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.

COCHISE REGIONAL HOSPITAL 2174 WEST OAK AVENUE DOUGLAS, AZ Feb. 19, 2014
VIOLATION: DRUG STORAGE Tag No: C0224
Based on observation, and staff interview it was determined the facility failed to ensure medications, chemicals, and supplies were disposed of when expired.

Findings include:

A tour of the facility conducted on 02/04/2014, accompanied by the CEO revealed:
Operating Room Suite:
Lab Tubes Expired (Exp) 2009 and 2010;
Butterfly vacutainers Expired - 04/2012;
Metronidazole 500 mg IV bags x 3 - Expired 07/2013;
Betadine 16 fluid (fl) ounces (oz) x 2 - Expired 08/2013;
Cavicide 24 fl oz; Exp - 10/2012, on sink in soiled work room;
Cavicide Wipes in hallway Exp - 04/2013;
2 - Oxygen concentrators - expired 11/2011.

OR soiled work room currently in use contained:
Isopropyl Alcohol 16 fl. oz. Exp - 11/2012;
Ruchof Biocide detergent disinfectant 16 fl. oz. Exp - 10/2012;
8 oz. Prepyzme - Exp - 01/2012;
16 oz. Endozyme Exp - 10/2011;
16 fl. oz. Surgistain Exp - 08/2011;
FACTS (Foaming Autoclave Cleaning Treatment System) 8 oz. Exp - 08/2012;

A large unmarked plastic container with unknown liquid was found covered with numerous "poison" stickers. The hospital staff present identified the liquid as Formaldehyde. They did not know how long it had been there.

The hallway in the Operating Room suite had a blanket warmer, currently in use, that contained 5 one liter bags of Intravenous fluid that were brown and bulging.

The CEO verified the medications, chemicals, and supplies found were expired and should have been disposed of once expired or no longer safe to use.
VIOLATION: POLICIES - MED ERRORS & ADRS Tag No: C0277
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and staff interviews, it was determined the hospital:

1. failed to ensure all medication errors were reported in accordance with their policies and procedures. (Patient #1).

2. failed to ensure factual and pertinent information of a medication error was documented in the clinical record (Patient #2).

Findings include:

The hospital's policy and procedures on the subject of Medication Administration (Policy 2.Z.66) included: "Medication errors: 1. Document medication as given including dose, time, route, and rate if applicable. 2. Notify Physician if appropriate. 3. Describe any unusual reactions if present. Document any follow up care given and continue to monitor patient for any untoward responses. 4. Notify the Pharmacist of errors occurring as a result of pharmacy dispensing errors or delays."

There was no documentation that medication errors were being analyzed, tracked, and trended and actions taken to prevent reoccurrences.

The Chief Executive Officer (CEO)acknowledged during an interview on 2/12/2014 that medication errors were not included in their current quality program.

1. Review of Patient #1's medical record revealed the patient was admitted to the facility on [DATE], with new onset atrial fibrillation. The medication orders included: "01/07/14 at 16:53 Penicillin VK 500 mg (milligram) PO (Per Os), every 6 hours, Oral, Routine. The order was signed off by the Registered Nurse (RN) at 18:36. The RN notes at 20:00 hours revealed: "Cannot obtain medications that we do not have in stock (penicillin) at this time-no staff freely available r/t (related/to) high census in ER. Will obtain asap. 22:58 hours: ER staff faxed with orders needing pharmacy fill. Will administer next dose of penicillin at scheduled time of 0300..." No adverse event form was found for the missed dose.

The ADON acknowledged in an interview conducted on 02/05/2014, there should be a medication error report for a missed dose. She verified the missed dose should be followed to prevent re-occurrence.

The on-site pharmacist acknowledged in an interview conducted on 02/07/14, he had not been notified there was a problem getting the missed dose. He verified there was no way for him to know when a dose is missed or a wrong dose is given by the RN.

2. Patient #2 was admitted to the hospital's "Observation Service-Telemetry" from the emergency room on 2/4/2014 at approximately 3 a.m. The admitting diagnoses included [DIAGNOSES REDACTED]"Coreg 3.125 mg tab, 1 tablet (3.125 mg), twice a day, oral, routine." Coreg is a medication used to treat hypertension.

The on-site physician orders revealed: 02/04/14, at 07:53 a.m.: "Coreg 3.125 mg Tab, 1 tablet, twice a day, Oral, Routine. Patient #2 received 6.250 mg of Coreg on 02/04/14, at 09:30 a.m.

The RN reported she notified the physician of the increased dose but did not document the patient's response in the medical record. No documentation was found in the medical record the ED physician/hospitalist was aware of the medication error.

The recertification survey included a review of the hospital's reports of medication errors and their policies and procedures for quality improvement. On 2/6/2014 the hospital provided a report dated 2/4/2014 that Coreg 6.25 mg was administered to the patient on that date at 9:30 a.m. rather than the physician ordered 3.125 mg dose. According to the report, the error was discovered when the patient's blood pressure dropped to 100/30 at approximately 12 p.m. The clinical record was reviewed and revealed no documentation in the Medication Administration Record that any dose of Coreg was administered the morning of 2/4/2014. Also, there was no documentation in the nursing notes that the patient was given 6.25 mg of Coreg rather than 3.125 mg as ordered. The hospital located "Intake Documentation" in one of the computer systems that included an entry on 2/4/2013 at 9:30 a.m. that the patient was administered "Coreg 3.125 mg Tab" by the RN on duty at that time.

The RN who administered the medication acknowledged the event during an interview on 2/6/2014. She reported the medication is furnished in a 6.25 mg tablet which must be halved prior to administration to ensure the correct dose of 3.125 mg. When the patient's blood pressure started dropping she stated she realized she gave the patient the whole tablet rather than breaking it in half. She said she reported it to the physician. The RN was asked where she documented in the clinical record what happened and what follow up actions were to be taken to monitor the patient and she responded she was told that medication errors are only documented on separate reports but not in the clinical record. A separate interview was conducted with another RN and she also stated that medication errors are not documented in the clinical records.

The ADON acknowledged in an interview on 2/7/2014 that factual information of an event that has an impact or potential impact on the patient's health should be documented in the clinical record. She stated there was "some confusion" with nursing documentation of medication "errors" in the clinical record.

The hospital's Pharmacist was interviewed on 2/7/2014 at 7:30 a.m. and Patient #2's clinical record was reviewed with him. The Pharmacist reported he does not receive medication error reports and because of the concerns with the current computer systems he "would never have been aware of the medication error."
VIOLATION: EQUIPMENT AND SUPPLIES Tag No: C0204
Based on policy and procedure review, document review, job description review, and interview, it was determined that the Critical Access Hospital (CAH) leadership failed to ensure that the Emergency Department Crash Cart contained all required equipment and supplies, and was constantly ready for use, according to the Hospital's policies and procedures.

The "Crash Cart Policy" revealed: "1. To ensure that all crash carts and Defibrillators are constantly ready for use in case of life threatening conditions, such as cardiopulmonary arrest... PROCEDURE... 2. A licensed staff member (RN, LPN, RT, CNA, or EMT) (Registered Nurse, Licensed Practical Nurse, Respiratory Therapist, or Emergency Medical Technician, respectively), as designated by the patient care area Charge Nurse or Manager, will be responsible for checking the crash cart, oxygen cylinder levels, defibrillator, and documenting compliance with the crash cart checklist. 3. Each emergency cart is equipped with a numbered lock and kept locked unless in use. The lock number will be recorded at each shift on the crash cart documentation form. If the lock is not intact, or is opened, the cart is to be checked and restocked according to the crash cart list. A new numbered lock shall be replaced by the Charge Nurse or the Nursing Supervisor...."

The "JOB DESCRIPTION" for an Emergency Department RN revealed: "...11. Maintains code cart, oxygen setup and suction at bedside...."

Direct observation, during tour conducted on 02-06-14 at 2:20 P.M., revealed that the adult Crash Cart in the ED trauma bay was unlocked. The Crash Cart was not in use at the time it was found to be unlocked.

Review was conducted of the "Emergency Department Code Cart Daily Checklist" for December, 2013, and January and February, 2014.

The nursing shifts at the Hospital were twelve (12) hour shifts. In December, 2013, there were a total of 24 shifts in which the code cart was not checked for "plugged in and working," 21 shifts in which the lock number was not recorded, and 29 shifts in which the defibrillator was not tested .

In January, 2014, there were a total of 24 shifts in which the code cart was not checked for "plugged in and working," 43 shifts in which the lock number was not recorded, and 25 shifts in which the defibrillator was not tested .

In February, 2014, from February 1 until afternoon on February 6th, there was a total of 5 shifts in which the code cart was not checked for "plugged in and working," 5 shifts in which the lock number was not recorded, and 5 shifts in which the defibrillator was not tested .

RN #1 acknowledged, during interview conducted on 02-06-14, that the crash cart should not have been unlocked when not in use. RN #1 acknowledged that unless the crash cart was locked, the staff could not be assured that all emergency equipment was on the crash cart in the event of an emergency.

Emergency Department Physician #1, stated during interview conducted on 02-06-14, that it was the nurses' responsibility to check the crash cart. ED Physician #1 acknowledged, that unless the crash cart was locked, that he and the staff could not be assured that all necessary equipment was on the crash cart in the event of an emergency.
VIOLATION: RESPONSIBILITIES OF DOCTOR Tag No: C0257
Based on observation, document review, and staff interviews, it was determined the facility failed to ensure:

1. Physician orders for wound care were obtained for Patient #2 on admission. Refer to Tag 294 for details on Patient #2's wound care.

2. Physician admission orders for urgent hospitalist consults were performed for Patient #2.

Findings include:

1. Patient #2 was admitted for observation to the facility with Atrial Fibrillation; Congestive Heart Failure (CHF), and Chronic Obstructive Pulmonary Disease (COPD) on 02/04/2014, at 02:59 a.m.

The ED physician admission orders on:
02/04/14, at 02:05 a.m. included: "Hospitalist consult-Urgent.
02:28 a.m. Saline Lock, one time, intravenous, STAT.
02:29 a.m. O2 to maintain SaO2 (Oxygen saturation) > 90.
02:29 a.m. Coumadin 2.5 mg (milligram) tablet, 1 tablet (2.5 mg), daily, Oral, Routine.
02:31 a.m. Lasix 40 mg for twice a day, Injection, Routine.
02:33 a.m. KCL (Potassium) 20 mEq (millequivilent) PO, twice a day, Oral, Routine.
02:36 a.m. Admit as 24 HR. (hour) Observation - Telemetry.
02:38 a.m. Lovenox 30 mg/0.3 ml (milliliter) Sub-Q Syringe, Daily, Subcutaneous.
02:39 a.m. Digoxin 0.125 mg PO, daily, Oral, Routine.

Review of admission orders revealed the physician's admitting orders did not contain orders for wound care.

The ADON verified on 02/05/2014, at 10:00 a.m., no physician orders were found in Patient #2's medical record.

2. The ED physician admission orders on 02/04/14, at 02:05 a.m. included: "Hospitalist consult-Urgent."

RN clinical note on 02/05/14, at 7:55 p.m., included: "Additional Comments-Patient resting in bed. Shows no signs of pain or discomfort at this time. BP low at 84/49, rechecked manually at 78/48. Heartrate elevated between 107 and 135 at rest. Rest of vitals stable. Dr._____ (hospitalist in Chicago) notified of patient's vitals and increased lethargy since this morning. Dr._____ (hospitalist in Chicago) gave orders to transfer to a facility for higher care and several medication orders...."

The hospitalist (in Chicago) ordered: "STOP MED: Lovenox 30 mg/0.3 ml. Sub-Q Syringe" at 6:59 p.m. and "Coreg 3.125 mg Tab" at 7:29 p.m.

The hospitalist ( in Chicago) consult was documented on 02/05/2014 at 8:44 p.m. The hospitalist ordered a CT scan of the chest for acute pain; EKG; Arterial Blood Gas; Vancomycin 1 GM IV, one time dose; and Levofloxacin 500 mg IV every 24 hours. The hospitalist ordered a Normal Saline bolus - 350 ml x 1 at 8:34 p.m. and Naloxone 0.4 mg/ml Injection, one time dose STAT at 8:36 p.m. A Foley Catheter to gravity until ambulatory was ordered and inserted at 8:54 p.m. He ordered a CBC (complete blood count); Urinalysis; Urine culture; Blood Cultures x 2; at 9:10 p.m. and Diltiazem (given for angina, hypertension, a fib) 5 mg/ml IV (intravenous) 10 mg over 2 minutes) STAT x 1 at 9:18 p.m.

The ED physician (hospitalist on site) revealed in the discharge summary on 02/05/14, at 9:20 p.m. "The patient has been unstable during his entire stay, with low systolic and diastolic BP, A-fib with RVR, and continued Hypoxia, requiring ventimask at 40 - 45 %, it was felt tonight that this patient is too unstable to keep at the hospital and I was asked to transfer him out, MR.____ (name of patient #2) was accepted by Dr.____(Hospitalist at area hospital), to their Med Telemetry unit, and he will be transferred tonight via ____Ambulance."

Patient #2 was ordered to be transferred to a higher level of care at 9:49 p.m. He was transferred at 9:55 p.m. by ambulance.

The ADON verified on 02/06/2014, at 08:30 a.m., Patient #2's condition had deteriorated and he had been transferred to an acute care hospital for further care.
VIOLATION: NURSING SERVICES Tag No: C0294
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, staff interviews, and reviews of: clinical records; policies and procedures; logs; staffing schedules; and personnel records, it was determined:

1. the hospital failed to ensure there were nursing staff trained and competent assigned to read and interpret cardiac rhythms of patients on telemetry and that were able to trouble shoot problems with the monitors.

2. the hospital failed to ensure nursing care was provided to meet the specialized needs of patients requiring telemetry/cardiac monitoring and requiring complex wound care. (Patients #2 and #4.)

3. the hospital failed to ensure there were adequate numbers of nursing personnel available to meet the needs of a psychiatric patient who eloped from the ED (Patient #7) and for two patients on the in-patient unit who required the attention of an RN at the same time. There was only one RN assigned and available on the acute care unit. (Patients #1 and 12.)

4. the hospital failed to ensure the nursing staff consistently checked the emergency "crash" cart on the acute care nursing unit according to the hospital's policies and procedures to meet the needs of patients in the event of an emergency.

5. the hospital failed to ensure all nursing staff were provided with appropriate orientation and training to meet the level of care required by patients.

Findings include:

1. The facility policy: Telemetry Monitoring includes: "...Procedure: 1. The CAN (sic) (Certified Nursing Assistant) shall observe, recognize and immediately report all changes in rate or rhythm to the Charge Nurse. 2. The RN shall notify the attending physician of any changes in rhythm or patient's condition....7. Alarms may be adjusted for each specific patient's rhythm but alarm system may not be turned off."

Patient #2 was admitted for observation to the facility with Atrial Fibrillation; Congestive Heart Failure (CHF), and Chronic Obstructive Pulmonary Disease (COPD) on 02/04/2014, at 02:59 a.m. Telemetry was ordered by the emergency room physician.

Observation in the nursing station on 02/04/2014, at 01:30 p.m. revealed Patient #2's heart rhythm being traced on the telemetry monitor. The monitor read v-tach ([DIAGNOSES REDACTED]) with a rate of 109 to 162 noted by the surveyor. No nursing staff were in the nurses stations watching the telemetry monitor. The RN was across the corridor in the staff kitchen with a volunteer. The CNA was in a patient room. No alarms sounded from the telemetry unit.

The Assistant Director Of Nursing (ADON) arrived in the nursing station and was asked what the Heart Rate (HR) parameters were for the alarm on the telemetry monitor. When the monitor was checked the parameters were set at 45 to 150, and the alarms were turned down so low they were turned off; or muted. When attempting to reset the alarms the monitor shut down and had to be re-booted in the server room off the unit. The power in the facility was disrupted shortly therafter, and the telemetry monitor did not have capability to re-start when the generator kicked in emergently. The ADON, the Case Manager, and IT (Information Technologist) could not get the telemetry monitor to power on for 30 to 40 minutes. The facility was unable to monitor the telemetry patients.

The ADON and RN on duty verified on 02/04/2014, they could not hear the alarm for the telemetry monitor when the patient's heart rate was over 150. They acknowledged the alarm had been muted or the volume was turned down so low they could not hear it. The RN on duty stated the "parameters were pre-set and she was not able to check the specific parameters for Patient #2".

The ADON acknowledged on 02/04/14, at 3:30 p.m., the Emergency Department (ED) staff also monitored the telemetry unit for the Acute Care Unit. The surveyors went to the ED on 02/04/14, at 4:15 p.m. and no one was found watching the telemetry unit. The alarm in the ED telemetry monitor was also found to be muted. No one was found watching the telemetry monitor in the ED on 02/05/14, at 08:00 a.m., and 11:00 a.m.

2. The surveyor accompanied RN #3 on a medication pass to Patient #2 on 02/05/14 at 9:30 a.m. During the medication pass the surveyor observed a large skin tear on the patient's left elbow. The Kerlix wrap had slipped down the patient's arm. The skin had not been approximated over the tear and there was a large area of exposed pink subcutaneous skin. After the medication pass was completed, the surveyor asked the RN what treatment was being used for the skin tear. The RN replied that they were using "Telfa" and that they were also using Telfa on the pressure area of the patient's coccyx. Because telfa is not commonly used to treat pressure ulcers, the surveyor requested to observe the status of the pressure ulcer on the patient's coccyx. With the patient's permission, he was assisted by the RN and CNA to turn on his right side. The patient had stooled himself and needed to be cleaned in order to observe the wounds. There were several open areas surrounded by a large area of red fragile skin. The patient was also observed at that time to have two large open areas over his left scapula which appeared to be both pressure and shearing related. There were also three to four red areas directly over bony prominences of his spine. Further observations were made of scratches and scabs on the patient's knees and lower extremities. The patient's right lower leg was wrapped in Kerlix and appeared to have drainage on it. At that time, the surveyor requested the ADON be contacted to come to the patient's room which she did. The Kerlix was removed from the patient's right shin which revealed a large open wound covered with yellow exudate. The ADON obtained a culture of the exudate at that time. (The final report of the wound culture dated 2/11/2014 revealed: "1. Heavy Staphylococcus aureus. 2. Heavy Enterobacter cloacae.") The patient was flinching, moaning and grimacing during the wound assessment. The ADON directed the RN to check the patient's record to see if there was pain medication ordered by the physician. The RN left the room and was gone for approximately 20 minutes. She reported she had to go to the emergency room to get the medication (Tylenol #3).

The ADON reported to the surveyor that she had not been made aware of the number of and severity of the patient's wounds. The RN #3 reported there were no physician orders for wound care which was confirmed by the ADON after she reviewed the record. The ADON contacted the emergency room physician who acknowledged he was aware of the patient's skin breakdown but had not ordered any wound care.

The ADON directed RN #3 to take photographs of all of the patient's wounds to be placed in the clinical record. She reported it was normal practice to photograph all wounds and did not know why they were not obtained at the time of his admission.

Review of the medical record for Patient #2 revealed the ED Nursing note on 02/04/14, at 01:52 a.m., included: "Skin-Numerous old scabs, skin tears. New skin tear to L. elbow, unsure of how occurred."

The MD Notes for 02/04/2014 at 02:02 a.m., included: "History...Neg, Skin....Skin: No pallor/rashes warm & moist, stasis changes both lower extremities, with fluid oozing from skin....Extremity: Location-Low Ext Bilateral/Pain-Tenderness-None/Sub Location-Distal/Appearance-Edema-Severe/ROM (Range of Motion)Full...."

The RN admission nursing assessment at 03:40 a.m., included: "Wound Assessment: No wounds at this time; no further assessment necessary. Total Number of Wounds-multiple ecchymosis and skin tears on bilateral upper and lower extremities as well as back and pressure ulcer on coccyx....Wound treatment -Continuing the skin and wound care treatment guidelines for each wound site listed below based upon the type and/or stage of wound present...."
Wound Locations-
1. Buttocks; "Dressing-Is dry and remains intact; Pressure Ulcer; Stage II (Partial thickness skin loss, shallow crater). Size - 3.5x2.5 inches...Small amount serosanguinous exudate; no odor; surrounding skin - [DIAGNOSES REDACTED]. "Comments: cleaned and duoderm applied to area."
2. Left upper back - Skin tear; Dressing is dry and remains intact. Wound - superficial; measures 23.5x2 inches. Surrounding skin intact; no exudate.
3. Right upper arm x 2 wounds. Type - skin tear. Non-pressure wound - Partial thickness; measures 2x1.5 inches. Surrounding skin intact. "Comments: Non adherent dressing applied with moist gauze."
4. Left Forearm-skin tear. Non-pressure wound-Partial thickness. Dressing dry and intact - applied in ED. "Comments: ED staff dressed and cleansed. States it is an 'L shape' wound."
5. Bilateral lower extremity multiple superficial abrasions. Lower extremities bilaterally with 4+ edema noted with weeping on right lower extremity.
6. Perianal and anal area rash - "Type of wound-Incontinent associated dermatitis."

The RN Clinical Note on 02/04/2014 at 08:30 a.m., included: Wound assessment: Total number of wounds - 8.
1. Buttocks: "Dressing-Change as follows -Duoderm re-applied after becoming soiled with BM (bowel Movement). Pressure ulcer-Stage I. Length 1 cm (centimeter; Width 1 cm. [DIAGNOSES REDACTED]; no exudate; no odor."
2. Knees- bilateral. "Open to air. Abrasions. Length - 0.2 cm; Width 0.2 cm. [DIAGNOSES REDACTED]; no exudate; no odor."
3. Left foot-heel; "Open to air - Pressure ulcer, Yellow slough; Stage I; measures Length- 0.3 cm; Width-0.1cm. [DIAGNOSES REDACTED]; no odor; no exudate "
4. Right foot - Wound is open to air - Pressure ulcer -Stage I; Length 0.3 cm; Width 0.5 cm; [DIAGNOSES REDACTED]; no odor; no exudate."
5. Posterior upper right extremity, "Dressing -dry and remains intact. Skin tear. Length 0.2 cm Width - 0.5 cm. [DIAGNOSES REDACTED]; no exudate; no odor."
6. Posterior left upper extremity. "Dressing - Change as follows- Applied Telfa dressing and covered in Cling Kerlex. Skin tear. Length - 3 cm; Width - 1 cm. Exudate Small amount serosanguinous; No odor.
8. Left shin - "Dressing is dry and intact. Lower extremity ulcer - venous; Length - 0.7 cm; Width - 0.5 cm. Exudate - Moderate serosanguinous; No odor."

No physician orders for wound care were found in Patient #2's medical record for 02/04/2014.

The ADON verified on 02/05/2014, at 10:00 a.m., no wound care protocols or physician orders were found int Patient #2's medical record. She acknowledged the hospital had no wound care protocols, guidelines, or standing orders for wound care.

RN Clinical note on 02/05/14 at 02:52 a.m., included: "Patient awake to use urinal. Noticed left upper arm bandage soiled scant serosanguinous drainage. Site cleaned and rebandaged with gauze and antibiotic ointment. Patient denies pain, resps (respirations) even/unlabored. Needs constant reminder to leave venti mask on but complies when informed of rationale."

RN Clinical Note on 02/05/2014 at 06:18 a.m., revealed: "Assisted (name of CNA) with repositioning and cleaning/applying new brief on patient. Patient had loose/mucous stool. Pressure ulcer on coccyx cleaned and redressed. Perineal area applied with ointment."

RN Clinical Note for Pt #2 on 02/05/2014 at 10:10 a.m. included: "Wounds - 8.
1. Buttocks: "Open to air. Incontinent associated dermatitis (Staging is for pressure ulcers only) Stage II." Measures: Length 40 cm; Width 20 cm.
2 and 3. Left elbow: Skin tear. Open to air. measures: Length 10 cm; width 0.5 cm. Small amount serous exudate. (documented x 2)
4. Bilateral knees: Abrasions. Open to air. Length 0.5 cm; width 0.5 cm.
5. Scapula-left. "Shearing x 3." Measures Length 2.5 cm; Width 3.8 cm.
6. Right heel. "Pressure ulcer" Open to air. "Yellow (slough). Stage I."

Physician wound care orders were noted in the medical record on 02/05/2014, at 3:06 p.m.: 1. "Duoderm to the coccyx area BID (AM & PM)." 2. "Apply Neosporin oint (ointment) to other skin lesions with Telfa pad and Kling-curlex BID.

RN Clinical Note 02/05/14, at 7:55 p.m. included: Wound Assessment: 7 wounds.
1. Buttocks: Open to air Pressure ulcer. Stage II.
2. Below Left Scapula: Open to air. Skin tear.
3. Spine: Open to air. Pressure ulcer. Stage I
4. Right elbow: Open to air. Skin tear.
5. Above left elbow: Open to air. Skin tear.
6. Right shin: Open to air. Skin tear.
7. Left shin: Open to air. Skin tear. Moderate amount serous drainage.

The ADON acknowledged on 02/05/2014, the RN's were inconsistent in listing, measuring and treating the patient's wounds. She verified wound care orders should have been obtained from the physician when Patient #2 was admitted to the facility. The medical record revealed the RN's documented they left all wounds open to air after receiving the orders for Duoderm and Neosporin..

-Patient #4 was admitted on [DATE] and was still an in-patient at the time of the survey. The admitting diagnosis was congestive heart failure and the admitting physician documented the patient was to be admitted "Acute with telemetry." The physician's admission orders dated 1/29/2014 at 5:04 a.m. included: "Oxygen 2L NC (nasal cannula) and titrate to greater than 95% sat (saturation)."

The last nurses note that referenced the patient being on telemetry was on 1/31/2014 at 6:50 a.m. and included: "Cardiac monitor sinus with bundle branch block rate 63-72 while up in room." An RN documented at 8:45 a.m. on that date: "(name) from Zoll fitted patient with external defibrilator (sic) ordered by patient's cardiologist..."

There was no physician's order for the external defibrillator; no documentation by the person who "fitted" the patient with the device; and no documentation of training or education provided to the nursing staff or patient regarding the device including nursing care and responsibilities.

An interview was conducted on 2/3/2014 at approximately 3 p.m. with the RN on duty on the unit and the RN Case Manager who was present. They reported the patient's telemetry monitoring was discontinued when the defibrillator vest was applied. The RN on the unit was asked about a physician's order for the vest and she replied that they did not need one because it was ordered by a cardiologist in Tucson and not by a physician at Douglas Community Hospital. The RN stated she was told by the person who applied the device that they did not need to continue telemetry monitoring. She acknowledged there was no doctor's order to discontinue telemetry monitoring. The RN was asked if there was education provided to the staff or patient on the device and what the hospital's responsibility was to monitor it. The RN was not aware of any training or if there was anything the nursing staff needed to know or do. The RN also stated the patient "refuses" to wear the device, however, the patient was never placed back on telemetry.

The external defibrillator was observed by the surveyor on 2/3/2014 at approximately 3 p.m. It was in a cloth bag on the floor next to a wall. There was literature in the bag with the "Zoll Life Vest" device.

A Licensed Practical Nurse (LPN) documented on 1/31/2014 at 9:08 p.m. that the patient had a temperature of 102.2 degrees F and 1000 mg of Tylenol was given to the patient. There was no documentation on the Medication Administration Record that the Tylenol was administered on that date at that time. The physician's order for "Tylenol ES (500 mg) 2 tab PO (by mouth), every 6 hours as needed" did not include parameters when the nurse was to administer the Tylenol and when to call the physician, and there was no documentation the physician was notified.

A review of the patient's 41 recorded sets of vital signs for the period from 1/29/2014 to 2/4/2014 revealed his highest blood pressure was 118/64 on 1/29/2014 at 5:50 a.m. His lowest readings were as follows:
1/29/2014 at 8 a.m. - 87/56
1/29/2014 at 8:09 p.m. - 88/52
1/30/2014 at 4:29 a.m. - 84/43
1/31/2014 at 12:05 a.m. - 83/43
2/1/2014 at 8 p.m.- 88/46
2/2/2014 at midnight - 83/48
2/3/2014 at 4 a.m. - 86/44

Daily nursing documentation included: "Vital signs assessed and stable" and "patient remains neurologically and hemodynamically stable." For example the nursing documentation on on 2/3/2014 at 4:02 a.m. included: "Vitals stable and wnl (within normal limits) for patient (BP 86/44)."

Another example was the nursing documentation on 2/4/2014. At 4 a.m. the patient's vital signs were: Blood Pressure (BP)-108/58; Pulse (P)- 73 beats per minute; Respirations (R)- 18 per minute; Temperature (T)- 98.1 degrees Fahrenheit (F); and oxygen saturation level- 96%. At 8 a.m. his vital signs were: BP- 104/67; P- 103 beats per minute (an increase of 30 beats from 4 a.m.); R- 22 per minute; T- 97.5 degrees Fahrenheit (F); and oxygen saturation level- 90% on 3 Liters of oxygen (a decrease of 6% from 4 a.m.). The RN documented at 8 a.m. that the patient was sitting on the heating unit in his room "shivering." She documented the patient's oxygen saturation level was 90% on 3 liters of oxygen and that his other vital signs were assessed and "stable." She documented the CNA: "...assisted with application of patient's jacket. Patient denied any needs or concerns at this time." At 11:29 a.m. the RN documented: "No major changes from previous assessment, patient remains neurologically and hemodynamically stable." At 12 p.m. the patient's vital signs were: BP-100/60; P-48 beats per minute (his pulse rate was 103 at 8 a.m.); R-26 per minute (his respirations were 18 at 4 a.m. and 22 at 8 a.m.); T- 97.5 F; and oxygen saturation 93% on 3 liters of oxygen. At 12:03 p.m. the RN documented: "No major changes from previous assessment, patient remains neurologically and hemodynamically stable. Vital signs assessed and stable...."

The patient was transferred for a direct admit to the telemetry unit in an acute care hospital in Tucson on 2/6/2014. The physician's documentation on that date at 11:55 a.m. included: "SAMC (Southeast Arizona Medical Center) Hospitalist agrees with need for higher level of Cardiology care...per cardiologist suspect severe left ventricular dysfunction with a low ejection fraction."

3. Patient #7, an adult male, presented to the ED (Emergency Department) on 02-06-14, at 6:14 P.M. The "MD Notes" (Physician #1) revealed: "Patient with paranoid schizophrenia exacerbation...The symptoms are severe...Additional symptoms or pertinent history also involve h/o (history of) paranoid schizophrenia, with multiple psychiatric hospitalization s...brought into the ED for medical stabilization to transfer to mental health facility (court ordered)...."

On 02-06-14 at 6:50 P.M., a Crisis Risk Assessment was performed. In the field titled "Ideation" was documented: "Yes, I have thoughts of hurting myself...I will be killing myself...."

In the field titled "Lethality" was documented: "Threatening to hurt (public servant named)...."

In the field labeled "Dangerousness" was documented: "Long Hx (history) of DTO...."

In the field titled "Behavioral Cues," the following cues were circled: "impulsivity, hostility, and rage...."

The Crisis Risk Assessment "Summary/Conclusions" revealed: "...Presents highly delusional, highly paranoid, talks about hurting others and hurting himself...(Patient) talks about not caring if he lives or dies...."

On 02-07-14, at 6:45 A.M., the "Clinical-Interdisciplinary Notes" revealed: Pt (patient) amb (ambulated) out of hospital through admitting. Admitting staff asked pt where he was going he replied 'Some where safe.' Refused to come back into building..."

On 02-07-14, at 6:55 A.M., the "Clinical-Interdisciplinary Notes" revealed: "Sheriff office called at this time, to bring pt back to hospital. Pt is to be admitted to Psych (psychiatric) facility when there is an opening. Again attempted to get pt to come back and he refused...."

Physician #2 documented on 02-07-14, at 1:43 P.M.: "Patient with psychosis. Title 36 with aggressive threatening affect. Brought by (name of police department), handcuffed, loud outbursts, threatening, kicking at staff and police...DTS/DTO (danger to self/danger to others)...."

On 02-07-14 at 1:43 P.M., Physician #2 wrote an order for: "Sitter to bedside."

There was no documented evidence that a sitter was with the patient from the time the order was written until 7:00 P.M. that evening. There was no documented evidence that a sitter was with the patient from 7:00 A.M. on 02-08-14, to 11:21 A.M., at the time of the patient's second elopement.

On 02-08-14, at 11:21 A.M., Physician #3 documented: "Note: this patient woke up, was aggressive verbally, refused to stay in his room , reported he was going to sue (public servant)..., he was given 2 mg (milligrams) Ativan (anxiolytic), Benadryl 50 mg IM (intramuscularly) (sedative), and Haldol 5 mg IM (antipsychotic), about 10 min (minutes) later he was discovered behind the hosp. (hospital) was asked to come back inside, then started walking down Hosp. Rd (road), the (county) Sheriff was called and they said they would send a patroll (sic) car to pick him up...."

The Director of Nursing (DON), acknowledged, during interview conducted on 02-08-14, that there was no sitter as ordered between the hours of 02-07-14 at 1:43 P.M., and 7:00 P.M. on 02-07-14. The DON acknowledged that the order for the sitter had not been discontinued at the time Patient #7 eloped for the second time from the Hospital on 02-08-14, at 11:21 A.M. The DON acknowledged that the physician's order for a sitter was not followed as required by the nursing staff.

Direct observation conducted on 02-08-14 at 9:00 A.M., revealed there were two (2) inpatients on the acute care unit. RN #3 was the nurse on duty on the unit on the 7 A.M.-7 P.M. shift.

Observation revealed that on 02-08-14, at 9:50 A.M., RN #3 was in the room of Patient #1. Simultaneously, observation revealed the intravenous pump of Patient #12 was alarming.

There was no other nursing staff on the nursing unit at the time that both patients on the acute care unit presented simultaneous nursing needs.

RN #3 stated, during interview conducted on 02-08-14 at 9:00 A.M., that there were no other nursing personnel on the unit, or scheduled to be on the unit, at the time of the observation.

4. The "Position Description/Performance Evaluation" for the Director of Nursing (DON) revealed: "Under general direction of Chief Executive Officer, the Director of Nursing develops patient care goals, objectives, standards of performance, policies and procedures in all inpatient and outpatient settings; organize services in accordance with administrative guidelines in order to provide specific services to meet the local, State, federal, legal and medical staff guidelines. DUTIES AND RESPONSIBILITIES: 1. Plans, organizes, directs and controls nursing resources to assure quality efficient patient care services. 2. Defines and maintains the quality of nursing standards of practice within patient care services... 6. Assess the quality of care rendered by the nursing staff and ensures sound practice..."

The "JOB DESCRIPTION" for an Emergency Department Registered Nurse (RN) revealed: "Job Summary": Under general direction of the Chief Nursing Officer, the RN-ER (Registered Nurse-emergency room ) coordinates total nursing care for patients according to the Nursing Process and partakes in patient and family teaching and provides leadership by working cooperatively with ancillary nursing and other patient team personnel in maintaining standards for professional nursing practice in the clinical setting. DUTIES AND RESPONSIBILITIES: 1. Assesses the patient's condition and nursing needs; follows set standards for emergency room Nursing Care; understands triage and priority of care... 11. Maintains code cart, oxygen setup and suction at bedside... 13. Assigns nursing care to ER Technicians in accordance with the patient's needs and the personnel capabilities and qualifications, and assigns other duties as needed..."

The "Crash Cart Policy" revealed: "1. To ensure that all crash carts and Defibrillators are constantly ready for use in case of life threatening conditions, such as cardiopulmonary arrest... PROCEDURE... 2. A licensed staff member (RN, LPN, RT, CNA, or EMT), as designated by the patient care area Charge Nurse or Manager, will be responsible for checking the crash cart, oxygen cylinder levels, defibrillator, and documenting compliance with the crash cart checklist. 3. Each emergency cart is equipped with a numbered lock and kept locked unless in use. The lock number will be recorded at each shift on the crash cart documentation form. If the lock is not intact, or is opened, the cart is to be checked and restocked according to the crash cart list. A new numbered lock shall be replaced by the Charge Nurse or the Nursing Supervisor...."

The "Appendix-Acute Care Crash Cart Check Sheet" dated "Dec (December) 2013," revealed the Crash Cart was not locked according to the policies and procedures on 6 consecutive shifts from 7:00 A.M. on December 1, 2013, to 7:00 A.M. on December 4, 2013. The log revealed "No lock" or a zero with a diagonal slash, representing "no." There was no documented Crash Cart checks on 3 shifts in December, 2013.

The "Appendix-Acute Care Crash Cart Check Sheet" dated "01/2014," revealed the Crash Cart was not locked according to the policies and procedures on twelve (12) consecutive shifts from 7:00 A.M. on January 1, 2014, to 7:00 A.M. on January 7, 2014.
The log revealed either "No lock" or "open" on those shifts. There was no documented evidence of a check of the crash cart on 8 shifts in January, 2014.

RN #2 stated, during interview conducted on 02-06-14, that there were no Crash Cart locks available to the nursing staff to lock the Crash Cart when it was documented as unlocked. RN #2 acknowledged that with no locks on the Crash cart, there could be missing emergency medications or equipment in the event of a code.

5. The facility policy, Orientation of Staff included: "Patient Care Staff are required to complete orientation and demonstrate competency as defined by professional licensure, required core and job-specific competencies including age-specific competencies. Acute Care nurses are to be oriented by working with another nurse who has more than one (1) year of nursing experience in our facility. Orientation may consist of a total of 18 shifts for Acute Care depending on experience of RN. These shifts include working 3 weeks on day shift and 3 weeks on night shift. Orientation also includes review of Orientation packet and completion of Orientation modules. New staff nurses will also be required to cross-train to the Emergency Department with a nurse who has more than one (1) year of experience in the Emergency Department. Orientation is to include a total of 18 shifts that consists of 3 weeks on days and 3 weeks on nights. Evaluation of the orientee's skills is to be made between the preceptor, nurse manager, and Director of Nursing (DON)."

The facility policy, Competency Validation includes: "Competency validation is conducted annually to ensure that services are provided by qualified and competent staff. Procedure...Competency Evaluation: New employees are evaluated by the conclusion of the six-month introductory period, using competency/skills assessment checklist. Evaluation is performed for all staff members during random observation, peer review, and the annual performance review. During the annual review, the supervisor and the employee identify procedures and equipment requiring competency retesting during the coming year. Determinations are based on the criteria listed in the performance standards, supervisory observation, and the professional goals of the employee who may suggest additional areas for competency validation. Clinical staff is trained in the use of new equipment and procedures on an ongoing basis. Competencies must be demonstrated before being used with patients...Guidelines for Completing Skills Competency List: Individual Assessment checklist will be completed during orientation of new staff and annually. The checklist will also be utilized at each employees review...."

Review of personnel records for Registered Nurse (RN), Employee #3 revealed: Date of Hire: 06/13/2013, for a full-time position of 36 hours/week in Acute Care. No orientation documentation was found in her file. She graduated and received her RN in May, 2013. Her competencies were reviewed with no observation or return demonstration found for cardiac monitoring and wound/sterile dressing care.

RN, Employee #4's personnel file revealed her Date of Hire (DOH) was 10/21/2013, for a 36 hour full time position in Acute Care. The file did not contain a job description; orientation, or competency.

RN, Employee #5's personnel file included her Date of Hire as 11/11/2013, for a 36 hour full time position in Acute Care. The file did not contain an orientation or competencies.

The Assistant Director of Nursing's personnel file revealed the Date of Hire as 01/03/2010. The file contained a performance evaluation but no documentation of orientation or competencies were found.

Employee #6's Date of Hire was 08/30/1999, for a scrub technician. She is currently a Certified Nursing Assistant. No orientation was found in her personnel file.

Employee #7's Date of Hire 02/06/03. She is a Licensed Practical Nurse/Emergency Medical technician. No orientation or inservices were found in her personnel file.

RN, Employee #7's DOH is 11/17/2013 for a per diem position. No orientation or competencies were found in her personnel file.

RN, Employee #8's DOH is 12/09/2013, full time for Acute Care and the Emergency Department. RN competencies were completed on 02/04/2014. No orientation was found in her personnel file.

Employee #10's Date of Hire was 11/03/2003 as a Certified Nursing Assistant. He is currently a per diem Licensed Practical Nurse and Emergency Medical Technician. No competency or orientation was found in his personnel file.

The ADON verified on 02/07/2014, current competencies had not been done on all employees and documentation of orientations were not found for the above employees. She acknowledged the new hire RN's were working in Acute Care without supervision and should have documentation for completed orientations and competencies.
VIOLATION: RECORDS SYSTEM Tag No: C0303
Based on job description review and interview, it was determined that the Hospital failed to have a designated member of the professional staff responsible for overall maintenance and security of the medical records.

Findings include:

The "Job Description" for the Medical Records Clerk revealed: "Job Summary: Under the general supervision of the Head of Medical Records...."

The Medical Records Clerk stated, during interview conducted on 02-07-14, that she had not been employed in a medical records capacity prior to her current employment start date of 05-12, at the Hospital. The Clerk stated that she had been trained by another Medical Records Clerk. The Clerk stated that the only time since her employment that she has had a supervisor was when the Hospital was under previous management. The Clerk stated that the previous supervisor, while on site weekly, did not interact with her regarding management of the medical records department. The Clerk acknowledged there was no professional department head of the medical records department with ultimate responsibility for all medical records.

The Interim Chief Executive Officer (CEO) stated, during interview conducted on 02-07-14, that she was aware of the need for a "supervisor" in medical records.
VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
Based on observation, document review, and staff interview, it was determined the facility failed to ensure all areas in the hospital were clean, orderly, and maintained to prevent the spread of infection.

Findings include:

The facility "Infection Prevention Control Plan" includes: "...10. Provide preventive, surveillance, and control procedures relating to the hospital and clinical environments, to include: sterilization, disinfection practices, housekeeping, laundry engineering, and maintenance, food sanitation, central supply purchasing, and waste management. Such procedures shall be evaluated on a continuing basis and revised as necessary."

The Steam Sterilization policy included: Purpose: "To destroy all micro-organisms present and to render sterile items used in surgery, emergency room , x-ray, and all nursing units where sterile supplies are imperative. Procedure: ...3. Wrap each item or set as per card. Use only freshly laundered muslin double thickness or equivalent in paper. Do not stack or nest utensils unless they are separated by muslin. Mark with sterilization and expiration date and load number, and content on autoclave tape. 4. Load Autoclave: ...f. Mark with sterilization date, expiration date and load number, and contents of each tray, pack or set...7. When items are sterilized, remove from autoclave and allow to cool, quarantine all items 24 hours until results of biological indicators are received. After receiving results, store items in proper place or return to appropriate department."

The CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, includes: "...Storage...Heat-sealed, plastic peel-down pouches and wrapped packs sealed in (3/1000 inch) polyethylene overwrap have been reported to be sterile for as long as 9 months. Supplies wrapped in double-thickness muslin comprising four layers, or equivalent, remain sterile for at least 30 days. Any item that has been sterilized should not be used after the expiration date has been exceeded or if the sterilized package is wet, torn, or punctured...."

A tour of the Operating Room suite conducted on 02/04/2014, accompanied by the Chief Executive Officer, revealed the clean work room currently used for sterilization. None of the equipment had a Preventative Maintenance sticker. The sterilizers included in the latest Aramark Preventative Maintenance have not had repairs or PM's since 06/28/2012.

A large number of wrapped surgical instruments were stored in cabinets of OR rooms #1 and #2. The OR rooms had not been cleaned and maintained since July, 2012. Dates on the autoclave tapes (had turned brown) of the sterile packs were 2006, 2010, 2011, and 2012.

A large amount of rust was noted in the cabinet under the sink in the soiled work room. The janitor's closet off the soiled work room did not have a light, was dirty and had cob webs.

The CEO acknowledged the areas had not been cleaned and maintained.

Observation of the surgical instrument packs in the Operating Room (OR) and the emergency room (ER) revealed many instruments without expirations dates. The sterilization dates on the autoclave tapes included: The ER cabinet revealed a OB (obstetric) basin wrapped in muslin that had been sterilized 05/17/2012; wrapped Simpson OB forceps x 2 with dates 09/20/06; Trumpet Guide Buck Needles x 3 with dates 02/21/06; and a amniotic hook dated 08/07/08.

The ER Registered Nurse acknowledged during an interview conducted on 02/05/2014, the dates on the instruments were when the articles were sterilized; and they were kept until the packages were opened or damaged.

The Attest Biological Incubator last used 01/02/2014, had not had a PM since 07/10/2010.

The scrub technician verified in an interview conducted on 02/04/2014, she had been using the Attest incubator for the biological monitoring even though it had not been tested or maintained since 2010.

The ceiling in the clean work room had a large panel missing with exposed pipes and debris.

The ceiling in the anteroom of the clean sterilization room had a large bulging tile near the center, and water damage to the tile on the left of the bulging tile.

The autoclave on the right side as you enter the room, had a large hole below it covered with a blue drape that fell apart when touched, with dead bugs lying on the floor outside the drape. The binder board was pulled away from the wall to the right of the large hole with plaster falling out and bugs inside.

Review of the Biological Monitoring System for Steam Sterilization Log revealed 1 - 2 loads of instruments were steam sterilized in October, November, December of 2013, and January, 2014. No documentation was found for the cleaning of the autoclave.

The closet behind the clean work room containing the autoclaves was dirty with debris and bugs on the floor.

The CEO verified in an interview conducted on 02/04/2014, the Operating Rooms were not in current use but the soiled and clean work rooms continued being used for hospital sterilization. She acknowledged the rooms and equipment need to be cleaned and maintained.

A tour of the Emergency Department conducted on 02/06/14, accompanied by the ADON, included the soiled utility room with a large hole located behind the hopper, and a smaller hole on the right side of the hopper. The hopper is approximately 3 feet from the sink where cleaned instruments are soaked in Cidex. The room contained 3 cleaned commodes; and 2 clean IV (Intravenous) pumps. The counter contained 3 broken portable suction machines, and 5 non-reusable pillows (paper).

The ADON reported the staff keeps and re-uses the pillows because they don't have funds to get enough pillows.

The ADON verified the pillows should have been disposed of since they were not re-usable. She acknowledged the clean equipment and supplies should be separated from the dirty areas.





Observations of the Respiratory Therapy storage room was made on 2/11/2014 with one of the hospital's Respiratory Therapists. The room contained numerous shelves of patient equipment and supplies. The floor of the room had a visible build up of dirt, dust and other debris including dead bugs. The shelves and bins were also dusty and dirty. One of the corners in the ceiling had brown and black stains and areas of bulging which appeared to be a result of a water leak.

The Respiratory Therapist present on tour confirmed that the above findings were correct.
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, document review, and staff interview, it was determined the facility:

1. failed to ensure medication orders were received and verified by the pharmacist promptly and medications were available for patient use;

2. failed to ensure policies and procedures for the provision of safe dispensing and administering of medications were addressed in the Pharmacy and Therapeutics Committee.

Findings include:

1.
A tour of the facility conducted on 02/04/2014, revealed a sign in the Pharmacy window: Pharmacy Hours: Monday, Wednesday, Friday
5:00 PM - 8:00 PM.
Tuesday, Thursday
-On Call-

Observation on the acute care unit revealed the multiple electronic record systems used for medication administration. The Empower Computer System did not include a printable Medication Administration Record (MAR). The Next Gen Computer System included the printable MAR. RN#3 revealed the night RN had to fax the medication orders in the Empower System from the last 24 hours to the night pharmacist under contract. If he had any questions he had to call the RN for any information not in the Next Gen system i.e., lab results; diagnoses; history and physicals; progress notes; and nurses notes.

The facility policy: Pharmacist Order Verification included: "A pharmacist shall review all written physician drug orders for inpatients, during open Pharmacy hours, before the first dose is administered to the patient. This policy shall also apply when automated dispensing machines are used...For orders initiated when the Pharmacy is closed, an off-site pharmacist will review new orders with all pertinent patient information in order to adequately review and verify the orders. The on-site pharmacist will conduct a retrospective review of the order(s) as soon as the pharmacist is available or the pharmacy reopens. When questions arise about a medication order, the prescriber will be contacted for clarification."

The contract for Cardinal Pharmacy revealed a 90 day notice for cancellation of the contract sent by registered letter on 12/31/2013. The pharmacy contract was not included in the facility's current contracts. The contract was signed by the hospital on [DATE] and Cardinal Health on 01/04/12; An amendment signed regarding fee's and mountain time versus pacific time was signed by the hospital on [DATE] and Cardinal Health on 07/27/12.

The contract revealed: "...Article I Definitions and Duties: a. RxE-source Services: Cardinal Health shall provide Customer its service of remote entry of physician medication orders. b. Order Lines: Individual medication orders entered, discontinued, or modified, including duplicate reviews, patient demographic additions or changes, and MAR printing, review, or modifications performed by Cardinal Health. c. Order Entry Variance: Includes, but is not limited to, a medication error or a medication entry entered by Cardinal Health that varies from the standard procedure according to Customer's hospital policy and procedures...."
"...Article II Services and Compensation 2.01 RxE-source Services Cardinal Health RxE-source Services include: a. Cardinal Health staff shall review and enter all medication Order Lines into Customer's hospital pharmacy information system with a turnaround for stat Order Lines consistent with Customer's hospital policy;
b. Cardinal Health pharmacists shall intervene on incomplete or questionable orders with appropriate Customer medical staff and shall make best efforts to resolve interventions during the shift;
c. Cardinal Health Pharmacists to be available by telephone to respond and/or provide information and clinical support to Customer hospital staff; and
d. Customer Director of Pharmacy ("DOP") or designee shall have access to Cardinal Health's web-based client portal from which Customer may print reports detailing Cardinal Health's Order Line processing activities;
e. Daily Order Line volume will be recorded and maintained by Cardinal Health to support Cardinal Health's Order Line processing activities;
f. Cardinal Health shall provide reports, at least annually, measuring operational, financial and clinical progress towards goals in its customary form. In addition, Cardinal Health shall provide reports in a manner sufficient to meet the Elements of Performance (EOP) for contracted services as required by TJC (The Joint Commission)..."
"...2.06 Customer Computer System a. In the event Customer chooses to change its pharmacy computer system and/or hospital computer system during the term of this Agreement, Cardinal Health requires advance notice from Customer of at least ninety (90) days prior to when Customer plans to implement its new system. It may be determined that Cardinal Health does not support Customer's new system and may not be able to provide service to Customer once the new system is operational. Therefore, Cardinal Health shall have the right to exercise its option to terminate services with Customer according to the termination provisions under this Agreement. b. If Customer's new system is acceptable to Cardinal Health, Cardinal Health requires that it revisit Customer premises to assess Customer's new system to determine its integration into Cardinal Health processes..."

The Governing Body minutes for August, 2013, revealed the Empower Computer System was installed in July, 2013. No documentation was provided notifying Cardinal Health of the new system or their assessment and integration of the system.

The ADON verified in an interview conducted on 02/07/13, the reports she received from Cardinal Health included the Order Line information for billing. No documents were provided for review.

The P&T committee minutes on November 22, 2013 revealed: "...III. Medication Utilization Review - Mr.____ (on-site pharmacist) stated that the doctors' orders were coming in correctly. A. Cardinal Remote Pharmacy Service - There was discussion that Cardinal cannot see the EMAR in the NextGen or Empower System. Mr.____spoke to (name of remote pharmacist) who is the contact for Cardinal and stated that Mr.____(remote pharmacist) only sees "Ascend and ONLY "Ascend." He has no access to verify and approve doctors' orders. He can only see the "Patient and Medications through the "Ascend Program" and cannot do anything else with them."

"Mr.____(on-site pharmacist) states that the main thing is that the doctors' orders are not functioning because they are being verified on "Ascend." It could be because the nurses can't see this. They have no access to NextGen and the orders are being faxed. They also cannot get access to the lab."

"B. CONTRACT - There was discussion that the contract with Cardinal is overnight, 11 PM to 7 AM and then for 24 hours on weekends. Mr.___(on-site pharmacist) suggested that the hospital should speak to (remote Pharmacist's) Supervisor, in order to get a 24 hour coverage. There was discussion that Mr.___(on-site pharmacist) needs a tablet in order to verify orders. Patients and Lab need to be viewed and verified and the ER needs to be evaluated. Suggestions were that the ER orders should be sent to Mr.___ (on-site pharmacist) for review and that the nurses should be called from Cardinal to inform them that it has been verified or for any other inquiries. IV. Patient Charges-Policy & Procedure Discussion - Ms.___ (Pharmacy Technician) stated that there are no privileges to access EMAR. They (remote pharmacist) can only access the orders in "Ascend. Orders can be seen on NextGen, the information is retrieved from Empower and the charges are done on Medigenix. It is suggested that adjustments need to be made on Empower in order to be able to access this data and avoid these steps."

The on-site pharmacist acknowledged in an interview conducted on 02/07/14, at 0700 A.M., the contract pharmacy verifies the medication orders at night; sent by fax. The facility Pharmacist comes into the facility Monday, Wednesday, and Friday mornings from 6:00 AM to 8:00 AM. He verified there is a breakdown with the computer systems; and he has been telling management the Pharmacy needs more coverage and their system is not working.

The facility policy: Medication Access While Pharmacy Services Are Closed included: "It is the policy of Southeast Arizona Medical Center that in the absence of 24-hour pharmaceutical service, a mechanism shall be provided for obtaining medications and providing safe medication administration in the absence of a Pharmacist. Access to the pharmacy shall only be available to authorized nurses for use in obtaining urgent and necessary medications. Floor stock and automated dispensing machines (no longer in service) shall be used primarily to obtain medications when Pharmacy Services is closed. After hours, a Pharmacist shall be available on an "on-call" basis for consultation and to provide emergency medications, when other methods are inadequate."

The ADON reviewed recent "After Hours Pharmacy Logs" on 02/06/2013, and acknowledged the medications removed after hours were not all urgently needed. 73 medications were removed from 12/27/13 through 02/04/14.

The CEO and the ADON verified in a interview conducted on 02/07/14, the Cardinal Pharmacist did not have access to the patient record; H & P; labs; diagnosis; medication orders. They acknowledged chart audits were not being done to follow med errors, missed doses, and other pharmacy reports.

Registered Nurses on duty during the survey voiced their concerns with the current system of documenting in two different computer systems and the potential for medication errors.

The hospital had documentation of medication errors related to different computer systems through staff generated occurrence reports including the following:

-1/30/2014: "Medication error. Orders not entered in both electronic health records. Patient has been without medications since admission."

-12/30/2013: "Order in Empower for Percocet 1-2 tablets every 4 hours at 08:55; noted by (name of RN) at 09:20 and documented given at 09:25 in Empower. No order was transcribed to NextGen."

-12/30/2013: "On 12/25/13 at 08:48, order in NextGen for Lasix 20 mg tab. No order in Empower. Cardinal Pharmacy called at 08:00 on 12/27/13. However, order for Lasix 20 mg po for Patient L in Empower. Given by RN (name) and in Empower. Not found in NextGen. RN was contacted to verify that the medication was given to Patient L, not Patient M. But was not corrected in EHR when called by Cardinal."

2. The facility policy: Incident Reports includes: "...All occurrences relating to medication errors are reviewed by the Pharmacy and Therapeutics (P&T) Committee monthly meeting, the Task Force team on medications, the Assistant Administrator for Patient Care Services, and the Quality & Safety Committee. If a significant event/error occurs, the event will be intensely analyzed by completing a Root Cause Analysis."

The hospital was not able to locate and provide a specific policy and procedure for the P&T Committee.

The Pharmacy and Therapeutics (P&T) Committee meeting's were July 20, 2012; August 30, 2013, and November 22, 2013. Those meeting minutes did not include documentation that medication errors were addressed.

The Pharmacist verified there weren't any P&T committee meetings from July, 2012 to August, 2013, a period of 13 months. He acknowledged he hasn't received any med errors to review or track and trend. The last P&T Committee meeting was November 22, 2013; 4 months prior to the survey.
VIOLATION: PHYSICAL PLANT AND ENVIRONMENT Tag No: C0220
Based on observations, reviews of policies and procedures, documents, logs, and staff interviews, it was determined:

(C-222) - the facility failed to require routine and preventive maintenance (PM); testing activities; and ensure ongoing maintenance inspections were performed.

(C-224) - the facility failed to ensure medications, chemicals, and supplies were disposed of when expired.

The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0240
Based on observations, reviews of policies and procedures, organizational chart, governing body meeting minutes, reports, and staff interviews, it was determined the governing body did not monitor the development and implementation of policies and procedures for the hospital's total operation.

(C-220)- Physical Plant and Environment: The governing body failed to provide an on-going maintenance program to ensure all equipment was safe and functioning properly and that all medications, chemicals and supplies were discarded after expiration or determined to be unsuitable for use.

(C-270)- Provision of Services: The governing body failed to ensure policies and procedures for the provision of Pharmaceutical Services (C-276); Reporting medication errors (C-277); Infection Control (C-278); and Nursing Services (C-294) were implemented and monitored.

(C-330)- Periodic Evaluation & QA Review: The governing body failed to ensure their policies and procedures were followed and included areas of concern identified by the hospital including pharmaceutical services and medication errors.

The cumulative effect of these systemic problems resulted in the governing body's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PROVISION OF SERVICES Tag No: C0270
Based on observations, staff interviews, and reviews of clinical records, policies and procedures, hospital logs and reports, it was determined the hospital failed to ensure that all services provided were in accordance with written policies and procedures for:

(C-276): Pharmaceutical Services;

(C-277): Medication Errors;

(C-278): Infection Control;

(C-294): Nursing Services.

The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on clinical record review, review of hospital policies and procedures and reports and staff interviews, it was determined the Critical Access Hospital failed to ensure:

(C-337):1. all medication errors were analyzed by appropriate staff including the Pharmacist and that they were analyzed, tracked, trended and included in the hospital's quality program; and

2. all reported unplanned/unexpected events affecting or with the potential to affect patient care were investigated, tracked, corrected and documented.

The cumulative effect of the systemic problem resulted in the Critical Access Hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: QUALITY ASSURANCE Tag No: C0337
Based on clinical record review, review of hospital policies and procedures and reports and staff interviews, it was determined the Critical Access Hospital failed to ensure:

1. all medication errors were analyzed by appropriate staff including the Pharmacist and that they were analyzed, tracked, trended and included in the hospital's quality program.

2. all reported unplanned/unexpected events affecting or with the potential to affect patient care were investigated, tracked, corrected and documented.

Findings include:

The hospital's "Southeast Arizona Medical Center Quality & Safety Plan" (Reviewed/Revised 3/13), was reviewed as a part of the recertification survey. The plan included: "Southeast Arizona Medical Center integrates safety, error prevention, and quality improvement into a single set of processes in order to implement an institution-wide quality and safety management approach to the delivery of high quality health care and to ensure a safe environment for patients, staff, and visitors at all SAMC (Southeast Arizona Medical Center) facilities. Quality Improvement, Clinical Safety Management, and Environment of Care Safety Management Plans are integrated into one Quality and Safety Plan. The Plan is approved by the Medical Staff, Quality Council, and Community Healthcare of Douglas Board of Directors...The quality system shall incorporate a means to identify, report, and analyze both the quantity and the underlying causes of errors in the environment. All errors (even in non-clinical areas) shall be included because system errors anywhere in the hospital environment have the potential to lead to a clinical consequence...The physical environment shall be designed, to the extent achievable, to eliminate preventable error as well as to promote patient and staff safety...An organized approach to establishing and monitoring professional practice standards is necessary in a quality organization...Compliance with applicable regulations and standards supports a culture of quality...The quality system shall incorporate a means to identify, report, and analyze both the quantity and the underlying causes of errors in the environment. All errors (even in non-clinical areas) shall be included because system errors anywhere in the hospital environment have the potential to lead to a clinical consequence...The physical environment shall be designed, to the extent achievable, to eliminate preventable error as well as to promote patient and staff safety. An organized approach to establishing and monitoring professional practice standards is necessary in a quality organization...Compliance with applicable regulations and standards supports a culture of quality...The following data is collected and analyzed for the purpose of identifying quality and safety related issues that may warrant follow-up. All data is collected for the purpose of identifying opportunities for improvement. Data is tracked and trended. Process improvement activities are data driven. Incident Reporting...Adverse Drug Event Reporting...Infection Surveillance...Environment Care Surveillance/Patient Safety Rounds."

1. The hospital's policy and procedure on the subject of Medication Errors (Policy 2.Z.62) included: "Medication errors are a corrective quality of care issue and shall be investigated and measures be taken to prevent their occurrence or reoccurrence...Performance review regarding medication errors and trends, if present, is accomplished through the Risk Management Committee and is the ultimate responsibility of the Director of Nursing Services. Medication errors are also reported...to the Medical Staff on a monthly basis...."

There was no documentation that medication errors were being analyzed, tracked, and trended and actions taken to prevent reoccurrences. The Chief Executive Officer (CEO)acknowledged during an interview on 2/12/2014 that medication errors were not included in their current quality program.

2. The hospital's log of occurrence reports for 2013 were reviewed to determine if the reports were investigated, analyzed, tracked and trended following their policies and procedures. According to the documentation provided, there were 35 reports for the period from 9/9/2013 to 1/30/2014 that had no documentation of investigation and outcome. The occurrence reports included medication errors, patient falls, and problems with the electronic medical record system.

The CEO acknowledged during the interview on 2/12/2014 that there was no documentation that the above reports were investigated and resolved. She stated that the outstanding reports are discussed in the monthly Quality Committee Meetings.
VIOLATION: MAINTENANCE Tag No: C0222
Based on observation, document review, and staff interview, it was determined the facility failed to require routine and preventive maintenance (PM); testing activities; and ensure ongoing maintenance inspections were performed.

Findings include:

A tour of the facility conducted on 02/04/2014, accompanied by the CEO, revealed PM's in the Operating Room Suite:
Dinamap monitor's x 3 - last calibration 04/2011;
Welch Allyn BP cuff last calibration 03/2011;
Anesthesia Cart with PM date of 03/1996 with Datascope - no dates in OR #1;
Datascope monitor OR #2 - last calibration 04/2011;
The Steri-Vac Aeration Cabinet in the clean work room had a PM on 03/30/97; and the Steri-Vac Gas Sterilizer on 11/13/97;
No dates were found on the Castle autoclave currently in use;
No dates on the AMSCO Vacamatic "S" sterilizer or the Pelton Crane autoclave;
Cautery Unit last calibrated 12/2010;
Gemini 300 High Intensivity light last calibration 03/2011;
Fiber optic light last calibration on 03/2011;
Attest Biological Incubator last calibration 07/10/2010 - currently in use;
No PM's on the Alcon Eye Olympus Instrument or the Stryker Endoscopy Unit
OR #2 Alcon Eye Emulsifier and Aspirator last PM on 12/01/2010, used last on 07/03/2012;
OR #1 Electrocautery Unit with last PM 01/2011;
Blanket warmer currently in use - no date for PM.

A tour of the Emergency Department conducted on 02/05/2014, accompanied by the Registered Nurse, revealed equipment currently in use:
Welch Allyn defibrillator - 12/2012;
Portable Suction Machine - 02/2012;
Fluid Warmer - 03/24/2006;
Datascope monitor - 03/06/2012;
Glidescope blade with Camera - no PM date;
Defibrillator 08/06/2012;
Datascope monitors x 2 - 06/20/12;
Datascope monitors x 2 - 06/21/2012;
Infant scale 06/21/2012;
Infant Warmer - no date found but listed as done by Aramark 06/21/2012.

Review of the Aramark Clinical Technology Services report included:
"06/20/2012 - PM's and minor repairs in the ER;
06/25/12 - Sterilizer repair;
06/28/12 - Sterilizer repair & PMs;
07/31/2012 - PMs in PT ward & CT repair;
08/06/2012 - PMs in OR & minor repairs
09/07/2012 - X-ray repairs;
09/12/2012 - Repairs & PMs
09/28/2012 - PM Repairs."

The CEO verified the Aramark list of PM's was the last record for preventative maintenance, testing and repairs found. She acknowledged no current PM's and calibrations have been performed since 2012.
VIOLATION: PROTECTION OF RECORD INFORMATION Tag No: C0308
Based on policy and procedure review and interview, it was determined that the Critical Access Hospital (CAH) failed to require that patient records were protected from unauthorized use.

Findings include:

The "Health Information Management Policies and Procedures" titled: "Access to Storage and Retrieval Areas" revealed: "Only authorized personnel shall be permitted direct access to the file room areas so that the following are achieved: proper safeguards against unauthorized use are maintained fixed responsibility for file integrity and accuracy is assigned. The following personnel are authorized to retrieve medical records from the HIM (Health Information Management) department: Administrator, Administrator on Call, Admitting Clerk and Nursing Supervisor."

The Medical Records Clerk stated, during interview conducted on 02-07-14, when asked how medical records were accessed after hours, that she kept a log of records retrieved after hours. The Clerk stated that when the Emergency Department (ED) physicians needed to access a past medical record, that a technician from the ED would sign out the record.

The Interim Chief Executive Officer (CEO) stated, during interview conducted on 02-07-14, that she was aware of the need for a "supervisor" in medical records, but was unaware that ED technicians had access to the medical records after hours.