HospitalInspections.org

Based on observation, review of the North Dakota Century Code, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to limit and prevent access to the hospital pharmacy by unauthorized personnel in 1 of 1 pharmacy on the nursing unit. Failure of the CAH to adequately secure and restrict access of all medications allowed an opportunity for unsafe and unauthorized use of medications and has the potential to create insufficient distribution, control, and accountability of medications.

Findings include:

The North Dakota Century Code, Chapter 61-07-01 "Hospital Pharmacy" stated, ". . . 61-07-01-05. Absence of pharmacist. 1. General. During such times as a hospital pharmacy may be unattended by a pharmacist, arrangements must be made in advance by the director for the provision of drugs to the medical staff and other authorized personnel of the hospital, by use of the night cabinets or floor stock, or both, and in emergency circumstances, by access to the pharmacy . . . 3. Access to pharmacy. Whenever any drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy in accordance with the requirements of this section. One supervisory registered professional nurse and only one in any given eight-hour shift is responsible for removing drugs therefrom. The responsible nurse, in times of emergency, may delegate this duty to another nurse. The responsible nurse must be designated by position, in writing, by the appropriate committee of the hospital and, prior to being permitted to obtain access to the pharmacy, shall receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required. . . ."

Review of the policy "Obtainment Of Pharmaceuticals" occurred on 11/30/11. This policy, revised November 2011, stated, ". . . 6. An RN [Registered Nurse] or the consultant pharmacist oversees obtainment of all medications. The charge nurse has access to all medication locked storage areas. . . . To obtain medications from locked hospital storage area: 1. Licensed nursing personnel have access to pharmacy areas secured with computer managed door locks. . . . 3. Licensed nursing personnel, Director of Nursing, or Pharmacy Coordinator from the acute/swingbed unit obtain needed medications from the locked medication storage area . . ."

Observation of the pharmacy on the nursing unit with a pharmacy supervisory staff member (#8), on 11/29/11 at 2:20 p.m., showed the room locked with a combination key code lock system. The pharmacy contained a large amount of over the counter medications, injectables, and narcotics. The staff member (#8) stated all nursing staff on duty have access to the pharmacy and may access and enter the pharmacy to obtain medications. The pharmacy supervisory staff member (#8) stated the nurses entered the pharmacy and obtained medications when the supply in the medication room was empty and to restock the medications in the medication room.

Based on review of medication event reports, review of pharmacy committee meeting minutes, review of policy and procedure, and staff interview, the Critical Access Hospital (CAH) failed to implement an effective system to review effects, analyze causative factors, and implement corrective action to prevent errors in administration of medications for 5 of 5 months reviewed (June 2011 through October 2011) as evidenced by review of 13 medication error/occurrence reports. Failure to take a proactive approach to medication errors/occurrences has the potential to affect all patients served by the CAH.

Findings include:

Review of the policy "General Policies" for the Pharmaceutical Services Department occurred on 11/30/11. This policy, revised November 2011, stated, ". . . To ensure the safe and appropriate use of medications. . . . The pharmacy committee monitors the over-all pharmaceutical services. . . . ROLE OF CONSULTANT PHARMACIST . . . Monitors and inspects all medication . . . to determine compliance with current policies and procedures and applicable laws related to pharmaceutical services and QI [Quality Improvement] standards. Is a member of the . . . pharmacy . . . committee and attends meetings . . . Is available for consultation as needed in pharmacy related areas. Presents in-service to . . . staff on pharmacy related subjects as needed or requested. . . ."

Review of the policy "Medication Errors" occurred on 11/30/11. This policy, revised March 2011, stated, "To provide a mechanism for . . . evaluating any incidents involving medications. 1. Any incident involving medications shall be reported by the person involved on the Online Healthcare Safety Portal Zone Report. . . . 3. . . . The report will automatically be sent to the administrators of the site: Risk Management, Clinical Coordinator, Director of Nursing Service [DNS], and CEO [Chief Executive Officer] . . . 6. DNS reviews all medication errors . . . and investigates as indicated. . . . 8. Quarterly medication error reports are submitted to . . . pharmacy . . . committees. 9. For all significant errors, DNS reviews activities that resulted in the error, the staff involved in the error is asked to describe in detail the process they followed, the focus of the review is on fixing the system . . . compliance with written policy and procedures is essential. Attention to details is critical to preventing medication errors and non-compliance with policies and procedures is unacceptable. 10. Based on the findings of the medication error . . . Pharmacy Coordinator, Consultant Pharmacist, Director of Nursing Service . . . may determine further actions and recommendations. The Online Healthcare Safety Portal Zone Report is an . . . educational forum to increase our awareness of events that signal harm to our patients . . . and support our efforts to enhance service and safety"

Review of the policy "Pharmacy And Therapeutics Committee" occurred on 11/30/11. This policy, revised 08/29/11, stated, "Assists in . . . all . . . matters relating to medications in the health center . . . Serves as an advisory group on matters concerning: 1. Choice of medications. 2. Additions and deletions to hospital formulary. 3. Policy and Procedure. 4. Annual Inspections. 5. Evaluation of clinical data concerning new medications or preparations requested for use in the health center. 6. Makes recommendations concerning medications stocked on the nursing units and other ancillary departments. 7. Telepharmacy"

Review of the CAH's medication event reporting forms on 11/30/11 identified the following:
*Six reports involved administration of the wrong medication:
Two reports, dated 06/20/11 and 10/16/11, involved the administration of Percocet or oxycodone (a medication used to treat pain) instead of hydrocodone (a medication used to treat pain) for one dose; one report, dated 07/24/11, involved the administration of the wrong medications to a patient for one dose (the report lacked specification of which medications); one report, dated 09/02/11, involved the administration of Lactated Ringers (an intravenous [IV] infusion for fluid and electrolyte replenishment, made of sodium, chloride, potassium, and calcium) instead of Normal Saline (an IV infusion for fluid replenishment, made of sodium chloride); one report, dated 09/06/11, involved the administration of isosorbide dinitrate (a medication used to treat chest pain or prevent chest pain) instead of isosorbide mononitrate (a medication used to treat chest pain or prevent chest pain) for one dose; and one report, dated 10/24/11, involved the administration of hydrocodone 5/500 milligrams (mg) instead of Percocet 5/325 mg for one dose.
*Three reports involved omissions of medications:
One report, dated 06/14/11, involved omission of one dose of Invanz (an antibiotic) IV; one report, dated 09/15/11, involved the omission of all morning medications to a patient (the report lacked specification of which medications); and one report, dated 09/19/11, involved the omission of Levaquin (an antibiotic) daily for three doses.
*Three reports involved extra doses of medications:
One report, dated 07/29/11, involved the administration of Lactated Ringers after receiving an order to discontinue; one report, dated 09/19/11, involved the administration of bumetanide (a diuretic, a medication used to decrease fluid in the body) two times a day for one dose after receiving an order to decrease administration of the medication to once daily; and one report, dated 10/03/11, involved the administration of Levaquin daily (unable to determine the number of doses given) when the order indicated the medication as a one time dose.
*One report, dated 08/10/11, involved the wrong dose of Zosyn (an antibiotic) administered to a patient for one dose (the order indicated 4.5 grams, but staff administered 3.375 grams).

Review of the above 13 medication event reporting forms from June 2011 to October 2011, identified the forms lacked documentation in the "actions to avoid future errors" section, and lacked administrative staff's comments regarding the medication errors. The forms lacked evidence the administrative staff investigated and determined the cause and effect of the medication error to the patient, and developed and implemented corrective action to decrease and prevent further reoccurrence of errors. The reports lacked review from the pharmacy coordinator and the consulting pharmacist. Review of the reports identified administrative staff failed to follow the CAH medication errors policy.

Review of the pharmacy committee meeting minutes (08/03/11 and 10/05/11) occurred on 11/30/11. The minutes showed the pharmacy coordinator, clinical coordinator, director of nursing, and CEO attended the meetings in August and September, and identified the consulting pharmacist only attended the meeting in August. Review of the minutes lacked evidence the administrative staff discussed medication errors, or identified a plan to decrease or prevent future medication errors. The meetings lacked evidence of the pharmacy coordinator or consulting pharmacist's involvement regarding medication errors as identified in the above CAH policies.

During an interview on 11/29/11 at 2:20 p.m., an administrative pharmacy staff member (#8) stated the CEO, DON, clinical coordinator, and risk manager received and reviewed the medication event reports and discussed the reports at the QI meetings. The staff member (#8) stated the consulting pharmacist does not review the medication error reports.

During an interview on 11/30/11 at 2:10 p.m., an administrative nurse (#2) stated she reviewed the medication reports, but does not document a response on the reports. The nurse (#2) stated the consulting pharmacist does not review medication errors, nor does the pharmacy committee members at the scheduled meetings.

The medication event reports reviewed lacked evidence the CAH had an effective system to analyze the errors, identify trends or patterns, and lacked evidence of corrective action to decrease the chances of further errors. The administrative staff members (#2 and #8) did not provide additional information or evidence of documented investigation, analysis, corrective action taken, or education provided for the 13 reviewed medication errors.

Based on review of personnel files, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure all nursing staff possessed the adequate qualifications, training, and education related to each of their specific roles within the CAH, and received ongoing evaluations of their competency and skills for 3 of 5 staff nurse (#5, #6, and #7) personnel files reviewed which lacked evidence of Cardiopulmonary Resuscitation (CPR)/Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) certification, and ongoing performance/competency reviews. Failure to ensure all nursing staff possessed the certifications, training, and competency needed to perform their clinical duties has the potential for nursing services to not meet the needs of the patients.

Findings include:

- Review of the policy "Registered Nurse" occurred on 12/01/11. This policy, revised February 2011, stated, ". . . REQUIRED CERTIFICATION: . . . CPR certification. . . . H. Maintains a safe environment for patients . . . b. Attends . . . in-services . . . I. Demonstrates professional behavior and acceptance of leadership responsibility. . . . c. Takes personal responsibility for education and professional growth . . ."

Review of the policy "Registered Nurse Job Description" for the Cardiac Rehab Department occurred on 12/01/11. This policy, reviewed and revised January 2001, stated, "To establish guidelines for the position of Cardiac Rehabilitation Registered Nurse. 1. The cardiac rehabilitation program will staff Cardiac Rehabilitation Registered Nurses. . . . 2. Responsible for all behaviors in this job description. . . . 5. Current CPR and ACLS certification. . . ."

During an interview on 11/30/11 at 8:40 a.m., an administrative nurse (#4) stated nurses working in the Cardiac Rehab Department must have current ACLS certification and indicated three staff nurses (#4, #5, and #11) worked in the department.

During an interview on 11/30/11 at 2:10 p.m., an administrative nurse (#2) stated all nurses working in the CAH must have CPR/BLS certification.

Review of personnel files occurred on 11/30/11 at 4:00 p.m. The file of a staff nurse (#5) currently working in the Cardiac Rehab Department lacked evidence of CPR/BLS and ACLS certification.

During an interview on 11/30/11 at 5:05 p.m., an administrative nurse (#3) stated the staff nurse (#5) has not yet taken a class to obtain ACLS certification.

During an interview on 12/01/11 at 8:45 a.m., an administrative nurse (#2) stated the staff nurse's (#5) CPR/BLS certification expired in July 2011, and confirmed the staff nurse (#5) is not ACLS certified at this time.

- Review of the policy "Licensed Practical Nurse" occurred on 12/01/11. This policy, reviewed and revised in 2011, stated, ". . . REQUIRED CERTIFICATION: . . . CPR certification. . . . b. Performs a variety of treatments and nursing procedures. . . . g. Responds to and assists in CODES and other emergency situations. . . . Maintains knowledge of current health practices . . . F. Performs other duties as assigned. . . ."

During an interview on 11/30/11 at 2:10 p.m., an administrative nurse (#2) stated all nurses working in the CAH must have CPR/BLS certification.

Review of personnel files occurred on 11/30/11 at 4:00 p.m. The file of a staff nurse (#6) presently working within the CAH lacked evidence of current CPR/BLS certification.

During an interview on 11/30/11 at 4:30 p.m., an administrative nurse (#3) stated all staff nurses must have CPR/BLS certification, and indicated the CAH will hold a class in January 2012 for all staff to attend and receive certification. The nurse (#3) confirmed the staff nurse's (#6) file lacked evidence of current CPR/BLS certification.

- Review of the policy "Licensed Practical Nurse" occurred on 12/01/11. This policy, reviewed and revised in 2011, stated, ". . . REQUIRED CERTIFICATION: . . . CPR certification. . . . ESSENTIAL JOB FUNCTIONS: A. Assists in the assessment of patients and collaborates with other nursing personnel . . . B. Provides direct patient care . . . b. Performs a variety of treatments and nursing procedures. c. Administers medications. d. Performs selected components of IV [Intravenous] therapy . . . e. Implements assigned portions of a teaching plan . . . g. Responds to and assists in CODES and other emergency situations. C. Maintains a safe environment for patients . . . D. Works closely with other members of the health care team . . . E. Projects a professional image. . . . e. Maintains knowledge of current health practices . . . F. Performs other duties as assigned. G. . . . follows established policies and procedures in all aspects of care given."

Review of the policy "Surgical Technician" occurred on 12/01/11. This policy, revised February 2001, stated, "Provides technical assistance and support to the surgical team before, during, and after a surgical procedure. POSITION QUALIFICATIONS: . . . REQUIRED CERTIFICATION: CPR Certification . . . ESSENTIAL JOB FUNCTIONS: A. Performs pre-operative duties. . . . B. Performs intraoperative duties . . . C. Performs post operative duties . . . D. . . . follows established policies and procedures in all aspects of care given. a. Enhances and updates skills . . . d. Follows hospital procedures . . . e. Participates in annual evaluation. . . . E. Performs other duties as assigned."

During an interview on 11/29/11 at 1:15 p.m., an administrative nurse (#11) stated a staff nurse (#7) employed with the CAH recently started working in the Surgical Department as a scrub nurse and is currently undergoing orientation and training to this role.

During an interview on 11/30/11 at 2:10 p.m., an administrative nurse (#2) stated all nurses working in the CAH received ongoing education and completed verification of competency or skills every year.

Review of personnel files occurred on 11/30/11 at 4:00 p.m. The file of a staff nurse (#7) showed a performance or competency evaluation three months post employment at the CAH in 2007. The file lacked evidence of a current performance or competency evaluation.

During an interview on 12/01/11 at 8:10 a.m., an administrative staff member (#1) stated the CAH employed the staff member (#7) in 2007, and confirmed the staff member's (#7) personnel file lacked a current performance or competency evaluation since 2007.

1. Based on record review, review of professional literature, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to assess and document the code level status of each patient to ensure care in accordance with the patient's preference for 2 of 3 active patient (Patient #2 and #3) records, and 2 of 9 closed patient (Patient #18 admitted on 09/03/11 and 09/09/11) records reviewed. Failure to assess and document the code level status of hospitalized patients allowed an opportunity for CAH staff to not follow the patient's wishes in the event they experienced a life-threatening emergency.

Findings include:

Review of the policy "Code Levels" occurred on 12/01/11. This policy, revised 07/02/00, stated, "To establish guidelines for the type of care or limitations of care desired by patient and to communicate this to all persons involved in the care of the patient. Patients admitted to First Care Health Center for Acute of [sic] Swing bed care should [sic] a code level specified in physician's orders. If no specific order is written, patient is assumed to be Level 1. Any Code Level determinations are done with consultation between attending physician, patient, and/or responsible party. . . . Levels: Level I: Everything possible will be done, including CPR [Cardiopulmonary Resuscitation], artificial ventilation, and other aggressive treatment as is available within the facility . . . Level II: Standard available therapies will be excluding CPR, ventilators, defibrillation, and other modalities as desired by the individual . . . Level III: Includes pain relieving and therapeutic comfort measures only. . . . Physician meets with patient and family and discusses Code Levels and determines their wishes in this regard. I [sic] desired, representatives from other disciplines within the hospital such as nursing . . . may participate in this discussion. . . . When the Code Level has been determined, physician writes order on Physician's Orders. . . . Physician's progress notes or history and physical includes a summary of the discussion with the patient . . . and the decision reached. . . ."

Review of active and closed medical records occurred on November 28-30, 2011.

- Review of Patient #2's active record identified the CAH admitted the patient on 11/26/11 with a diagnosis of bronchopneumonia. The patient transferred to the CAH from a long term care facility. Review of the admission orders showed the provider failed to complete and indicate the code status of the patient at the time of admission. The history and physical (H&P) and progress notes lacked documentation of a determined code status. Review of Patient #2's paperwork from the transferring facility and medical record lacked evidence of the patient's code status.

- Review of Patient #3's active record identified the CAH admitted the patient on 11/17/11 with a diagnosis of right total knee replacement. The admission orders showed the provider failed to complete and indicate the code status of the patient at the time of admission. The H&P and progress notes lacked documentation of a determined code status. Review of Patient #3's medical record lacked evidence of the patient's code status.

- Review of Patient #18's closed inpatient record identified the CAH admitted the patient on 09/03/11 with diagnoses of hyperglycemia with dehydration, urinary tract infection (UTI), atrial fibrillation (AFib), diabetes, hypertension, and osteoarthritis including a history of cerebrovascular accident. The admission orders showed the provider failed to complete and indicate the code status of the patient at the time of admission. The H&P and progress notes lacked documentation of a determined code status. Review of Patient #18's medical record lacked evidence of the patient's code status.

- Review of Patient #18's closed swing bed record identified the CAH admitted the patient on 09/09/11 with diagnoses of UTI secondary to systemic inflammatory response syndrome, AFib, diabetes, and dehydration. The admission orders showed the provider failed to complete and indicate the code status of the patient at the time of admission The H&P and progress notes lacked documentation of a determined code status. Review of Patient #18's medical record lacked evidence of the patient's code status.

During an interview on 11/28/11 at 3:35 p.m., an administrative nurse (#3) stated the physician determined code level status on patients, and stated when the patient transferred from another facility the CAH followed the code status identified on the patient's paperwork from that facility. The nurse (#3) stated if no code status is documented, the CAH staff considered the patient a code level one and would perform all means necessary to save a patient's life during a code situation.

During an interview on 11/29/11 at 4:10 p.m., an administrative nurse (#2) stated CAH staff must address, determine, and document code status on every patient admitted to the CAH. The nurse (#2) stated documenting code status is a process the CAH lacked and confirmed Patient #2 and #3's medical records lacked documentation of code status. The administrative nurse (#2) stated she expected the provider to discuss code level status with the patient or family and document code level status on the medical record.

2. Based on record review, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to develop and implement a plan of care for 1 of 1 active inpatient (Patient #1) with a pressure ulcer. Failure to establish and initiate a plan of care to treat pressure ulcers has the potential to impede the healing process and promote further problems.

Findings include:

Review of the policy "Decubitus Prevention And Care" occurred on 12/01/11. This policy revised 07/17/00, stated, ". . . Any patient who is at risk for developing pressure areas should be watched closely and special procedures instituted at physician's order or at nursing discretion. 1. Inspect all patient's skin condition carefully on admission and note on chart. Chart location of any skin problems on admission notes and skin care flow sheet. 2. All patients should be inspected frequently. . . . 10. Patients with skin problem areas should be monitored through the use of a skin care flow sheet. . . . Decubitus Treatment: To promote healing and increase in decubitus present on admission or that develop during a patient's stay. Each case is treated on an individual basis under orders of the physician."

Review of Patient #1's active record occurred on November 28-29, 2011 and identified the CAH admitted the patient on 11/24/11 with diagnoses of seizure and fever. A progress note, dated 11/26/11, stated, ". . . She has a pressure ulcer. It looks smaller to me, there is a necrotic area in the middle with the same eschar. When that is loose, we can debride it."

Patient #1's nursing notes stated the following:
*11/25/11 at 12:38 a.m.: ". . . Decubitus ulcer to left lower back measuring 1 cm [centimeter] x [by] 4 cm. Stage 1 with reddened skin around area. Padded tegaderm applied for protection. . . ."
*11/25/11 at 8:03 a.m.: ". . . Pressure ulcer to lower left back . . . dressing applied duoderm to pressure ulcer . . ."
*11/25/11 at 8:00 p.m.: ". . . Wound on left lower back 2 inch x 1/2 inch with yellow wound bed and red unapproximated edges . . . Dressing reinforced . . ."
*11/26/11 at 8:00 a.m.: ". . . Wound (left lower back-moist, yellow, dark center, edges pink) . . . charge nurse notified of sore on back which was cleaned, dried and covered with super sponge"
*11/26/11 at 8:00 p.m.: ". . . Wound (bottom left side of back) . . . dressing reinforced . . ."
*11/27/11 at 8:00 a.m.: ". . . Wound (lower back) . . . Area left to open air . . ."
*11/27/11 at 8:00 p.m.: ". . . Wound--left lower back in fold, dry gauze dressing in place, wound bed appears reddened and without drainage from wound or on dressing. . . . Area left to open air . . ."
*11/27/11 at 9:19 p.m.: ". . . Rated pain 2/10 to left lower back related to skin tear being discomforting 'lying down on it'. . . . assessed wound and drsg [dressing]. Drsg dry and wound did not appear to be draining. . . ."
*11/28/11 at 9:08 a.m.: ". . . Decubitus to back with dry dressing intact . . ."
*11/28/11 at 8:00 p.m.: ". . . Decubitus left lower back, dry dressing intact . . ."
*11/29/11 at 8:15 a.m.: ". . . Decubitus left back . . . Dry dressing in place. . . ."
*11/29/11 at 8:30 p.m.: ". . . Decubitus lower left back . . . Dry dressing intact. . . ."

The nursing staff performed Braden Scale (an assessment of risk for obtaining skin breakdown) assessments two times a day from November 25-28, 2011. The findings from the assessments identified Patient #1 as a "high risk" for skin breakdown.

Patient #1's record lacked evidence CAH staff instituted special procedures to care for the patient's pressure ulcer per physician's order, or developed a consistent form of treatment per nursing discretion as stated in the facility policy. The record lacked evidence nursing staff consistently documented Patient #1's pressure ulcer through the use of a skin care flow sheet as stated in the facility policy. Patient #1's record lacked evidence of specific interventions to manage and aid the healing of the current pressure ulcer as to prevent further problems.

During an interview on 11/30/11 at 2:10 p.m., an administrative nurse (#2) stated Patient #1's provider should have addressed the pressure ulcer and directed nursing staff how to treat the ulcer. The nurse (#2) stated the nursing staff should have obtained direction from the provider on how to treat the pressure ulcer and developed and implemented a care plan aimed at interventions to promote healing of the pressure ulcer.

Based on record review, review of professional literature, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff developed, implemented, updated, and maintained nursing care plans for 2 of 3 active patient (Patient #1 and #2) and 2 of 3 closed patient (Patient #17 and #18) records reviewed. Failure to develop, implement, update, and maintain care plans limited the CAH's ability to communicate treatment approaches, assist the patient to attain/maintain their highest physical, mental, and psychosocial well-being, and ensure continuity of care. Failure to maintain current care plans could result in failing to manage patient's needs.

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. . . . When nurses use the client's nursing diagnoses to develop goals and nursing interventions, the result is a holistic, individualized plan of care that will meet the client's unique needs. . . . 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 handwritten, computerized, or standardized, nursing care must be individualized to fit the unique needs of each client. . . ."

Review of the policy "Care Plans/: Acute Care" occurred on 12/01/11. This policy, revised February 2001, stated, "To provide a comprehensive written plan of care for the acute patient, that all staff members can refer to and follow. 1. Each patient's nursing care plan is based on identified patient care needs and patient care standards and is consistent with the therapies of other disciplines. 2. Each patient will have a plan of care initiated at the completion of the admission assessment, completed within 24 hours, and updated as needed. . . . 4. The plan of care will be measureable [sic], outcome-based, and developed in collaboration with the medical plan of care. 5. The plan of care will guide the staff in providing care to the patient. 1. Upon completion of the admission assessment, the admitting nurse chooses preprinted care plan from file, which coincides with patient's admitting diagnosis. If patient has significant secondary diagnosis that will impact on the plan of care, those may be used as well. 2. Printed plan of care are individualized for each patient . . . 4. Add additional problems or needs . . . if necessary. 5. Place Care Plan sheet in the Nursing Documentation section of the chart. 6. Nurse caring for patient on each shift should check the Care Plan and make changes or additions as indicated. . . ."

Review of active and closed medical records occurred on November 28-30, 2011.

- Patient #1's active record identified the CAH admitted the patient on 11/24/11 with diagnoses of seizure and fever including a history of diabetes. A nursing assessment completed on 11/25/11 indicated Patient #1 as having a high risk for falls. Review of Patient #1's provider progress notes from November 26-28, 2011, identified a urinary tract infection with methicillin resistant staphylococcus aureas, positive blood culture results with coagulase negative staphylococcus species, low blood glucose levels, and a pressure ulcer. The record lacked evidence CAH staff initiated a care plan which included a plan of treatment for Patient #1's identified and ongoing needs.

- Patient #2's active record identified the CAH admitted the patient on 11/26/11 with a diagnosis of bronchopneumonia. A nursing assessment, dated 11/27/11 at 7:45 p.m., identified an issue of constipation. The record lacked evidence CAH staff initiated a care plan which included a plan of treatment for Patient #2's identified and ongoing needs.

- Patient #17's closed record identified the CAH admitted the patient on 10/10/11 with diagnoses of urinary tract infection and confusion problems secondary to dementia. The record lacked evidence CAH staff initiated a care plan.

- Patient #18's closed record identified the CAH admitted the patient on 09/03/11 with diagnoses of hyperglycemia with dehydration, urinary tract infection, atrial fibrillation, diabetes mellitus type 2, hypertension, osteoarthritis, and history of cerebrovascular accident. The record lacked evidence CAH staff initiated a care plan.

During an interview on 11/30/11 at 2:10 p.m., an administrative nurse (#2) stated she would expect staff to initiate care plans for patients within 24 hours of admission, and confirmed staff did not develop care plans for Patient #1 and #2.

During another interview at approximately 4:00 p.m. on 11/30/11, an administrative nurse (#2) confirmed staff did not develop care plans for Patients #17 and #18.

Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to obtain consents for treatment for 5 of 12 emergency room records (Patients #1, #10, #11, #12, and #13) reviewed. Failure to obtain consents for treatment limited the CAH's ability to ensure patients received information regarding their treatment and placed the CAH at risk of providing unwanted treatment.

Findings include:

Review of the Emergency Room policy and procedure titled "Consent for Treatment" occurred on 12/01/11. This policy and procedure, revised 04/02/02, stated,
"Policy
1. Written permission for all treatment must be obtained.
2. If patient is of age (18 or over) and is able to sign, he should sign record on admission. . . .
3. If the patient is unable to sign for any reason, the record may be signed by the nearest relative or responsible party. . . .
Procedure . . .
3. Signature required in 1 place on back of ER record. . . ."

Reviewed November 29-30, 2011, the following emergency room medical records lacked evidence of signed consents for treatment:
* Patient #1 treated on 11/24/11 for possible seizure activity
* Patient #10 treated on 10/08/11 for injuries as a result of assault
* Patient #11 treated on 09/24/11 for suicide attempt
* Patient #12 treated on 09/05/11 for urinary tract infection
* Patient #13 treated on 08/20/11 for abdominal pain and spontaneous delivery

During interview at approximately 4:00 p.m. on 11/30/11, two administrative staff members (#2 and #9) confirmed they would expect staff to have ER patients sign consents for treatment and the five ER records listed above lacked signed consents.

Based on policy review, Quality Improvement (QI) record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the quality improvement program evaluated the patient care services of nursing for health and safety for 12 of 12 months reviewed (October 2010-September 2011); and failed to ensure the evaluation of quality of care provided to the CAH's patients for 1 of 1 record (Patient #10) reviewed of a patient who eloped from the CAH. Failure to participate in QI activities places patients at risk of not receiving appropriate care and services and limits the CAH's ability to implement corrective action if necessary. Failure to evaluate an elopement places the CAH at risk of not identifying possible inappropriate care and limits the CAH's ability to ensure the patient received appropriate follow-up care.

Findings include:

Review of the CAH's FACILITY QUALITY IMPROVEMENT PLAN occurred on the afternoon of 11/29/11. The plan, dated 02/25/11, stated,
"PURPOSE:
First Care Health Center has an ongoing, comprehensive Quality Assurance/Quality Improvement Program to strive to ensure that patient care/relations are continually improved to the degree possible with the available resources in this facility.

Each department involved directly or indirectly in patient care shall be included in Quality Improvement and Quality Control activities according to the frequency assigned (See report schedule). . . .

OBJECTIVES:
1. To identify areas in which changes of procedure and/or equipment will result in improved service or quality of patient care.
2. To recommend changes in procedures and/or equipment which will further assure the safety, freedom from healthcare associated infections or injury, appropriateness of care, and general well-being and comfort of all patients. . . .
5. To allow means of identification of problems in service and quality of care.
6. To objectively assess the cause of problems and what the problem involves, including the determination of priorities.
7. To implement the actions designed to correct these problems.
8. To monitor the activities designed to assure that the desired results have been achieved and are being maintained on an ongoing basis. . . .
ORGANIZATION:
. . . 6. The Quality Coordinator is responsible for the integration and coordination of pertinent aspects of the QI program. These responsibilities include: a. Collecting, aggregating, and displaying quarterly QI statistics. . . . g. Informing departments and committees of their reporting interval and obtaining reports for presentation to the QI committee. h. Reviewing follow -up activities to ensure improved patient care and compliance with the QI Plan. . . .
7. The QI Committee is functionally responsible to the Quality Coordinator in all matters relating to QI. . . .
8. . . . Information collected and action taken to resolve identified problems must be reported to the QI Committee as per established reporting schedule. . . .

INTEGRATION:
. . . Unresolved problems are dealt with first at the department level then at the committee level. The status of identified problems is tracked by the QI Committee. . . ."

Review of the policy titled "Event Reporting (Incident/Variance Reports)" occurred on 12/01/11. This policy, revised in 2009, stated, "Purpose: To provide a method for reporting and recording any unusual or out of the ordinary happening involving patient . . . For the protection of the individual(s) involved in the event in case of injury or future complication . . . Policy: Event reports are to be filled out for any unusual occurrence involving any patient . . . The report should be made by the person (employee) involved in the incident as soon as possible following the event happening. Procedure: . . . 3. . . . Designated staff will be responsible for the event review, possible comment, possible follow-up, and any corrective action that may/will take place pertaining to the event. . . ."

Review of the policy titled "Code Search - Vulnerable Patient Elopement" occurred on 12/01/11. This policy, developed in 2007, defined elopement as unauthorized departure from hospital care.

Review of the QI reporting schedule identified Nursing Service scheduled to report quarterly to the QI Committee.

Review of the QI Committee Meeting Minutes occurred on the afternoon of 11/29/11. The minutes identified the department of Nursing Service failed to provide a QI report in the last quarter of 2010, the first quarter of 2011, the second quarter of 2011, and third quarter of 2011.

Review of a Healthcare Safety Zone Portal Patient Event Summary report (incident/accident reports) for the six month period from May 2011 through October 2011 identified 14 medication events (errors) and 13 patient falls occurred to patients within six months. Review of the individual reports identified the nursing supervisor failed to review the 14 medication error event reports and reviewed one of the 13 fall reports.

During interview on 11/30/11 at 9:30 a.m., the QI director (#4) confirmed nursing service failed to report to the QI committee within the last year as required according to the QI plan.

During interview on 11/30/11 at 5:20 p.m., a supervisory nursing staff member (#2) stated she has not reported any QI reports to the QI committee nor documented any QI reports since starting her position the beginning of 2011. The staff member stated she does not track or trend, nor investigate medication errors or falls when questioned regarding the 14 medication errors and 13 falls which occurred between May and October 2011.

Review of Patient #10's medical record occurred on 11/29/11. The ER (emergency room) record indicated Patient #10 presented to the ER at 11:40 p.m. on 10/08/11 by ambulance. The ER nurses notes stated, ". . . Assessment of pt. [patient] shows that he is extremely intoxicated . . ." A radiological report from a left ankle examination on 10/09/11 indicated a fibular fracture. The ER nurses notes at 2:30 a.m. on 10/09/11 stated, ". . . MD [medical doctor] here to splint L) [left] ankle. Pt. hardly woke . . . Needed quite a bit of encouragement. Tried to explain why. . . . Did get ankle splinted . . ." The ER nurses notes at 4:00 a.m. stated, "Pt to be placed in observation for mental status r/t [related to] alcohol intoxication and trauma. . . ." The CAH admitted Patient #10 to an observation bed at 4:00 a.m. on 10/09/11 per physician's orders with diagnoses of trauma and head injury. According to the history and physical, the CAH admitted the patient to monitor his mental status and do routine neurological examinations. The nurses notes at 8:04 a.m. stated, "Pt sitting up . . . Polite, cooperative. alert et [and] oriented x3 [times 3]. . . . States he is waiting to talk to the doctor to see what the plan is. . . ." The nurses notes at 8:20 a.m. stated, "Pt wheeled self down hallway . . ." The nurses notes at 8:30 a.m. on 10/09/11 stated, "Down to check on pt. Pt nowhere to be found. Empty wheelchair sitting by road. Unable to locate pt. Notified MD." The history and physical stated, ". . . Unfortunately, early this morning, the patient left the hospital with nobody knowing and without adequate discharge instructions."

Reviewed on 11/30/11, the Healthcare Safety Zone Portal Patient Event (incidents/accidents) Summary report for October 2011 lacked evidence staff filed an incident/variance report for Patient #10's elopement from the CAH.

During interview at approximately 4:00 p.m. on 11/30/11, an administrative nursing staff member (#2) stated she would expect staff to file an incident report for an elopement; and confirmed staff did not file an incident report for Patient #10's elopement, the CAH did not investigate the elopement, and the CAH did not contact the patient after the elopement to ensure appropriate follow-up care.

During interview at approximately 8:10 a.m. on 12/01/11, the Risk/Safety Manager (#10) stated he would expect CAH staff to file an incident report for a patient elopement.

Based on review of the Quality Improvement Plan, review of Medical Staff bylaws, policy review, review of medication event reports, pharmacy meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to develop and implement an effective quality improvement (QI) program for 6 of 6 months reviewed (May 2011 through October 2011) to identify the causative factors, investigate, and implement corrective action for medication errors. Failure to investigate and implement corrective action for medication errors places all patients at risk for harm.

Findings include:

Review of the CAH's FACILITY QUALITY IMPROVEMENT PLAN occurred on the afternoon of 11/29/11. The plan, dated 02/25/11, stated,
"PURPOSE:
First Care Health Center has an ongoing, comprehensive Quality Assurance/Quality Improvement Program to strive to ensure that patient care/relations are continually improved to the degree possible with the available resources in this facility.

Each department involved directly or indirectly in patient care shall be included in Quality Improvement and Quality Control activities according to the frequency assigned. . . .

OBJECTIVES:
1. To identify areas in which changes of procedure and/or equipment will result in improved service or quality of patient care.
2. To recommend changes in procedures and/or equipment which will further assure the safety, freedom from healthcare associated infections or injury, appropriateness of care, and general well-being and comfort of all patients. . . .
5. To allow means of identification of problems in service and quality of care.
6. To objectively assess the cause of problems and what the problem involves, including the determination of priorities.
7. To implement the actions designed to correct these problems.
8. To monitor the activities designed to assure that the desired results have been achieved and are being maintained on an ongoing basis. . . .

INTEGRATION:
. . . Unresolved problems are dealt with first at the department level then at the committee level. The status of identified problems is tracked by the QI Committee. . . ."

Review of the CAH's Medical Staff By-Laws occurred on the afternoon of 11/28/11. The bylaws, dated 03/18/11, in Article VII, Section 3. defined the Medical Review and Evaluation Committee. The committee is responsible for reviews related to Pharmacy and Therapeutics. "As a part of its function it shall engage in the following tasks: . . .
5. Pharmacy and Therapeutics: The committee shall be responsible for the development and surveillance of all drug utilization policies and practices within the health center in order to assure optimum clinical results and a minimum potential for hazard. The committee shall assist in the formulation of broad professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, safety procedures, and all other matters relating to drugs in the health center. . . ."

Review of the following policies occurred on 11/30/11:
* PHARMACY AND THERAPEUTICS COMMITTEE policy, revised 08/29/11, stated:
"PURPOSE: Assists in formulation of procedures and all other matters relating to medications in the health center. . . .
Serves as an advisory group on matters concerning:
1. Choice of medications
2. Additions and deletions to hospital formulary
3. Policy and Procedure
4. Annual Inspections
5. Evaluation of clinical data concerning new medications or preparations requested for use in the health center
6. Makes recommendations concerning medications stocked on the nursing units and other ancillary departments.
7. Telepharmacy"

* PHARMACY QUALITY IMPROVEMENT AND EDUCATION, dated 07/05, stated:
"PURPOSE: To measure quality in the area of pharmacy and to keep staff current in pharmacy issues.
POLICY:
1. Continuous Quality Improvement for Pharmacy is included in the QI [quality improvement] plan for the Nursing Department. . . .
2. Medication errors are reported to QI Committee quarterly. . . .

* MEDICATION ERRORS, dated 03/11, stated:
PURPOSE: To provide a mechanism for reporting and evaluating any incidents involving medications. . . .
PROCEDURE:
1. As soon as the occurrence is discovered notify attending physician of variance if any potential for patient harm or change in plan of treatment.
2. Access and fill out the Online Healthcare Safety Portal Zone Report. . . .
3. Submit report . . . The report will automatically be sent to the administrators of the site: Risk Management, Clinical Coordinator, Director of Nursing Service [DNS], and CEO [Chief Executive Officer].
4. If any serious patient consequences occur, notify DNS or designee at time of incident
5. Document any changes in patient's condition or actions taken on EMR [electronic medical record]
6. DNS reviews all medication errors, classifies each error according to the severity scale listed below, and investigates as indicated. . . .
8. Quarterly medication error reports are submitted to QI, pharmacy, and safety committees.
9. For all significant medication errors, DNS reviews activities that resulted in the error, the staff involved in the error is asked to describe in detail the process they followed, [sic] The focus of the review is on fixing the system . . .
10. Based on the findings of the medication error, Risk Management, Clinical Coordinator, Pharmacy Coordinator, Consultant Pharmacist, Director of Nursing Service, and CEO may determine further actions and recommendations. . . ."

The Pharmacy and Therapeutics (P & T) Committee policy lacked evidence of a role in monitoring medication errors.

Review of Pharmacy Committee Meeting minutes held between December 2010 and October 2011 occurred on all days of survey. The minutes lacked evidence of review of medication errors.

Review of a Healthcare Safety Zone Portal Patient Event Summary report for the six month period from May 2011 through October 2011 identified 14 medication events (errors) occurred within the facility within these six months. An event summary identified each of these events occurred to patients and included a brief description of the medication (med)error/event:
"Wrong dosage form" - 1
"Wrong dose" - 1
"Unauthorized/wrong drug" - 4
"Extra dose" - 2
"Other" - 2
"Wrong patient" - 1
"Omission" - 1
Two reports lacked comments on the med event or med error type.

Comments written on the actual reports included "causes of the error" and "factors that contributed to this event" included:
"Look alike/sound alike . . . Fatigue . . . "
"Brand names sound alike - Communication - Drug shortage - Generic names sound alike . . . MED UNAVAILABLE . . ."
"Staff, inexperienced"
"Computer entry - Written order confusing/incomplete . . . A contributing factor not determined . . ."
"Computer entry . . . pt's ordered [Levaquin - an antibiotic] changed on 9/16/2011, IV medication was D/c'd [discontinued] and po [oral] was started. orders were observed but medication was never entered to OMAR [online medication administration record]. doses for 9/16 thru 9/18 were not given. dose for 9/19 was given ASAP [as soon as possible] when error was discovered. next dose due 9/20/11. . . lack of transcribing meds to omar, . . ." The event report identified the physician was not notified, and "various" staff members were responsible for the medication error.
"Communication . . . pt's [patients] assessment was assigned to writer, writer did not assign medications. writer thought other staff was going to give medications. miscommunication on part of writer, no direct harm done. Distractions - Workload increase . . ."
"Brand/generic names sound alike - Medication reconciliation - Reconciliation - admission . . . meds transcribed incorrectly. med list not up to date . . ."
"Distractions - Fatigue"
"Performance (human) deficit . . . A contributing factor not determined"
"Knowledge deficit/training insufficient - Look alike/sound alike . . . Staff, inexperienced . . ."

The above 14 medication error reports lacked evidence of investigation, including an analysis of data for patterns/trends, evidence of corrective action taken for the factors contributing to the error, and monitoring to achieve the desired results to reduce the occurrence of medication errors. The MEDICATION ERROR policy stated the supervisor of the nursing department/DNS would complete this review. The reports also lacked consistent evidence of review by Risk Management, the Clinical Coordinator, Pharmacy Coordinator, Consultant Pharmacist, Director of Nursing Service, and CEO as identified in the MEDICATION ERROR policy (The event report lacked a line entry for the Pharmacy Coordinator or Consultant Pharmacist). All reports lacked pharmacist comments, supervisor (DNS) comments, and risk manager comments, as permitted in the computerized generated reports.

During interview on 11/29/11 at 2:20 p.m., a supervisory pharmacy staff member (#8) stated the consulting pharmacist does not review medication error reports. During interview on 11/30/11 at 2:10 p.m., a supervisory nursing staff member (#2) stated the pharmacist does not review medication errors, and stated she reviews the medication reports, however, does not document a response on the reports, nor does she investigate, and track and trend the reports for QI.

Based on review of a list of providers, review of the operating room (OR) log, policy review and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the treatment furnished by 2 of 2 nurse anesthetists (CRNAs) (Providers #1 and #2) providing care to the CAH's patients within the past year. Failure to have a physician experienced in anesthesia evaluate the quality and appropriateness of the treatment furnished by a CRNA has the potential to affect patient outcomes involving surgical procedures requiring anesthesia services provided by the CRNAs.

Findings include:

Review of the FACILITY QUALITY IMPROVEMENT PLAN occurred on the afternoon of 11/29/11. The plan, dated 02/25/11, identified the "ORGANIZATION" responsibilities including:
"1. The Governing Board requires and supports that establishment and maintenance of a comprehensive, integrated QI [quality improvement] program. The Governing Board delegated the authority and accountability to operate the program to the Medical Staff and Hospital Administration. A summary of QI activities is reported to the Board at least once a quarter. . . .
2. The Medical Staff is responsible to set and monitor professional standards of care, to ensure that set standards are met, and to take corrective action when the care does not meet the set standards. Physician directed care will be reviewed by members of the Medical Staff. (See separate Peer Review Policy). . . ."

The PEER REVIEW policy, dated 03/10, stated:
"PURPOSE:
To establish a non-biased activity performed by the medical staff to measure, assess, and where necessary, improve performance on an organization-wide basis.
POLICY:
. . . 7. Criteria/indicators for peer review are established an [sic] approved by the Medical Staff for the following areas:
* Medical Services
* Surgical Services
* Emergency Services . . .
9. All members of active medical staff are involved in the peer review process.
10. Anyone who functions in any category of the medical staff is subject to review as indicated by the criteria. . . .
13. Certain circumstances may require external review. Provisions for this are contained in the Rural Health Network Agreement . . . These may include . . . Need for specialty review . . ."

Review of the CAH's current list of providers occurred on the afternoon of 11/28/11. The list identified two affiliate CRNAs on staff, Provider #1 and Provider #2. Review of the operating room (OR) log identified both providers provided services in the OR within the last year.

During interview on the morning of 11/30/11, the quality improvement director (#4) stated the CAH did not have a physician evaluate the quality and appropriateness of the treatment provided by the affiliate nurse anesthetists (Providers #1 and #2).

Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to establish and implement a comprehensive care plan within seven days for 2 of 3 closed swing bed patient (Patient #19 admitted on 05/27/11 and 07/05/11) records reviewed. Failure to establish a comprehensive care plan within seven days limited the CAH's ability to improve the patient's functional abilities and provide the greatest benefit to the patient.

Findings include:

Review of the swing bed policy titled "Care Planning" occurred on 12/01/11. This policy revised 03/10, stated,
"Purpose: To provide a means by which to plan for and communicate appropriate care for the Swing Bed patient that all disciplines involved can refer to and follow.
Policy: . . . 2. Patient assessment will begin upon admission, with the patient care plan initiated within 24 hours of admission and fully developed within seven days of admission to SB [Swing Bed]. . . ."

Reviewed on 11/30/11, Patient #19's closed swing bed record identified the CAH admitted the patient on 05/27/11 and discharged the patient on 06/30/11. Patient #19 had admitting diagnoses including cellulitis status post abscess of foot, diabetes, hypertension, and diabetic neuropathy. The CAH staff initiated a care plan on 06/14/11. The CAH staff had no plan of care to follow for 18 days after admission.

Reviewed on 11/30/11, Patient #19's closed swing bed record identified the CAH admitted the patient on 07/05/11 and discharged the patient on 07/27/11. Patient #19 had admitting diagnoses including status post skin graft of foot, diabetes, hypertension, and diabetic neuropathy. The CAH staff initiated a care plan on 07/19/11. The CAH staff had no plan of care to follow for 14 days after admission.

During interview at approximately 4:00 p.m. on 11/30/11, an administrative nursing staff member (#2) stated she would expect staff to initiate care plans for swing bed patients within 24 hours of admission and confirmed staff did not start care plans for the above listed records in the expected timeframe.