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NEW CASTLE, DE 19720

PATIENT RIGHTS: PERSONAL PRIVACY

Tag No.: A0143

Based on policy review, document review and staff interview, it was determined that for 1 of 3 (33%) patients (Patient #6) in the sample who brought medications in from home, the hospital failed to protect the patient's right to privacy. Findings include:

Review of the patient handbook, given to all patients on admission stated, "...MeadowWood Behavioral Health Systems responsibilities include...Maintain the privacy of your health information...and appropriate, physical, administrative...safeguards to protect information..."

On 11/18/10, the State Agency received a referral from the Delaware Board of Pharmacy that had been forwarded by the Delaware State Police. It was reported that Patient #1 presented to the police station on 11/16/10 at approximately 2:40 PM, with a prescription bottle labeled for another hospitalized patient with 69 tablets and three (3) 1/2 tablets of Clonazapam (used for anxiety, muscle relaxant, seizures). Patient #1 reported to the police that the prescription had been given to her in error on 11/15/10, at the time of hospital discharge. In addition to other information, the police reported that the prescription contained:

- First and last name of Patient #6.

Review of the "Controlled Substance Inventory & Administration Record" documentation revealed the following:

Patient #1: Prescription for Clonazapam 2 gm tablets - contained 74 tablets
Patient #6: Prescription for Clonazapam 2 gm tablets - contained 69 whole tablets and three (3) 1/2 tablets

Interview with the Director of Performance Improvement/Risk Management on 12/9/10 at 11:40 AM confirmed that the incident occurred and that Patient #1 "had private possession" of Patient #6's private information, which was a "breach in confidentiality certainly with the name".

NURSING CARE PLAN

Tag No.: A0396

Based on medical record review, policy review and staff interview, it was determined that for 1 of 2 (50%) patients in the sample (Patient #1) with documented pain, staff failed to develop and/or revise the plan of care. Findings include:

Review of the hospital policy entitled "Integrated Initial Assessment" stated, "...Treatment Plan...initiated by the RN (registered nurse) who completes the nursing assessments...plan reviewed and amended (if appropriate) by the first multidisciplinary treatment team meeting following admission. Additional goals and interventions are added by the team..."

A. Patient #1 (admitted 11/11/10 & discharged 11/15/10)

Review of the admission "Acute Needs Assessment" dated 11/11/10, revealed that Patient #1 had diagnoses that included stage 3 breast cancer with possible metastasis to the lung. Patient #1 reported "daily pain in chest" during the assessment and use of Oxycodone (narcotic) every 4 - 6 hours as needed for pain. Patient #1 reported that she last self-administered Oxycodone on the day of admission.

Review of the "Interdisciplinary Assessment" included a "Screening for Pain". Patient #1 reported current use of Oxycodone and Neurontin (prescribed for nerve pain) to relieve pain.

Review of the pain assessment "How My Pain Makes Me Feel", completed by RN A, revealed that Patient #1 complained of "Throbbing", "Shooting" pain with a severity level of 8 on a scale of 0 to 10 (0 = pain free; 10 = severe pain). Patient #1 reported that the pain had persisted over the last eight months and had affected her mood, appetite and sleep.

Review of the "Medication Assessment and Response" documentation revealed Patient #1 received Oxycodone or Oxy IR (Oxycodone immediate release) medication for chest pain on:

11/12/10: 12:15 AM
11/13/10: 1:00 AM and 9:15 PM
11/14/10: 10:00 AM, 3:00 PM and 8:30 PM
11/15/10: 12:00 AM and 4:40 AM

Review of the "Initial Treatment Plan" and "Master Treatment Plan" revealed that staff had failed to initiate a care plan problem for Patient #1 that addressed pain, interventions, anticipated outcomes and achievable goals.

During an interview with the Director of Nursing on 12/13/10 at 9:00 AM, the Director confirmed that staff should have initiated a care plan for pain using the available "template".

FORM AND RETENTION OF RECORDS

Tag No.: A0438

I. Based on policy review and staff interview, it was determined that for 1 of 5 (10%) patients (Patient #4) in the sample, the hospital failed to ensure that staff was able to promptly retrieve the medical record when requested. Findings include:

Review of the hospital policy entitled "Purpose and Philosophy of the Medical Record" stated, "...medical records are...readily accessible, and permit prompt retrieval of information..."

On 12/9/10 at 10:25 AM, Surveyor A requested Patient #4's medical record. Surveyor A requested the medical record again at 1:50 PM and at 4:10 PM. The Director of Performance Improvement/Risk Management confirmed at both time intervals that staff was unable to readily locate Patient #4's medical record. When Surveyor A returned to the facility on 12/13/10 at 9:00 AM, the Director of Performance Improvement/Risk Management produced the medical record.
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II. Based on medical record review, policy review and staff interview, it was determined that for 2 of 5 (40%) patients (Patient #'s 1 and 4) in the sample, the hospital failed to ensure that the medical record was complete and accurately written. Findings include:

Review of the hospital policy entitled "Purpose and Philosophy of the Medical Record" stated, "...medical records are documented accurately..."

Review of the hospital policy entitled "Integrated Initial Assessment" stated, "...Medication Reconciliation List...RN (registered nurse) records current medications on the medication reconciliation list. The RN assigned to do the nursing assessment reviews the list with the patient for accuracy..."

Review of the hospital policy entitled "Plan of Duty - Day & Evening Shift RN" stated, "...nursing responsibilities...reviews and signs medication list..."

Review of the hospital policy entitled "Medication Security - Nursing Responsibilities" stated, "...Controlled substance brought from home...procedure...admitting nurse notifies pharmacy of medications, in order that the pharmacist can positively identify the medications...A specific physician's order must be obtained to use patient supply, and physician or pharmacist must first identify product..."

A. Patient #1
1. Review of the "Patient Belongings Sheet" documentation revealed that at the time of admission, Patient #1 was observed to have personal items including five (5) bracelets and earrings (couldn't read number). Patient #1 did not sign and/or date the document. There was no documentation by mental health associate (MHA) A to support if Patient #1 had reviewed the document for accuracy and/or if Patient #1 refused to sign the document when it was presented.

During an interview with the Director of Nursing on 12/13/10 at 9:00 AM, the Director confirmed that staff should have either had the patient sign the "Patient Belongings Sheet" or written a note documenting the patient's refusal to sign.

2. Review of the "Medication Reconciliation List", completed at the time of admission by the RN, included a list of nine (9) prescribed medications. The area identified as "Signature of Patient/Guardian" had not been signed by Patient #1 and there was no evidence to support that Patient #1 reviewed the medication list for accuracy. There was no documentation by the RN to support that Patient #1 had reviewed the document for accuracy and/or refused to sign the document.

During an interview with the Director of Nursing on 12/13/10 at 9:00 AM, the Director confirmed that staff should have either had the patient sign the "Medication Reconciliation List" acknowledging the accuracy of the listed medications or written a note documenting the patient's refusal to sign.

3. Review of the "Patient's Personal Supply of Medications" log revealed that staff failed to document the following information in the log upon receipt of medication brought from home:

- Date of medication receipt
- Medication validation by the pharmacist or MD
- Location of medication (including if medication returned to family)
- Advisement of return of medication on discharge (stipulations)
- Disposition of medication at the time of discharge

During an interview with the Director of Nursing on 12/13/10 at 9:00 AM, the Director reported that staff was expected to document/complete all of the elements listed on the "Patient's Personal Supply of Medications" log. The Director reported that the logs were utilized as performance improvement monitoring and tracking tools and were reviewed by the Director on a monthly basis.

4. Review of the "Discharge Instructions Sheet" documentation revealed an entry by RN B that Patient #1 had signed for receipt of "belongings". However, review of the "Patient Belongings Sheet" documentation revealed that at the time of discharge, RN B and Patient #1 failed to sign and date the document.

During an interview with RN B on 12/9/10 at 1:55 PM, RN B confirmed that the documentation was contradictory.

5. Review of the "Medication Reconciliation List", completed at the time of discharge, contained the typed statement "All stored medications returned to the patient (If prescribed by Our MD [medical doctor])." The identified section was signed by Physician A, RN B and Patient #1.

Licensed practical nurse (LPN) A was interviewed on 12/9/10 at 1:05 PM. LPN A reported that on the day of Patient #1's discharge, the following occurred:

- LPN A failed to return Patient #1's secured bottle of Oxycodone tablets
- LPN A inadvertently gave Patient #1 a prescription bottle belonging to Patient #6

LPN A confirmed that Patient #1 was not discharged with all of the stored medications that Patient #1 had brought from home and that the documentation on the "Medication Reconciliation List" was inaccurate.

B. Patient #4
1. Review of the "Patient's Personal Supply of Medications" log dated 3/11/10, revealed a written statement "using Pts (patient's) meds" for the medication identified as prometrium (hormone).

Review of "Physician's Orders" revealed no written or verbal orders for the use of Patient #4's personal medications.

During an interview with the Director of Nursing on 12/13/10 at 12:55 PM, the Director reviewed the medical record and confirmed that Patient #4 received only medication dispensed by the hospital pharmacy and that the notation regarding the use of Patient #4's personal medication while hospitalized was inaccurate.
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III. Based on closed medical record review, policy review and staff interview, it was determined that for 2 of 4 (50%) discharged patients (Patient #'s 1 and 4) in the sample, the hospital failed to ensure that the "Medication Reconciliation List" was current at the time of discharge and included in the medical record. Findings include:

Review of the hospital policy entitled "Discharge Instructions & Arrangements" stated, "...Physician Responsibility...Discharge medication(s) are listed on the 'Medication Reconciliation List'. The patient is given the yellow copy...The RN/LPN gives the prescriptions to the patient and reviews the prescriptions with the patient...The Discharge Instruction Sheet is kept on the patient's medical chart...The white and pink copies of the discharge instruction form remain in the chart..."

A. Patient #1
Review of the closed medical record revealed a written prescription, dated 11/15/10, for Cymbalta (prescribed for depression, anxiety, chronic pain) 60 milligrams (mg) by mouth every morning with three (3) refills.

Review of the "Medication Reconciliation List" signed and dated on 11/15/10 by Patient #1, Physician A and RN B revealed that at the time of discharge, the medication list had not been updated to reflect the addition of the medication, Cymbalta.

During an interview on 12/13/10 at 9:45 AM, Physician A confirmed that it was the responsibility of the physician to ensure that the "Medication Reconciliation List" was current at the time of discharge and that he should have updated the medication instructions to include Cymbalta.

B. Patient #4
Review of the closed medical record revealed the absence of the "Medication Reconciliation List".

On 12/13/10 at 2:25 PM, the Director of Performance Improvement/Risk Management and the Director of Nursing reviewed the chart and confirmed that the medical record failed to include a "Medication Reconciliation List". The Director of Nursing confirmed that the list should have been in the medical record.

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on medical record review, document review and staff interview, it was determined that the hospital failed to ensure that physician orders for 2 of 5 (40%) patients in the sample (Patient #'s 1 and 4), were dated and/or timed at the time of medical record entry or authentication. Findings include:

The hospital document entitled "Rules & Regulations of the Medical Staff" stated, "...Orders...must be complete, including...time...Physicians making verbal or telephone orders...shall sign, date and time orders with in 48 hours..."

A. Patient #1 - "Physician's Orders" failed to include:

11/12/10
- Written order - Failed to include time of order entry

B. Patient #4 - "Physician's Orders" failed to include:

3/11/10
- 7:10 PM: Telephone order - Physician failed to include the date and time of order authentication
- 9:00 PM: Telephone order - Physician failed to include the time of order authentication

Interview with the Director of Nursing on 12/13/10 at 1:10 PM confirmed these findings.

CONTENT OF RECORD: FINAL DIAGNOSIS

Tag No.: A0469

Based on closed medical record review, hospital document review and staff interview, it was determined that for 1 of 4 (25%) discharged patients (Patient #4) in the sample, staff failed to ensure that the medical record was completed within 30 days of discharge. Findings include:

The hospital document entitled "Rules & Regulations of the Medical Staff" stated, "...discharge summaries...shall be completed within 30 days following the patient's discharge..."

Review of the closed medical record revealed Patient #4 was discharged from the hospital on 3/15/10.

Review of the "Discharge Summary" revealed Physician A dictated Patient #4's discharge summary on 5/30/10, 76 days post hospitalization. The discharge summary was signed and dated by Physician A on 6/10/10 (87 days after discharge).

Surveyor A and the Director of Nursing reviewed Patient #4's "Discharge Summary" on 12/13/10 at 12:55 PM and confirmed that the medical chart, which included the patient's discharge summary, was not completed within 30 days of discharge.

DELIVERY OF DRUGS

Tag No.: A0500

Based on policy review, document review and staff interview, it was determined that for 2 of 3 (67%) patients (Patient #'s 1 and 6) in the sample who brought medications in from home, the hospital failed to distribute medication in accordance with applicable standards of practice, consistent with Federal and State law. Findings include:

Standards of Nursing Practice, Delaware Code, Title 24, Chapter 19 Nursing stated, "..."Dispensing"means providing medication to an order of a practitioner...Record keeping must...allow retrospective review of accountability...The dispensing nurse shall assume the responsibility of proper storage..."

Review of the hospital policy entitled "Medication Security - Nursing Responsibilities" stated, "...Controlled substance brought from home...procedure...medications must be counted at each change of shift by nurses along with controlled substances supplied by pharmacy. Signature on Count Record confirms that patient supply agrees with amount listed on Inventory Record...Controlled medication brought in and administered via the above policy which are no longer required by the patient may be returned to the patient...at the discretion of the physician upon a written order. The patient or significant other signs the Controlled Substance Inventory & Administration Record for the amount returned..."

Review of the hospital policy entitled "Plan of Duty - Day & Evening Shift RN" stated, "...shift responsibilities...Count controlled drugs with off-going nurse, sign off on Controlled Drug Inventory Sheet...reviews and signs medication list...End of shift responsibilities...Count controlled drugs with oncoming nurse to whom the medication keys will be given and sign off-going line on Controlled Drug Inventory sheet..."

On 11/18/10, the State Agency received a referral from the Delaware Board of Pharmacy that had been forwarded by the Delaware State Police. It was reported that Patient #1 presented to the police station on 11/16/10 at approximately 2:40 PM, with a prescription bottle labeled for another hospitalized patient with 69 tablets and three (3) 1/2 tablets of Clonazepam (used for anxiety, muscle relaxant, seizures).

A. Patient #1 (admitted 11/11/10)
Review of the "Controlled Substance Inventory & Administration Record" documentation revealed that Patient #1 brought the following medications from home:

1. Clonazepam 2 milligrams (mg) - 74 tablets
2. Oxycodone HCL 5 mg - 3 tablets

Review of the above document dated 11/15/10, included the signatures of Patient #1 and licensed practical nurse (LPN) A. The signatures were an attestation that the two (2) medications were removed from the unit and returned to Patient #1 at the time of discharge (on 11/15/10).

B. Patient #6 (admitted 11/14/10)
Review of the "Controlled Substance Inventory & Administration Record" documentation revealed that Patient #6 brought the following medication from home:

1. Clonazepam 2 milligrams (mg) - 69 whole tablets and three (3) 1/2 tablets

C. Review of the "Controlled Substance Count Record" (log signed by two nurses at the beginning of each eight hour shift, attesting to the accuracy of the controlled substance count) revealed the following:

11/15/10 (7:00 AM - 3:00 PM shift): The controlled substance count was signed off as accurately reconciled by LPN's A and B at 3:00 PM.

11/15/10 (3:00 PM - 11:00 PM shift): While performing the controlled substance count at 11:00 PM, one bottle of Clonazepam 2 mg - 69 tablets, belonging to Patient #6, was identified as missing by LPN's B and C.

During an interview with LPN A on 12/9/10 at 1:05 PM, LPN A confirmed that on the day of Patient #1's discharge, she had failed to return Patient #1's secured bottle of Oxycodone tablets and had inadvertently given Patient #1 a prescription bottle belonging to Patient #6 from the locked medication cabinet. LPN A confirmed that she had signed off on 11/15/10 at 3:00 PM as having an accurate controlled substance count. LPN A reported that it was not until the following day that she recognized when/how the error occurred.

During an interview with the Director of Nursing on 12/13/10 at 10:10 AM, the Director reported that as a result of the hospital's investigation, it was determined that there was a "gap in the system - clearly somebody trusted somebody else when counting". The Director reported that the process regarding keeping patient's personal controlled medication on the units was changed and that all staff were educated.