HospitalInspections.org

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. The issue was found to be out of compliance during the previous survey completed in 2007.

Based on record review, medical staff rules and regulations review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the availability of a health care practitioner for patients presenting to the emergency department (ED) on a 24-hour a day basis for 1 of 14 closed ED records (Patient #36). Failure to ensure the availability of 24 hour emergency services for patients presenting to the ED placed patients seeking emergency treatment at risk of not receiving appropriate treatment.

Findings include:

Review of the CAH's Medical Staff Rules and Regulations occurred on December 13-15, 2010. This document, approved 02/23/10, stated, ". . . IX. EMERGENCY SERVICES: A. . . . The on-call physician is available within 30 minutes. B. The medical staff shall adopt a method of providing medical coverage in the emergency services area. . . ."

Review of the facility's emergency department log on 12/13/10 identified a hand-written entry, dated 04/19/10, which stated, "1010 [10:10 a.m.] . . . Pt [patient] consented to be seen in clinic - see form."

Reviewed on 12/14/10, Patient #36's emergency department record identified a 19-month-old female presented to the emergency department on Monday, 04/19/10, at 10:10 a.m. with blisters on her tongue. Patient #36's emergency department record stated, ". . . MD [medical doctor] on call in clinic [and] pt consents to see MD in clinic now. Walked pt over to clinic [and] pt seen by MD."

Review of a clinic progress note provided by a staff member (#3) occurred on 12/14/10. This clinic progress note, dated 04/10/10, stated, "S: [subjective] She is a 19-month-old female brought in by her mother because of several problems. She was seen initially in the ER [emergency room] but wished to come to the clinic . . ."

During interview on 12/15/10 at 11:00 a.m., an administrative nurse (#5) stated she was not aware the on-call physician saw Patient #36 at the clinic after presenting to the emergency department. This administrative nurse (#5) stated she expected the health care provider on-call to see all patients who present to the emergency department within 30 minutes at the emergency department in accordance with hospital policy. The administrative nurse (#5) stated the CAH's quality assurance program failed to examine or review Patient #36's record/situation.


16379




28086

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. The issue was found to be out of compliance during the previous survey completed in 2007.

Based on record review, medical staff rules and regulations review, and staff interview, the Critical Access Hospital (CAH) failed to ensure a health care practitioner arrived on-site within 30 minutes for 4 of 14 closed emergency department (ED) records reviewed (Patients #5, #6, #11, and #27). Failure to ensure a health care practitioner arrives on-site within 30 minutes for patients presenting to the ED placed patients at risk of not receiving timely treatment.

Findings include:

Review of the CAH's Medical Staff Rules and Regulations occurred on December 13-15, 2010. This document, approved 02/23/10, stated, ". . . IX. EMERGENCY SERVICES: A. . . . The on-call physician is available within 30 minutes. . . ."

- Review of the following ED patient records occurred on December 13-15, 2010:

Patient #5 presented to the ED on 12/12/10 at 11:05 a.m. with diagnoses including chest pain, rule out acute coronary syndrome, coronary artery disease status post coronary artery bypass grafting, weakness, and anxiety. Notification of provider occurred at 11:15 a.m., re-notification occurred at 12:50 p.m., and the provider arrived at 1:00 p.m. (one hour and forty-five minutes after patient presented).

Patient #6 presented to the ED on 12/11/10 at 7:35 a.m. with diagnoses including cerebral vascular accident (recurrent), seizures, anxiety, hypertension, history of multiple lacunar infarcts, and right lower lobe pneumonia. Notification of the provider occurred at 7:40 a.m., and the provider arrived at 9:15 a.m. (one hour and thirty-five minutes after patient presented).

Patient #11 presented to the ED on 08/09/10 at 6:45 p.m. with chest pain. The record documented the physician arrival time as 7:30 p.m. (45 minutes after patient presented).

Patient #27 presented to the ED on 05/31/10 at 7:20 p.m. with pneumonia. The record lacked documentation of the physician arrival time.

During interview on 12/15/10 at 11:00 a.m., an administrative nurse (#5) stated she expected the health care provider on-call to see patients who present to the emergency department within 30 minutes in accordance with hospital policy.

1. Based on observation, review of policy and procedure, and staff interview, the Critical Access Hospital (CAH) failed to ensure the safety of patients, staff, and the public regarding unsecured oxygen storage in 1 of 2 oxygen storage areas (garage). Failure to secure oxygen tanks placed any person in the vicinity at risk of injury if the tank became damaged.

Findings include:

Review of the policy and procedure "Storage and Handling of Compressed Gas" occurred on 12/15/10. This document, dated 06/06, stated,
". . . II. PURPOSE: To ensure safety of personnel who store . . . medical gas cylinders. A. Storage:
. . . 2. Cylinders: . . . b. Full O2 [oxygen] cylinders are kept . . . designated area in garage. . . ."

Review of the policy and procedure "Safety" occurred on 12/15/10. This document, dated 11/04, stated, ". . . II. POLICY: Unity Medical Center will protect the health and safety of . . . staff by providing guidelines and standards for prevention of accidents and/or injury. . . . III. . . . G. Handling of oxygen cylinders: . . . 2. Empty cylinders secured in hospital garage. . . ."

During the tour of the respiratory therapy department, on 12/14/10 at 10:30 a.m., observation of the oxygen storage area in the attached garage identified two storage cabinets containing unsecured oxygen tanks in an upright position on the bottom of the cabinet. One cabinet contained 12 "E" size tanks and one cabinet contained 12 "M" tanks, partially used and full, as described by a respiratory therapy staff member (#6) present during the tour. This staff member agreed staff did not store the oxygen tanks in a secure manner.


28086

- A tour of the ER took place on 12/14/10 at 4:00 p.m. with an ER nurse (#11). During the tour, observation showed a small room located down the hall from the main ER, which the nurse (#11) called the second ER or treatment room. The ER nurse (#11) stated the facility used the treatment room to treat patients who present to the ER with minor injuries/illnesses (cuts, sore throats, sprains, broken bones, etc.), keeping the main ER available for major or more serious injuries/trauma. Observation showed the treatment room lacked a call light system.

During interview on 12/14/10 at 4:00 p.m., an ER nurse (#11) confirmed the lack of a call light system in the treatment room.













21202


2. Based on observation, staff interview, and review of hospital construction standards, the Critical Access Hospital (CAH) failed to ensure functioning call lights in 1 of 1 clean utility room, 1 of 1 dirty utility room, and 1 of 2 emergency rooms (ER) (treatment room). Non-functioning and inaccessible call lights posed a safety hazard to patients and staff, if during the course of care/treatment, patients or staff were unable to summon assistance.

Findings include:

The 1992-93 Guidelines for Construction and Equipment of Hospital and Medical Facilities has outlined the standards regarding a nurses calling system. ". . . In patient areas, each patient room shall be served by at least one calling station for two-way voice communication. Each bed shall be provided with a call device. Calls shall activate a visible signal in the corridor at the patient's door, in the clean workroom, in the soiled workroom, and at the nursing station of the nursing unit . . . The emergency call system shall be designed so that a signal activated at a patient's calling station will initiate a visible and audible signal distinct from the regular nurse calling system. The signal shall activate an enumerator panel at the nurses station, a visible signal in the corridor at the patient's door and at other areas defined by the functional program. Provisions for emergency calls will also be needed in outpatient and treatment areas where patients may be subject to incapacitation."

- On 12/14/10 at 4:30 p.m., during the tour of the CAH's physical environment, observation showed the facility lacked a functioning call light in the clean and dirty utility rooms.

During interview on 12/14/10 at 4:35 p.m., an administrative maintenance staff member (#10) confirmed the CAH lacked a functioning call light in the clean and dirty utility rooms.

Based on observation, policy and procedure review, professional literature review, and staff interview, the Critical Access Hospital (CAH) failed to store all drugs and biologicals in locked rooms and/or containers, failed to store all drugs and biologicals in a manner to prevent access by unauthorized personnel, and failed to ensure proper labeling and/or removal of drugs and biologicals available for patient use in 6 of 8 medication storage areas (Medication Room, Operating Room, Emergency Room, Outpatient Oncology Room, Radiology Department, and Report Room). Failure of the CAH to adequately secure and restrict access of all drugs and biologicals created an opportunity for unsafe and unauthorized use of medications. Failure to ensure proper labeling of drugs and biologicals had potential for the availability of outdated, mislabeled, or unusable medications for patient use.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for the storage of all drugs and biologicals including mobile or readily portable containers. The CAH must keep all drugs and biologicals in a locked room or container and store to prevent access by unauthorized individuals. The CAH must keep drugs and biologicals stored in mobile or readily portable containers, when not in use, in a location such as a locked room, that will ensure the security of all the drugs and biologicals. Also, when not in use, medication carts (anesthesia carts, nursing medication carts, crash carts) must be stored in a locked room, monitored area, or secure location where persons with legal access to the drugs and biologicals are able to monitor the cart and be aware of other people's activities near the cart.

The Centers for Disease Control and Prevention (CDC) has outlined the standards of practice for multi-dose vials. Manufacturer's label multi-dose vials as such when the medication is intended for administration of more than one dose. Typically, multi-dose vials contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative does not protect against contamination caused by healthcare personnel failing to follow safe injection practices. Multi-dose vials should always be dated when they are opened or accessed, and discarded within 28 days from this date unless the manufacturer specifies a different date for the opened vial. Medication vials should always be discarded whenever the sterility is questioned or compromised. The United States Pharmacopeia (USP) General Chapter 797 recommends this practice for multi-dose vials of sterile pharmaceuticals.

The USP Revised General Chapter 797, Pharmaceutical Compounding-Sterile Preparations, June 01, 2008, sets practice standards and mentions the expiration dates for multi-dose vials. According to the chapter, multi-dose containers are to be used within 28 days under any condition. The chapter recognizes the best by date (BUD) on some products may be labeled for more or less than 28 days, at the discretion of the manufacturer.

"APIC [Association for Professionals in Infection Control and Epidemiology] Position Paper: Safe Injection, Infusion and Medical Vial Practices in Healthcare," APIC online article, dated July 30, 2009, stated, ". . . Vials . . . Dispose of opened multidose medication vials 28 days after opening, unless specified otherwise by the manufacturer, or sooner if sterility is questioned or compromised. . . . Date opened multidose vials to reflect date opened and/or date of expiration. . . ."

Review of the CAH's policy and procedure "Medication Area Inspection" occurred on 12/15/10. This document stated, "I. PURPOSE: Assure adequate labeling, storage conditions, and control of drugs.
II. POLICY: A. Inspection of all medication storage areas will be done monthly.
B. The Pharmacist will distribute inspections forms to be completed to each Department/Service with drug storage. The Pharmacy Technician will be responsible for all areas except . . . chemo [chemotherapy] which will be inspected by nursing staff for that area.
C. The Department/Service Manager will assure inspection completed and will validate results by signature. . . . 5. All medications expiring on the month of inspection will be removed and logged on the attached medication sheet and returned to the pharmacy with the completed inspection form. . . .
E. Medication storage areas are located: 1. Ambulatory Care: a. ER [Emergency Room] stock and ER Crash Cart, Treatment Room, OB [Obstetrics] cart, Peds [Pediatrics] crash cart. . . . d. Laminated Hood Room (Chemo) and Central Nursing Medication Room. e. Surgery, PAR [Post Anesthesia Recovery], Anesthesia Cart.
2. Ancillary Services: a. X-ray Emergency Tray.
3. Central Nursing: a. Medication Room and Crash Cart. . . ."

Review of the CAH's policy and procedure "Monthly Drug Checks Protocol" occurred on 12/15/10. This document stated, "Central Nursing/Emergency Room/Surgery/Anesthesia/ Clinic/Oncology/Radiology/Treatment Room, When doing monthly drug checks for outdates: 1. Check medications in all areas: a. Non-Narcotic PO [by mouth]. b. Non-Narcotic IM [intra muscular] & [and] IV [intravenously]. c. Metal Cupboard. d. Crash Cart. . . ."

During a tour of the nursing unit on 12/14/10 at 1:20 p.m., a staff nurse (#9) stated the facility stored the crash cart in the report room and directed the surveyor down the hall, away from the nurses station, into the report room. The report room door lacked a lock, and the room showed a table and chairs, bathroom, cupboards, lockers for staff, and a crash cart located against the west wall. Observation of the crash cart showed it contained various medications used in life-threatening situations. The facility had the crash cart locked with a plastic break away lock. The facility placed additional plastic locks, used as replacements for the lock on the cart, in a clear plastic bag on top of the crash cart. The staff nurse (#9) stated nurses and nurse aides used this room prior to their shift for report and for breaks and some of the providers used the room. The staff nurse (#9) confirmed the facility did not monitor the room.

During an interview on 12/14/10 at 1:30 p.m., a pharmacy staff member (#12) stated the CAH should store medications securely or monitored to prevent unauthorized access and use.

During a tour of the CAH on the afternoon of 12/13/10, observation of the hallway by the Emergency Room (ER) showed a closed door along the north wall. A nursing staff member (#4) walked down the hallway and opened the unlocked door and identified it as the Operating Room (OR). This staff member stated the facility used the room only on days when staff scheduled surgery or procedures.

During a tour of the OR on 12/14/10 at 2:50 p.m. with an OR nurse (#11), observation showed two OR suites, a small sterilizing room, and a recovery room. The OR nurse (#11) stated the facility did not keep the four rooms locked. Observation of one OR suite, identified by the nurse (#11) as the main suite used for general anesthesia, showed an unlocked anesthesia cart containing various medications used in surgery. An unlocked cupboard in the suite contained the following medications: 7 vials of Lidocaine, 5 vials of Xylocaine, 1 vial of Xylocaine with Epinephrine, 3 vials of Sodium Bicarbonate, 2 vials of Sensorcaine, 2 vials of Dexamethasone, 2 vials of Gentamicin, 2 vials of Cefazolin, and 1 bottle of liquified Phenol. Observation of the second OR suite, identified by the nurse (#11) as the endoscopic suite used for scope procedures, showed an unlocked cart containing medications (Atropine and Narcan) used for conscious sedation during procedures. Observation of the sterilizing room showed an unlocked refrigerator containing 1 bottle of Proparacaine eye drops and 11 vials of Zemuron. Observation of the recovery room showed 1 vial of Procainamide, 2 vials of Furosemide, 6 vials of Dantrolene, and a syringe of Dextrose stored in a drawer of an unlocked bedside table.

During an interview on 12/14/10 at 2:50 p.m., an OR nurse (#11) stated the facility keeps the main door leading to the OR area locked and keeps the key for the door on the ER key ring, which the charge nurse carries at all times. The OR nurse (#11) stated the facility monitors the OR area only during the time when used for surgeries or procedures. The OR nurse (#11) stated housekeeping and physical plant staff have unmonitored access to the OR area for cleaning and performing maintenance giving these staff access to the unlocked, non-secured medications.

During a tour of the ER on 12/14/10 at 4:00 p.m., observation showed three portable containers stored in an unlocked cupboard containing various types of nose, eye, and ear drop medications and an unlocked refrigerator containing various medications.

During an interview on 12/14/10 at 4:00 p.m., an ER nurse (#11) stated the ER remains unlocked at all times and the facility monitors the area during the time when used for patients. The nurse (#11) stated housekeeping and physical plant staff have unmonitored access to the ER for cleaning and performing maintenance when needed giving these staff access to the unlocked, non-secured medications.

During an interview on 12/15/10 at 9:20 a.m., an administrative nurse (#5) stated she was not aware of all the unsecured medications within the CAH, including the unsecured/unmonitored crash cart on the nursing unit. This nurse (#5) stated the OR must remain locked at all times and the CAH must secure or lock all medications within the CAH to prevent unauthorized access.

- Observation of the refrigerator in the medication room on the nursing unit, on 12/14/10 at 10:30 a.m. with a staff nurse (#8), showed 1 vial of Novolin R, 1 vial of Humulin N, and 1 syringe of Lantus available for patient use, opened, punctured/used, and unlabeled/undated. Observation of the cupboard in the medication room showed 2 vials of Lidocaine available for patient use, opened, punctured, and unlabeled/undated. Observation of an intravenous (IV) tray in the medication room showed 1 vial of Lidocaine and 1 vial of sodium chloride available for patient use, opened, punctured, and unlabeled/undated.

During an interview on 12/14/10 at 10:30 a.m., a nursing staff member (#8) stated staff must label opened multi-dose medication vials with the date of opening, or date of expiration 28 days from opening per CAH policy. The staff member (#8) stated labeling opened insulin vials/syringes was especially important.

During an interview on 12/14/10 at 1:30 p.m., a pharmacy staff member (#12) stated labeling opened insulin vials/syringes was especially important due to the loss of stability with the medication and he expected staff to label all multi-dose medication vials upon opening.

Observation of the anesthesia cart in the main OR suite, on 12/14/10 at 2:50 p.m. with an OR nurse (#11), showed 1 vial of Anectine available for patient use, opened, punctured, and unlabeled/undated. Observation of the cart in the second OR suite showed 1 vial of Atropine available for patient use, opened, punctured, and unlabeled/undated.

Observation on 12/14/10 at 3:25 p.m., of the medication refrigerator in the outpatient oncology "prep area" with staff member (#6) showed two open, undated vials of medications (octreotide acetate and dexamethasone).

Observation of a locked cupboard in the ER, on 12/14/10 at 4:00 p.m. with an ER nurse (#11), showed 1 vial of Lidocaine, 1 vial of Lidocaine with Epinephrine, and 1 vial of Ondansetron available for patient use, opened, punctured, and unlabeled/undated.

During an interview on 12/14/10 at 5:00 p.m., a nursing staff member (#11) stated she could not confirm when staff opened the above vials of medications for patient use.

During an interview on 12/15/10 at 9:20 a.m., an administrative nurse (#5) confirmed staff must label all multi-dose medication vials upon opening and stated the procedure is a standard of practice.

- During the tour of the Radiology Department, observation of a cabinet in the computerized tomography (CT) room identified two unopened 50 milliliter vials of Omnipaque Contrast labeled with expiration dates of 05/08/10. Supervisory staff member (#1) and radiology staff member (#2) present at that time confirmed the vials were outdated and staff should have removed them from available service.


16379




21202

Based on observation, review of Medical Staff Bylaws, policy and procedure review, review of infection control reports and committee meeting minutes, record review, patient interview, and staff interview, the Critical Access Hospital (CAH) failed to follow infection control practices for 3 of 4 active patients (Patient #1, #2, and #4) observed in contact isolation and failed to implement a system to identify, report, investigate, and control infections and communicable diseases among personnel of the CAH for 11 of 11 months (January to November 2010) reviewed. Failure to follow infection control practices may allow transmission of organisms/bacteria from patients to staff, other patients, or visitors. Failure to identify and address infections among personnel had the potential for infections to go unreported and to spread or reoccur affecting the health of all patients and personnel of the CAH.

Findings include:

Review of the CAH's Medical Staff Bylaws occurred on December 13-15, 2010. This document, approved 01/08/08, stated, ". . . G. Infection Control: . . . 5. Assure reports received confirm the following essential infection control processes are carried out: a) Surveillance of nosocomial infection and employee practice, analysis of findings of surveillance, and action to improve practice and patient outcome. . . ."

Review of the policy "Infection Prevention and Control Standard Precautions and Isolation" occurred 12/15/10. This policy, undated, stated, "I. PURPOSE: To prevent the spread of infection and infectious diseases in acute and ambulatory settings. II. POLICY-STANDARD OF CARE: Two levels of precautions will be used to prevent the spread of infectious disease to healthcare workers and patients. A. Standard Precautions . . . B. Transmission-based precautions . . . Those precautions include contact . . . isolation protocol. III. PROCEDURE-STANDARD OF PRACTICE: A. Infection Prevention and Control Measures 1. Handwashing is a fundamental and the single most important infection control measure to reduce the spread of infection. . . . a. Hands must be washed: *Between patient contacts *After contact with . . . body fluids . . . excretions *After removing gloves *After contact with equipment or articles that are known or suspected to be contaminated . . . b. An anti-microbial soap . . . may be required in certain departments or for certain isolation precautions. . . . d. Hand antisepsis with hospital approved alcohol gel product . . . is acceptable in lieu of hand washing with soap and water when hands are free of debris. . . . C. Transmission Based Precautions (Isolation Precautions) . . . 2. Contact Isolation a. This isolation protocol is used for patients known or suspected to have serious illnesses easily transmitted by contact (skin to skin or by equipment) . . . b. Use Standard Precautions as well as the following steps: . . . *Wear gloves when entering the patient's room. . . . Remove gloves before leaving the room and wash with an antimicrobial soap. Handwashing is especially critical to prevent the spread of drug resistant organisms such as . . . MRSA [methicillin resistant Staphylococcus aureus]. *Wear a gown when entering a patient's room. Remove the gown before leaving the room. . . . *Dedicate Non-critical patients [sic] care items . . . to the patient. These items must be adequately cleaned before reuse by another patient. . . . D. Temporary Precautions - Patients are often admitted before a definitive diagnosis is made and before infection or disease is ruled out. The following precautions are indicated on admission in order to control nosocomial transmission based on clinical syndrome: . . . 5. [Clinical Syndrome or Condition] Risk of Multidrug-Resistant Microorganisms: History of infection or colonization with multidrug-resistant organisms
. . . [Empiric Precautions] Contact . . ."

Review of the policy "Infection Prevention and Control Plan" occurred 12/15/10. This policy, undated, stated, "I. PURPOSE: To outline plan . . . to reduce the risk of acquiring and transmitting infections among patients, employees, physicians, and other licensed independent practitioners, contract service workers, volunteers, students, and visitors . . . II. POLICY: To reduce or minimize the number of actual or potential infection outcomes among our patients, visitors, and associates by providing services, education, and information related to Infection Control. . . . V. PRIORITY SERVICES: . . . C. Comply with regulations, guidelines . . . appropriate to the practice of infection control. . . . F. Work collaboratively with employee health to develop policies and procedures for healthcare personnel and implement appropriate preventative measures. . . ."

During a tour of the CAH on the afternoon of 12/13/10, observation showed signage posted on the doors of Patients #1, #2, and #4's rooms, identifying the need for staff and visitors to follow "Contact Isolation Precautions" prior to entering these rooms.

- Observation on 12/13/10 at 4:20 p.m., showed two staff nurses (#14 and #15) donned gloves and gowns, entered Patient #4's room, and provided personal cares. During personal cares, observation showed the two nurses (#14 and #15) removed and replaced Patient #4's soiled (with urine and stool) brief. After personal cares, both nurses (#14 and #15) removed their soiled gloves, failed to perform hand hygiene, and donned a new pair of gloves. Then they assisted Patient #4 to sit on the edge of the bed. One staff nurse (#14) removed her gloves and exited Patient #4's room to obtain a gait belt. The staff nurse (#14) failed to perform hand hygiene prior to leaving the room. Observation showed the nurse (#14) entered the laundry room, obtained a robe, entered the nurses station to obtain a gait belt, then donned a gown and gloves and entered Patient #4's room. After placing the gait belt around Patient #4, the nurses (#14 and #15) indicated the gait belt did not fit, so they removed the gait belt and placed it on a shelf in the patient's room.

The nurses (#14 and #15) ambulated Patient #4 out of the room into the hallway, returned and then assisted the patient back to bed. Observation showed a nurse (#14) grabbed the gait belt from the shelf and placed it in her pocket, thus contaminating her clothing. Before the nurse (#14) finished assisting Patient #4, she removed her gloves, grabbed a plastic cup and mouth swab from the patient's bed-side stand, went into the bathroom touching the door handle, filled the cup with water by turning on the faucet with her hand, walked out of the bathroom touching the door handle, and handed the plastic cup and mouth swab to Patient #4. With mouth cares completed, Patient #4 handed the plastic cup and mouth swab back to the nurse (#14). The nurse (#14) walked into the bathroom touching the door handle, threw the mouth swab in the garbage, dumped the water out of the plastic cup into the sink, walked out of the bathroom touching the door handle, and placed the plastic cup on the bed-side stand. The nurse (#14) removed her gown, performed hand hygiene with hand sanitizer, and left the room. The nurse (#14) failed to wash her hands with antimicrobial soap before exiting the patient's room. The other nurse (#15) removed her gloves and gown, performed hand hygiene with hand sanitizer, and exited the room. This nurse (#14) failed to wash her hands with antimicrobial soap before exiting the patient's room.

Review of Patient #4's active medical record occurred 12/14/10 and identified the CAH admitted the patient 12/09/10 with diagnoses of abdominal pain, small bowel obstruction/ileus, electrolyte disturbance, and gastroenteritis. The record identified the patient had a past history of MRSA in a leg wound. The physician's orders and plan of care failed to address the need for the implementation of contact isolation precautions.

During an interview on 12/14/10 at 9:25 a.m., a staff nurse (#13) stated staff placed Patient #4 in contact/isolation precautions because of a past history of MRSA per the CAH's new policy.

- Review of Patient #2's medical record occurred on December 13-15, 2010. The CAH admitted Patient #2 to swing bed on 12/01/10. Medical diagnosis for Patient #2 included cellulitis of the left lower foot and trophic ulcer to the sole of the left foot.

Observation during medication administration on 12/14/10 at 8:00 a.m. showed a staff nurse (#8) failed to perform hand hygiene or don gloves prior to entering Patient #2's room.

During interview on 12/14/10 at 9:10 a.m., Patient #2 stated his foot ulcer tested positive for "MRSA" (methicillin resistant Staphylococcus aureus) and staff placed him in contact isolation precaution since his admission to the CAH.

Patient #2's physician orders and plan of care failed to address the need for the implementation of contact isolation precautions.

- Review of Patient #1's medical record occurred on December 13-15, 2010. The CAH admitted Patient #1 to swing bed on 11/12/10 with diagnoses including right hip resection. Patient #1's transfer form identified the need for contact isolation precautions secondary to testing positive with MRSA and Candida fungi.

Observation during medication administration on 12/14/10 at 8:10 a.m. showed staff nurse (#9), upon leaving Patient #1's room, failed to perform hand hygiene.


28086


During an interview on 12/15/10 at 9:20 a.m., an administrative nurse (#5) stated staff must complete hand hygiene or hand washing upon exiting an isolation room and staff must clean and properly disinfect patient care items removed from a contact isolation room before reusing on another patient.

During an interview on 12/15/10 at 10:35 a.m., the infection control nurse (#4) stated the above examples of breached infection control practices by nursing staff were unacceptable. The nurse (#4) stated staff must always complete hand hygiene or hand washing prior to entering and exiting isolation rooms and staff must place all patient care items removed from an isolation room in the soiled utility room for cleaning and disinfecting before reusing on another patient. The nurse (#4) stated all staff must perform proper infection control practices at all times to prevent the spread of infection and disease within the CAH.

- The CAH's Infection Report forms, Infection Log, and Infection Control Meeting Minutes (January to November 2010), reviewed December 14-15 2010, lacked evidence the CAH identified and recognized infections for personnel of the CAH. The CAH failed to maintain a log of infections among personnel for the past 11 months (January to November 2010).

The CAH lacked a system or process for personnel to document and report suspected cases of infections to the infection control nurse/officer for further investigation, monitoring, and recommendations.

During an interview on 12/15/10 at 10:35 a.m., the infection control nurse (#4) stated the CAH failed to include personnel in their infection control surveillance and confirmed the CAH had no infection control log for personnel.

Based on observation, record review, review of policy and procedure, review of professional literature, and staff interview, the Critical Access Hospital (CAH) failed to assess a patient prior to utilizing side rails, and ensure restraint use in accordance with the order of a physician or other licensed independent practitioner (LIP) who is responsible for the care of the patient for 1 of 1 active patients (Patient #4) restrained with four elevated side rails. Failure to assess and evaluate the use of side rails has the potential to restrict a patient's movement and place the patient at risk for injury. Failure to ensure the use of restraints in accordance with the order of a physician or LIP has the potential for inappropriate use of restraint which could result in physical or psychological harm.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for restraint use. Federal regulations require staff to obtain an order from the physician or LIP prior to the application of restraint. In an emergency situation, the need for a restraint intervention may occur so quickly staff cannot obtain an order prior to the application of restraint. In these emergency application situations, staff must obtain the order either during the emergency application of the restraint or immediately (within a few minutes) after staff apply the restraint. The failure to immediately obtain an order is viewed as the application of restraint without an order.

Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings, Hospital Bed Safety Workgroup, Food and Drug Administration, April 2003, stated,
"Guiding Principles . . . 2. Decisions to use or to discontinue the use of a bed rail should be made in the context of an individualized patient assessment using an interdisciplinary team with input from the patient and family or the patient's legal guardian. . . . Policy Considerations: 1. Regardless of the purpose for which bed rails are being used or considered, a decision to utilize or remove those in current use should occur within the framework of an individual patient assessment. . . . 3. Use of bed rails should be based on patients' assessed medical needs and should be documented clearly and approved by the interdisciplinary team. Bed rail effectiveness should be reviewed on a regular basis. The patient's chart should include a risk-benefit assessment that identifies why other care interventions are not appropriate or not effective if they were previously attempted and determined not to be the treatment of choice for the patient.
. . . 7. Creating a safe bed environment does not necessarily preclude the use of bed rails. However, a decision to use them should be based on a comprehensive assessment and identification of the patient's needs, which include comparing the potential for injury or death associated with use or non-use of bed rails to the benefits for an individual patient. In creating a safe bed environment, the following general principles should be applied: Avoid the automatic use of bed rails of any size or shape. . . . Re-assess the patient's needs and re-evaluate the equipment if an episode of entrapment or near-entrapment occurs, with or without serious injury. This should be done immediately because fatal 'repeat' events can occur within minutes of the first episode. Process/Procedure Considerations . . . 1. Individualized Patient Assessment: Any decision regarding bed rail use or removal from use should be made within the framework of an individual patient assessment.
. . . Risk Intervention: Assessment of risk should be part of the individual patient's assessment, and steps to address the risk should be incorporated into the patient's care plan. . . . Bed Rails as Restraints: When bed rails have the effect of keeping a patient from voluntarily getting out of bed, they fall under the definition of a physical restraint. If they are not necessary to treat medical symptoms, and less restrictive interventions have not been attempted and determined to be ineffective, bed rails used as restraints should be avoided. . . ."

Review of the policy "Restraint Policy Acute Medical and Surgical Care" occurred 12/15/10. This policy, undated, stated, "I. PURPOSE: To ensure that patient's [sic] receiving medical . . . care at our facility, are free from physical restraints . . . of any form that are not medically necessary. . . . A physical restraint is any . . . physical or mechanical device . . . attached or adjacent to the patient's body that he or she cannot easily remove that restricts movement or normal access to one's body. . . . III. PROCEDURE: . . . B. The use of restraints will be based on the patient's medical needs and will be used in the least restrictive manner possible. . . . Documentation will include: 1. Vital signs 2. Circulation 3. Hydration 4. Level of distress and agitation . . . D. . . . the condition of the patient will be assessed, monitored and reevaluated based on, Physician orders and plan of care which is based on patient's individual needs and circumstances. E. Document less restrictive measures that may be considered, diagnosis, comprehensive assessment, plan of care, and any revisions, evaluations, treatment notes, nursing notes, medications and follow-up care. F. All staff who have direct patient care will have training in the proper use of restraints. . . . H. Physician Orders will include: 1. Type of restraint needed after nurse has reported to M.D. [medical doctor] 2. Less restrictive measures attempted and found to be ineffective. I. Medical record will contain: 1. Physician Order 2. Progress notes 3. Nursing Notes 4. Assessments and evaluations 5. Physician's summary with provisions for follow-up care 6. Treatment notes . . ."

Observation of Patient #4, while the patient rested in bed on 12/13/10 at 3:30 p.m., identified four half rails elevated on the patient's bed. At 6:00 p.m., further observation of this patient showed the four half rails remained elevated while the patient continued to rest in bed. Observation of Patient #4, on 12/14/10 at 8:25 a.m., showed three half rails elevated while the patient rested in bed.

Review of Patient #4's active medical record occurred December 13-14, 2010 and identified the CAH admitted this patient on 12/09/10. Patient #4's Fall Prevention and Management Intervention Guideline, from December 09-14, 2010, stated, ". . . Caution use of siderails, document reason for. . . ." The record lacked evidence nursing staff documented side rail use on Patient #4, the reason for side rail use, or evidence the patient exhibited any medical or behavioral need for the four elevated side rails.

Patient #4's record lacked documentation of the least restrictive interventions or alternatives staff implemented and attempted before elevating all four side rails on the patient's bed. The record lacked documentation of an individualized assessment of risk and safety for the utilization of side rails, lacked a care plan for side rails, and lacked documentation of monitoring Patient #4 during the time of elevated side rails. The record lacked evidence staff assessed the use of four side rails as a restraint for Patient #4 and lacked a physician's order for the initiation of the four side rails.

During an interview on 12/15/10 at 9:20 a.m., an administrative nurse (#5) stated the CAH considers elevation of four side rails as a restraint and confirmed the CAH requires physician's orders for restraints. The nurse (#5) stated staff should use side rails after individual patient assessments and nursing staff must document side rail use and the rationale for use in the medical record.

Based on record review, review of Medical Staff Rules and Regulations, and staff interview, the Critical Access Hospital (CAH) failed to maintain clinical records in accordance with the Rules and Regulations for 2 of 7 closed outpatient surgical records (Patient #16 and #18), 1 of 3 closed inpatient surgical records (Patient #19), 1 of 3 closed inpatient records (Patient #25), and 1 of 4 closed swing bed patient records (Patient #28). Failure to complete the medical records limited the CAH's ability to ensure the accuracy of the medical records.

Findings include:

Review of the CAH's Medical Staff Rules and Regulations occurred on December 13-15, 2010. This document, approved on 02/23/10, stated,
". . . III. MEDICAL RECORDS: A. The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. . . .
C. A complete admission history and physical examination including the plan of action shall be recorded within 7 days prior to or 24 hours after admission. . . .
O. A discharge summary including instructions to the patient shall be written or dictated on all medical records of patients hospitalized over 48 hours . . . All summaries shall be authenticated by the responsible practitioner.
P. The patient's medical record is to be complete within 15 days after discharge including progress notes, final diagnosis, and discharge summary dictated. . . .
VI. GENERAL RULES REGARDING SURGICAL CARE: . . .
C. Pre-operative History and Physical Requirement. 1. . . . Pre-operative physicals on outpatients can be done 30 days prior to surgery and updated within 7 days prior to surgery with any changes since the prior H & P [History and Physical] or to address any areas where more current data is needed. . . ."

Review of the following closed medical records occurred on December 14-15, 2010 and lacked the information identified.
*Patient #28 - admitted on 05/03/10 to swing bed status for care after orthopedic procedures and discharged to home on 06/16/10. The date on the physician's discharge summary was 07/07/10, 21 days after discharge.
*Patient #16 - admitted on 07/13/10 for day surgery cataract removal. The physician failed to sign the H & P, dated 06/15/10. The CAH staff and surgeon failed to complete an interim H & P.
*Patient #19 - admitted on 08/28/10 for an inpatient cholecystectomy and discharged on 08/29/10. The admitting physician failed to sign the H & P, dated 08/28/10.
*Patient #25 - admitted on 10/18/10 for pneumonia and discharged on 10/21/10. The admitting physician failed to sign the H & P, dated 10/18/10, and failed to sign the discharge summary, dated 10/27/10.
*Patient #18 - admitted on 10/26/10 for day surgery, excision of a cyst on the right foot. The H & P was dated 10/12/10. The CAH staff and the surgeon failed to complete an interim H & P.

The medical records had "flags" attached to the H & P's for Patients #19 and #25 and the discharge summary for Patient #25. During interview, on 12/15/10 at 10:30 a.m., a medical records management staff member (#3) reported the CAH staff attached the "flag" to the documents to alert the physicians of the need for the signatures. This staff member (#3) did not know why the physicians had not signed the documents 108 days and 47 days, respectively, after dictation.

During interview, on 12/15/10 at 1:30 p.m., a supervisory surgical staff member (#4) reported the CAH staff check the surgical patient H & P pre-operatively to ensure the provider completes the H & P or an update within 7 days. The staff member (#4) did not know why Patients #16 and #18 did not have updated H & P's.

Based on observation, record review, Medical Staff Bylaws review, and staff interview, the Critical Access Hospital (CAH) failed to maintain a complete medical record including physician's orders for contact isolation for 2 of 3 active swing bed records (Patient #1 and #2) and 1 of 3 active inpatient records (Patient #4) and for insulin administration for 1 of 3 active swing bed records (Patient #3). Failure to ensure the medical record included physician orders for all treatment provided limited the CAH staff's ability to ensure continuity of care.

Findings include:

Review of the CAH's Medical Staff Rules and Regulations occurred on December 13-15, 2010. This document, approved 02/23/10, stated, ". . . III MEDICAL RECORDS: . . . M. Orders for treatment shall be dated, timed, and written by the attending practitioner. . . ."

Review of the policy "Infection Prevention and Control Standard Precautions and Isolation" occurred 12/15/10. This policy, undated, stated,
". . . D. Temporary Precautions -Patients are often admitted before a definitive diagnosis is made and before infection or disease is ruled out. The following precautions are indicated on admission in order to control nosocomial transmission based on clinical syndrome: . . . 5. [Clinical Syndrome or Condition] Risk of Multidrug-Resistant Microorganisms: History of infection or colonization with multidrug-resistant organisms
. . . [Empiric Precautions] Contact . . . Standing Orders for Contact Isolation used for patients known or suspected to have serious illnesses easily transmitted by contact . . ."

Review of Patients #1, #2, #3, and #4's medical records occurred on December 13-15, 2010.

- Observation on the afternoon of 12/13/10 showed signage posted on the doors to Patients #1, #2 and #4's rooms identifying the need for staff and visitors to follow "Contact Isolation Precautions" prior to entering these rooms.

Reviewed on December 13-15, 2010, Patients #1, #2, and #4's medical records lacked evidence of a physician's order for contact isolation.

During an interview on 12/15/10 at 9:20 a.m., an administrative nurse (#5) stated the CAH utilized standing orders for contact precautions in all patients suspected, confirmed, or having a history of methicillin resistant Staphylococcus aureus (MRSA), which the providers initiate in the medical record.

- The facility admitted Patient #3 on 12/10/10 with diagnoses of groin abscess, acute renal failure, and insulin dependent diabetes.

Review of physician orders, dated 12/10/10, identified the physician prescribed the following types/dosages of insulin for Patient #3:
*Humalog 70/30 insulin 30 units subcutaneous (SQ) two times daily
*Lantus insulin 50 units SQ every evening before bed

Review of Patient #3's Treatment Administration Record (TAR), dated 12/11/10 at 9:00 p.m., identified a blood glucose reading of 209 milligrams/deciliter (mg/dl).

Review of Patient #3's Patient Care Notes, dated 12/11/10 at 9:00 p.m., stated, "Pt [patient] refuses 50 units of Lantus insulin. States he only wants to take 35 units of Lantus. 35 units of Lantus given per pt request."

Review of Patient #3's Patient Care Notes, dated 12/12/10 at 9:15 p.m., stated, "Blood sugar 140; pt states he will take 25 units of Lantus. Lantus 25 units given."

Review of Patient #3's medical record lacked evidence nursing staff notified Patient #3's health care provider of his refusal to take his scheduled dose of 50 units of Lantus insulin on December 11 and 12 and lacked physician orders for nursing staff to administer a lower dose of insulin on December 11 and 12.

During interview on 12/15/10 at 11:00 a.m., the surveyor informed an administrative nurse (#5) of the two occasions Patient #3 refused his scheduled dose of Lantus insulin and nursing staff administered a lower dose of insulin. This administrative nurse (#5) stated she would expect nursing staff to contact the physician, inform him/her of the Patient #3's refusal to take the 50 units of Lantus insulin, and obtain further orders.



28086

Based on observation, record review, professional reference review, policy and procedure review, patient interview, and staff interview, the Critical Access Hospital (CAH) failed to develop a comprehensive care plan that included measurable objectives and timetables to meet the medical, nursing, mental, and psychosocial needs for 3 of 3 active swing bed patient (Patients #1, #2, and #3) records reviewed. Failure to develop the comprehensive care plan limited the CAH's ability to manage patient needs, communicate treatment approaches, and to ensure continuity of care.

Findings include:

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, pages 212-215, stated, ". . .
A formal nursing care plan is a written or computerized guide that organizes information about the client's care. The most obvious benefit of a formal written care plan is that it provides for continuity of care. . . . Care plans include the actions nurses must take to address the client's nursing diagnoses and produce the desired outcomes. The nurse begins the plan when the client is admitted to the agency and constantly updates it throughout the client's stay in response to changes in the client's condition and evaluations of goal achievement. . . . Regardless of whether care plans are written, computerized, or standardized, nursing care must be individualized to fit the unique needs of each client. . . ."

Pages 215-216 stated, ". . . Multidisciplinary (Collaborative) Care Plans: A multidisciplinary care plan is a standardized plan that outlines the care required for clients with common, predictable - usually medical - conditions. . . . Like the traditional nursing care plan, a multidisciplinary care plan can specify outcomes and nursing interventions to address client problems (including nursing diagnoses). However, it includes medical treatments to be performed by other health care providers as well. . . . Multidisciplinary care plans do not include detailed nursing activities. They should be drawn from but do not replace standards of care and standardized care plans. . . ."

Review of the facility policy "Professional Services Provided, Swing Bed" occurred on 12/14/10. This policy, dated 02/13/08, stated, ". . . II. POLICY: From admission to discharge, the swing bed patient will receive the appropriate level of care needed to assist them in achieving their maximum potential and discharge goals. . . . IV: NURSING: . . . Within 72 hours and 30 day intervals thereafter, the nursing staff and other health care team members shall develop, modify, and initiate individualized care plans specific to their discipline and the patient's needs, progress and discharge goals. . . ."

Review of the facility policy "Patient Care Plans - Swing Bed" occurred on 12/14/10. This policy, dated 02/13/08, stated, ". . . POLICY: The team reviews all new admissions, formulates a care plan within seven days after the completion of the comprehensive assessment. The team will update the care plan weekly or more often as patient status dictates. III: TEAM PARTICIPANTS AND DUTIES: . . . B. Nursing: 1. Primary identifier of patient's medical needs in conjunction with the physician. 2. Nursing input into the care plan is based on comprehensive assessment, nursing diagnosis and observation. . . . IV: PROCEDURE: A. Patient needs/problems and potential problems shall be identified by the team. The team will indicate if there is a decline, no change, or improvement in a patient's physical, mental or psychosocial well being. . . . V. GUIDELINES TO DEVLOPING [sic] PATIENT CARE PLAN: A. The care plan will address those medical, nursing, mental, and psychosocial needs that are identified in the comprehensive assessment. It will include measurable objectives [sic] time tables. B. The care plan must be developed within seven days after the completion of the comprehensive assessment. . . ."

- Patient #1's active swing bed record, reviewed on December 13-14, 2010, identified the CAH admitted the patient on 11/12/10 with a diagnosis of left girdle stone hip resection (a type of surgical procedure to repair a hip fracture). Patient #1's progress notes and transfer forms from the receiving facility identified Patient #1 had a history of methicillin resistant Staphylococcal aureus (MRSA) and Candida fungi. Observation of Patient #1 on December 13-14, 2010, identified the patient in contact isolation.

Patient #1's undated "Swing Bed Assessment" (a form completed by nursing staff after admission to swing bed) identified nursing staff failed to complete or document information pertaining to the following: prior living situation and level of function, special treatments/procedures, precautions (such as isolation), weight bearing status, current medications, discharge planning, pain, continence (bladder and bowel) status, toilet transfers, personal hygiene, and leisure activity.

Patient #1's "Patient Care Notes," dated 11/12/10, indicated the patient was non-weight bearing on the left leg, required two person physical assistance and use of crutches with transfers, and had an open draining wound on her left hip. Patient #1's nurses notes identified facility staff members medicated her frequently with oral pain medications. A "Patient Care Note" written at 11 p.m. stated, "Staff found a plastic bag containing white caplets (110 [caplets] - marked G-254) in personal bag - these were removed [without] pt [patient] knowing. Will show pharmacist."

Review of Patient #1's care plan, dated 11/17/10, lacked evidence of a nursing care plan regarding interventions to promote healing of the patient's left hip surgical incision, to control her pain including non-pharmacological modalities, behavioral plan to address the patient's history of narcotic abuse, and infection control interventions implemented in response to the patient's positive history of MRSA.

During interview on 12/14/10 at 5 p.m., an administrative nurse (#5) confirmed Patient #1's care plan lacked specific interventions and measurable objectives to meet all of Patient #1's medical and psychosocial needs.

- Patient #3's active swing bed record, reviewed on December 13-14, 2010, identified the CAH admitted the patient on 12/10/10 with diagnoses of groin abscess, acute renal failure, and insulin dependent diabetes.

Patient #3's "Swing Bed Assessment" identified a hand-written note, dated "12/12 [10]," attached to the form, which stated, "started this - [no] time to finish."

During interview on 12/14/10 at 10:00 a.m., a staff member (#16) stated nursing staff needs to complete the "Swing Bed Assessment" within 72 hours from the time of admission and confirmed nursing staff failed to complete Patient #3's assessment within the designated time frame.

Failure of nursing staff to complete Patient #3's swing bed admission form within the designated time led to a delay in the initiation of a plan of care to meet Patient #3's individualized medical, nursing, mental, and psychosocial needs.

- Patient #2's active swing bed record, reviewed on December 13-14, 2010, identified the CAH admitted the patient on 12/01/10 with diagnoses of left foot cellulitis, left foot ulcer, and non-insulin dependent diabetes mellitus. Patient #2's physician orders identified treatment orders including intravenous antibiotics, daily whirlpool therapy, and monitoring of blood glucose levels four times daily. Observation of Patient #2 on December 13-14, 2010, identified the patient was in contact isolation.

During interview on 12/14/10 at 9:10 a.m., Patient #2 stated his foot ulcer tested positive for "MRSA" (methicillin resistant Staphylococcus aureus), and staff had placed him in contact isolation precaution since his admission to the CAH.

Patient #2's care plan, dated 12/03/10, lacked evidence of a nursing care plan regarding infection control interventions implemented in response to the patient's positive history of MRSA.