" dated 9/16/17, indicated "...Got report-[Pt 1] hypoglycemia during the night pt had went by ambulance to [name of ACH]. RN stated that his glucose was now 250. pt didn't arrive to [name of dialysis center] until 7:05 [a.m.]...blood sugar checked and was 54...code called CPR initiated...pt pronounced dead..."

The hospital's policy and procedure titled, "Medical Screening Examination" dated 3/15, indicated "Purpose: To outline the policies regarding the provisions of a medical screening exam...Supportive Data...State and Federal regulations require the provision of a medical screening examination...The medical screening exam may include the provision of ancillary diagnosis services routinely available...to determine whether the individual has an emergency medical condition...Content...A. It is the policy of the Hospital...2. If it is determined that the individual has an emergency medical condition, to provide such further medical examination and treatment necessary to stabilize the medical condition...II. Definitions...C. 'Emergency Medical Condition' means: 1. A medical condition manifesting itself by acute (sudden onset) symptoms of sufficient severity...E. 'Medical Screening Examination' means the screening process required to determine, with reasonable clinical confidence, whether an Emergency Medical Condition does or does not exist...III. Procedure: B. medical Screening Exam (MSE)...2. The MSE will be based on the patient's condition and prior history and will include at least the following:...c. Initiation and documentation of any necessary testing, treatments...3...The MSE is an ongoing monitoring process, which continues until a medical emergency condition is found not to exist or until appropriate steps to stabilize the presenting emergency medical condition begin..."

The hospital's policy and procedure titled, "Triage Nurse Policy" dated 5/13, indicated "Purpose: To outline the responsibilities and function of the Triage Nurse in the Emergency Department...Content...5. If determined that the patient does not need immediate intervention or observation, complete an initial nursing history...and initiate appropriate order per protocol..."

The hospital's policy and procedure titled, "Standard of Care" dated 6/15, indicated "Purpose: These are the fundamental components of care that are to be applied to any patient presenting for treatment to the Emergency Department (ED)...Policy: 2. All patient conditions will be classified and prioritized utilizing the Emergency Severity Index (ESI) algorithm as follows...ESI Level 2: The patient is assessed as high risk. The patient presents with a condition that has the potential for major life and organ threat. The patient's condition may deteriorate if left unattended, and therefore should not wait..."

The hospital's policy and procedure titled, "Discharge of Patients Procedure" dated 6/15, indicated "Purpose: To assess continuing care needs and provide referrals as appropriate...Preparation for Discharge: 1. In preparation for discharge, continuing care needs are assessed on admission and throughout the patient's stay..."14. Documentation in addition to Discharge Summary/Instructions will include: a. Nursing Assessment of the patient prior to discharge to include any unresolved patient problems..."