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Based on interview and record review, the hospital failed to ensure the chief executive officer (CEO) reviewed and managed the hospital's electronic medical record (EMR) system's ability to track medical record delinquency rates. The hospital failed to oversee the EMR system to ensure the provision of privacy and confidentiality for inpatient and outpatient security. The hospital failed to ensure verbal and telephone orders were signed in a timely manner. These failures resulted in the hospital's inability to maintain an effective medical record deficiency tracking system for delinquent medical records, and allowed unauthorized individuals' access to patient confidential information.

Findings:

During an interview with the Manager of Quality Management (MQM), on 8/11/11, at 10:30 AM, she stated the Board of Supervisors (the hospital's governing body) was involved in the selection process of the electronic medical record system. She stated the Governing Body minutes would address the EMR decision.

During a concurrent interview and document review on 8/11/11, at 1:17 PM, the Health Information Services Manager (HISM) and the Health Information Services Supervisor (HISS), discussed concerns identified with the OpenVista (the hospital's electronic medical record system) incomplete medical record tracking system. They stated the inability to track delinquent medical records was identified prior to the EMR "go live" date of 5/10/11. An email document regarding IRT Deficiency (tracked deficiencies) from the HISS, to the HISM and two clinical analysts, dated 11/16/10, indicated she was experiencing difficulty with the IRT deficiency set up testing. An email document from the HISS to the HISM, and the facility project manager and representative from the EMR company, dated 4/6/11, indicated "The transcribed reports that are not signed or co-signed are not showing on the unsigned/un-cosigned report consistently... There is no way that we would be able to track deficiencies and delinquencies with what we have now. If they do not provide a functional report for us to manage delinquent medical records we will...be out of compliance..." An email from the HISS, copied to the HISM, sent to the Manager of Quality Management (MQM), Chief of Staff and Chief Nursing Officer (CNO), regarding a Joint Commission Mock Survey, dated 4/8/11, indicated "(The EMR system) currently have any way to track delinquent medical records... They have several reports that do not allow for an accurate count of incomplete/delinquent medical records."

1. During an interview with the HISS, on 8/11/11, at 12:15 PM, she stated since the hospital's electronic medical record system "go live" date (5/10/11, the date the system became active) the medical record department had been unable to track medical record delinquencies for physicians. She stated they were three months behind and had not followed their procedure for suspending physician privileges due to delinquent records.

During a concurrent interview and record review with the HISM and the HISS, on 8/11/11, at 1:25 PM, they stated the estimated medical record deficiency count for delinquent medical records was 1200 records per month. A facility reported generated from the hospitals EMR system, titled "List of Unsigned orders by Provider", dated 8/11/11, indicated 4,394 patient medical record entries were not signed by the physician between 5/10/11 to 8/11/11. Prior to the "Go Live" date of 5/10/11, the medical record monthly delinquent deficiency report averaged from 98 to 353 delinquent records.

The hospital's Medical Staff Rules and Regulations, effective 1/6/09, Section B. Medical Records 9. Completion c. read, "The patient's medical record shall be complete at time of discharge, including progress notes, final diagnosis, and clinical summary. Records are considered complete when the responsible practitioners and health care professionals have dictated or written and authenticated all necessary reports and have authenticated all record entries....Records may remain in the incomplete category for no longer than fourteen (14) days following date of discharge. Records, if not completed during the 14-day period, become delinquent records."

2. During an interview with the HISM, on 8/9/11, at 9:45 AM, when asked if patient electronic records are kept secure and viewed only when necessary by individuals having a part in the patient's care, she stated the EMR system is "...an open system...everyone has the same level (of security) and can look (view) any record. If you have access to patient records you have access to all records." The HISM was unable to verify that clinical records were only viewed when necessary by persons authorized access to a particular patient's record. She was unable to state what precautions were taken to prevent unauthorized persons from gaining electronic access to information in patient records.

During an interview with the Clinical Director of Compliance/Privacy Officer (CD/PO), on 8/9/11, at 2 PM, she stated "...if access to patient records, access to all." She stated there are not any restrictions on access to the electronic medical record "because the system does not allow it." The CD/PO stated employees are expected to maintain confidentiality and all employees sign a confidentiality statement upon hire. The CD/PO stated the Human Resources Department was responsible for auditing the completion of all employee's confidentiality statement. She stated there was not a routine audit report generated or reviewed to ensure the confidentiality and security of a patient's EMR. As the Privacy Officer, she only audited for "cause", as in a patient complaint, privacy investigation or a real time complaint due to suspicious behavior.

During an interview with the Director of Information Systems (IT), on 8/9/11, at 3:20 PM, he stated the EMR system did not allow restrictions to limit or restrict access per discipline or assigned unit because that (restricted access) would impair continuity of patient care. The IT stated the EMR system "...had templates for different categories of users and there are levels of 'auditability' (who has been where in the EMR) that could be turned off or on based upon 'reasonableness'."

The hospital form titled "Confidentiality Statement", undated, indicated the signer would protect records against inappropriate access and use. The form included a "User Code Agreement" that indicated "6. I understand that only those individuals who have signed a user access code agreement will be given access to the local network and the hospital information system." The employee's signature indicated the employee had read and understood the hospital's privacy and confidentiality policy and would fulfill the expectations in the treatment of confidential information.

During a telephone interview with the MQM, on 8/12/11, at 2:10 PM, she stated the audio tape of the Board of Supervisor's Meeting(the hospital's Governing Body) that she reviewed, indicated the EMR privacy was addressed "at a very high level", which she then defined as discussed "on the surface." The Board of Supervisors (BOS) inquired if the EMR system protected patient's privacy and if it had restrictions. No detailed information was provided to the BOS. The BOS reviewed the contract and propriety. The MQM stated the CEO and CNO "did due diligence" prior to implementation of the EMR. She stated problems were identified during the "Go Live" on 5/10/11. The MQM stated the hospital's leadership (Administration and management staff), and physicians were involved in the selection process for the EMR. She stated the audio tape recording indicated the BOS asked questions with a "lot of discussion and legal involvement", but no detailed information relating to the protection of patient confidentiality was provided to the BOS. The MQM stated the EMR system was discussed at the Medical Executive Committee and BOS meeting, and the minutes did not provide any detailed information.

3. During a concurrent interview and record review with the HISM and the HISS, on 8/11/11, at 1:25 PM, they reviewed a hospital report generated from the EMR system titled, "List of Unsigned orders by Provider," dated 8/11/11. The report indicated 4,394 patient medical record entries were not signed by the physician between 5/10/11 to 8/11/11. They stated the (EMR) system did not track the unsigned orders in a manner that would enable the hospital to identify deficiencies per provider according to standards. Therefore, the medical record department could not accurately track unsigned orders as part of a providers deficiency identification. A "notice" was electronically sent to the provider (and co-signer, if indicated), of orders requiring an electronic signature.

Based on interview and record review, the hospital failed to obtain one of 23 sampled patients (6) signature's, date, and time on the surgical consent, which had the potential to result in violation of Patient 6's rights not being fully informed of her medical care.

Findings:

The electronic medical record (EMR) for Patient 6 was reviewed on 8/10/11. Patient 6 had a consent dated 7/14/11, for Endometrial (inner lining of the uterus) Biopsy. However, the consent had no signature, date or time from Patient 6. There was no signature by an authorized employee to verify that the physician had explained risk and benefits and that the patient had consented.

During an interview with Quality Management Nurse (QM) 2, on 8/10/11, at 11:45 AM, she was asked about the consent not being signed by the patient. The EMR was reviewed by QM 2, and she stated, "Maybe the procedure was cancelled." She was unable to find documentation of the procedure being cancelled.

The EMR was again reviewed on 8/10/11. The "OB/GYN Progress note" dated "7/15/11 at 05:31" indicated under Assessment/Plan "S/p EMB (Endometrial biopsy) yesterday, will follow results when available." The "Pathology (study of diseases) Report" dated 7/18/11 indicated that an endometrial biopsy sample had been received.

The Medical Staff "Rules and Regulations" approved 1/6/09, indicated in Section E. "General Rules Regarding Surgical Care" #4 "Except in severe emergencies no surgery shall be initiated in the operating room without the verification by those in control of the patient...that a properly executed informed consent is in the patient's chart."

The hospital policy and procedure titled "Consent, How to obtain" dated July 2011, indicated "...treatment is rendered only after the patient, or the patient's Consent Giver has consented to treatment." In the section "Addendum A: Procedures requiring Informed Consent for Each Time Performed..." Biopsy (cervix, endometrium, etc.) was listed.

Based on observation, interview, clinical record review, and review of the hospital's policy and procedure, it is determined the hospital failed to maintain an effective Quality Assessment and Performance Improvement (QAPI) program to use the information collected to identify its policy and procedure for skin care prohibited registered nurses to initiate "Standardized Procedure" for wound management (A-276). The hospital failed to furnish necessary nursing services when Skin Care Champion (SCC) did not provide requested consultation timely (A-385 Findings 1 and 2). The hospital QAPI program failed to assess patients' skin condition in accordance with the hospital policies and procedures (A 395). The hospital failed to initiate or revise treatment plans for patients with skin issues to meet their specific condition and needs (A-396). The hospital failed to monitor current performance improvement actions and failed to sustain improvement of hospital acquired pressure ulcers (A 291). The hospital failed to ensure the chief executive officer (CEO) reviewed and managed the hospital's electronic medical record (EMR) system's ability to track medical record delinquency rates (A 057). The hospital failed to implement necessary measures to ensure the accuracy and integrity of all patient medical records (A-0431). The hospital failed to acquire appropriate computer program to track unauthentic entries and delinquent medical records (A 432). The hospital failed to ensure the electronic medical record was promptly completed for 4,394 inpatient entries that were not signed by the provider, failed to select a computer system to track the accurate number of delinquent medical records for the past three months, and failed to ensure the new electronic medical record system had the ability to secure all patients' information (A 438). The hospital failed to ensure the new electronic medical record system had the ability to prevent unauthorized access to patient information (A 441). The hospital failed to ensure unauthorized individuals were not given access to patient records (A 442). The hospital failed to ensure medical record entries were completed within 14 days (A 450). The hospital failed to ensure all orders, including verbal/telephone orders were authenticated promptly (A 454). The hospital failed to ensure verbal/telephone orders were authenticated within 48 hours (A 457). The hospital failed to obtain an informed consent prior to a surgical procedure (A 466).

The cumulative effects of these systemic practices resulted in the failure of the hospital to safeguard its patients quality of care and to maintain a complete and accurate medical record in accordance with regulations and hospital policies.

Based on interview and record review, the hospital quality assessment and performance improvement (QAPI) program failed to recognize the delayed initiation of treatment for pressure ulcers as a contributing factor to the development and worsening of pressure ulcers and failed to analyze the information collected on in-house pressure ulcers to identify the deficits in the hospital policy and procedure, effective 1/2010, titled, "Standardized Procedure for Pressure Ulcers, Skin Tears and Incontinence Associated Dermatitis Treatment." Such failure caused the hospital's "Standardized Procedure" for wound management to not be initiated timely by registered nurses who provided direct supervision for three of 23 sampled patients' (1, 16, and 20) care and allowed their wounds to deteriorate.

Findings:

1. On 8/9/11, at 3 PM, during a concurrent interview and record review with a registered nurse (RN) 3, Patient 1's clinical record was reviewed. On 7/21/11, Patient 1 was referred by a registered nurse to Skin Care Champion (SCC) to evaluate his small skin tear between gluteal (buttocks) fold. On 7/23/11, another consultation request was sent to the SCC for "perineum (between buttocks) redness, moist weeping appears to be iad (Incontinence Associated Dermatitis, an inflammation of skin related to incontinence)." On 7/28/11, a third consultation was requested again for "redness to left buttock, and small open area in between gluteal fold." The last request for wound consultation was sent on 8/1/11, for "perineum redness, moist weeping appears to be iad." Patient 1 was finally evaluated on 8/2/11 by the SCC, 12 days after the first referral. His wound between gluteal fold had worsened from a skin tear on 7/21/11 to a draining, yellow wound on 8/2/11. Patient 1's Medication Administration Record from 7/21/11 to 8/1/11 revealed only one treatment was administered on 7/21/11. Patient 1's wound was left untreated for 11 days.

On 8/9/11, at 1:30 PM, during an interview, the SCC stated, "Only PT (Physical Therapists) and SCC can stage ulcers. Licensed (nurse) notifies PT and SCC for wound vac (using a sealed wound dressing connected to a pump to promote wound healing), surgical wounds, not healing wounds...PT and SCC would assess referrals in 24 hours. They (PT and SCC) refer to the 'Standardized Procedure' based on the stage (of the pressure ulcer). These protocols are not part of physicians' orders; they are part of standardized procedures." The SCC further explained, "Only the SCC or PT can stage a wound-to maintain consistency and standardization of assessment/staging."



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2. The clinical record for Patient 16 was reviewed with Quality Management Nurse (QM) 2 on 8/11/11, at 9:25 AM. Patient 16's Skin Care Wound Consultation request, dated 7/21/2011, read "...skin tear to back of neck," and the status of the request was "pending." QM 2 reviewed the Consultation Sheet and recognized the consultation request read, "No Consultation Results available." QM 2 then stated, "I don't think it was done. Don't see it."

During an interview with the Clinical Supervisor (CS), on 8/11/11, at 9:30 AM, she reviewed the clinical record and stated, "The 'P' in front of the request means it's pending. It's not done, but you can call the Skin Care Champion to ask her what happened."

During an interview with SCC on 8/11/11, at 9:38 AM, she was asked about the request for wound consultation on 7/21/11. The SCC asked, "What day was the 21 st? Well, I don't know why it wasn't done, but I will look into it. If it says 'P' then it's not done." The SCC was asked what is the policy on request for wound consultation, and she stated, "It should be completed within 24 hours by myself or Physical Therapy...It's not done."



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3. During a concurrent interview and record review with the CS, on 8/10/11, at 3:20 PM, the record indicated Patient 20 was admitted on 7/29/11 with a diagnosis of post abdominal surgery. The nursing assessment dated 8/9/11, indicated the presence of a wound "Location: right ankle, Type: Pressure Ulcer, Dressing: clean, dry, intact." On 8/10/11, the nursing assessment did not identify the right ankle wound. No measurements of the pressure ulcer or referral to the SCC was found in the record, as confirmed by the CS.

A nursing plan of care for impaired skin integrity, dated 8/10/11, was reviewed. One intervention indicated "All wounds to be measured upon admission, discovery and on designated 'Wound Wednesdays'." The plan of care did not specify treatment for the right ankle pressure ulcer. Staging of the pressure ulcer was not found. Measurements of the right ankle wound and referral to the SCC was not found in Patient 20's medical record, as confirmed by the CS.

Further review of the hospital's policy and procedure with an effective date of 1/2010, on "Standardized Procedure for Pressure Ulcers, Skin Tears and Incontinence Associated Dermatitis Treatment," under VI "REQUIREMENTS," it read, "This Standardized Procedure will not be initiated until a Skin Care Champion Registered Nurse or Physical Therapist assesses the patient."

On 8/11/11, at 1 PM, during an interview, the Manager of Quality Management stated a study was conducted on pressure ulcers in June 2011. The outcome of the study indicated lack of wound documentation and knowledge deficit were the causes of this pressure ulcer adverse event. The hospital management was not aware of the policy and procedure, dated 12/2010, on "Wound and Skin Care Interdisciplinary Management" had restricted licensed staff to initiate treatment in accordance with the "Standardized Procedure" on discovery of wounds.

Based on interview and document review, the hospital failed to monitor current performance improvement actions and failed to sustain improvement of hospital acquired pressure ulcers (HAPU). This failure resulted in the hospitals inability to prevent hospital acquired pressure ulcers, which had the potential to place patients at risk of developing HAPU.

Findings:

During an interview with the hospital Manager of Quality Management (MQM), on 8/11/11, at 10:08 AM, she stated the hospital selected HAPUs as a high risk, problem prone project. The routine data by nursing unit was reviewed for "areas out of the norm". Quality Management staff was assigned to (nursing) units to work on improvement strategies. The MQM explained the hospital committee process by which quality improvement data was presented, analyzed and reviewed. She stated HAPU had been on the list for quality improvement projects "for years...it was never dropped as a focus of Quality Improvement."

On 8/11/11, at 12:30 PM, a document review of the hospital's Quality Management Committee minutes, Quality Council minutes, Joint Conference minutes and Medical Executive Committee minutes for 2010 to July 2011, was conducted. Neither HAPU data, nor Quality Improvement presentations for 2011 were found in any of the committee minutes provided and reviewed. The 2010 data presented indicated unsustained improvements in HAPU. Committee minutes reflected a general overview of HAPU's via a bar graph and did not contain ongoing data analysis.

During an interview with the MQM, on 8/11/11, at 1 PM, when asked about current, 2011 HAPU data, she stated she was currently preparing 2011 information for the August monthly committee review (Quality Management Committee, Quality Council Committee, and Joint Conference Committee). She acknowledged the inconsistency of nursing wound documentation in patients medical records and indicated there was a knowledge deficit.

Based on interview, clinical record review, and review of policies and procedures, it was determined that the hospital failed to furnish necessary nursing services when Skin Care Champion (SCC) did not carry out requested wound consultation timely. The hospital failed to ensure registered nurses assess and evaluate the wound care needs for its patients on admission and on weekly basis (A-395). The hospital registered nursing staff failed to develop and revise nursing care plan on admission and as patients' condition changed (A-396).

The cumulative effect if these systemic practices resulted in patients' pressure wounds not being evaluated, planned, or treated timely.

Based on interview and record review, the hospital failed to ensure patients were assessed and evaluated for appropriate wound treatment for eight of 23 sampled patients (1, 3, 4, 9, 11, 14, 16, and 20).

1. For Patient 1, 4, and 16, the hospital failed to ensure Skin Care Champion (SCC) provided requested wound consultation within 24 hours according to the hospital policy and procedure which had caused delay of treatments.

2. For Patient 1, 3, 9, and 20, the hospital failed to: 1) measure the wound and document the measurement in their medical record and 2) summarize or re-evaluate their wounds weekly on Wednesdays (Wound Wednesday), which had caused these wounds to deteriorate unnoticed.

3. For Patient 11 and 14, the hospital nursing staff failed to measure their wound on admission, which had caused the hospital staffs' failure to assess their wound progress.

4. For Patient 4, the hospital nursing staff failed to track the number and location of her pressure wounds consistently on admission and in the subsequent evaluations, which caused inconsistency in would site documenting.

Findings:

1. A. On 8/9/11, at 3 PM, during a concurrent interview and record review with a Clinical Supervisor (CS), Patient 1's clinical record was reviewed. Patient 1 was admitted without any pressure wounds on 7/2/11. On 7/21/11, at 6:37 PM, a registered nurse requested a consultation for a SCC to evaluate Patient 1's skin. The reason for the request read, "Please evaluate small skin tear between gluteal (buttocks) fold." On 7/23/11, at 7:20 PM, another consultation request was sent to a SCC. This time the request read, "perineum (groove between buttocks) redness, moist weeping appears to be iad (Incontinence Associated Dermatitis)." On 7/28/11, at 6:56 PM, the third consultation request was sent to the SCC again. The reason for the third request was, "redness to left buttock, and small open area in between gluteal fold." The last request for wound consultation was sent on 8/1/11, at 7:59 PM, for the reason "perineum redness, moist weeping appears to be iad."

On 8/2/11, at 5:06 PM, after four consultation requests, the SCC evaluated Patient 1's skin and identified a wound to inner gluteal cleft (between buttocks) which measured 1.3 centimeters (cm) in length, 0.9 cm in width, and 0.1 cm in depth. The SCC documented the wound bed was "Yellow," the surrounding skin was "Erythema (red)," and "with scant amount of drainage." Patient 1's wound to the groove between his buttocks worsened from small skin tears to an unstageable pressure ulcer (a lesion caused by unrelieved pressure, friction, humidity, shearing forces, temperature, age, continence, and medication to any part of the body, especially portions over bony part of body) from 7/21/11 to 8/2/11. It took the SCC 12 days to provide consultation services.

On 8/9/11, at 1:30 PM, during an interview, the SCC described the procedures on pressure ulcer prevention. She stated, "Only PT (Physical Therapist) and Skin Care Champion can be SCC to stage pressure ulcers. Licensed nurse notifies SCC and PT for wound vac (using a sealed wound dressing connected to a vacuum pump to promote wound healing), surgical wounds, not healing wounds, and wounds not familiar (to staff). PT and SCC would assess referrals in 24 hours and initiate standardized procedure for wound care..." She was asked the reason for the delay of Patient 1's wound evaluation, SCC stated, "I was not aware of the referrals."

B. The electronic medical record (EMR) for Patient 4 was reviewed on 8/10/11, with the Quality Management Nurse (QMN). The patient was admitted from home with eight pressure ulcers. A consultation request for SCC to evaluate Patient 4's wounds was placed on 8/6/11. The "Nursing Supplemental Wound Documentation" in the EMR, dated 8/8/11, at 6:28 PM, two days after admission, Patient 4's wounds were assessed by the SCC.

C. The clinical record for Patient 16 was reviewed with QMN 2 on 8/11/11 at 9:25 AM. The Skin Care Wound Consult request for "...skin tear to back of neck" dated 7/21/2011 stated "pending". QMN 2 reviewed and printed the Consultation Sheet and the chart copy indicated "No Consultation Results available." QMN 2 then stated, "I don't think it was done. Don't see it."

During an interview with the Clinical Supervisor (CS), on 8/11/11, at 9:30 AM, she reviewed the clinical record and stated, "The 'P' in front of the request means it's pending. It's not done, but you can call the Skin Care Champion to ask her what happened."

During an interview with the SCC on 8/11/11, at 9:38 AM, she was asked about the request for wound consultation on 7/21/11. The SCC asked, "What day was the 21 st? Well, I don't know why it wasn't done, but I will look into. If it says 'P' then it's not done." The SCC was asked what is the policy on request for wound consultation, and she stated, "It should be completed within 24 hours by myself or Physical Therapy...It's not done."

2. A. On 8/9/11, at 3 PM, during a concurrent interview and record review with the CS, Patient 1's clinical record was reviewed. Patient 1 was admitted without any pressure wounds on 7/2/11. On 7/21/11, at 6:37 PM, a registered nurse documented "small skin tear between gluteal (buttocks) fold." On 7/23/11, at 7:20 PM, another RN (registered nurse) documented, "perineum (between buttocks) redness, moist weeping appears to be iad (Incontinence Associated Dermatitis, an inflammation of skin related to incontinence)." On 7/28/11 at 6:56 PM, a third RN wrote "redness to left buttock, and small open area in between gluteal fold." A fourth RN entered a note on 8/1/11, at 7:59 PM, it read, "perineum redness, moist weeping appears to be iad." None of these documentations had measurements of the wound.

On 8/9/11, at 1:30 PM, during an interview, the SCC described the responsibilities of floor registered nurses in pressure ulcer prevention. She stated the nursing staff should measure all wounds on admission and re-evaluate the wounds on "Wound Wednesday." The SCC explained it is the hospital policy to have all wounds measured and evaluated weekly, on Wednesdays.

On 8/9/11, during the record review, CS was unable to locate any measurement of Patient 1's buttock wound in his electronic records. She was also unable to locate any documentation completed on "Wound Wednesday."

B. The clinical record for Patient 3 was reviewed on 8/10/11. The "Med/Surg Nursing Assessment" dated 8/3/2011, at 8:05 PM indicated the following wounds: 1. right buttock, 2. right lateral foot, 3. right thigh/hip area, 4. left heel. There were no measurements documented for the four wounds. The day shift "Med/Surg Nursing Assessment" was also reviewed, and QMN 2 was unable to find documentation of measurements for the four wounds.

During an interview with RN 1 on 8/10/11, at 3:05 PM, she was asked about wound measurement for patients. RN 1 stated, "Any patient with a wound gets them measured and redressed on Wound Wednesday." When RN 1 was asked about Patient 3 not having measurements for 8/3/11, she stated, "I don't know how it was missed."

C. On 8/10/11, at 10:55 AM, Patient 9's clinical record was reviewed with the CS. Patient 9 was admitted on 5/2/11 for antibiotic therapy related to an infected wound with foul drainage to his back. He was discharged on 5/10/11. The CS could not find any wound measurement on 5/4/11, the Wednesday his wound should have been measured and re-evaluated. She was unable to locate any documents to explain why the measurement was not done.

During a concurrent interview at 11:30 AM, the CS stated "Wound care Wednesday is to measure all open wounds. Should be done on day shift and if not, night shift should do it."

D. During a concurrent interview and record review with the the CS, on 8/10/11, at 3:20 PM, the record indicated Patient 20 was admitted on 7/29/11 with no pressure wound. The daily nursing assessment dated 8/9/11, indicated the presence of a wound "Location: right ankle, Type: Pressure Ulcer, Dressing: clean, dry, intact." On 8/10/11, the nursing assessment did not identify the right ankle wound. No measurements of the right ankle pressure ulcer were found in the record, as confirmed by the CS.

3. A. On 8/10/11, Patient 11's clinical record was reviewed with the CS. Patient 11 was admitted on 7/14/11 with an infected wound to his right foot. A wound vac (a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of these wounds) was placed after a surgery on 7/15/11 to assist healing of the wound five days later. The CS could not find any measurement of the wound on admission. During a concurrent interview, the CS stated the measurement of any wound was required on admission.

B. On 8/11/11, Patient 14's clinical record was reviewed with CS. Patient 14 was admitted on 8/9/11 for an open wound filled with pus to her left buttock. The CS was unable to find the wound measurement on the admission assessment. The CS could not offer any further information.

4. During an interview with the CS, on 8/8/11, at 4:20 PM, she stated Patient 4 had multiple hospital acquired pressure ulcers (HAPU).

During an interview with the SCC, on 8/9/11, at 1:30 PM, she stated that nursing identifies pressure ulcers present on admission during a patient's admission assessment. If a problem (impaired skin integrity) was identified, a wound consultation would be ordered, which would be referred to the SCC or a licensed PT. Referrals for a wound consultation may be ordered for wounds that are not healing or are getting worse. The turn-around time for a wound consultation is 24 hours from order to assessment. She stated, wounds are to be measured and documented every Wednesday, according to the hospital policy and procedure.

The EMR for Patient 4 was reviewed on 8/10/11, with the QMN. The patient was admitted from home with multiple pressure ulcers. The nursing admission assessment, dated 8/6/11, indicated eight wounds as follows:

#1: Right outer ankle, pressure ulcer, measured 2.5 centimeters (cm) in length, 1.5 cms width, and 0 cms depth. The dressing was "open to air." #2: Right heel, pressure ulcer, measured 2 cms length, 2 cms width, and 0 cms depth. The dressing was "open to air." #3: Right inner ankle, pressure ulcer, measured 4 cms length, 1.5 cms width, and 0.1 cms depth, dressing was "intact". #4: Left outer ankle, pressure ulcer, measured 1.5 cms length, 1.5 cms width, and dressing "open to air". #5: Left heel, pressure ulcer, measured 3.5 cms length, 3.5 cms width, and dressing "open to air". #6: Left lateral chest, pressure ulcer, measured 5 cms length, 3 cms width, 0.5 cms depth, and dressing "dry, intact". #7: Coccyx, pressure ulcer, measured 8.5 cms length, 4.5 cms width, 0.1 cms depth, dressing "open to air". #8: Left buttock, pressure ulcer, measured 4 cms length, 2 cms width, and dressing "open to air". The nursing plan of care for impaired skin integrity, dated 8/6/11 at 10:54 PM, indicated "wound care per standardized wound care order sheet."

The "Nursing Supplemental Wound Documentation" in the EMR, dated 8/8/11, at 6:28 PM, two days after admission, indicated Patient 4's wounds were assessed by the SCC. Six wounds were assessed, rather than the eight wounds that were addressed on nursing's initial assessment. The SCC's recommendation for the left heel wound indicated "Keep blister intact per STD Procedure" and for the right outer buttock wound "Per STD (standardized) procedure (Hydrocolloid - a jelly like substance used in wound care to improve healing)". At 6:43 PM the SCC entered an order into the EMR for "Pressure Relieving Interventions" per the hospital's standardized procedure for six of the patient's wounds. No orders for dressing changes or use of hydrocolloid agent was written, as confirmed by the QMN.

The nursing assessment, dated 8/10/11, at 9:15 AM, indicated the following wounds: 1. right heel, 2. left heel, 3. right outer heel, 4. left outer heel, 5. right inner ankle, 6. left upper back/flank, 7. right upper back/flank, 8. coccyx, and 9. left buttocks. The location of the wounds in the 8/10/11 nursing assessment did not match the location identified in the 8/6/11 nursing admission assessment or the skin care champion's assessment on 8/8/11. The inconsistent wound location documentation made it difficult to assess the progress of each wound and appropriate treatment per the standardized procedure.

During a concurrent interview and record review with the CS, on 8/11/11, at 9:50 AM, she stated Patient 4 had dressing changes to eight wounds. She stated some of the wounds were open to air and some had dressings. When asked about the orders for the wounds receiving dressing changes, the CS stated the nurses were changing the dressings "per the orders on the MAR (Medication Administration Record)." The CS stated the nurse caring for the patient said the "SCC ordered the dressing changes." At 10:05 AM, the CS provided a copy of the "24 Hour MAR", dated 8/11/11 at 7 AM, that indicated, handwritten, "FYI Wound care: Rt ankle wet to dry drsg daily, Lt lateral chest wet to dry drsg daily." An order was not found in the EMR for the dressing changes. A start date for the wound care on the MAR was not found.

The facility policy and procedure titled "Standardized Procedure for Pressure Ulcers, Skin Tears and Incontinence Associated Dermatitis Treatment", effective date of January 2010, indicated a Skin Care Champion or licensed Physical Therapist may initiate the Standardized Pressure Ulcer Treatments Orders as specified in the policy and procedure. A wet to dry dressing was not listed in any of the policy's standardized treatments.

The hospital's policy and procedure on "Wound and Skin Care Interdisciplinary Management" with an effective date of December 2010 was reviewed. Subtitle VIII. B. read, "All wounds, including pressure ulcers are measured on admission, upon discovery and on Wednesdays. If the measurements are not done the reason must be clearly documented in the Progress Notes section of the Patient Medical Record."

Based on interview and record review, the hospital staff failed to develop or revise five of 23 sampled patients' (1, 9, 12, 14, and 20) plan of care on maintaining skin integrity. For Patient 1, the hospital did not revise his plan of care for skin integrity when he developed skin problems. For Patient 9, 12, 14, and 20, the hospital failed to develop a plan of care to treat their infected wounds on admission. Such failure had caused an un-established goal or outcome of treatment plan to these patients and ultimately, their needs to promote wound healing were not met.

Findings:

1. On 8/9/11, at 3 PM, during a concurrent interview and record review with Clinical Supervisor (CS), Patient 1's clinical record was reviewed. Patient 1 was admitted without any pressure wounds on 7/2/11. On 7/21/11, at 6:37 PM, a registered nurse (RN) documented "small skin tear between gluteal (buttocks) fold." On 7/23/11, at 7:20 PM, another RN documented, "perineum (between buttocks) redness, moist weeping appears to be iad (Incontinence Associated Dermatitis)." On 7/28/11 at 6:56 PM, a third RN wrote "redness to left buttock, and small open area in between gluteal fold." A fourth RN entered a note on 8/1/11, at 7:59 PM, it read, "perineum redness, moist weeping appears to be iad." None of these documentations had measurements of the wound.

During further review, when Patient 1 was admitted, a plan of care for "POTENTIAL IMPAIRED SKIN" was initiated at the time. However, nursing staff failed to revise the plan of care to reflect the changes of Patient 1's skin condition on several occasions: 7/21, 23, 28, and 8/1/11. Patient 1 was evaluated on 8/2/11 by the Skin Care Champion (SCC), but his wound between gluteal fold had worsened from a skin tear on 7/21/11 to a draining, yellow wound. This wound later, on 8/4/11, became an unstageable pressure ulcer (when the severity of a pressure wound cannot be determined through assessment). The hospital nursing staff did not provide any interventions to treat the wound. The CS confirmed the above findings. She stated the practice at the hospital required nursing staff to initiate or revise the plan of care and treatments at the time of discovery.

2. On 8/10/11, at 10:55 AM, Patient 9's clinical record was reviewed with the CS. Patient 9 was admitted on 5/2/11 for antibiotic therapy related to an infected wound with foul drainage to his back. He was discharged on 5/10/11. The CS could not find any plan of care related to the wound issue during his stay.

3. On 8/11/11, at 8:30 AM, Patient 12's clinical record was reviewed with the CS. Patient 12 was admitted with infected wound to her left lower leg. Her physician prescribed two antibiotics to be given intravenously to treat the infection. Three days into her stay at the hospital, the licensed staff had not developed a plan of care to address the wound care. An interview was conducted concurrently, the CS stated, "They (staff) should have done it (plan of care)."

4. On 8/11/11, at 9:20 AM, Patient 14's clinical record was reviewed with the CS. Patient 14 was admitted on 8/9/11 for an open wound filled with pus to her left buttock. The CS was unable to find a wound care plan developed by the hospital staff since his admission.



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5. During a concurrent interview and record review with the CS, on 8/10/11, at 3:20 PM, the record indicated Patient 20 was admitted on 7/29/11 with no pressure wound. The daily nursing assessment dated 8/9/11, indicated the presence of a pressure wound "Location: right ankle, Type: Pressure Ulcer, Dressing: clean, dry, intact."

A nursing plan of care for impaired skin integrity, dated 8/10/11, was reviewed. One intervention indicated "All wounds to be measured upon admission, discovery and on designated 'Wound Wednesdays'." The plan of care did not specify treatment for the right ankle pressure ulcer. Staging of the pressure ulcer was not found. Measurements of the right ankle wound and referral to the SCC was not found in Patient 20's medical record, as confirmed by the CS.

The hospital's policy and procedure on "Wound and Skin Care Interdisciplinary Management" with an effective date of 12/10 was reviewed. In a list of registered nurses responsibilities during patient hospitalization, number 5, read, "Ensure that all care and interventions associated with skin and wound care is accurately documented on the 24-hour PCR (Patient Care Record)." Number 6.c read, "Patient Care Plan must be initiated/updated to include problems and interventions associated with skin breakdown/pressure ulcers."

Based on observation, interview, and record review, the hospital failed to implement measures to ensure medical records were completed, which had the potential to result in medical records lacking vital patient care information, and making it unavailable for patient care.

1. The hospital failed to ensure the computer program had the ability to track incomplete entries and incomplete medical records. (A 432)

2. The hospital failed to ensure the electronic medical record was promptly completed for 4,394 inpatient entries that were not signed by the provider. (A 438)

3. The hospital failed to ensure the computer program had the ability to track incomplete medical records for the past three months. (A 438)

4. The hospital failed to ensure the new electronic medical record system had the ability to ensure patient confidentiality. (A 441)

5. The hospital failed to ensure the new electronic medical record system had the ability to prevent unauthorized access to patient information. (A 442)

6. The hospital failed to ensure unauthorized individuals were not given access to patient records. (A 442)

7. The hospital failed to ensure medical record entries were completed within 14 days of patient discharge per Medical Staff Bylaws, Rules and Regulations. (A 469)

8. The hospital failed to ensure all orders, including verbal/telephone orders were authenticated promptly. (A 454)

9. The hospital failed to ensure verbal/telephone orders were authenticated within 48 hours. (A 457)

10. The hospital failed to obtain an informed consent prior to a surgical procedure. (A 131, A 466 and A 955)

The cumulative effects of these systemic practices resulted in the failure of the hospital to maintain a complete and accurate medical record in accordance with regulations and hospital policies.

Based on interview and record review, the hospital failed to ensure the computer program had the ability to track incomplete entries and incomplete medical records. Such failures caused the hospital's non-compliance with its own policy and procedure to authenticate medical orders in 48 hours and close delinquent record in 14 days.

Findings:

On 8/11/11, at 12:30 PM, A concurrent interview and review of incomplete medical entries reports were conducted with the Health Information Services Supervisor (HISS) and the Health Information Services Manager (HISM), . The report titled "List of UNSIGNED orders by PROVIDERS" from 5/10/11 to 8/11/11 were reviewed and it indicated there were a total of 4,394 unsigned orders waiting to be authenticated by providers. Some of these entries were entered on 5/10/11, the day the hospital implemented the new computerized medical record system, and were still left unsigned. The HISS stated these medical entries could be entered by physicians, pharmacists, or nurse practitioners. However, she stated this report was not accurate. She simply stated the new electronic medical record (EMR) system, could not track any unsigned verbal or telephone orders.

At the same interview and record review, at 1:25 PM, the delinquent medical record report for the same period was requested for review. The HISM could not provide such information. The HISS stated the new EMR system could not track the delinquent records either. Both the HISS and HISM agreed the inability of the new system had made the delinquency tracking situation worse. For example, the hospital had an average of 1200 delinquent medical records per month. In three months, from 5/10/11 to 8/11/11, the HISS and HISM stated there were at least 3600 records accrued in the health information services which could not be closed because of the problem with the new computer system.

During further interview, both the HISS and HISM stated in order to complete or close these medical entries and medical records, the staff had to go into each patient's medical information, page by page, order by order, to ensure the information was complete. "That would take a long time." When asked if such issue had been brought to the administration's attention, they both stated, "Yes." They presented copies of several emails they wrote, dated 11/16/10, 4/6/11, and 4/8/11, to the administration regarding the inability in tracking incomplete medical entries. The HISM stated the administration looked into different computer programs in June this year but "I have not heard anything yet."

Based on interview and record review, the hospital failed to ensure the timely completion of patient electronic records for an undetermined number of inpatient records from 5/10/11 to 8/11/11. The hospital failed to maintain the security of patient's electronic medical record (EMR) entries from 5/10/11 to 8/11/11 when any employee granted access to the EMR system had access to any patient record. These failures had the potential to affect the integrity of patients' records and impact the care patients may receive.

Findings:

1. During a concurrent interview and record review with the Health Information Services Manager (HISM) and the Health Information Services Supervisor (HISS), on 8/11/11, at 1:25 PM, they stated the estimated medical record deficiency count for delinquent medical records was 1200 records per month. Since the "Go Live" date (the date the EMR became active for the hospital), 5/10/11, to 8/11/11, there were at least 3600 delinquent medical records.

The hospital's Medical Staff Rules and Regulations, effective 1/6/09, Section B. Medical Records 9 Completion c. read, "The patient's medical record shall be complete at time of discharge, including progress notes, final diagnosis, and clinical summary. Records are considered complete when the responsible practitioners and health care professionals have dictated or written and authenticated all necessary reports and have authenticated all record entries.... Records may remain in the incomplete category for no longer than fourteen (14) days following date of discharge. Records, if not completed during the 14-day period, become delinquent records."

2. During an interview with the HISM regarding the security of patient records, on 8/9/11, at 9:45 AM, she stated the EMR system is "...an open system...everyone has the same level (of security) and can look (view) any information. If you have access to patient records you have access to all patient records (in the system)."

During an interview with the Clinical Director of Compliance/Privacy Officer (CD/PO), on 8/9/11, at 2 PM, she stated "...if access to patient records, access to all." She stated there was no restrictions on access to the electronic medical record because the system does not allow us to restrict the access to specific individuals who are for a patient. An outpatient staff can access an inpatient record. The CD/PO stated employees are expected to maintain confidentiality and all employees sign a confidentiality statement upon hire. She further explained there was not a routine audit generated for review to ensure the confidentiality and security of a patient's EMR was intact. As the Privacy Officer, she only audited for "cause", as in a patient complaint, privacy investigation, or a real time complaint due to suspicious behavior.

The hospital's new EMR system could not provide restricted access to its staff, which limited the hospital's capability to ensure patient confidentiality proactively.

Based on interview and record review, the hospital failed to ensure the confidentiality of patient's electronic medical record (EMR) entries for one of 23 sampled patients (23), when a physician failed to verify patient name and entered medical information into another patient's (22) record. This failure had the potential to affect the integrity of patients' records and impact the care patients may receive.

Findings:

During an interview with the Clinical Director of Compliance/Privacy Officer (CD/PO), on 8/8/11, at 3:40 PM, she stated Patient 22 and Patient 23 were seen in the same clinic on 7/29/11, by a doctor (Dr. A). Patient 22 was given an aftercare instructions with correct instructions, but the the form had another patient's name (23) on it. After investigation, the hospital determined Dr. A erroneously entered Patient 22's aftercare instructions in Patient 23's EMR. A Licensed Vocational Nurse 1 then handed Patient 22 the aftercare instructions with Patient 23's name and confidential information.

During an interview with the Project Manager for outpatient clinics, on 8/11/11, at 9:10 AM, she stated "...computers are available in each outpatient exam room to encourage providers to chart at the time (of visit)", but "physicians often chart in the clinic nursing stations or doctor's room for online records." She stated the physicians were trained for the EMR and staff was to remind the physicians to verify patient names when documenting in the EMR.

Based on interview and record review, the hospital failed to take necessary precautions prior to the implementation of the new electronic medical record (EMR) system to restrict unauthorized personnel access to medical records and failed to ensure patient records were secured at all times. These failures had the potential to allow unauthorized individuals to gain electronic access to confidential patient records or to alter patient information without being noticed.

Findings:

During an interview with the Health Information System Manager (HISM), on 8/9/11, at 9:45 AM, when asked if patient electronic records are kept secure and viewed only when necessary by individuals having a part in a patient's care, she stated the hospital's EMR system was "...an open system...everyone has the same level (of security) and can look (view) any record. If you have access to patient records you have access to all records." The HISM was unable to verify that clinical records were only viewed when necessary by persons authorized access to a particular patient's record. She was unable to state what precautions were taken to prevent unauthorized persons from gaining electronic access to information in patient records.

During an interview with the Clinical Director of Compliance/Privacy Officer (CD/PO), on 8/9/11, at 2 PM, she stated "...if access to patient records, access to all." She stated there are not any restrictions on access to the electronic medical record "because the system does not allow it." The CD/PO stated employees are expected to maintain confidentiality and all employees sign a confidentiality statement upon hire. She stated there was not a routine audit report generated or reviewed to ensure the confidentiality and security of a patient's EMR. As the Privacy Officer, she could only audit who accessed a record when she was informed of a breach of privacy event.

During an interview with the Director of Information Systems, on 8/9/11, at 3:20 PM, he stated the EMR system did not allow restrictions to limit or restrict access per discipline or assigned unit because that (restricted access) would impair continuity of patient care. He admitted that outpatient clinic staff could access the hospital's new EMR system to view an inpatients' confidential information.

Based on interview and record review, the hospital failed to follow its policy and procedure in authentication of medical entries within 48 hours, which resulted in 4,394 inpatient entries not signed by providers in three months, from 5/10/11 to 8/11/11, after the the activation of the electronic medical record (EMR) system.

Findings:

During a concurrent interview and record review with the Health Information Services Manager and the Health Information Services Supervisor, on 8/11/11, at 1:25 PM, the hospital generated report from the hospital's EMR system, titled "List of Unsigned orders by Provider", dated 8/11/11, was reviewed. The report indicated there were 4,394 patient medical record entries not signed by providers from 5/10/11 to 8/11/11. The activation date for the EMR system was 5/10/11.

The hospital's Medical Staff Rules and Regulations, effective 1/6/09, Section B. 7. b., indicated, "...The ordering practitioner or a responsible practitioner caring for the patient shall authenticate all telephone orders at the next visit not to exceed forty-eight (48) hours."

Based on interview and record review, the hospital failed to ensure all orders, including verbal/telephone orders were authenticated promptly. These failures resulted in an undetermined number of incomplete inpatient records from 5/10/11 to 8/11/11.

Findings:

During an interview with the Health Information Services Manager (HISM), on 8/9/11, at 9:45 AM, she stated the authenticity of verbal orders was ensured by the electronic signature in the electronic medical record (EMR) system. She stated, "The order is electronically signed by the nurse (taking the order) and also signed by the physician within 24 hours." The system for following up unsigned orders is tracked by the patient's medical record number.

During a subsequent interview with the Health Information Services Supervisor (HISS), on 8/11/11, at 12:15 PM, she stated since the EMR systems "go live" date, 5/10/11, (the date the system became active) the medical record department had been unable to track medical record delinquencies for physicians. She stated they were three months behind so they had not followed their procedure to suspend physicians.

During a concurrent interview and record review with the HISM and the HISS, on 8/11/11, at 1:25 PM, the hospital generated report from the hospital's EMR system titled "List of Unsigned orders by Provider", dated 8/11/11, was reviewed. The report indicated there were 4,394 patient medical record entries not signed by providers from 5/10/11 to 8/11/11, a three-month period. The HISS stated these medical entries could be entered by physicians, pharmacists, or nurse practitioners.

On 8/11/11, a copy of an email, dated 4/6/11, read, "...There is no way that we could be able to track deficiencies and delinquencies with what we have now (EMR system)....and be out of compliance..."

The hospital's Medical Staff Rules and Regulations, effective 1/6/09, Section B. 7. b. "...The ordering practitioner or a responsible practitioner caring for the patient shall authenticate all telephone orders at the next visit not to exceed forty-eight (48) hours."

Based on interview and record review, the hospital failed to ensure all verbal/telephone orders were authenticated by providers within 48 hours of receiving of the orders. Such failure had the potential to decrease the hospital's ability to promptly identify possible transcription errors and to immediately intervene for an adverse event.

Findings:

During an interview and concurrent record review with the Clinical Supervisor (CS), on 8/11/11, at 11:05 AM, a summary report, dated 8/11/11, was reviewed. The CS explained this report included all inpatient orders for the selected date range from 8/4/11 to 8/11/11. The report indicated there were 935 verbal orders and 870 telephone orders generated in the hospital's electronic medical record (EMR) system between the selected date range. She stated the hospital was unable to determine the number of unsigned orders from this report.

During further interview with the Health Information Services Supervisor (HISS) regarding the tracking ability of the new health information system, on 8/11/11, at 12:15 PM, she stated since the hospital's EMR system "go live" date (5/10/11, the date the system became active),the medical record department had been unable to track unsigned orders by providers.

During a concurrent interview and record review with the Health Information Services Manager (HISM) and the HISS, on 8/11/11, at 1:25 PM, they both stated a hospital report generated from the EMR system titled "List of Unsigned orders by Provider", dated 8/11/11, indicated there were 4,394 patient medical record entries were not signed by the physician between 5/10/11 to 8/11/11. The hospital was unable to determine how many of the 4,394 unsigned entries were verbal/telephone orders.

The hospital's Medical Staff Rules and Regulations, effective 1/6/09, Section B. 7. b. "...The ordering practitioner or a responsible practitioner caring for the patient shall authenticate all telephone orders at the next visit not to exceed forty-eight (48) hours."

Based on interview and record review, the hospital failed to follow its policy and procedure to obtain a consent from one of 23 sampled patients (6) prior to the surgery procedure which had the potential to violate patients' rights to be fully informed of their medical care.

Findings:

The electronic medical record (EMR) for Patient 6 was reviewed on 8/10/11. Patient 6 had a consent dated 7/14/11, for Endometrial Biopsy (a procedure that is used to remove a sample of the lining of the uterus). However, the consent did not have Patient 6's signature. There was no signature by an authorized employee to verify that the physician had explained risk and benefits to the patient before the procedure.

During an interview with Quality Management Nurse (QMN) 2, on 8/10/11, at 11:45 AM, she was asked about the consent not being signed by Patient 6. The EMR was reviewed by QMN 2, and she was unable to find documentation or the informed consent of the procedure.

The EMR was further reviewed on 8/10/11. The "OB/GYN Progress note" dated "7/15/11 at 05:31" indicated under Assessment/Plan "S/p EMB (Endometrial biopsy) yesterday, will follow results when available." The "Pathology (study of diseases) Report" dated 7/18/11 indicated that an endometrial biopsy sample had been received. This confirmed the surgical procedure was performed on 7/14/11 but the consent or documented risk and benefits for the procedure could not be found.

The hospital administrative policy and procedure titled "Consent, How to obtain" approved by the Medical Executive Committee on 7/1/08 was reviewed on 8/11/11. The "POLICY STATEMENT," read in part, "The policy of (name of the hospital) is that treatment is rendered only after the patient, or the patient's Consent Giver has consented to treatment... For procedures that are complex, as defined by the Medical Executive Committee, it is the treating physician's responsibility to obtain informed consent by explaining the risk, benefits and alternatives of the procedure to obtain the patient's consent. The hospital's responsibility is to validate that the appropriate consent was obtained." Further review of this policy, Addendum A, "PROCEDURES REQUIRING INFORMED CONSENT FRO EACH TIME PERFORMED IN ADDITION TO CONDITIONS OF ADMISSION," was examined. The first procedure on the list read, "Gynecology Biopsy (cervix, endometetrium, etc.)."

Based on interview and record review, the hospital failed to obtain one of 23 sampled patients (6) signature's, date, and time on the surgical consent, which had the potential to result in violation of Patient 6's rights not being fully informed of her medical care.

Findings:

The electronic medical record (EMR) for Patient 6 was reviewed on 8/10/11. Patient 6 had a consent dated 7/14/11, for Endometrial Biopsy (a procedure that is used to remove a sample of the lining of the uterus). However, the consent did not have Patient 6's signature. There was no signature by an authorized employee to verify that the physician had explained risk and benefits to the patient before the procedure.

During an interview with Quality Management Nurse (QMN) 2, on 8/10/11, at 11:45 AM, she was asked about the consent not being signed by Patient 6. The EMR was reviewed by QMN 2, and she was unable to find documentation or the informed consent of the procedure.

The EMR was further reviewed on 8/10/11. The "OB/GYN Progress note" dated "7/15/11 at 05:31" indicated under Assessment/Plan "S/p EMB (Endometrial biopsy) yesterday, will follow results when available." The "Pathology (study of diseases) Report" dated 7/18/11 indicated that an endometrial biopsy sample had been received. This confirmed the surgical procedure was performed on 7/14/11 but the consent or documented risk and benefits for the procedure could not be found.

The hospital policy and procedure titled "Consent, How to obtain" dated July 2011, indicated "...treatment is rendered only after the patient, or the patient's Consent Giver has consented to treatment." In the section "Addendum A: Procedures requiring Informed Consent for Each Time Performed...Biopsy (cervix, endometrium, etc.)" was listed.