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1214 COOLIDGE AVENUE

LAFAYETTE, LA 70503

NURSING SERVICES

Tag No.: A0385

Based on record review and interview the hospital failed to ensure drugs were administered in accordance with physician's orders in 1 of 3 outpatient departments reviewed for administration of conscious sedation (Gastroenterology Department). The routine practice for nursing staff in the Gastroenterology Department was to administer Versed and Demerol as Conscious Sedation without a physician's order (See findings cited at A0404)

An immediate jeopardy situation was identified on 12/01/2010 at 4:10 p.m. and reported to the hospital's Director of Nursing S1. The immediate jeopardy was a result of the hospital's failure to develop and implement policies for gastroenterology (GI) procedures which directed Registered Nurses in the use of physician's orders for administering moderate sedation (analgesia). This was evident by Registered Nurses in the GI Department determining the medication they would administer and the amount of medication they would administer to patients for the purpose of conscious sedation without a physician's order. Registered Nurses in the GI Department routinely administered IV Demerol and Versed without a physician's order (See findings cited at A0397 AND 0404).

A corrective action plan was submitted by the hospital on 12/02/2010 to address the immediate jeopardy situation which revealed the following:
Plan:
Beginning immediately (12/02/2010), all nurses in the GI lab must have an order from the physician to administer any medication.
No moderate sedation is to be administered until the ASA (American Society of Anesthesiologists physical status classification system) score is documented by the physician prior to the procedure.
All entries in the medical record made by the physician must be dated and timed by the physician at the time of documentation.
Revisions are to be made to the moderate sedation policy to include removal of the moderate sedation reference guidelines grid and special notes. This information is to be replaced by a statement indicating that the nurse cannot be responsible for the medication administration and monitoring of the sedated patient with an ASA score > (greater than) III.
Do:
The Moderate Sedation Policy was revised on 12/01/2010 as stated in plan. The policy was distributed to and reviewed with all GI Lab nurse prior to the first case on 12/02/2010.
All GI Lab nurse were educated prior to the first case on the morning of 12/02/2010 (confirmed with sign in sheets and handouts). The education included the expectation that the nurse does not administer any medication without a prior physician's order. In addition, the medication is not administered until the physician documents the ASA score and the nurse verifies that the patient does not have an ASA score >III. Finally, the nurse were educated on the expectation that the physician documents the date and time when signing entries in the medical record and the nurse is not to complete the date and time for the physician. The nurses were also provided with a copy of the conscious sedation guidelines from the Louisiana State Board of Nursing as well as a detailed description of the ASA guidelines.
The CEO (Chief Executive Officer) with physician leadership is meeting with all GI physicians in a face to face meeting within the next 24 hours to educate these physicians on all expectations related to patient care in the GI lab. The Chain of Command policy was communicated to the nurses. The nurses were told that any disruptive behavior from physicians that may occur as a result of this process change are to be reported to the Compliance Department for action.
LGMC (Lafayette General Medical Center) is in the process of contracting CRNA (Certified Registered Nurse Anesthetist) coverage for sedation in GI Lab as of 12/02/2010, to be completed within 14 days.
Check:
. . . 50 cases per month for the next 4 months will be monitored by direct observation by a member of leadership. The monitoring will include observation of a documented physician's order and ASA score prior to medication administration. Also included will be observation to confirm that nurses are not dating/timing entries signed by the physician.
Act:
The results of monitoring will be presented to the Shared Governance Core Council and appropriate Medical Staff committee on a monthly basis. The committees will analyze the results and implement any process changes if indicated. In addition, the Assistant Director of the GI Lab will hold noncompliant staff accountable.

As a result of the hospital's action plan, the Immediate Jeopardy situation was removed on 12/02/2010 at 10:30 a.m. due to the hospital's implementing processes to ensure no patient in the GI lab received conscious sedation without a physician's order and without an evaluation of their ASA level prior to Registered Nurses administration of physician ordered conscious sedation. The deficient practice remains at a Standard Level.

PATIENT CARE ASSIGNMENTS

Tag No.: A0397

Based on record review and interview the hospital failed to ensure patient assignments were made in accordance to the qualifications of available nursing staff for 3 of 7 patients (#8, , #11, #12, #13) reviewed for the administration of conscious sedation out of a total sample of 30. This finding was evidenced by assigning the administration of conscience sedation to Registered Nurses when there was no documented evidence of an ASA score (#8, #12), and assigning a Patient with a history of Congestive Heart Failure to a Registered Nurse for the administration of conscious sedation which violates the hospital's policy for Conscious Sedation (#13), and assigning conscious sedation to a Registered Nurse with no current certification in ACLS (#11, #12). Findings:

Review of the Louisiana State Board of Nursing's Declaratory Statement on the role and scope of practice of the Registered Nurse in the Administration of Medication and Monitoring of patients during the levels of procedural sedation revealed in part, "The Board defined the scope of authorized practice for registered nurses regarding intravenous conscious sedation in September 1990 the administration of intravenous conscious sedation is within the realm of practice of a registered nurse as delineated by the Board's specific criteria. . . The Registered Nurse (non-CRNA) shall have documented education and competency to include: Advanced Cardiac Life Support and/or Neonatal Resuscitation Program, Pediatric Life Support, Emergency Nursing Pediatric Course based on the patient's age. . . The institutional policy and plan for sedation practice shall include: Physicians responsibilities for the patient's history and physical, the patient assessment to include the American Society of Anesthesiologist classification to ensure appropriateness for sedation, assessment immediately prior to sedation, and selection and ordering of medications. A Registered nurse (non-CRNA) will not monitor an adult patient with an ASA classification higher than Class III and a pediatric patient higher than Class II for deep sedation."

Review of the hospital policy titled, "Sedation/Analgesia Guidelines, IV-A.51" presented by the hospital as their current policy revealed in part, "Special Note: Adult- When patient's physical statis is assessed and determined to pose a high risk such as, O2 Sat , 90 pre procedure, systolic blood pressure below 90, heart rate >130 or < 40 beats/minute, history of congestive heart failure; persistent angina; advance pulmonary, renal, or hepatic dysfunction. The nurse will notify the attending of the assessment findings and indicate that management of this type of patient is beyond the nurse's scope of practice. Anesthesia consultation should be considered."

Review of Patient #8's medical record revealed the patient received conscious sedation as administered by a Registered Nurse on the date of 11/05/2010 (Versed 2.5 milligrams given intravenously as sedation for a bone marrow aspiration). Further review of the entire medical record revealed no documented evidence of an ASA (American Society of Anesthesiologist Classification) score for Patient #8 (Registered Nurse Scope of Practice does not allow for a Registered Nurse to monitor a patient for Conscious Sedation with an ASA classification higher than a Class III). This finding was confirmed by Assistant Director of Outpatient Services S5 after she reviewing the medical record.

Review of Patient #12's medical record revealed the patient received conscious sedation as administered by a Registered Nurse on the date of 11/05/2010 (Versed 3 milligrams given intravenously as sedation for a bone marrow aspiration). Further review of the entire medical record revealed no documented evidence of an ASA (American Society of Anesthesiologist Classification) score for Patient #12 (Registered Nurse Scope of Practice does not allow for a Registered Nurse to monitor a patient for Conscious Sedation with an ASA classification higher than a Class III). This finding was confirmed by Assistant Director of Outpatient Services S5 after she reviewing the medical record.

During a face to face interview on 11/30/2010 at 10:40 a.m., Assistant Director of Outpatient Services S5 indicated there should have been an ASA classification score done by the patient's physician prior to a Registered Nurse accepting responsibility for the administration and monitoring of conscious sedation on Patients #8 and #12. S5 confirmed that it was not within the scope of practice for a Registered Nurse to administer and monitor conscious sedation to a patient with a score greater than III and the nurse should have reviewed the medical record for the score prior to accepting the assignment and administering Intravenous Sedation to these patients (#8, #12). S5 indicated the absence of an ASA score should have triggered nursing staff to seek clarification by the patient's physician.

Patient #13:
Review of Patient #13's medical record revealed the 83 year old female patient was admitted to the hospital on 10/20/2010 through the Emergency Department. Emergency Department's Physician's notes (no documented time) indicated the patient had a Past Medical History which included "Congestive Heart Failure, Critical Aortic Stenosis, and Sjogren's" and the Final Impression was documented as "Severe Nausea, R/O (rule out) Gastric Bezoar (balls of undigested materials), Chronic Diastolic CHF (Congestive Heart Failure)". Further medical record review revealed Patient #13 with a history of Chronic Diastolic Congestive Heart Failure received intravenous sedation as administered by Registered Nurse S19 on 10/21/2010 at 3:45 p.m. without an order from a physician (See findings cited at A0404). At 3:51 p.m. Registered Nurse S19 noted ventricular fibrillation on the cardiac monitor and a code was called. Patient #S13 was transferred to the Intensive Care Unit at 4:05 p.m.

During a face to face interview on 12/01/2010 at 9:30 a.m., Assistant Director of Outpatient Services S5 indicated the hospital policy regarding Conscious Sedation by Registered Nurses was probably too strict in regards to stating that the Registered Nurse should not give conscious sedation to a patient with a history of Congestive Heart Failure; however, as long as it was policy it should have been followed. S5 further indicated in the case of Patient #13, the Registered Nurse should not have administered Conscious Sedation without a physician's order. S5 further indicated based on the pre-procedure physical condition of Patient #13 along with her diagnosis of Congestive Heart Failure, hospital policy indicated the patient should not have been under the care of a Non-CRNA Registered Nurse for the administration of conscious sedation.

Medical Record review revealed Patients #11(Age 69) and #12 (Age 40) were administered conscious sedation by Registered Nurse S35. Patient #11 was administered Versed on 11/11/2010 by RN S35 and Patient #12 was administered Versed on 11/05/2010 by Registered Nurse S35.

Review of Registered Nurse (RN) S35's personnel file revealed her Certification in Advanced Cardiac Life Support (ACLS) expired in 9/2010.

During a face to face interview on 11/30/2010 at 2:00 p.m., Assistant Director of Out Patient Services S5 indicated all nursing staff involved in the administration of conscious sedation should be current in ACLS. S5 confirmed that RN S35 was not current. S5 indicated there had been difficulty in scheduling the course for S35. S5 confirmed that S35 had administered conscious sedation on 11/05/2010 and 11/11/2010 after her ACLS had expired 9/2010.

No Description Available

Tag No.: A0404

Based on record review and interview the hospital failed to ensure drugs were administered in accordance with physician's orders in 1 of 3 outpatient departments reviewed for administration of conscious sedation (Gastroenterology Department). The routine practice for nursing staff in the Gastroenterology Department was to administer Versed and Demerol as Conscious Sedation without a physician's order. Findings:

Patient #13:
Review of Patient #13's medical record revealed the 83 year old female patient was admitted to the hospital on 10/20/2010 through the Emergency Department. Emergency Department's Physician's notes (no documented time) indicating the patient was positive for "Orthopnea" and had a Past Medical History which included "Congestive Heart Failure, Critical Aortic Stenosis, and Sjogren's" and Final Impression "Severe Nausea, R/O (rule out) Gastric Bezoar (balls of undigested materials), Chronic Diastolic CHF (Congestive Heart Failure)". Review of Patient #13's Emergency Nursing Assessment dated 10/20/2010 at 4:42 p.m. revealed in part, "Respiratory effort: Labored. Breath Sounds Assessment Grid: Diminished, pt. (patient) oxygen saturation on RA (room air) = 86%. applied 2L (two liters/oxygen) NC (nasal canula), oxygen saturation increased to 97%. Abdominal accessory muscle use observed." Review of Patient #13's Registered Nurse Admission Assessment dated 10/21/2010 at 1:52 a.m. revealed in part, "Breath Sounds. . . Diminished. Oxygen Flow: 2 L/min (liters per minute). Airway: Mouth Breathing. Respiratory Pattern: Irregular, Tachypnea. Respiratory Effort: Labored. Cough: Non-productive."

Further Medical Record review revealed Patient #13 was transferred to the hospital's GI (Gastroenterology) Lab for the performance of Esophogeal Dilation/ Esophagogastroduodenoscopy on 10/21/2010 (consents signed at 2:00 p.m. for procedure and for conscious sedation). Review of Patient #13's "Universal Moderate Sedation History and Physical" form dated 10/21/2010 at 1400 (2:00 p.m.) and signed by Physician S13 revealed in part, "Cardiovascular: RRR (Regular Rate Rhythm), Respiratory: Labored". Review of Patient #13's medical record revealed the patient was rated an ASA (American Society of Anesthesiologists physical status classification system) score of III (3-Moderate to severe disease with some functional limitations) by Physician S13 (10/21/2010 at 1400).
Review of #13's Moderate Sedation/Analgesia Record revealed the patient's vital signs at 1533 (3:33 p.m.) to be Blood Pressure (B/P) 100/75, Pulse (P) 121, Respirations (R) 35, Oxygen Saturation (O2 Sat) 91 (on 3 liters of oxygen). Review of Patient #13's Addendum Narrative Nursing Notes dated 10/21/2010 revealed the following, "(Patient #13) was given 3 mg (milligrams) Versed IVP (intravenous push) followed by Demerol 30 mg (milligrams) IVP (intravenous push). Saline lock flushed with 6 ml (milliliters) saline. This was administered over a period of 4 - 5 minutes, beginning at 1545 (3:45 p.m.). Patient was extremely anxious prior to this, becoming more anxious over time. I noted her pules to increase as well - beginning with a already fast pulse of 121. At 1551 (3:51 p.m./6 minutes after the IVP was initiated) noted V-fib (ventricular fibrillation) on monitor. (Physician S13) notified at once. He immediately entered procedure room to assess the situation. Procedure aborted and Code 9 called. Crash cart brought in immediately and placed on monitor. Oxygen cranked up and (Physician S13) began mechanical ventilations. Monitor advised 'no shock'. Code team arrived and took over the code. . . 1605 (4:05 p.m.) Transported to ICU (Intensive Care Unit)."

During a face to face interview on 11/30/2010 at 12:40 p.m., Registered Nurse S19 indicated she was the nurse that provided care to Patient #13 in the GI Department on 10/21/2010. S19 indicated Patient #13 presented in the Department sitting straight up in bed stating repeatedly, "Don't lay me down. Don't lay me down. I can't breathe." S19 indicated she approached Physician S13 and questioned him as to whether he wanted to proceed with the procedure or not. S19 indicated Physician S19 instructed her to proceed slowly. S19 indicated she administered Versed 3 milligrams and Demerol 30 milligrams Intravenous Push at a slow rate. S19 indicated Physician S13 was in the area but not in the procedure room. S19 indicated Patient #13's heart rate went up and she had to be ventilated with an Ambu bag. S19 indicated the patient was later transferred to Intensive Care.

During a face to face interview on 12/01/2010 at 8:45 a.m. Physician S13 confirmed that he had evaluated Patient #13 prior to her scheduled Gastroscope on 10/21/2010. S13 further indicated he assigned the patient an ASA score of III (Moderate to severe disease with some functional limitations) ; however retrospectively he believed the patient should have been assigned a level IV (Severe system disease presenting a constant threat to life with functional incapacitation). S13 further indicated he did not know that the Louisiana Board of Nursing's standards of practice for conscious sedation would not allow for a Registered Nurse to administer Conscious Sedation on a patient with an ASA score higher than a Level III. Physician S13 indicated he would have expected the nurse administering Conscious Sedation to Patient #13 to titrate it slowly based on the patient's response. S13 indicated his expectation would be that Versed would have been given in i milligram increments with an evaluation of the patient's response before administering more medication. Physician S13 further indicated he had not ordered the medication (Demerol or Versed) or amount to be administered to Patient #13. Physician S13 indicated it had been the practice in the GI Department for nurses to handle the administration of conscious sedation and to inform the physicians after the procedure was completed as to what medications were administered and the amount that had been administered to the patient. Physician S13 indicated his practice was to sign an order behind the nurses at the completion of the procedure.

During a face to face interview on 12/01/2010 at 9:30 a.m., Registered Nurse S18 confirmed that she had no physician's order to administer Versed and/or Demerol Intravenous Push to Patient #13 on the date of 10/21/2010. S18 indicated she had been instructed during her orientation to the GI Department in March 2010 that nurses were to use their judgement as to medication administration for Conscious Sedation. S18 indicated she was taught to use the Grid listed in the hospital policy titled, "Sedation/Analgesia Guidelines IV-A.51" which contained a list of medications used for Adult Moderate Sedation/Analgesia to include Versed, Valium, Demerol, Fentanyl, and Morphine. S18 indicated the practice in the GI Department had been to use Versed and Demerol as the primary drugs of choice for conscious sedation unless the patient had been allergic to the medications in which case the physician would be contacted to determine which alternative medication to administer. S18 indicated there were no standing orders for conscious sedation in the department and it had been the practice of nursing staff to determine the drug and the amount for the purpose of conscious sedation based on their nursing judgement.

During a face to face interview on 12/01/2010 at 9:30 a.m., Assistant Director of Outpatient Services S5 indicated the Grid contained in the hospital policy titled, "Sedation/Analgesia Guidelines" was a reference only and was never written as a physician's order and never intended to be used as a physician's order for Conscious Sedation. S5 indicated there were no standing orders for Conscious Sedation in the GI Department. S5 indicated she had not been aware that nursing staff in the GI Department had been administering Conscious Sedation without a physician's order.

During a face to face interview on 12/01/2010 at 10:10 a.m., Registered Nurse S25 indicated she had been a nurse in the GI Department of the hospital for the past 20 years. S25 indicated physicians who routinely perform procedures in the GI Department were aware that nurses were administering sedation; however, there were no physician's orders for the sedation of patients prior to nursing staff administering conscious sedation- no standing orders, no verbal orders, and no written orders. S25 indicated the GI Department's practice had been to administer Versed and Demerol unless the patient was allergic to the medication. S25 indicated as long as the amount of the medication did not exceed the maximum dose listed on the grid in the policy titled, "Sedation/Analgesia Guidelines" nurses would administer the medication without an order from the patient's physician. S25 indicated at the end of the case, the Registered Nurse would inform the physician performing the case as to what medications had been given and the amount that had been given. S25 indicated it would be at that time that the physician would sign an order for the medications that the nurse had administered. S25 indicated that the only time a nurse would discuss the medication with the physician would be be if the patient was allergic to Versed or Demerol, if the maximum dose as per the policy's grid for sedation had been reached, or if there was some concern for the patient based on the nurse's judgement. S25 indicated Registered Nurses on the unit had been administering conscious sedation in the manner she outlined for many years and had never made it a practice to have a physician's written or verbal order when the nurse chose to use Versed and/or Demerol. S25 confirmed that the grid listed in the policy titled, "Sedation/Analgesia Guidelines" was not a standing order. S25 confirmed that nurses in the GI Department were giving Conscious Sedation based on their judgement without a physician's order. S25 confirmed that Registered Nurses are not licensed for prescriptive authority.

Review of the hospital policy titled, "Sedation/Analgesia Guidelines, IV-A.51" presented by the hospital as their current policy revealed in part, "Moderate Sedation may be performed in any area that has the equipment available and the available staff that has the documented education and competency. . . Moderate Sedation may be administered by the attending physician with credentialing through the Medical Staff or a registered nurse meeting competency skills under the direction of a Licensed Independent Practitioner. . . Physician Responsibilities: Physician is responsible for obtaining an appropriate procedure specific informed consent, documenting the patient's history and physical in accordance with the medical Staff Rules and Regulations, the patient assessment to include the American Society of Anesthesiologist and airway classification to ensure appropriateness for sedation, assessment immediately prior to sedation, and selection/ordering medications. Medication Selection: Selection of medications is in conjunction with the protocols set forth by the Anesthesia Department. . . Registered Nurse (non-CRNA) managing the care of the patient receiving sedation/analgesia: 1. May administer moderate sedation/analgesia medications under the direction and in the presence of the physician. The physician must be present in the department/unit and immediately available. . . Special Note: Adult- When patient's physical statis is assessed and determined to pose a high risk such as, O2 Sat , 90 pre procedure, systolic blood pressure below 90, heart rate >130 or < 40 beats/minute, history of congestive heart failure; persistent angina; advance pulmonary, renal, or hepatic dysfunction. The nurse will notify the attending of the assessment findings and indicate that management of this type of patient is beyond the nurse's scope of practice. Anesthesia consultation should be considered. . . Sedation Analgesia Guidelines: Adult Moderate Sedation/Analgesia Guidelines (Age >sixteen (16) years of age). Drug Classification Versed. . . Administration Technique: Titrate to pt (patient) response, never administer in bolus, slowly over 2 minutes into infusing IV line; when pt. response achieved, Stop, Wait 2 minutes to evaluate effects, Dosage 5 mg (milligrams) 17 - 60 years of age, 3.5 mg (milligrams) > 60 years of age, Maximum Dose: Generally 5 mg (milligrams), rarely >10 mg. for IV mod. (moderate) sedation. . . Demerol: Administration Technique: Over 30 second period into infusing IV line. May repeat every 1 - 5 minutes. Dosage 25 mg (milligrams), Maximum Dose Generally 100 mg. in 60 min (minutes). . . Valium. . . Fentanyl . . . Morphine."

Review of the Louisiana State Board of Nursing's Declaratory Statement on the role and scope of practice of the Registered Nurse in the Administration of Medication and Monitoring of patients during the levels of procedural sedation revealed in part, "The Board defined the scope of authorized practice for registered nurses regarding intravenous conscious sedation in September 1990 the administration of intravenous conscious sedation is within the realm of practice of a registered nurse as delineated by the Board's specific criteria. . . The institutional policy and plan for sedation practice shall include: Physicians responsibilities for the patient's history and physical . . . selection and ordering of medications."

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on record review and interview the hospital failed to ensure that medical record entries were authenticated for 10 of 30 sampled records reviewed (#3, #5, #7, #8, #10, #11, #12, #13, #17, #23) and timed for 1 of 30 patients. (#19). Findings:

Review of the medical record of Patient #3 revealed a "History and Physical" dictated on 8/31/2010 at 1:35 p.m. and a "Report of Operation" dictated on 9/01/2010 at 1:50 p.m.. Further review revealed no documented evidence of authentication by the dictating physician for either the History and Physical or the Report of Operation. The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record of Patient #5 revealed a "History and Physical" dictated on 8/06/2010 at 1:10 p.m. and a "Report of Operation: dictated on 8/09/2010 at 2:39 p.m.. Further review revealed no documented evidence of authentication by the dictating physician. The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record of Patient #7 revealed a "Report of Operation" dictated on 8/10/10 at 10:11. Further review revealed no documented evidence of authentication by the dictating physician. The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record of Patient #8 revealed a "Moderate Sedation/Analgesia Record" with no documented date (timed 11:12 a.m. through 12:45p.m.) with no documented signature authenticating who the Registered Nurse was that administered medication and monitored the patient for Conscious Sedation. The line for the "RN (Registered Nurse) Signature" was blank.

Review of the medical record of Patient #10 revealed a "Moderate Sedation/Analgesia Record" with no documented date (timed 12:30 p.m. until 1:30 p.m.) and no documented signature authenticating who the Registered Nurse was that administered medication and monitored the patient for Conscious Sedation. The line for the "RN (Registered Nurse) Signature" was blank.

Review of the medical record of Patient #11 revealed a "Moderate Sedation/Analgesia Record" with no documented date (timed 11:01 a.m. through 11:16 a.m.) and no documented signature authenticating who the Registered Nurse was that administered medication and monitored the patient for Conscious Sedation. The line for "RN (Registered Nurse) Signature" was blank.

Review of the medical record of Patient #12 revealed a Consent for Conscious Sedation dated 11/05/2010 at 8:50 a.m. Further review revealed no documented evidence of physician certification ("Physician Certification: I hereby certify that I have provided and explained the information set forth herein, including any attachment and answered all questions of the patient, or the patient's representative, concerning the medical treatment or surgical procedure, to the best of my knowledge and ability."). The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record of Patient #13 revealed a "Discharge Summary" dictated on 10/23/2010 at 3:24 a.m.. Further review revealed no documented evidence of authentication by the dictating physician. The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record of Patient #17 revealed a "History and Physical" dictated on 10/14/2010 at 10:09 a.m. and a Discharge Summary dictated on 11/13/2010 at 10:26 a.m.. Further review revealed no documented evidence of authentication by the dictating physician of either dictated note (History and Physical or Discharge Summary). The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record of Patient #23 revealed a "Report of Operation" dictated on 6/08/10 at 10:07 a.m., "Report of Operation " dictated 7/09/2010 at 2:43 p.m., "Discharge Summary" dictated on 6/10/2010 at 7:00 a.m., and a "Discharge Summary" dictated 7/11/2010 at 7:59 p.m.. Further review revealed no documented evidence of authentication by the dictating physician of these dictated notes. The line for the physician's signature was blank. Further review revealed no documentation of an electronic signature.

Review of the medical record for Patient #19 revealed a Operative note dated 05/14/10 was not timed. This was confirmed on 11/30/10 3pm by S5, Assistant Director of Outpatient Surgery Department. .

Review of the Medical Staff Bylaws revealed in part, "8. All clinical entries in the patient's medical record shall be accurately, dated, timed and signed."

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on record review and interview the hospital failed to ensure all physician's orders, including verbal orders were dated timed, and authenticated promptly by the ordering physician. for 3 of 30 sampled patients. (#16, #18, and #23)

Review of Patient #16's medical record revealed a physician's verbal Induction of Labor Orders dated 07/07/10 10:40am was not authenticated by the physician within 10 days of receiving the order. Review of the Post Partum Orders dated 07/22/10 12:27am were not authenticated by the physician.

Review of Patient #18's medical record revealed a physician's verbal order dated 09/30/10 for Vancomycin IVPB with no documented time that the order was written. The order was not authenticated by the physician within 10 day of receiving the order.

Review of Patient #23's medical record revealed a physician's order dated 7/12/2010 for Vancomycin 1,200 milligrams Intravenously every 12 hours with no documented time that the order was written.

Review of the Medical Staff Bylaws revealed in part, "20. All verbal and telephone orders shall be signed by the prescribing practitioner as soon as possible and in accordance with hospital policy, but not later than 10 days."

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on record review and interview the hospital failed to ensure a properly executed informed consent by having a patient sign a blank consent for a surgical procedure for 1 of 30 sampled patients (#18) Findings:

Patient #18: Review of the record for patient #18 revealed the patient had a procedure for the removal of a pace maker on 09/28/10. Further review revealed Patient #18 signed a consent for conscious sedation on on 09/26/10 witnessed by S32, RN and the physician. Further there was a consent for the procedure signed by the patient, S32 and the physician. The lines for the type of procedure, description of the procedure and the purpose of the procedure was left blank.

S5, Assistant Director of Outpatient Services was interviewed face to face on 11/30/10 at 2:25pm. S5 reviewed the record for Patient #18. S5 indicated the consent was for the placement of a pace maker, however pages 1 and 2 were left blank but Patient #18 had confirmed by signature his knowledge of understanding of all the information in the consent document. S5 confirmed the consent was witnessed by the RN. S5 indicated S29, Cardiologist does not always send a completed consent but the RN should have gone online and downloaded a preprinted pacemaker consent that indicated the procedure, description and risks. Further the RN would have witnessed the signature of the patient, who confirmed his understanding of the procedure. Further S5 indicated she was not sure why the RN had the patient sign a blank consent and witnessed it.