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Based on review of the medical record, the hospital failed to ensure that the medical staff provided quality of care to patient # 1, when they failed to recognize the early signs of the emergency condition of hypovolemia related to blood loss during surgery as evidenced by:

Patient #1 entered Civista Medical Center on October 11, 2010 for a scheduled C-Section. On 10/11/10 the patient delivered a baby but developed complications. The baby was delivered at 1:29 PM on 10/11/10, was out of the OR at 2:18 PM, and out of the PACU by 2:45 PM. Initially The patient's vital signs were within normal limits with systolic pressure ranging between 110-125 and diastolic pressure between 69-88.

The vital signs at 4:30 PM were B/P 121/80, HR 121, respirations 22 with oxygen saturation of 99%. At 5:30 PM the patient was transferred to 1 East, which was documented in the medical record including pain scale but no vital signs were noted. On 10/11/10 at 6:00 PM the patient pain level was reassessed with patient validating relief of pain. At 6:50 PM there is a note by nursing regarding the subnormal temperature of 93 degrees via ear and 92.9 degrees orally. The patient received warmed IV fluids and Bair Hugger blanket. The temperature was retaken by the RN and found to be 96.4 degrees rectally. The subnormal temperature was not reported to the physician until 1 hour and 20 minutes later.

The next documented note by nursing at 8:15 PM revealed that the physician was called and informed of the temperature and pulse, warmed IV fluids and the Bair Hugger. The physician ordered a stat hemoglobin and hematocrit. When the nurse called the physician back at 8:27 PM to review the vital signs since the C-section, the stat Hemoglobin and Hematocrit (H&H) was changed to a complete blood count (CBC). At 9:00 PM the nurse called the physician back to inform her that the patient's status had not changed. It's documented in the medical record by the nurse that the physician stated she believes the patient is septic and that she was coming to the hospital now. Orders to start Levaquin, Rocephin, and Flagyl and labs ordered.

By 9:26 PM on 10/11/10 the patient's blood pressure had dropped to 79/51 with a pulse of 142. By 9:31 PM, the blood pressure was 71/44 with a pulse of 144. At 9:33 PM the nurse called the physician with the two previous vital signs. The physician stated she was on her way to the hospital. The patient was described in the progress note as pale and diaphoretic.

The patient continued her downward spiral until the Rapid Assessment Team was called at 9:54 PM when the patient's blood pressure was 76/53, pulse 160, with patient complaining of chest pressure. Per the Rapid Assessment Team Activation form the patient's hemoglobin was 9.5 and hematocrit 28.7 at 7:30 PM on 10/11/10. The patient had an electrocardiogram (EKG) done at 10:05 PM and complained of feeling dizzy at 10:13 PM. At 10:22 the patient's hemoglobin was 7.1 and her hematocrit 21.4. At 10:25 the patient was refusing to sign the blood transfusion consent stating she is not a baptized Jehovah Witness but she practices their teaching.

At 10:32 PM chest x-ray was being performed. The patient vital signs at 10:37 PM temperature 96.0 degrees, pulse 165, B/P 105/68, respirations 22 with oxygen saturation of 100%. The patient was prepared for surgery. The medical record revealed the patient was taken to the OR at 11:09 PM and an exploratory laparotomy and hysterectomy were performed. The patient was transported to the post anesthesia care unit (PACU) on 10/12/10 at 12:20 AM, where she was suddenly found to be pulseless. CPR, and ACLS protocols were initiated at 12:28 AM. The patient was resuscitated and coded a second time. Once stable the patient was transported to intensive care unit (ICU).

In the ICU, the assigned ICU nurse refused to accept the patient because the patient was receiving blood products that were authorized by the family but had been previously refused by the patient when she was alert. The Director of Nursing was called into the hospital to deal with the ICU staff while the on-site nursing administrative staff attempted to get the ICU staff to care for patient #1. The patient was being ventilated by anesthesia and respiratory staff since transport to the PACU. While in the ICU attempts to place the patient on a ventilator were unsuccessful until chest tubes were placed bilaterally between 5:30 AM and 6:00 AM. The chest x-ray obtained at 1:48 AM revealed opacified right lung with partial collapse related to right mainstem intubation. The left lung revealed no infiltrates.

Per a 3:55 AM x-ray report on 10/12/10 the endotracheal tube was retracted, the diffuse opacified right lung may represent aspiration or bleeding. The left lung remained clear. The patient was cared for by the OR and PACU staff from 1:36 AM until 3:20 AM, when the assigned ICU accepted her assignment after other ICU nurses volunteered to give the blood products. The Intensivist who was called by the obstetrician per the telephone logs starting at 2:03 AM, continued to give orders over the telephone for patient #1. The telephone logs revealed the obstetrician called the Intensivist on 10/12/10 at 2:42 AM, 3:15 AM, and 3:53 AM. Per the documentation the Intensivist did not arrive on-site until approximately 6:00 AM to assume care for the patient.

Review of the care/treatment for patient #1 revealed multiple patient care and system/processes concerns which affected the care of the patient. At admission to the hospital, the patient did not sign her consent for treatment, which begins at registration. The history and physical was performed by the obstetrician but was incomplete in that it did not contain the physical exam portion of the history and physical. The patient underwent the removal of the leiomyomata (fibroid) and the C-section to deliver her baby. Her estimated blood loss per the anesthesiologist during the surgery was 1600 cc. The post-op Cesarean section orders stated to monitor vital signs over a 5 hour period starting with every 15 minutes x 4, then every 30 minutes x 4, then every hour x 2 then respirations and level of sedation every 2 hours x 2, temperature, pulse, and blood pressure (B/P) every 4 hours x 24 hours, then per routine. Also on the pre-printed order sheet were orders for CBC on Post-op Day 1 and Post-op Day three despite significant blood loss during the initial C-section surgery which should have prompted a CBC, PT/INR be performed in the PACU to determine her hematocrit and hemoglobin levels. The nursing staff obtained the vital signs but did not seem to recognize the importance of notifying the physician in a timely manner regarding the documented changes in the patient's low body temperature, progressive drop in the patient's blood pressure and progressive increase in her pulse. There were gaps of up to 3 hours between documented temperature post surgery of 94.2 degrees at 2:45 PM on 10/11/10. Forty-five minutes later the patient's temperature was 94.0 degrees. The temperatures were taken orally, tympanic, axillary and rectally. The patient temperature was 96.4 rectally at 6:00 PM. The 8:00 PM vital signs were temperature 94.9, axillary, pulse 140, respirations 16, B/P 97/69 with oxygen saturation of 98 % on room air. The focus initially was on the possibility of sepsis but when the patient began to have progressive decline in her B/P and the increased pulse, her hemoglobin and hematocrit revealed a decline of hemoglobin from 13.2 to 9.5 (range 12.0-15.5) and a hematocrit from 39.7 to 28.3 (range 35.0-46.0), an indication of a possible hemorrhage. When the patient complained of chest pressure and dizziness, although the rapid assessment team was called, significant time was loss in identifying the cause of the patient's symptoms and providing appropriate care. The hospital staff's failure to recognize the clinical signs of hypothermia along with hypotension and tachycardia as an emergency medical condition post a C-section, may have been a contributory factor to her coding. In addition the patient was being ventilated for approximately six hours before she could be placed on a ventilator. This led to a prolonged period of bagging the patient while trying to place her on the ventilator and eventual placement of chest tubes.

At discharge on 10/18/10 the patient was discharged with acute respiratory failure, on ventilation, pulmonary edema, acute lung injury, most likely secondary to massive blood transfusion, anemia thrombocytopenia, one episode of seizure, status post CPR, possible anoxic encephalopathy, status post C-section, and acute renal failure, on hemodialysis.

Based on review of the medical record, hospital on-call schedule and other pertinent documentation, the on-call Intensivist failed to report to the hospital after receiving several phone calls from staff regarding patient #1's critical state as evidenced by:

Patient #1 is a 31 year old female who presented to Civista Medical Center full-term pregnancy for a scheduled Caesarean Section (C-section) on 10/11/10. The patient developed complications after delivery of the infant and the removal of a leiomyomata. With progressive drop in blood pressure and tachycardia, the patient was prepared for an exploratory laparotomy with possible hysterectomy. The patient refused blood products prior to the second surgery. Upon admission to the PACU the patient arrested times two. The Obstretical surgeon obtained permission from the mother to give blood products, Which were started in the PACU. The patient was transferred to the ICU on 10/12/10 at 1:36 AM. Once in ICU the ICU receiving nurse refused to accept the patient while she was receiving blood. Per the medical record, the respiratory therapists were having difficulty ventilating the patient. Per the hospital telephone log the OB called the physician assistants at 1:48 AM and the Intensivist initially at 2:03 AM. The OB per the hospital telephone log again contacted the Intensivist on 10/12/10 at 2:42 AM, 3:15 AM, and 3:53 AM. The Intensivist per the medical record did not report to the hospital until 6:00 AM to assume care of the patient.

Although the hospital had an on-call schedule and staff contacted the on-call Intensivist, he did not report to the hospital until four hours later. When the Intensivist did not report to the hospital, the hospital did not have a second on-call or back-up to respond to the emergency. The patient's condition was critical due to blood loss, difficulty ventilating with inability to place and maintain the patient on a ventilator. The obstetrical physician was trying to manage the patient over the phone with the Intensivist as well as providing nursing to the patient.

Based on review of medical records , policy and procedures and personnel and credentialing records and interviews with staff, it was determined that the hospital failed to honor the rights of patient #1 who had a C- section and hysterectomy subsequent to complications as evidenced by:

? Failing to inform patient #1 of her rights as cited at A 0117;
? Failing to allow patient #1 to participate in her care planning as cited at A 0130; and
? Failing to honor patient #1 expressed wishes that she not have a blood transfusion due to religious beliefs as cited at A 0131

Based on review of policies and procedures, staff interviews and review of 20 medical records, in 1 of 20 medical records, the hospital failed to inform patient #1 and her representative of her rights as an inpatient as evidenced by:

Patient #1 was a 31 year old female who presented to Civista Medical Center, full-term pregnancy for a scheduled C-section on 10/11/10. Per the medical record, patient #1 did not receive her notice of rights on admission.

Review of the medical record revealed that there was an unsigned Consent To Treatment and authorization for release of medical information. The patient who presents to Labor and Delivery will sign the above forms in the L&D suite. Per the hospital's chief nursing officer (CNO), the registrar will usually begin this process with follow through by the nursing staff in Labor and Delivery (L&D). In the case of patient #1, there was no indication that this process was carried out as evidenced by the blank forms found in the patient's medical record.

Based on review of the policy and procedure and 20 medical records, in 1 of 20 medical records reviewed, the hospital failed to honor patient #1's right to participate in the development of her plan of care when the hospital failed to document revisions in the patient's plan of care as her condition changed, as evidenced by:

Patient #1 was a 31 year old female who presented to Civista Medical Center, full-term pregnancy for a scheduled C-section. Review of the medical record revealed that patient #1 was involved in her plan of care following her C-section. Although the plan of care did not take into consideration the potential risk of bleeding nor the discussion with the patient for the potential need of blood transfusions. As the patient's condition deteriorated, there was no evidence of revision of the plan of care with the patient nor the patient's representative (mother). No plan of care could be found during the provision of care in the Intensive Care Unit (ICU). There was intermittent documentation that the physician had spoken with the mother but no formalized plan.

Based on review of policies and procedures and 20 medical records, in 1 of 20 medical records reviewed, the hospital failed to ensure that the provision of care was in accordance with the fully informed consent of the patient as evidenced by:

Patient #1 is a 31 year old female who presented to Civista Medical Center on 10/11/10 and was admitted to Labor and Delivery with a full-term pregnancy. The patient had a leiomyomata or benign tumor (such as a fibroid) consisting of smooth muscle fibers in the lower segment of the uterus. The patient was admitted at 10:30 AM and stated her religion as Christian. After undergoing the C-Section, post-operatively the patient developed tachycardia and hypotension. Due to the patient's symptoms the OB surgeon recommended an exploratory laparotomy and possible hysterectomy. Prior to surgery the patient stated she is not a baptized Jehovah Witness but she practices their teachings and signed a consent for the procedure but refused blood products. The patient had an exploratory laparotomy followed by a hysterectomy. The patient had a large blood loss, which staff attempted to replace with volume expanders. Following the hysterectomy the patient went into cardiac arrest twice while in the PACU. The patient's mother was asked for permission to give blood, but instead an aunt of the patient signed for the blood transfusions. The blood transfusions were started in the PACU.

Patient #1 had informed the physician that although she was not a baptized Jehovah Witness, she practiced their teachings and refused blood products just prior to the second surgery. There is no documentation regarding the physician informing the patient of the risk and benefits of blood transfusions and the potential risk of death due to hemorrhaging without the transfusion of blood products. The exploratory laparotomy was performed, which revealed bleeding from the leiomyomata and 1700 cc of old blood in the abdomen and additional blood loss of 250 cc from the procedure.

Although the patient's condition required the infusion of blood products, the patient had given a directive to the hospital for no blood products when she wrote this request on the authorization for the surgical procedure. The hospital violated the patient's rights when they transfused her against her wishes by asking the mother to give permission to give blood products once the patient coded in the PACU. In addition, the mother did not sign the consent, rather the patient's aunt signed the consent.

Based on review of the medical record of patient #1 and the OB surgeon's personnel file, the hospital failed to act on data regarding the surgeon's performance during proctoring as evidenced by:

Review of the personnel file of the Obstetrician revealed that the physician was being proctored. The forms for evaluation of the physician and the attestation forms were to be completed for each obstetrical delivery. Some of the proctor attestation forms were not signed by the proctor and others weren't signed by the proctored practitioner. The majority of the practitioner's cases were C-sections. Comments on the proctoring report range from did not communicate well her desire to do labs as stat, did not want to give local anesthetic, due to thrombocytopenia but this is not contra-indicated, should have suctioned infant on perineum due to meconium. Many of the forms have scratches through information as if it had been changed. The proctor for patient #1's C-section cannot be found on the OR schedule. The physician's performance, other than the proctoring form, which is a checklist with an area for comments, did not capture concerns and specifics regarding assessment and documentation skills. There is a letter, which was sent to the proctored practitioner that she was in violation of her proctoring plan when she performed two deliveries, without a proctor.
Her privileges were suspended and resumed when she signed a new policy and proctoring plan.

Based on review of the medical record, staff interviews and other pertinent documentation, the hospital's supervisory staff failed to respond in a timely manner to the ICU nurses refusal to care for patient #1 as evidenced by:

Patient #1 entered Civista Medical Center on October 11, 2010 for a scheduled C-Section. On 10/11/10, the patient delivered a baby but developed complications requiring a second surgery, a hysterectomy. The patient was typed and crossed for blood. Although the patient was not a baptized Jehovah's Witness, she practiced their teachings and therefore, refused blood products when signing the authorization for the exploratory laparotomy. Volume expanders were given without success, so the patient's mother gave permission for the administration of blood but the consent was signed by the aunt. The patient was taken to the PACU after the second surgery, where she coded twice. Once stable the patient was transported to the ICU. Upon the patient's arrival in ICU, the nursing staff in the Intensive Care Unit refused to help the transporting staff. The assigned ICU nurse and other nurses refused to care for the patient since she was receiving blood transfusions authorized by the patient's family. The nurses were concerned about being sued. The transporting staff continued to care for the patient while the ICU nurses continued to refuse to care for the patient. The Director of Nursing was called and reported to the hospital. After much discussion, approximately two hours, the assigned ICU nurse accepted report and care of the patient.

The supervisory staff spent a great deal of time talking to the ICU staff about why they would not care for the patient. Additional staff were not called in to relieve the OR/PACU staff and to replace the ICU staff. The supervisory staff did not act in a timely manner to provide immediate care to patient #1 and to address the nurses refusal to provide care.

The ICU nurse assigned to patient #1 was later terminated, although no documentation of disciplinary action for other four nurses who refused to care for the patient. The hospital did refer all the nurses involved to the Maryland Board of Nursing for their actions. Not one of the other four nurses offered to change assignment or to take care of the patient. The hospital supervisor and administrative staff did not have any contingency or back-up plans in place to deal with emergency situations as well as personnel issues.

During the investigation, it was revealed that during report between the evening shift nurse supervisor and the night shift nursing supervisor, the PACU called on 10/12/10 at 12:30 AM to request an IV pump as patient #1 was being coded again. Both nursing supervisors responded to the PACU with the code blue in progress. It was during this time that the evening shift nursing supervisor noted she was not aware of the first code blue in the PACU. When the hospital calls a silent code in the OR and PACU and the anesthesiologist, respiratory therapy and nursing staff are already available to run the code, there is no notice. If additional staff is needed, the code may be formally called overhead.

The nursing supervisor in the leadership role is responsible for coordinating the care and services throughout the hospital on her designated shift. She/he are also a resource person for the facility, for example, if he or she are made aware of situations and incidents within the hospital, she is responsible for obtaining additional staff, supplies and equipment to the unit where needed. The fact that the nursing supervisor was not aware of the first code blue call on patient #1 indicates a breakdown of the effectiveness of nursing leadership since basic communication was lacking regarding provision of care.

Based on review of the medical record, assignment sheet, staff interviews and other pertinent information, the hospital failed to provide nursing care for patient #1, when the ICU nursing staff refused to assume care of the critically ill patient upon transfer from the PACU to ICU as evidenced by:

Patient #1 entered Civista Medical Center on October 11, 2010 for a scheduled C-Section. On 10/11/10 the patient delivered a baby but developed complications requiring a second surgery, a hysterectomy. The patient was typed and crossed for blood. Although the patient was not a baptized Jehovah's Witness, she practiced their teachings and therefore refused blood products when signing the authorization for the exploratory laparotomy. Volume expanders were given without success, so the patient's mother gave permission for the administration of blood. The patient was taken to the PACU after the second surgery, where she coded twice. Once stable the patient was transported to the ICU.

Upon the patient's arrival in ICU, the nursing staff in the Intensive Care Unit refused to help the transporting staff. The assigned ICU nurse and other nurses refused to care for the patient since she was receiving blood transfusions authorized by the patient's family. The nurses were concerned about being sued. The transporting staff continued to care for the patient while the ICU nurses continued to refuse to care for the patient. The Director of Nursing was called and she reported to the hospital. After much discussion, approximately two hours, the assigned ICU nurse accepted report and care of the patient. The transporting team had difficulty ventilating the patient via ambu bag and were unsuccessful in placing the patient on a ventilator. Once chest tubes were placed at 6:30 AM, the patient was placed on a ventilator.

The patient had extensive blood loss, coded twice while in the PACU and had extensive period of time being ventilated, which possibly contributed to her anoxic encephalopathy.

Based on review of the medical record, policies and procedures, and staff interviews, the hospital failed to ensure the medical records were complete, accurate, and legible as required by the Federal regulation and as evidenced by:

1. In 1 of 20 medical record reviews (patient #1) information (EKG) could not be found in the medical record.

Patient #1 is a 31 year old female who presented to Civista Medical Center on 10/11/10 and was admitted to Labor and Delivery with a full-term pregnancy.

Review of the medical record revealed that a EKG was performed by the Rapid Assessment Team (RAT) on 10/11/10 at 9:54 pm. The patient complained of chest pressure three minutes later and had a 12 lead EKG performed by the ICU nurse. Per the RAT note on 10/11/10 at 11:00pm two physicians reviewed the EKG before the patient was taken into surgery. The hospital has been unable to locate the EKG performed on 10/11/10 at 10:05 pm.

2. In 2 of 20 medical record reviews (patient #1 and patient #7) parts of the medical record are incomplete or inaccurate.

Patient #1 is a 31 year old female who presented to Civista Medical Center on 10/11/10 and was admitted to Labor and Delivery with a full-term pregnancy. Her history and physical does not reveal a review of systems and physical exam. There is no mention of the fibroid in the lower segment of the patient's uterus and that the general risk and benefits of the surgery were reviewed with the patient. No documentation was found in the H&P regarding discussion of the significant risk of hemorrhage, possible death along with need for blood transfusion.

Patient #7 is a 60 year old female who was sent from her PCP office for evaluation of left foot puncture wound. The patient was admitted with diagnosis of cellulitis. The patient's admission ordered of 6/6/11 at 8:00 PM has an order #14 for DNR (Do Not Resuscitate). The patient's attending progress note for 6/7/11 under code status has the patient as a full code. The patient has conflicting documentation in the medical record regarding her code status, which could have placed her at risk. No corresponding documentation could be found in the medical record regarding the DNR, which appeared to be an error.

3. In 5 of 20 medical records reviewed (patient's #6, #10, #12, #14, and #17) parts of the medical record were incomplete. The documentation lacked dates, times, signatures, and allergies.

Patient #6 is a 27 year old, admitted on 5/13/11 at 41 week gestation. Patient authorization for C-section lacks the nurse (RN) signature that the time out verification procedure was completed and documented before procedure. The space provided for the nurses signature and date are blank. The patient medication administration record for single pre-op orders is addressographed with her name but no diagnosis or allergies are listed at the top of the sheet, both areas are blank. In addition there is no date time and initials for documentation of when the Ancef 2 grams IV was given. The patient's personal belongings list was completed without the signature, date, and time of the person completing the form nor did the patient sign, date or time the form. This patient had a VTE prophylaxis order which was stamped with her name and identifying information. The form, under nursing, designated use of graduated elastic compression stockings and intermittent pneumatic compression. The form lacked a date, time, height, weight, allergies, risk category score, the date, time, and signature of the nursing taking off the order and the time the order was faxed to pharmacy.

Patient #10 is a 31 year old, admitted to Labor and Delivery (L&D) on 6/28/11. The order for Continuous Epidural Analgesia for Laboring Women Orders lacks a date, time, and nurse signature as well as the time the order was faxed to pharmacy. The single dose pre-op medication administration record lack diagnosis and allergies.

Patient #12 is a 24 year old, admitted to L&D on 6/22/11. The Cesarean Section Orders lacked time, allergies, the date, time, and signature of the nurse taking off the order and time faxed to the pharmacy. The medication administration record (MAR) revealed the nurse initialed the record for the administration of Mylicon at 1200 but failed to document her initials and signature at the bottom of the form.

Patient #14 is a 32 year old, admitted to L&D 5/24/11. The patient's discharge medications list lacks the signature of the nurse giving the information to the patient. The pre-op single dose MAR lacks the patient's diagnosis or allergies.

Patient #17 is a 27 year old admitted to L&D on 6/14/11. The Induction/Augmentation Elective Cesarean Section Checklist is lacking a time and the date, time and signature of the nurse who transcribed the order.

The use of checklist and pre-fabricated form are tools that still must be completed or documented as to why the task was not performed. Since the hospital's medical record is a hybrid (half paper and half computer entry), it's important for staff to complete the paper forms with dates, times, allergies and requested information, not only to produce a time sequence of events but to document provision of care and compliance with medical record policies, procedures and regulations.

Based on review of the medical record the hospital failed to ensure that all orders were authenticated promptly as required by the Federal requirement as evidenced by:

In 5 out of 20 records reviewed (patient #2, #3, #4, #5, and #6) medication and treatment orders were not signed off by the physician in the paper or electronic medical record.

Patient #2 had two verbal orders in the paper medical record which were not signed by the ordering practitioner. Per the pharmacist the verbal/telephone orders are scanned into the system and the pharmacist enter the information into the computer as a verbal order/telephone order. When the ordering practitioner logs onto the system they will receive a message to sign the order. In the case of patient #2 both orders were scanned and entered by the pharmacy but as written order, therefore the ordering practitioner did not receive the message to sign the orders.

Patient #3 had a telephone order for transfer written on 6/5/11. The order was not signed in the paper medical record nor the electronic medical record at time of survey 8/4/11.

Patient #4 had a telephone order to discharge home written on 6/30/11. The order was not signed in the paper or electronic medical record at the time of survey 8/4/11.

Patient #5 had telephone order for laboratory work ordered on 6/4/11. The order was not signed in the paper or electronic medical record at the time of survey 8/4/11.

Patient #6 had telephone orders for pain medication written on 5/13/11 and 5/14/11. The orders were not signed in paper or the electronic medical record at the time of the survey 8/4/11.

Based on review of the medical record and policies and procedures, the hospital failed to document the patient's informed consent for those procedures and treatments that have been specified as requiring informed consent as evidenced by:

Patient #1 is a 31 year old female who presented to Civista Medical Center on 10/11/10 and was admitted to Labor and Delivery with a full-term pregnancy. No consent for treatment or authorization for release of information could be found in the patient's medical record. The consent for treatment also applies to the infant, if the patient is pregnant.

Patient #5 is a 61 year old female who suffered a debilitating stroke in January 2011. She presented to the hospital for evaluation and treatment of decubitus ulcers on 6/4/11. The authorization for a PICC (Peripherally Inserted Central Catheter) line placement lacked the name of the physician who would perform the procedure as evident by a blank space. In addition the space for the name of the physician who would discuss the specifics of the procedure, alternatives, risk and benefits was also blank.

Patient #10 is a 31 year old, admitted to Labor and Delivery (L&D) on 6/28/11. The Anesthesia Consent was labeled with the patient's name, no date or time at the top of the consent form nor did the anesthesiologist document on the form the type of anesthesia to be administered to the patient.

Patient #12 is a 24 year old, admitted to L&D on 6/22/11. The Patient Designated Contact/Authorization to Release Information does not note the access code to be used by the husband to receive protected health information nor was the form signed by a witness as evident by a blank space for signature.

Patient #17 is a 27 year old admitted to L&D on 6/14/11. The Anesthesia Consent was labeled with the patient's name, no time, no designation of type of anesthesia to be administered and date, time or signature in the space for anesthesia staff securing consent.

The medical record review revealed that the medical records lacked the minimum elements of a properly executed informed consent as required by Federal/State law and hospital policies and procedures.