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Based on interview and record review, the facility failed to ensure the emergency needs of its patients were met in accordance with acceptable standards of practice as evidenced by:

The well-being of the fetus was not adequately assessed for two of three Emergency Department (ED) records reviewed (Patients 6 and 8) which involved pregnant patients (Refer to C 201); and

Triage, vital signs, and pain assessments were not performed in accordance with the facility's policy for six of eight ED records reviewed (Patients 1, 2, 4, 6, 8, and 9) (Refer to C 201).

These failures put patients at risk for substandard care and poor outcomes. The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Emergency Services Condition of Participation.

Based on interview and record review, the facility failed to have adequate emergency services available when patient assessments were not completed to meet the emergency needs for six of eight patients (Patients 1, 2, 4, 6, 8, and 9) seen in the emergency department (ED).

1. The well-being of the fetus (unborn baby) was not adequately assessed for two of three pregnant ED patients (Patients 6 and 8), using an available, external fetal monitor (device attached to the pregnant patient's abdomen, provides a continuous fetal heart rate, detects if there are contractions, and is commonly used to assess fetal well-being), vital signs and/or pain assessments were not done in accordance with the facility's policy, and medications were not clearly documented when given for Patient 6.

2. Triage (the process of deciding which patients should be treated first), vital signs, and/or pain assessments were not done in accordance with the facility's policy for four of six additional ED patients (Patients 1, 2, 4, and 9).

These failures resulted in the inability to assess how Patient 6's and Patient 8's medical conditions affected the fetuses and if the fetuses were in distress.

These failures potentially contributed to the post delivery status of the fetus for Patient 6 and put all patients at risk for substandard care, poor outcomes, and potential death.

Findings:

1 a. The following was noted in an article published in 3/2009 by the American College of Emergency Physicians (ACEP), titled, "Focus On: Preeclampsia." Preeclampsia is defined as hypertension (high blood pressure) and proteinuria (protein in the urine) that occurs after 20 weeks gestation. Management should focus on blood pressure control, seizure prophylaxis (prevention) and treatment, and delivery when necessary. Although obstetric (relating to childbirth) consultation is warranted in every case of preeclampsia, emergency physicians should be comfortable with the initial management.

Diagnostic criteria for preeclampsia include a systolic BP (the first or top number in a BP reading) greater than 140 or a diastolic BP (the last or bottom number in a BP reading) greater than 90 in a woman who was normotensive (normal BP) prior to 20 weeks gestation. Severe preeclampsia is diagnosed by a systolic BP greater than 160 or diastolic BP greater than 110, excess proteinuria, severe oliguria (lack of urine), cerebral or visual disturbances, pulmonary edema (excess fluid in the lungs), impaired liver function, epigastric or right upper quadrant pain, thrombocytopenia (abnormally low amount of platelets, part of the blood that help it to clot), or fetal growth retardation.

Delivery is the definitive treatment for preeclampsia and should be considered after 34 weeks gestation in the case of severe preeclampsia and 37 weeks gestation in mild preeclampsia. . . . . Any patient with severe preeclampsia should be started on magnesium, because it has been proven to prevent progression to eclampsia (new onset grand-mal seizures in a woman with preeclampsia)."

The American College of Obstetricians and Gynecologists (ACOG) published an article in 4/2017, titled, "Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum (immediately after giving birth) Period." It read as follows, "Pregnant women or women in the postpartum period with acute-onset severe systolic (greater than or equal to 160) or severe diastolic hypertension (greater than or equal to 110) or both require urgent antihypertensive therapy. Close maternal and fetal monitoring by a physician and nursing staff are advised during the treatment of acute-onset, severe hypertension."

The facility's policy titled, "OB Fetal Heart Rate," expiration date of 7/11/17, was reviewed and indicated, "Because the fetal heart rate ranges from 120-160 beats per minute, auscultation (listening) with a doppler (hand held device that gives a one time heart rate of the fetus) is only an average rate; it can detect gross signs of fetal distress and is recommended in the uncomplicated pregnancy. For the high risk pregnancy, external or internal fetal monitoring is more accurate and provides more information regarding fetal well being."

A review of Patient 6's record indicated she presented to the ED at 9:47 am, at 41 weeks gestation (one week past due) with complaints of cramping in her abdomen off and on for five days. She had received regular prenatal care and had no complications during her pregnancy. At 9:58 am, Patient 6's initial vital signs indicated a blood pressure (BP) of 163/111 and no complaints of pain. At 10 am, the ED physician completed a vaginal exam which showed no sign of fluid or blood and the cervix was one centimeter dilated. Doppler fetal heart tones were 160 beats per minute (normal 120-160) at 10:37 am. No other fetal heart tones were recorded. Patient 6's BP was next checked at 10:57 am and was 157/102, followed by another BP of 129/85 at 12:01 pm, and 127/71 at 12:30 pm.

A urinalysis showed 3 plus protein (normal is no protein) in Patient 6's urine. An Obstetrical (OB, dealing with pregnancy) physician consult was obtained by the ED physician, who recommended four grams (gm) of magnesium sulfate IV (intravenous) to treat preeclampsia and labetalol IV to treat the high blood pressure. The ED physician's assessment was: 41 weeks gestation pregnancy with hypertension and proteinuria, possible preeclampsia. At 1 pm, Patient 6 was transferred to another hospital that provided OB services.

Information provided by the receiving hospital indicated Patient 6 arrived at 2:06 pm, with high blood pressure, proteinuria concerning for preeclampsia with magnesium drip running, pelvic cramping with headache. Patient 6's baby was delivered and was limp, flaccid (hanging loosely), with poor color, needing cardiac (heart) compressions and intubation (tube inserted into the lungs to assist with breathing). The OB reported an abnormal neurologic exam, apnea (no spontaneous breathing), hypovolemia (low circulating blood volume in the body), meconium (materials ingested during the time the infant spends in the uterus) aspiration and that baby was transferred to a higher level of care for sepsis (bloodstream infection that results in an overwhelming infection) watch and hypoglycemia (low blood sugar).

During an interview on 6/7/17 at 10:45 am, ED Registered Nurse (ED RN) 3 stated they have an external fetal monitor machine in the ED and place it on pregnant patients to monitor the fetus. The machine automatically prints out a fetal monitor strip which should be included in the patient's medical record.

During a concurrent interview and record review on 6/7/17 at 10:55 am, the Chief Nursing Officer (CNO) confirmed Patient 6's triage had been completed at 10 am but fetal heart tones were not documented until 10:37 am and not repeated. The CNO confirmed there were four bags of magnesium sulfate 1 gm (gram) in 100 milliliters (ml) taken out of the automatic drug dispensing cabinet at 11 am for Patient 6 and confirmed the RN's note at 11:20 am: "IV magnesium up, patient tolerated well." The CNO confirmed 4 gm of magnesium sulfate was given as ordered but was unable to state, from the documentation in the record, when each of the four bags was started or if all four bags were given between 11 am and 11:20 am.

During a concurrent interview and record review on 6/8/17 at 8 am, ED RN 2 confirmed he cared for Patient 6 during her ED visit. He confirmed triage was done at 10 am and fetal heart tones, by doppler were done at 10:37 am and not repeated. He stated he did not know why there was a delay in getting the initial fetal heart tones. ED RN 2 confirmed, although he had training and knew how to use the external fetal monitor, he did not use it for Patient 6, but should have done so.

ED RN 2 stated he gave the first 1 gm of magnesium sulfate starting at 11 am and finished at 11:20 am. The remaining doses were given one right after the other until all 4 gms were given. He said the last dose was almost finished around the time Patient 6 was transferred out of the facility. He stated Patient 6's initial BP was 163/111 and did not know why her BP wasn't rechecked again until approximately one hour later. He confirmed all patients who are on IV drips, including Patient 6, should have vital signs checked every 15 minutes. He stated he would have ordinarily programmed the automatic BP machine to take her BP every 15 minutes but did not know what happened in this case.

The facility's policy for vital signs, expiration date 4/29/18, was reviewed and indicated, "Frequent vital signs are required for: i.e. During administration of any IV drip (continuous, slow administration of medication into a vein) or IV push (rapid injection of medication into a vein) antihypertensive (used to treat high blood pressure) or cardiac medication."

1 b. The facility's policy for triage, expiration date 12/2/17, was reviewed and indicated, "Triage will be performed by a Registered Nurse of all patients presenting to the Emergency Department for care within 15 minutes of arrival."

The facility's policy for ED assessment, expiration date 7/11/17, was reviewed and indicated, "Initial vital signs include temperature, heart rate, BP, respiratory rate, oxygen saturation, weight and pain level (0-10 scale). Additional vital signs shall be obtained depending on patient's condition: critical patients - every 5 to 15 minutes. Urgent patients every 1 hour minimum, non-urgent patients every two hours or prior to discharge whichever is less. All patients will have discharge vital signs taken and documented: including heart rate, respiratory rate, BP, oxygen saturation, and pain level re-evaluation immediately before discharge to home, immediately before admission to the hospital, immediately prior to transfer to another healthcare facility."

A review of Patient 8's record indicated she presented to the ED at 12:16 pm with a chief complaint of abdominal cramps and was 5 1/2 months pregnant. Triage was done at 12:41 pm, 25 minutes after arrival. The initial vital signs were normal and the initial pain assessment was 7/10. According to the ED physician's note, Patient 8 had previously been seen with a urinary tract infection, had some spotting and bleeding with a threatened abortion (symptoms indicate a miscarriage is possible) which did not happen. A urinalysis was done, and the baby was monitored by the nursing staff with the fetal heart rate being normal. The physician's assessment was: "mid-trimester pregnancy, urinary tract infection." Patient 8 was given a prescription for antibiotics. Vital signs were repeated at 2:23 pm but the pain assessment was not. Patient 8 was discharged home at 2:56 pm.

During a concurrent interview and record review on 6/8/17 at 9:40 am, the CNO stated she was unable to tell if Patient 8 was placed on the external fetal monitor or if heart tones had been done by doppler. She confirmed the following was charted at 1:12 pm, when ED RN 4 noted the following: "Fetal heart tones assessed and are WNL (within normal limits) for gestational age." She confirmed there was no fetal heart monitor strip and the pain assessment was not repeated with the last set of vital signs, prior to discharge in accordance with their policy.

ED RN 4 was unavailable for interview; however, on 6/8/17 at 12:30 pm, the CNO was able to confirm with ED RN 4 that she used a doppler and not the external fetal monitor on Patient 8. ED RN 4 stated she would usually use the external fetal monitor if abdominal cramping was involved but did not do so in this case, indicating she knew Patient 8 had recently been seen in the clinic by her OB physician.

2 a. A review of Patient 2's record indicated he presented to the ED on 4/1/17 at 9:38 am with a complaint of an abscessed (infected) tooth. He left without being seen at 10:33 am, almost one hour later.

During a concurrent interview and record review on 6/6/17 at 1:30 pm, the CNO confirmed there had been no triage assessment or vital signs, although according to their policy, it should have been done within 15 minutes of arrival to the ED.

2 b. A review of Patient 4's record indicated she was brought to the ED on 4/23/17 at 9:25 pm for shortness of breath, by ambulance and had two IVs started prior to arrival. She was noted to have eloped (left the premises) at 9:55 pm, 30 minutes later. According to the ED physician's note, Patient 4 left against medical advice in stable condition.

During a concurrent interview and record review on 6/6/17 at 1:40 pm, the CNO confirmed there was no triage assessment documented. She stated she would have expected the nurse to have charted if the patient had refused to allow the assessment or refused to allow the IVs to be discontinued.

2 c. A review of Patient 1's record indicated she presented to the ED on 4/24/17 at 1:54 pm with nausea, vomiting, diarrhea, and kidney pain. Vital signs were taken at 2:09 pm with a pain assessment of 9/10. Vital signs were repeated once at 5:53 pm and Patient 1 was discharged at 6:35 pm. The pain assessment was not repeated.

During a concurrent interview and record review on 6/6/17 at 9:40 am, ED RN 1 confirmed she had not repeated the pain assessment after the initial assessment.

During a concurrent interview and record review on 6/6/17 at 1:55 pm, the CNO confirmed the above. The CNO stated vital signs and the pain assessment should have been done every two hours and were not.

2 d. A review of Patient 9's record indicated she presented to the ED on 4/28/17 at 2:32 pm, six months pregnant with possible contractions. The external fetal monitor was applied immediately and was evaluated by the ED physician. Vital signs were taken at 2:46 pm but were not repeated prior to discharge at 3:37 pm.

During a concurrent interview and record review on 6/8/16 at 9:40 am, the CNO confirmed vital signs were taken once and not repeated prior to discharge as required by their policy.

Based on observation, interview, and document review, the hospital failed to have an adequate supply of medications for immediate use in a medical emergency as evidenced by:

1. The hospital failed to have cold normal saline immediately available in case of a malignant hyperthermia (MH, a disease that causes a fast rise in body temperature and severe muscle contractions) emergency.

2. The hospital did not have an adequate emergency supply of Crotalidae Polyvalent Immune Fab (anti-venom for poisonous snake bites) in accordance with manufacturer's specifications, which was four to six vials for an initial dose, when the hospital stored a partial initial dose of two vials of anti-venom.

Findings:

1. A review on 6/6/17 of the undated hospital policy titled, "Management of Patient with Malignant Hyperthermia" indicated, "Patients experiencing malignant hyperthermia may exhibit...fever, with temperatures elevating rapidly as much as 1.8 F (Fahrenheit) (1 C, Celsius) every three minutes, creating temperatures as high as 114 F (45.5 C). This may constitute an emergent situation...Cooling the patient is of vital importance. To reduce body temperature: Infusion of iced solutions as fast as one liter/10 minutes for 30 minutes may be required..."

According to the Malignant Hyperthermia Association of the United States, a nationally recognized Malignant Hyperthermia resource, in the entitled online search Stocking an MH Cart, indicated, "What should be on an MH Cart...Therapy should be aimed at prompt cooling to a target core temperature...Refrigerated cold saline solution-A minimum of 3,000 ml (milliliters)... "

During an observation on 6/6/17 at 11:22 am in the Operating Room, a list of medications that was available for a MH emergency was observed on the outside cover of the MH cart. The list did not include cold saline. It was also observed that there was no cold saline in the medication refrigerator.

During a concurrent interview on 6/6/17 at 11:22 am, the Certified Registered Nurse Anesthetist stated that the cold saline was supposed to be in the medication refrigerator. She also stated she did not know why there was no cold normal saline in the medication refrigerator. She acknowledged the importance of having cold saline in a life-threatening MH emergency. She said that she would correct the issue right away.

2. A review on 6/5/17 of the manufacturer's information for the Crostalidae Polyvalent Immune Fab indicated, "A safe, effective way to treat...snakebites in the emergency setting...recommended initial dose...4 to 6 vials infused IV (intravenous) over 60 minutes. Repeat, if necessary, until initial control is achieved. Initial control is defined as complete arrest of local manifestations and normalization of coagulation test results and systemic signs..."

During an observation on 6/6/17 at 11:25 am in the emergency department (ED) medication refrigerator, it was observed that there were two vials of anti-venom. On the outside cover of the refrigerator there was a notice that four to six vials was needed for an initial dose of anti-venom. During a concurrent interview with Registered Nurse 1 (RN 1), she stated that there was supposed to be at least four vials in the ED medication refrigerator and she did not know why there were not enough doses.

During an interview on 6/6/17 at 1:15 pm, the Chief Nursing Officer stated that they did not have any other anti-venom vials in the hospital. She acknowledged the importance of have enough anti-venom and she said that she would have some ordered immediately.

During an interview on 6/8/17 at 8:58 pm, the Pharmacist in Charge stated that he pulled the anti-venom because it became expired. He also stated that he forgot to reorder more anti-venom. He stated that the hospital was in a rural area and having enough anti-venom to administer an initial dose was very important.

Based on observation, interview, and facility document review, the hospital failed to ensure the Medical/Surgical Department's emergency crash cart had equipment, necessary in performing life-saving procedures, that was ready and available for use. The pediatric and adult defibrillator (equipment used to deliver a dose of electric current to the heart) pads (necessary part of the defibrillator that is attached directly to the patient's chest through which a shock to the heart is delivered) were expired and available for use.

This failure had the potential for patients to not receive life-saving treatment in a timely and appropriate manner, resulting in further decline, including death.

Findings:

During a concurrent observation and interview with Medical/Surgical Department Registered Nurse (RN) 10, on 6/5/17 at 11 am, RN 10 stated the emergency crash cart was unlocked and used earlier in the morning for a "Code" (a patient in need of immediate medical attention) in the Emergency Department. RN 10 confirmed both the pediatric and adult defibrillator pads had an expiration date of 12/6/16. RN 10 confirmed the emergency crash cart had been checked earlier that morning to ensure the defibrillator, suction, and oxygen were in working order and that the cart was locked. RN 10 stated the entire crash cart was checked monthly and after each use.

The facility policy and procedure titled, "Crash Cart Checks," expiration date 4/4/18, was reviewed and indicated, "To insure the crash cart is always stocked to the level established on contents list and all equipment functions properly...
B. Monthly Check:
1. Entire cart contents including outdates and blade lights."

During an interview with the Chief Executive Officer, Chief Nursing Officer (CNO), and the Quality/Risk Manager on 6/8/17 at 10:05 am, the CNO stated the crash carts were to be checked monthly for outdates and necessary supplies, and there shouldn't be any expired items.

Based on observation, interview, and document review, the hospital failed to store medications appropriately as evidenced by:

1. Expired medications, emergency medication, and dispensed medications were stored in an unorganized and crowded manner in an unused sterile compounding room.

2. The hospital staff failed to store "protect from light" medications appropriately when Lidocaine with Epinephrine (medication used for local anesthesia) and IV Nitroglycerin (medication used for heart conditions) were stored on shelves in direct light.

3. The hospital failed to store refrigerated medications in accordance with hospital policy (between 36-46 degrees F, Fahrenheit) and manufacturer's recommendations to ensure stability, potency, and safety of refrigerated medications.

4. The hospital failed to date 100 ml (milliliter) bags of Sodium Chloride (NACL) 0.9 %, out of the overwrap (plastic cover used to maintain shelf-life), with a beyond use date (expiration date). There were no beyond use dates on the 100 ml bags of NACL 0.9 % which were primarily used as diluent for intravenous (IV) medications.

Findings:

1. A review on 6/6/17 of an undated hospital policy titled, "Storage of Drugs in Current Use" indicated, "Drugs shall be stored in an orderly manner..."

An observation on 6/6/17 at 2:35 pm, in an unused sterile compounding room located in the pharmacy, revealed over one hundred different types of medications that were stacked up into several different piles from one to three feet high inside the IV hood and the surrounding area. The IV hood was an area used to prepare IV medications. There were also emergency medications (found on the floor), in addition to oral suspensions, injectable medications, topical medications, and oral medications.

During an interview on 6/7/17 at 10:30 am, the Chief Nursing Officer (CNO) stated she did not know why the medications were unorderly and placed in different stacked piles. She also stated she was aware the medications were stored unorderly and needed to be organized. She acknowledged the increased risk of medication errors when multiple medications were crowded.

During an interview on 6/8/17 at 8:58 am, the Pharmacist in Charge (PIC) stated that he was aware of the overcrowding of the medications and was working on improving the disorganization. He also stated that he did not have the time to organize the medications.

2. A review on 6/5/17 of the undated hospital policy titled, "Storage of Drugs in Current Use" indicated, "No contaminated or deteriorated drugs shall be available..."

A review on 6/5/17 of the manufacturers' inserts indicated to protect from light, the 2 % Lidocaine with Epinephrine and IV Nitroglycerin. The Lidocaine with Epinephrine and the IV Nitroglycerin were to be stored away from light.

During an observation on 6/5/17 at 2:36 pm, the Lidocaine with Epinephrine was found under direct light in the emergency department. There were thirteen 20 ml vials of the Lidocaine with Epinephrine that were under direct light.

During an observation on 6/5/17 at 3:24 pm, the IV Nitroglycerin was found under direct light in the hospital pharmacy. There were three 250 ml vials of IV Nitroglycerin that were under direct light.

The above mentioned medications were found under direct light, were uncovered, and inappropriately stored. Medications that require protect from light deteriorate under direct light. The labels of each of these medications indicated "protect from light."

During an interview on 6/7/17 at 9:05 am, the PIC stated that he did not know that the Lidocaine with Epinephrine and the IV Nitroglycerin were to be stored away from direct light. He also stated that he would ensure that the medications were stored away from light.

During an interview on 6/7/17 at 10:30 am, the CNO stated that she did not know why the 2 % Lidocaine with Epinephrine and IV Nitroglycerin were stored under direct light. She also stated that she would discard the medications and restock with appropriately stored medication.

3. A review on 6/5/17 of the undated hospital policy titled, "Storage of Drugs in Current Use" indicated, "Drugs requiring refrigeration are stored between 35 and 46 degrees F..."

An observation on 6/5/17 at 3:03 pm, of the Medical-Surgical nursing station medication refrigerator, revealed that the electronic thermometer indicated a temperature of 32 degrees F.

During an observation the next day on 6/6/17 at 10:16 am, the same medication refrigerator indicated a temperature of 33 degrees F. The medication refrigerator stored 10 to 15 different types of medications, which included vaccines and anesthesia medications, and each type of medication had several doses. The labeling on the medications indicated store at refrigeration between 36-46 F.

When refrigerated medications are not appropriately stored, below 36 F and above of 46 F, the medications may reduce in potency and/or compromise sterility.

During an interview on 6/8/17 at 9:10 am, the PIC stated that he was not aware that the Medical-Surgical nursing station medication refrigerator temperatures were out of range. He also stated that he would follow up and look into the medication refrigerator temperature excursions.

4. During an observation on 6/5/17 at 3:26 pm, the ADC (automatic dispensing cabinet- computerized medication dispensing machine) stored a 100 ml bag of NACL 0.9 % out of the overwrap. The 100 ml bag of NACL 0.9 % did not have a beyond use date.

A review on 9/6/16 of the manufacturer's information on the 100 ml bag of NACL 0.9 %, in the document titled, "Viaflex Container Directions," indicated that the beyond use date was 30 days outside of the overwrap. After taking off the overwrap, the 100 ml bag of NACL 0.9 % would have to be discarded after 30 days.

During an interview on 6/5/17 at 3:26 pm the CNO stated that she was not aware that the beyond use date should have been 30 days outside of the overwrap on the 100 ml bag of NACL 0.9 %. She acknowledged that the solution gets more concentrated without the overwrap and that the IV bag of NACL 0.9 % should not be used after 30 days once taken out of the overwrap.

During an interview on 6/8/17 at 9:15 am, the PIC stated that he did not know that the nurses were not dating the NACL 0.9 % with a beyond use date after they had been taken out of the overwrap. He said that if he had seen the undated NACL 0.9 % IV bags, he would have discarded the solution.

Based on interview and record review, the hospital failed to have a Governing Body that assumed full legal responsibility for determining, implementing, and monitoring policies that governed the hospital's operations, and for ensuring quality of care in a safe environment when:

1. Emergency services failed to ensure the needs of its patients were met in accordance with acceptable standards of practice when the well-being of fetuses was not adequately assessed, the triage of patients and vital signs and pain assessments were not performed for emergency department patients, and an emergency crash cart, necessary for performing life-saving procedures, had expired supplies available for use.

These failures resulted in the inability to accurately assess the status of fetuses for distress, potentially contributing to the post delivery status of the fetus. Inadequate assessment and expired equipment put all patients at risk for substandard care, poor outcomes, and potential death (Refer to C 201 and C 204).

2. Surgical services failed to ensure sterilization procedures for hinged instruments met the required industry standards, the general conditions of the changing room, Operating Room (OR), and reprocessing room were unsanitary, expired supplies were available for use in the OR, surveillance of post surgical site infections was not monitored, a contracted Registered Nurse did not have a completed employee file per hospital requirements, a minor child's post-operative orders included medication doses for an adult, and an admission order/consent form did not include dates, times, and signatures in accordance with hospital policies and procedures, the Infection Control Nurse and/or the OR Manager/Chief Nursing Officer (ORM/CNO) did not monitor the cleaning of the OR and OR instruments, and the ORM/CNO did not have specialized education or training in the sterilization of instruments, general cleaning of the surgical services area, and OR to provide acceptable oversight and management (Refer to C 320).

3. The facility failed to have a robust quality program designed to identify and remedy deficient practices. The facility quality program failed to identify Emergency Department and Surgical Services deficiencies (Refer to C 337).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure compliance with the mandated Condition of Organizational Structure and placed all patients at risk for worsening conditions, harm, and death.

Based on interview and record review, the hospital's governing body failed to ensure that medical staff rules and regulations were implemented to ensure quality health care was provided in a safe environment when:

1. Verbal orders were not authenticated for one of 33 sampled patients (Patient 12) in accordance with the the timeframe established by the Medical Staff Rules and Regulations.

2. A discharge summary was not completed for one of 33 sampled patients (Patient 17) in accordance with the timeframe established by the Medical Staff Rules and Regulations.

These failures had the potential for patients to experience a delay in care, poor quality health care, and to suffer unintended consequences to their overall health and safety.

Findings:

The Medical Staff Rules and Regulations, approved 12/3/14, were reviewed and indicated "Discharge Summaries: As soon as possible, but no later than 7 days after discharge from inpatient care, a discharge summary shall be prepared by the Practitioner concisely summarizing the reason for hospitalization, the significant findings, Hospital course, the procedures performed and treatment rendered ... Verbal and telephone orders or orders dictated over the telephone shall be signed by the person who dictated, and shall indicate the name of the Practitioner issuing the order. The Practitioner who issued the order shall countersign the order within 48 hours."

The hospital's policy and procedure titled, "Administration and Ordering Privileges, Verbal Orders," expiration date of 2/25/18, was reviewed and indicated, "... will be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. Verification of verbal order will be to read order back to the prescriber by the receiving party. The prescriber must countersign the order within 48 hours."

1. The clinical record for Patient 12 was reviewed on 6/6/17. Patient 12 was admitted to the hospital for outpatient treatment with diagnoses that included dehydration, heart failure, and diabetes.

Review of the [Facility Outpatient] Care Physician Order sheet, dated 2/8/17 at 9 am, indicated a physician's order for "Type & Cross 2 units PRBC (Packed Red Blood Cells). Transfuse 2 units PRBC at 2 [hours] per unit."

Review of the [Facility Outpatient] Care Nursing Documentation Form, dated 2/8/17, indicated Patient 12's first PRBC was initiated at 4:15 pm. The [Facility Outpatient] Care Nursing Documentation Form indicated at 7:40 pm, the nurse documented "Call MD (Medical Doctor)... pt (patient) BP (blood pressure) 190/100, 184/108, order for 40 mg (milligrams) of Lasix (medication to treat heart failure) IV (intravenously) once before next PRBC infusion."

Review of the Consent to Blood Transfusion signed by the patient, dated 2/8/17, indicated "1940 (7:40 pm) TO (telephone order) from [MD]. Administer 40 mg of Lasix IV, once for high BP. Give before second dose of PRBC."

During an interview on 6/6/17 at 11:45 am, the Quality Risk/Manager (QIRM) stated the telephone order should have also been placed on a Physician Order sheet for the physician to sign. The QIRM confirmed a Physician Order sheet was not in the clinical record and that a physician had not signed off on the telephone order.

The [Facility Outpatient] Care Nursing Documentation Form (2/8/17) indicated at 8:35 pm, BP 104/110, 8:30 pm 192/118, pt stated he did not take his BP [medications] today. Called [MD], new order for Clonidine (medication to treat high blood pressure) 0.2 mg po (by mouth), and 10 mg Lisinopril (medication to treat high blood pressure) po one for high BP, will administer."

During an interview on 6/6/17 at 1:30 pm, the QIRM confirmed the "new orders" were not documented on a Physician Order form. The QIRM confirmed both telephone orders were not signed off by the physician.

2. The clinical record for Patient 17 was reviewed on 6/7/17. Patient 17 was admitted to the hospital with diagnoses that included right lower leg cellulitis (skin infection) and sepsis (immune response triggered by an infection).

During a concurrent interview and record review with the QIRM on 6/7/17 at 11:05 am, the QIRM confirmed Patient 17 was discharged 2/27/17 and that the discharge summary was dictated on 3/6/17. The QIRM confirmed the discharge summary was not authenticated with an electronic signature or handwritten signature until 3/28/17 at 2 pm, 31 days after discharge. The QIRM confirmed the discharge summary was not authenticated within the timeframe established by the Medical Staff Rules and Regulations.

Based on interview and record review, the facility failed to ensure adequate procedures for patients with a latex allergy.

This had the potential for patients to unnecessarily experience an allergic reaction to latex. (Symptoms of a latex allergy can be mild or severe and may include itchy, red, watery eyes, sneezing or runny nose, and rash or hives. Though rare, symptoms can include anaphylaxis, which causes sudden, widespread, potentially severe and life-threatening allergic reactions.)

Findings:

The facility's policy titled, "Latex Sensitivity," expiration date of 7/11/17, was reviewed and indicated the standard was for staff members and patients, who have a sensitivity to or are allergic to latex, a substitute shall be made available. The policy indicated a list of "examples of products which may contain latex" with the following direction: "Some of these products are available in latex-free forms. Latex free materials are available for patient and staff use." The policy indicated staff would "learn to recognize the symptoms of latex allergy: a. skin rashes b. hives c. flushing d. itching e. nasal, eye or sinus symptoms f. asthma g. shock."

On 6/6/17 at 2:10 pm, during a concurrent interview and review of the Latex Sensitivity policy, the Infection Control Nurse (ICN) confirmed it was the only latex policy and procedure available in the facility. The ICN confirmed the facility's latex sensitivity/allergy procedure was unclear when items required to be substituted (latex containing) were not identified. The ICN confirmed this left patients and staff (with latex sensitivity/allergies) at risk for avoidable allergic reactions.

Based on observation, interview, and document review, the facility failed to ensure proper storage of medications and medication supplies when:

1. An emergency medication kit, located in the CT room (a radiological testing room), contained medications that had expired.

2. Expired supplies were available for use.

These failures had the potential for patients to receive medications/supplies with compromised effectiveness and/or integrity which could negatively impact patient outcomes.

Findings:

1. On 6/5/17 at 4:30 pm, during an observation of the CT room and a concurrent interview, the Manager of Diagnostic Imaging (MDI) confirmed a Crash Box (CT scan emergency medication box) had expired on 6/1/15.

On 6/6/17 at 7:45 am, the Chief Nursing Officer (CNO) confirmed the contents of the CT scan emergency medication box included medications with expiration dates as follows:

a. dexamethasone (for inflammation) 4 milligram (mg)/milliliter (ml), expired 10/30/15
b. epinephrine (for severe asthma attacks and allergic reactions) 1 mg/10ml, expired 7/30/15
c. glucagon (for severe low blood sugar) 1 mg, expired 5/30/15
d. ammonia inhalant (for use when reviving someone from fainting spell), expired 11/30/15
e. diphenhydramine (for life-threatening allergic reactions) 50 mg/ml, expired 10/30/15
f. lidocaine (for irregular heartbeats/to relieve pain and numb the skin) 2 grams/500 ml bag, expired 6/30/15
g. lidocaine 100 mg/5 ml, expired 6/1/15
h. lactated ringers 1000 ml, sodium bicarbonate 40 milliequivalent /50 ml (intravenous fluids to replenish electrolytes), expired 10/1/16
i. atropine (for low heart rate/antidote for drug overdose) 1 mg/10 ml, expired 6/30/16
j. epinephrine 1:1000 ampule, expired 8/1/15

The CNO provided a copy of the content list which indicated the box had been delivered by the pharmacy on 3/24/15. The CNO confirmed the medications were not stored or managed in a safe, appropriate manner. The CNO confirmed the CT Crash Box was not inspected on a regularly scheduled basis as required (at least monthly) which resulted in the expired medications being available for use. No evidence was found, regarding pharmacy follow-up, after delivering the CT crash box 3/2015.

The facility's policy regarding pharmacy services titled, "Drug Storage Area Inspections," expiration date of 2/25/18, indicated the purpose of the policy was to "list the expectations for drug area inspections" and to "provide control of storage and administration of all drugs" within the facility. The policy indicated drug storage areas would be inspected on a regularly scheduled basis. The policy indicated problem areas and deficiencies would be discussed with the CNO and findings reviewed at the quarterly pharmacy committee meetings.

2. On 6/5/17 at 4:30 pm, during an observation of the CT room and a concurrent interview, the MDI confirmed expired supplies available for use included 18 gauge (size) intravenous catheters, 14 expired 4/2015 and four expired 3/2014. Three coiled injection lines expired 2/2015 and an additional three expired 3/2014. The MDI removed the expired items from service and confirmed the supplies were not inspected on a regular basis as required (at least monthly) to ensure the safety and integrity of these items.

The facility's job description titled, "Manager of Diagnostic Imaging," dated 10/2008, indicated position responsibilities included ensuring that "all areas are properly stocked with supplies."

Based on interview and record review, the facility failed to ensure all orders were completed for one of 33 sampled patients (Patient 1) when the dosage for the medication was not included.

This had the potential to result in a medication error.

Findings:

A review of Patient 1's outpatient record indicated an order to do a monthly port-a-cath (central intravenous line implanted under the skin that allows for intermittent medication infusions) flush. There was no medication name or amount. The port-a-cath was noted to be flushed via hospital procedure.

During a concurrent interview and record review on 6/7/17 at 2:10 pm, Registered Nurse (RN) 7 stated there was a hospital protocol they followed that included heparin when flushing the port-a-cath. When asked what amount of heparin solution would be used, RN 7 stated the protocol included the amount and she understood it had been approved by the medical staff committee.

During a concurrent interview and record review on 6/7/17 at 2:50 pm, the Chief Nursing Officer stated there was no protocol or standing order approved by the medical staff committee to flush a port-a-cath. She reviewed the order and confirmed it was not adequate since it did not include the medication amount.

Based on observation, interview and record review, the facility failed to ensure policies and procedures for infection control prevention were followed when:

1. Early identification and transmission prevention of Multidrug-Resistant Organisms (MDRO, germs that have developed resistance to multiple types of antibiotics) was not implemented for two of 33 sampled patients (Patients 16 and 17) when they were not screened for methicillin-resistant Staphylococcus aureus (MRSA, a common MDRO) upon admission.

This failure had the potential to expose all patients to MDROs, leading to a worsening of patient conditions and possibly death.

2. The facility failed to identify and control the possible spread of infection to patients in the Emergency Department (ED) when one bed was close to a hopper (toilet) without an adequate splashguard (covering).

This failure had the potential to result in the spread of infectious organisms to all patients in this specific ED room.

Findings:

The California Health and Safety Code 1255.8(b)(1), effective 2009, indicated "(b) (1) Each patient who is admitted to a health facility shall be tested for MRSA in the following cases, within 24 hours of admission...
(B) It has been documented that the patient has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission..."

The facility policy and procedure titled, "Methicillin-Resistant Staphylococcus Aureus (MRSA) Nasal Swab Procedure," with an expiration date of 4/4/18, indicated, "Admission Active Surveillance Cultures (ASC): Each patient who is admitted to Trinity Hospital...shall be tested for MRSA in the following cases, within 24 hours of admission...previously discharged from a general acute care hospital within 30 days prior to the current hospital admission...the patient is homeless..."

1a. The clinical record for Patient 17 was reviewed on 6/7/17 at 11:05 am. Patient 17 was admitted to the hospital with diagnoses that included right lower leg cellulitis with sepsis (immune system is unable to fight the germs and overcome the infection) and protein C deficiency (increased risk of developing blood clots).

During a concurrent interview and record review with the Quality/Risk Manager Registered Nurse (QIRM) on 6/7/17 at 11:05 am, the QIRM confirmed a swab for MRSA was not collected within 24 hours after admission for Patient 17. The QIRM confirmed the swab should have been collected.

Review of the admission History and Physical, dated 2/21/17 at 11:46 am, indicated Patient 17 had received previous "surgical debridement (removal of unhealthy tissue from a wound to promote healing)" and antibiotic therapy one week prior to this hospital visit, left "Against Medical Advice and hitch-hiked to this ED...Currently unemployed and homeless."

1b. The clinical record for Patient 16 was reviewed on 6/7/17 at 8:25 am. Patient 16 was admitted to the hospital with diagnoses that included uveitis (inflammation in the middle layer of the eye), heart failure, high blood pressure, and weakness.

During a concurrent interview and record review with the QIRM on 6/7/17 at 8:25 am, the QIRM confirmed a swab for MRSA was not collected within 24 hours after admission to the hospital or upon admission to a swing bed (hospital bed for either acute or skilled level of care) status. The QIRM stated the MRSA swab "should have been done."

During an interview with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), QIRM, and the Infection Control Nurse (ICN) on 6/8/17 at 10:05 am, the QIRM confirmed the two cases did not have MRSA swabs according to the hospital policy and procedure. The ICN stated the "hospital current policy and procedure is more prescriptive than what is required."



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2. On 6/5/17 at 1:50 pm, the ED was observed to have two rooms with two beds in each room. In ED room 2 there was a hopper with a splashguard that covered the top half of the hopper. The bottom half of the hopper and the area closest to the bed was open and approximately 18 to 24 inches from the ED bed.

During an interview on 6/5/17 at 2 pm, the Emergency Room Tech said the hopper was used to empty bedpans.

During a concurrent observation and interview on 6/5/17 at 2:15 pm, the hopper was shown to the CNO who agreed there was an infection control problem with it.

Based on observation, interview, and facility document review, the hospital failed to ensure the inpatient and emergency menus had a comprehensive nutritional analysis in accordance with recognized dietary practices.

This failure had the potential to result in inadequate menus placing patients at risk for impaired nutritional status, weight loss, changes in medical condition, and functional decline.

Findings:

During a concurrent observation, interview, and facility document review with the Director of Dietary Services (DDS) on 6/5/17 at 9:50 am, the DDS reviewed the emergency menu. The emergency menu plan included provisions to provide meals for 50 people (staff and patients) for three days. A random comparison of the hospital emergency inventory indicated an inadequate supply of available food, based on what was listed on the emergency menu. The emergency menu indicated to have 12 cans of fruit, any kind, on hand. The menu indicated four cans per meal were required to provide 4 ounce servings of fruit for 26 people. The DDS confirmed eight of the 12 cans of fruit would be used during breakfast on day one, not leaving enough canned fruit for the remaining two days.

During a phone interview with the contracted Registered Dietitian (RD) on 6/6/17 at 4 pm, the RD stated the DDS created the emergency menu, and that she was unaware of any emergency menu and supplies, and had not reviewed any menus for the facility.

During a phone interview with the RD on 6/7/17 at 7:45 am, the RD stated she could review the menus if requested by the facility, but it was not part of her usual responsibility per the contract. The RD stated she had not been asked to do so.

During an interview on 6/7/17 at 8:15 am with the DDS, the DDS stated the current menu plan was purchased in 2010 and had not been reviewed by the RD. The DDS stated the emergency menus did not have any Institute of Medicine Food and Nutrition Board's Dietary Reference Intakes (DRIs, nutrient reference values intended to serve as a guide for good nutrition).

During a hospital record review on 6/8/17 at 7:35 am, the Agreement for Dietary Consultant Services, dated 10/1/16, indicated, "Menu planning and review of services as requested by Facility staff. (Contracted) dietitians will not write menus unless requested by the appropriate administrative personnel of Facility."

Review of the hospital Diet Manual, which includes all of the hospital approved and available diets for physicians to order, indicated "a current therapeutic diet manual be approved by the dietitian and the Interdisciplinary Practice Committee, Medical Executive Committee (MEC), and Board of Directors (BOD)... It shall be reviewed annually and revised at least every five years." The last revised date indicated on the Diet Manual was 2010.

Review of the hospital's policy and procedure titled, "Menus," with an expiration date of 4/4/18, indicated "Menus are created by the food service manager and approved by the Registered Dietician."

During a concurrent interview and hospital document review, on 6/8/17 at 7:35 am, the Quality/Risk Manager confirmed the Diet Manual was last reviewed by the MEC on 6/30/09 and by the BOD on 7/15/09.

During an interview with the Chief Executive Officer (CEO) on 6/8/17 at 11:07 am, the CEO was unaware the menus had not been reviewed by the RD and that the last review date of the Diet Manual was in 2009.

Based on interview and record review, the hospital failed to ensure timely assessment, reassessment, and monitoring was documented after medication administration to ensure the intended effects, and hospital blood administration procedures for monitoring, evaluation, and documentation were followed for four of 33 sampled patients (Patients 11, 12, 13, and 17) when:

1. Patient 12 was discharged less than one hour after a blood transfusion was completed, and the Suspected Transfusion Investigation Nursing Report was missing.

2. Temperatures were not documented during the blood transfusion for Patient 13.

3. The discharge time and post transfusion nursing assessment was not recorded for Patient 11.

4. Assessments, reassessments, and monitoring after medication administration to ensure the intended effects were not documented for Patient 17.

5. Physician notification was not documented for Patient 12 when he refused the ordered dose of blood pressure medication.

The lack of documented assessment, reassessment, and monitoring had the potential to result in unintended negative outcomes, missed opportunities for timely initiation of appropriate corrective action, worsening of patient conditions, unrecognized transfusion reactions, adverse outcomes, and death.

Findings:

The facility policy and procedure titled, "Blood Product Transfusion Administration Procedure," with an expiration date of 4/28/18, indicated in all caps and bolded, "OUTPATIENTS MUST REMAIN IN THE HOSPITAL AT LEAST ONE HOUR AFTER TRANSFUSION IS COMPLETED." The policy and procedure indicated, "During Infusion and Post Infusion Assessment... Vital Signs including temperature should be repeated during any change in patient's condition or at the discretion of the [Registered Nurse] and placed on a frequent vital sign flow sheet, during 1st hour of infusion vital signs and [temperature] every 15 minutes, then hourly until completed."

The hospital policy and procedure titled, "Blood Handling and Transfusion," with an expiration date of 6/1/18, included transfusion reaction symptoms by type, as follows:

"Febrile, minor - fever, often delayed
Grossly (extreme) - chill, fever, tachycardia (fast heart rate), convulsions, contaminated blood
Mismatched (wrong blood type) - chill, fever...dyspnea (shortness of breath)...hypertension (high blood pressure)...
Pyrogenic (causing fever) - fever with or without chills.

If transfusion reaction is suspected:...Notify attending physician...Complete the 'Suspected Transfusion Investigation Nursing Report' form and fax to the laboratory along with the 'Blood Administration Record.'"

1. The clinical record was reviewed for Patient 12 on 6/6/17. Patient 12 was admitted with diagnoses that included dehydration, heart failure, diabetes, and anemia (low blood count).

During a concurrent interview and record review with the Quality/Risk Manager (QIRM) on 6/6/17 at 11:45 am, the QIRM confirmed Patient 12 received two units of Packed Red Blood Cells (PRBC) on 2/8/17.

Review of the Crossmatch Transfusion form, dated 2/8/17, indicated the second unit of PRBC infusion was completed on 2/8/17 at 10:30 pm.

Review of the [Facility Outpatient] Care Nursing Documentation Form, dated 2/8/17 at 10:45 pm, indicated, "Discharge via wheelchair, ...in car." The QIRM confirmed Patient 12 was discharged less than one hour after the blood transfusion was completed.

The QIRM confirmed Patient 12 had high blood pressure, a fast heart rate, a slight fever, and met criteria to rule out a transfusion reaction. The QIRM confirmed there was no "Suspected Transfusion Investigation Nursing Report" completed or any other documentation to indicate the policy and procedure for Blood Handling and Transfusion was followed.

2. The clinical record was reviewed for Patient 13 on 6/6/17. Patient 13 was admitted to the Emergency Department with diagnoses that included vomiting and upper gastrointestinal (stomach) bleeding.

During a concurrent interview and record review with the QIRM on 6/6/17 at 1:40 pm, the QIRM confirmed Patient 13 received two units of PRBCs. The QIRM confirmed there were no temperatures recorded at the 15 minute, 30 minute, and 45 minute marks for the second unit of PRBCs. The QIRM confirmed this was not in accordance with the Blood Product Transfusion Administration Procedure.

3. The clinical record was reviewed for Patient 11 on 6/6/17. Patient 11 was admitted on an outpatient status on 3/30/17 with diagnoses that included anemia (low blood count) and advanced esophageal (throat) carcinoma (cancer).

During a concurrent observation and interview with the QIRM on 6/6/17 at 10:45 am, the QIRM confirmed there was no discharge time documented on the [Facility Outpatient] Care Documentation Form. The QIRM confirmed the second unit of PRBCs was completed at 8:50 pm. The QIRM confirmed there was no indication that vital signs and a nursing assessment were documented upon discharge. The QIRM confirmed this was not in accordance to the Blood Product Transfusion Administration Procedure.

4. The clinical record was reviewed for Patient 17 on 6/6/17. Patient 17 was admitted to the hospital with diagnoses that included right lower leg infection, nausea, and Protein C Deficiency (increases the risk of developing abnormal blood clots).

During a concurrent interview and record review with the QIRM on 6/7/17 at 11:05 am, the QIRM confirmed Patient 17 had an order for acetaminophen (Tylenol) 500 mg (milligram) 1 tablet po (by mouth) every 6 hours as needed for fever. The Flowsheet View Report (provides observations/data) indicated on 2/23/17 at 8:25 am, Patient 17's temperature was 102.1 degrees Fahrenheit (F), at 11:59 am it was 104.5 degrees F, and at 4:05 pm it was 103.0 degrees F. The Medication Record of Activity (list of medications administered) indicated Patient 17 received acetaminophen on 2/23/17 at 11:05 am and at 5:24 pm. The QIRM agreed the temperature taken at 11:05 am was reassessed in accordance with the policy and procedure at 11:59 am. The QIRM confirmed there was no correlation between when the temperatures were taken at 8:25 am and 4:05 pm and when the acetaminophen was given at 5:24 pm.

During a concurrent interview and record review with the QIRM on 6/7/17 at 11:05 am, the QIRM confirmed Patient 17 had an order for oxycodone IR (Immediate Release) 5 mg 1 tablet po every 4 hours as needed for right leg pain. The Medication Record of Activity indicated Patient 17 received oxycodone one tablet on 2/22/17 at 4:18 am and 9:15 am, on 2/23/17 at 2:17 pm, and on 2/24/17 at 5:23 pm. The QIRM confirmed there was no documentation on the Flowsheet View Report on 2/22/17, 2/23/17, and 2/14/17 indicating Patient 17's pain was reassessed in accordance with the policy and procedure timeframes.

The hospital policy and procedure titled, "Pain Management," with an expiration date of 2/25/18, indicated, "The patient will be assessed for the presence/absence of pain upon admission, each time the vital signs are done or more often as indicated... After the administration of appropriate pain intervention measures reassess the patient within fifteen to forty-five minutes and record the result."

The QIRM confirmed the reassessments were not done in accordance with the policy and procedure.

5. The clinical record was reviewed for Patient 12 on 6/6/17. Patient 12 was admitted with diagnoses that included dehydration, heart failure, diabetes, and anemia (low blood count).

During a concurrent interview and record review with the QIRM on 6/6/17 at 11:45 am, the [Facility Outpatient] Care Nursing Documentation Form, dated 2/8/17, was reviewed and indicated at 8:35 pm, the nurse documented "New order for Clonidine (blood pressure medication) 0.2 mg po and Lisinopril (blood pressure medication) 10 mg one for high [blood pressure], will administer." The [Facility Outpatient] Care Nursing Documentation Form indicated at 8:44 pm, "Pt (patient) states 10 mg of Lisinopril might make him crash, administer 5 mg Lisinopril and 0.2 mg Clonidine, will monitor." The QIRM confirmed there was no return communication with the physician regarding the change to Patient 12's Lisinopril dose. The QIRM stated that this was not done in accordance with the hospital policy and procedure.

Based on interview and record review, the facility failed to ensure the Emergency Department (ED) log was maintained in accordance with its policy when white-out correction tape was used to delete a time.

This resulted in an inability to determine the time a patient entered and left the ED.

Findings:

The facility policy titled, "Charting Basic Principles," with an expiration date of 4/29/18, was reviewed. It read as follows: "Correct errors by drawing a single line through the error, write the words mistaken entry (ME) above it and initial the error. Do not change an entry by blackening out the entry, using correction tape or attempting to erase an entry."

A review of the ED log for 6/5/17 contained white out correction tape for one patient who presented to the ED then decided not to be seen. The time of presentation to the ED had been covered with white-out correction tape.

During a concurrent interview and review of the ED log on 6/5/17 at 2:55 pm, the Emergency Room Tech (ERT) confirmed he had used the white-out correction tape. The ERT said this patient decided to go to the clinic to be seen.

Based on interview and record review, the facility failed to ensure all parts of the medical record were kept when a fetal monitor strip could not be located for one of eight Emergency Department (ED) records reviewed (Patient 9).

This resulted in an incomplete record and had the potential to result in an inability to verify the status of the fetus.

Findings:

A review of Patient 9's record indicated she presented to the ED on 4/28/17 at 2:32 pm, six months pregnant with possible contractions. The external fetal monitor was applied immediately and was evaluated by the ED physician. The fetal monitor strip could not be located in the record.

During an interview on 6/7/17 at 10:45 am, ED Registered Nurse (ED RN) 3 stated they have an external fetal monitor machine in the ED which automatically prints out a fetal monitor strip which should be included in the patient's medical record.

During a concurrent interview and record review on 6/8/16 at 9:40 am, the Chief Nursing Officer confirmed the fetal monitor strip was missing from the record.

Based on observation, interview, and record review, the facility failed to ensure the safe provision of surgical services when:

1. a. Sterilization procedures for hinged instruments (instruments that have metal to metal action that are used during surgery) did not meet required standards.
b. The Operating Room Technicians (ORTech) did not have specialized education and training to meet required sterilization standards.
c. The monitoring of sterilization procedures and sterile supplies was not done by qualified staff.

2. a. The area for staff to change into required surgical attire (scrubs) was also a bathroom, was not in sanitary condition, and was not set up as a changing area.
b. The surgical suite floors had a buildup of dark discoloration (brownish/black) on the floor edges and door thresholds throughout the area.
c. The endoscope (a medical device used to look inside a body cavity or organ) reprocessing room (used for high level disinfection) floor was not maintained in clean condition.
d. Environmental cleaning services for the Surgical Suite did not include oversight by the Infection Control Nurse (ICN) or Operating Room Manager/Chief Nursing Officer (ORM/CNO).

3. Two previously opened tracheal tubes (tube inserted into the trachea to establish and maintain an open airway), expired gloves, and expired humidifiers were available for use.

4. Monitoring for post-operative surgical site infections (SSI) did not include a process to obtain information (regarding post-operative SSIs) from the physician that provided the patient's post-operative care.

5. The ORM/CNO did not have specialized training in the provision of surgical services/management of surgical services operations.

6. The employee file for a contracted Registered Nurse (CRN, hired to provide circulating nurse duties, including making preparations for operations, assisting surgical team, completing paperwork, replenishing surgical supplies) did not meet facility requirements.

7. The record for one of 33 sampled patients (Patient 26, a child that received surgical services) included the following errors:
a. Post-operative physician orders for medications were dosed for an adult.
b. A physician's order for admission did not include the date or time.
c. A consent form (for anesthesia) did not include the time and the relationship (to the patient) of the substitute's signature (parent-guardian) for Patient 26.

These failures had the potential to negatively impact patient outcomes due to cross-contamination (spread of germs/viruses) to surgical patients, inadequate staff education and training, inadequate monitoring/surveillance of surgical services, and inaccuracies in medication dosing for a pediatric patient. The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Surgical Services Condition of Participation.

Findings:

1. The facility's policy and procedure titled, "Wrapping Items to be Sterilized," expiration date of 2/25/18, was reviewed and indicated the purpose of the policy was to "establish a procedure to assure a certain standard in wrapping articles." The procedure included direction to "place instruments, after washing, into proper size peel tubing or envelope." The procedure indicated "no more than two (instruments) to a package." The procedure indicated "all hinged instruments will be unlocked and packaged in the open position."

On 6/7/17 at 9:30 am, during a concurrent observation of the sterile instrument supplies, located in Operating Room 1 (OR 1), and interview with Operating Room Technician (ORTech) A (responsible for instrument sterilization), ORTech A confirmed multiple hinged instruments had been packaged and sterilized with the hinge in the "closed position." The improperly packaged hinged instruments, packaged in peel envelopes/peel packs (paper/plastic pouches), included the following:

32 peel packs with scissors,
17 peel packs with needle drivers (used when suturing),
five peel packs with schnidts (used for grasping and holding objects),
six peel packs with kochers (used to grasp moderate to heavy tissue or occlude vessels),
13 peel packs with right angles (used for clamping, dissection, or grasping tissue), and
one peel pack with a bone ronguer (used for gouging out bone).

The improperly packaged sterile supplies included one peel pack with nine nerve stimulators (all in the same peel pack). One wrapped instrument set (sterilized in the facility) was opened by ORTech A and contained 26 hinged instruments that were sterilized with the hinges in the "closed position."

ORTech A explained that she sterilized some of the instruments and others had been sterilized by ORTech B. ORTech A explained she packaged the hinged instruments the way she was trained, when ORTech B was leaving the position. ORTech A stated the facility had provided no other education or training regarding sterilization/packaging standards for hinged instruments and confirmed the facility did not provide or require competency.

On 6/7/17 at 3 pm, during an interview, the ORM/CNO stated the facility followed the Association of Peri-Operative Registered Nurses (AORN) standards. The ORM/CNO confirmed the facility had not provided ORTech A or ORTech B with specific education/training regarding AORN sterilization standards and confirmed there were no competencies in place regarding the sterilization process. The ORM/CNO confirmed that while sterile supplies were monitored monthly for outdates and package integrity, staff responsible for monitoring did not have the necessary education, training, or expertise to evaluate appropriate packaging of sterile supplies. While ORTech A's last performance review was completed by ORM/CNO, ORM/CNO confirmed the review did not include competency in the sterilization process.

The facility provided an AORN policy and procedure titled, "Surgical Instruments, Cleaning and Care-All Types," dated 2015. The policy indicated instruments would be sterilized according to the manufacturer's written IFU (instruction for use). The policy indicated the quality management program would include monitoring. Regarding staff competency, the procedure indicated, "perioperative personnel involved in the cleaning and care of surgical instruments and equipment will receive education and complete competency verification."

The AORN Guidelines for Sterilization Recommendation XVII, dated 1/2017, was reviewed and indicated, "Personnel should receive initial and ongoing education and competency validation for sterilization practices. Initial and ongoing education of perioperative personnel on sterilization practices facilitates the development of knowledge, skills, and attitudes that affect safe patient care. Periodic educational programs provide the opportunity to reinforce the principles of sterilization, the compatibility of equipment and accessories, and the potential hazards to patients and personnel; and to introduce new information on technology changes and new applications. Competency validation measures individual performance and provides a mechanism for documentation. Competency assessment verifies that perioperative personnel have an understanding of sterilization and sterilization practices. XVII.a. An introduction to and review of policies and procedures should be included in personnel orientation to sterile processing of surgical instruments in the perioperative setting...."

The facility's job description titled, "Operating Room Technician", dated 5/2016, was reviewed and indicated the position responsibilities and duties were "rated as part of the employee's competency-based performance appraisal. Within the parameters established by the CNO, and approved policies and procedures, the incumbent (OR Tech) is assigned the following position responsibilities and duties: Understands ... sterilization techniques.... Is able to process items in the washer/sterilizer, autoclave or cold sterilization liquid, following proper procedures...." The job description indicated required "position knowledge" included "... must have broad knowledge of instruments, sterilization, sterile techniques ...."

The facility's policy titled, "Inservice Education, Continuing Education," dated 4/4/18, was reviewed and indicated the purpose of the policy was "to define the current processes used at (the facility) to provide personnel with education opportunities that enable them to: (1) maintain competencies, (2) create new competencies, or (3) correct deficiencies identified in CQI (continuous quality improvement) findings." The policy standard indicated "inservice education consists of those activities that assist personnel to fulfill assigned responsibilities specific to the performance expectations for their respective job/working environment. These activities are conducted within the facility and are directed at current hospital, department, and unit-specific standards. The aim of in-service is to maintain competency (in relation to existing standards); to create new competencies (in relation to newly developed standards/requirements); and to respond to CQI findings (convert non-compliance to compliance)."

2. a. On 6/8/17 at 9:40 am, during a concurrent observation and interview, the Infection Control Nurse (ICN) confirmed the area for staff to change into surgical attire (scrubs) was also a bathroom (for emergency and operating room staff), which was not in sanitary condition and was not set up to serve as a changing area. The bathroom had a buildup of black/brown removable substances and debris throughout the floors, especially along the floor edges, and spider webs behind the door. There was no place to set/hang clothing while changing. While the bathroom had a separate stall for the toilet, a shower, and shower entrance area, there was no designation that indicated which area of the bathroom was intended for changing into scrubs. The ICN confirmed this had the potential for cross-contamination from the bathroom onto scrub attire, and subsequently to patients provided with surgical services. The area adjacent to the ER/OR bathroom was a staff breakroom which was also used to change into scrubs by some of the staff. The ICN confirmed the staff breakroom was not clean or sanitary when food debris and a buildup of dark removable substances were observed throughout the floor.

b. On 6/5/17 at 2:40 pm, during an observation of OR 1, and a concurrent interview, Housekeeping Staff (HKS, responsible for cleaning the surgical services suite) 11 confirmed the floors in OR 1 had a buildup of dark discoloration on the edges of the flooring that did not come off with regular mopping.

On 6/5/17 at 3 pm, during an interview, the ICN stated the OR floors were recently "stripped (removal of old wax, soil, and debris)" by Maintenance Staff (MS) 12.

On 6/8/17 at 9:10 am, during an interview, MS 12 stated he had used a buffer machine (with scrubbing pad attached) to deep clean the floor of OR 1 using a disinfectant solution. ICN was present during the interview and confirmed the buffer pad would not be effective to clean the curved edges of the floors.

On 6/8/17 at 9:40 am, during an observation of the surgical services suite and a concurrent interview, the ICN confirmed the floors throughout the area had a buildup of dark discoloration on the floor edges and door thresholds. ICN confirmed additional deep cleaning methods were needed.

c. On 6/5/17 at 2:30 pm, during an observation of the endoscope reprocessing room and a concurrent interview, HKS 11 confirmed the floors on the right side of the room were not maintained in a clean condition when the floor and room drain included a buildup of dust, dirt, and debris.

On 6/8/17 at 9:40 am, during an observation of the scope reprocessing room, and a concurrent interview, the ICN confirmed that regular daily housekeeping should include the entire floor.

d. On 6/7/17 at 3 pm, the ORM/CNO confirmed oversight of environmental services for surgical services had been delegated to the housekeeping manager. The ORM/CNO confirmed nursing management had not been involved in monitoring the specifics of what was being cleaned.

On 6/8/17 at 9:40 am, during an interview, the ICN confirmed she had not been involved in oversight of environmental cleaning for surgical services.

3. On 6/5/17 at 10:50 am, during the initial tour of the surgical services suite, an interview with the ORM/CNO took place. The ORM/CNO confirmed two sterile packages, that had been previously opened, contained 5.0 french (a measurement) tracheal tubes and were available for use in OR 1. The ORM/CNO confirmed a box of size 9 gloves that expired 5/2017 was located in the surgical supply area and was available for use. The ORM/CNO confirmed these expired and previously opened supplies should have been removed from service.

On 6/5/17 at 2 pm, during an observation of the ventilator (breathing machine) cart and a concurrent interview, the Certified Registered Nurse Anesthetist (CRNA) confirmed a bag of humidifiers had expired 12/2011. The CRNA stated these humidifiers were no longer used, but should have been removed from the cart so that they were not available for use.

4. On 6/6/17 at 2:10 pm, during an interview, the ICN explained the procedures for surveillance of post-operative SSIs. The ICN acknowledged that monitoring for post-operative SSIs did not include a process to obtain information (regarding post-operative SSIs) from the physician that provided the patient's post-operative care.

The facility's policy titled, "Infection Control Program," dated 1/26/18, was reviewed and indicated the purpose of the policy was to "provide policies and procedures for Infection Control (IC) surveillance, infection identification, infection prevention, data interpretation ...." The policy indicated that important aspects of the program included activities to "develop, implement and monitor systems for identifying, collecting data, analyzing and reporting incidents and causes of infection." The policy indicated tracking would include the development of wound infections after clean surgical procedure, and development of wound infections following ambulatory surgery.

5. On 6/8/17 at 3 pm, during an interview, the ORM/CNO confirmed she did not have specialized training in the provision of surgical services/management of surgical service operations.

6. On 6/7/17 at 4 pm during an interview and concurrent review of contracted RN 9's file (a contract employee), the Human Resource Manager (HR) confirmed that RN 9's contract indicated she would provide circulating nurse duties in the OR. HR provided a "contractor checklist" (used to complete files for contract employees). HR stated RN 9 had been hired prior to implementation of the checklist and confirmed items missing from RN 9's file included license verification, background and reference checks, date of last PPD (a test to determine exposure to tuberculosis, an infectious disease), employee physical, drug screen, date of last influenza vaccine, human resource notifications, and orientation with the Director of Staff Development.

On 6/7/17 at 4 pm, during an interview, the ORM/CNO confirmed that orientation and training for RN 9 should be the same as that provided to other staff. Missing training from RN 9's file included N95 mask fit test (a mask that has specific fit requirements to be effective), annual house-wide competencies, annual infection control review, CQI/Safety (included incident reporting and quality assurance form), mandated reporters of abuse including "Your Legal Duty" video and test, and competencies specifically related to circulating nurse duties.

7. Review of the admission records indicated Patient 26 (a child) was admitted for an outpatient surgical procedure on 1/17/17 with diagnoses that included enlarged tonsils.

a. On 6/8/17 at 9:55 am, during an interview and concurrent record review, the CRNA confirmed Patient 26's record included "PACU ORDERS" (post anesthesia care unit orders), dated 1/17/17 at 10:30 am, for medications that were dosed for an adult. At 10:45 am, the CRNA provided appropriate dosages (pediatric) for the child. Review of Patient 26's PACU ORDERS indicated a preprinted form with available spaces to fill in the date and time. The form included a selection of medications with pre-printed dosages, to be check marked, if indicated in the order. The form had a handwritten notation which indicated "per anesthesia" after the medications check marked in the order. The CRNA confirmed that pediatric doses were not available on the preprinted form. The CRNA explained that pediatric dosages were based on weight and "should be handwritten individualized orders for each pediatric patient."

The CRNA confirmed the adult doses in the order, as compared to appropriate pediatric doses for Patient 26, were as follows:

Morphine (for pain) 2 milligrams (mg) intravenous (IV), may repeat every five minutes to a maximum dose of 10 mg (maximum dose for Patient 26 was 6 mg), Dilaudid (for pain) 1-2 mg IV, may repeat one time in five minutes as needed (appropriate dose for Patient 26 was 0.35 mg every 10 minutes, may repeat one time), Demerol (for shivering) 12/5 mg IV, may repeat in five minutes as needed (appropriate dose for Patient 26 was 11.8 mg to 23.6 mg every 15 minutes, may repeat one time), Ondansetron (for nausea) 4 mg IV, as needed, may repeat one time (appropriate dose for Patient 26 was 3.54 mg every four to six hours), Romazicon (reversal agent) 0.2 mg IV, as needed, may titrate slowly to max of 0.5 mg (appropriate dose for Patient 26 was one 0.2 mg dose), Narcan (reversal agent) 0.1 mg IV, as needed, may titrate slowly to max of 0.4 mg (appropriate dose for Patient 26 was 0.02 mg (1 microgram/ kilogram) to 0.23 mg (10 micrograms/kilogram) titrated.

b. On 6/8/17 at 9:50 am, during an interview and concurrent record review, RN 8 confirmed Patient 26's physician orders for admission did not include the date or time.

c. On 6/8/17 at 9:55 am, during an interview and concurrent record review, the CRNA confirmed Resident 26's "Consent for Anesthesia Services" form was not complete when it did not include the time it was signed. The CRNA confirmed the area of the form to indicate the "substitute's signature" (parent-guardian) relationship (to the patient) was left blank.

Based on observation, interview, and record review, the hospital failed to ensure the care provided was adequately evaluated to ensure hospital practices reflected hospital policies and procedures, Medical Staff Rules and Regulations, federal and state law, and/or standards of practice when:

1. Emergency services failed to ensure the needs of its patients were met in accordance with acceptable standards of practice when the well-being of fetuses (unborn babies) was not adequately assessed, the triage of patients and vital signs and pain assessments were not performed for emergency department patients, and an emergency crash cart, necessary for performing life-saving procedures, had expired supplies available for use (Refer to C 201 and C 204).

2. Surgical services failed to ensure sterilization procedures for hinged instruments met the required industry standards, the general conditions of the changing room, Operating Room (OR), and reprocessing room were unsanitary, expired supplies were available for use in the OR, surveillance of post surgical site infections was not monitored, a contracted Registered Nurse did not have a completed employee file per hospital requirements, a minor child's post-operative orders included medication doses for an adult, and an admission order/consent form did not include dates, times, and signatures in accordance with hospital policies and procedures, the Infection Control Nurse and/or the OR Manager/Chief Nursing Officer (ORM/CNO) did not monitor the cleaning of the OR and OR instruments, and the ORM/CNO did not have specialized education or training in the sterilization of instruments, general cleaning of the surgical services area, and OR to provide acceptable oversight and management (Refer to C 320).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure compliance with Emergency Services, Surgical Services, and with Periodic Evaluation and Quality Review. The continued systemic problems had the potential to persist and lead to compromised patient care outcomes.

Based on interview, record review, and facility document review, the hospital failed to ensure that all patient care services affecting the health and safety of patients were evaluated.

This resulted in the facility's failure to identify quality issues and had the potential for problems to persist and compromise patient care outcomes.

Findings:

The hospital policy and procedure titled, "Organizational Performance Improvement Plan," with an expiration date of 4/28/18, was reviewed and indicated, "Our quality improvement efforts will focus on care delivery processes and support processes that promote optimal patient outcomes and effective business practices. This is accomplished through peer review, clinical outcomes review, variance analysis, and other quality improvement techniques...The Scope of the Performance Improvement (PI) Program is organization wide...The program includes:
*All patient care services and other services affecting patient health and safety...

The administration shall oversee the development and implementation of PI activities for all hospital departments and ensure the integration and coordination of department-specific activities into the organization-wide PI program...The medical staff at...participates in surgical case review; blood usage review; medical record review; infection control; pharmacy and therapeutics review; mortality review; utilization management; and credentialing...Each department shall review their scope of service and goals and maintain quality control measures and quality control activities."

During an interview on 6/8/17 at 10:05 am with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Quality/Risk Manager (QIRM), and the Infection Control Nurse (ICN), they acknowledged lack of compliance with the following deficient practices:

*Patient needs were not met in accordance with acceptable standards of practice when the well-being of fetuses was not adequately assessed in the Emergency Department (ED).

*Triage (the process of deciding which patients should be treated first) of patients, vital signs and pain assessments were not performed for ED patients in accordance with the hospital's policy and procedure.

*Emergency supplies, Operating Room (OR) supplies, and medications were expired and available for use throughout the hospital.

*The sterilization procedures for hinged instruments (instruments that have metal to metal action that are used during surgery) did not meet the required industry standards.

*The general conditions of the changing room, OR, and reprocessing room (room where sterilization of reusable equipment takes place) were unsanitary.

*The Infection Control Program failed to ensure surveillance of post surgical site infections, failed to identify and control the possible spread of infection to patients in the Emergency Department (ED) when an inadequate hopper (toilet) splashguard (covering) was used, and failed to ensure policies and procedures for early identification and transmission prevention of Multidrug-Resistant Organisms were followed.

*A contracted Registered Nurse did not have a completed employee file per hospital requirements.

*There was an inadequate supply of cold normal saline immediately available for use in case of a malignant hyperthermia (a disease that causes a fast rise in body temperature and severe muscle contractions) emergency, and there was an inadequate emergency supply of Crotalidae Polyvalent Immune Fab (anti-venom for poisonous snake bites), in accordance with manufacturer's specifications.

*The hospital pharmacy failed to store all medications, emergency medications, and dispensed medications in an organized and uncrowded manner and in accordance with manufacturer's guidelines.

*A child's post-operative orders included medication doses for an adult and an admission order/consent form did not include dates, times, and signatures in accordance with the hospital's policies and procedures.

*The hospital did not ensure adequate procedures for patients with a latex allergy.

*The hospital did not ensure all physicians orders, including dosages, were complete.

*Menus were not reviewed and approved by the Registered Dietician and the Diet Manual was not approved by the Board of Directors.

*The hospital did not ensure compliance with appropriate documentation of blood product administration, including timely assessment, reassessment, monitoring, and medication administration.

*The hospital did not ensure the ED log was maintained in accordance with its policy.

*The hospital did not ensure all parts of the medical record were kept.

*The hospital did not ensure the ORM/CNO had specialized education and/or training in the sterilization of instruments, and general cleaning of the surgical services area and OR to provide acceptable oversight and management for the OR.

In the interview, the QIRM confirmed there were no specific quality indicators (measures of performance or outcome of healthcare delivery, commonly chosen to correlate with greater patient safety and decreased mortality) regarding care provided to pregnant patients. The CNO stated they had been working on assessment of vital signs and pain in the ED but were not 100 % compliant. The CEO, CNO, QIRM, and ICN agreed the quality program would have to be more robust to ensure compliance with the Medicare Conditions of Participation and State Licensing requirements.