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Based on observation, record review, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the availability of all equipment, supplies, and medication used in treating emergency cases when using 1 of 1 Emergency Room (ER) for outpatient procedures as evidenced by review of 2 of 15 outpatient procedures performed in the ER (Patient #27 and #28). Failure of the facility to have an alternate room for cardiac and trauma patients arriving to the ER while performing outpatient procedures in the main ER has the potential to affect the facility's ability to treat all emergency cases.

Findings include:

Review of facility policy "Outpatient Services" occurred on 03/10/10. This policy, approved 11/21/00, stated, "Northwood Deaconess Health Center will provide services and procedures on an outpatient basis when appropriate. The Emergency Outpatient Department will be used to provide treatment, procedures and services as per established plan of care or protocol. . . . The Emergency Outpatient Department will be used for inpatient services that require the space and equipment available in the outpatient area. . . ."

Review of facility policy "Procedures that can be performed in the Emergency Room" occurred on 03/10/10. This policy, undated, stated, ". . . Flexible Sigmoidoscopy . . . Local Skin Lesion Excision and Biopsies . . ."

Review of facility policy "Flexible Sigmoidoscopies" occurred on 03/10/10. This policy, revised 02/99, stated, ". . . Admit patient to ER [emergency room] per routine. . . . Set up equipment . . . Assist doctor as requested. . . . After procedure is done, scope needs to be flushed with at least 600-800 cc [cubic centimeters] distilled H2O [water]. . . . Prepare biopsy specimen for pathology (if done). . . . Chart procedure, patient's tolerance on ER form. . . . Go over doctor's instructions with patient. . . . Discharge patient. . . . Bring scope to CSR [central supply reprocessing]."

During a tour of the Emergency Room (ER) on the morning of 03/09/10 with an administrative nursing staff member (#2), observation of the ER showed one large room identified by the staff member (#2) as the main and only ER room within the CAH, containing all of the facility's emergency supplies, medications, and equipment.

During an interview on 3/10/10 at 11:00 a.m., an administrative nursing staff member (#1) stated the facility occasionally performed outpatient procedures (OP) such as flexible sigmoidoscopies and lesion removals in the ER. The staff member (#1) confirmed the facility performed one flexible sigmoidoscopy and 13 lesion removals in 2009 and one flexible sigmoidoscopy in 2010. When asked about the time frame of the procedures, the staff member (#1) estimated 30-45 minutes. Due to the lack of an OP procedure log, the total number of hours facility staff utilized the ER for OP procedures could not be determined.

Review of the OP procedure record for Patient #28 occurred on 03/10/10. The record showed the patient underwent a left cheek lesion removal in November 2009. The "Emergency Room Record-Preliminary Report" stated, ". . . This area is cleansed, prepped, draped, anesthetized with 1% Xylocaine with epinephrine . . . An elliptical incision is made. One deep bleeder is clamped and ligated. The deeper tissues are then brought together with 3 deep sutures . . . The skin is reapproximated with a running vertical mattress suture. . . ." The "Specimen for Pathologic Diagnosis" form identified the physician collected a specimen and sent it to the laboratory. The "Outpatient Emergency Room Record" identified the patient's admission occurred at 9:20 a.m. and discharge at 10:00 a.m. Review of this record showed access to the main ER limited for 40 minutes.

Review of the procedure record for Patient #27 occurred on 03/10/10. The record showed the patient underwent a flexible sigmoidoscopy in January 2010. The "Emergency Room Record- Final Report" stated, ". . . Starting just after the rectosigmoid junction, we were stopped by a sharp turn in the colon. We took five biopsies from 25 cm going back down to 10 cm in to the rectum. . . ." The "Nurses Note" stated, ". . . biopsy obtained and sent for pathology. . . ." and indicated the procedure started at 9:30 a.m. and ended at 10:30 a.m. Review of this record showed access to the main ER limited for one hour.

During an interview on 03/10/10 at 11:00 a.m., a nursing staff member (#1) stated the CAH lacked a plan to ensure the treatment of patients needing lifesaving measures upon arrival to the ER when an OP procedure is in progress in the ER. The staff member (#1) agreed lesion removal and flexible sigmoidoscopy involve time, prep, invasive procedures, equipment, clean or sterile technique, and clean up, and confirmed moving the patients to another room upon arrival of a patient requiring emergency care would be difficult and unsafe.

Based on policy review, observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure the safety of patients, staff, and the public by not securely storing 2 of 13 oxygen K-tanks (in the corner next to the E-tank storage rack) in the oxygen storage room. Failure to secure oxygen tanks places any person in the vicinity at risk for injury should the tank become damaged.

Findings include:

Review of the policy titled "Oxygen Storage" occurred on 03/10/10 at 12:15 p.m. This policy, dated 11/26/03, stated, "Northwood Deaconess Health Center (NDHC) seeks to assure that all oxygen tanks are safely stored and secured at all time. . . . The tanks are to be secured by chain at all times. . . ."

During the environmental tour on 03/10/10 at 9:40 a.m., observation identified two oxygen K-tanks stored unsecured on the floor next to the E-tank storage rack in the oxygen storage room near the maintenance shop. Draped over the top of one K-tank was a loose chain.

During interview on 03/10/10 at 9:40 a.m., a facility services staff member (#22) confirmed the CAH staff failed to store the oxygen in a secure manner.

Based on review of bylaws, procedures, agreements, and credentialing files, and staff interview, the governing body of the Critical Access Hospital (CAH) failed to ensure credentialing of providers followed the CAH's bylaws and procedures for 4 of 9 providers' (Providers #14, #15, #16, and #17) files reviewed.

Findings include:

Review of "Medical Staff Bylaws, Rules and Regulations of Northwood Deaconess Health Center" occurred the afternoon of 03/08/10. These bylaws, approved 03/28/06, stated,
". . . ARTICLE VI . . . Section V. Allied Health Professional: Nurse Practitioner/Physicians's Assistant/CRNA [certified registered nurse anesthetist] . . . Subsection 2. An application for specified services for an Allied Health Professional shall be submitted and processed in the same manner as provided in Article V, Sections II and III. Processing for reappointment shall be accomplished in the same manner as specified in Article V, Section IV. . . .
ARTICLE VII . . . Section II. Committees . . . 1.2 Executive Committee: . . . This committee has the following credentialing functions: qualifications for staff appointments, reappointments and for recommendations of privileges and limitations.
. . ."

Review of "Northwood Deaconess Health Center Procedures of the Medical Staff Credentialing" occurred the afternoon of 03/08/10. These procedures, approved 11/06, stated,
". . . Appointment to the Medical Staff . . . Duration of Initial Appointment: All initial appointments to the Medical Staff shall be for a period not to exceed two years, regardless of the category of the staff to which the appointment is made and all initial clinical privileges shall be provisional for a period of 12 months from the date of the appointment or longer . . . During the term of this provisional appointment, the individual receiving the provisional appointment shall be evaluated by the Chief of Staff and Medical Staff Committee and the hospital as to the individual's clinical competence and general behavior and conduct in the hospital. . . . Continued appointment after the provisional period shall be conditioned on an evaluation of the factors to be considered for reappointment.
. . . Reappointment Procedures . . . The Chief Executive Officer or designee shall also collect relevant information since the time of the member's last appointment regarding the individual's professional and collegial activities, performance, clinical or technical skills and conduct at NDHC. These include: Findings from the performance review and utilization management activities; . . . Level of clinical activity at NDHC; Health status; Timely and accurate completion of medical records; Cooperativeness in working with other practitioners and hospital personnel; General attitude toward and interaction with peers, patients and NDHC's personnel and will include results from patient satisfaction and employee surveys as available; Compliance with all applicable Bylaws, department rules and regulations, and policies and procedures of the medical staff and NDHC; Peer references; . . . Executive Committee Action: The Executive Committee shall review the member's file, the department reports, and any other relevant information available to it and either make a recommendation for reappointment or nonreappointment . . ."

Review of the "Rural Health Network Agreement" occurred the afternoon of 03/08/10. This agreement, dated 11/25/05, stated, ". . . 9. Credentialing and quality assurance. . . . [Name of network hospital] will provide expertise and assistance as reasonably requested and agreed upon by both parties in this process. . . ."

Review of the providers' credentialing files occurred the afternoon of 03/09/10.

- Prior to reappointing Provider #14 on 05/23/08, the CAH provided no evidence of evaluation of the following information required by the CAH for reappointment: findings from the performance review and utilization management activities; level of clinical activity at NDHC; health status; timely and accurate completion of medical records; cooperativeness in working with other practitioners and hospital personnel; general attitude; compliance with bylaws and policies and procedures; and peer references. On behalf of the Medical Staff, Provider #14 approved reappointment for himself on 05/23/08. The CAH provided no evidence of review of Provider #14's reappointment information by another physician member of the Medical Staff or by their Network Hospital.

- Prior to reappointing Provider #15 on 05/26/08, the CAH provided no evidence of evaluation of the following information required by the CAH for reappointment: findings from the performance review and utilization management activities; level of clinical activity at NDHC; health status; timely and accurate completion of medical records; cooperativeness in working with other practitioners and hospital personnel; general attitude; and compliance with bylaws and policies and procedures. Physician #14 completed a "Physician Appraisal" for Provider #15 on 06/17/08 (approximately three weeks after the CAH reappointed Provider #15).

- Prior to reappointing Provider #16 on 05/23/08, the CAH provided no evidence of evaluation of the following information required by the CAH for reappointment: findings from the performance review and utilization management activities; level of clinical activity at NDHC; health status; timely and accurate completion of medical records; cooperativeness in working with other practitioners and hospital personnel; compliance with bylaws and policies and procedures; and peer references. Physician #14 completed a "Physician Appraisal" for Provider #16 on 06/17/08 (approximately three weeks after the CAH reappointed Provider #16).

- Provider #17's credentialing file indicated the CAH granted Provider #17 initial privileges on 05/23/08. The CAH granted permanent status to Provider #17 on 12/04/08 (approximately six months after initial appointment, instead of the required 12 month provisional status). Physician #14 signed Provider #17's delineated request for privileges on 10/06/09 (approximately 16 months after initial appointment). The physician did not check the specific privileges approved. The CAH provided no evidence of evaluation by the Chief of Staff and Medical Staff Committee and the hospital as to Provider #17's clinical competence and general behavior and conduct in the hospital as required by the CAH before granting Provider #17 permanent status on 12/04/08.

During interviews at 8:20 a.m. and 10:10 a.m. on 03/10/10, an administrative staff member (#19) and an administrative assistant (#20) confirmed Provider #14 on behalf of the Medical Staff had approved himself for reappointment in May 2008; the CAH reappointed Providers #14, #15, and #16 in May 2008 without all the required information; and the CAH did not follow the appointment procedures for Provider #17.

Based on review of the Medical Staff Bylaws, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure a doctor of medicine periodically reviewed and signed the medical record for 1 of 5 closed acute (Patient #9) and 2 of 9 (Patient #21 and #24) closed emergency department (ED) records reviewed of patients cared for by a nurse practitioner or physician assistant. Failure to ensure a physician reviewed and signed records limited the physician's and the CAH's ability to ensure the quality of patient care provided by the nurse practitioner and physician assistant.

Findings include:

Review of the CAH's Medical Staff Bylaws occurred on 03/08/10. This document, approved on 03/28/06, stated ". . . Article VI. . . .Section V. Allied Health Professional : Nurse Practitioner/Physician's [sic] Assistant . . . Subsection 3. The responsibilities of an Allied Health Professional shall be to:
3.1 Provide specified patient care services
under the supervision and direction of a
physician or dentist member of the Medical
Staff;
3.2 Write orders which shall be countersigned
within 72 hours by the attending practitioner;
3.3 Emergency room charts or orders should
be countersigned within 72 hours by the
attending practitioner; . . ."

- Patient #9's closed acute care medical record, reviewed on March 9-10, 2010, identified the CAH admitted the patient on 06/19/09 and discharged the patient on 06/22/09. The medical record included a progress note by a nurse practitioner or physician assistant health care provider (HCP) (#16), dated 06/20/09. This progress note lacked a physician's signature.

- Patient #21's closed ED medical record, reviewed on 03/10/10, identified the CAH admitted the patient to the ED on 06/16/09. The record included treatment orders and a treatment note by HCP (#16). These record entries lacked a physician's signature.

- Patient #24's closed ED medical record, reviewed on 03/10/10, identified the CAH admitted the patient to the ED on 02/17/10. The record included treatment orders and a treatment note by HCP (#17). These record entries lacked a physician's signature.

During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) confirmed a physician failed to countersign the HCP's entries in the medical records previously identified. This staff member reported she was not aware of any monitoring of medical records for countersignatures by a physician.

Failure to monitor countersignatures limited the CAH's ability to track and trend this issue and implement corrective action.

1. 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 1 of 1 hospital pharmacy by unauthorized personnel during 3 of 3 days of survey (March 08-10, 2010). Failure of the CAH to adequately secure and restrict access of all drugs and biologicals allowed an opportunity for unsafe and unauthorized use of medications and has the potential to create insufficient distribution, control, and accountability of drugs.

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 facility policy titled "Storage, handling, dispensing of drugs and biologicals" occurred on 03/10/10. This policy, revised April 2009, stated, ". . . Pharmacy Keys: 1. The hospital pharmacists and DON [director of nursing] will have a set of keys that will allow entry to the hospital pharmacy . . . and allow access to all the medications that are available in the hospital including all classes of controlled substances. The charge nurse and med nurse on each shift will have a key to enter the outer pharmacy to access and obtain if needed the medications that are not securely locked. . . ."

A tour of the CAH pharmacy took place on 03/09/10 at 3:15 p.m. with a pharmacy staff member (#7). Observation during the tour identified access to the pharmacy controlled by lock and key. When asked which staff members have access to the pharmacy, the pharmacy staff member (#7) stated the pharmacist, pharmacy tech [pharmacy technician], director of nursing, charge nurse, and med [medication] nurse.

During an interview on 03/09/10 at 10:20 a.m., an administrative nursing staff member (#2) stated both the charge nurse and medication nurse on duty have a key to the pharmacy and may access and enter the pharmacy in the absence of pharmacy staff to obtain medications.

During an interview on 03/09/10 at 3:30 p.m., a pharmacy staff member (#7) stated the charge nurse and med nurse have access to the hospital pharmacy by key and may enter in the absence of the pharmacist and pharmacy tech.

2. Based on observation, review of the North Dakota Century Code, and staff interview, the CAH failed to ensure staff kept current and accurate records of all drugs and biologicals in accordance with accepted professional principles for 1 of 1 hospital pharmacy on 3 of 3 days of survey (March 8-10, 2010). Failure to keep and maintain sufficient records/reports to follow the flow of pharmaceuticals from the pharmacy limited the CAH's ability to prevent unauthorized use and distribution of drugs and biologicals. The failure placed patients and staff at risk of unsafe and inappropriate use of drugs and biologicals.

Findings include:

The North Dakota Century Code, Chapter 61-07-01 "Hospital Pharmacy" stated, ". . . 61-07-01-05. Absence of pharmacist. . . . 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. . . . 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. Such education and training must be given by the director of pharmacy, who shall require, at a minimum, the following records and procedures: a. Removal of any drug from the pharmacy by an authorized nurse must be recorded on a suitable form showing patient name, room number, name of drug, strength, amount, date, time, and signature of nurse. b. Such form must be left with the container from which the drug was removed, both placed conspicuously so that it will be found by a pharmacist and checked properly and promptly . . . 61-07-01-07. Drug distribution and control. . . . 2. Responsibility. The director is responsible for the safe and efficient distribution of, control of, and accountability for drugs. The other professional staff of the hospital shall cooperate with the director in meeting this responsibility and in ordering, administering, and accounting for pharmaceutical materials so as to achieve this purpose. Accordingly, the director is responsible for, at a minimum, the following: . . . h. Records of all transactions of the hospital pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials. . . . 9. Records and reports. The director shall maintain, and submit, as appropriate, such records and reports as are required to ensure patient health, safety, and welfare, and, at a minimum, the following: . . . e. Inventories of the pharmacy. . . ."

A tour of the CAH pharmacy took place on 03/09/10 at 3:15 p.m. with a pharmacy staff member (#7). Observation during the tour identified access to the pharmacy controlled by lock and key and showed a locked room within the pharmacy, which pharmacy staff member (#7) stated contained the scheduled medications. Observation showed all other medications contained on shelves in the main room of the Pharmacy. When asked what process nursing staff members follow to obtain a medication from the pharmacy in the absence of pharmacy staff, the pharmacy staff member (#7) stated nursing staff obtain the medication from the shelf, remove the medication from the pharmacy and administer to the patient, and return it to the pharmacy, or place it in the lower drawer of nurse's medication cart. The pharmacy staff member (#7) stated the following day pharmacy staff check the counter in the pharmacy or check the lower drawer of the nurses medication cart for any medications. She confirmed this is the facility's process to track medications removed from pharmacy.

During interview on 03/09/10 at 3:30 p.m., a pharmacy staff member (#7) stated nursing staff do not record medications on a log when removing medications from the pharmacy.

During interview, on 03/09/10 at 4:00 p.m., when asked what process nursing staff follow to obtain a medication from the pharmacy in the absence of pharmacy staff, a nursing staff member (#6) confirmed the process identified by pharmacy staff member (#7). The nursing staff member (#6) stated when removing medications from pharmacy, nursing staff only record the medications on a log if nursing staff note the stock of that particular medication is low.

During interview on 03/10/10 at 9:30 a.m., a nursing staff member (#5) agreed/confirmed the information provided by nursing staff member (#6).

During telephone interview on 03/10/10 at 11:20 a.m., a pharmacy staff member (#8) stated nursing staff enter pharmacy and obtain the medication in the absence of pharmacy staff. The pharmacy staff member (#8) stated the following day pharmacy staff check the counter in the pharmacy or check the lower drawer of the nurse's medication cart for any medications. He also stated, on occasion, nursing staff notify pharmacy staff directly to inform them of the removed medications. He confirmed this is the facility's process to track medications removed from pharmacy. The pharmacy staff member (#8) confirmed nursing staff is not required to record medications removed from pharmacy.

Failure to maintain accurate records and monitor inventory of the pharmacy limited the pharmacists ability to follow the flow of pharmaceuticals through the CAH and permitted nursing staff to perform duties outside their scope of practice.

Based on policy and procedure manual review and staff interview, the Critical Access Hospital (CAH) failed to have 3 of 11 policy and procedure manuals (Cardiac Rehab, Laboratory-Larimore Clinic, and Radiology-Larimore Clinic) reviewed annually by the required members of a group of professional personnel in 2006-2009. By not having the required group annually review the policies and procedures, the CAH cannot ensure the policies and procedures model the CAH's current practices and are in compliance with federal and state regulations.

Findings include:

The policy titled "Patient Care Policy Review," revised 11/04, did not include a requirement for annual review of the CAH's policies and procedures by a group of professional personnel including a physician; a physician assistant, nurse practitioner, or clinical nurse specialist; and a non-staff member.

Reviewed on all days of survey, the Cardiac Rehab, Laboratory-Larimore Clinic, and Radiology-Larimore Clinic policy and procedure manuals lacked evidence of annual review by the three required members of a group of professional personnel (a physician; a physician assistant, nurse practitioner, or clinical nurse specialist; and a non-staff member) in 2006-2009.

During interview on 03/09/10 at 2:15 p.m., a radiology staff member (#23) confirmed the three required members had not annually reviewed the Radiology-Larimore Clinic's policy and procedure manual.

During interview on 03/10/10 at 10:55 a.m., a cardiac rehab nursing staff member (#11) confirmed the three required members had not annually reviewed the Cardiac Rehab policy and procedure manual.

During interview on 03/10/10 at 11:00 a.m., a laboratory administrative staff member (#24) confirmed the three required members had not annually reviewed the Laboratory-Larimore Clinic's policy and procedure manual.

Based on observation, review of a professional reference, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) staff failed to obtain/access a patient's identity during observation of 1 of 5 active patients (Patient #29). Failure to ensure identification of patients has the potential to place the patient at risk of improper care or treatment, therefore, risking patient safety.

Findings include:

Beyea's "Patient Identification: A Crucial Aspect of Patient Safety-Patient Safety First," AORN (Association of Perioperative Registered Nurses) Journal, dated September 2003, stated, ". . . Concern for proper patient identification is evidenced in the 2003 National Patient Safety Goals. One of the six identified goals is to improve the accuracy of patient identification. . . . Most fundamental nursing textbooks and courses describe the importance of verifying a patient's identity. This basic ritual and routine is integral to the medication administration process, treatments, and procedures. . . . All clinicians need to be concerned with the processes and systems that support correct identification of patients. An approach to ensuring a best practice for patient identification includes implementing a clearly written, easy-to-understand policy and procedure. . . . The importance of this basic practice cannot be minimized. No assumptions about identity can be made. Every clinician providing care for the patient must make it a routine practice to verify identity. . . . a patient has the right to be identified correctly."

Review of facility policy "Admission of Patient" occurred 03/10/10. This undated policy stated, "I. Purpose: To admit the patient to the nursing unit for therapeutic and nursing care. II. Equipment . . . C. Identification band . . . III. Essential Steps in Procedure. A. Prepare patient . . . e. Identify with identification band . . ."

Observation of medication pass occurred on 03/09/10 at 12:00 p.m. A licensed nurse (#3) administered warfarin (a medication used to thin the blood) orally to Patient #29 and failed to identify the patient prior to medication administration. Observation of Patient #29 wrists showed staff failed to place an identification band/bracelet on the patient. Observation showed a lack of any other means to identify Patient #29.

During interview on 03/09/10 at 12:10 p.m., the nursing staff member (#3) stated she did not confirm Patient #29's identity before medication administration because she knew the patient. The staff member (#3) stated Patient #29 did not have a name band because not all patients receive one when admitted. The staff member (#3) stated since this is a small community and the CAH often re-admits patients, staff know most of the patients. The nursing staff member (#3) stated all CAH staff knew Patient #29.

During interview on 03/10/10 at 10:20 a.m., the surveyor informed an administrative nursing staff member (#1) of the observations and interview on 03/09/10 involving the identification of Patient #29. The administrative nursing staff member (#1) stated the CAH identified admitted patients by a nameband placed around the patient's wrist, which included name, birthdate, and patient identification number. The staff member (#1) confirmed the CAH utilized locum doctors and travel nurse staff at times and other staff members have contact with patients including providers, laboratory, radiology, and therapy staff. The administrative nursing staff member (#1) stated she expected identification bands placed on all patients and for all staff to confirm identification of patients prior to any care, treatment or procedure, regardless of knowing the patient.

Based on observation, review of professional reference, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure nursing staff administered medications according to accepted standards of practice during 2 of 3 medication administration observations (Patient #4 on 03/08/10 and Patient #29 on 03/09/10). Failure to confirm identification of a patient prior to medication administration risks patient safety and has the potential for staff to administer medication to the wrong patient.

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 848-849, stated, ". . . Process of Administering Medications. When administering any drug, regardless of the route of administration, the nurse must do the following: 1. Identify the client. Errors can and do occur, usually because one client gets a drug intended for another. One of the . . . National Patient Safety Goals is to improve the accuracy of client identification. This goal requires a nurse to use at least two client identifiers whenever administering medications. Neither identifier can be the client's room number. Acceptable identifiers may be the person's name, assigned identification number, telephone number, photograph, or other person-specific identifier . . . In hospitals, most clients wear some sort of identification, such as a wristband with name and hospital identification number. Before giving the client any drug, always check the client's identification band. . . . 3. Administer the drug. . . . There are aspects of medication administration that are important for the nurse to check each time a medication is administered. These are referred to as the 'rights.' Traditionally there were five rights to medication administration. More rights have been added . . . with the latest being the ten rights."

Page 850, Box 35-4 stated, "Ten 'Rights' of Medication Administration . . . Right Client. Medication is given to the intended client. Check the client's identification band with each administration of a medication. . . ."

Page 852-854, Skill 35-1 stated, "Administering Oral Medications . . . Performance . . . 6. Prepare the client. Check the client's identification band. Rationale: This ensures that the right client receives the medication. . . ."

Review of facility policy "Administering Medications" occurred on 03/10/10. This policy, revised October 2003, stated, "Purpose: To give medications safely and efficiently. Procedure For Administering Medications . . . 2. Administer meds [medications] to patient . . . after verifying proper identification . . . A. Orally . . . 4. Verify the name on the patient's identaband [identification band] . . . with the name . . . on the MAR [medication administration record] . . ."

Observation of medication pass occurred on 03/08/10 at 4:10 p.m. A licensed nurse (#4) prepared to administer a medication of ipratropium and albuterol (a combination medication used to treat breathing problems in patients with lung disease) per nebulizer (a device used to administer medication to patients in the form of a mist inhaled into the lungs) to Patient #4. The licensed nurse (#4) entered Patient #4's room, emptied the medication contents into the nebulizer, assisted the patient with the device, and started the device. Observation showed the licensed nurse (#4) failed to identify the patient prior to medication administration.

Observation of medication pass occurred on 03/09/10 at 12:00 p.m. A licensed nurse (#3) prepared to administer warfarin (a medication used to thin the blood) orally to Patient #29. The licensed nurse (#3) entered Patient #29's room, handed the patient a medication cup containing warfarin, and witnessed the patient swallow the medication. Observation showed the licensed nurse (#3) failed to identify the patient prior to medication administration.

During interview on 03/08/10 at 4:15 p.m., a nursing staff member (#4) stated she forgot to identify Patient #4 before medication administration and confirmed staff must always identify patients prior to medication administration.

During interview on 03/09/10 at 12:10 p.m., a nursing staff member (#3) stated she did not confirm Patient #29's identity before medication administration because she knew the patient. The staff member (#3) stated since this is a small community, staff know most of the admitted patients.

During interview on 03/10/10 at 10:20 a.m., an administrative nursing staff member (#1) stated prior to medication administration, the nurse must perform the five rights, the most important being the confirmation of the correct patient. The staff member (#1) stated nursing staff need to confirm the identity of all patients prior to performing any care, whether staff know the patient or not.

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 2005.

Based on record review, review of a professional reference, review of policy and procedure, and staff interview, the Critical Access Hospital (CAH) failed to develop, update, and ensure staff kept nursing care plans current for 3 of 3 active swing bed patients (Patient #2, #3, and #4), 1 of 4 closed acute patient (Patient #7), and 1 of 5 closed swing bed patient (Patient #16) records reviewed. Failure to develop and update 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. . . ."

Page 216 stated, ". . . The nurse should use the following guidelines when writing nursing care plans: 1. Date and sign the plan. The date the plan is written is essential for evaluation, review, and future planning. The nurse's signature demonstrates accountability to the client and to the nursing profession, since the effectiveness of nursing actions can be evaluated. . . ."

Page 237-239 stated, ". . . After drawing conclusions about the status of the client's problems, the nurse modifies the care plan as indicated. Whether or not goals were met, a number of decisions need to be made about continuing, modifying, or terminating nursing care for each problem. . . . After making the necessary modifications to the care plan, the nurse implements the modified plan and begins the nursing process cycle again. . . ."

Review of facility policy "Admission of Patient" occurred on 03/10/10. This policy, undated, stated, "I. Purpose. To admit the patient to the nursing unit for therapeutic and nursing care. . . . C. Method. 6. Initiate care plan. . . ."

Review of facility policy "Discharge Planning" occurred on 03/10/10. This policy, revised June 2009, stated, "Procedure. 1. Develop a care plan within 24 hours [sic] admit to acute and within 24 hours after admission to swingbed program. Care plans/discharge plans are started on day of admission. . . . 5. Discuss plans and goals with the patient and family. 6. Review each plan as often as necessary - at least every 1-2 days for acute, and every few days for swing bed . . ."

- Patient #4's active swing bed record, reviewed March 8-9, 2010, identified the CAH admitted the patient on 03/04/10 with diagnoses of exacerbation of COPD (chronic obstructive pulmonary disease), right heart failure, possible pneumonia, and delirium. Review of Patient #4's medical history included a mechanical aortic valve replacement, for which the patient took warfarin (a type of medication to thin the blood and prevent blood clots) daily.

Patient #4's physician admission orders included a medication order for Prednisone (a type of steroid used to treat inflammation in the lungs, which may cause a rise in blood sugar) daily. Patient #4's medication administration record showed Prednisone given daily from March 4-9, 2010. Review of Patient #4's nursing documentation showed frequent elevated blood sugars in the mid to upper 200's mg/dL (milligrams per deciliter) from March 4-9, 2010.

Patient #4's nursing documentation on admit showed a fall risk assessment completed 03/04/10 and identified the patient as high risk for falls. Record review showed the problem "weakness/fatigue" initiated on the care plan on 03/04/10.

Review of Patient #4's care plan failed to indicate nursing staff identified the medications warfarin and prednisone, elevated blood sugar, and the high fall risk as potential problems and failed to include them on the care plan. The problems indicated on the care plan lacked a signature or initial of the individual responsible for initiating them. The care plan, dated 03/04/10, lacked documentation of ongoing patient needs, the patient's response to interventions, measurement of goals, and updating/revising the care plan in response to assessments.

- Patient #3's active swing bed record, reviewed 03/09/10, identified the CAH admitted the patient 02/15/10 with diagnoses of metastatic rectal cancer and post surgical stabilization of recent pathological right tibia fracture.

Review of Patient #3's care plan identified staff failed to date some of the problems to identify when the problems began and when staff initiated interventions. The problems indicated on the care plan lacked a signature or initial of the individual responsible for initiating them. The care plan, dated 02/16/10, lacked documentation of ongoing patient needs, the patient's response to interventions, measurement of goals, and updating/revising the care plan in response to assessments. The facility staff failed to keep the care plan current.

- Patient #2's active swing bed record, reviewed 03/10/10, identified the CAH admitted the patient 02/19/10 with diagnoses of recent necrotizing fascitis of groin with Fournier's gangrene, long term antibiotics, and end stage renal disease. The physician's admission orders included an order for contact isolation.

Review of Patient #2's care plan failed to indicate staff identified contact isolation as a potential problem and failed to include it on the care plan. The care plan, dated 02/19/10, lacked documentation of ongoing patient needs, the patient's response to interventions, measurement of goals, and updating/revising the care plan in response to assessments. The facility staff failed to keep the care plan current.

During interview, on 03/10/10 at 10:30 a.m., an administrative nursing staff member (#1) stated she expected nursing staff to initiate a care plan upon admission in accordance with the patient's medical condition(s), and review and update the care plan as the patient's condition warrants. The administrative nursing staff member (#1) agreed staff must keep care plans current to assess and meet patients needs.



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- Patient #7's closed acute care medical record, reviewed on March 9-10, 2010, identified the CAH admitted the patient on 10/02/09 and the patient expired on 10/05/09. The physician's admission orders included an order for contact isolation precautions.

Patient #7's Nurse's Notes included:
*10/02/09, 7:15 p.m.- "Shingles are quite large on left flank area with quite a few pustules. Pt. [Patient] also has 2 pustules on his face that could be ? [possibly] shingles. . . ."
*10/03/09, 9:00 a.m. - ". . . Shingle vesicles visualized on pt's [patient's] left flank and mid back region. . . ."
*10/03/09, 2:00 p.m. - ". . . leg examined and reveals 3-4 shingle appearing vesicles present near groin region. . . ."

Patient #7's care plan failed to indicate the CAH staff identified contact isolation precautions or the patient's possible infection as a potential problem and approaches for staff to implement.

- Patient #16's closed swing bed medical record, reviewed on March 9-10, 2010, identified the CAH admitted the patient from a tertiary care facility on 11/30/09 and discharged the patient on 12/21/09. The patient's admission diagnoses included venous thrombosis and "bacteremia and sepsis." The transfer form from the tertiary care facility included "Isolation type, Contact (MRSA) [Methicillin Resistant Staphylococcus Aureus]."

Patient #16's physician orders on admission included "Isolation-Contact." The patient's Nursing Assessment, dated 11/30/09, and the patient's care plan, initiated on 11/30/09, failed to identify the MRSA or the contact isolation precautions as potential problems and failed to identify approaches for staff to implement.

Based on review of policies and procedures, record review, and staff interview, the Critical Access Hospital (CAH) failed to have written policies and procedures for the maintenance of the medical records system for 3 of 3 days of survey (March 8-10, 2010.) Failure to have written policies and procedures limited the CAH's ability to provide the staff with direction for administering the medical records program.

Findings include:

During interview at approximately 2:00 p.m. on 03/08/10, a medical records management staff member (#9) reported the CAH adopted an electronic medical records system approximately 1 1/2 years earlier. This staff member reported the CAH continued to transition some of the records between the electronic and "hard copy" system.

Review of the policy and procedure manual for the Medical Records Department occurred on March 8-10, 2010. Documentation identified the CAH staff reviewed and approved this manual on 05/20/09. The manual included policies and procedures related to issuing birth certificates. During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) reported the CAH stopped live births several years earlier and these policies and procedures were no longer applicable.

The current Medical Records policy and procedure manual lacked specific policies and procedures such as requirements for completion of records by CAH staff; frequency of documentation by CAH staff; location of documentation in the medical record; confidentiality of records; staff responsibilities for monitoring of records completeness; and, required deadlines for documentation.

Based on review of Medical Staff Rules and Regulations, policies and procedures, and professional reference, and staff interviews, the Critical Access Hospital (CAH) failed to ensure the completion and accurate documentation of medical records for 1 of 1 emergency room (ER) log, 7 of 9 closed ER records (Patient #20, #21, #22, #23, #24, #25, and #26), 1 of 5 closed acute care medical records (Patient #9), and 2 of 5 closed swing bed medical records (Patient #13 and #14) reviewed, regarding disposition of ER patients, ER transfer records, ER record timing, admission and discharge orders, and progress notes. Failure to ensure the accuracy and completeness of medical records limited the CAH staff and the receiving tertiary facility's abilities to ensure accuracy and continuity of care, including those patients transferred from the CAH's ER to the tertiary care facilities.

Findings include:

The Centers for Medicare & (and) Medicaid Services (CMS) requires each hospital with an emergency department to maintain a central log on each individual who comes to the emergency department seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged.

Review of the Medical Staff Rules and Regulations - Acute Service, occurred on March 9-10, 2010. These rules and regulations, approved on 12/01/08, stated,
"2. . . . B. The practitioner will see the patient in the emergency room within the following time - the time limit being determined by the seriousness of the nature of the problem presenting.
(1) Emergent problems will be seen within no
more than 15 minutes and desirably much
less.
(2) Non-emergent problems will be seen
with-in one-half hour or desirably less. . . .
5. All orders for treatment shall be written. An order shall be considered to be in writing if dictated to a licensed nurse. The attending practitioner shall sign such orders within 48 hours.
6. The attending practitioner shall be held responsible for the preparation of a complete medical record for each patient. No medical record shall be filed until it is complete except on order of the Medical Records Department after conferring with Chief of Staff. . . .
12. Patients shall be discharged only on written order of the attending practitioner. The practitioner shall have no more than 15 days to complete the medical record. . . ."

Review of the CAH policy and procedure "Admission/Transfer/Discharge" occurred on March 9-10, 2010. This policy and procedure, approved 10/01/02 and revised 06/29/09, stated, "POLICY: All patients of Northwood Deaconess Health Center will be admitted, transferred and discharged per policy.
PROCEDURE: . . . 4. Patients transferred from our hospital to any other health facility must have a transfer form and any other medical record the attending physician may request. For emergency room transfers, may copy ER Record, which would include Nurses Notes, MD's [physician's] history, and other pertinent information. Transfer forms are available at the Nurses Station. . . . The transfer form must be signed by MD unless transferred to an acute care hospital; then a nurse may sign.
5. Discharged patients may leave when the discharge order is given by the doctor. If patients leave without consent of their M.D., they must sign a form which designates they left without the doctor's advice or consent. . . ."

Review of the CAH policy and procedure "Emergency Transfer Protocol" occurred on March 9-10, 2010. This policy and procedure, approved 11/21/00 and revised 08/07, stated,
"POLICY: It is the goal of Northwood Deaconess Health Center to facilitate access to a designated Level II Trauma Center for patients requiring higher level trauma care, and to facilitate access to an appropriate facility which is able to provide services and treatment that is out of Northwood Deaconess Health Center's capabilities.
PROCEDURE: 1. Once the need for transfer is suspected . . . Phone contact should be made immediately with receiving institution.
GUIDELINES FOR TRANSFERRING PATIENTS:
1. Transferring medical provider initiates the transfer of the patient to the receiving institution, and obtains consent of the receiving hospital . . . A transfer form is completed and a copy sent with the patient. . . ."

Review of the CAH policy and procedure "ER Record/ Documentation" occurred on March 9-10, 2010. This policy and procedure stated,
"POLICY: A complete medical record for all patients treated in the Emergency Department will be maintained by nursing staff and medical staff personnel.
PROCEDURE: A. The ER Record will include: . . . Physician notification time and arrival time. . . ."

- On 03/08/10 at approximately 2:00 p.m., a medical records management staff member (#9) provided the CAH's ER log, requested during the entrance conference, on 03/08/10 at 11:30 a.m. This computerized log included an "admitting diagnosis" for most, but not all patients; and did not include the patient's disposition (refused treatment, transferred, admitted and treated, stabilized and transferred, or discharged.) The staff member (#9) reported she would obtain this information from another part of the computer system. At approximately 4:30 p.m., this staff member (#9) returned with a partial list of patient dispositions for the ER log and reported she would contact computer support for the remaining information. On 03/09/10 at approximately 9:00 a.m., the staff member (#9) reported she did not have all the patient dispositions for the ER log. On 03/09/10 at 1:30 p.m., the staff member (#9) provided a complete list of patient dispositions for the CAH's ER log.

During interview, staff member (#9) reported the CAH adopted the electronic medical records system approximately 18 months ago and discontinued use of the written ER log. This staff member (#9) reported she expected each patient's diagnosis to be included on the ER log and was not aware of the requirement for maintaining an ER log. Staff member (#9) reported she was not aware of any monitoring for accuracy or completeness of the ER log.

- Review of the closed ER records identified the CAH transferred the following patients to tertiary care facilities for treatment, the dates of service, admitting diagnosis, additional information, health care provider (HCP).
*Patient #20 - 04/11/09, right wrist, forearm, and ankle pain. X-ray machine not operable. The ER record lacked evidence the CAH contacted the tertiary care facility or physician and failed to include a transfer form or consent for transfer. HCP #17.
*Patient #21 - 06/16/09, unstable angina (chest pain). The ER record failed to include a transfer form identifying the risks and benefits of transfer, the patient's consent, and the HCP's certification of the benefits of transfer. HCP #16.
*Patient #23 - 10/21/09, overdose, substance unknown. The ER record identified the patient was unresponsive and the patient's spouse was intoxicated, therefore, staff could not obtain consent. The ER record lacked a transfer form including the HCP's certification of the benefits of the transfer and any attempt to explain the risks and benefits of the transfer. HCP #15.
*Patient #24 - 02/17/10, irregular heart rate, dizzy. The ER record lacked a transfer form including the risks and benefits of transfer, the patient's consent to transfer, and the physician's certification of the benefits of transfer. HCP #17.

During interview, on 03/10/10 at 9:30 a.m., a medical records management staff member (#9) reported the CAH used the "Patient Transfer Form" for transfers to tertiary care facilities. This staff member reported she was not aware of any form including the risks and benefits of transfer, the patient's consent for transfer, and the physician's certification for transfer. This staff member (#9) also reported she was not aware of any monitoring activities for completing a transfer form.

- Review of closed ER records identified the following records lacked arrival times of the health care provider (HCP):
*Patient #21 - admitted 06/16/09
*Patient #22 - admitted 08/26/09
*Patient #23 - admitted 10/21/09
*Patient #25 - admitted 07/04/09
*Patient #26 - admitted 11/08/09

During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) reported the HCPs may have been at the ER when patients arrived. This staff member confirmed that without documentation it is unknown if the HCP was in the ER at the time of the patient's arrival or when the HCP arrived. This staff member (#9) reported she was not aware of any monitoring of HCP arrival times or the time between the patient's arrival and the HCP's arrival.

- Review of closed medical records, on March 8-10, 2010, revealed the following:
*Patient #9, acute - admitted on 06/19/09, discharged 06/22/09. HCP Progress Note dated 06/22/09, signed on 09/07/09 (77 days after discharge.) HCP #14.
*Patient #13, swing bed - admitted on 01/07/10 from the CAH's acute care, discharged on 01/11/10. Lacked HCP discharge orders. HCP #15.
*Patient #14, swing bed - admitted on 04/01/09 from a tertiary care facility's renal dialysis unit., discharged on 04/15/09. The CAH's HCP failed to write admission orders or co-sign the referring physician's recommended admission orders. HCP #14.

During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) confirmed the above findings. This staff member (#9) also reported she was not aware of any monitoring for completion of records for accuracy or completeness.

Based on review of the Medical Staff Rules And Regulations - Acute Service, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure completion of a discharge summary in a timely manner for 1 of 2 acute care patient records (Patient #7) and for 1 of 5 closed swing bed patient records (Patient #14); and, completion of authorization for treatment for 1 of 2 acute care patient records (Patient #8) and 1 of 1 closed respite care patient records (Patient #18). Failure to complete discharge summaries in a timely manner limited the CAH's ability to ensure the continuity of care. Failure to complete authorization for treatment placed the patients and the CAH at risk in the event of providing unauthorized treatment.

Findings include:

Review of the CAH's Medical Staff Rules And Regulations - Acute Service occurred on March 9-10, 2010. This document, approved on 12/01/08, stated,
". . . 6. The attending practitioner shall be held responsible for the preparation of a complete medical record for each patient. No medical record shall be filed until it is complete except on order of the Medical Records Department after conferring with Chief of Staff. . . .
12. . . . The practitioner shall have no more than 15 days to complete the medical record. . . .
14. . . . In case of re-admission of a patient, all previous records shall be available for the use of the attending practitioner. . . ."

Review of the CAH's policy and procedure, Informed Consent/Authorization For Treatment, occurred on March 9-10, 2010. This policy and procedure, approved on 11/21/00 and revised on 04/03/01, stated,
"POLICY: Northwood Deaconess Health Center (NDHC) staff will obtain proper informed consent and authorization for treatment on all patients within the facility as appropriate.
PROCEDURE: A. Authorization for treatment will be obtained from all patients seen in the ER [emergency room] or admitted to the hospital. . . .
F. The nurse in charge must secure the signature on the consent form. . . .
2. If the patient is an adult but cannot -
for mental or physical reasons - sign
their own consent, the legal next of kin
signature should be obtained. . . . "

- Patient #7's closed acute care medical record, reviewed on March 8-10, 2010, identified the CAH admitted the patient, under health care provider (HCP) #14's care, on 10/02/09 and the patient expired on 10/05/09. The medical record lacked a discharge summary.

- Patient #14's closed swing bed medical record, reviewed on March 8-10, 2010, identified the CAH admitted the patient, under HCP #14's care, on 04/01/09 and discharged the patient on 04/15/09. HCP #14 signed the patient's discharge summary on 06/19/09 (65 days after discharge).

- Patient #18's closed respite care record, reviewed on 03/10/10, identified the CAH admitted the patient on 09/15/09 and discharged the patient on 09/20/09. The medical record lacked an authorization for treatment for this admission.

- Patient #8's closed acute care medical record, reviewed on March 8-10, 2010, identified the CAH admitted the patient in an unresponsive state on 01/16/10 and the patient expired later that day. The medical record identified the patient's spouse and responsible party was present during that stay. The medical record lacked an authorization for treatment for this admission.

During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) confirmed these medical records lacked a discharge summary or authorizations for treatment and the HCP did not complete Patient #14's discharge summary within 15 days. This staff member (#9) also reported she was not aware of any monitoring activities for completion of discharge summaries or authorizations for treatment.

Based on review of Medical Staff Rules And Regulations, medical records review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the closed medical records included signed histories and physicals for 2 of 7 acute care patients (Patient #7 and #11) and failed to ensure the timely completion of histories and physicals for 2 of 7 acute care patients (Patient #8 and #13) and 2 of 5 swing bed patients (Patient #14 and #15). Failure to complete the histories and physicals and in a timely manner limited the CAH staff's ability to ensure continuity of care.

Findings include:

Review of the CAH's Medical Staff Rules And Regulations - Acute Service occurred on March 9-10, 2010. These rules and regulations, approved 12/01/08, stated,
". . . 6. The attending practitioner shall be held responsible for the preparation of a complete medical record for each patient. No medical record shall be filed until it is complete except on order of the Medical Records Department after conferring with Chief of Staff.
7. A physical exam must be made and a medical history taken of a patient by a member of the medical staff no more than fourteen days before or twenty-four hours after the patient's admission to the hospital. . . .
12. . . . The practitioner shall have no more than 15 days to complete the medical record. . . .
14. . . . In case of re-admission of a patient, all previous records shall be available for the use of the attending practitioner. . . ."

Review of the following patient records occurred on March 8-10, 2010. The identified health care provider (HCP) failed to sign the history and physical (H & P) or signed it after the patient's discharge, as noted.
- Patient #7 - admitted 10/02/09, expired 10/05/09. H & P not signed. HCP #14.
- Patient #11 - admitted 11/13/09, discharged 11/18/09. H & P not signed. HCP #14.
- Patient #14 - admitted 04/01/09, discharged 04/15/09. H & P signed 06/19/09 (80 days after admission.) HCP #14.
- Patient #15 - admitted 07/16/09, discharged 10/06/09. H & P signed 09/07/09 (54 days after admission.) HCP #14.
- Patient #8 - admitted 01/16/10, expired 01/16/10. H & P signed 02/04/10 (20 days after admission.) HCP #14.
- Patient #13 - admitted 01/03/10, discharged 01/07/10. H & P signed 01/12/10 (9 days after admission.) HCP # 15.

During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) confirmed the HCPs did not sign the histories and physicals for the medical records previously noted in a timely manner. This staff member also reported she was not aware of any monitoring of records for completion of histories and physicals.

Based on review of the Medical Staff Bylaws, Rules And Regulations, and records, and staff interview, the Critical Access Hospital (CAH) failed to ensure medical records included dated signatures of the doctor of medicine or other health care professional providing patient care for 1 of 5 closed acute care (Patient #11), 1 of 5 closed swing bed (Patient #15), and 5 of 9 closed emergency room (ER) (Patient #20, #21, #23, #24, and #26) patient records reviewed. Failure to include dated signatures in the medical records limited the CAH's ability to ensure the accuracy of the patients' records.

Findings include:

Review of CAH's Medical Staff Bylaws occurred on March 9-10, 2010. These Bylaws stated,
". . . ARTICLE VI. Division of the Medical Staff . . .
Section V. Allied Health Professional: Nurse Practitioner/Physician's Assistant . . .
Subsection 3. The responsibilities of an Allied Health Professional shall be to: . . .
3.2 Write orders which shall be countersigned
within 72 hours by the attending practitioner;
3.3 Emergency room charts or orders should
be countersigned within 72 hours by the
attending practitioner . . ."

Review of the CAH's Medical Staff Rules And Regulations - Acute Service occurred on March 9-10, 2010. These rules and regulations, approved 12/01/08, stated,
". . . 4. Standing orders shall be formulated by conference between the Medical Staff and Director of Nursing. . . . These orders shall be followed insofar as proper treatment of the patient will allow, and when specific orders are not written by the attending practitioner, they shall constitute the orders. . . .
6. The attending practitioner shall be held responsible for the preparation of a complete medical record for each patient. No medical record shall be filed until it is complete except on order of the Medical Records Department after conferring with Chief of Staff. . . .
12. . . . The practitioner shall have no more than 15 days to complete the medical record. . . .
14. . . . In case of re-admission of a patient, records shall be available for the use of the attending practitioner. . . ."

Review of the following closed medical records occurred on March 8-10, 2010. The following records identified issues regarding doctor of medicine (MD) (health care practitioner) (HCP) or allied health professional (AHP) (HCP) signatures:
- Patient #11 - admitted to acute care 11/13/09, discharged 11/18/09. Progress notes, dated 11/14/09, 11/15/09, 11/16/09, and 11/17/09, and discharge summary, dated 11/18/09, lacked MD's (HCP #14) signature.
- Patient #15 - admitted to swing bed 07/16/09, discharged 10/06/09. Progress notes, dated 07/27/09, 09/01/09, 09/02/09, 09/08/09, and 10/01/09, lacked MD's (HCP #14) signature.
- Patient #20 - admitted to ER 04/11/09. Verbal orders lacked AHP's (HCP #17) signature and MD's (HCP #14) countersignature. Treatment note lacked AHP's (HCP #17) signature and MD (HCP #14) countersigned on 06/19/09 (70 days after the episode of care.)
- Patient #21 - admitted to ER 06/16/09. Standing orders lacked AHP's (HCP #16) signature and MD's (HCP #14) countersignature. Treatment note lacked MD's (HCP #14) countersignature.
- Patient #23 - admitted to ER 10/21/09. The record lacked orders and MD's (HCP #15) signature for the treatment provided, including intravenous fluids, medications, and x-rays, identified in the treatment note.
- Patient #24 - admitted to ER 02/17/10. Treatment orders for electrocardiogram and laboratory tests and the treatment note lacked AHP's (HCP #17) signature and MD's (HCP #14) countersignature.
- Patient #26 - admitted to ER 11/18/09. Treatment note lacked AHP's (HCP #17) signature and MD (HCP #14) countersigned on 02/04/10 (79 days after the episode of care.)

During interview, on 03/10/10 at 10:30 a.m., a medical records management staff member (#9) confirmed the records previously noted lacked the HCPs' signatures and countersignatures. This staff member also reported she was not aware of any monitoring of completion of the medical records regarding dated signatures.

Based on quality assurance (QA) plan review, QA report review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the QA program evaluated all patient care services and other services affecting CAH patient health and safety for 12 of 12 months reviewed (January-December 2009). The CAH has the potential of failing to identify risk factors affecting patient care and failing to implement corrective action if necessary by not ensuring all departments providing patient care participate in QA monitoring, report to the QA Committee, and perform quality of care monitoring.

Findings include:

Review of the Quality Assurance & Improvement (QA & I) Plan occurred on 03/10/10 at 8:30 a.m. This plan, revised 06/05/09, stated,
"I. Purpose: Northwood Deaconess Health Center (NDHC) will have a facility wide, ongoing Quality Assurance & Improvement Program to maintain delivery of quality care; to review and evaluate patient and resident care, to identify problems relative to the provisions of quality services to patients and residents in a systematic ongoing manner, to identify improvement opportunities, and to act on them in a timely manner.
II. Goals: The goal of the QA & I Program of NDHC is to achieve optimal service and quality of patient/resident care for all who come to NDHC for care. The program shall apply to all departments, services and practitioners involved in the delivery of patient/resident care. . . .
IV. Scope: A. The QA & I program is designed to integrate and coordinate all review activities pertaining to quality issues involving, but not limited to, medical staff, patient care services, resident care services, and multi-disciplinary support services. It provides for comprehensive, objective and systematic assessment of the quality of patient and resident care. . . .
VI. Implementation: . . . 2. All review activities from the departments listed must include the following components: a. Development of monitors that evaluate the quality and appropriateness of services provided. . . ."

Reviewed on 03/10/10, the 2009-2010 Quality Assurance Quarterly Reports (including monthly reporting from January-December 2009) lacked evidence the following departments reported to the QA Committee: central supply, laundry, and surgical services.

The following departments reported results to the QA Committee for the attached long term care unit, but did not include separate results of CAH monitoring activities: dietary, social services, and activities.

The following departments did not include an evaluation of the quality of patient care as part of the monitoring activities reported to the QA Committee: health information services, dietary, and rehabilitation services.

During interview on 03/10/10 at 10:30 a.m., an administrative health information services staff member (#9) confirmed the health information services department did not monitor the following areas: emergency room (ER) log, ER transfer records, ER time documentation, ER patient disposition, provider arrival times to see patients in the ER, admission and discharge orders, progress notes, discharge summaries, authorizations for treatment, histories and physicals performed within 24 hours of admission and signed for acute patients, and dating of medical record entries.

During interview on 03/10/10 at 10:55 a.m., a cardiac rehabilitation services nursing staff member (#11) confirmed the cardiac rehabilitation services department did not monitor quality of care for CAH patients.

During interview on 03/10/10 at 11:20 a.m., an administrative rehabilitation services staff member (#10) confirmed the rehabilitation services department did not monitor quality of care for CAH patients.

During interview on 03/10/10 at 1:25 p.m., a central supply staff member (#21) confirmed the central supply department did not report QA monitoring to the QA Committee.

During interviews on 03/10/10 at 12:15 p.m. and 1:35 p.m., an administrative clinical support services staff member (#18) confirmed central supply, laundry, and surgical services did not report monitoring to the QA Committee; not all departments monitored quality of care; and several departments did not report separate results for CAH patient monitoring and the attached long term care unit monitoring in 2009.

Based on credentialing file review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the diagnosis and treatment furnished by 2 of 2 nurse practitioner/physician's assistants (#16 and #17) providing care to the CAH's patients in 2009.

Findings include:

Review of the policy titled "Quality Assurance & Improvement Plan," occurred on 03/10/10 at 8:30 a.m. This policy, dated 06/05/09, stated, "I. Purpose: Northwood Deaconess Health Center (NDHC) will have a facility wide, ongoing Quality Assurance & Improvement [QA & I] Program to maintain delivery of quality care; to review and evaluate patient and resident care, to identify problems relative to the provisions of quality services to patients and residents . . . II. Goals: The goal of the QA & I Program of NDHC is to achieve optimal service and quality of patient/resident care. The program shall apply to all departments, services and practitioners involved in the delivery of patient/resident care.
. . ."

The CAH did not provide a policy and procedure for the evaluation of the quality and appropriateness of the diagnosis and treatment provided by nurse practitioners and physician's assistants.

Reviewed on 03/09/10, Provider #16's credentialing file indicated a physician evaluated one emergency room trauma record in 2009 for care furnished by Provider #16. The CAH provided no other evidence a physician evaluated the quality and appropriateness of the diagnosis and treatment provided by Provider #16 in 2009.

Reviewed on 03/09/10, Provider #17's credentialing file did not include evidence a physician evaluated the care furnished by Provider #17 in 2009. The CAH provided no other evidence a physician evaluated the quality and appropriateness of the diagnosis and treatment provided by Provider #17 in 2009.

During interview at 12:15 p.m. on 03/10/10, an administrative Clinical Support Services staff member (#18) confirmed the CAH did not have a physician evaluate the quality and appropriateness of the diagnosis and treatment provided by the nurse practitioner and physician's assistant in 2009 and did not have an established policy and procedure to perform an evaluation of the nurse practitioner and physician's assistant.