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

RIDEOUT MEMORIAL HOSPITAL 726 4TH ST MARYSVILLE, CA 95901 March 4, 2015
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the facility failed to ensure nursing services were furnished or supervised by a registered nurse consistent with nationally accepted standards of practice as evidenced by:

1. Patient 3 did not receive two doses of a time critical (see facility policy below) antibiotic (medications used to treat infections), one dose of an anticoagulant (blood thinner medication used to prevent blood clots and stroke), and one dose of aspirin, as ordered by the physician. The physician was not notified of the missed medications as required by the facility policy. Patient 3's nursing plan of care was not followed when her intake and output was not recorded. (Refer to A 405 finding 1, A 500 finding 3, and A 396 finding 4)

2. Patient 1 did not receive six doses of antibiotics, two doses of medication to treat a fungal infection, and two doses of anticoagulants, as ordered by the physician. (Refer to A 405 finding 2)

3. Patient 2 did not receive one dose of cholesterol lowering medication as ordered by the physician. The physician's plan of care and orders were not implemented by nursing staff when Patient 2 did not have an abdominal sonogram (imaging test that uses sound waves to produce pictures of the organs in the abdomen) completed. (Refer to A 405 finding 3 and A 396 finding 3)

4. Patient 9 did not receive one dose of antibiotics and anticoagulant, and received two other antibiotics more than 24 hours after they were ordered by the physician. The physician was not notified of the missed medications, as required by the facility policy. (Refer to A 405 finding 4)

5. Patient 10 did not receive two antibiotics as ordered by the physician for two days. The physician was not notified of the missed medications as required by the facility policy. Patient 5's lab tests were not completed as ordered by the physician. (Refer to A 405 finding 5 and A 583 finding 2)

6. Patient 11 did not receive one antibiotic for two days, did not receive one antibiotic for more than 24 hours after it was ordered by the physician, and did not receive one medication to prevent ulcers for three days. The physician was not notified of the missed medications as required by the facility policy. Patient 5's lab tests were not completed as ordered by the physician. (Refer to A 405 finding 6 and A 583 finding 3)

7. Patient 5 did not receive two antibiotics for one day as ordered by the physician, received another antibiotic and anticoagulant too early, and received double doses of a cholesterol lowering medication for three days. The physician was not notified of the missed medications as required by the facility policy. Patient 5's admission and ongoing assessments were not performed, completed, documented and filed in her medical record for each shift, and there was no physician notification of a significant change in heart rate as required by hospital policy. Patient 5's lab tests were not completed as ordered by the physician. (Refer to A 405 finding 7, Refer to A 396 finding 1, and Refer to A 583 finding 1)

The cumulative effect of the systemic problems resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Nursing Services and resulted in medication errors which had the potential to compromise the health of patients and cause a decline in their condition due to improper medication administration, delays in treatment, and failure to follow the nursing and physician ordered plan of care.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on interview and record review, the hospital failed to ensure their emergency room staff were able to correctly define medication allergies for one of 19 sampled patients (Patient 5).

This had the potential to result in adverse drug reactions and a decline in the patient's health status.

Findings:

Patient 5's Triage Exam Assessment (assessment of a patient to determine the severity of condition and how soon he should be seen by the physician), dated 2/13/15 at 11:48 am, included a section for Allergies: "No Known Drug Allergies" was documented.

Patient 5's emergency room (ER) Nurse Note at 1 pm on 2/13/15 showed she was ready for a physician exam, that her allergies had been reviewed with her and a No Allergy arm band had been applied.

Patient 5's Medication Reconciliation (a list of medicines the patient ordinarily takes at home that include allergies), dated 2/13/15 at 4:35 pm, showed she had multiple drug and other allergies that included: Coumadin (a blood thinner), morphine (narcotic pain medication frequently given in emergency room s), hydrachlorathiazide (a diuretic water pill), Reglan (assists bowel motility), triamcinalone (corticosteroid cream), red dye and yellow dye.

On 3/2/15 at 12:23 pm, the Director of ED (DED) stated that NKDA stood for what allergies were known at the time by the nurse. When it was explained that NKDA meant that the patient does not have any known drug allergies and DED was shown that Patient 5 had multiple significant allergies, DED stated that the nurse was concerned about more important issues.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure four of 18 sampled patients' (Patients 5, 4, 2, and 3) care was provided as planned by the nurses and physicians, following the hospital's Electronic Health Record data loss between 2/13 and 2/14/15 when:

1. Patient 5's admission and ongoing assessments were not performed, completed, documented and filed in her medical record for each shift, medication administration records were completed accurately, and physician notification of a serious heart rhythm was not done, as required by hospital policy.

2. Patient 4's medication administration records were not completed accurately.

3. Patient 2's abdominal sonogram (imaging test that uses sound waves to produce pictures of the organs in the abdomen) was not completed, as ordered by his physician.

4. Patient 3's Intake and Output (I&O) was not recorded, as indicated in her care plan.

This resulted in a delay in completing tests and treatment as ordered by the physician, and the lack of accurate information had the potential to negatively impact patients' treatments, clinical status and recovery.

Findings:

1. Patient 5 was transferred by ambulance and admitted to the hospital's emergency room (ER) for shortness of breath (SOB) and low blood pressure at 11:38 am on 2/13/15.

a. On 3/2/15, the hospital's Adult Admission Assessment/Screen for Multidisciplinary Needs Form (Manual Method) - Nursing policy, dated 8/8/12, showed the admission assessment was to be completed on every adult patient and was to include objective data and nursing diagnoses. The admission assessment was then utilized to obtain a comprehensive data base to identify each patients' needs, problems and limitations and the information was used to formulate the patient's multidisciplinary care and discharge plan.

On 3/2/15 at 9:45 am Quality Improvement Staff (QIS) C confirmed that Patient 5's Admission Assessment, dated 2/13/15 at 9 pm, was not complete. QIS C confirmed that Patient 5's Admission Assessment exam portion was not completed with her vital signs and that the Objective Data and Nursing Diagnoses columns were left blank and had not been completed.

QIS C concurrently confirmed that Patient 5's Admission Assessment reason for coming to the hospital was completed as CP (chest pain) and SOB. QIS C concurrently reviewed Patient 5's Plan of Care and Problem List, dated 2/13/15, that listed her chief complaint as CP. Under the Problems List section, "Cardiac" was left unchecked. QIS C confirmed this was an error.

On 3/2/15 at 3:40 pm, Admitting Nurse (AN) E stated that the admitting nurses were instructed not to complete the Objective and Nursing Diagnoses column approximately two years ago. AN E stated that the hospital had told them and trained them that they were not to complete it when manually charting during downtime. AN E confirmed that this did not meet the hospital's Adult Admission Assessment/Screen for Multidisciplinary Needs Form (Manual Method) - Nursing policy, dated 8/8/12. AN E stated that the hospital had instructed the admitting nurses of the change even though they may not have "formally" changed the written policy.


b. The hospital's 24 Hr Med-Surg (Downtime) Flow Sheet (Manual/Paper Method of Recording) - Nursing policy, dated 6/17/2013, showed that the Med-Surg downtime flow sheet would be used to describe the patient's condition and nursing actions in order to show a clear and concise overall clinical picture [DIAGNOSES REDACTED]'s 24 Hour Medical Surgical Flowsheet.

Patient 5's record was reviewed on 2/18/15 and revealed that the 24 Hour Medical Surgical Flowsheets included columns for each shift and sections for Nutrition, Equipment and MD's (medical doctor) visits that were left blank between 2/14 and 2/17/15 when the hospital's electronic documentation system was down. In between Patient 5's 24 Hour Medical Surgical Flowsheets were three sets of four page E-Doc Missing Documentation Notifications that read, "The following document is currently missing from this record: Form Title: 24 Hour Medical Surgical Flowsheet Page 1 of 4" followed by Page 2 of 4, Page 3 of 4 and Page 4 of 4.

On 3/3/15 at 3 pm, QIS C confirmed that Patient 5's record contained E-Doc Missing Documentation Notification slips for the 24 Hour Medical Surgical Flowsheets.

c. Patient 5 MARs were reviewed on 3/2/15 and included a set that had no date on them to indicate when the medications were given to her. There were no initials to show they had been check by the nurses for accuracy on Day or Night Shift. .

Patient 5's MARs, dated 2/15/15, were not initialed as checked by the Day shift nurse for accuracy.

Patient 5's MARs for 2/16/15 were dated on one of the four pages and there were no allergies listed on the two pages of routine medications. None of the four pages were not intialed as checked by the Day shift nurse for accuracy and three of the four pages were not initialed as checked by the Night shift nurse for accuracy.

Patient 5's MARs for 2/17/15 were nor initialed by the Day or Night shift nurses as checked for accuracy on any of the four pages. The Triamcinalone was omitted from the list of allergies written in.

The hospital's unapproved Downtime Procedures - Hospitalwide policy, dated 1/23/15, showed that both the Night and Day shift nurse would check the MAR for accuracy and initial in the "MAR checked" column.

d. Patient 5 was transferred by ambulance and admitted to the hospital's emergency department (ED) for shortness of breath (SOB) and low blood pressure at 11:38 am on 2/13/15.

On 2/18/15, Patient 5's hospital admission orders, dated 2/13/15 at 5:50 pm, were to admit her to medical surgical unit on telemetry (method of remotely monitoring the heart rhythm of a patient).

The hospital's Telemetry Monitor - Nursing policy, dated 10/29/14, showed its purpose was "To provide safe consistent care and early recognition of cardiac arrhythmias to the patient requiring continuous telemetry monitoring." The policy showed that if arrhythmia caused the telemetry unit to send an alarm, the nurse was to notify the MD, Rapid Response Team or the Code Blue Team and document this in the patient's record.

A review of Patient 5's records showed her in [DIAGNOSES REDACTED](irregular chronic rhythm) with a rate between 70 and 100 beats per minute (HR, normal) from 2/13 until 2/18/15. Patient 5's record included multiple arrhythmia events on
2/19/15 from 4:23 until 4:25 am, where her HR doubled and ranged from 166 to 173. There was a handwritten notation on the arrhythmia event record that the charge nurse was informed.

There was no documentation in Patient 5's record that the MD was informed as it stated in the policy.

During an interview and concurrent record review on 3/2/15 at 9:45 am, Quality Improvement Staff (QIS) C confirmed that Patient 5's Admission Assessment reason for coming to the hospital was CP (chest pain) and SOB. QIS C confirmed Patient 5's chief complaint on her Plan of Care and Problem List, dated 2/13/15, was listed as CP.

On 3/3/15 at 4 pm, QIS C confirmed that Patient 5's heart rate had significantly changed and there was no documentation that her MD was notified.

2. On 2/18/15, the hospital's unapproved Downtime Procedures - Hospitalwide policy, dated 1/23/15, showed that "When administering a med you must document the time and initials under the appropriate column. Exact times will be entered at time of administration...Any medications that are discontinued will be highlighted out with a yellow highlighter."

Patient 4 was admitted on [DATE].

On 2/18/15. Patient 4's physician orders, dated 2/14/15 at 9 am, to discontinue his intravenous (IV)fluids and change his IV Protonix to PO (by mouth) were reviewed.

Patient 4's MARs were reviewed for 2/13 and 2/14/15. All of the medications listed on the 2/13/14 MAR were highlighted in yellow. Patient 4's intravenous fluid and intravenous Protonix (medication given for heartburn) had handwritten red ink notations that they were d/c ed (discontinued) at 10 am. There were scheduled administration times printed on the MARs but no times with initials noted, to show when the medications were actually administered.

On 2/18/15 at 2:30 pm, Registered Nurse (RN) L stated that she should have used the yellow highlighter to discontinue the medications on 2/14/15, not written in red ink. RH L stated that the 2/13/15 MARs should not have had the all of the medications highlighted in yellow unless they were discontinued.

On 2/18/15 at 2:20 pm, QIS M stated that nursing had not followed the hospital's policy for discontinued medications on their MARs. QIS M stated they should have used a yellow highlighter to identify the discontinued medications and not used it elsewhere.





3. A review of Patient 2's record indicated he (MDS) dated [DATE] at 12:04 am and was admitted to medical unit at 9:34 pm with diagnoses that included [DIAGNOSES REDACTED]. Patient 2 was discharged on [DATE] at 2:40 pm. No results for an abdominal ultrasound could be found in the record.

During an interview on 3/3/15 at 3:25 pm, Quality Improvement Staff (QIS) F confirmed the abdominal sonogram was not done as ordered by the physician. Since the facility's electronic medical record was not functioning, the test had to be delivered to the imaging department instead of entered directly into the computer. QIS F explained that the imaging department had not received the order from nursing.

4. A review of Patient 3's record indicated she was admitted to the Emergency Department (ED) on 2/12/15 at 3:38 pm with a complaint of stomach pain. She was treated and discharged on [DATE] at 1:22 am. Patient 3 was readmitted on [DATE] at 9:15 pm with complaints of stomach pain, nausea and vomiting. She was admitted to the hospital and was transferred from the ED to a medical floor on 2/15/15 at 12:45 pm and discharged on [DATE] at 3:30 pm.

A review of Patient 3's care plan indicated that her Intake and Output (I&O) would be recorded in the record daily. No I&O could be found in Patient 3's record.

During an interview on 3/3/15 at 2:15 pm, Regulatory and Quality Improvement Staff (RQIS) B confirmed there was no I&O recorded for Patient 3. She said the nurses would ordinarily enter the I&O into the computer as part of the electronic medical record system (EMR). RQIS B confirmed the EMR was not functioning during Patient 3's admission and the nurses did not chart the I&O on the hard copy (handwritten) record they used during that time.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure medications were given, as ordered by the physician and according to hospital policy and procedure, for seven of 19 patients, six of whom had serious infections, as evidenced by:

1. Patient 3 did not receive two doses of a time critical antibiotic (medications used to treat infections), one dose of an anticoagulant (blood thinner medication used to prevent blood clots and stroke), and one dose of aspirin, as ordered by the physician. The physician was not notified of the missed medications, as required by the facility policy. (Refer to A 500)

2. Patient 1 did not receive six doses of antibiotics, two doses of medication to treat a fungal infection, and two doses of anticoagulants, as ordered by the physician.

3. Patient 2 did not receive one dose of cholesterol lowering medication, as ordered by the physician.

4. Patient 9 did not receive one dose of antibiotics and anticoagulant, and received two other antibiotics more than 24 hours after they were ordered by the physician. The physician was not notified of the missed medications, as required by the facility policy.

5. Patient 10 did not receive two antibiotics, as ordered by the physician, for two days. The physician was not notified of the missed medications, as required by the facility policy.

6. Patient 11 did not receive one antibiotic for two days, did not receive one antibiotic for more than 24 hours after it was ordered by the physician, and did not receive one medication to prevent ulcers for three days. The physician was not notified of the missed medications, as required by the facility policy.

7. Patient 5 did not receive two antibiotics for one day, as ordered by the physician, received another antibiotic and anticoagulant too early, and received double doses of a cholesterol lowering medication for three days. The physician was not notified of the missed medications, as required by the facility policy.

These failures resulted in medication errors and had the potential for patients to experience a significant decline in their health condition due to improper medication administration.

Findings:

On 2/18/15 at 1 pm, Registered Nurse (RN) L stated that on 2/13/15 following the Electronic Health Record crash, medications were administered late for newly admitted patients because their medicines were not in the Accudose (automated drug dispensing machine). RN L stated she had to run the orders to the pharmacy or call them to come and get them.

A facility policy titled, "Medication Administration - Hospitalwide," created 9/23/14 and last reviewed 2/24/15, was reviewed. The policy gave the following definition for "time critical scheduled medications: medication for which an early or late administration of greater than 30 minutes might cause harm or have a significant impact on the intended therapeutic or pharmacological effect." An antibiotic, Nafcillin was listed in the policy as a time critical medication. The policy indicated that non-time-critical scheduled medications may be administered within one hour before or after the scheduled dosing time. Medications ordered "Now" should be administered, "no more than one hour from time of physician order. Subsequent doses would be profiled according to standard administration times..." The standard medication administration time for twice per day would be 9 am and 9 pm. Medications prescribed for daily or longer administration intervals may be administered with two hours before or after the scheduled dosing time. The nurse must document in the electronic medication administration record (MAR) the reason for missed medication administrations. The reporting of medication errors that are the result of missed or late dose administration must be reported to the physician.

1 a. A review of Patient 3's record indicated she was admitted to the Emergency Department (ED) on 2/12/15 at 3:38 pm with a complaint of stomach pain. She was treated and discharged on [DATE] at 1:22 am. Patient 3 was readmitted on [DATE] at 9:15 pm with complaints of stomach pain, nausea and vomiting. She was admitted to the hospital and was transferred from the ED to a medical floor on 2/15/15 at 12:45 pm.

It was noted in the MD consultation report, dated 2/15/15, Patient 3 had a PEG tube (percutaneous endoscopic gastrostomy, tube placed into the stomach for nutrition and medications) site cellulitis (a serious skin infection that happens when bacteria spreads through the skin to deeper tissues). There was a physician's order dated 2/15/15 at 7 pm for Nafcillin 500 milligrams (mg) intravenous (IV) every six hours. The scheduled administration times were 7 pm, 1 am, 1 pm, and 7 am.

A review of Patient 3's MAR for 2/16/15, indicated the medication was given at 1:50 am. The 7 am and 1 pm doses were circled to indicate the medication had not been given and at the bottom of the MAR the following was noted at 12:20 pm: "Nafcillin not available from pharmacy - not given at 0700."

During a concurrent record review and interview on 3/3/15 at 10:10 am, Nurse Manager (NM) D confirmed the Nafcillin was not given at 7 am and 1 pm, and stated the nurses would usually call the pharmacist if a medication was missing.

During an interview on 3/3/15 at 11:30 am, the Director of Pharmacy (DOP) stated the pharmacy had not mixed enough Nafcillin to comply with the physician's order.

b. A review of Patient 3's MAR for 2/17/15 indicated the scheduled 9 am doses for Aspirin and Lovenox (anticoagulant) were not given. At the bottom of the MAR, it was noted that these medications were not available from the pharmacy.

During a concurrent record review and interview on 3/3/15 at 10:10 am, Nurse Manager (NM) D confirmed the Aspirin and Lovenox was signed as not given because they were unavailable.

During an interview on 3/3/15 at 11:30 am, the Director of Pharmacy (DOP) stated Aspirin was available and had been taken out of the Accudose (automatic drug dispensing cabinet) for Patient 3. He stated he was unsure why the nurse took it out then wrote not given on the MAR. DOP confirmed the Accudose was out of Lovenox at the scheduled dosing time of 9 am, however, the Accudose was restocked at 9:46 am, so had the nurse checked again, the Lovenox would have been available.

During an interview on 3/4/15 at 9:55 am, Regulatory and Quality Improvement Staff (RQIS) B stated it was reasonable for the pharmacy to restock the Accudose in 45 minutes and the nurse should have checked back later that morning to see if the Lovenox was available. RQIS was unable to get any more information regarding why the Aspirin, although removed from the Accudose, was signed as not given.

c. No documentation regarding notification of the physician regarding the missed doses of Nafcillin and Lovenox could be located in Patient 3's record.

During an interview on 3/4/15 at 9:55 am, RQIS B stated she found documentation on 2/16/15 at 11 am that the doctor was notified of the patient's condition. She confirmed it did not specifically state the doctor was notified of the missing dose of Nafcillin. She was unable to find any documentation that the doctor had been notified of the second missing dose of Nafcillin on 2/16/15 or the missing dose of Lovenox on 2/17/15.

2. a. A review of Patient 1's record indicated she was admitted to the facility on [DATE] with a complaint of [DIAGNOSES REDACTED], wound cellulitis, and possible sepsis (a serious illness caused by bacteria and infection in the blood). A review of physician orders indicated an order, dated 2/11/15 at 6 pm, for Zosyn (antibiotic) 3.376 Grams every six hours for ten days, IV. The MAR showed daily scheduled administration times for 6 pm, 12 am, 6 am, and 12 pm. Zosyn was not signed as given on the MAR for any doses due on 2/12/15 and at 12 am on 2/14 and 2/15/15.

Other physician orders for Patient 1 included an order, dated 2/11/15 at 4 pm, for Lovenox (anticoagulant) 40 milligrams (mg) daily and for Diflucan (used to treat fungal infections) 100 mg daily. The MAR showed daily scheduled administration times for 9 am. These medications were not signed as given on the MAR for 2/12/15 and 2/16/15. Further review of the MAR for 2/12/15 indicated that no medications had been signed as given for this date.

During a concurrent review of Patient 1's record and interview on 3/2/15 at 11:15 am, Registered Nurse (RN) I (the charge nurse) confirmed there was no MAR to show what medications were given for 2/12/15. RN I was not able to find any documentation to show that the Zosyn, Diflucan, and Lovenox were given, at the dates and times as indicated in the above review, or documentation to indicate why the medications were not given as ordered.

The missing documentation regarding the MAR for 2/12/15 was discussed with the Director of Regulatory Compliance (DRC) on 3/3/15 at 9:05 am, and a MAR was provided for 2/12/15. This report listed the medications and times they were to be given to Patient 1, but did not include nurses initial or signatures to indicate that the medications had been given.

b. Other orders for Patient 1 included another antibiotic (Zyvox) 600 mg, IV every 12 hours, ordered on [DATE] and not started until more than five hours later. Nursing documentation indicated this medication was pending from the pharmacy and not started until 8:52 pm.

During an interview on 3/3/15 at 10:55 am, DOP stated when the EHR first went down, the nurses faxed through Paragon (the facility's computer system) even though it was nonfunctioning, then would call the pharmacy and ask for medications. DOP said they explained to the nurses, they had to fax to the pharmacy departmental number and this was the reason for some of the late or missing medications.

During a concurrent review of the above documentation and interview on 3/3/15 at 12:05 pm, the DOP confirmed the order for Zyvox had been received and confirmed in the pharmacy at 3:18 pm on 2/11/15. DOP confirmed the medication had been prepared and sent to the unit by 4 pm for the nurses to give. DOP said he didn't know why the nurses noted this medication was pending from pharmacy or why it was not started until 8:52 pm.

3. A review of Patient 2's record indicated he (MDS) dated [DATE] at 12:04 am and was admitted to medical unit at 9:34 pm with diagnoses that included [DIAGNOSES REDACTED]. A review of the MAR indicated Lipitor had not been given.

During an interview on 3/3/15 at 11:45 am, DRC confirmed Lipitor had not been given to Patient 2.





4. Patient 9's record review indicated she was brought to the ED on 2/11/15 at 1:41 pm with worsening symptoms in her legs related to swelling, redness and discharge. Patient 9 was admitted at 11:46 pm to the hospital with cellulitis of both legs.

The physician medication orders indicated as follows:
a. 2/11/15 at 9:50 pm, Levaquin (antibiotic) 500 milligrams (mg) IV every 24 hours.
b. 2/11/15 at 9:50 pm, Vancomycin (antibiotic) 1 gram IV every 24 hours.
c. 2/14/15 at 9:45 am, Cipro (antibiotic) 40 mg IV twice a day (BID).
d. 2/15/15 at 8:40 am, Lovenox (anticoagulant) 1 mg/kilogram subcutaneous twice a day discontinue when INR (international normalized ratio, lab test used to determine the effectiveness of anticoagulants) more than or equal to 2.0.

The MAR's were reviewed and no paper or electronic medication administration records could be found for the entire date of 2/12/15. The MAR's from 2/13-2/17/15 noted the following:
a. The first dose recorded of Levaquin was given on 2/13/15 at 7 am, 33 hours after the physician's order.
b. The first dose recorded for Vancomycin was given on 2/13/15 at 5 am, 31 hours after the physician's order.
c. Cipro was not given on 2/15/15 at the scheduled time of 2 am.
d. The first dose recorded for Lovenox was on 2/16/15 at 9:50 am, one day after the physician order. There was only one dose given on 2/17/15 at 9:30 am, the physician order was for twice a day.

There was documentation regarding missing medications noted for Ciproflaxin (Cipro) 40 mg IV BID for the 2 am and 2 pm doses. The form was faxed on 2/15/15 at 2:21 pm to the pharmacy. The Cipro was not given at 2 am on 2/15/15 and the 2 pm dose was given at 3:30 pm, a hour and a half later.

During a concurrent interview and record review on 3/4/15 at 9:30 am, Registered Nurse (RN) G confirmed there was no paper nor electronic record for the medication administration for Patient 9 on the date of 2/12/15. RN G further confirmed the missing documentation for the administration of Lovenox and documentation which noted missing medications for Cipro. RN G could not find any documentation in the record that the physician was aware of the missing medication doses.

5. Patient 10's record review indicated he was brought to the ED on 2/14/15 at 4 pm with shortness of breath, coughing and wheezing. Patient 10 was admitted same day at 6:38 pm for right lower lobe pneumonia and renal insufficiency (poor kidney function).

The physicians orders, dated 2/14/15 at 4 pm, were as follows:
a. Rocephin (antibiotic) one gram IV every 12 hours for 5 days.
b. Zithromax (antibiotic) 500 mg IV daily for 5 days.

During a concurrent interview and record review on 3/2/15 at 1:30 pm, RN G confirmed there was no record of antibiotic administration for Rocephin and Zithromax on 2/14/15 and 2/17/15. RN G further stated there was no physician notification of the missed doses.

6. A review of Patient 11's record indicated she was brought to the ED after being found on the floor in her home for an unknown amount of time. Patient 11 was admitted on [DATE] at 6:11 pm, with a myocardial infarction (heart attack), low blood pressure and sepsis.

The Medical Doctor (MD) indicated in the History and Physical plan area, dated 2/12/15, that Patient 11 was given IV Cipro and Zosyn, pending her blood and urine culture report.

The physicians orders, dated 2/12/15 at 6:11 pm, indicated Cipro 400 mg IV every 12 hours, Zosyn 3.375 grams IV every 6 hours and Protonix (treats excessive stomach acid) 40 mg IV every 24 hours.

The ED orders that were completed on 2/12/15, did not indicate that Cipro, Zosyn. nor Protonix were given before Patient 11 was transferred to the medical surgical floor. The medical orders noted that Rocephin (antibiotic) was completed on 2/12/15 at 6:10 pm.

During a concurrent interview and record review on 3/2/15 at 11:30 am, the MAR's from 2/12/15 through 2/17/15 were reviewed with RN G. The Cipro was incorrectly transcribed into the electronic medical record as to be given once a day at 10 pm, although it was ordered as twice a day. There was no record that Cipro, Zosyn, nor Protonix were given on 2/12/15. The Zosyn was discontinued by the MD on 2/13/15 at 7 am. It was not given on 2/13/15 at 5 am as scheduled, 11 hours after ordered. The Cipro order was corrected on the MAR to twice a day on 2/13/15 with a schedule for 8 am and 10 pm, it was given at 10:40 pm, 28 hours after being ordered by MD. The Protonix was given for the first time on 2/14/15 at 10:40 pm, 3 days after it was initially ordered. RN G confirmed during the record review that there was no record these medications were given as ordered by the physician and that the physician was not notified of the medication administration errors.




7. Patient 5 was transferred by ambulance and admitted to the ED for shortness of breath (SOB) and low blood pressure at 11:38 am on 2/13/15.

On 2/18/15, Patient 5's Admitting Physicians Orders, dated 2/13/15 at 5:50 pm, showed that Rocephin (an antibiotic) was ordered IV BID (twice per day), Eliquis (anticoagulant was ordered by mouth (PO), Florastor (probiotic) PO BID, and Zoloft (antidepressant) PO daily, Atorvastatin (Lipitor, anticholesterol medication) was ordered once daily.

Patient 5's ED Nursing Notes showed she received the first dose of Rocephin at 1 am the following morning on 2/14/15 (over 7 hours later).

A review of Patient 5's Physician Progress Note, dated 2/18/15, showed she had sepsis and continued with Rocephin treatment.

During an interview with Pharmacy Project Manager on 3/2/15 at 10 am, he stated that antibiotics were to be administered within one hour of being ordered.

Patient 5's undated MAR listed Eliquis, Florastor and Zoloft with no administrations indicated. The handwritten notation "Not available" was written in the Eliquis and Florastor 9 pm dose areas. Patient 5's MAR showed that her 9 am Eliquis, Florastor and Zoloft doses were not initialed as given. According to LexiComp online, Eliquis has a U.S. Boxed Warning (black box warning, most serious type of warning mandated by the U.S. Food and Drug Administration) that reads, "Premature discontinuation of any oral anticoagulant, including apixaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic (blood clot) events."

The Atorvastatin was listed on the undated MAR as once daily. Patient 5's MAR, dated 2/15/15, showed the Atorvastatin had been transcribed inaccurately as BID and in fact, administered BID in the morning and evening on 2/15, 2/16, and 2/17/15.

Lovenox (anticoagulant) was ordered BID "Start Now" on 2/15/15 and was given at 5:30 pm and again at 11 pm the same evening. Vancomycin (an antibiotic) was ordered BID on 2/15/15 at 4:30 pm and given at both 4:30 pm and 9 pm (4 1/2 hours apart).

The hospital's Medication Administration Hospitalwide policy, dated 2/20/15, showed that medications ordered "Now" should be administered, "no more than one hour from time of physician order. Subsequent doses would be profiled according to standard administration times..." The policy showed that the antibiotic Vancomycin would be on an every 12 hour dose to be administered at 9 am and 9 pm. The Standard Administration Times Guidelines showed that the second doses for the BID Lovenox (start now) and Vancomycin should not have been administered until 9 am on 2/16/15. The policy showed that the provider was to be notified of missed doses and an occurrence report completed.

On 3/3/15 at 12:00 pm, Patient 5's MAR for 2/16/15 showed her intravenous Rocephin was not administered at 9 pm and there was no explanation. The MAR showed her 9 am dose of Vancomycin was not administered with no explanation. During a concurrent interview, DOP stated Patient 5's Rocephin and Vancomycin doses were missed on 2/16/15 and that her second doses of Lovenox and Vancomycin were given too soon on 2/15/15. DOP confirmed that those second doses should have been administered at 9 am on 2/16/15. DOP stated that the missed Eliquis was serious due to risk of stroke.

On 3/2/15 at 9:45 am, Quality Improvement Staff (QIS) C stated they were not able to verify that the provider was notified about Patient 5's missed doses of antibiotics or that occurrence reports were done.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0431
Based on interview and record review, the facility failed to ensure a medical record was maintained for all patients and ensure responsibility for all patients' medical records when its Electronic Health Record (EHR) ceased to operate. The facility failed to ensure:

There was a complete and accurate medication administration record and/or lab reports on 2/12/15 for five of six sampled patients (Patients 1, 11, 15, 18, and 19), who were present in the facility on that date. (Refer to A 405 finding 2, A 438 finding 1, A 494, and A 583 finding 3)

All prior medical records were readily available and accessible when physicians needed to access current and prior records for two of 19 sampled patients (Patients 3 and 10) and one patient outside the sample. (Refer to A 438 findings 2, 6, and 8)

It had a method to ensure labs and radiology orders were implemented, as ordered by the physician, for four of 19 patients (Patients 2, 5, 10, and 11). (Refer to A 438 findings 3, 7, and 9, A 583 findings 1 - 3)

It had the capability to perform all scheduled cardiac imaging for 15 days. (Refer to A 438 finding 4)

It had the capability to administer cancer radiation treatment to patients for 10 days. (Refer to A 438 finding 5)

This resulted in a delay in and/or failure to administer medication, inability to review prior medical records including radiology films, delay in completion of labs and radiology tests, an inability to follow the trail of Controlled Drugs from delivery to the facility to administration of the drugs to patients, and cancellation of radiation cancer treatments and cardiac cath procedures (heart related tests and procedures that includes those such as when a catheter is inserted into an artery and threaded into the heart to check for blockages, if a blockage is found a small metal tube can be placed in the artery to prevent it from reclosing), placing patients at risk for serious decline of their health conditions.

The cumulative effect of the systemic problems resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Medical Record Services.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, when the facility's electronic health record (EHR) system failed, it was unable to ensure:

There was a complete and accurate medication administration record and/or lab reports for 2/12/15, for five of six sampled patients (Patients 1, 11, 15, 18, and 19) who were present in the facility on that date. (Refer to A 494,and A 583 findings 1- 3)

All prior medical records were readily available and accessible when physicians need to access current and prior records for two of 19 sampled patients (Patients 3 and 10) and one patient outside the sample.

There was a method to ensure labs and radiology orders were implemented as ordered by the physician for four of 19 patients (Patients 2, 5, 10, and 11). (Refer to A 396 finding 3, A 583 findings 1-3)

It had the capability to perform all scheduled cardiac imaging for 15 days.

It had the capability to administer cancer radiation treatment to patients for 10 days.

This resulted in a delay in and/or failure to administer medication, inability to review prior medical records including radiology films, delay in completion of labs and radiology tests, an inability to follow the trail of Controlled Drugs from delivery to the facility to administration of the drugs to patients, and cancellation of radiation cancer treatments and cardiac catherization procedures (heart related tests and procedures that include those such as when a catheter is inserted into an artery and threaded into the heart to check for blockages, if a blockage is found a small metal tube can be placed in the artery to prevent it from reclosing) placing patients, at risk for serious decline of their health conditions.

Findings:

On 3/3/15 at 7:09 am, the facility's Chief Executive Officer emailed a document titled, "Information Systems Disaster Recovery Timeline" to Centers for Medicare/Medicaid Service (CMS). This document had been completed by the Chief Information Officer (CIO). The following was noted to have occurred on 2/13/14 at 4:15 am: "At this point, the full extent of the disruption was being assessed, but the main enterprise patient information systems that were known to be down were:
*McKesson Paragon (EHR System) - Pharmacy Information System, Radiology Information System, Patient Registration System, Patient Financial System, Materials Management System
*Horizon Patient Folder (Permanent Medical Record)
*Horizon Cardiology
*Sunquest LIS (Lab information) system
*Varian/Aria System (Cancer Center EHR)
2/16/15 4 pm: "Lab system is up to support all lab operations. Interfaces kept down to allow for orderly reconciliation and catch-up."
2/17/15 at 2 pm: "Paragon system running well. Radiology up 100% and Nursing directed to begin using full system functionality at 7 pm."
2/18/15 4 pm: "LIS system fully functional with all interfaces. Paragon functioning at 100%. Accudose medication cabinet interfaces re-enabled."
2/21/15 9 am: "Varian System fully operational for Cancer patients to resume treatments at our location."
2/29/15 7 pm: "Horizon Cardiology interface catch-up completed. System fully operational."

1. A review of Patient 1's record indicated she was admitted to the facility on [DATE]. A review of the medication administration record (MAR) for 2/12/14 indicated that no medications had been signed as given for this date. Physician orders included antibiotics to treat a serious infection.

During a concurrent record review and interview on 3/2/15 at 11:15 am, Registered Nurse (RN) I (the charge nurse), confirmed there was no MAR to show what medications, including the antibiotics, were given for 2/12/15.

The missing documentation regarding the MAR for 2/12/15 was discussed with the Director of Regulatory Compliance (DRC) on 3/3/15 at 9:05 am, and a MAR report was provided. This report listed the medications and times they were to be given to Patient 1 but did not include nurses' initials or signatures to indicate that the medications had been given.

During an interview on 2/20/15 at 11 am, the Director of Pharmacy (DOP) was asked to describe the failure of the hospital computer systems. DOP's description included that the hospital lost the use of Paragon in the early hours of 2/13/15. Paragon was a computer program to manage the hospital's electronic health records (EHR). The EHRs were stored in Horizon Patient Folder (HPF) to create the hospital's permanent electronic medical records. DOP's description included the restoration of Paragon's electronic medication administration record to hospital use on 2/18/15.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10 am, Pharmacy Technician (Pharm Tech 1) and Pharmacist (Pharm 1) identified an AcuDose-Rx (ADC) schedule II dispensing record. Inspection of the 1 West station (nursing station, patient care area)record showed on 2/12/2015 04:42:57 and 2/12/2015 09:03:51, HYDROcodone (narcotic used for pain relief)/APAP (acetaminophen, used for pain relief) 5/325MG (milligram) (CII) 1 TAB was dispensed for Patient 18. Pharm Tech 1 and Pharm 1 reviewed Patient 18's MAR for documentation of the administration of the two CII dispenses from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the two CIIs dispensed by the ADC.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10:05 am, Pharm Tech 1 and Pharm 1 identified an ADC CII controlled substances dispensing record. Inspection of the station 1W record showed on 2/12/15 17:39:46 fentaNYL (narcotic used for pain relief) TRANSDERMAL SYSTEM (skin patch) 50 MCG (microgram)/HR (hour) (CII) 1 (patch). Further inspection showed 17:39:56 and 17:42:17 fentaNYL TRANSDERMAL SYSTEM 100 MCG/HR (CII) (1 patch each time for a total of two), and 2/12/2015 21:51:04 HYDROmorphone (narcotic used for pain relief) (CII) 4 MG TAB 1 TAB, was dispensed for Patient 1. Pharm Tech 1 and Pharm 1 reviewed Patient 1's MAR for documentation of the administration of the CII dispenses from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the four CIIs dispensed by the ADC.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10:10 am, Pharm Tech 1 and Pharm 1 identified an ADC CII controlled substances dispensing record. Inspection of the station 2W record showed on 2/12/2015 10:00:54 Morphine SULFATE (narcotic used for pain relief) (CII) 10 MG INJ (injection) was dispensed for Patient 15. Pharm Tech 1 and Pharm 1 reviewed Patient 15's MAR for documentation of administration of the CII dispense from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the CII dispensed by the ADC. Pharm 1 stated that due to the 2/13/15 computer failure not all of the 2/12/15 hospital electronic medical record MARs were available in HPF.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10:15 am, Pharm Tech 1 and Pharm 1 identified an ADC CII controlled substances dispensing record. Inspection of the station 2W record showed on 2/13/2015 00:03:39 Morphine SULFATE (CII) 2 MG INJ was dispensed for Patient 19. Pharm Tech 1 and Pharm 1 reviewed Patient 19's MAR for documentation of the administration of the CII dispense from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the CII dispensed by the ADC.

During an interview on 3/4/15 11:40 am, the missing MARs (medications included antibiotics and/or controlled narcotics) for Patients 1, 15, 18, and 19 were discussed with the CIO. He stated that Paragon does a 24 hour feed and had not done the back up feed for 2/12/15 when the computer system went down on 2/13/15, so they knew the data for 2/12/15 would not be available. He stated they were going through the entire census for all patients (177) in the hospital on [DATE] and getting that information from their backup system and putting it into the patients' medical records. He was unable to give an estimate when all information for all patients would be completely restored.

2. A review of Patient 3's record indicated she was admitted to the Emergency Department (ED) on 2/12/15 at 3:38 pm with a complaint of stomach pain. She was treated and discharged on [DATE] at 1:22 am. Patient 3 was readmitted on [DATE] at 9:15 pm with complaints of stomach pain, nausea and vomiting. She was admitted to the hospital and was transferred from the ED to a medical floor on 2/15/15 at 12:45 pm.

During the ED visit on 2/12/15, Patient 3 had a CT (computerized axial tomography) scan of the abdomen and pelvis. This radiology test was compared to a prior test Patient 3 had done in 2012. Upon Patient 3's return to the ED on 2/15/15, another CT of the abdomen and pelvis was done. This test noted there were no relevant prior studies available even though Patient 3 had the same test done three days before.

The following was noted in the MD consultation report, dated 2/15/15, "It should be noted that our history is very limited because the Paragon EHR has not been functioning for three days. Our data is extremely limited and we are currently trying our best."

During an interview on 3/3/15 at 1:40 pm, the Chief Operating Officer (COO) reviewed the above reports and confirmed their contents. He stated the interface to the radiology system was still down at that time. The COO stated that "prior patient records being available to the physicians in the method the physicians were accustomed to using," was down from 2/13/15 until 2/17 or 2/18 and referred to the CIO for the exact date.

3. A review of Patient 2's record indicated he (MDS) dated [DATE] at 12:04 am and was admitted to medical unit at 9:34 pm with diagnoses that included uncontrolled high blood pressure and coronary artery disease. A review of the physician orders indicated an order, dated 2/14/15 at 1 pm, for an abdominal sonogram (imaging test that uses sound waves to produce pictures of the organs in the abdomen) to be done the following morning (2/15/15). Patient 2 was discharged on [DATE] at 2:40 pm. No results for an abdominal ultrasound could be found in the record.

During an interview on 3/3/15 at 3:25 pm, Quality Improvement Staff (QIS) F confirmed the abdominal sonogram was not done as ordered by the physician. Since the facility's electronic medical record was not functioning, the test had to be delivered to the imaging department instead of entered directly into the computer. QIS F explained that the imaging department had not received the order from nursing.

4. During an interview on 3/3/14 at 1:40 pm, the COO confirmed that the cardiac cath lab (where heart related procedures are performed such as a catheter is inserted into an artery and threaded into the heart to check for blockages, if a blockage is found a small metal tube can be placed in the artery to prevent it from reclosing) was significantly affected by the EHR malfunction. Images from the cardiac cath lab were unable to be recorded onto the hospital's system, so the cardiologists elected to postpone elective (non-emergency) procedures, although an emergency procedure could have been done.

During an interview on 3/4/15 at 11:40 am, the CIO confirmed that the cardiology system was not fully functional until the night of 2/28/15.

5. During an interview on 2/18/15 at 3 pm, the Chief Operating Officer (COO) confirmed all Radiation Oncology (cancer) treatments had to be canceled for all patients since Friday (2/13/15) due to computer server damage. He said there was no way, due to the system being down, to tell how much radiation had been received by the patients in the past to enable them to transfer elsewhere.

The schedule provided by the facility showed 18 patients had to be cancelled on 2/13/15. Thirteen of the 18 patients on the schedule were noted to have daily treatments, Monday through Friday.

During an interview on 2/20/15 at 3 pm, the Vice-President of the Cancer Center stated that the treatments patients had completed on 2/12/15, were not showing up in their records.

During an interview on 3/4/15 at 11:40 am, the CIO confirmed that patients were not ready to be seen until 2/23/15.




6. Patient 10's record review indicated he was brought to the ED on 2/14/15 at 4 pm with shortness of breath, coughing and wheezing. Patient 10 was admitted the same day at 6:38 pm for right lower lobe pneumonia and renal insufficiency (poor kidney function).

During a review of the physician documentation of Patient 10's initial assessment, the cardiologist made a statement during the history of present illness, "I do not have access to computerized records and I am using written records as our Paragon system is down." Another comment was noted under the assessment and plan section which stated, "At this point and time, I have to monitor his Protime (PT, how long blood takes to clot) and International Normalized Ratio (INR, blood clotting time in seconds) as I do not have access to that information secondary to the malfunctioning computer system."

7. A review of Patient 11's record was reviewed and indicated she was admitted on [DATE] at 6:11 pm, with a myocardial infarction (heart attack), low blood pressure and sepsis (infection).

The physicians orders dated 2/12/15 at 6:11 pm were reviewed and indicated laboratory requests as follows:
a. Blood cultures (detect an infection in the blood) with culture and sensitivity (C&S, helps identify specific bacteria and antibiotics that are most effective in treating the infection) by two, STAT.
b. CBC to be done in am.
c. Comprehensive metabolic panel (CMP, metabolic test) to be done in am.
d. Cardiac enzymes (indicates level of heart injury by heart attack) every 8 hours times two.

There was no paper or electronic record of the laboratory tests for the CBC and CMP for 2/13/15.

The ED records were reviewed for 2/12/15 and there was no record under diagnostics which indicated any blood cultures were drawn by the laboratory. There was one set of cardiac markers done at 1:46 pm and no record that a second set of cardiac enzymes was performed eight hours later, as ordered by physician.

During a concurrent interview and record review on 3/2/15 at 11:30 am, RN G confirmed he could not find any paper or electronic record to show the blood cultures and second set of cardiac enzymes were done. The Laboratory summary indicated no record of blood cultures, CBC, CMP, or cardiac enzymes on 2/12-2/13/15. RN G confirmed the missing laboratory tests as ordered by physician and could not find documentation that the physician was notified.

8. During a tour of the intensive care unit (for critically ill patients) on 2/20/15 at 11 am, MD 3 stated he was still unable to access his patient's (not included in the sample) prior record and history in the HPF (patient's legal record) computer system. As a result, he stated it took longer to make treatment decisions for his patient.




9. Patient 5 was transferred by ambulance and admitted to the hospital for shortness of breath (SOB) and low blood pressure at 11:38 am on 2/13/15.

Patient 5's record included a Physician's Order, dated 2/16/15 at 6:10 am, for a CTA (Computerized Tomography Angiogram, scans with dye injected to show blood flow through vessels and tissue).

Patient 5's physician's Progress Note, dated 2/17/15 at 6:25 am, that showed that he assessed there was a blood clot in a pelvic artery and noted, "CTA pending."

Patient 5's physician's Progress Report, dated 2/18/15, read, "CT angio results still pending."

On 2/18/15, the hospital's, Downtime Procedures - Hospitalwide policy, created 1/23/15 but not yet approved, included a method for printing forms needed for physicians orders, progress notes, and flowsheets, in addition to how to access patients' MARs and active orders.


On 2/18/15 at 11:36 am, Nursing Informatics (NI) was interviewed about what problems arose on the floors following its "Catastrophic Data Failure" (a term used by the COO to refer to the facility's EHR failure) and the necessity for nurses to transition to downtime procedures. NI stated that the nurses on 4 Main had problems accessing the forms because they did not know they needed to "log off" of the network and it was not clarified in the unapproved policy. NI stated that no extra clerks were brought in to assist the nurses. When asked how long it took for the nurses to access their patients' orders to be able to provide their care, she stated she did not know.

On 2/18/15 at 2:30 pm, Emergency Preparedness Coordinator and Registered Nurse (EPC) stated that physicians and other staff were having problems getting patients' labs, x-rays, and seeing their history and physicals (H&Ps). EPC stated that staff were unable to get patients' previous EKGs (electrocardiograms, heart rhythm report). EPC stated that nurses did not know how to get to patients' active orders after the electronic record systems went down. EPC stated that the system crash slowed everything down and there were 20 to 25 patients in the lobby at any one time.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interview, and administrative record review, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The facility failed to ensure intravenous (IV, directly into a vein) antibiotics were available to be administered on schedule. For three (Patients 3, 6, 7) of three patient records reviewed, the hospital did not administer IV antibiotics within the required timeframe. For these three patients, the hospital documented a pharmacy issue (pending from Rx (pharmacy), multiple calls to pharmacy, not available from pharmacy) in obtaining four scheduled antibiotic doses. These failures resulted in the potential, from 2/13/15-2/16/15, for 123 patients a day, to be exposed to avoidable medication errors (missed and/or late doses of IV medications). (Refer to A 500)

2. The facility failed to ensure drug administration errors (medication errors) were reported to the physicians. For three (Patients 3, 6, 7) of three patient records reviewed, the hospital did not administer intravenous (IV, directly into a vein) antibiotics within the required timeframe. In three of three patient records, the hospital did not document the physicians were notified of the four missed and/or late doses of IV antibiotics.

These failures resulted in the potential for patients to be exposed to avoidable medication errors and the potential for patients to be exposed to avoidable infections due to missed and/or late doses of antibiotics. (Refer to A 508)

3. The facility failed to maintain readily retrievable, current and accurate records of the administration of schedule II drugs (CII) controlled substances (medications that have a high potential for diversion (theft) and abuse). In four (Patients 1, 15, 18, 19) of seven patient records reviewed, the hospital did not maintain readily retrievable documentation of the administration of eight schedule II drugs. The hospital documented schedule II drugs were dispensed by automated medication dispensing cabinets (ADC). The corresponding patient medical records did not document the administration of the schedule II drugs.

These failures resulted in the potential for undetected diversion of schedule II controlled substances. (Refer to A 494)

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on interview and record review, the facility failed to maintain readily retrievable, current and accurate records of the administration of schedule II drugs (CII) controlled substances (medications that have a high potential for diversion (theft) and abuse). In four (Patients 1, 15, 18, 19) of seven patient records reviewed, the hospital did not maintain readily retrievable documentation of the administration of eight schedule II drugs. The hospital documented schedule II drugs were dispensed by automated medication dispensing cabinets (ADC). The corresponding patient medical records did not document the administration of the schedule II drugs.

These failures resulted in the potential for undetected diversion of schedule II controlled substances.

Findings:

During an interview on 2/20/15 at 11 am, the Director of Pharmacy (DOP) was asked to describe the failure of the hospital computer systems. DOP's description included that the hospital lost the use of Paragon in the early hours of 2/13/15. Paragon was a computer program to manage the hospital's electronic health records (EHR). The EHRs were stored in Horizon Patient Folder (HPF) to create the hospital's permanent electronic medical records. DOP's description included the restoration of Paragon's electronic medication administration record (MAR, record of medication administration) to hospital use on 2/18/15.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10 am, Pharmacy Technician (Pharm Tech 1) and Pharmacist (Pharm 1) identified an AcuDose-Rx (ADC) schedule II dispensing record. Inspection of the 1 West station (nursing station, patient care area)record showed on 2/12/2015 04:42:57 and 2/12/2015 09:03:51, HYDROcodone (narcotic used for pain relief)/APAP (acetaminophen, used for pain relief) 5/325MG (milligram) (CII) 1 TAB was dispensed for Patient 18. Pharm Tech 1 and Pharm 1 reviewed Patient 18's MAR for documentation of the administration of the two CII dispenses from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the two CIIs dispensed by the ADC.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10:05 am, Pharm Tech 1 and Pharm 1 identified an ADC CII controlled substances dispensing record. Inspection of the station 1W record showed on 2/12/15 17:39:46 fentaNYL (narcotic used for pain relief) TRANSDERMAL SYSTEM (skin patch) 50 MCG (microgram)/HR (hour) (CII) 1 (patch). Further inspection showed 17:39:56 and 17:42:17 fentaNYL TRANSDERMAL SYSTEM 100 MCG/HR (CII) (1 patch each time for a total of two), and 2/12/2015 21:51:04 HYDROmorphone (narcotic used for pain relief) (CII) 4 MG TAB 1 TAB, was dispensed for Patient 1. Pharm Tech 1 and Pharm 1 reviewed Patient 1's MAR for documentation of the administration of the CII dispenses from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the four CIIs dispensed by the ADC.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10:10 am, Pharm Tech 1 and Pharm 1 identified an ADC CII controlled substances dispensing record. Inspection of the station 2W record showed on 2/12/2015 10:00:54 Morphine SULFATE (narcotic used for pain relief) (CII) 10 MG INJ (injection) was dispensed for Patient 15. Pharm Tech 1 and Pharm 1 reviewed Patient 15's MAR for documentation of administration of the CII dispense from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the CII dispensed by the ADC. Pharm 1 stated that due to the 2/13/15 computer failure not all of the 2/12/15 hospital electronic medical record MARs were available in HPF.

During a concurrent interview and electronic medical record review (HPF and EMR) on 3/4/15 at 10:15 am, Pharm Tech 1 and Pharm 1 identified an ADC CII controlled substances dispensing record. Inspection of the station 2W record showed on 2/13/2015 00:03:39 Morphine SULFATE (CII) 2 MG INJ was dispensed for Patient 19. Pharm Tech 1 and Pharm 1 reviewed Patient 19's MAR for documentation of the administration of the CII dispense from the ADC. Pharm Tech 1 and Pharm 1 stated the MAR did not document the administration of the CII dispensed by the ADC.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on interview and record review, the facility failed to ensure intravenous (IV, directly into a vein) antibiotics were available to be administered on schedule. In three (Patients 3, 6, 7) of three patient records reviewed, the hospital did not administer IV antibiotics within the required timeframe. In three of three patient records, the hospital documented a pharmacy issue (pending from Rx (pharmacy), multiple calls to pharmacy, not available from pharmacy) in obtaining four scheduled antibiotic doses. These failures resulted in the potential, from 2/13/15-2/16/15, for 123 patients a day, to be exposed to avoidable medication errors (missed and/or late doses of IV medications).

Findings:

During an interview on 2/20/15 at 11 am, the Director of Pharmacy (DOP) was asked to describe the failure of the hospital computer systems. DOP's description included that the hospital lost the use of Paragon in the early hours of 2/13/15. Paragon was a computer program to manage the hospital's electronic health records (EHR). The EHRs were stored in Horizon Patient Folder (HPF) to create the hospital's permanent electronic medical records. DOP's description included that Paragon's pharmacy information system provided logistical information including patient location, antibiotic dose, date antibiotic was due, and time antibiotic was due. DOP stated that Paragon was restored to pharmacy on 2/16/15.

1. During a concurrent interview and electronic medical record review (HPF and EMR) on 3/2/15 at 1:30 pm, Pharmacist (Pharm 1) identified Patient 6's IV antibiotic order. Inspection of the antibiotic order, submitted 2/11/15 17:54 by Physician (MD 1), showed "Zosyn (piperacillin-tazobactim) (antibiotic) 4.5 grams intravenous (IV, directly into a vein) Piggyback (mixed in a small bag of IV fluid) every 8 hours." The pharmacy prepared Patient 6's Zosyn in the sterile (germ free) IV compounding (mixing) area. Inspection of the MAR, dated 2/16/15, showed "Zosyn 4.5g (gram) q (every) 8 (hour) ...03-11-19." Continued inspection of the 2/16/15 MAR, for Zosyn scheduled for administration at 11 am, showed "pending from Rx (waiting for pharmacy)." Further inspection of the 2/16/15 MAR, for Zosyn, showed the next dose was administered at 1550 (5 hours later). Review of the nurses notes, dated 2/16/15 at 1350, showed "Pharmacy has been called multiple times since 1100 for Zosyn 4.5g am dose. The medication was not delivered until this time. Medication administered." Inspection of the MAR, dated 2/17/15, showed "Zosyn 4.5g IVPB (IV piggyback) q 8, 08, 1600, and 0000." Continued inspection of the 2/17/15 MAR, for Zosyn scheduled for administration at 08, showed "pending from Rx." Further inspection of the 2/17/15 MAR, for Zosyn, showed the next dose was administered at 1140 (greater than 3 hours later).

During a concurrent interview and electronic medical record review on 3/2/15 at 2:25 pm, Registered Nurse (RN H) identified Patient 6's medical record. RN H acknowledged the 2/16/15 MAR, for Zosyn scheduled for administration at 11, showed "pending from Rx." RN H acknowledged the 2/17/15 MAR showed "Zosyn 4.5g IVPB q 8, 08, 1600, and 0000." Continued inspection of the 2/17/15 MAR, for Zosyn scheduled for administration at 8 am, showed "pending from Rx."

2. During a concurrent interview and electronic medical record review (HPF and EMR) on 3/2/15 at 3:30 pm, Pharm 1 identified Patient 7's IV antibiotic order. Inspection of the antibiotic order, order phys: MD 1, submitted 2/13/15 18:16, showed "vancomycin (antibiotic) 1500 mg (milligram) intravenous every 12 hours." The pharmacy prepared Patient 7's vancomycin in the sterile IV compounding area. Inspection of the MAR, MAR check dated 2/14/15, showed "vancomycin 1,500 mg IV q 12 hrs." Continued inspection of the 2/14/15 MAR showed vancomycin 1,500 mg was administered at 0630. Further inspection of Profile: PB (MAR) (dated 2/14/15), for 1,500 mg vancomycin, showed "2/14/15 18:00 (entry timed at 1900) Pending from pharmacy not in AcuDose (ADC, automated medication dispensing cabinet)."

3. During a concurrent interview and electronic medical record review (HPF and EMR) on 3/3/15 at 1 pm, Pharm 1 and Registered Nurse (RN G) identified Patient 3's IV antibiotic order. Inspection of the antibiotic order, dated 2/15/15 at 19:00 by Physician (MD 2) showed "nafcillin (antibiotic) 500 mg IV q6h." The pharmacy prepared Patient 3's nafcillin in the sterile IV compounding area. Inspection of the MAR, dated 2/16/15, showed "nafcillin 500 mg IV q6 hr ...0100, 0700, 1300, 1900." Continued inspection of the 2/16/15 MAR, for nafcillin scheduled for administration at 0700, showed 0700 was circled. RN G stated the circled 0700 documented the nafcillin was not administered. Further review of the MAR, one time only medications/comments, timed 1220, showed "Nafcillin not available from pharmacy-not given at 0700."

During an interview on 3/4/15 at 11 am, Registered Nurse (RN J) was requested to provide the hospital census. RN J stated at both the main campus and its off site campus, the census was 116 on 2/13/15, 126 on 2/14/15, 142 on 2/15/15, and 175 on 2/16/15. RN J stated the average daily census at the offsite campus was 16.

During an administrative record review, of the hospital's policy and procedure for Medication Administration-Hospitalwide (v4), (Last Periodic Review: 2/24/15), showed III Policy, C. Medication Administration Schedule:, 2. Medication Not Eligible for Scheduled Dosing Times; a. "Medications not eligible or scheduled dosing times require exact or precise timing of administration, based on drug levels, urgency of need, peri-procedural, or based on other needs such as pain. This applies to all areas of the hospital. These medications include: ...i. Antibiotics dosed by serum level ( ...Vancomycin) ...3. Non-time-critical scheduled medications are: ...b. These medications may be administered within 1 hour before or after the scheduled dosing time, for a total window that does not exceed 2 hours." Continued review showed, Addendum A, Time Critical Medications, List of medications that should be administered within a 60 minute window of administration time, Antibiotics: "Nafcillin." The hospital failed to administer piperacillin-tazobactim within a 2 hour dosing window. The hospital failed to administer nafcilliln and vancomycin within a 1 hour dosing window.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
Based on interview and record review, the facility failed to ensure drug administration errors (medication errors) were reported to the physicians. In three (Patients 3, 6, 7) of three patient records reviewed, the hospital did not administer intravenous (IV, directly into a vein) antibiotics within the required timeframe. In three of three patient records, the hospital did not document the physicians were notified of the four missed and/or late doses of IV antibiotics.

These failures resulted in the potential for patients to be exposed to avoidable medication errors and the potential for patients to be exposed to avoidable infections due to missed and/or late doses of antibiotics.

Findings:

During an interview on 2/20/15 at 11 am, the Director of Pharmacy (DOP) was asked to describe the hospital's computer systems. DOP's description included that the hospital used Paragon. Paragon was a computer program to manage the hospital's electronic health records (EHR). The EHRs were stored in Horizon Patient Folder (HPF) to create the hospital's permanent electronic medical records.

1. During a concurrent interview and electronic medical record review (HPF and EMR) on 3/2/15 at 1:30 pm, Pharmacist (Pharm 1) identified Patient 6's IV antibiotic order. Inspection of the antibiotic order, submitted 2/11/15 17:54 by Physician (MD 1), showed "Zosyn (piperacillin-tazobactim) (antibiotic) 4.5 grams intravenous Piggyback (mixed in a small bag of IV fluid) every 8 hours." The pharmacy prepared Patient 6's Zosyn in the sterile (germ free) IV compounding (mixing) area. Inspection of the medication administration record (MAR, record of medications administered), dated 2/16/15, showed "Zosyn 4.5g (gram) q (every) 8 (hour) ...03-11-19." Continued inspection of the 2/16/15 MAR, for Zosyn scheduled for administration at 11, showed "pending from Rx (waiting for pharmacy)." Further inspection of the 2/16/15 MAR, for Zosyn, showed the next dose was administered at 1550 (5 hours later). Review of the nurses notes, dated 2/16/15 at 1350, showed "Pharmacy has been called multiple times since 1100 for Zosyn 4.5 am dose. The medication was not delivered until this time. Medication administered." Inspection of the 2/17/15 MAR showed "Zosyn 4.5g IVPB (IV piggyback) q 8, 08, 1600, and 0000." Continued inspection of the 2/17/15 MAR, for Zosyn scheduled for administration at 08, showed "pending from Rx." Further inspection of the 2/17/15 MAR, for Zosyn, showed the next dose was administered at 1140 (greater than 3 hours later).

During a concurrent interview and EMR review on 3/2/15 at 2:25 pm, Registered Nurse (RN H) identified Patient 6's medical record. RN H acknowledged the 2/16/15 MAR, for Zosyn scheduled for administration at 11, showed "pending from Rx." RN H acknowledged the 2/17/15 MAR showed "Zosyn 4.5g IVPB q 8, 08, 1600, and 0000." Continued inspection of the 2/17/15 MAR, for Zosyn scheduled for administration at 08, showed "pending from Rx." Pharm 1 and RN H reviewed the medical record and acknowledged it did not document the physician was informed of the two missed/late doses of piperacillin-tazobactim.

2. During a concurrent interview and electronic medical record review (HPF and EMR) on 3/3/15 at 11:15 am, Pharm 1 identified Patient 7's IV antibiotic order. Inspection of the antibiotic order, order phys: MD 1, submitted 2/13/15 18:16, showed "vancomycin (antibiotic) 1500 mg (milligram) intravenous every 12 hours." The pharmacy prepared Patient 7's vancomycin in the sterile IV compounding area. Inspection of the MAR, MAR check dated 2/14/15, showed "vancomycin 1,500 mg IV q 12 hrs." Continued inspection of the 2/14/15 MAR showed vancomycin 1,500 mg was administered at 0630. Further inspection of Profile: PB (MAR) (dated 2/14/15), for 1,500 mg vancomycin, showed "2/14/15 18:00 (entry timed at 1900) Pending from pharmacy not in AcuDose (ADC, automated medication dispensing cabinet)." Pharm 1 and Registered Nurse (RN G) reviewed the medical record and acknowledged it did not document the physician was informed of the late dose of vancomycin.

3. During a concurrent interview and electronic medical record review (HPF and EMR) on 3/3/15 at 1 pm, Pharm 1 and RN G identified Patient 3's IV antibiotic order. Inspection of the antibiotic order, dated 2/15/15 at 19:00 by Physician (MD 2) showed "nafcillin (antibiotic) 500 mg IV q6h." The pharmacy prepared Patient 3's nafcillin in the sterile IV compounding area. Inspection of the MAR, dated 2/16/15, showed "nafcillin 500 mg IV q6 hr ...0100, 0700, 1300, 1900." Continued inspection of the 2/16/15 MAR, for nafcilliln scheduled for administration at 0700, showed 0700 was circled. RN G stated the circled 0700 documented the nafcillin was not administered. Further review of the MAR, one time only medications/comments, timed 1220, showed "Nafcillin not available from pharmacy-not given at 0700." Pharm 1 and RN G reviewed the medical record and acknowledged it did not document the physician was informed of the missed nafcillin dose.

During an administrative record review of the hospital's policy and procedure for Medication Administration-Hospitalwide (v4), (Last Periodic Review: 2/24/15), showed, III Policy, C. Medication Administration Schedule: 2. Medication Not Eligible for Scheduled Dosing Times; a. "Medications not eligible or scheduled dosing times require exact or precise timing of administration, based on drug levels, urgency of need, peri-procedural, or based on other needs such as pain. This applies to all areas of the hospital. These medications include: ...i. Antibiotics dosed by serum level ( ...Vancomycin) ...3. Non-time-critical scheduled medications are: ...b. These medications may be administered within 1 hour before or after the scheduled dosing time, for a total window that does not exceed 2 hours." Continued review showed, Addendum A, Time Critical Medications, List of medications that should be administered within a 60 minute window of administration time, Antibiotics: "Nafcillin." Continued review showed V. This Policy Will Be Evaluated Annually to Determine Whether it Assures Safe and Effective Medication Administration, A. "The reporting of medication errors that are the result of missed or late dose administration must be reported to the attending physician." The hospital failed to administer piperacillin-tazobactim within a 2 hour dosing window. The hospital failed to administer nafcilliln and vancomycin within a 1 hour dosing window. The hospital failed to report these medication errors to the physician.
VIOLATION: EMERGENCY LABORATORY SERVICES Tag No: A0583
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to assure emergency laboratory (lab) services were provided to meet patient needs when three of 19 sampled patients' (Patients 5, 10, and 11) labs were not drawn, tested or reported, according to hospital policy and accepted standards of care, during the hospital's Electronic Health Record (EHR) data loss between 2/13 and 2/14/15.

This had the potential to delay diagnosis and treatment for patients and negatively impact their clinical status.

Findings:
On 2/18/15, the hospital's STAT (immediate) List of Tests and Result Reporting Turnaround Time policy, dated 8/14/14, showed that its purpose was to ensure that results were reported timely to optimize patient care and patient outcomes. It defined STAT tests as "Test results that are urgently needed for the diagnosis and treatment of the patient. The delay can be life threatening..." It showed that STAT test results were to be reported within one hour or less from the time the sample was received in the lab.

On 2/18/15 at 11:30 am, Nursing Informatics (NI) stated that after the hospital's EHR system crashed, there was a problem with patients' lab results getting delivered. NI stated that the physicians were upset that their patients' labs were not available to them.

1. Patient 5 was transferred by ambulance and admitted to the hospital's emergency department (ED) for shortness of breath (SOB) and low blood pressure at 11:38 am on 2/13/15.

On 2/18/15, Patient 5's Ambulance Run sheet, dated 2/13/15, showed she had difficulty breathing and had a history of heart disease, [DIAGNOSES REDACTED](irregular heartbeat that can lead to blood clots), complained of low blood pressure and had tightness in the chest the previous day.

Patient 5's Emergency Department Orders, dated 2/13/15, showed that Cardiac Markers (cardiac enzymes, lab tests used to diagnose, stratify risk of patients with chest pain and suspected acute coronary syndrome (ACS), evaluate severity and guide treatment decisions) were ordered at 12:08 pm on 2/13/15.

Patient 5's Laboratory Discreet Summary (screen printed 3/3/15) showed that her first Troponin Panel (cardiac markers) was ordered and the specimen collected at 1:30 pm on 2/13/15, one hour and 22 minutes after the ER physician's order. The second Troponin Panel showed it was ordered and collected on the following day 2/14/15 at 2:21 am (10 hours and 51 minutes after the first in the series). There was no evidence in Patient 5's record that the third set of cardiac markers (includes Troponin panel) was ever done.

Patient 5's ED Record, dated 2/13/15, included a Clinical Note for 2/13/15 at 5:02 pm (nearly 5 hours after it was ordered by the physician) that read, "cardiac markers still pending have DW (discussed with) lab multiple times and results still pending."

On 3/2/15 at 12 pm, Nurse Manager (NM) K stated that all labs in the ER were STAT. NM K stated that Patient 5's cardiac markers were diagnostics ordered to rule out MI (heart attack) and confirmed they were drawn at 1:30 pm on 2/13/15. Patient 5's physician admitting orders (issued after her emergency orders) were concurrently reviewed with NM K and included an order for cardiac enzymes every eight hours times two. NM K stated that these would have been Patient 5's second and third set of cardiac markers in a series of three. NM K stated that the second cardiac markers should have been drawn at 9:30 pm on 2/13/15, eight hours after the first set. NM K stated that the test was drawn 11 hours after the first set and confirmed it was three hours late.

On 3/3/15 at 2:06 pm, Lab Support Supervisor (LSS) stated that all draws in the ER were STAT orders to draw. When LSS was asked what the typical expectation was from the time the test was ordered until the specimen was tested in the lab, and said it was 30 minutes, including transport time.

On 3/3/15 at 2:10 pm, Quality Supervisor Lab (QSL) stated that the turnaround time for labs ordered in the ER was one hour, from order to result. She confirmed that Patient 5's second cardiac markers were late when ordered nearly 12 hours later.

On 3/3/15 at 2:30 pm, LSS stated Patient 5's second cardiac markers were late because their computer system generated lab test intervals that were ordered in a series (like cardiac markers). During the hospital's Electronic Health Record data loss, the system was not working or generating the follow up interval labs. LSS stated that when the hospital realized patients were not getting their follow up tests, the physicians were instructed to order the tests individually (not as a series).

On 3/3/15 at 3 pm, QSL was asked why the ER labs were not getting drawn timely and the physicians were not getting the results timely, she stated that the phlebotomists (lab technicians that draw blood for tests) were not seeing the orders in the ER. QSL stated that the lab results were being dispensed to multiple people and not getting to the physicians (that needed them to appropriately treat). QSL was not able to provide evidence that the third set of cardiac markers was drawn or done.

On 3/3/15 at 2:50 pm, Lab Tech Supervisor (LTS) confirmed that Patient 5's cardiac markers were drawn on 2/13/15 at 1:30 pm and the results were scanned at into the lab's system at 2:14 pm.





2. Patient 10's record review indicated he was brought to the ED on 2/14/15 at 4 pm with shortness of breath, coughing and wheezing. Patient 10 was admitted the same day at 6:38 pm for right lower lobe pneumonia and renal insufficiency (poor kidney function).

During a review of the physician documentation of Patient 10's initial assessment the cardiologist made a statement during the history of present illness, "I do not have access to computerized records and I am using written records as our Paragon system is down." Another comment was noted under the assessment and plan section which stated, "At this point and time, I have to monitor his Protime (PT, how long blood takes to clot) and International Normalized Ratio (INR, blood clotting time in seconds) as I do not have access to that information secondary to the malfunctioning computer system."

The physician orders reviewed indicated laboratory orders as follows:
a. 2/15/15 at 12:15 pm, Complete Blood Count (CBC, evaluates overall health) Renal panel (tests kidney function) , B-type Natriuretic Peptide (BNP, checks for heart failure), and PT/INR in am.
b. 2/16/15 at 4:50 pm, INR am.
c. 2/17/15 at 6:20 pm, Troponin (checks for heart damage) panel every six hours by two.
d. 2/17/15 at 6:20 pm, Lactic acid (checks for heart failure).

During a review of the Laboratory summary and results there were no indications that the CBC, Renal panel, BNP, PT/INR for 2/15/15, the INR for 2/16/15, and the Troponin for 2/17/15 were performed. The record indicated STAT (now) results on 2/18/15 for Troponin and Lactic acid, both one day late and PT/INR, 3 days later.

During a concurrent interview and record review on 3/2/15 at 1:30 pm, RN G confirmed that no paper or electronic record could be found for the physician ordered laboratory tests. RN G further stated no documentation could be found in the record that the physician was notified of the missing laboratory results.

3. A review of Patient 11's record was reviewed and she was brought to the ED after being found on the floor in her home for an unknown amount of time. Patient 11 was admitted on [DATE] at 6:11 pm, with a myocardial infarction (heart attack), low blood pressure and sepsis (infection).

The physicians orders dated 2/12/15 at 6:11 pm were reviewed and indicated laboratory requests as follows:
a. Blood cultures (detect an infection in the blood) with culture and sensitivity (C&S, helps identify specific bacteria and antibiotics that are most effective in treating the infection) by two, STAT.
b. CBC to be done in am.
c. Comprehensive metabolic panel (CMP, metabolic test) to be done in am.
d. Cardiac enzymes (indicates level of heart injury by heart attack) every 8 hours times two.

The physicians orders, dated 2/17/15, were reviewed and indicated a Creatnine Phosphokinase (CPK, determines muscle damage in heart attack) in am.

There was no paper or electronic record of the laboratory tests for the CBC and CMP for 2/13/15.

The Emergency Department records were reviewed for 2/12/15 and there was no record under diagnostics which indicated any blood cultures were drawn by the laboratory. There was one set of cardiac markers done at 1:46 pm and no record that a second set of cardiac enzymes was performed eight hours later, as ordered by physician.

During a concurrent interview and record review on 3/2/15 at 11:30 am, RN G confirmed he could not find any paper or electronic record to show the blood cultures and second set of cardiac enzymes were done. The Laboratory summary indicated no record of blood cultures, CBC, CMP, or cardiac enzymes on 2/12-2/13/15. The CPK for 2/17/15 was missing from the laboratory summary. RN G confirmed the missing laboratory tests as ordered by physician and could not find documentation that the physician was notified.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on interview and record review, the hospital failed to ensure one of 18 sampled patients was screened for the multi drug resistant organism MRSA [methicillin resistant staphylococcus aureus]) in the emergency room (ER), prior to her hospital admission on 2/14/15, and her flu screening form was completed accurately.

This had the potential for MRSA to be undetected and spread to patients and staff without proper protection and confusion as to the status of Patient 5 regarding her flu immunizations.

Findings:

1 a. Patient 5 was transferred by ambulance and admitted to the hospital's emergency room (ER) from a skilled nursing facility (SNF) for shortness of breath (SOB) and low blood pressure at 11:38 am on 2/13/15.

On 2/18/15, Patient 5's SNF-Facility Transfer Nursing sheet, dated 2/13/15, did not include any information about her history or whether she had or did not have any infections.

The hospital's Screening of Patients for MRSA on Admission-Hospitalwide Format policy, dated 7/10/14, showed that a screening tool would be used to screen patients for MRSA upon admission. The Screening Criteria showed that, "5. Any patient transferred from a skilled nursing facility" would be tested for MRSA within 24 hours of hospital admission.

A review of Patient 5's MRSA Active Surveillance Test Patient Screening Tool, dated 2/13/15, showed a question that read, "is patient being admitted from a long-term care facility?" and was inaccurately checked "No." The tool showed that Patient 5's MRSA screen was inaccurately checked for AST (Active Screening Test, nasal swab to test for MRSA) not performed and no MRSA test was done.

On 3/2/15 at 12:40 pm, Clinical Coordinator for the Emergency Department (CCED) stated, "Anyone coming from long term care (SNF) is suspect for MRSA" and should be screened.

On 3/2/15 at 2:18 pm, Quality Improvement Staff (QIS) C stated Patient 5 should have been tested for MRSA and that her screening tool was checked as not needing the test, in error. QIS C confirmed that not screening her could negatively impact other patients in the hospital by potentially exposing them to MRSA.

b. Patient 5's Admission Assessment, dated 2/13/15, was marked that she received her Pneumonia vaccine less than 5 years ago and received her "flu" shot this year in 2014.

Patient 5's Influenza/Pneumococcal Vaccination Screening form, dated 2/13/15, included Screening Criteria for each vaccine that included Exclusion Criteria boxes. The Influenza Vaccination Exclusion Criteria had a box for "Received influenza vaccine this flu season" that was left unchecked and a box for "Patient refuses" that was checked in error. The Pneumococcal Vaccination Exclusion Criteria included a box for "Received Pneumococcal vaccine less than or equal to 5 years ago" that was left unchecked and a box for "Patient refuses" that was checked in error.

On 3/2/15 at 2:14 pm, QIS C confirmed that the Patient 5's Influenza/Pneumococcal Vaccination Screening form was incorrectly completed when the box for "Patient refuses" had been checked for both.
VIOLATION: INTEGRATION OF OUTPATIENT SERVICES Tag No: A1077
Based on interview and record review, the facility failed to ensure outpatient services was sufficiently integrated to provide continuity of care when the Electronic Health Record (EHR) ceased operation. This resulted in cancer treatments being canceled and unavailable from 2/13/15 until 2/23/15 and cardiac cath procedures (heart related procedures such as an angiogram where a catheter is inserted into an artery and threaded into the heart to check for blockages, stenting where a small metal tube can be placed in the artery to prevent it from reclosing, etc.) being canceled, except for emergencies, from 2/13/15 until 2/28/15.

This resulted in missed radiation treatments for cancer and had the potential to result in a decline in the health condition of the affected patients.

Findings:

On 3/3/15 at 7:09 am, the facility's Chief Executive Officer emailed a document titled, "Information Systems Disaster Recovery Timeline" to Centers for Medicare/Medicaid Service (CMS). This document had been completed by the Chief Information Officer (CIO). The following was noted to have occurred on 2/13/14 at 4:15 am: "At this point, the full extent of the disruption was being assessed, but the main enterprise patient information systems that were known to be down were:
*McKesson Paragon (EHR System) - Pharmacy Information System, Radiology Information System, Patient Registration System, Patient Financial System, Materials Management System
*Horizon Patient Folder (Permanent Medical Record)
*Horizon Cardiology
*Sunquest LIS (Lab information) system
*Varian/Aria System (Cancer Center EHR)
2/21/15 9 am: "Varian System fully operational for Cancer patients to resume treatments at our location."
3/1/15 7 pm: "Horizon Cardiology interface catch-up completed. System fully operational."

1. During an interview on 2/18/15 at 3 pm, the Chief Operating Officer (COO) confirmed all Radiation Oncology (cancer) treatments had to be canceled for all patients since Friday (2/13/15) due to computer server damage. He said there was no way, due to the system being down, to tell how much radiation had been received by the patients in the past to enable them to transfer elsewhere.

The schedule provided by the facility showed 18 patients had to be cancelled on 2/13/15. Thirteen of the 18 patients on the schedule were noted to have daily treatments, Monday through Friday.

During an interview on 2/20/15 at 3 pm, the Vice-President of the Cancer Center stated that the treatments patients had on 2/12/15 was not showing up in their records.

During an interview on 3/4/15 at 11:40 am, the CIO confirmed that patients were not ready to be seen until 2/23/15.

2. During an interview on 3/3/14 at 1:40 pm, the COO confirmed that the cardiac cath lab was significantly affected by the EHR malfunction. Images from the cardiac cath lab were unable to be recorded onto the hospital's system, so the cardiologists elected to postpone procedures, although an emergency procedure could have been done.

During an interview on 3/4/15 at 11:40 am, the CIO confirmed that the cardiology system was not fully functional until the night of 2/28/15.