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Based on record review and staff interview, it was determined that the hospital failed to ensure that the medical staff provided the necessary care and treatment to meet the needs of all its patients, as evidenced by: a failure of the attending physician of record to acknowledge, address and/or manage one (1) patient with an abnormally low and critically reported blood glucose level. Patient # 27.

The findings included:

According to hospital policy # CS.082, entitled " Critical Values Tests and Results Reporting " , last reviewed and revised September 2010, the following directives were included: I. Purpose, " To define critical tests and critical results (value) reporting; To identify clinical tests and results (value) that are considered to be life-threatening " . II. Policy, " Critical results require rapid communication even if from a routine test, as any delay in reporting may result in serious adverse outcome for the patient. The intent of this critical values and result notification policy is to promote the initiation of potentially life-saving therapy to help improve patient outcome. III. Procedure d. B., and e., " When critical lab results are reported to the nurse, the House officer and/or attending physician will be notified in 30 minutes ...Upon notifying the physician and orders obtained, the patient is to be treated or physician recommendations implemented. "

Included on "List a" of the Critical Labs Values was the following blood chemistry results alert: "Glucose: Low Value (less than): 40 mg/dL".

Hospital Policy # CS.062, entitled 'Glucose Monitoring', last reviewed November 2010, stipulated and included the following under Section III, Procedure, items # 8: "If the results are abnormal (below 60 mg/dL) the nurse will follow the Hypoglycemia treatment protocol in the Standardized Subcutaneous Insulin order unless a different order has been specified by the physician."

The Standardized Subcutaneous Insulin Orders, last revised September 2010, stipulated and included the following standardized policy and practice under item # 7, titled 'Hypoglycemia Treatment' : "B. If the patient cannot take PO (oral), give: 12.5 grams (25ml) Dextrose 50% IV push (intravenous), or 1 mg Glucagon IM (intramuscular) if no IV access and insert IV; C. Recheck FSBG (finger stick blood glucose) every 20 minutes until FSBG greater than or equal to 90 mg/d/L or [as determined by the physician]. If repeat FSBG less than 90 mg/d/L, repeat treatment as in (A) or (B) above; and E. If FSBG less than or equal to 40 mg/dL, repeat FSBG with bedside monitor to confirm value; Treat as in A-C above and if patient does not have symptoms of low blood glucose, send STAT serum glucose to confirm value was low."

Medical record review revealed that Patient # 27 had a significant change and decline in his/her clinical condition, on November 24, 2010. The nursing note entry and the physician's progress note both confirmed that the patient was found to be severely hypoxic with labored respirations; had an abnormally low oxygen saturation level; unstable vital signs; and a significant decline in his/her neurological status (level of consciousness).

A Rapid Response was initiated at approximately 8:12 A.M on November 24, 2010. The patient was reportedly volume resuscitated, suctioned and briefly provided with assisted ventilations via ambu bag. According to medical record documentation, the patient's respiratory status improved, however, the level of consciousness remained altered and
"lethargic", with a Glasgow Coma Scale (GCS) of 6T (six)/Severe Classification. Previously documented neurological assessments entered onto the Nursing Daily Flow sheets, revealed the patient's baseline GCS as 14T/Mild Classification. [GCS is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessment. If patient is tracheally intubated then verbal response designated with " T ".]

Subsequent to the Rapid Response, diagnostic laboratory (lab) studies were ordered by the attending physician to determine a possible cause for the patient's sudden change in level of consciousness.

At approximately 2:20 P.M. on November 24, 2010, critical lab results were received by the nursing staff and documented on the "Critical Value Results" sticker (CVR). The following critical lab finding was included and recorded on the sticker: "Glucose 39."

Documentation in the nursing notes and on the CVR sticker confirmed that the covering attending physician was immediately notified by the nurse of the critical findings on November 24, 2010 at 2:20 PM.

A subsequent review of the physician's progress note, dated November 24, 2010 at 2:25 P.M., revealed that the physician failed to acknowledge and/or address the patient's critically low blood glucose level.

The following assessment findings were documented by the physician in the progress note dated November 24, 2010 at 2:25 P.M.: "Severe Anemia secondary to possible bleeding; Hypotension; Encephalopathy (Multifactorial); R/O Retroperitoneal Bleeding; Hypothyroidism; and Acute on Chronic Kidney Injury." There was no documentation of an associated diagnosis or reference to the critical glucose level.

Concurrent physician orders documented at 2:45 P.M. addressed only the management of the patient's severe, acute blood loss anemia. The order directed the infusion of 500ml of intravenous normal saline bolus and the transfusion of two (2) units of Packed Red Blood Cells (PRBC) after type and cross match.

There was no documented evidence in the medical record that the patient's critically low blood glucose level was ever medically treated, managed or corrected. There was furthermore no evidence that that the accepted standard of practice for managing patient's with critically low blood glucose levels was initiated; nor was the hospital's standardized protocol for hypoglycemic initiated.

Additionally, documentation lacked evidence that the critically low blood glucose level was ever reassessed or that a serum sample or finger stick was ever redrawn and submitted for lab re-analysis to verify its accuracy and/or severity.

Documentation confirmed that the patient continued to decline neurologically and hemodynamically throughout the remainder of the day. He/she became increasingly unresponsive, tachycardic and hypotensive. Patient # 27 subsequently expired while receiving the 2nd (second) unit of PRBCs on November 25, 2010 at 6:20 A.M.

A face-to-face interview was conducted with the Vice President of Patient Care Services (VP/PCS) on January 26, 2011 at approximately 11:20 A.M. After a thorough review of the medical record, the VP/PCS acknowledged that the attending physician of record failed to acknowledge, address and/or manage Patient # 27's abnormally low and critically reported blood glucose level; and that the accepted standard of practice for managing patient's with critically blood glucose levels was not initiated and immediately put into practice without delay. The record was reviewed January 26, 2011.

Based on record review and staff interview for one (1) patient, it was determined that the nursing staff failed to provide on-going monitoring and re-evaluation of a patient with a critically reported lab result and to follow through with the attending physician to ensure the process for communicating critical laboratory values was confirmed. Patient # 27.

The findings included:

According to hospital policy # CS.082, entitled "Critical Values Tests and Results Reporting", last reviewed and revised September 2010, the following directives were included: I. Purpose, "To define critical tests and critical results (value) reporting; To identify clinical tests and results (value) that are considered to be life-threatening." II. Policy, "Critical results require rapid communication even if from a routine test, as any delay in reporting may result in serious adverse outcome for the patient. The intent of this critical values and result notification policy is to promote the initiation of potentially life-saving therapy to help improve patient outcome." III. Procedure d. B., and e., " When critical lab results are reported to the nurse, the House officer and/or attending physician will be notified in 30 minutes ...Upon notifying the physician and orders obtained, the patient is to be treated or physician recommendations implemented."

Included on "List a" of the Critical Labs Values was the following blood chemistry results alert: " Glucose: Low Value (less than): 40 mg/dL".

Hospital Policy # CS.062, entitled 'Glucose Monitoring', last reviewed November 2010, stipulated and included the following under Section III, Procedure, items # 8 and 10 respectively: "If the results are abnormal (below 60 mg/dL) the nurse will follow the Hypoglycemia treatment protocol in the Standardized Subcutaneous Insulin order unless a different order has been specified by the physician"; and, "When the results are abnormal (high or low) the nurse must document in the progress notes, the clinical intervention and the patient reaction."

The Standardized Subcutaneous Insulin Orders, last revised September 2010, stipulated and included the following standardized policy and practice under item # 7, titled 'Hypoglycemia Treatment': "B. If the patient cannot take PO (oral), give: 12.5 grams (25ml) Dextrose 50% IV push (intravenous), or 1 mg Glucagon IM (intramuscular) if no IV access and insert IV; C. Recheck FSBG (finger stick blood glucose) every 20 minutes until FSBG greater than or equal to 90 mg/d/L or [as determined by the physician]. If repeat FSBG less than 90 mg/d/L, repeat treatment as in (A) or (B) above; and E. If FSBG less than or equal to 40 mg/dL, repeat FSBG with bedside monitor to confirm value; Treat as in A-C above and if patient does not have symptoms of low blood glucose, send STAT serum glucose to confirm value was low."

Medical record review revealed that Patient # 27 had a significant change and decline in his/her clinical condition, on November 24, 2010. The nursing note entry and the physician's progress note both confirmed that the patient was found to be severely hypoxic with labored respirations; had an abnormally low oxygen saturation level; unstable vital signs; and a significant decline in his/her neurological status (level of consciousness).

A Rapid Response was initiated at approximately 8:12 A.M on November 24, 2010. The patient was reportedly volume resuscitated, suctioned and administered assisted ventilations via ambu bag. According to medical record documentation, the patient's respiratory status improved, however, the level of consciousness remained altered and "lethargic", with a Glasgow Coma Scale (GCS) of 6T (six)/Severe Classification. Previously documented neurological assessments entered onto the Nursing Daily Flow sheets, revealed the patient's baseline GCS as 14T/Mild Classification. [GCS is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessment. If patient is tracheally intubated then verbal response designated with "T" .]

Subsequent to the Rapid Response, diagnostic laboratory (lab) studies were ordered by the attending physician to determine a possible cause for the patient's sudden change in level of consciousness.

At approximately 2:20 P.M. on November 24, 2010, critical lab results were received by the nursing staff and documented on the "Critical Value Results" sticker (CVR). The following critical lab finding was included and recorded on the sticker: "Glucose 39."

Documentation in the nursing notes and on the CVR sticker indicated that the nurse immediately notified the covering attending physician of the critical findings at 2:20 P.M. on November 24, 2010.

A review of the physician's progress note, dated November 24, 2010 at 2:25 P.M., revealed that the physician failed to acknowledge and/or address the patient's critically low blood glucose level.

Furthermore, a concurrent review of the nursing documentation revealed the following deficient practice findings related to the subsequent nursing management of the patient after notification of the critical lab values: failed to provide any documented evidence that the RN followed up with the physician to confirm his/her acknowledgement of patient's critical lab results and to initiate subsequent orders; failed to document evidence of on-going patient assessment for signs and symptoms of worsening Hypoglycemia or a re-evaluation of patient's critically low glucose results; failed to comply with the glucose monitoring policy when it was determined that the patient had a critically low glucose level; and failed to initiate the standardized subcutaneous insulin orders for hypoglycemia treatment.

There was furthermore, no documented evidence in the medical record that the patient's critically low blood glucose level was ever medically treated, managed or corrected; or that the accepted standard of practice for managing patient's with critically low blood glucose levels was initiated and immediately put into practice.

Additionally, there was no documented evidence that the critically low blood glucose levels were ever reassessed or that a serum sample or finger stick was ever redrawn and submitted for lab re-analysis to verify its accuracy and/or severity.

Documentation confirmed that the patient continued to decline neurologically and hemodynamically throughout the remainder of the day. He/she became increasingly unresponsive, tachycardic and hypotensive. Patient # 27 subsequently expired while receiving the 2nd (second) unit of PRBCs on November 25, 2010 at 6:20 A.M.

A face-to-face interview was conducted with the Vice President of Patient Care Services (VP/PCS) on January 26, 2011 at approximately 11:35 A.M. After a thorough review of the medical record, the VP/PCS acknowledged that the nursing staff failed to provide on-going monitoring and re-evaluation of a patient with a critically reported lab result; failed to follow through with the physician to ensure the process for communicating critical laboratory values was confirmed; and failed to comply with and initiate the accepted standard of practice for managing patient's with critically low blood glucose levels. The record was reviewed January 26, 2011.

Based on record review and staff interview for one (1) patient, it was determined that the nursing staff failed to consistently adhere to the hospital ' s established policy on the transfusion of blood/blood products, specifically the section related to the completion of administration and the disposition of partially unused blood. Patient # 27.

The findings include:

According to hospital policy # CS.107, entitled ' Transfusion of blood/blood products ' , last revised June 21, 2010, the following directives were included under Section VIII, ' Completion of Administration ' , items # C, D, and H respectively: " If the blood transfusion is not completely transfused, the amount transfused must be documented on the transfusion Record and a physician/licensed independent practitioner (LIP) member of the patient care team notified; Partially and wholly unused products must be returned to the Blood Bank so proper disposition of each product can be recorded. When returning partially transfused or wholly unused blood products, notify the Blood Bank about the return and the reason for the return; and, after the completion of each blood product transfusion, an entry from the caregiver must be written in the note section of the medical record ... "

Medical record review revealed that Patient # 27 had a significant change and decline in his/her clinical condition, on November 24, 2010. A Rapid Response was initiated at approximately 8:12 A.M on November 24, 2010. The patient was reportedly volume resuscitated, suctioned and administered assisted ventilations via ambu bag. Subsequent to the Rapid Response, diagnostic laboratory (lab) studies were ordered by the attending physician.

At approximately 2:20 P.M. on November 24, 2010, critical lab results were received by the nursing staff and documented on the " Critical Value Results " sticker (CVR). The following critical lab findings were recorded on the sticker: " Glucose 39; BUN 113 (Blood Urea Nitrogen level); Hgb 4.5 (Hemoglobin) and Hct 14.9 (Hematocrit). "

Subsequent to these critical value findings, the physician documented an order on November 24, 2010 at 2:45 P.M. to transfuse the patient with two (2) units of Packed Red Blood Cells (PRBC).

Review of the " Transfusion Record " revealed that Patient # 27 began receiving the first (1st) unit of PRBCs on November 25, 2010 at 12:45 A.M.

During the administration of the blood products, hemodynamic monitoring of the patient ' s vital signs and observations for signs and symptoms of possible transfusion reaction revealed that Patient # 27 was clinically and hemodynamically unstable as evidenced by the following:

Nursing documentation revealed that during the first hour of the transfusion, the patient was neurologically unresponsive and had sustained and continuous tachycardia with recorded heart rates of 121-131. Additionally, hemodynamic monitoring revealed that the patient was acutely hypotensive with systolic range of 55-73 mm Hg and diastolic range of 20-49 mm Hg.

Continued reviews of the Transfusion Record revealed that after the first hour of required monitoring, staff was no longer able to detect or palpate the patient ' s blood pressure (BP). Documentation indicated that the patient continued without a recordable BP for the next four (4) hours successively. The monitoring record confirmed that from 2:45 A.M. on November 25, 2010 until the patient was pronounced dead at 6:20 A.M. on November 25, 2010, the BP was documented as " nonpalpable " .

According to the Transfusion Record, the administration of the blood products was stopped at 6:25 A.M., secondary to the patient ' s death, with approximately 150ml of the PRBC remaining and not infused.

Subsequent review of the nursing progress notes failed to provide evidence that a documented entry was made as to the disposition of the patient ' s unused blood product after his/her death.

A face-to-face interview was conducted with the Vice President of Patient Care Services (VP/PCS) on January 26, 2011 at approximately 11:40 A.M. Inquiry was made as to the disposition of the remaining and unused blood products. After review of the medical record failed to provide further clarification, the V.P. stated that the blood was " probably " returned to the Blood Bank. However, there was no documented evidence to confirm and corroborate the assumption. The record was reviewed January 26, 2011.

Based on record review and staff interview, it was determined that the attending physician failed to promptly complete and accurately record a comprehensive progress note detailing the events surrounding a critical change and subsequent death of one (1) patient, in accordance with federal regulation standards and the hospital's Medical Staff Rules and Regulations, on the date in which the patient expired. Patient # 27

The findings included:

Federal Standard 42 CFR 482.24 (b) guidelines included and very specifically stipulated that the hospital must ensure that all medical records accurately and completely document all evaluations, treatments, interventions, care provided and the patient's response to those treatments, interventions and care.

The hospital's Medical Staff Rules and Regulations, last reviewed and signed by the Medical Director and the Governing Body on January 18, 2006, stipulated the following under Section C, items #1 and # 6, respectively: "All patients shall be seen daily by the admitting physician or his/ her designated coverage, with appropriate notation of any significant events in the physician progress notes "; and, "A practitioner note summarizing the patient's condition and the rationale for any change in treatment shall be entered into the progress note each day."

Medical record review revealed that Patient # 27 had a significant change and decline in his/her clinical condition, on November 24, 2010. The nursing note entry and the physician's progress note both confirmed that the patient was found to be severely hypoxic with labored respirations; had an abnormally low oxygen saturation level; unstable vital signs; and a significant decline in his/her neurological status (level of consciousness).

A Rapid Response was initiated at approximately 8:12 A.M on November 24, 2010. The patient was reportedly volume resuscitated, suctioned and administered assisted ventilations via ambu bag. According to medical record documentation, the patient's respiratory status improved, however, the level of consciousness remained altered and "lethargic".

Subsequent to the Rapid Response, diagnostic laboratory (lab) studies were ordered by the attending physician to determine a possible cause for the patient's sudden change in neurological status.

At approximately 2:20 P.M. on November 24, 2010, critical lab results were received by the nursing staff and documented on the "Critical Value Results" sticker (CVR). The following critical lab findings were recorded on the sticker: "Glucose 39; BUN 113 (Blood Urea Nitrogen level); Hgb 4.5 (Hemoglobin) and Hct 14.9 (Hematocrit)."

Subsequent to these critical value findings, the physician in attendance documented an order on November 24, 2010 at 2:45 P.M. to transfuse the patient with two (2) units of Packed Red Blood Cells (PRBC).

Review of the "Transfusion Record" revealed that Patient # 27 did not begin receiving his/her first (1st) unit of PRBCs until November 25, 2010 at 12:45 A.M.

During the administration of the blood products, hemodynamic monitoring of the patient's vital signs and observations for signs and symptoms of possible transfusion reaction revealed that Patient # 27 was clinically and hemodynamically unstable, as evidenced by the following:

Nursing documentation revealed that during the first hour of the transfusion, the patient was neurologically unresponsive and had sustained and continuous tachycardia with recorded heart rates of 121-131. Additionally, hemodynamic monitoring revealed that the patient was acutely hypotensive with systolic range of 55-73 mm Hg and diastolic range of 20-49 mm Hg.

Continued reviews of the Transfusion Record revealed that after the first hour of required monitoring, staff was no longer able to detect or palpate the patient's blood pressure (BP). Documentation from the Transfusion Monitoring record indicated that the patient continued without a recordable BP for the next four (4) hours successively. The monitoring record confirmed that from 2:45 A.M. on November 25, 2010 until the patient was pronounced dead at 6:20 A.M. on November 25, 2010, the BP was documented as "nonpalpable".

According to the Transfusion Record, the administration of the blood products was stopped at 6:25 A.M., five minutes after the patient expired at 6:20 A.M., with approximately 150ml of the PRBC remaining and not infused.

A thorough and comprehensive review of the medical record failed to provide documented evidence that the physician promptly completed and accurately recorded a comprehensive progress note detailing the events surrounding the critical change in Patient # 27's clinical condition and his/her subsequent death on the actual date on which the patient expired.

A face-to-face interview was conducted with the Vice President of Patient Care Services (VP/PCS) on January 26, 2011 at approximately 11:20 A.M.

He/she acknowledged that during the course of a previous telephone investigation inquiry conducted by the Department of Health on January 18, 2011, concerning specific events surrounding the administration of blood to a hemodynamically unstable patient, the hospital referenced the patient's medical record.

The VP/PCS stated that it was during the review of the patient's record, that administration realized that the physician failed to document a detailed progress note related to the patient's subsequent death.

He/she stated that subsequent to the off-site telephone inquiry findings, the physician and nurse, specifically involved with the patient's care, were questioned concerning the omitted progress note. According to the VP/PCS, both the physician and the nurse had initially insisted that the physician had documented a progress note in Patient # 27's medical record after the patient's demise on November 25, 2010.

In fact, record review on January 26, 2011 had concluded that there had been no additional documentation entered into Patient # 27's medical record from the medical staff since the date prior to the patient's death (November 24, 2010) until January 19, 2011.

Investigation revealed that, as a result of the Department of Health's preliminary telephone inquiry and discovery made on January 18, 2011, a late entry Discharge Summary was dictated by the attending physician on January 19, 2011.

However, when the physician managing the care of the patient on November 25, 2010 had been called by hospital administration to review the record, it was again acknowledged and determined that no documentation of a death summary had been recorded in the medical record on the actual date of the patient's death (November 25, 2010), or on any date thereafter. Furthermore, it was discovered that there were no recorded progress notes of any sort or from any licensed practitioner, either medicine or nursing, entered on the date in which the patient died (November 25, 2010).

The Vice President of Patient Care Services stated that the physician was then directed to document a "late entry" progress note in order to complete the record. However, on the date of on-site survey, January 26, 2011, the progress note from the physician of record, related to the death of the Patient # 27 on November 25, 2010, had still not been documented and entered into the medical record.

The record was reviewed January 26, 2011.

1. Based on record review and staff interview for one (1) patient, it was determined that the attending physician failed to adhere to federal regulations regarding the necessity to document the course and results of care, treatment and services for patients; and failed to adhere to the hospital's established policy related to physician responsibilities for post mortem care and the completion of medical records.. Patient # 27.

The findings included:

The Medical Staff Bylaws, last adopted and amended by the Medical Staff on January 15, 2008 and approved by the Board of Directors on March 25, 2008, specifically directed and included the following under Section 2.4.4, entitled 'Basic Responsibilities of Medical Staff Membership: "Once appointed, the ongoing responsibilities of each member of the medical staff, both physicians and AHPs (Allied Health Professionals) alike, to the extent such responsibilities are applicable, include: Preparing and completing in a timely, accurate and factually-correct manner medical records and other required records for all the patients to whom the member provides care in the hospital."

Hospital policy # CS.031, last reviewed September 30, 2008, entitled " Post Mortem Care", directed and included the following concerning 'Physician Responsibilities' in the death of a patient: "Pronounce the patient's death; Determine if the patient is a coroner's case, document in the medical record, and notify the medical examiner as necessary; Notify the family immediately of death. Notification of death shall be documented in the physician progress notes of the medical record, and shall include who was notified and at what time notification occurred; and Complete Death Certificate Worksheet and write a death note in the progress notes.

Medical record review revealed that Patient # 27 had a significant change and decline in his/her clinical condition, on November 24, 2010. The nursing note entry and the physician's progress note both confirmed that the patient was found to be severely hypoxic with labored respirations; had an extremely low oxygen saturation level; unstable vital signs; and a significant decline in his/her neurological status (level of consciousness).

A Rapid Response was initiated at approximately 8:12 A.M on November 24, 2010. The patient was reportedly volume resuscitated, suctioned and briefly provided with assisted ventilations via ambu bag. According to medical record documentation, the patient's respiratory status improved, however, the level of consciousness remained altered and
"lethargic".

Subsequent to the Rapid Response, diagnostic laboratory (lab) studies were ordered by the attending physician to determine a possible cause for the patient's sudden change in neurological status.

Later documentation revealed that the patient was managed for severe, acute blood loss anemia and transfused with PRBCs. During the administration of the blood products, hemodynamic monitoring of the patient's vital signs revealed that Patient # 27 was clinically and hemodynamically unstable.

Nursing documentation confirmed that the patient continued to decline. He/she became increasingly unresponsive, tachycardic and hypotensive. Patient # 27 subsequently expired while receiving the 2nd (second) unit of PRBCs on November 25, 2010 at 6:20 A.M.

A thorough and comprehensive review of the medical record failed to provide evidence that the physician documented, in compliance with federal regulations and hospital policies, a comprehensive progress note detailing the events surrounding Patient #27's subsequent death on the actual date on which he/she expired.

Record review revealed that there was no official death note summary/documentation found in the medical record from any physician on November 25, 2010 or thereafter. Additionally, the record lacked evidence of a physician's note that corroborated the actual death of the patient with the time and date of death; coroner notification or coroner release; and no documentation from the physician as to which family member was notified and at what time the notification was made.

A face-to-face interview was conducted with the Vice President of Patient Care Services (VP/PCS) on January 26, 2011 at approximately 11:20 A.M. After review of the medical record, the VP/PCS acknowledged that the physician failed to document a detailed and accurate death summary progress note in accordance with federal regulations and hospital policy.

The record was reviewed January 26, 2011.

Addendum:
Subsequent to the on-site visit and investigation conducted on January 26, 2011, the hospital had directed the physician to document a "late entry" progress note for the November 25, 2010 patient encounter.

Review of the submitted document, dictated by the physician on January 27, 2011 and sent to the surveyor on January 28, 2011, revealed the following identified inconsistencies:

1) In accordance with Federal Regulations (A-0438, 42 CFR 482.24 (b), Standard Form and Retention of Record), the physician failed to provide an accurate, complete and timed detail of the pertinent events involving the patient's sudden change in clinical condition and subsequent death. Documentation presented was vague, incomplete and not sequential. Pertinent information was not detailed for critical timing of events.

In the submitted progress note, the physician prefaced the documentation by stating the following: "The note below is based on the review and based on the recollection of the memory of the events that happened".

2) The physician's documentation failed to satisfy the hospital's Health Information Management's (HIM) departmental policy and requirements for the submission of "late entry" progress notes. Departmental Policy # 8010.017, entitled "Patient Amendment of Medical Records" very clearly stipulated and included the following: "C. When a pertinent entry was missed or not written in a timely manner, the author must meet the following requirements: Identify the new entry as a "late entry"; Enter the current date and time ...; When making a late entry, document as soon as possible. There is no limit for writing a late entry; however, the longer the time lapse, the less reliable the entry becomes".

Review of the physician's note revealed the following related to the aforementioned HIM policy requirements for late entry notes: the physician failed to title the document as a "late entry"; failed to enter the current date and time in the heading of the document referencing a "late entry" note; and because the documentation submitted lacked pertinent information; was not sequentially documented clearly depicting the intensity of services rendered during the significant phase; submitted two (2) months late, and an admitted attempt at memory recall, the entry could not be conclusively accepted as an accurate and factual rendering of a death summary note.

2. Based on record review and staff interview, it was determined that the nursing staff failed to adhere to the federal regulations and hospital documentation policy related to proper documentation entry and medical record content, as evidenced by a failure to accurately document complete and properly time-formatted progress notes detailing the events related to one (1) patient who had a significant change in his/her clinical condition, became hemodynamically unstable and subsequently died. Patient # 27.

The findings included:

The Conditions of Participation for Hospitals (CoP), Federal Standard A-0450, 42 CFR 482.24 (c) (1), for Medical Record Content, included and stipulated in its guidelines, the following related to the timing, dating and authenticating of all medical records: "The time and date of each entry (orders, reports, notes, etc.) must be accurately documented...Timing establishes when an order was given, when an activity happened ... Timing and dating entries is necessary for patient safety and quality of care; and, Timing and dating of entries establishes a baseline for future actions or assessments and establishes a timeline of events."

The hospital policy entitled "SBAR Communication/Documentation", last reviewed July 6, 2009, included the following directive under Section I, Purpose: "Establish a standardized model for communicating essential and significant patient information between clinical and non-clinical personnel ...Complete, timely and accurate communication is essential to ensure continuity in patient care as well as ensuring proper operational efficiency." The policy identified SBAR as follows: "SBAR is an acronym that stands for Situation-Background-Assessment-Recommendation."

A review of the nursing progress notes dated November 24, 2010 at 6:10 P.M. and November 26, 2010 at 7:00 AM. was done and revealed the following findings:

Patient # 27 had a significant change and decline in his/her clinical condition on November 24, 2010. The nursing progress note documented that the patient had an episode of severe respiratory distress; was found to be severely hypoxic with labored breathing; had an abnormally low oxygen saturation level (87%); unstable vital signs; and a significant decline in his/her neurological status (level of consciousness).

According to documentation on the Rapid Response Team Record, a Rapid Response was initiated at approximately 8:12 A.M on November 24, 2010. The patient was reportedly volume resuscitated, suctioned and administered assisted ventilations via ambu bag.

Subsequent to the Rapid Response, nursing documentation indicated that diagnostic laboratory (lab) studies were ordered by the attending physician.

The nursing progress note further documented that critical lab results were "called in with Glucose - 39, BUN- 113, Hgb- 4.5, Hct- 14.9. MD made aware of above results. "

Subsequent to these critical value findings, the physician documented an order on November 24, 2010 at 2:45 P.M. to transfuse the patient with two (2) units of Packed Red Blood Cells (PRBC).

There was no nursing progress note documentation found in the medical record for November 25, 2010. Further record review confirmed that there was also no documentation entered into the medical record from any physician on November 25, 2010.

The nursing progress note dated November 26, 2010 at 7:00 A.M. documented that the patient's "Situation" was deteriorating and patient had a low H&H (hemoglobin and hematocrit).

The documentation included the following: "2 units PRBC (Packed Red Blood Cells) transfusion. Patient obtunded with agonal breathing, pupils dilated, sluggish reaction, then no reaction at all. No response noted with verbal or tactile stimuli. At 2210 (10:10 P.M.), called House Officer (H.O.) notified of patient status (tachycardia, low BP) with no orders made."

The November 26, 2010 nursing note further revealed that during the administration of the blood products, the patient continued to become clinically and hemodynamically more unstable as evidenced by the following progress note entry: "At 0615 (6:15 A.M.), patient has no more pulse noted, on monitor with PEA (Pulseless Electrical Activity). Non responsive with painful stimuli, no pupillary light reaction noted. H.O. notified, seen patient and pronounced patient dead from cardiopulmonary arrest at 0620."

After a thorough review of the nursing documentations referenced above, subsequent findings revealed that: the progress notes were not documented within the standardized model specifically established by the hospital; and were not in compliance with the federally regulated mandate for medical record content. The progress notes instead were documented in a summarized narrative format with block-timing and failed to consistently specify the actual times, timeframes, and proper sequence of order in which the significant and critical events leading up to the patient's demise genuinely occurred.

A face-to-face interview was conducted with the Vice President of Patient Care Services (VP/PCS) on January 26, 2011 at approximately 11:30 A.M. After review of the nursing documentation for the dates referenced above: he/she acknowledged that the Registered Nurse (RN) failed to follow the practice and policy for proper documentation adopted by the hospital.

The V.P. further clarified that block-charting was not the acceptable practice.
He/she suggested that the RN documented the wrong date on the November 27, 2010 entry. But after further discussion, agreed that this was an assumption and could not be corroborated. The record was reviewed January 26, 2011.

Based on record review and staff interview for one (1) patient, it was determined that the attending physician failed to adhere to federal regulations and Medical Staff Rules and Regulations related to the documentation of a discharge summary with final diagnosis and the completion of the medical record within a specifically stipulated timeframe. Patient # 27.

The findings included:

Federal regulation A-0468's interpretive guidelines included and very clearly stipulated that all patient medical records must contain a discharge summary and that the discharge summary must document the outcome of patient's hospital course and the disposition of the patient. Additionally, the regulation stipulated that the final diagnosis must be included in the discharge summary. The succeeding federal regulation, A-0469, further stipulated that the medical record must document a final diagnosis with the completion of the medical record within 30 days following discharge.

The Medical Staff Rules and Regulations for the hospital, last reviewed and approved by the governing board on January 18, 2006, stipulated the following directives under Section F, Medical Records Requirements, items 3 (e), 4 and 8, respectively: "3 (e) ' Timeliness Criteria is as follows: Discharge summary within 14 days; 4. Final diagnosis shall be recorded in full without the use of symbols or abbreviations, dated and signed by the attending or responsible physician at the time of discharge; and 8. If the record still remains incomplete 30 days after discharge ...the CEO shall notify the physician by mail, return receipt requested, that they have 72 hours to complete their records or their privileges shall be suspended until the records have been completed ...This applies to Active, Consulting, and Courtesy members of the Medical Staff. "

During a telephone investigative inquiry and fact-finding interview with the attending physician on January 18, 2011, at approximately 4:30 P.M., concerning prior CLIA survey findings related to the transfusion of blood products, the following clinical services findings were also discovered:

When questioned concerning the documentation of Patient # 27's discharge summary findings, the attending physician admittedly failed to comply with federal regulations and medical staff rules and regulations to document a completed discharge summary with final diagnosis, within the stipulated timeframe. No explanation was given for the omission.

As a result of the telephone inquiry, a thorough and comprehensive review of the medical record confirmed the attending physician's failure to meet compliance with the aforementioned regulations to document a completed discharge summary at the time of the patient's death or within 14 days. It was furthermore determined that there was no official death note summary/documentation found in the medical record from any physician on November 25, 2010 (date patient expired) or on any date thereafter until the day of surveyor inquiry.

Subsequent to the telephone investigative inquiry and fact-finding interview, the attending physician documented a late discharge summary for patient # 27 and forwarded a copy of the summary to the Department of Health on January 19, 2011.

The record was reviewed January 26, 2011.