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4755 OGLETOWN-STANTON ROAD

NEWARK, DE 19718

LICENSURE OF PERSONNEL

Tag No.: A0023

Based on review of personnel records, policy review and staff interview, it was determined that for 2 of 8 (25%) employees (Employee #'s 3 and 4) in the sample, adult abuse and child abuse registry checks had not been performed as required by Delaware Code. Findings include:

The Department of Labor "Special Employment Practices Relating to Health Care and Child Care Facilities" stated, "...The General Assembly enacted two laws, 'Special Employment Practices Relating to Health Care and Child Care Facilities' (19 Del.C. ?708 and 11 Del.C. ?8563) and 'Adult Abuse Registry Check' (11 Del.C. ?8564) in order to provide a degree of protection for the 'vulnerable' population in hospitals...Together, the two laws require employers to...check two registries to ensure that they are not hiring individuals with a past history of...individuals who have engaged in abuse or neglect to adults or children in their care..."

The hospital policy entitled "A-3 Employment & Placement" from the "Supervisors Manual" stated, "...In accordance with Delaware State law, all candidates for any position within the health system are subjected to a further...background check. This check includes...checks with the Adult Abuse and Child Abuse Registries and is intended to identify any past history of neglect, abuse, or violence toward patients or others..."

Review of employee personnel records revealed the following:

1. Employee #3 - hired in 2/08, lacked evidence of adult and child abuse registry checks

2. Employee #4 - hired 4/24/00, lacked evidence of adult and child abuse registry checks

Interview with the Manager of Accreditation Services A on 11/19/10 at 11:40 AM confirmed these findings.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on review of medical records, policies and other hospital documentation and staff interview, it was determined that the hospital failed to ensure the safety of 4 of 10 (40%) patients (Patient #'s 4, 5, 6 and 7) in the sample and the remaining patient population. Findings include:

The hospital "Patient's Rights and Responsibilities" given to every patient stated, "...You have the right...To considerate, respectful service with identification of your needs including safety...To be free from physical and mental abuse..."

The hospital policy entitled "Abuse or Neglect: Reporting of Child, Adult" stated, "...It is the policy of Christiana Care System to...investigate patient allegations of abuse or neglect brought against...a member of the health care team...The following criteria define 'abuse'...This also includes...patient report of physical abuse, rape, attempted rape or other sexual assault..."

The hospital policy entitled "Safety First Learning Report: Event Reporting Policy and Procedure" stated, "...A Safety First Learning Report (event report) shall be generated by...employees or physicians who witness, discover or become aware of circumstances indicative of an 'event'...An event is an occurrence not consistent with the desired operation of Christiana Care Health Services...or the routine care of patients...Upon discovery of an event...the employee: Provides and documents intervention to the person involved as indicated...Notifies Public Safety Department by telephone. Notifies manager (person administratively responsible on your shift), if appropriate...Post event Documentation...In the patient's medical record, document a brief factual description of what happened or was observed. Staff member's and patient's account of event...Description of patient's condition following event:...patient's complaints...The person most closely involved and/or discovering the event will complete the Safety First Learning Report (event report) and transmit it immediately - or - forward the report to the Risk Management Department before the end of shift...Follow-up: the Department Head is responsible for follow-up...Risk Management will review and initiate referrals, when appropriate..."

A media report dated 11/13/10, from The News Journal, a Wilmington, Delaware newspaper, stated, "Three female patients at Christiana Hospital were fondled by a man posing as a doctor, police said Friday night. In addition to investigating the crimes, which have been classified as 'unlawful sexual contact', police are also looking into why the first incident was not reported to them for two weeks...The man posed as a doctor, entered the rooms of women who had been admitted to the hospital, 'then performed a physical exam...where he improperly touched and fondled the victims'..."

A document summarizing the assaults and submitted to the State Agency on 11/15/10 revealed a fourth patient assault was reported to hospital security on 11/13/10.

Review of medical records and the event reports revealed the following:

1. Patient #7
- The medical record contained a progress note dated 10/29/10 at 10:16 PM, that stated, "Pt concern...Pt called nurse into room and said a staff member (she was unsure who he was) assessed her and made her feel uncomfortable. Pt stated the man asked her to lift or remove her bra and was trying to look under her shirt. She said he pressed her abd (abdomen) and she felt very uncomfortable. She states 'none of the other Dr touch me that way.' Made charge nurse aware of pt. complaint...Therefore, pt. given patient relations number which she will call on Monday. Charge nurse also aware."

- The "Event Report" was not generated until 11/13/10, 16 days later. This finding was confirmed by Chief of Security A on 11/18/10 at 9:30 AM.

2. Patient #4
- The "Event Report" generated on 11/13/10 (5 days after the incident) reported that during report on 11/8/10 at 7:00 AM, the day time patient care tech (PCT) reported to the night nurse that Patient #4 stated she had been inappropriately touched by someone who came in the room. After report the night nurse and the PCT went into the room to speak with the patient. The night nurse stated that a doctor had come into the room to speak with the patient. Review of the record revealed that there was no notation by any physician at that time. The charge nurse completing the report stated that "the patient never stated to me that this situation happened and I had taken care of her for monday, tues and wed [sic] following this event."

- The medical record lacked documentation in the nurses notes of any report of improper touching or fondling.

3. Patient #5
- The medical record contained a notation that the patient made the registered nurse (RN) aware of the assault on 11/10/10 at 7:30 AM. This patient was on suicide watch and had a 1:1 sitter. The RN stated in the note, dated 11/10/10 at 7:55 AM, "...that a doctor...came in around 4 AM and started to press on her stomach and then felt on her breasts...Made pt aware that from 0400 - 0445 I had been in her room relieving the sitter and that no doctors came in or out of the room. She then stated it could have been earlier...I told her that I would make the charge nurse aware and that we would make our nurse manager aware..."

- On 11/10/10 at 10:45 AM the Forensic Nurse Examiner examined the patient and documented, "...Pt. acknowledges speaking to hospital staff and security concerning incident..."

- The "Event Report" generated and submitted by the Nurse Manager was dated 11/10/10.

During an interview on 11/18/10 at 8:30 AM, the Manager of Accreditation Services A reported that the mental health aide saw the man come into the room and heard the exchange.

4. Patient #6
- On 11/12/10 at 12:25 AM a consult was generated to the Forensic Team regarding a possible sexual assault. The RN completing the exam wrote, "DSP (Delaware State Police) notified..."

- The medical record lacked documentation in the progress notes, by the RN to whom the incident was reported, of any report of improper touching or fondling.

- The "Event Report" was not generated until 11/15/10, 4 days after the event date and time of 11/11/10 at 8:00 PM.

During an interview with Chief of Security A on 11/18/10 at 9:30 AM, it was revealed that while investigating the episodes from 11/10 and 11/11/10 (Patient #'s 5 and 6), the other cases (Patient #'s 7 and 4), were identified. Chief of Security A confirmed that the incidents for Patient #'s 7 and 4 which occurred on 10/29 and 11/8/10 respectively, were not reported promptly.

PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT

Tag No.: A0145

Based on review of media reports, medical records, hospital policies and other hospital documentation and staff interview, it was determined that the hospital failed to ensure that 4 of 10 (40%) patients (Patient #'s 4, 5, 6 and 7) in the sample were protected from abuse. Findings include:

A media report dated 11/13/10, from The News Journal, a Wilmington, Delaware newspaper, stated, "Three female patients at Christiana Hospital were fondled by a man posing as a doctor, police said Friday night. In addition to investigating the crimes, which have been classified as 'unlawful sexual contact', police are also looking into why the first incident was not reported to them for two weeks...The man posed as a doctor, entered the rooms of women who had been admitted to the hospital, 'then performed a physical exam...where he improperly touched and fondled the victims'..."

A document summarizing the assaults and submitted to the State Agency on 11/15/10 revealed a fourth patient assault was reported to security on 11/13/10. In addition, the summary stated that on 11/11/10 the Nursing units were alerted in the form of a short memo describing the individual and what to do if he is observed. On Friday 11/12/10 an announcement was posted on the Christiana Care employee and physician portals.

The hospital document entitled "Patient's Rights and Responsibilities" given to every patient stated, "...You have the right...To considerate, respectful service with identification of your needs including safety...To be free from physical...abuse...To know the names of your treating doctors, and the names and duties of other staff having direct contact with you..."

The hospital policy entitled "Safety First Learning Report: Event Reporting Policy and Procedure" stated, "...A Safety First Learning Report (event report) shall be generated by...employees or physicians who...become aware of circumstances indicative of...an occurrence not consistent with...routine care of patients...Upon discovery...the employee: Provides and documents intervention to the person involved...Notifies Public Safety Department by telephone. Notifies manager (person administratively responsible on your shift), if appropriate...Post event Documentation...In the patient's medical record, document a brief factual description of what happened or was observed...person most closely involved and/or discovering the event will complete the Safety First Learning Report (event report) and transmit it immediately - or - forward the report to the Risk Management Department before the end of shift...Follow-up: the Department Head is responsible for follow-up...Risk Management will review and initiate referrals, when appropriate..."

Review of the medical records and other pertinent documentation revealed Patient #'s 4, 5, 6 and 7 had complained to staff of being sexually assaulted (fondling of breasts) during their hospitalizations on the following dates:

1. Patient #7
Incident: 10/29/10 at 6:00 PM (alleged time of sexual assault)

- 10/29/10 at 10:16 PM - Incident reported to staff member and charge nurse; Staff member gave Patient #7 contact number for Patient Relations Department with instructions to call Department Representative on Monday

- 11/13/10 - "Event Report" generated 16 days after reported allegation of abuse
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2. Patient #4
Incident: 11/8/10 (alleged time of sexual assault - during night shift)

- 11/8/10 at 7:00 AM - Incident discussed during report; No documentation in the medical record regarding the allegation of abuse

- 11/13/10 - "Event Report" generated 5 days after reported allegation of abuse
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3. Patient #5
Incident: 11/10/10 (alleged time of sexual assault - approximately 4:00 AM)

- 11/10/10 at 7:30 AM - Incident reported to charge nurse; Patient was on suicide watch with a 1:1 sitter at the time of the alleged assault. During an interview with Manager of Accreditation Services A on 11/18/10 at 8:30 AM, Manager A reported that the mental health aide saw the man come into the room and heard the exchange, but did not witness the assault. Manager A reported that the mental health aide did not ask the male "examiner" his name.
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4. Patient #6
Incident: 11/11/10 at 8:00 PM (alleged time of sexual assault)

- 11/11/10 - Incident reported to registered nurse; No documentation in the medical record regarding the allegation of abuse

- 11/15/10 "Event Report" generated 4 days after reported allegation of abuse

During an interview with Chief of Security A on 11/18/10 at 9:30 AM, it was revealed that while investigating the episodes from 11/10 and 11/11/10 (Patient #'s 5 and 6) the other cases were identified. Chief of Security A confirmed that the incidents for Patient #'s 7 and 4 which occurred on 10/29 and 11/8/10 respectively, were not reported promptly.

PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS

Tag No.: A0147

Based on medical record review, policy review and staff interview, it was determined that staff failed to ensure confidentiality of patient records for 1 of 10 (10%) patients (Patient #10) in the sample. Findings include:

The hospital policy entitled "Patient Rights and Responsibilities" stated, "...You have the right...To confidentiality, regarding your medical care and information related to that care..."

The following issue related to patient confidentiality was identified during the review of patient grievances and medical record review:

Patient #9 was examined and treated in the emergency department (ED) on 9/28/10. Patient #9 was given discharge instructions, a prescription for pain medication and discharged to home.

Patient #9 returned to the hospital later on 9/28/10 and reported to Patient Relations Representative A that he had gone home, looked at the hospital discharge paperwork and realized that he had been given discharge documents and a prescription with Patient #10's name on the paperwork.

Review of Patient #9's "ED Discharge Instruction Sheet" dated 9/28/10 at 11:45 AM, revealed that Patient #9 had been given the following confidential information belonging to Patient #10:

Patient #10's:
- First and last name
- Date of birth
- Patient identification number
- Medical record number
- Home address
- Home phone number

Review of the prescription dated 9/28/10 at 11:45 AM revealed a typed prescription for a controlled substance. The prescription contained Patient #10's:
- First and last name
- Date of birth
- Home address

Interview with Senior Counsel and Privacy Officer A on 11/18/10 at 1:27 PM confirmed this finding.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

Based on medical record review, policy review and staff interview, it was determined that the medical record for 1 of 1 (100%) restrained patients in the sample (Patient #1), lacked a written modification to the plan of care addressing the use of a restraint. Findings include:

The hospital policy entitled "Restraints and Seclusion..." stated, "...Modification to the Interdisciplinary Plan of Care...Within 2 hours of the initiation of the restraint...RN (registered nurse) will modify the interdisciplinary plan of care to include...identified problem...goal and intervention...time frames required for assessment and reassessment...time-limit of order..."

A. Patient #1

Review of the "Emergency Department Assessment Sheet/Interdisciplinary Record" revealed documented use of restraints on 7/13/10 at 6:25 PM.

Review of the "Safety Companion Observation Record" revealed documented use of restraints on 7/14/10 at 3:00 PM, 4:00 PM and 6:40 PM.

Review of the "Interdisciplinary Patient Progress Note" revealed documented use of restraints on 7/14/10 at 5:00 PM.

Review of the "Hospital/Nursing Home Inpatient Contacts" revealed documented use of restraints on 7/15/10 at 11:00 AM.

Review of the "Plan of Care and Education Record" and "Interdisciplinary Rounds Worksheet/Plan of Care" revealed no care plan modification for the use of restraints.

During an interview with the Nurse Manager (RN A), on 11/17/10 at 9:40 AM, RN A confirmed that staff failed to update the plan of care to reflect the use of restraints. RN A reported that staff was expected to generate a "supplemental care plan" at the time of restraint initiation.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0171

Based on medical record review, policy review and staff interview, it was determined that the physicians' orders for 1 of 1 (100%) restrained patients in the sample (Patient #1), failed to include a time limit for restraint use. Findings include:

The hospital policy entitled "Restraints and Seclusion..." stated, "...Orders for restraint...Include in the order...duration..."

Review of the "Medical-Dental Staff Rules" stated, "...Orders for restraints...will include...Duration of order..."

A. Patient #1
Review of the "Emergency Department (ED) Doctor's Order Sheet" dated 7/13/10 at 6:15 PM included a verbal order for 4-point restraints. The restraint order failed to include a duration of time.

Review of the 7/13/10 "Assessment Sheet/Interdisciplinary Record" nurse's note entry at 6:25 PM, revealed Patient #1 was placed in four point restraints as per physician's order.

Interview on 11/17/10 at 10:55 AM with Physician A and the ED Program Manager, confirmed that the restraint order failed to include a duration of time.

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on review of medical records, policies, documents and staff interview, it was determined that at the time of discharge, medical staff failed to ensure that a medication reconciliation was performed by the physician for 1 of 9 (11%) patients (Patient #1) in the sample. Findings include:

Review of the document entitled "Medical-Dental Staff Bylaws" stated, "...Active Staff...responsibilities...Abide by the Staff Bylaws and Rules, rules of the department to which appointed, and rules and policies..."

Review of the document entitled "Medical-Dental Staff Rules" stated, "...Transfer and Discharge...When a patient is discharged to an Extended Care Facility...the discharging physician will complete the Medication Reconciliation Order Sheet for Extended Care Facilities..."

Review of the hospital policy entitled "Medication Reconciliation" stated, "...inpatients will have medications reconciled...at discharge...Discharge to Extended Care Facility...When an order is written to discharge a patient to an Extended Care Facility, the Medication Reconciliation Order Sheet for Extended Care Facility will be printed...form will replace the medication section of the Interagency Discharge Orders Form and serve as the primary source of current medications for the receiving facility...form will be completed by the discharging physician...A copy will be maintained in the discharge section of the patient's chart..."

Review of the "Discharge Summary" dictated on 7/23/10 by Physician C, revealed Patient #1 was discharged from the hospital to an extended care facility on 7/22/10.

Review of Patient #1's medical record revealed no "Medication Reconciliation Order Sheet for Extended Care Facilities" had been completed by Physician C. In addition, there was no documentation in the medical record to support that, at the time of discharge, a current medication list accompanied Patient #1 to the extended care facility.

During an interview with Pharmacist A on 11/17/10 at 8:25 AM, Pharmacist A reported that at the time of discharge to an extended care facility, the physician was required to complete a "Medication Reconciliation Order Sheet for Extended Care Facilities", which was an addendum to the interagency form. Pharmacist A reported that the form served as a physician's order form until orders could be obtained from the responsible physician at the extended care facility. Pharmacist A confirmed that Physician C had failed to complete the "Medication Reconciliation Order Sheet for Extended Care Facilities".

During a phone interview with Department of Medicine Physician Advisor A on 11/17/10 at 2:15 PM, Physician Advisor A reported that the physician should have followed the medication reconciliation process and updated the information to ensure that medication information was consistent with the "Discharge Summary". Physician Advisor A reported that the reconciliation process enabled physicians to re-evaluate medications prior to discharge.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on review of medical records, policies and staff interview, it was determined that for 3 of 10 (30%) patients (Patient #'s 1, 2 and 9) in the sample, staff failed to ensure that medical record entries were accurate. Findings include:

Review of the hospital policy entitled "Documentation in the Medical Record" stated, "...policy applies to...Christiana Care Health Services and its Medical-Dental Staff...Verify that record/form has the correct patient name...Make entries that are timely, consistent and avoid contradictions..."

A. Patient #1
Review of documents entitled "Orders" revealed the following medication orders from Physician C:

7/14/10
- 1:27 PM: Lovenox (anticoagulant) 40 milligrams (mg) to be administered subcutaneously (injection administered directly below the skin) every 24 hours

7/19/10
- 10:23 AM: Levaquin (antibiotic) 250 mg daily by mouth
- 2:20 PM: Levaquin 250 mg discontinued
- 2:20 PM: Levaquin 500 mg daily by mouth for seven (7) doses

7/21/10
- 10:21 AM: Levaquin 500 mg discontinued (per Medication Administration Record - MAR)
- 1:33 PM: Keflex 500 mg by mouth every six (6) hours for seven (7) days
- 2:55 PM: Keflex changed to a suspension (liquid form)

Review of Patient #1's MAR on the day of discharge, revealed that in addition to other ordered medications, Patient #1 received the following on 7/22/10:

7/22/10
- Lovenox 40 mg - Administered at 9:22 AM
- Keflex 500 mg - Administered at 12:23 AM, 5:46 AM and 12:00 PM

Review of the "Discharge Summary" dictated on 7/23/10 by Physician C, revealed inconsistencies in the medications prescribed/administered at the time of Patient #1's discharge and the medication plan documented in Patient #1's "Discharge Summary".

Review of the "Discharge Summary" revealed Patient #1 was discharged from the hospital to an extended care facility on 7/22/10. Physician C's summary included "...discharged on...no aspirin, no clonazepam (prescribed for seizures/panic and bipolar disorders) and Levaquin 250 mg and his Lovenox 40 mg b.i.d. (twice daily) for the next 120 days...Assessment and Plan...Major considerations include continuing the Lovenox at a thrombophlebitis (blood clot formation in a vein) dose...his Levaquin 250 mg daily..."

At the time of discharge, the "Discharge Instructions for Home Medications" signed and dated by Physician C on 7/16/10, had not been updated to reflect the discontinuation of Levaquin, aspirin or clonazepam or the addition of Lovenox as noted in the "Discharge Summary". At the time of discharge, Patient #1 was receiving Keflex, not Levaquin and the Lovenox was being administered daily, not two times a day. The following documents were also completed by Physician C on 7/16/10:

- "Interagency Discharge Orders": Included the notation "See Med List" in the section of the form identified as "Medication orders upon discharge: Medication Prescribed..."

- "Discharge Instructions for Home Medications": Failed to include any medication additions or discontinuations after 7/16/10

- "Discharge/Transfer Instructions" section, identified as "Medications": Included the notation "See Med List"

Review of the medical record failed to support that a current and accurate medication list accompanied Patient #1 to the extended care facility at the time of discharge.

During a phone interview with Department of Medicine Physician Advisor A on 11/17/10 at 2:15 PM, Physician Advisor A reported that there was "clearly a discrepancy" between the summary (discharge) and the medication list and that accuracy was "the most important piece". Physician Advisor A reported that the "missing step" was the accuracy of the discharge instructions.

B. Patient #2
Record review revealed that on 9/6/10, Patient #2 was transported from home to the emergency department (ED) for treatment of burns and smoke inhalation. Patient #2 was stabilized and transported via helicopter to Hospital #2.

On 10/20/10, the State Agency received a complaint regarding concerns related to the accuracy of medical information sent to Hospital #2 at the time of Patient #2's transfer to that facility. The complainant reported that the medication administration record (MAR) belonged to Patient #2's spouse, who had diagnoses including Parkinson's and diabetes mellitus. The MAR contained 21 medications prescribed for Patient #2's spouse.

Review of Patient #2's medical records provided by Hospital #2 included a "Burn Patient Referral Record" dated 9/6/10 at 6:35 PM and a MAR that reportedly accompanied Patient #2 when transferred from Christiana Hospital to Hospital #2.

1. Burn Patient Referral Record
Review of this document revealed that at the time of phone referral, the physician at Christiana Hospital reported to the physician at Hospital #2 that Patient #2 had diagnoses including Parkinson's disease, diabetes mellitus, midgut volvulus (twisting of the intestine). However, Patient #2 did not have these diagnoses; these diagnoses were consistent with Patient #2's spouse's diagnoses listed on the MAR.

2. MAR, dated 7/1/08 belonged to Patient #2's spouse who resided in a nursing home. The MAR, a 7 page form contained the following information:

- the first and last name of Patient #2's spouse on each page
- listed diagnoses of Parkinson's disease, diabetes mellitus, hypertension, left shoulder degenerative joint disease, obesity, anxiety, midgut volvulus and hernia
- a list of 21 medications - including carbidopa (improves symptoms of Parkinson's disease) and neurontin (used to treat nerve pain)

Review of the ED document entitled "Trauma Service History and Physical" completed on 9/6/10 by Physician D revealed that some of the documented diagnoses and medications were specific to Patient #2's spouse. Inaccuracies included the following:

- incorrect first name: listed spouse's name
- incorrect diagnoses: listed spouse's diagnoses of Parkinson's disease, obesity, degenerative joint disease, anxiety, midgut volvulus
- incorrect medications: listed spouse's medications including carbidopa and neurontin

Review of the ED "Trauma Flow Sheet" included the following inaccurate information:

- incorrect diagnoses: listed spouse's diagnoses of Parkinson's disease and diabetes mellitus

Interview with registered nurse (RN) C on 11/17/10 at 11:50 AM confirmed these MAR findings. During the same interview, RN C reported that the hospital was aware of the complaint and that the concerns regarding incorrect information in the medical record had been addressed in the Trauma Performance Improvement Committee on 9/29/10.

During an interview with Physician E on 11/17/10 at 12:50 PM, Physician E reported that he had since reviewed Patient #2's electronic record and Patient #2's spouse's medical records and confirmed that Patient #2 did not have a history of volvulus. Physician E reported that he had reviewed the initial trauma assessment and did not believe that the false information presented, altered his "therapeutic regime" or the stabilization of Patient #2.

C. Patient #9
Review of Patient #9's "ED Discharge Instruction Sheet" dated 9/28/10 at 11:45 AM, included the following information belonging to Patient #10:

Patient #10's:
- First and last name
- Date of birth
- Patient identification number
- Medical record number
- Home address including zip code
- Home phone number

Review of the prescription given to Patient #9 at the time of discharge from the ED dated 9/28/10 at 11:45 AM, revealed a typed prescription for a controlled substance. The prescription contained Patient #10's:
- First and last name
- Date of birth
- Home address including zip code

During an interview with RN C on 11/18/10 at 11:00 AM, RN C reported that the instructions, diagnoses and prescription given to Patient #9 were correct. However, RN C reported that the entries (identified above) on the discharge instructions for Patient #9 were incorrect.

PROTECTING PATIENT RECORDS

Tag No.: A0441

Based on medical record review, policy review and staff interview, it was determined that staff failed to ensure confidentiality of patient information for 1 of 10 (10%) patients (Patient #10) reviewed in the sample. Findings include:

The hospital policy entitled "Patient Rights and Responsibilities" stated, "...You have the right...To confidentiality, regarding your medical care and information related to that care..."

The hospital policy entitled "Information Security - Information Confidentiality and Security" stated, "...Information...use and safekeeping must be protected from unauthorized access...Protected Health Information is any health information that includes the following...Name, Zip Code...Any Dates (except year)...Telephone numbers...Medical Record numbers...Account numbers..."

The following issue related to patient confidentiality was identified during the review of patient grievances and medical record review:

Patient #9 was examined and treated in the emergency department (ED) on 9/28/10. Patient #9 was given discharge instructions, a prescription for pain medication and discharged to home.

Patient #9 returned to the hospital later on 9/28/10 and reported to Patient Relations Representative A that he had gone home, looked at the hospital discharge paperwork and realized that he had been given discharge documents and a prescription with Patient #10's name on the paperwork.

Review of Patient #9's "ED Discharge Instruction Sheet" dated 9/28/10 at 11:45 AM, revealed that Patient #9 had unauthorized access to the following confidential information belonging to Patient #10:

Patient #10's:
- First and last name
- Date of birth
- Patient identification number
- Medical record number
- Home address including zip code
- Home phone number

Review of the prescription dated 9/28/10 at 11:45 AM revealed a typed prescription for a controlled substance. The prescription contained Patient #10's:
- First and last name
- Date of birth
- Home address including zip code

Interview with Senior Counsel and Privacy Officer A on 11/18/10 at 1:27 PM confirmed this finding.

CONTENT OF RECORD

Tag No.: A0449

Based on review of media reports, medical record review, policy review and staff interview, it was determined that the medical records for 2 of 4 (50%) patients (Patient #'s 4 and 6) in the sample who had been identified as being sexually assaulted at the hospital, failed to contain information to describe the patient's response to services. Findings include:

A media report dated 11/13/10, from "The News Journal", a Wilmington, Delaware newspaper, stated, "Three female patients at Christiana Hospital were fondled by a man posing as a doctor, police said Friday night. In addition to investigating the crimes, which have been classified as 'unlawful sexual contact', police are also looking into why the first incident was not reported to them for two weeks...The man posed as a doctor, entered the rooms of women who had been admitted to the hospital, 'then performed a physical exam...where he improperly touched and fondled the victims'..."

The hospital policy entitled "Safety First Learning Report: Event Reporting Policy and Procedure" stated, "...An event is an occurrence not consistent with the desired operation of Christiana Care Health Services...or the routine care of patients...Upon discovery of an event...the employee: Provides and documents intervention to the person involved as indicated...Post-event Documentation...In the patient's medical record, document a brief factual description of what happened or was observed. Staff member's and patient's account of event...Description of patient's condition following event:...patient's complaints..."

On 11/16/10 at 10:55 AM, the names and medical records for 3 of the involved patients were provided. The fourth record was provided on 11/17/10.

Medical record review revealed the following:

1. Patient #4
- The medical record lacked documentation in the progress notes by the registered nurse (RN) of any report of improper touching or fondling.

On 11/18/10 at 12:15 PM, a Nurse Manager (RN D) confirmed the lack of documentation of the event reported to the RN.

2. Patient #6
- The medical record lacked documentation in the progress notes by the RN to whom the incident was reported of any report of improper touching or fondling.

On 11/17/10 at 9:45 AM, a Nurse Manager (RN A) was interviewed. RN A confirmed the lack of documentation and stated that it was expected that the nurse receiving a report of any event by the patient should document the exchange in the medical record.

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on medical record review, policy review and staff interview, it was determined that the hospital failed to ensure that the medical record entries for 4 of 10 (40%) patients in the sample (Patient #'s 1, 8, 9 and 10), were legible, dated, timed and authenticated. Findings include:

The hospital policy entitled "Documentation in the Medical Record" stated, "...Guidelines for Documentation...Date, time...sign entries as you make them...Write or print legibly..."

Review of the document entitled "Medical-Dental Staff Rules" stated, "...Verbal orders shall be signed dated and timed by the originator at the completion of the emergency situation or procedure, but no later than 48 hours after the transmission of the verbal order. Verbal orders shall be authenticated...within forty-eight (48) hours of the transmission of the order..."

I. Patient #1 - Review of the "Emergency Department (ED) Doctor's Order Sheet" revealed the following:

a. Verbal orders received on 7/13/10 at 6:15 PM and 6:32 PM were not authenticated by the ordering physician.

b. Verbal orders received on 7/13/10 at 6:39 PM and 6:40 PM were not timed and dated at the time of physician authentication.

Interview with Manager of Accreditation Services A on 11/17/10 at 1:10 PM confirmed these findings.

II. Patient #8 - Review of the "Interdisciplinary Patient Progress Record" revealed the following:

a. The time of medical record entry was not documented on the following dates: 11/10, 11/12 and 11/14/10.

Interview with registered nurse (RN) A, on 11/17/10 at 3:30 PM confirmed this finding.

III. Patient #9 - Review of the "Emergency Physician Record" dated 9/28/10 revealed the following:

a. Physician B performed Patient #9's history and physical during Patient #9's ED encounter. The document was only partially legible.

On 11/19/10 at 9:20 AM, Manager of Accreditation Services A attempted to read Patient #9's history and physical including allergy information without success. The Manager confirmed that the document could not be read in its entirety.

IV. Patient #10 - Review of the "Emergency Physician Record" dated 9/28/10 at 9:50 AM revealed the following:

a. Physician B performed Patient #10's history and physical during Patient #10's ED encounter. The document was only partially legible.

On 11/17/10 at 9:15 AM, Project Manager of Patient Safety and Patient Peer Review A attempted to read Patient #10's history and physical without success. From 9:45 - 9:50 AM, Case/Peer Review Specialist A and the ED Program Manager (RN B), attempted to read Physician B's entries on the history and physical and confirmed that the document could not be read in its entirety.

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on medical record review, policy review and staff interview, it was determined that the hospital failed to ensure that verbal orders for 1 of 8 (13%) patients in the sample (Patient #1), were dated, timed and authenticated. Findings include:

The hospital policy entitled "Documentation in the Medical Record" stated, "...Guidelines for Documentation...Date, time and sign entries as you make them..."

Review of the document entitled "Medical-Dental Staff Rules" stated, "...Verbal orders shall be signed dated and timed by the originator at the completion of the emergency situation or procedure, but no later than 48 hours after the transmission of the verbal order. Verbal orders shall be authenticated...within forty-eight (48) hours of the transmission of the order..."

I. Patient #1 - Review of the "Emergency Department (ED) Doctor's Order Sheet" revealed the following:

a. Verbal orders received on 7/13/10 at 6:15 PM and 6:32 PM were not authenticated by the ordering physician.

b. Verbal orders received on 7/13/10 at 6:39 PM and 6:40 PM were not timed and dated at the time of physician authentication.

Interview with Manager of Accreditation Services A on 11/17/10 at 1:10 PM confirmed these findings.

CONTENT OF RECORD: STANDING ORDERS

Tag No.: A0457

Based on medical record review, policy review and staff interview, it was determined that the hospital failed to ensure that verbal orders for 1 of 8 (13%) patients in the sample (Patient #1), were authenticated. Findings include:

The hospital policy entitled "Documentation in the Medical Record" stated, "...Guidelines for Documentation...Date, time and sign entries as you make them..."

Review of the document entitled "Medical-Dental Staff Rules" stated, "...Verbal orders shall be signed dated and timed by the originator at the completion of the emergency situation or procedure, but no later than 48 hours after the transmission of the verbal order. Verbal orders shall be authenticated...within forty-eight (48) hours of the transmission of the order..."

Patient #1 - Review of the "Emergency Department (ED) Doctor's Order Sheet" revealed the following:

Verbal orders received on 7/13/10 at 6:15 PM and 6:32 PM were not authenticated by the ordering physician.

Interview with Manager of Accreditation Services A on 11/17/10 at 1:10 PM confirmed this finding.