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.

GIFFORD MEDICAL CENTER 44 SOUTH MAIN STREET RANDOLPH, VT 05060 Sept. 10, 2014
VIOLATION: RECORDS SYSTEM Tag No: C0301
Based on observation and interview, the CAH failed to assure all medical records were maintained and stored in accordance with established policies and procedures. Findings include:

Per observation, during tour of the Health Center at Berlin, at 8:20 AM on 9/10/14, medical records were stored on open shelving in unlocked cabinets and accessible to cleaning staff. Per review, the facility's established Storage and Security of Medical Records policy, dated 3/30/2009, stated as it's purpose; "To provide maximum security to the confidentiality of the medical record.... All medical record areas are restricted except to authorized personnel. Medical record storage doors will remain locked unless a Health Information representative is present......Health records should not be left unattended in areas accessible to unauthorized individuals." The Vice President of Surgery, responsible for the oversight of the clinic, confirmed, at the time of tour, that contracted cleaning staff, who have no need to access medical records, do have unmonitored access to the medical records during after hour cleaning of the room.
VIOLATION: RECORDS SYSTEM Tag No: C0302
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, nursing and pharmacy staff failed to accurately document the omission of a medication and failed to complete documentation in 1 of 23 applicable records for the notification to the prescribing physician of a medication omission and lack of medication availability as well as to request a change in order for the unavailable medication. (Patient # 10) Findings include:

Per medical record review, Patient #1 was admitted to the facility on [DATE] for the treatment of a traumatic laceration and tendon injury of his/her foot. Unrelated to the foot injury, the admission orders included an order for Elmiron 100 mg capsules three times per day, a medication that Patient #10 was taking prior to his/her hospitalization (Elmiron is a medication used to treat interstitial cystitis, a chronic bladder condition that is often associated with pain and bladder pressure).

Per 9/9/14 at 2:09 PM interview, the Pharmacy Manager reported that Elmiron was non-formulary and unavailable. The pharmacist reported that when medications are not available in the hospital pharmacy attempts are made to obtain the medication from home, use therapeutic substitutions, utilize other hospitals, or fill prescriptions from retail stores so a patient will not miss doses. The pharmacist reported visiting Patient #10 to see if s/he could bring the medication from home as it was not available in the hospital pharmacy.

Per review of the MAR (Medication Administration Record), on 9/5/14, 1 dose of Elmiron was not administered to Patient #10; on 9/6/14, 2 doses of Elmiron were not administered; notations were made in the MAR on 9/5/14 that Elmiron was "omitted: pt own med, not in pyxis;" on 9/6/14 a notation states "med not available" for the 2 omitted doses. A note was added to the Elmiron order, "Pt Own Med." On 9/9/14 at 11:45 AM, a facility pharmacist documented, "I spoke with patient about [his/her] Elmiron. [S/he] is OK skipping one dose because [s/he] will not be able to supply it until 9/10/14 in the morning;" however, on the MAR, the 9/9/14 14:36 nursing entry states that "Patient Refused" Elmiron. On 9/9/14 during an interview at 2:09 PM with the Pharmacy Manager, the staff pharmacist reported that Patient #10's wife could not bring more Elmiron to the hospital until 9/10/14 and that there was only 1 Elmiron capsule left following his/her morning dose and Patient #10 opted to miss the 9/9/14 afternoon dose but planned to take the PM dose. When asked if the provider was contacted about the change in the medication order, the staff pharmacist called a staff hospitalist for approval during the interview.

Per review, the policy "Nonformulary Medications and Patient's Own Medications " (effective 2013-11-18) states that "The pharmacy department is responsible for ensuring medications are available to meet patient needs while they are receiving care at Gifford Medical Center." Under the heading Non-formulary medications, Section B. states "The pharmacy will make all attempts to get the medication in house within 24 hrs. If the medication is not going to be available within 24 hours, documentation will be placed in the patient ' s chart in the progress notes by the pharmacist regarding the status of the needed medication. C. If the medication is expected on the following day, the patient ' s chart and MAR must reflect that start date. Also, the staff pharmacist who receives the order will leave a detailed report for the pharmacist coming on the following day that a medication is expected and what further steps need to be taken. The pharmacist will then be responsible for ensuring that the medication is made available to the patient. D. If the pharmacy is closed, the charge nurse and on call provider will assess if the patient will need the medication prior to 7 AM and what steps should be taken prior to the pharmacy reopening. If the medication is a patient ' s own medication and deemed critical, a dose can be given only if it is identified using the imprint code and Clinical Pharmacology Online... E. If nursing sees that a medication is still unavailable after 24 hours, they are to call the pharmacy so that the steps outlined below can be taken."

On 9/10/14 at 9:43 AM, the Pharmacy Manager reported that a 24 hour time frame was determined as an appropriate in-house time frame to assure that ordered medications are available for patients. When asked for clarification for the process for contacting the ordering provider about a change in orders when medications are not available (as it was not specified in the above policy), the Pharmacy Manager confirmed that provider contact was not included in the policy and confirmed that s/he could not provide documentation that the provider was contacted for a change in orders for Patient #10 when the Elmiron was not available on the first 2 days of admission. S/he reported that since Patient #10 received Elmiron within 24 hours as per the above policy, there was no need for further pharmacy documentation. S/he confirmed that there is no list of critical medications that can safely be omitted for 24 hours and added that the pharmacists use professional judgment to determine whether a medication should not be missed for 24 hours.
On 9/10/14 at 8:14 AM, the medical-surgical unit Nurse Manager (NM) stated that nonformulary medication unavailability is discussed at interdisciplinary grand rounds (attended by hospitalists, nursing, pharmacy, Quality, care management and rehab staff). S/he reported that pharmacy takes the lead to obtain nonformulary medications. The NM confirmed there was a documentation discrepancy in the MAR on 9/9/14 between a staff nurse documenting that Patient #10 "refused" Elmiron on 9/9/14 at 14:36 while the pharmacist documented that Patient #10 was "...OK skipping one dose" of Elmiron on 9/9/14 as s/he was not able to supply it until 9/10/14; the NM confirmed that documentation on the MAR should have read "med unavailable." The NM confirmed that there was no documentation in the record that nursing staff had contacted the physician to notify that Patient #10 was not administered Elmiron on 9/5 and 9/6/14 and there was no documentation of a request to change the order for the medication when it was not available. S/he further added that there is no specific " nursing policy " that addresses the use of nonformulary/home medications to provide direction to staff re notification to physicians when the medication is unavailable or for the need to obtain a new order when medications are not available.
On 9/10/14 during an interview beginning at approximately 11:00 AM, the current and former Vice Presidents of Patient Care Services confirmed that the issue of nursing responsibilities for patients taking nonformulary medications had not been addressed and that a nonformulary medication policy is under development. There was agreement that physician orders were not followed when a patient does not get medications as ordered and that nursing staff should notify the physician when a medication is unavailable and a new order should be obtained.
Per 9/10/14 interview with the Medical Director of the Hospital Division, s/he confirmed that discussions about non-formulary medications occur but changes in medication orders are not documented; s/he confirmed that an order to omit non-formulary/unavailable medications should be obtained and confirmed that the process for non-formulary medication availability and responsibilities for nursing, pharmacy and physicians needs to be "....tightened" to make medication orders clearer when there are medication omissions.
VIOLATION: PROTECTION OF RECORD INFORMATION Tag No: C0308
Based on observation and interview, the CAH failed to assure the confidentiality of medical record information was maintained to prevent unauthorized access. Findings include:

1. During tour of the Health Center at Berlin, outpatient clinic, at 8:20 AM on 9/10/14, medical records were observed stored on the open shelves of unlocked cabinets in the reception area. The Vice President of Surgery, who is responsible for oversight of the clinic, confirmed, at the time of tour, that contracted cleaning staff, who have no need to access medical records, do have unmonitored access to the medical records during after hour cleaning of the room.
VIOLATION: QUALITY ASSURANCE Tag No: C0337
Based on interview and record review, the CAH failed to assure all patient care services affecting patient health and safety were effectively monitored and failed to assure CAH staff consistently complied with the process for reporting and incident/adverse event and also filing reports as mandated by State statute. Findings include:

1. The Quality Assurance/Performance Improvement (QA/PI) program had failed to identify opportunities for improvement within the CAH that were subsequently identified by surveyors at the time of survey. There was a failure within the QA/PI program to identify the provision of Pharmacy services was not consistently assuring the safe and secure storage and ongoing monitoring of all drug storage areas within the hospital for content, usage and outdated drugs as per professional standards of practice. The CAH Infection Control program failed to assure staff consistently maintained infection control standards of practice and failed to conduct ongoing surveillance and monitoring of the CAH environment to assure a sanitary and safe environment was being maintained. Infection Control concerns were identified to include patient care locations to include Peri-operative, Emergency Department and the Radiology Department. Per interview on 9/10/14 at 2:30 PM the Senior Director of Quality and Risk Management confirmed there has been a lack of consistent hospital-wide environmental safety rounds and/or Infection Control risk assessments

Per CAH policy Incident/Adverse Event Reporting effective date 8/27/2014, staff "A. When a patient or visitor incident/event occurs and/or is recognized, it should be reported using the Safety Event Reporting link found on Gifnet within 24 hours of the event occurrence or when the event or error is identified. ...." Once a report is filed a preliminary assessment of the event and situation is conducted. Following a review, a determination would be made to assure reporting to outside agencies as mandated by law was completed. However, on 7/10/14 Patient #18 and Nurse #1 were involved in an incident resulting in an allegation of "assault" made by both the patient and the patient's family. Although the Patient Relations Specialist, nursing staff, and various administrative staff, were aware of the event to include the Senior Director of Quality and Risk Management, no one completed a Incident/Adverse event report, as per CAH policy. As a result, there was a failure to identify opportunities for improvement and to evaluate present processes. In addition, there was no review by Quality and Risk Management of the event on 7/10/14 to determine if staff had completed the State mandated report to APS, within the required time frame. These omissions were also confirmed by the Senior Director of Quality and Risk Management on the afternoon of 9/10/14.
VIOLATION: COMPLIANCE WITH STATE AND LOCAL LAWS Tag No: C0152
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and record review, during the provision of care and services staff failed to maintain patient rights in accordance with State statute, Title 18, Chapter 42; Bill of Rights for Hospital Patients; 1852. " The patient has the right to considerate and respectful care at all times and under all circumstances with recognition of his or her personal dignity " for 1 applicable patient. ( Patient #18). The CAH also failed to report an allegation of abuse in accordance with State statute, Title 33, Chapter 69: Reports of Abuse, Neglect, and Exploitation of Vulnerable Adults; 6903 for 1 applicable patient. (Patient #18) Findings include:

1. Per record review, Patient # 18 was admitted on [DATE] for alcohol withdrawal, atypical chest pain and pancreatitis. The patient has a past history of long term substance abuse, Traumatic Brain Injury (TBI), chronic head and neck pain and generalized anxiety disorder. Upon admission Patient #18 was placed on a CIWA protocol (Clinical Institute Withdrawal Assessment for alcohol. A 10 item scale used in assessment and management of Alcohol withdrawal). Patient #18 also reported during his/her initial treatment on 7/9/14 in the Emergency Department s/he was also experiencing narcotic withdrawal. Upon admission a nursing assessment rated Patient #18 to be a fall risk and a "High Risk" protocol was initiated to include: chair and bed alarm, 1 hour safety rounds by nursing and the use of a gait belt/ one person assisting Patient #18 with ambulation. On 7/10/14 Patient #18's CIWA score was rated as "Moderate to Severe" and required repeat doses of Lorazepam (benzodiazepine/antianxiety) to help reduce the patient's symptoms of withdrawal which included tremors of extremities, anxiety and agitation. The patient also began receiving Dilaudid (narcotic/pain medication) for ongoing pain complaints related to Pancreatits and chronic issues associated with neck and shoulder injury.

Per interview on 9/9/14 at 4:30 PM, Nurse #1, assigned to Patient #18 on the evening of 7/10/14 stated s/he heard the bed alarm go off at approximately 5:30 PM and entered the patient's room and observed Patient #18 attempting to enter the bathroom without assistance. Nurse #1 stated the intravenous pole had fallen to the floor and the patient's intravenous (IV) access was in jeopardy of being pulled out as the patient advanced toward the bathroom. Nurse #1 stated s/he requested the patient to stop and prevented Patient #18 from entering the bathroom. Per the nursing progress note for 7/10/14, Nurse #1 states "I immediately prevented the patient from continuing forward by placing one hand on the door and one hand on the patient's left upper arm (above the IV site)...." . Nurse #1 requested the patient to return to bed so the patient's IV access could be checked. The progress note further states Patient #18 then told Nurse #1 " Don't touch my arm". This statement was again repeated by the patient. Eventually Patient #18 cooperated, returned to bed, IV was checked, a gait belt was applied and Patient #18 with assistance by Nurse #1, the patient was brought to the bathroom.

Within approximately 30 minutes, the evening charge nurse on 7/10/14 was notified by Registration that Patient #18 had called saying that s/he was "assaulted" by a nurse. The nurse manager notified the Patient Relations Specialist of the allegation. The Patient Relations Specialist choose to come to the CAH to speak with Patient #18, whom s/he has known during Patient #18's repeated hospitalization s. After discussions with Patient #18, and despite the fragility of Patient's #18's emotional and physical compromise and allegation of assault by staff, the Patient Relations Specialist requested Nurse #1 meet with Patient #18 so the patient could apologies. However, per interview on 9/9/14 at 4:40 PM Nurse #1 stated " I thought I don ' t know what s/he feels s/he needs to apologize for ..it was odd ... I said to (Patient #18) I ' m also sorry if there ' s anything I did to offend you ...s/he (Patient 18) started crying and s/he said I just don ' t want you to get angry ....I didn ' t hear anything more about holding her/his arm ...if there was any harm to her/him that I had caused I wish someone had come to tell me but nobody did..." Nurse #1 further stated the Patient Relations Specialist never informed her/him of the allegations made by Patient #18. Per interview on 9/9/14 at 3:58 PM, the Patient Relations Specialist confirmed Patient #18 was "...very emotional..." about the event. Per interview on 9/10/14 at 10:00 AM, Nurse #2 (evening charge nurse on 7/10/14) confirmed s/he had not interviewed the patient or assessed the patient for injuries but felt "...it was better to have the Public Relations Specialists address the issue".

Consideration of the circumstances alleged by Patient #18 were not appropriately addressed by staff and a failure to assure an emotionally safe environment was maintained. Although an incident had occurred and a allegation of assault was made by Patient #18 who expressed concern for not wanting staff to "..get angry", the patient was subjected to a face to face encounter with Nurse #1 (the alleged perpetrator) for the purpose of "apologizing". Within 2 hours of the alleged incident, Nurse #2 overheard Patient #18 weeping while informing his/her family member by phone that Nurse #1 " ...had brutally assaulted ..." her/him. In addition, there was no additional consideration by staff to assign a different nurse to provide care to Patient #18 on the evening of 7/10/14. It was not until the patient's family contacted Nurse #2 at approximately 10:00 PM voicing concern about Patient #18's safety and requesting Nurse #1 no longer provide care to the patient, a change in the nursing assignment was made, removing Nurse #1 from having contact with Patient #18.

2. CAH staff, identified as mandated reporters, failed to report to Adult Protective Services (APS) an allegation of abuse made by Patient #18 on 7/10/14 within the required time frame of 48 hours. As above mentioned, Patient #18 alleged that on 7/10/14, Nurse #1 had physically assaulted her/him while preventing the patient from using the bathroom. Although several staff became involved in the incident, to include the Public Relations Specialist, Nurse #2 (charge nurse), both Nurse Manager and Assistant Nurse Manager for Howell Pavilion (Patient Care Unit) and the Director of Quality/Risk, all failed to take on the responsibility of reporting, as required, to APS within 48 hours of the incident. It was not until 7/21/14, 9 days later, when the VP of Hospital Services did file a report of the alleged "assault" to APS. Per interview on 9/10/14 at 10:00 AM, when asked why s/he had not filed the report to APS, Nurse #2 (charge nurse on the evening of 7/10/14) stated " I didn ' t think anything at the time ...thought if anything needed to be done the Public Relations Specialist would take care of it ...".
VIOLATION: NUMBER OF BEDS Tag No: C0211
Based on observation and staff interview the facility failed to maintain no more than 25 inpatient beds. Findings include:

During tour of the facility, with the Nurse Manager of the Medical Surgical Unit, on the afternoon of 9/9/14, the surveyor noted a total of 26 beds in or adjacent to locations where the beds could be used for inpatient care. This was confirmed by the Nurse Manager of the Medical Surgical Unit at the time of tour.
VIOLATION: PROVISION OF SERVICES Tag No: C0270
Based on observations, interviews and record review the Condition of Participation: Provision of Services was not met as evidenced by:


C - 271: The CAH staff failed to follow policies and procedures related to the process, management and resolution of a patient complaint.

C- 276: The CAH Pharmacy Department failed to assure the safe and secure storage and ongoing monitoring of all drug storage areas within the hospital for content, usage and outdated drugs as per professional standards of practice.

C - 277: The CAH Pharmacy Department failed to assure a physician was notified in a timely manner when a medication prescribed by the physician was unavailable for administration.

C - 278: The CAH Infection Control program failed to assure staff consistently maintained infection control standards of practice and failed to conduct ongoing surveillance and monitoring of the CAH environment to assure a sanitary and safe environment was being maintained.

C - 283: The CAH Radiology Department failed to maintain a sanitary environment.

C - 294: Nursing staff failed to meet the emotional needs of a patient who expressed concern and anxiety regarding an encounter with a nurse during the provision of services.
VIOLATION: PATIENT CARE POLICIES Tag No: C0271
Based on interview and record review, the CAH staff failed to follow policies and procedures related to the process, management and resolution of a patient complaint for 1 applicable patient. (Patient # 18) Findings include:

1. Per record review, the CAH policy Resolution of Patient and Visitor Complaint or Grievance effective 1/10/2014 states: "Swift and effective resolution of a concern is an opportunity to be a more successful health care facility and can prevent an issue from escalating to more complex patient concerns." The procedure for handling a complaint and/or grievance states "Hospital or Medical Staff members who receive a complaint from a patient or visitor have the responsibility to resolve or attempt to resolve the issue in a timely manner by: listening to the complaint, offering a sincere apology....doing what they can (within their authority) to promptly fix the problem ....". However, when informed by hospital staff on 7/10/14 that Patient #18 was alleging s/he was "assaulted" by a nurse on the Howell Pavilion/Patient care unit, the evening charge nurse failed to speak directly with Patient #18 regarding the patient's allegations. Instead, the nurse manager choose to contact the Patient Relations Specialist, who was familiar with Patient #18's previous medical and psychosocial history, who subsequently came to the CAH and met with Patient #18.

The process for a "....swift and effective resolution..." of Patient #18's concerns did not follow process. The policy further states: "All patient or visitor complaints or grievances are to be dealt with in a timely, satisfactory and uniform manner by making the special effort necessary to satisfy an aggrieved patient or visitor when there was an actual or potential breakdown in services" On 9/10/14 at 4:00 PM the Patient Relations Specialist confirmed s/he brought Nurse #1 into the patient's room and informed the nurse Patient #18 was going to tell her/him why the Patient Relations Specialist had been contacted to visit with Patient #18. The "resolution" of this complaint was a confrontation between the "alleged victim" and the "alleged perpetrator" resulting in the patient informing Nurse #1 s/he had hurt the patient earlier in the evening when attempting to assist the patient back to bed. Upon leaving the CAH after making the onsite visit to Patient #18 the Patient Relations Specialist assumed his/her actions were sufficient and appropriate to manage the complaint voiced by Patient #18 stating at the time of interview: " ....in this particular instance I did not want to be stirring the pot...".

Resolution had not resulted. Patient #18 continued to complain and approximately 2 hours after the visit with the Patient Relations Specialist on 7/10/14 a family member contacted the evening charge nurse voicing concern about the continued nursing care being provided by Nurse #1 despite the concerns raised by Patient #18. Nursing failed to eliminate further potential complaints and allegations by failing to remove Nurse #1 from the responsibility for the provision of care of Patient #18. Patient #18's family member was informed in a phone call by the Patient Relations Specialist at approximately 10:00 PM on 7/10/14 that s/he had been in contact with all parties involved, no "assault" had occurred and Patient #18 and Nurse #1 had "made up". However, concerns continued to be made by Patient #18's family, further alleging on 7/15/14 the patient experienced brushing of the right arm which was directly attributed to the event of 7/10/14. As per policy Resolution of Patient and Visitor Complaint or Grievance when a complainant remains dissatisfied "A formal grievance procedure has been established to provide for a discussion and a decision regarding a complainant's unresolved concerns regarding quality of care.....". There was a failure to recognize the complaint as a grievance or to formally resolve issues identified. This eliminated the opportunity for Quality/Risk Management and Nursing Department to assure all circumstances regarding the event of 7/10/14 were effectively reviewed to determine if resolutions and actions by both Nursing and the Patient Relations Specialist were appropriate, effective and maintained patient rights.
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
Based on observation, interview and record review, the CAH Pharmacy Department failed to assure the safe and secure storage and ongoing monitoring of all drug storage areas within the hospital for content, usage and outdated drugs as per professional standards of practice. This had the potential to affect patients receiving medications in the radiology and medical surgical department. Findings include:

Per the American Society of Hospital Pharmacy (ASHP) Drug Distribution and Control revised 1981 states regarding Drug Storage and Inventory Control: "Storage is an important aspect of the total drug control system. Proper environmental control (i.e., proper temperature, light, humidity, conditions of sanitation, ventilation and segregation must be maintained wherever drugs and supplies are stored in the institution. Storage areas must be secure; fixtures and equipment used to store drugs should be constructed so that drugs are accessable only to designated and authorized personnel."

1. Per observation, on the morning of 9/9/14, an unlocked cabinet containing (18) 100 ml vials of Isovue-370 (lopamidol) 76% injectable contrast solution and a 250 ml bag of intravenous saline 0.9% solution was unsecured, and unmonitored in the CT room of the radiology department. The door to the room was unlocked and accessible by a common hallway used by housekeeping, patients and other unauthorized staff. The lack of secure storage and oversight of the contrast solution cabinet and intravenous solution was confirmed by the department supervisor at the time of the observation at 10:28 AM.

2. Per observation on the medical surgical unit during the afternoon of 9/9/14, 10 unsecured bins of patient medications were observed in the medication room. The bins were labeled with patient names and included the following medications: fenofibrate 145 mg (a cholesterol lowering medication), Humalog mix 75/22 pen and needles (an injectable Insulin), 3 syringes prefilled with Lantus (an injectable insulin), Levetiracetam 100 mg/ml oral solution (a treatment used for seizures), Nystatin powder (an antifungal powder), Aubagio tablets (used in the treatment of Multiple Sclerosis), Fish oil capsules, Vytorin 10-20 mg (cholesterol lowering medication), a Spiriva inhaler (used for respiratory conditions), Brilinta (an antiplatelet medication), Elmiron (used to treat cystitis), Hydocerin cream, Res-Q omega 3 supplement, Januvia 25 mg (used to treat diabetes) and Lantanoprost eye drops (used to treat glaucoma). Per interview at 2:54 PM at the time of the initial observation, Staff Nurse #1 reported that she has observed unescorted housekeeping staff in the medication room cleaning the floor and taking out trash. At 3:10 PM the Nurse Unit Manager, confirmed that housekeeping staff have the access code to enter the medication storage room unescorted for cleaning purposes and that the medications in the bins were not stored in a secure manner to prevent access from unauthorized staff.

Per review, the facility policy Medication Inspections and Refrigerator Checks, states that "A. Each department and provider practice in the hospital system that stores medications will be inspected intermittently by a pharmacist or his/her designee. The following will be inspected on each visit: 1. Medication cabinets 2. Refrigerators 3. Emergency meds 4. Stock supplies 5. Sample medication storage and procedure 6. Narcotics 7. Any area that could store medication." ... "G. All medication are to be stored in locked cabinets, drawers and refrigerators, At no time are any medications (including cleaning agents such as hydrogen peroxide and isopropyl alcohol as well as over-the-counter medications) to be available to the general public or non-clinical staff." The policy Contrast Material Stored in Radiology states that "All contrast material and drugs stored in the Radiology Department must be kept in the locked radiology storage room, a locked radiology exam room, the locked contrast warmer in the CT room, or a locked cabinet in an exam room within the radiology department."

On 9/9/14 during an interview at 2:09 PM, the Pharmacy manager stated that the Pharmacy department is responsible for all medications in the hospital. S/he reported that s/he and a pharmacy tech perform periodic clinic and department inspections looking for safe and secure storage, expired medications and correct labeling on multi-dose vials (dated when opened) and other parameters; however, s/he reported that the department did not have adequate staff to do monthly inspections and that those had stopped in December 2013. Per review of a list of inspections provided by the pharmacy manager, the radiology nuclear medicine department was last inspected on 6/2/14 (the previous inspection was documented as occurring on December 11, 2014); the acute care unit was last inspected on 6/3/14 (the previous inspection occurred on December 11, 2013). S/he confirmed that pharmacy had not inspected the OR (Operating Rom) malignant hypothermia cart, refrigerators or cabinets in the past year; the OR Crash cart was listed as inspected on 6/11/14. The manager stated that the individual departments had assumed inspection of the facilities crash carts; in the past pharmacy had checked monthly.

Per the American Society of Hospital Pharmacy (ASHP) Drug Distribution and Control revised 1981 states regarding Emergency Medication Supplies: " Emergency drug supplies should be inspected by pharmacy personnel on a routine basis to determine contents have become outdated and are maintained at adequate levels."

3. During a tour of the Ambulatory Care Unit and special procedure rooms on 7/9/14 at 2:20 PM with the Surgical Services nurse manager unsecured medications were found in the Endoscopy room. The door of a metal wall cabinet was open and a key remained inserted into the lock. Within the cabinet were 2 plastic boxes containing the following drugs: in the "Conscious Sedation Kit 1": 4 vials of Fentanyl 100 mcg/2ml per vial (Opioid analgesic/controlled substance/scheduled II) and 16 vials of midazolam 2 mg./2 ML vials (Anxiolytic used for sedation/controlled substance/schedule IV). Within the Conscious Sedation Reversal Kit 1: Flumazenil 0.5mg/5 ML (used to reverse sedation), Nitrolingual tablets (used to treat chest pain), 2 vials Ondansetron 4 mg/2ml ( used to treat nausea), 2 vials Naloxone 0.4 mg/ml (to reverse effects of narcotic), 2 vials of Atropine 1 mg/1 ml (used to treatcardiac antiarrhythmics), 1 vial Glycopyrrolate (anticholinergic used preoperatively) and 1 vial Labetalol 5 mg/ml (antihypertensive). The nurse manager confirmed the medications should not have been left in the cabinet after the completion of endoscopic procedures and the kits would be returned to the pharmacy. The cabinet should never be left unlocked and open to unauthorized individuals.

4. During a tour of the Peri-operative area on the afternoon of 9/8/14 the Surgical Services nurse manager identifed a small refirgerator as the location where multiple medications used during surgical eye procedures were stored. Review of the temperture monitoring sheet noted the refrigerator temperatures were consistently documented once every 24 hours, however the acceptable temperature range for medication storage (approximately 36 - 46 F) was not noted on the monitoring sheet and there was no evidence of monitoring the temperatures during weekends. The thermometer presently used by staff did not provide or record continuous monitoring to assure the medications were consistently maintained within acceptable parameters. This was confirmed by the Surgical Services nurse manager.
VIOLATION: POLICIES - MED ERRORS & ADRS Tag No: C0277
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the CAH Pharmacy Department failed to assure the availability of a medication to prevent the occurrence of drug error by omission for 1 of 23 patients in the survey sample (Patient # 10). Findings include:

Per medical record review, Patient #1 was admitted to the facility on [DATE] for the treatment of a traumatic laceration and tendon injury of his/her foot. Unrelated to the foot injury, the admission orders included an order for Elmiron 100 mg capsules three times per day, a medication that Patient #10 was taking prior to his/her hospitalization (Elmiron is a medication used to treat interstitial cystitis, a chronic bladder condition that is often associated with pain and bladder pressure).

Per 9/9/14 at 2:09 PM interview, the Pharmacy Manager reported that Elmiron was non-formulary and unavailable. The pharmacist reported that when medications are not available in the hospital pharmacy attempts are made to obtain the medication from home, use therapeutic substitutions, utilize other hospitals, or fill prescriptions from retail stores so a patient will not miss doses. The pharmacist reported visiting Patient #10 to see if s/he could bring the medication from home as it was not available in the hospital pharmacy.

Per review of the MAR (Medication Administration Record), on 9/5/14, 1 dose of Elmiron was not administered to Patient #10; on 9/6/14, 2 doses of Elmiron were not administered; notations were made in the MAR on 9/5/14 that Elmiron was "omitted: pt own med, not in pyxis;" on 9/6/14 that "med not available."A note was added to the Elmiron order, "Pt Own Med.." On 9/9/14 at 11:45 AM, a facility pharmacist documented, "I spoke with patient about [his/her] Elmiron. [S/he] is OK skipping one dose because [s/he] will not be able to supply it until 9/10/14 in the morning;" however, on the MAR, the 9/9/14 14:36 entry states that "Patient Refused" Elmiron. On 9/9/14 during an interview at 2:09 PM with the Pharmacy Manager, the staff pharmacist reported that Patient #10's wife could not bring more Elmiron to the hospital until 9/10/14 and that there was only 1 Elmiron capsule left following his/her morning dose, so Patient #10 opted to miss the 9/9/14 afternoon dose but will take the PM dose. When asked if the provider was contacted about the change in the medication order, the staff pharmacist called a staff hospitalist for approval during the interview.

Per review, the policy Nonformulary Medications and Patient's Own Medications (effective 2013-11-18) states that "The pharmacy department is responsible for ensuring medications are available to meet patient needs while they are receiving care at Gifford Medical Center." Under the heading Non-formulary medications, Section B. states "The pharmacy will make all attempts to get the medication in house within 24 hrs. If the medication is not going to be available within 24 hours, documentation will be placed in the patient ' s chart in the progress notes by the pharmacist regarding the status of the needed medication. C. If the medication is expected on the following day, the patient ' s chart and MAR must reflect that start date. Also, the staff pharmacist who receives the order will leave a detailed report for the pharmacist coming on the following day that a medication is expected and what further steps need to be taken. The pharmacist will then be responsible for ensuring that the medication is made available to the patient. D. If the pharmacy is closed, the charge nurse and on call provider will assess if the patient will need the medication prior to 7 AM and what steps should be taken prior to the pharmacy reopening. If the medication is a patient ' s own medication and deemed critical, a dose can be given only if it is identified using the imprint code and Clinical Pharmacology Online... E. If nursing sees that a medication is still unavailable after 24 hours, they are to call the pharmacy so that the steps outlined below can be taken."

On 9/10/14 at 9:43 AM, the Pharmacy Manager reported that a 24 hour time frame was determined as an appropriate in-house time frame to assure that ordered medications are available for patients. When asked for clarification for the process for contacting the ordering provider about a change in orders when medications are not available (as it was not specified in the above policy), the Pharmacy Manager confirmed that provider contact was not included in the policy and confirmed that s/he could not provide documentation that the provider was contacted for a change in orders for Patient #10 when the Elmiron was not available on the first 2 days of admission. S/he reported that since Patient #10 received Elmiron within 24 hours as per the above policy, there was no need for further pharmacy documentation. S/he confirmed that there is no list of critical medications that can safely be omitted for 24 hours and added that the pharmacists use professional judgment to determine whether a medication should not be missed for 24 hours.

Per 9/10/14 interview with the Medical Director of the Hospital Division, s/he confirmed that discussions about non-formulary medications occur but changes in medication orders are not documented; s/he confirmed that an order to omit non-formulary/unavailable medications should be obtained and confirmed that the process for non-formulary medication availability and responsibilities for nursing, pharmacy and physicians needs to be "....tightened" to make medication orders clearer when there are medication omissions.
VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
Based on observation and interview, the CAH Infection Control program failed to assure staff consistently maintained infection control standards of practice and failed to conduct ongoing surveillance and monitoring of the CAH environment to assure a sanitary and safe environment was being maintained. Findings include:

1. During tour of the ED (Emergency Department) at 10:20 AM on 9/8/14, with the ED Nurse Manager the following observations were made:

a. 3 of the 6 patient stretchers had wheels and or frames heavily soiled with dirt and/or dust
b. there was used tubing and a nebulizer mouthpiece attached to the oxygen wall equipment in a clean patient exam room that had been made ready for patient use.
c. there were 2 patient commodes, 2 wheel chairs and a rapid infuser IV pump stored in the hallway leading to the ambulance doors, all without evidence of whether or not the equipment had been cleaned after last use.
During interview at the time of tour, the ED Nurse Manager confirmed the soiled wheels and/or frames of the patient stretchers. S/he also confirmed the failure of staff to remove the used oxygen tubing and nebulizer mouth piece when cleaning the room for subsequent patient use, and stated that although equipment is typically stored in the hallway after being cleaned, there is currently no process to assure the stored equipment has been cleaned.
2. During a tour of the Endoscope cleaning and processing area on the afternoon of 9/8/14, flexible gastrointestinal Endoscopes, ( a semicritical instrument requiring a high level of disinfectant) which had been processed and deemed clean and ready for patient use were observed hanging in a vertical position on a rack suspended on a wall which was not enclosed exposing the endoscopes to not only movement from staff within the area, it was not free from dust or other contaminates. Also noted was a soiled and stained towel laying on the floor approximately 6 inches below the scopes. Per the Society of Gastroenterology Nurses and Associations, Inc. Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopy " last revised 2012, page 21 states: "A storage area should be clean well ventilated and and dust free thus discouraging any microbial contamination" and per the Healthcare Infection Control Practices Advisory Committee (HIPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 states: "Store the endoscope in a way that prevents recontamination and promotes drying". The Surgical Services nurse manager confirmed the unprotected storage of the Endoscopes.
3. During a tour of the Peri-operative areas on the afternoon of 9/8/14 with the Surgical Services nurse manager, multiple laryngoscope blades were stored unprotected in a plastic container on the top shelf of the anesthesia storage/supply room and multiple laryngoscopes blades were also stored unprotected in a anesthesia cart. The laryngoscope blades (used during the process of intubation and which come in direct contact with patient mucous membranes) are identified as a semi-critical device requiring high-level disinfection upon use. Per interview on 9/8/14 at 3:15 PM, the charge technician of Central Sterile Supply and reprocessing department confirmed although there is a process for cleaning the laryngoscope blades using a high-level disinfectant there is no process in place to assure the blades after processing are individually protected by an application of a covering to eliminate the risk of contamination while being stored. Per Healthcare Infection Control Practices Advisory Committee (HICPAC) and the Centers for Disease Control (CDC) document entitled Guidelines for Preventing Healthcare-Associated Pneumonia, 2003 states on page 58 regarding the packaging of semi-critical items "....after disinfecting, proceed with appropriate rinsing, drying and packaging, taking care not to contaminate the disinfected item.....".
4. During a tour on 9/9/14 starting at approximately 9:00 AM with the Vice President of Surgical Services, the following observations were made and confirmed in the radiology department:
a. In x-ray room #2, a heavy dust build up was observed on the top and sides of a linen cabinet (where patient gowns and drapes were stored); open cell foam positioning blocks and an apron/shield worn for protection during x-ray procedures were stored on the top of the cabinet in contact with the dusty surface. Dust was observed on the x-ray tubing elbow which is positioned over the x-ray table during imaging. Tech #1 (radiology department technician) stated that department techs are responsible for cleaning the exam tables and all equipment; s/he reported that housekeeping was responsible for cleaning floors and bathrooms, emptying trash and restocking paper supplies. S/he confirmed that there is a risk that image quality of x-rays could be affected by the environmental dust. S/he stated that s/he was not aware of a specific policy regarding sanitizing foam positioners and that some staff covered the positioners in plastic wrap to aid in keeping them clean. S/he reported that newer positioners purchased by the department were vinyl clad to ease cleaning between patients.
b. In the nuclear radiology room, the center of the floor was stained with black scuff marks and a large area of dark discoloration (approximately the size of the exam table).
c. In x-ray room #1, scattered metal filings were observed on the tube tower head (which is part of the x-ray equipment and positioned over the x-ray examination table). Heavy dust build up was observed on the top of the storage cabinet; open cell foam positioners and a lead apron were stored in contact with the dusty surface. Tech #1 confirmed there was a risk that the environmental dust and metal filings could fall onto the exam table and affect imaging quality. S/he reported that s/he was not aware if there was a check list for cleaning examination rooms.
d. In the cardiac rehab room, 02 (oxygen) and suction tubing was observed unpackaged and wound loosely over the wall connections. The top surface of the 02 regulator and suction canister were heavily soiled with dust. When asked how staff assure that the tubing has not been used, the Respiratory Tech stated that staff depend that the tubing was replaced by the previous staff member after it was used.
e. In the Echo lab, the top surface, vents and tube caps of the unit that is used to clean esophageal probes was heavily soiled with dust.
f. In the CT room, 02 (oxygen) and suction tubing was observed unpackaged and wound loosely over the wall connections. The top surface of the 02 regulator and suction canister were soiled with dust. A 250 cc bag of saline 0.9 % solution for intravenous injection hung from an IV pole. The bag was dated 9/9/14 at 8:00 AM. The radiology supervisor stated that staff withdraw saline to flush IV tubing for multiple patients for up to 24 hours after the initial use.
g. In the EEG room, the vinyl cover on a patient positioning block was torn on four corners exposing open cell foam.
Per review, the policy, Infection Prevention in Radiology (Effective date 2012-01-16)under Personnel Responsibilities, lists the responsibilities of the Department Head as: "a. Responsible for proper patient care and equipment safety. b. Maintain a clean and safe environment for the patient and employee. c. Assure that personnel comply with infection control guidelines within the department and throughout the hospital ... " Under the section "Equipment & Supplies" section 5. Any non-disposable patient equipment and trays must be washed in detergent-germicide solution before sending to Central Sterile ...8. Clean gowns must be used for each patient ... 11. To avoid contamination sponges can be covered with pillowcase/towel when possible. The policy titled, Infection Prevention Program (which applies to Gifford Medical Center; Effective date 2013-07-19) states that Gifford Health Center observes Standard Precautions for all patients. Additionally, Gifford Health Center will determine the need for and provide Transmission Based Expanded Precautions when indicated to prevent the spread of infection.
Per 9/10/14 interview, beginning at approximately 2:20 PM, The Director of Quality and Risk Management and the Clinical Quality Specialist, RN who share infection prevention oversight at the facility confirmed that there had been no recent infection control rounds done in the radiology department. The Clinical Quality Specialist, RN confirmed that the observations listed above for the radiology department were infection control issues.
4. Per observations of medication administration to 2 patients in the medical surgical unit on 9/8/14 commencing at 1:25 PM, the following breaches in infection prevention practice for hand sanitization were observed:
a. Registered Nurse (RN) #3 entered room 129 at 1:25 PM to administer via s.c. (subcutaneous) injection, 2 units Novolog Insulin, to Patient #5. The RN failed to sanitize hands upon entering the room and prior to donning gloves to administer the injection to the patient. When the RN was asked about the lack of hand cleansing prior to donning gloves, he/she replied that he/she sanitized after removing gloves.
b. RN #3 entered Room 125 on 9/8/14 at 1:38 PM to administer 3 units s.c. of Novolog Insulin to Patient #6. The RN failed to cleanse/sanitize hands prior to donning gloves (after entering the room) and after removing the gloves. The nurse left the room and went to the nursing station where it was confirmed during surveyor interview that she/he had not sanitized hands either prior to and after direct contact with a patient.
c. RN #3 entered room 129 at 2:30 PM to administer an oral oral dose of thyroid medication and set up and start the IV (intravenous) administration of antibiotic therapy for treatment of a urinary tract infection for Patient #5. The RN failed to sanitize hands upon entering the room and administering the oral medication. The RN forgot some of the needed IV supplies and left the patient's room to get additional supplies and then returned to Patient #5's room; the RN again failed to sanitize/cleanse hands prior to setting up the IV tubing and attaching the medication for the IV administration of the antibiotic medication.
These observations of failure to adhere to infection prevention practices (per hospital policy/procedure) during patient care were confirmed with the RN immediately after leaving the patient's room. Per review on 9/8/14, the hospital's policy/procedure, Nursing - Hand Hygiene, stated "decontaminate hands with either a hygienic hand rub or by washing with disinfectant soap prior to and after direct contact with the patients or objects immediately around the patient."
VIOLATION: RADIOLOGY SERVICES Tag No: C0283
Based on observation and staff interview, the Radiology Department failed to assure that environmental cleaning and infection control practices were followed to maintain a safe and sanitary environment. The deficient practices had the potential to effect patients undergoing imaging procedures in the radiology department. Findings include:
During a tour on 9/9/14 starting at approximately 9:00 AM with the Vice President of Surgical Services, the following observations were made and confirmed in the radiology department:
a. In x-ray room #2, a heavy dust build up was observed on the top and sides of a linen cabinet (where patient gowns and drapes were stored); open cell foam positioning blocks and an apron/shield worn for protection during x-ray procedures were stored on the top of the cabinet in contact with the dusty surface. Dust was observed on the x-ray tubing elbow which is positioned over the x-ray table during imaging. Tech #1 (radiology department technician) stated that department techs are responsible for cleaning the exam tables and all equipment; s/he reported that housekeeping was responsible for cleaning floors and bathrooms, emptying trash and restocking paper supplies. S/he confirmed that there is a risk that image quality of x-rays could be affected by the environmental dust. S/he stated that s/he was not aware of a specific policy regarding sanitizing foam positioners and that some staff covered the positioners in plastic wrap to aid in keeping them clean. S/he reported that newer positioners purchased by the department were vinyl clad to ease cleaning between patients.
b. In the nuclear radiology room, the center of the floor was stained with black scuff marks and a large area of dark discoloration (approximately the size of the exam table).
c. In x-ray room #1, scattered metal filings were observed on the tube tower head (which is part of the x-ray equipment and positioned over the x-ray examination table). Heavy dust build up was observed on the top of the storage cabinet; open cell foam positioners and a lead apron were stored in contact with the dusty surface. Tech #1 confirmed there was a risk that the environmental dust and metal filings could fall onto the exam table and affect imaging quality. S/he reported that s/he was not aware if there was a check list for cleaning examination rooms.
d. In the cardiac rehab room, 02 (oxygen) and suction tubing was observed unpackaged and wound loosely over the wall connections. The top surface of the 02 regulator and suction canister were heavily soiled with dust. When asked how staff assure that the tubing has not been used, the Respiratory Tech stated that staff depend that the tubing was replaced by the previous staff member after it was used.
e. In the Echo lab, the top surface, vents and tube caps of the unit that is used to clean esophageal probes was heavily soiled with dust.
f. In the CT room, 02 (oxygen) and suction tubing was observed unpackaged and wound loosely over the wall connections. The top surface of the 02 regulator and suction canister were soiled with dust. A 250 cc bag of saline 0.9 % solution for intravenous injection hung from an IV pole. The bag was dated 9/9/14 at 8:00 AM. The radiology supervisor stated that staff withdraw saline to flush IV tubing for multiple patients for up to 24 hours after the initial use.
g. In the EEG room, the vinyl cover on a patient positioning block was torn on four corners exposing open cell foam.
Per review, the policy, Infection Prevention in Radiology (Effective date 2012-01-16) under Personnel Responsibilities, lists the responsibilities of the Department Head as: "a. Responsible for proper patient care and equipment safety. b. Maintain a clean and safe environment for the patient and employee. c. Assure that personnel comply with infection control guidelines within the department and throughout the hospital ... " Under the section "Equipment & Supplies" section 5. Any non-disposable patient equipment and trays must be washed in detergent-germicide solution before sending to Central Sterile ...8. Clean gowns must be used for each patient ... 11. To avoid contamination sponges can be covered with pillowcase/towel when possible. The policy titled, Infection Prevention Program (which applies to Gifford Medical Center; Effective date 2013-07-19) states that Gifford Health Center observes Standard Precautions for all patients. Additionally, Gifford Health Center will determine the need for and provide Transmission Based Expanded Precautions when indicated to prevent the spread of infection.
Per 9/10/14 interview, beginning at approximately 2:20 PM, The Director of Quality and Risk Management and the Clinical Quality Specialist, RN who share infection prevention oversight at the facility confirmed that there had been no recent infection control rounds done in the radiology department. The Clinical Quality Specialist, RN confirmed that the observations listed above for the radiology department were infection control issues.
VIOLATION: NURSING SERVICES Tag No: C0294
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, nursing staff failed to meet the emotional needs of 1 of 23 applicable patients who expressed concern and anxiety regarding an encounter with a nurse during the provision of services. ( Patient #18) Findings include:

1. Per record review, Patient # 18 was admitted on [DATE] for alcohol withdrawal, atypical chest pain and pancreatitis. The patient has a past history of long term substance abuse, Traumatic Brain Injury (TBI), chronic head and neck pain and generalized anxiety disorder. Upon admission Patient #18 was placed on a CIWA protocol (Clinical Institute Withdrawal Assessment for alcohol. A 10 item scale used in assessment and management of Alcohol withdrawal). Patient #18 also reported during initial treatment in the Emergency Department s/he was also experiencing narcotic withdrawal. Upon admission a nursing assessment rated Patient #18 to be a fall risk and a "High Risk" protocol was initiated to include: chair and bed alarm, 1 hour safety rounds by nursing and the use of a gait belt/ one person assisting Patient #18 with ambulation. On 7/10/14 Patient #18's CIWA score was rated as "Moderate to Severe" and required repeat doses of Lorazepam (benzodiazepine/antianxiety) to help reduce the patient's symptoms of withdrawal which included tremors of extremities, anxiety and agitation. The patient also began receiving Dilaudid (narcotic/pain medication) for ongoing pain complaints related to Pancreatits and chronic issues associated with neck and shoulder injury.

Per interview on 9/9/14 at 4:30 PM, Nurse #1, assigned to Patient #18 on the evening of 7/10/14 stated s/he heard the bed alarm go off at approximately 5:30 PM and entered the patients room and observed Patient #18 attempting to enter the bathroom without assistance. Nurse #1 stated the intravenous pole had fallen to the floor and the patient's intravenous (IV) access was in jeopardy of being pulled out as the patient advanced toward the bathroom. Nurse #1 stated s/he requested the patient to stop and prevented Patient #18 from entering the bathroom. Per the nursing progress note for 7/10/14, Nurse #1 states "I immediately prevented the patient from continuing forward by placing one hand on the door and one hand on the patient's left upper arm (above the IV site)...." . Nurse #1 requested the patient to return to bed so the patient's IV access could be checked. The progress note further states Patient #18 then told Nurse #1 " Don't touch my arm". This statement was again repeated by the patient. Eventually Patient #18 cooperated, returned to bed, IV was checked, a gait belt was applied and Patient #18 with assistance by Nurse #1, the patient was brought to the bathroom.

Within approximately 30 minutes, the evening charge nurse on 7/10/14 was notified by Registration that Patient #18 had called saying that s/he was "assaulted" by a nurse. The Patient Relations Specialist was notified of the allegation and proceeded to come to the CAH to speak with Patient #18. After discussions with Patient #18, and despite the fragility of Patient's #18's emotional and physical compromise and allegation of assault by staff the Patient Relations Specialist requested Nurse #1 meet with Patient #18 so the patient could apologize.

The circumstances alleged by Patient #18 were not appropriately addressed by nursing staff and they failed to meet the patient's emotional needs and fears expressed. Although an incident had occurred and a allegation of assault was made by Patient #18, nursing staff failed to direct the handling of the alleged incident, transferring all responsibility to the Patient Relations Specialist. Patient #18 who expressed concern for not wanting staff to "..get angry", was subjected to a face to face encounter with Nurse #1 (the alleged perpetrator) for the purpose of "apologizing". Per interview on 9/9/14 at 3:58 PM, the Patient Relations Specialist confirmed Patient #18 was "...very emotional..." about the event. Per interview on 9/10/14 at 10:00 AM, Nurse #2 (evening charge nurse on 7/10/14) confirmed s/he had not interviewed the patient or assessed the patient for injuries but felt "...it was better to have the Public Relations Specialists address the issue".

Within 2 hours of the alleged incident, Nurse #2 overheard Patient #18 weeping while informing his/her family member by phone that Nurse #1 " ...had brutally assaulted ..." her/him. In addition, there was no additional consideration by nursing staff to assign a different nurse to provide care to Patient #18 on the evening of 7/10/14. It was not until the patient's family contacted Nurse #2 at approximately 10:00 PM voicing concern about Patient #18's safety and requesting Nurse #1 no longer provide care to the patient, a change in the nursing assignment was made, removing Nurse #1 from having contact with Patient #18 during the rest of the 3:00 PM to 11:00 PM shift.
VIOLATION: NURSING SERVICES - DRUG ADMINISTRATION Tag No: C0297
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, nursing staff failed to administer a medication in accordance with physician orders and/or report that the medication was unavailable for 1 of 23 patients in the survey sample (Patient #10). Findings include:
Per medical record review, Patient #1 was admitted to the facility on [DATE] for the treatment of a traumatic laceration and tendon injury of his/her foot. Unrelated to the foot injury, the admission orders included an order for Elmiron 100 mg capsules three times per day, a medication that Patient #10 was taking prior to his/her hospitalization (Elmiron is a medication used to treat interstitial cystitis, a chronic bladder condition that is often associated with pain and bladder pressure).

Per 9/9/14 at 2:09 PM interview, the Pharmacy Manager reported that Elmiron was non-formulary and unavailable. The pharmacist reported that when medications are not available in the hospital pharmacy attempts are made to obtain the medication from home, use therapeutic substitutions, utilize other hospitals, or fill prescriptions from retail stores so a patient will not miss doses. The pharmacist reported visiting Patient #10 to see if s/he could bring the medication from home as it was not available in the hospital pharmacy.

Per review of the MAR (Medication Administration Record), on 9/5/14, 1 dose of Elmiron was not administered to Patient #10; on 9/6/14, 2 doses of Elmiron were not administered; notations were made in the MAR on 9/5/14 that Elmiron was "omitted: pt own med, not in pyxis;" on 9/6/14 a notation states "med not available" for the 2 omitted doses. A note was added to the Elmiron order, "Pt Own Med." On 9/9/14 at 11:45 AM, a facility pharmacist documented, "I spoke with patient about [his/her] Elmiron. [S/he] is OK skipping one dose because [s/he] will not be able to supply it until 9/10/14 in the morning;" however, on the MAR, the 9/9/14 14:36 nursing entry states that "Patient Refused" Elmiron. On 9/9/14 during an interview at 2:09 PM with the Pharmacy Manager, the staff pharmacist reported that Patient #10's wife could not bring more Elmiron to the hospital until 9/10/14 and that there was only 1 Elmiron capsule left following his/her morning dose and Patient #10 opted to miss the 9/9/14 afternoon dose but planned to take the PM dose. When asked if the provider was contacted about the change in the medication order, the staff pharmacist called a staff hospitalist for approval during the interview.

Per review, the policy "Nonformulary Medications and Patient's Own Medications " (effective 2013-11-18) states that "The pharmacy department is responsible for ensuring medications are available to meet patient needs while they are receiving care at Gifford Medical Center." Under the heading Non-formulary medications, Section B. states "The pharmacy will make all attempts to get the medication in house within 24 hrs. If the medication is not going to be available within 24 hours, documentation will be placed in the patient ' s chart in the progress notes by the pharmacist regarding the status of the needed medication. C. If the medication is expected on the following day, the patient ' s chart and MAR must reflect that start date. Also, the staff pharmacist who receives the order will leave a detailed report for the pharmacist coming on the following day that a medication is expected and what further steps need to be taken. The pharmacist will then be responsible for ensuring that the medication is made available to the patient. D. If the pharmacy is closed, the charge nurse and on call provider will assess if the patient will need the medication prior to 7 AM and what steps should be taken prior to the pharmacy reopening. If the medication is a patient ' s own medication and deemed critical, a dose can be given only if it is identified using the imprint code and Clinical Pharmacology Online... E. If nursing sees that a medication is still unavailable after 24 hours, they are to call the pharmacy so that the steps outlined below can be taken."

On 9/10/14 at 9:43 AM, the Pharmacy Manager reported that a 24 hour time frame was determined as an appropriate in-house time frame to assure that ordered medications are available for patients. When asked for clarification for the process for contacting the ordering provider about a change in orders when medications are not available (as it was not specified in the above policy), the Pharmacy Manager confirmed that provider contact was not included in the policy and confirmed that s/he could not provide documentation that the provider was contacted for a change in orders for Patient #10 when the Elmiron was not available on the first 2 days of admission. S/he reported that since Patient #10 received Elmiron within 24 hours as per the above policy, there was no need for further pharmacy documentation. S/he confirmed that there is no list of critical medications that can safely be omitted for 24 hours and added that the pharmacists use professional judgment to determine whether a medication should not be missed for 24 hours.
On 9/10/14 at 8:14 AM, the medical-surgical unit Nurse Manager (NM) stated that nonformulary medication unavailability is discussed at interdisciplinary grand rounds (attended by hospitalists, nursing, pharmacy, Quality, care management and rehab staff). S/he reported that pharmacy takes the lead to obtain nonformulary medications. The NM confirmed there was a documentation discrepancy in the MAR on 9/9/14 between a staff nurse documenting that Patient #10 "refused " Elmiron on 9/9/14 at 14:36 while the pharmacist documented that Patient #10 was "...OK skipping one dose" of Elmiron on 9/9/14 as s/he was not able to supply it until 9/10/14; the NM confirmed that documentation on the MAR should have read "med unavailable." The NM confirmed that there was no documentation in the record that nursing staff had contacted the physician to notify that Patient #10 was not administered Elmiron on 9/5 and 9/6/14 and there was no documentation of a request to change the order for the medication when it was not available. S/he further added that there is no specific "nursing policy" that addresses the use of nonformulary/home medications to provide direction to staff re notification to physicians when the medication is unavailable or for the need to obtain a new order when medications are not available.
On 9/10/14 during an interview beginning at approximately 11:00 AM, the current and former Vice Presidents of Patient Care Services confirmed that the issue of nursing responsibilities for patients taking nonformulary medications had not been addressed and that a nonformulary medication policy is under development. There was agreement that physician orders were not followed when a patient does not get medications as ordered and that nursing staff should notify the physician when a medication is unavailable and a new order should be obtained.
Per 9/10/14 interview with the Medical Director of the Hospital Division, s/he confirmed that discussions about non-formulary medications occur but changes in medication orders are not documented; s/he confirmed that an order to omit non-formulary/unavailable medications should be obtained and confirmed that the process for non-formulary medication availability and responsibilities for nursing, pharmacy and physicians needs to be "....tightened" to make medication orders clearer when there are medication omissions.
VIOLATION: PATIENT VISITATION RIGHTS Tag No: C1000
Based on record review and confirmed through staff interview the CAH's Patient Visitation policies did not identify the clinical rationale for restricting or limiting visitors in the SCU (Special Care Unit) and did not address how CAH staff would be trained to assure appropriate implementation of the policies and procedures. Findings include:

Per review the CAH policy, titled CAH Patient Access and Visits, dated 2/20/2012, stated, as it's purpose; ".......recognizes the importance of visits by family and friends. At the same time, we want to ensure that our patients receive the rest and quiet they need to recover. Visiting hours and number of visitors are flexible but may be subject to restriction according to the individual needs of patients as determined by physicians or nursing staff." Although a section regarding visitation for the SCU stated; "Immediate family only. Two visitors at a time for no longer than five minutes at the discretion of the nurse in charge", it did not clarify the clinical rationale for restricting visitation to immediate family only, and the time limit of no longer than 5 minutes. In addition the policies did not address how CAH staff who play a role in facilitating or controlling visitor access to patients will be trained to assure appropriate, consistent implementation of the visitation policies to avoid unnecessary restrictions/limitations on patients visitors.

The Vice President of Patient Care Services confirmed, during interview on the afternoon of 9/10/14, that the policies did not address staff training, and the SCU visitation policy did not include clinical rationale for the restriction of visitors to immediate family only, or the visitation time restriction in that unit.