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Based on observation, interview, medical record review and review of hospital documents, the hospital failed to have an effective governing body to oversee the overall functioning of the hospital when it did not enforce the bylaws of the medical staff and to ensure the medical staff followed the by laws of the hospital.

The hospital failed to identify the pharmacy dosing of medications without approved protocols as a patient safety issue.

The hospital failed to monitor the safety of the contracted service used for dialysis.

Findings:

1. The governing body did not ensure the medical staff followed it's bylaws for medical record completion. See A 047.

2. The governing body did not ensure the medical staff was held accountable when the bylaws of the medical staff were not enforced to ensure the accuracy of the medical record. See A 049.

3. The governing body did not ensure the contracted service for dialysis was provided in a safe manner. See A 084.

4. The governing body did not ensure the hospital was maintained in a safe and sanitary manner. See A 144.

5. The governing body failed to ensure the QAPI program for the hospital identified opportunities for improvement regarding the number of unsigned telephone orders and lack of an approved system for the authentication of physician signatures. See A 276.

6. The governing body failed to identify through the QAPI program the lack of an approved protocol for the pharmacist dosing of Coumadin as a patient safety issue. See A 285.

7. The governing body failed to take action to improve performance by ensuring the prompt completion of medical records and implementation of an approved system of physician signature authentication to decrease potential medical errors. See A 289

8. The governing body failed to ensure the implementation of a QAPI program to reduce medical errors. See A 311.

9. The governing body failed to ensure there was adequate staffing in the medical records department to ensure prompt completion of the medical record. See A 432.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and document review, the hospital failed to develop and maintain a hospital-wide QAPI program to monitor the care and services provided in order to reduce the potential for medical errors.

Findings:

1. The hospital failed to identify and track quality indicators for patient care issues such as incomplete medical records, the use of unapproved multiple pre-printed medical records forms and the need to evaluate and provide a mechanism to authenticate medical staff signatures. See A 267.

2. The hospital failed to ensure performance improvement activities were implemented for high risk medications dosed by the pharmacist to determine if dosing errors or adverse events had occurred and, if so, what improvements needed to be made. See A 285.

3. The hospital failed to take action to improve the delinquent completion of medical records.
See A 289.

4. The governing body failed to ensure and implement a program for patient safety, including the reduction of potential medical errors and the monitoring of a contract service to provide dialysis care for patients. See A 311.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and medical record review the hospital failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients.

Findings:

1. The hospital failed to ensure the medical staff was accountable to the governing body by allowing pharmacists to regulate Coumadin (a high risk medication) without a hospital approved protocol. In the absence of a hospital protocol, the pharmacists adjusted doses without an order required from the physician. This resulted in inconsistent dosing from one pharmacist to another and could potentially affect patient safety by putting them at jeopardy for a medication adverse event. See A 347.

2. The hospital failed to ensure the enforcement of it's bylaws by suspending medical staff when they failed to complete the medical record in a timely manner. Medical record review for 20 of 30 sampled patients (Patients 2, 3, 4, 5, 6, 8, 9, 10, 13, 14, 15, 16, 19, 20, 21, 22, 23, 24, 26, and 30) showed physician's telephone orders were not consistently legible, signed, dated and timed; dictated H&Ps and consultations were not reviewed and signed promptly by the appropriate physician; and the medical record was not completed promptly at discharge. See A 347.

3. The hospital failed to ensure there was an effective system in place to ensure the authentication of physicians' signatures. Review of one physician's signature in the authentication book did not show it matched his signature on the medical record. See A 438.

4. Various versions of a physician's progress note form were in use, with no documented approval for use by the hospital's Forms Committee. A progress note was found to be a fax copy with no documentation to show the physician actually visited the patient. This had the potential for unsafe medical practice. See A 438.

5. The medical staff failed to ensure that informed consent had been obtained from two patients, prior to administering a blood transfusion. See A 131.

6. The medical staff failed to comply with recommendations from the CDC for annual Tuberculosis testing. See A 749.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment

Based on interview and review of the medical records and hospital documents, the hospital failed to maintain a medical record service to ensure the completeness and accuracy of the medical record.

Findings:

1. The hospital failed to ensure there was adequate staff to enable the prompt completion of medical records on discharge of the patient. See A 432.

2. The hospital failed to ensure that medical records had been promptly completed for patients. The hospital failed to ensure that physician signatures had been authenticated and that the authentication system had been approved by an appropriate committee of the medical staff and/or the governing body. See A 438.

3. The hospital failed to ensure the pre-printed forms being used as progress notes by physicians had been reviewed and approved by the hospital's Forms Committee. See A 450.

4. The hospital failed to ensure the physicians' written and telephone orders were consistently signed, dated and timed. See A 454.

5. The hospital failed to ensure the admission H&Ps were available on the record as soon as possible after admission and were reviewed and signed promptly for accuracy. See 458.

6. The hospital failed to ensure the dictated consultative evaluations had been reviewed promptly for accuracy and signed by the physicians. See A 464.

7. The hospital failed to ensure the medical record contained a completed informed consent for blood transfusions and a PICC line insertion. See A 466.

8. The hospital failed to ensure the closed medical record contained a discharge summary of the patient's hospitalization that was completed promptly within the 14 day time frame as specified by hospital P&P. See A 468.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interviews, a review of selected documents supplied by the hospital and a review of 30 open and closed medical records, the governing body failed to ensure the medical staff implemented and enforced the bylaws and rules and regulations, approved by the governing body. This could lead to unsafe medical treatment of patients presenting for care in the hospital.

Findings:

A review of the policy and procedure for "Medical Record Completion" dated 11/25/09 revealed: "The attending physician will be responsible for the preparing of a complete and legible medical record for each patient. This record will include registration data, chief complaint, history, physical examination, reports of special procedures and consultation, progress notes, treatment plan, orders and a discharge/transfer summary for inpatients. The attending physician will account for the accuracy and completeness of the discharge/transfer policy by signing it".



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1. The Medical Director was interviewed on 8/3/10 at 1330 hours. The Medical Director was asked to review the different versions of physician progress notes in use in the hospital. The Medical Director stated the hospital had a forms committee to approve all forms being used in the hospital. The Medical Director stated he thought at least a couple of the different versions had been approved by the committee. When asked to review a progress note for Patient 14, the Medical Director stated no, this form had not been approved, this physician had typed the form specifically for Patient 14. The Medical Director was asked to provide documentation of the approval of the other forms.

Review of the P&P Creation, Chart Forms dated 1/2005, showed all forms must be approved through the proper channels to ensure forms comply with format standards and regulatory requirement.

At the time of exit of the survey team on 8/5/10, no documentation had been provided to show a forms committee had approved the use of the physician progress notes.

2. The Medical Director was asked to review the physician order form which did not have a specific area for the physician's signature. The Medical Director stated a box should be added for the physician's signature. The Medical Director was asked to review the unsigned telephone orders for Patients 2, 4, 5, 6, 14, 15, and 16. The Medical Director stated it was a constant battle to enforce the rule that all orders should be signed, dated and timed. The Medical Director stated, we ask the physicians all the time to complete their orders and do what the bylaws say they need to do. When asked if enforcement of the bylaws was done for incomplete records, he stated yes, we do enforce the requirement.

The P&P for Delinquent Records dated 10/1997, was reviewed on 8/3/10. The stated purpose was to ensure health records were completed in a timely manner. The P&P stated it is the responsibility of the practitioners involved in the care of the patient to create a complete, accurate, and legible record at the point of care. Delinquent charts were defined as any chart older than 14 days from discharge lacking in signatures or dictated reports. Physicians who were delinquent in completing their records would receive a five day notice to complete the record or they would face a suspension of their admitting privileges and other related privileges.

The Medical Staff Rules and Regulations were reviewed on 8/3/10. The document showed telephone orders must be signed within 48 hours. Orders must be written clearly, legibly and completely,

During an interview with the Director of Medical Records on 8/3/10 at 1500 hours, the Director provided a Performance Improvement Department report for the first two quarters of 2010 for review. Review of the report showed a delinquency rate of 50% for the first quarter and 45% for the second quarter. Actions for both quarters were to "continue to monitor and work on the delinquency rate. Will strongly enforce the P&Ps." When asked to state the specific actions the Medical Records department took to ensure the completeness of the record, she stated she called the physicians' offices and their cell phones to remind them to dictate and/or sign the discharge summary and to complete other deficiencies in the record. The Director stated the P&P of the hospital required the medical record to be completed within 14 days of the patient's discharge or the hospital privileges of the physician would be suspended. When asked how many physicians had been suspended since she began work here at the beginning of the year, she stated none. The Director stated she reported to the CEO of the hospital regarding the medical record delinquency rate.

The governing body failed to ensure compliance of its approved bylaws for legibility of medical records, signing, dating and timing of orders and for discharge summaries. See A 438 and A 450.

Based on interview, review of the medical record and document review, the hospital failed to ensure it's medical staff was accountable to the governing body when the bylaws of the medical staff were not enforced to ensure the accuracy and completeness of the medical record. Medical record review for 20 of 30 sampled patients (Patients 2, 3, 4, 5, 6, 8, 9, 10, 13, 14, 15, 16, 19, 20, 21, 22, 23, 24, 26, and 30) showed physicians' telephone orders were not consistently legible, signed, dated and timed; dictated H&Ps and consultations were not reviewed and signed promptly by the appropriate physician; and the medical record was not completed promptly at discharge. The system in place to ensure the authentication of physician's signatures did not show one physician's signature in the authentication book matched his signature on the medical record. Various versions of a physician's progress note form were in use, with no documented approval for use by the hospital's forms committee. A progress note was found to be a fax copy with no documentation to show the physician actually visited the patient. This had the potential to result in incorrect information regarding physician orders and the patient's medical history to be disseminated among other medical and nursing staff.

Findings:

1. During an interview with the Medical Director of the hospital on 8/3/10 at 1330 hours, the surveyors shared their findings of multiple patient records which contained missing physician signatures for telephone orders, physician orders without date and time to show when the order was written, illegible physician progress notes, and the use of multiple different physician progress note forms. The Medical Director stated he thought several of the different progress note forms had gone through the hospital's forms committee. When asked to provide documentation to show approval of the forms he was unable to do so. The Medical Director stated it was "a constant battle" to enforce the bylaw for physicians to time and date their orders and sign telephone orders, "we ask them all the time." The Medical Director was asked if enforcement was done for medical staff who did not comply with the bylaws. The Medical Director stated, yes, we enforce the requirement.

During an interview with the Director of Medical Records on 8/3/10 at 1500 hours, the Director stated the medical record delinquency rate was 50% for the first quarter of the year and 45% for the second quarter. When asked to state the specific actions the Medical Records department takes to ensure the completeness of the record, she stated she called the physicians' offices and their cell phones to remind them to dictate and/or sign the discharge summary and to complete other deficiencies in the record. The Director stated the P&P of the hospital required the medical record to be completed within 14 days or the hospital privileges of the physician would be suspended. When asked how many physicians had been suspended since she began work here at the beginning of the year, she stated none. The Director stated she reported to the CEO of the hospital regarding the medical record delinquency rate via the monthly completion statistics.


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2. The governing body failed to ensure that medical records had been promptly completed, with legible medical record entries and authenticated physician signatures. See A 438 and A 450.

3. The governing body failed to ensure a program for QAPI (quality assessment and performance improvement) had provided guidance regarding authenticated signatures and completion of medical records while the patient was in the hospital to provide for patient safety. See A 267.

Based on observation during a tour of the hospital conducted on 8/3/10, the governing body failed to ensure that services being performed under a contract to provide dialysis care were provided in a safe manner. This could result in the potential for the spread of infection throughout the hospital.

Findings:

1.On 8/2/10, during the initial tour of the ICU, Patient 9 was observed receiving renal dialysis treatment from Dialysis Nurse A, an employee of the hospital's contracted dialysis service company. Patient 9 was in contact isolation for MRSA. A warning sign outside the ICU cubicle indicated that all persons entering the cubicle should wear gloves upon entering the room, a mask if splashes of blood and body fluids are likely, and gowns when contact with patient or contaminated surfaces is anticipated.

Dialysis Nurse A was observed giving direct care to Patient 9 without wearing gloves. In addition, the nurse was not observed to wear a mask or face covering to protect her in the event of exposure to splashes of the patient's blood. The protective gown she wore was not secured and was open at the back, exposing her uniform at the shoulders and back. According to the ICU staff this same nurse went to other rooms in the hospital to give dialysis treatments after she left this patient.

The Dialysis Infection Control P&P was reviewed on 8/2/10. Documentation showed employees of the contracted service will be familiar with the hospital infection control policies and procedures including standard precautions, medical waste handling and disposal, hazardous material considerations, handwashing and general safety considerations. Orientation includes infection control guidelines.

The personnel file for Dialysis Nurse A was reviewed on 8/3/10. The file did not contain documented evidence the nurse had received hospital specific infection control orientation.

2. The hospital Dialysis Infection Control Policies, revised in 2005, and the preventative maintenance book provided to the hospital from the dialysis company were reviewed on 8/2/10. The P&P documented a routine culture will be drawn on each dialysis machine on a monthly basis and the results will be kept in the appropriate file that is maintained for each individual dialysis machine. A copy of each culture report will be provided to each client (contract) hospital on a monthly basis.

Review of the books provided showed cultures were done on the water and dialysate every month from 2006 to 2/28/07. From 2/28/07 to 12/16/09, there was no documented evidence cultures were done on the water and dialysate every month as required. When asked, the hospital CNO was unable to provide documentation to show cultures were done by the company or the hospital during this period of time. The CNO stated he was unaware the cultures had not been done from 2007 to 2009. Documentation of cultures of water and dialysate had resumed monthly on 12/16/09.

Based on interview, review of the medical record and hospital P&P, the hospital failed to ensure three of 30 sampled patients (Patients 2, 20 and 25) were provided the necessary information, in a form they could understand, to make an informed decision to give consent for procedures such as blood transfusions and a PICC line insertion. The name and the signature of the physician responsible for informing the patients of the risk and benefits of the proposed procedure(s) was not found on the consent forms. The required pamphlet which contained information regarding the risks and benefits of receiving a blood transfusion from a donor was not available in the hospital and therefore was not provided to the patients prior to obtaining consent for the procedure. This had the potential for patients to consent to procedures for which they did not have complete understanding.

Findings:

The P&P Consent for Medical Treatment: Guidelines For, reviewed date July, 2004, was reviewed on 8/3/10. The P&P showed as a general guideline, except in emergency situations, medical treatment without consent is battery and failure to allow patients this right to certain specific information prior to consenting to and undergoing certain procedures or therapy, constitutes malpractice. It was the physician's responsibility to obtain informed consent from the patient. For a blood transfusion consent, the physician should discuss the risks and benefits of the transfusion, the alternatives to the transfusion and whenever possible the use of directed donations and autologous blood. This informed consent was required in addition to the requirements of the Paul Gann Blood Safety Act.

The P&P Informed Consent, revised December 2004, was reviewed on 8/2/10. Documentation showed there shall be evidence of appropriate informed consent for any procedure or treatment for which it is appropriate including blood or blood products. The consent shall include the names of the individuals who will perform the treatment, indication that alternate means of therapy and the possibility of risks or complication have been explained to the patient, signature of the patient and the witness to that signature and the practitioner who informs the patient and obtained consent.

The P&P, Compliance with the Paul Gann Blood Safety Act revised date February, 2005, was reviewed on 8/3/10. Documentation showed the hospital would obtain verification from physicians that the provisions of the Paul Gann Blood Safety Act have been met when appropriate. The informed consent verification form was developed as a documentation tool for physician verification of informed consents. The patient would be provided with a copy of the Department of Health Services information pamphlet, "If You Need Blood: A Patient's Guide to Blood Transfusions." The patient would be given the opportunity to discuss this information concerning the advantages, disadvantages, rights and benefits of autologous blood (use of the patient's own blood) and of directed (friends/relatives) and non directed (volunteers unknown to the patient) homologous blood.

1. The medical record for Patient 2 was reviewed on 8/2/10 at 1340 hours. Review of the physician's orders showed an order dated 8/1/10 at 1200 hours, to infuse two units of packed red blood cells.

Review of the Informed Consent form for Patient 2 did not show the box used to indicate a patient education sheet had been provided to the patient was checked off. No physician's name was listed to show who had explained the risks and benefits of the procedure to the patient. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

During an interview with RN A on 8/2/10 at 1345 hours, the RN stated Patient 2 had received two units of blood on 8/1/10. The RN was asked to review the patient's consent form. When asked who would give the information to the patient when consent was obtained for a blood transfusion, the RN stated the nurse reviewed the consent form with the patient.

In an interview with the CNO on 8/2/10 at 1350 hours, the CNO stated the physician would sign the form later indicating the patient had received information regarding the procedure.

In an interview with RN C on 8/2/10 at 1355 hours, the RN stated she had obtained consent from Patient 2 for the blood transfusion on 8/1/10. The RN stated the physician had spoken to the patient previous to her obtaining the patient's consent. RN C stated the physicians did not usually sign the blood transfusion consents. The RN was unable to locate physician documentation of informed consent given to the patient. When asked about an information pamphlet for patient's who receive blood transfusions, the RN stated she did not have a pamphlet to give to a patient.

During an interview with the CNO on 8/3/10 at 0900 hours, the CNO stated he had reviewed the hospital's P&P, Paul Gann Blood Safety Act. The CNO stated the hospital did not have the information pamphlets to give to patients.


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2. The medical record for Patient 20 was reviewed on 8/4/10 at 1100 hours. Review of the Informed Consent: Surgery/Procedure form contained documentation that the patient's physician had recommended that the patient undergo the insertion of a PICC line. The patient was unable to give her consent, so the daughter of the patient had signed as her legal representative on 7/12/10 at 0840 hours. The box used to indicate that the patient or legal representative had been provided education about the risks, benefits or alternatives had not been checked off. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

In addition, the record for Patient 20 contained an Informed Consent: Surgery/Procedure form also signed by the daughter on 7/13/10 at 1520 hours, for a blood transfusion. The form did not show the box used to indicate a patient education sheet had been provided to the patient representative was checked off. No physician's name was listed to show who had explained the risks and benefits of the procedure to the patient's representative. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

3. The medical record for Patient 25 was reviewed on 8/4/10 at approximately 1300 hours. Review of the Informed Consent: Surgery/Procedure form contained documentation that it had been recommended that the patient undergo the insertion of a PICC line. The consent was signed on 6/15/10 by a friend. There was no documentation to indicate which physician recommended the procedure, which physician was to perform the procedure or whether the patient's agent had been given any explanation of the risks, benefits or alternatives of the procedure. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

Based on observation, interview and review of documents, the hospital failed to maintain a safe and sanitary environment for the care of patients. On initial tour of the hospital on 8/2/10, the pharmacy was observed to be cluttered, unorganized and dirty, the emergency call system for the tub and shower rooms on the medical/surgical unit was inoperable, and uncovered carts piled high with trash and linen were observed being transported through the hallways. Additional observations showed staff not wearing proper PPE in isolation rooms and not washing hands between patients. In addition there was no documentation to show three staff members and four physicians had been screened per the P&P and a CDC guideline for TB (RT A, Employee A, RN A; MD B, I and L; and the Medical Director); there was no documentation provided to show cultures of the dialysis machines in the hospital had been obtained monthly as per P&P from 2/28/07 to 12/16/09; and a syringe with an attached needle was found in a basin beside a patient gurney These findings had the potential to create an unsafe environment for patient care and infectious diseases to spread throughout the hospital.

Findings:

1. The P&P Pre-Placement Health Screening, revised 5/28/09, showed a pre-placement physical would be conducted after an offer of employment was extended. The pre-placement physical included TB screening for all candidates. In addition, a PPD test for TB would be required yearly or if the PPD was positive, a chest x-ray would be done every four years.

a. Review of the health record for RT A showed the last documentation of a PPD skin test for TB was dated 7/1/09.

b. Review of the health record for Employee A showed a date of hire of 1/4/10. No documentation of a test for TB was found in the record.

c. Review of the health record for RN A showed a date of hire as 6/28/06. The documentation of a PPD skin test for TB showed the new employee had a positive skin test. A notation on the Employee PPD Tuberculosis Skin Test Record documentation dated 6/26/06, stated the employee was "Bringing copy of CXR which was done a few months ago." The x-ray report provided by the employee was dated 11/30/05.

The Vice President of Human Resources was interviewed on 8/4/10 at 1115 hours. When asked to provide documentation to show Employee A, RN A and RT A were tested for TB as required in the hospital's P&P, the Vice President stated these employees "fell through the cracks." She stated the TB tests should have been completed.


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2. A review of the policy and procedure for Tuberculosis screening of physicians, licensed practitioners and/or professional staff dated 11/25/09 revealed: "All members of the medical staff and professional staff (AHP) are required to provide Medical Staff Services with documented TB screening as part of their appointment process and every two (2) years thereafter."

A review of the professional credentials files for MD B, MD I, MD L and the Medical Director revealed that each physician had received TB testing every two years.

Interviews with the Medical Director conducted on 8/3/10 at approximately 1330 hours, confirmed that professional staff TB testing was being conducted every two years. The recommendations of the CDC ( Center for Disease Control) were presented and discussed. The Medical Director agreed that the population of patients in the long term acute care hospital were at risk and vulnerable to exposure to tuberculosis. In view of the fact that no risk assessment had been conducted for the hospital, the Medical Director stated that annual testing, as recommended by the CDC, Communicable Disease Center, should be adopted.

3a. On 8/2/10, during the initial tour of the ICU, Patient 9 was observed receiving renal dialysis treatment from Dialysis Nurse A, an employee of the contracted dialysis service company. Patient 9 was in contact isolation for MRSA. A warning sign outside the ICU patient cubicle indicated that all persons entering the cubicle should wear gloves upon entering the room, mask if splashes of blood and body fluids are likely and gowns when contact with patient or contaminated surfaces is anticipated.

Dialysis Nurse A was observed giving direct care to Patient 9 without wearing gloves. In addition, the nurse was not observed to wear a mask or a face covering to protect her in the event of exposure to splashes of the patient's blood. The protective gown she wore was not secured and was open at the back, exposing her uniform at the shoulders and back. According to the ICU staff this same nurse went to other rooms in the hospital to give dialysis treatments after she left this patient.

The hospital's Dialysis Infection Control Policies were reviewed. The P&P documented that employees of the contracted service will be familiar with the hospital's infection control policies and procedures including standard precautions, medical waste handling and disposal, hazardous material considerations, handwashing and general safety consideration. Orientation includes infection control guidelines. The personnel file for the Dialysis Nurse was reviewed. The file did not contain documented evidence that the nurse had infection control orientation.

The Administrative staff was unable to provide evidence that the nurse had hospital orientation as required.

b. During an onsite visit to the intensive care unit conducted on 8/4/10 at approximately 1458 hours, Lab Tech 1 was observed entering an ICU room. The patient was in isolation with signage instructing all who entered to put on personal protective equipment. Lab Tech 1 was observed entering this room without personal protective equipment.


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4. On 8/2/10 at 0845 hours, during the initial tour of the hospital, housekeeping staff was observed transporting trash and dirty linen in large rolling carts through the hallway of the Medical/Surgical units. The lids to the trash and linen carts were folded open and not being utilized to contain the trash or the dirty linen. The two carts were piled with trash and linen bags at least 3 feet above the tops of the carts. Bags of trash were observed falling out on the floor as the trash cart was pushed down the hallway.

5. During the initial tour of the Medical/Surgical Units 100 and 200, on 8/2/10 at 0945 hours, the bath tub and shower rooms on both units were observed. On the Medical/Surgical unit 200, the emergency call system in the tub and shower rooms were activated. The emergency alarm sounded at the nursing station, but the emergency light in the hallway above the door to the tub and shower rooms failed to illuminate to indicate which room needed immediate assistance. On the Medical/Surgical unit 100 the entire emergency call system in both the tub and shower rooms was inoperable. There was no visual or auditory alarms when the emergency call system was activated.

Interview with the Medical Surgical Unit staff on 8/2/10 during the tour, revealed that they did not use the tub and shower rooms often and were not aware that the system did not operate properly.

6. On 8/2/10 at 1030 hours, RT B was observed giving tracheoscopy care to Patient 9. The therapist was observed to be wearing an isolation gown that was not secured at the neck to ensure that her uniform was covered and her clothing was protected from contact with infectious agents. The gown did not cover her shoulders and was falling forward exposing the therapist's front neck area, shoulders, and back areas.

The hospital's P&P entitled "Isolation Precautions" were reviewed on 8/2/10. The P&P documented that isolation gowns are used to protect the health care worker's arms and exposed body areas and prevent contamination of clothing with blood, body fluids and other potentially infectious material. The gown improperly put on by RT B, failed to protect her uniform from infectious agents.

7. The hospital Dialysis Infection Control Policies and preventative maintenance book provided to the hospital from the dialysis company were reviewed on 8/2/10. The P&P documented a routine culture will be drawn on each dialysis machine on a monthly basis and the results will be kept in the appropriate file that is maintained for each individual dialysis machine. A copy of each culture report will be provided to each client (contract) hospital on a monthly basis.

Review of the books provided showed cultures were done on the water and dialysate every month from 2006 to 2/28/07. From 2/28/07 to 12/16/09, there was no documented evidence cultures were done on the water and dialysate every month as required. When asked, the hospital ICP was unable to provide documentation to show cultures were done by the company or the hospital during this period of time. The ICP stated he was unaware the cultures had not been done from 2007 to 2009. Documentation of cultures of water and dialysate had resumed monthly on 12/16/09.

8. On 8/2/10 at 0900 hours, the PACU was inspected. The area was unattended at the time of entry. A 3 ml syringe with an attached needle was observed in a basin beside a patient gurney. Two 1000 ml plastic bags of sterile irrigation solution were in a cabinet available for use. The solution had expired 6/2010.

A supply cart was against the wall inside the unit. Clean supplies (DVT system and Kaso Press) and a 1000 ml bottle of Lactated Ringers IV solution was on the dirty, dusty floor wedged between the cart and wall.


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9. On 8/2/10 at 1404 hours, located in the main pharmacy were several rows of boxes containing intravenous medications. The boxes were left sitting on the floor, dusty, and unorganized. There were also boxes stacked in a medication aisle which completely blocked the aisle. The boxes contained intravenous medications and were stacked from the floor to at least 6 feet in height.

Located in the back room was the laminar flow hood which is used to compound intravenous medications that require sterile procedures and a sterile environment. On the back wall of the laminar flow hood was a filter. Located inside the filter was a brown gooey substance. When the DOP was asked what the substance was, he described it as "gunk."

The pharmacy continued to compound intravenous medications and failed to ensure a sterile compounding environment with "gunk" on the filter. Also, the laminar flow hood was last serviced in January 2010 and required service again by 7/15/10 which had not been performed as of 8/2/10.

Based on interview and medical record review the hospital failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients. Medical record review for 20 of 30 sampled patients (Patients 2, 3, 4, 5, 6, 8, 9, 10, 13, 14, 15, 16, 19, 20, 21, 22, 23, 24, 26, and 30) showed physicians' telephone orders were not consistently legible, signed, dated and timed; dictated H&Ps and consultations were not reviewed and signed promptly by the appropriate physician; and the medical record was not completed promptly at discharge.

The hospital failed to ensure an effective system in place for the authentication of physicians' signatures that was approved by the governing body. Review of one physician's signature in the authentication book showed it did not match his signature on the medical record.

Various versions of a physician's progress note form were in use, with no documented approval for use by the hospital's Forms Committee. A progress note was found to be a fax copy with no documentation to show the physician actually visited the patient. When physicians' orders were not legible and authenticated with a date, time and a signature, there was the potential for unsafe care of patients.

The hospital failed to provide documented evidence to show the Medical Executive Committee was examining the safety of medication practices in the hospital when a pharmacist was allowed to dose a high risk medication, Coumadin, without an approved hospital protocol. This had the potential to affect patient safety by increasing the risk of a medication adverse event.

Findings:

1. On 8/2/10 at 1409 hours, the DOP was interviewed. He stated the pharmacists regulated medications in the hospital based on approved hospital protocols. He stated the pharmacists ordered the medication(s), the doses, the laboratory tests, and if needed adjusted the doses. The DOP stated, "the protocols were approved by the hospital's pharmacy and therapeutics committee and medical committee before I started working here."

The DOP provided a list of the medications regulated by the pharmacist following the hospital protocols. One such medication was Coumadin. Coumadin is frequently prescribed to prevent patients from developing blood clots or when patients were at risk for blood clots to reoccur. The DOP was asked to produce a copy of the hospital's approved protocol pharmacists used to guide them in regulating Coumadin. After several minutes of searching his files, the DOP stated, "I can't find one." He called additional hospital staff to help him search for the protocol but in the end was told by the Medical Director, there wasn't one. The DOP was also unable to find documentation that pharmacists had passed a competency test to demonstrate they were qualified to regulate Coumadin dosing.

On 8/3/10 at 1322 hours, during an interview with the Medical Director, he stated he was unaware the hospital did not have an approved Coumadin protocol. He stated the hospital should have an approved protocol. He stated he checked with the hospital for an approved protocol but stated there wasn't one.

a. On 8/3/10, Patient 9's medical record was reviewed. He was admitted on 7/3/10 and on 7/4/10 there was an order for Coumadin per pharmacy. The pharmacist started Coumadin two days later on 7/6/10 and ordered INR laboratory tests daily. The INR is an abbreviation for international normalized ratio and is a Coumadin blood test to determine if the blood is thin enough to prevent blood clots. The pharmacist ordered the dose of Coumadin based on the daily INRs. However the patient continued to take another medication that increases the risk of bleeding when taken along with Coumadin. The medication was aspirin, 81 milligrams, which also can decrease the blood's ability to clot. There was no guidance for the pharmacist to continue, discontinue or consult with the patient's physician about the aspirin in the absence of a protocol. The patient continued on aspirin and on 7/9/10, MD C noted in Patient 9's medical record, "New onset bleeding/oozing from mouth." On 7/9/10, MD D noted, "Patient oozing from side of mouth and also on aspirin." MD D wrote an order on 7/9/10 to administer intravenous Vitamin K (antidote for Coumadin to reverse the blood thinning effects) due to oozing of the mouth.

b. On 8/3/10 at 1503 hours, Patient 16's medical record was reviewed. Patient 16 was admitted on 6/25/10 and on that day an order was written for Coumadin to be regulated per pharmacy. The pharmacist ordered the daily doses of Coumadin based on the daily INRs. On 7/5/10, Patient 16's physician ordered an additional anticoagulant, Lovenox 120 milligrams subcutaneously twice a day and discontinue the Lovenox when the INR was greater than 2.0. Lovenox is another blood thinning medication that is administered by injection. Blood levels to determine whether the blood is thin enough are not recommended with this medication since the full anticoagulant effect begins within 24 hours of starting. The pharmacist continued to order Coumadin doses daily with a goal of reaching an INR above 2.0 so the Lovenox could be discontinued. Patient 16 continued on both Coumadin and Lovenox from 7/5/10 until 8/3/10 without achieving an INR above 2.0 (30 days). The American College of Chest Physicians - Consensus Report June 2008, 133 (6 Supp) provides a national standard of practice for anticoagulant therapy and addresses Coumadin resistant patients who require higher doses than normal to achieve a therapeutic INR. They recommend for all general hospitals, that a thromboprophylaxis strategy (preventing blood clots from forming) be in the form of a written, institutional wide policy. Taking two anticoagulants at the same time increased the risk of bleeding.

On 8/5/10 at 1123 hours, a telephone interview was conducted with Patient 16's physician (MD A). He stated he was unaware the hospital did not have an approved Coumadin protocol. He was wondering why Patient 16 continued on Lovenox for such a long time. He also said, he spoke with the DOP and told him it was OK to increase the dose of Coumadin to 15-20 milligrams a day but this was not done.

On 8/5/10 at 1140 hours, the DOP stated he spoke on the telephone to MD A two to three times over the last month about Patient 16. He stated MD A recommended he increase Coumadin to 15 milligrams. The DOP was asked if he increased the Coumadin dose after his telephone conversation with MD A, he stated he did not increase the dose. The DOP was asked why he didn't but did not answer this question. The pharmacist dosed Coumadin for Patient 16 without the guidance from the physician and without an approved Coumadin protocol. The pharmacist also ordered doses which were too low to achieve an INR of greater than 2.0. Although, the INRs remained below 2.0, the levels of 1.4 and above are considered "low intensity" anticoagulation by the American College of Chest Physicians - Consensus Report June 2008, 133 (6 Supp). The INRs in nine of the 30 days were above 1.4 which put Patient 16 at jeopardy for developing a bleeding episode.

The medical staff was not accountable to the governing body by allowing pharmacists to regulate Coumadin (a high risk medication) without a hospital approved protocol. See A 500.


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2. During an interview with the Medical Director of the hospital on 8/3/10 at 1330 hours, the surveyors shared their findings of multiple patient records which contained missing physician signatures for telephone orders, physician orders without date and time to show when the order was written, illegible physician progress notes, and the use of multiple different physician progress note forms. The Medical Director stated he thought several of the different progress note forms had gone through the hospital's Forms Committee. When asked to provide documentation to show approval of the forms he was unable to do so. The Medical Director stated it was "a constant battle" to enforce the bylaw for physician's to time and date their orders and sign telephone orders, "we ask them all the time." The Medical Director was asked if enforcement was done for medical staff who did not comply with the bylaws. The Medical Director stated, yes, we enforce the requirement.

During an interview with the Director of Medical Records on 8/3/10 at 1500 hours, the Director stated the medical record delinquency rate was 50% for the first quarter of the year and 45% for the second quarter. When asked to state the specific actions the Medical Records department takes to ensure the completeness of the record, she stated she called the physician's offices and their cell phones to remind them to dictate and/or sign the discharge summary and to complete other deficiencies in the record. The Director stated the P&P of the hospital required the medical record to be completed within 14 days or the hospital privileges of the physician would be suspended. When asked how many physicians had been suspended since she began work here at the beginning of the year, she stated none. The Director stated she reported to the CEO of the hospital regarding the medical record delinquency rate.

Based on interview and medical record review, the hospital failed to ensure the plan of care was developed and kept current to reflect the actual care needs of three of 30 sampled patients (Patients 4, 7, and 16) when care issues such as restraints and infection had not been addressed. A lack of comprehensive care plan development may result in patient interventions not developed and/or assessed which can further compromise the patient's medical status.

Findings:

1. The medical record for Patient 16 was reviewed on 8/3/10 st 0945 hours. The patient was admitted to the hospital on 6/25/10.

During an interview with RN A on 8/3/10 at 0948 hours, the RN stated soft restraints were used for Patient 16 to prevent her from pulling out the tracheostomy tube (a tubing inserted through a surgically created hole at the front of the neck going into the windpipe). The RN stated the restraints had been in use since 6/25/10. RN A was asked to show how the use of restraints was care planned for the patient. After review of the care plan, the RN stated she could not find a care plan had been developed for the use of restraints.

2. The medical record for Patient 4 was reviewed with RN E on 8/2/10 at 1420 hours. The patient had been admitted to the hospital on 7/30/10. The RN stated the patient was admitted with an infection and was in contact isolation.

Review of the plan of care for Patient 4 did not show a care plan had been developed with approaches and outcome goals to address the patient's infection. RN E stated the care plan problem for infection should have been initiated on admission to include the use of contact isolation.

3. The medical record for Patient 7 was reviewed on 8/2/10 at 1500 hours. The patient was admitted to the hospital on 7/23/10 with diagnoses which included cellulitis of the right leg.

Review of the plan of care showed a care plan had been initiated to address Alteration in Comfort related to cellulitis, not dated. Although the nurses had initialed to show the care plan was evaluated daily, there were no printed interventions selected and no individualized interventions were developed to show the nursing approach to the patient's pain.

Based on observation and medical record review, the hospital failed to ensure that dosages administered were accurate when medications required reconstitution by a nurse. This resulted in a potential for ineffective therapy.

Findings:

On 8/3/10 at 0851 hours, RN D prepared to administer morning medications to Patient 6. One of those medications was methylprednisolone injection (medication to reduce inflammation) and required reconstitution by the nurse. The vial contained a diluent on the top and powder below. The nurse is to reconstitute the medication by mixing the diluent with the powder. RN D added the diluent to the powder but did not mix the two together to ensure all the powder went into solution. Powder was observed to be stuck around the glass of the vial as RN D withdrew the dose. Patient 6 received an inaccurate dose of methylprednisolone.

Based on interview, review of the medical record and hospital documents, the hospital failed to employ an adequate number of personnel in the medical records department to ensure the prompt completion of the medical record.

Findings:

1. The Director of Medical Records was interviewed on 8/4/10 at 0845 hours. The Director was asked to review the closed records for Patients 24, 25, and 26. The patients had been discharged from the hospital during the month of June, 2010. Each of the medical records contained numerous unsigned physician telephone orders, H&Ps, consultation reports and lacked a completed discharge summary. The Director stated the medical record delinquency rate was a big problem when she became the Director seven months ago. The Director stated when the Medical Records staff completed the medical record after discharge she called the physicians to come in and complete their deficient areas.

During a follow up interview with the Director of Medical Records on 8/4/10 at 1000 hours, the Director was asked to review the Deficiency Worklist form on the front of Patient 26's closed record. The patient was discharged from the hospital on 6/25/10. The assignment date for the physicians' deficiencies was listed as 7/30/10. The Director stated the assigned date was the date the record was completed by the medical records staff. The Director stated the expected turn around time for a record to be completed after discharge was three to five days. The Director was asked why Patient 26's medical record was not completed by the medical records staff for five weeks after discharge. The Director stated the department had only one other full time staff member other than herself. She stated that employee had recently been out on leave for three weeks so they were very behind in completing the discharged medical records.

2. At the time of interview of the Director of Medical Records, at approximately 0845 hours on 8/4/10, different pre-printed progress note forms were reviewed. These included progress notes sent to the hospital via fax transmission, infectious disease pre-printed progress notes and progress notes containing pre-printed notations for the "subjective", "objective findings", "diagnoses" (dx) and lab work. When interviewed, the Director of Medical Records stated that these different pre-printed forms were there before she was hired. She stated there was no Forms Committee or any committee of the medical staff that had approved the use of these forms. She stated that authentication of the initials noted in the medical records was not reviewed by a committee of the medical staff and was unable to determine if the governing body had approved the process for the authentication of these "signatures."

Based on interview and review of medical records and hospital documents, the hospital failed to ensure the medical records for 20 of 30 sampled patients (Patients 2, 3, 4, 5, 6, 8, 9, 10, 13, 14, 15, 16, 19, 20, 21, 22, 23, 24, 26, and 30) were accurately written and promptly completed. Physicians' telephone orders were not consistently signed, dated and timed; dictated H&Ps and consultations were not reviewed and signed promptly by the appropriate physician; and the medical record was not completed promptly at discharge. The system in place to ensure the authentication of physicians' signatures did not show one physician's signature in the authentication book matched his signature on the medical record. Physicians were using several different versions of a physicians' progress note, all of which had not been approved by the hospital. In addition, for Patient 14, documentation in the medical record did not reflect the actual care of the patient.

Findings:

A review of the policy and procedure, Medical Record Completion dated 11/25/09, showed the attending physician would be responsible for the preparing a complete and legible medical record for each patient. The record would include registration data, chief complaint, history, physical examination, reports of special procedures and consultation, progress notes, treatment plan, orders and a discharge/transfer summary for inpatients. The attending physician would account for the accuracy and completeness of the discharge/transfer summary by signing it.

During an interview with the Director of Medical Records on 8/3/10 at 0900 hours, she stated while a patient was in the hospital it was the responsibility of the nursing staff to tag missing items requiring physician review and signature in the medical record. After discharge, Medical Records staff completed the record and when items were missing, she notified the physicians to come in and complete their records. The Director stated while a patient was in the hospital, telephone orders should be signed within 48 hours. After discharge, the Director stated the medical record was to be completed within 14 days.

1. The medical record for Patient 14 was reviewed on 8/3/10 at 1030 hours. The patient was admitted to the hospital on 7/14/10, with diagnoses which included pneumonia and congestive heart failure.

a. Review of the dictated H&P for Patient 14 dated 7/15/10, did not show it had been reviewed and signed by the physician. A tag had been placed on the H&P to remind the physician to sign.

b. Review of the physician's orders for Patient 14 showed telephone orders dated 7/28/10 at 1150, 1220 and 1245 hours, for a consultation by a neurologist, a change in medication and a dietary supplement. None of the telephone orders had been reviewed and signed by a physician. There was no tab placed on the orders to show a physician signature was indicated.

c. Review of the physicians' Progress Note form for Patient 14 showed it was pre-printed with boxes in which the objective findings, vital signs, lab entries and diagnosis were written.

The Progress Note form was reviewed with the Director of Medical Records on 8/3/10 at 1000 hours. She stated she was aware of the various Progress Note forms used by physicians in the hospital. The Director stated the forms for different physicians had not been approved by a committee of the medical staff. Similar forms were used by MD K, the infectious disease consultant and MD B, the primary care physician for Patient 14.

d. Review of the MAR for Patient 14 dated 8/3/10, showed none of the 12 medications due at 0900 hours had been documented as administered to the patient.

Review of the Patient Care Record for Patient 14 dated 8/3/10, showed an entry by RN B at 0830 hours. The RN documented the patient was alert; medications were provided by mouth and tolerated well, with no regurgitation or aspiration.

During an interview with LVN A on 8/3/10 at 1035 hours, the LVN stated Patient 14 was assigned to her care for this shift and RN B was the RN assigned to cover her patients. The LVN stated she had held Patient 14's morning medications as the patient was too sleepy. She stated she was afraid the patient would choke on them if she was not more alert. When asked to review RN B's nursing documentation at 0830 hours, which showed the patient to be alert and had tolerated her medications, LVN A stated RN B must have "thought" the medications were administered. The LVN stated she had not yet informed him she had held the patient's medications. When asked for the policy on documentation of medications not administered when due, the LVN stated she should have circled the time the medication was due on the MAR and documented the reason for holding the medications.

During an interview with RN B on 8/3/10 at 1040 hours, the RN stated he was the RN assigned to work with LVN B. The RN stated he assessed Patient 14 that morning and documented her care in the nurse's notes. The RN stated he was unaware the patient had not received her morning medications.

2. The medical record for Patient 5 was reviewed on 8/2/10 at 1040 hours. The patient was admitted to the hospital on 7/8/10.

The medical record was reviewed with RN A on 8/2/10 at 1050 hours. Multiple telephone orders dated 7//9, 7/28 and 7/30/10 were not signed by a physician. Two telephone orders dated 7/27 and 7/28/10 showed a signature by a physician without a date and time to show when the orders were reviewed. In addition, orders written by a physician on 7/26, 7/30 and 7/31/10 showed the date the orders were written but no time. An order written to give a medication "now" was noted by the nurse on 7/25/10 at 1900 hours. The order was signed by a physician but it did not contain the date and time to show when the order was written. RN A stated they had a problem with physicians coming in to quickly make rounds and not signing, timing, and dating orders. The RN stated if she was not on the unit at the time the physician made his rounds she would have no idea the time the order may have been written. The RN verified there were no tabs on the medical record to remind the physicians to review the orders which were incomplete.

3. The medical record for Patient 6 was reviewed on 8/2/10 at 1100 hours. The patient was admitted to the hospital on 7/14/10.

Review of the physician's orders for Patient 6 showed two separate telephone orders dated 7/27/10. The orders for a chest x-ray to verify the placement of a PICC line and laboratory studies had not been reviewed and signed by a physician.

4. The medical record for Patient 2 was reviewed on 8/2/10 at 1340 hours. The patient was admitted to the hospital on 7/17/10.

a. Review of the physician's orders for Patient 2 showed an order dated 8/1/10 at 1200 hours, to infuse two units of packed red blood cells.

Review of a P&P for Informed Consent, revised December 2004, showed there shall be evidence of appropriate informed consent for any procedure or treatment for which it is appropriate including blood or blood products. The consent shall include the names of the individuals who will perform the treatment, indication that alternate means of therapy and the possibility of risks or complications have been explained to the patient, signature of the patient and the witness to that signature and the practitioner who informs the patient and obtained consent.

Review of the Informed Consent form for Patient 2 did not show a physician's name was listed to show who had explained the risks and benefits of the procedure to the patient. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

During an interview with RN A on 8/2/10 at 1345 hours, the RN stated Patient 2 had received 2 units of blood on 8/1/10. The RN was asked to review the patient's consent form. When asked who would give the information to the patient when consent was obtained for a blood transfusion, the RN stated the nurse reviewed the consent form with the patient.

In an interview with the CNO on 8/2/10 at 1350 hours, the CNO stated the physician would sign the form later indicating the patient had received information regarding the procedure.

In an interview with RN C on 8/2/10 at 1355 hours, the RN stated she had obtained consent from Patient 2 for the blood transfusion on 8/1/10. The RN stated the physician had spoken to the patient previous to her obtaining the patient's consent. RN C stated the physicians did not usually sign the blood transfusion consents. The RN was unable to locate physician documentation of informed consent given to the patient.

b. Review of the physician's orders for Patient 2 showed three separate orders from two physicians were received by telephone on 7/17/10. None of the orders had been reviewed and signed by a physician.

5. The medical record for Patient 4 was reviewed on 8/2/10 at 1420 hours. The patient was admitted to the hospital on 7/30/10.

Review of the physician's orders showed three telephone orders dated 7/30, 7/31 and 8/1/10 with no signatures by the physicians to show the orders had been reviewed and confirmed. In addition, three orders written by the physicians dated 7/31 and 8/1/10 did not show the time the order was written.

6. The medical record for Patient 16 was reviewed on 8/3/10 at 0945 hours. The patient was admitted to the hospital on 6/25/10.

During an interview with RN A on 8/3/10 at 0948 hours, the RN stated soft restraints were used for the patient to prevent her pulling out the tracheostomy tube. The RN stated the restraints had been in use since 6/25/10.

Review of the Physician Restraint Orders forms dated 7/24/10 through 8/3/10, with RN A showed only one of the 10 order forms documented the date and time of the physician's signature. RN A stated the physician was required to assess the patient and sign a new order sheet daily while restraints were in use.

7. The medical record for Patient 15 was reviewed on 8/3/10 at 1000 hours. The patient was admitted to the hospital on 7/22/10.

Review of the medical record showed tabs indicating a physician's signature was needed for a dictated H&P dated 7/23/10, and two dictated consultation reports dated 7/23/10.

8. The closed medical record for Patient 26 was reviewed on 8/4/10 at 0815 hours. The patient was admitted to the hospital on 5/18/10 and was discharged on 6/25/10.

On the front of the medical record was a Deficiency Worklist form. The form showed the Medical Records staff had identified deficiencies for the five physicians involved in the care of Patient 26. The list of deficiencies for MD B showed the Discharge Summary had not yet been dictated. The admission H&P, as well as a consent form, telephone orders and progress notes had not been signed by MD B at the time of discharge.

Review of the physician's orders for Patient 26 showed two pages of telephone ICU transfer orders dated 6/16/10 at 2045 hours. The transfer orders contained 29 medication orders. The orders were not reviewed and signed by the physician until 8/3/10, five weeks following the patient's discharge from the hospital. In addition, telephone orders dated 6/18/10, showed the patient was transferred back to the medical/surgical unit and the physician ordered the ICU medication orders were to be continued. The telephone order had not been reviewed and signed by the physician.

Review of the dictated consultation notes showed for consultations dated 5/19, 5/21, 5/22, and 6/4/10, had not been reviewed and signed by the consulting physicians.

Review of a dictated operative report dated 5/28/10 did not show the physician had reviewed and signed the dictation. Review of the progress notes showed a note dated 5/28/10, the physician had written a progress note regarding the operative procedure, but there was no time or signature on the progress note.

9. The log book containing physician signature cards was provided for review on 8/4/10 at 0800 hours.

Review of the P&P for Signature Validation dated January, 2008, showed any individual authorized to make written entries into the patient record must authenticate the record by entering their signature and initials in a central log maintained by the Medical Records department. This would help to identify who had documented in the record. The nursing supervisor, before the end of each shift, should review the charts to make sure all personnel who had performed treatment on the patient had documented and signed for each shift.

The CNO was interviewed on 8/4/10 at 0900 hours. The CNO was asked to view the medical record for Patient 26. The signature of MD B on a telephone order dated 6/16/10 at 2045 hours, was compared to MD B's signature in the Authentication Log Book. The signature in the patient record was illegible as compared to the signature in the Log Book. When asked to compare the two signatures, the CNO stated they did not match.

10. A review of the closed medical record for Patient 24 on 8/4/10, showed the patient was admitted to the hospital on 5/19/10. A "Deficiency Worklist" sheet had been placed on the front of the record by the Medical Records staff. According to the "Workslist", there were 46 unsigned physician orders. In addition, a review of the medical record entries for Patient 24 revealed entries of 6/22/10 and 6/23/10 that were not legible.

a. Review of the H&P dated 5/19/10, showed no physician signature.

b. Review of the record showed no discharge summary had been completed for the patient.

c. Dictated consultation notes of two different physicians dated 5/21 and 5/22/10, had not been reviewed and signed.

d. A review of the Physician Progress Note forms showed a pre-printed progress note dated 6/23/10, signed by MD B. The progress note contained a fax printed date and time indicating that the physician pre-printed progress note had been sent via fax transmission at 1933 hours on 6/23/10.

When interviewed on 8/3/10 at approximately 1330 hours, the Medical Director was unable to determine the time the patient had been seen by MD B in the hospital. The Medical Director stated that various progress note forms were being used by practitioners at the hospital. He stated that the hospital "Forms Committee" had approved the different pre-printed forms being used for patient medical record entries. When asked for documentation for governing body approval, the hospital was unable to produce such documentation.

In an interview on 8/3/10 at approximately 1500 hours, the Director of Medical Records stated she was unaware of a committee of the medical staff that had approved the various pre-printed medical record forms being placed on the medical record of patients in the hospital.

Review of the P&P for Creation, Chart Forms dated 1/2005, showed all forms must be approved through the proper channels to ensure forms comply with format standards and regulatory requirement.

11. The medical record for Patient 19 was reviewed on 8/3/10. The patient was admitted to the hospital on 3/22/10.

Review of the record showed a dictated H&P that had not been reviewed and signed by the physician.


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12. The medical record for Patient 23 was reviewed on 8/4/10 at 1100 hours. The patient was admitted by transfer from another hospital on 6/2/10.

Review of the record revealed that an H&P dated 5/30/09, from another hospital and physician was included in the record. The H&P was not signed and contained blanks that had not been corrected. There was no admitting note stating if there was any change noted in the patient's physical condition since her hospitalization at the previous hospital.

The Physician Progress Notes had an entry dated 6/3/10. The only readable words in the note indicated "H&P dictated." However, no dictated H&P from 6/3/10, was included in the record. On 8/4/10 at 1300 hours, the Director of Medical Records was asked to check the diction system for the H&P. She located the missing H&P dictated 6/3/10 and typed 6/4/10, on the system. She could not account for why the form was not on the patient's medical record.

A Consultation Report was included in the record that had been completed and dictated 6/4/10. The report was unsigned.

13. The medical record for Patient 20 was reviewed on 8/3/10 at 1045 hours.

The record did not include a H&P at the time of admission. An admit note on 7/11/10 documented that the patient had been transferred from another acute care hospital. The note included an update of the patient's condition.

According to the Director of Medical records, the H&P could be accepted from another hospital if it was done within 30 days and an admission note was written by the patient's physician to indicate any change in condition. The Director called the previous hospital for the H&P done there. It was faxed to the hospital on 8/3/10 at 1058 hours. However, the H&P dictated and typed on 6/24/10 was unsigned.

The Doctor's Progress Notes contained a pre-stamped order dated 7/15/10 and 7/22/10, to either continue or discontinue the patient's PICC line. The form required the physician to sign and date the order and indicate by checking a box whether the line was to be continued or discontinued. In addition, the physician had to document by checking a circle why the line was to be continued. All the boxes and circles were blank. The physician had only signed a name.

Review of the physicians' order sheets showed telephone admission orders to ICU on 7/11/10 at 2100 hours that were not reviewed and signed by a physician. In addition, the ventilator setting orders given 7/11/10 at 2130 hours by phone by a consulting physician were unsigned. None of the telephone orders that were signed by physicians included a date and time of signature.

The area of the order sheet that was provided for nursing to verify the 12 and 24 hour chart checks to ensure that orders were noted and carried out were left blank (i.e. 7/10/10, 7/26/10 and 8/2/10).

14. The medical record for Patient 9 was reviewed on 8/2/10 at 1100 hours. The patient was admitted on 7/3/10.

The admission H&P was dictated on 7/12/10. The document had not yet been reviewed and signed.

The physician order sheets contained numerous telephone orders that had not been reviewed and signed by a physician (i.e. 7/10, 7/11, 7/12, 7/19, and 7/27/10). Orders that were reviewed and signed by the physicians were not dated and timed (i.e. 7/10, 7/12, and 7/18 /10).

The 12 and 24 hour chart check was not documented as be done by nursing (i.e. 7/10, 7/12, 7/19, and 7/27/10).

15. The medical record for Patient 22 was reviewed on 8/3/10. The patient was admitted on 6/5/10.

The admission H&P was dictated by the admitting physician on 6/5/10 and had not been reviewed and signed. A consult had been done on 6/6/10, regarding the patient's respiratory care, but had not been reviewed and signed by the physician. Another consult had been done on 6/7/10. The consulting physician had not reviewed and signed the consult.

Progress notes had been dictated by a physician on 6/14/10 and 7/7/10. The physician had not reviewed or signed either note.

The physician orders were reviewed. There were telephone orders given by the physicians on 6/9, 6/24, 6/29, and 7/21/10 that had not been reviewed and signed by the physicians. In addition, any of the orders that had been reviewed and signed by the physicians were not dated or timed.

16. The medical record for Patient 21 was reviewed on 8/3/10. The patient was admitted to the hospital on 6/29/10.

The physician order sheets were reviewed. Physicians had given telephone orders on 7/3, 7/13, 7/14, 7/15, 7/16, and 7/17/10. The orders had not been reviewed and signed by the prescribing physician. In addition, orders throughout the sheets that had been signed by a physician did not have the date and time of the signatures.


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17. Patient 3 was admitted to the hospital on 7/13/2010. The open medical record for Patient 3 revealed medical record entries for orders on 7/21/10, 7/22/10, 7/26/10, and 7/28/10, showed a scrawled, illegible "signature." No time or date for the scrawled, illegible signature was noted in the medical record.

18. Patient 8 was admitted to the hospital on 7/21/10. A review of the open medical record for Patient 8 revealed physician orders dated 7/22/10, 7/29/10, and 7/30/10. A scrawled initial was noted, however, this initialed signature contained no time or date of the signature. Telephone orders were received for the treatment of Patient 8 on 7/23/10 and 7/30/10. There was no written documentation present on the order form to indicate that the orders had been signed.

The medical record for Patient 8 contained a form containing a series of check boxes on the "physician progress notes" form. The Director of Medical Records reviewed the form during an interview conducted at approximately 1000 hours on 8/3/10. The Director of Medical Records seemed aware of the version of the progress note form; however, she stated she was unaware if the form had been approved for use by MD B. The Director of Medical Records stated that a committee of the medical staff for approval of different progress notes had not been provided at the hospital.


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19. Patient 10's medical record was reviewed on 8/2/10 at 1511 hours. Review of the patient's allergies showed two medications were written on top of her chart. Ativan (a medication to treat nervousness and anxiety) and Haldol (a medication to treat psychiatric symptoms) were both documented as allergies. On further review of the medical record, the MAR was found to have a section designated for allergies. The nurse would administer medications by following the directions and precautions (such as allergies) on the MAR. Patient 10's MAR only showed Ativan as an allergy and not Haldol. Not having a complete allergy list on the MAR puts Patient 10 at risk of receiving a medication she does not tolerate and could cause harm.

20. On 8/2/10 at 1511 hours, review of Patient 10's medical record revealed a telephone order for Coumadin on 7/29/10 without a counter signature by the prescriber.

21. On 8/2/10 at 1315 hours, review of Patient 13's medical record revealed three telephone orders that were not cosigned by the prescriber. The orders were for Clonidine and written on 7/25/10, Nystatin Powder written on 7/25/10, and Tygacil written on 7/9/10.

22. On 8/2/10 at 1455 hours, review of Patient 30's medical record revealed a telephone order for potassium chloride that was written on 7/31/10 at 1300 hours. There was no countersignature by the prescriber.

Based on interviews, a review of the medical staff bylaws and rules and regulations of the hospital, and a review of 30 open and closed medical records, the hospital failed to ensure that medical record entries were legible and had been dated, timed and signed in accordance with P&Ps and Medical Staff Bylaws, Rules, and Regulations for 9 of 30 sampled patients (Patients 3, 5, 8, 9, 16, 20, 21, 22, and 24). When physicians orders were not legible and not authenticated with a signature this resulted in the potential for information not to be available for care of the patient and medical errors.

Findings:

A review of the policy and procedure, Medical Record Completion, dated 11/25/09, showed the attending physician would be responsible for preparing a complete and legible medical record for each patient.

1. Record review showed Patient 3 came to the hospital on 7/13/2010. The open medical record for Patient 3 revealed medical record entries for orders on 7/21/10, 7/22/10, 7/26/10, and 7/28/10 revealed a scrawled, illegible "signature". No evidence of the time or date that the scrawled, illegible signature was written in the medical record.

2. Patient 8 came to the hospital on 7/21/10. A review of the open medical record for Patient 8 revealed physicians' orders for 7/22/10, 7/29/10, and 7/30/10. A scrawled initial was noted, however, this initialed signature contained no time or date of the signature.

3. Patient 24 was admitted to the hospital on 5/19/10. A review of the medical record for Patient 24 revealed a "Deficiency Worklist". According to the Worklist, there were 46 unsigned physicians' orders. A review of the medical record entries for Patient 24 revealed entries of 6/22/10 and 6/23/10 that were not legible.


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4. The medical record for Patient 5 was reviewed on 8/2/10 at 1040 hours. The patient was admitted to the hospital on 7/8/10.

The medical record was reviewed with RN A on 8/2/10 at 1050 hours. Two telephone orders dated 7/27 and 7/28/10 showed a signature by a physician without a date and time to show when the orders were reviewed. In addition, orders written by a physician on 7/26, 7/30 and 7/31/10 showed the date the orders were written but no time. An order written to give a medication "now" was noted by the nurse on 7/25/10 at 1900 hours. The order was signed by a physician but it did not contain the date and time to show when the order was written.

5. The medical record for Patient 16 was reviewed on 8/3/10 at 0945 hours. The patient was admitted to the hospital on 6/25/10.

During an interview with RN A, on 8/3/10 at 0948 hours, the RN stated soft restraints were used for the patient to prevent her pulling out the tracheostomy tube. The RN stated the restraints had been in use since 6/25/10.

Review of the Physician Restraint Orders forms dated 7/24/10 through 8/3/10, with RN A showed only one of the 10 order forms documented the date and time of the physician's signature. RN A stated the physician was required to assess the patient and sign a new order sheet daily while restraints were in use.


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6. The medical record for Patient 20 was reviewed on 8/3/10 at 1045 hours. Review of the physician's order sheets showed none of the telephone orders that were signed by the physicians included a date and time of signature.

7. The medical record for Patient 9 was reviewed on 8/2/10 at 1100 hours. The patient was admitted on 7/3/10.

The physician order sheets showed orders dated 7/10/10, 7/12/10, and 7/18/10, that were reviewed and signed by the physicians but the signatures were not dated and timed.

8. The medical record for Patient 22 was reviewed on 8/3/10. The patient was admitted on 6/5/10

The physician orders were reviewed. Telephone orders that had been reviewed and signed by the physicians were not dated or timed.

9. The medical record for Patient 21 was reviewed on 8/3/10. The patient was admitted to the hospital on 6/29/10.

The physician order sheets were reviewed. Telephone orders throughout the sheets that had been signed by a physician did not have the date and time of the signatures.

Based on interview, review of the medical record and facility documents, the hospital failed to ensure the physicians' written and telephone orders were consistently signed, dated and timed for 17 of 30 sampled patients (Patients 2, 3, 4, 5, 6, 8, 9, 10, 13, 14, 16, 20, 21, 22, 24, 26, and 30) during the patients hospitalization. This had the potential for unsafe practices when orders given over the telephone were not reviewed promptly by the physician for accuracy.

Findings:

See A 438 1b, 2, 3, 4b, 5, 6, 8, 10, 13, 14, 15, 16, 17, 18, 19b, 20, and 21.

Based on medical record review, the hospital failed to ensure the admission H&Ps for 5 of 30 sampled patients (Patients 14, 15, 19, 24, and 26) were available on the record within 24 hours after admission. The dictated H&Ps were not consistently reviewed and signed promptly for accuracy. This had the potential to result in incorrect or no information regarding the patient's medical history to be available for care of the patient.

Findings:

1. The medical record for Patient 14 was reviewed on 8/3/10 at 1030 hours. The patient was admitted to the hospital on 7/14/10.

Review of the dictated H&P for Patient 14 dated 7/15/10, did not show it had been reviewed and signed by the physician. A tag had been placed on the H&P to remind the physician to sign.

2. The closed medical record for Patient 26 was reviewed on 8/4/10 at 0815 hours. The patient was admitted to the hospital on 5/18/10 and was discharged on 6/25/10.

On the front of the medical record was a Deficiency Worklist form. The form showed the medical record staff had identified deficiencies for the five physicians involved in the care of Patient 26. The list of deficiencies for MD B showed the admission H&P had not been reviewed and signed by MD B at the time of discharge.

3. The medical record for Patient 15 was reviewed on 8/3/10 at 1000 hours. The patient was admitted to the hospital on 7/22/10.

Review of the medical record showed tabs indicating a physician's signature was needed for a dictated H&P dated 7/23/10.

4. The medical record for Patient 19 was reviewed on 8/3/10. The patient was admitted to the hospital on 3/22/10.

Review of the record showed a dictated H&P that had not been reviewed and signed by the physician.

5. The closed medical record for Patient 24 was reviewed on 8/4/10. Review of the H&P dated 5/19/10, showed no physician signature.

Based on medical record review, the hospital failed to ensure the dictated consultative evaluations of two of 30 sampled patients (Patients 15 and 26) had been reviewed promptly for correctness and signed by the physicians. This had the potential for incorrect information to be available to other physicians.

Findings:

1. The closed medical record for Patient 26 was reviewed on 8/4/10 at 0815 hours. The patient was admitted to the hospital on 5/18/10 and was discharged on 6/25/10.

Review of the dictated consultation notes showed the consultations of four different physicians dated 6/4, 5/19, 5/21, and 5/22/10, had not been reviewed and signed by the consulting physicians during the patient's stay in the hospital.

2. The medical record for Patient 15 was reviewed on 8/3/10 at 1000 hours. The patient was admitted to the hospital on 7/22/10.

Review of the medical record showed tabs indicating a physician's review and signature was needed for two dictated consultation reports dated 7/23/10.

Based on interview, review of the medical record and hospital P&P, the hospital failed to ensure the medical record for three of 30 sampled patients (Patients 2, 20 and 25) contained a completed informed consent for procedures such as blood transfusions and a PICC line insertion. The name and the signature of the physician responsible for informing the patients of the risk and benefits of the proposed procedure(s) were not found on the consent forms. This had the potential for patients to consent to procedures for which they did not have complete understanding.

Findings:

Review of the P&P Consent for Medical Treatment: Guidelines For, reviewed date July, 2004, showed as a general guideline, except in emergency situations, medical treatment without consent is battery and failure to allow patients this right to certain specific information prior to consenting to and undergoing certain procedures or therapy, constitutes malpractice. It was the physician's responsibility to obtain informed consent from the patient. For a blood transfusion consent, the physician should discuss the risks and benefits of the transfusion, the alternatives to the transfusion and whenever possible the use of directed donations and autologous blood. This informed consent was required in addition to the requirements of the Paul Gann Blood Safety Act.

Review of a P&P Informed Consent, revised December 2004, showed there shall be evidence of appropriate informed consent for any procedure or treatment for which it is appropriate including blood or blood products. The consent shall include the names of the individuals who will perform the treatment, indication that alternate means of therapy and the possibility of risks or complication have been explained to the patient, signature of the patient and the witness to that signature and the practitioner who informs the patient and obtained consent.

These P&Ps were not followed for Patients 2, 20 and 25. See A 131.




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2. The medical record for Patient 20 was reviewed on 8/4/10 at 1100 hours. Review of the Informed Consent: Surgery/Procedure form contained documentation that the patient's physician had recommended that the patient undergo the insertion of a PICC line. The patient was unable to give her consent, so the daughter of the patient had signed as her legal representative on 7/12/10 at 0840 hours. The box used to indicate that the patient or legal representative had been provided education about the risks, benefits or alternatives had not been checked off. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

In addition, the record for Patient 20 contained an Informed Consent: Surgery/Procedure form also signed by the daughter on 7/13/10 at 1520 hours, for a blood transfusion. The form did not show the box used to indicate a patient education sheet had been provided to the patient representative was checked off. No physician's name was listed to show who had explained the risks and benefits of the procedure to the patient's representative. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

3. The medical record for Patient 25 was reviewed on 8/4/10 at approximately 1300 hours. Review of the Informed Consent: Surgery/Procedure form contained documentation that it had been recommended that the patient undergo the insertion of a PICC line. The consent was signed on 6/15/10 by a friend. There is no documentation to indicate which physician recommended the procedure, which physician was to perform the procedure or whether the patient's agent had been given any explanation of the risks, benefits or alternatives of the procedure. Review of the area on the form for the physician's signature indicating informed consent was given was blank.

Based on interview and medical record review, the hospital failed to ensure the closed medical record for 2 of 8 discharged patients (Patients 24 and 26) reviewed contained a discharge summary of the patient's hospitalization that was completed promptly within the 14 day time frame as specified by the hospital.

Findings:

A review of the policy and procedure, Medical Record Completion, dated 11/25/09, showed the attending physician would be responsible for preparing a complete and legible medical record for each patient. The record would include a discharge/transfer summary for inpatients. The attending physician would account for the accuracy and completeness of the discharge/transfer summary by signing it.

During an interview with the Director of Medical Records on 8/3/10 at 0900 hours, she stated after discharge, Medical Records staff completed the patient's medical record and when items were missing, she notified the physicians to come in and complete their records. After discharge, the Director stated the medical record was to be completed within 14 days.

1. The closed medical record for Patient 26 was reviewed on 8/4/10 at 0815 hours. The patient was admitted to the hospital on 5/18/10 and was discharged on 6/25/10.

On the front of the medical record was a Deficiency Worklist form. The form showed the medical record staff had identified deficiencies for the five physicians involved in the care of Patient 26. The list of deficiencies for MD B showed the Discharge Summary had not yet been dictated.

2. Review of the closed record for Patient 24 on 8/4/10, showed a discharge date of 6/23/10.

No discharge summary had been completed for the patient.

Based on observation, interview, medical record, and policy and procedure review, the hospital failed to ensure that pharmaceutical services carried out its full and complete oversight that meets the needs of the patients in the hospital.

Findings;

1. On 8/3/10 at 1630 hours, the Administration was notified of Immediate Jeopardy (IJ) to the health and safety of hospital patients with orders for Coumadin dosing per pharmacy. Coumadin is an anticoagulant (blood thinning medication) that is prescribed to prevent blood clots from forming in susceptible patients. Two patients received Coumadin dosing orders per pharmacy (Patients 9 and 16). Coumadin was started by the pharmacist who ordered the medication(s), the doses, the laboratory tests, and if needed, adjusted the doses. The pharmacists were regulating Coumadin without an approved hospital protocol to guide them.

Patients 9 and 16 received Coumadin and developed complications from therapy while being dosed by hospital pharmacists. Patient 9 developed bleeding from the mouth while taking another drug that increased the risk of bleeding. Patient 16 received Coumadin and Lovenox for a period of over 4 weeks when the patient should have been taken off Lovenox and maintained on Coumadin only. Lovenox is an anticoagulant medication that is given by injection and used for short periods of time and then discontinued when Coumadin's blood test, INR - international normalized ratio, reaches therapeutic levels. Continuing on two anticoagulant medications for long periods of time (weeks) can lead to an increased risk of bleeding.

On 8/4/10 at 1130 hours, the hospital's written plan of action to abate the IJ was verified as complete and accepted by the survey team. The plan of correction stated, "All patients receiving Coumadin dosing by a pharmacist were immediately switched to physician dosing. Each patient's primary care physician was called to discontinue the order for dosing of Coumadin by the the pharmacist and switched to dosing by physician. All patients' Coumadin dosing will be by the appropriate physician until such time that an adequate, detailed protocol is developed and approved by the medical staff." The IJ was abated on 8/4/10 at 1130 hours. See A 500 #1.

2. Pharmaceutical services failed to ensure the main pharmacy stored medications in a clean and orderly manner and the laminar flow hood (a sterile cabinet where sterile compounding of medications take place) was clean and serviced as required. See A 491.

3. Pharmaceutical services failed to ensure that medications available for patients were stored in a secure and locked area to prevent unmonitored access by unauthorized individuals. See A 502.

4. Pharmaceutical services failed to ensure that medications stored the in PACU (post anesthesia care unit) refrigerators were stored at required temperatures to guarantee stability and integrity. See A 500 #5.

5. Pharmaceutical services failed to ensure that vaccines stored in the pharmacy's refrigerator were monitored twice a day to guarantee stability and integrity. See A 500 #4.

6. Pharmaceutical services failed to ensure that medications contained in the emergency carts were listed on the outside of the cart. See A 500 #3.

7. Pharmaceutical services failed to ensure that a written policy was established and implemented so patients being discharged received information about their medications. See A 500 #2.

8. Pharmaceutical services failed to ensure that oral medications were segregated from topical medications. See A 500 #6.

9. Pharmaceutical services failed to ensure that verbal orders taken over the telephone for medications were countersigned by the prescriber within 48 hours. See A 500 #7.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation and interview, the hospital failed to ensure that medications in the main pharmacy were stored in a clean and orderly manner and the laminar flow hood was clean and serviced as required.

Findings:

On 8/2/10 at 1404 hours, located in the main pharmacy were several rows of boxes containing intravenous medications. The boxes were left on the floor, dusty and unorganized. There were also boxes stacked in a medication aisle which completely blocked the aisle. The boxes contained intravenous medications and were stacked from the floor to at least 6 feet in height.

Located in the back room was the laminar flow hood which is used to compound intravenous medications that require sterile procedures and a sterile environment. On the back wall of the laminar flow hood was a filter. Located inside the filter was a brown gooey substance. When the DOP was asked what the substance was, he described it as "gunk." The pharmacy continued to compound intravenous medications and in a sterile compounding environment with "gunk" on the air filter. Also, the laminar flow hood was last serviced in January 2010 and required service again by 7/15/10 which as of 8/2/10, had not been performed.

Based on staff observation, interview, medical record, and policy review, the hospital failed to ensure that:

* Pharmacists who were determining doses of warfarin (brand name Coumadin, an anticoagulant or blood thinning medication taken by mouth) for patients were following a protocol which was approved by the hospital's Pharmacy and Therapeutics Committee. Four patients had doses determined by a pharmacist and one of the four (Patient 9) developed bleeding from the mouth. The bleeding occurred when Patient 9 was taking another medication at the same time which increased the risk of bleeding. Another patient, Patient 16 received Coumadin and Lovenox (another anticoagulant or blooding thinning medication given by injection) together for a period of more than four weeks. Taking both warfarin and Lovenox for this length of time jeopardizes Patient 16's safety by increasing the risk of bleeding.
* The hospital established and implemented a written policy so that each patient received, at the time of discharge, information regarding medications dispensed and the DOP remained current on the AFLs (All facility letters) issued by the California Department of Public Health.
* The medication contents of the emergency code blue carts were listed on the outside of the cart.
* Temperature monitoring for vaccines stored in the refrigerator was being done twice a day.
* The temperature in the PACU (post anesthesia care unit) refrigerator containing medications was being monitored as required to ensure the temperature range was between 36 and 46 degrees F (Fahrenheit).
* Topical and oral medications were segregated and not stored together on the same shelf.
* Verbal orders taken over the telephone were countersigned by the prescriber within 48 hours.

Findings:

1. On 8/2/10 at 1409 hours, the DOP was interviewed. He said pharmacists regulated medications in the hospital based on approved hospital protocols. He said pharmacists ordered the medication(s), the doses, the laboratory tests, and if needed adjusted the doses.
The DOP said, "the protocols were approved by the hospital's Pharmacy and Therapeutics Committee, and medical staff committee, before I started working here." The DOP provided a list of medications pharmacists regulated by following hospital protocols. One such medication was Coumadin. Coumadin is frequently prescribed to prevent patients from developing blood clots or when patients are at risk for blood clots to reoccur. The DOP was asked to produce a copy of the hospital's approved protocol the pharmacists used to guide them in regulating Coumadin. After several minutes of searching his files, the DOP said, "I can't find one." He called additional hospital staff to help him search for the protocol but in the end was told by the Director of Medical Staff, there wasn't one. He was also unable to find documentation of competency training for pharmacists that they had passed a competency test to demonstrate they were qualified to regulate Coumadin dosing.

On 8/3/10 at 1322 hours, during an interview, the Medical Director stated he was unaware the hospital did not have an approved Coumadin protocol. He stated the hospital should have an approved protocol and he would check. Later that day the Medical Director announced the hospital did not have an approved protocol.

a. On 8/3/10, Patient 9's medical record was reviewed. He was admitted on 7/3/10 and on 7/4/10 there was an order for Coumadin per pharmacy. The pharmacist started Coumadin two days later on 7/6/10 and ordered INR laboratory tests daily. The INR is an abbreviation for international normalized ratio and is a Coumadin blood test to determine if the blood is thin enough to prevent blood clots. The pharmacist ordered the dose of Coumadin based on the daily INRs. However the patient continued to take another medication that increases the risk of bleeding when taken along with Coumadin. The medication was aspirin, 81 milligrams, which also can decrease the blood's ability to clot. In the absence of a protocol, there was no guidance for the pharmacist to continue, discontinue or consult with the patient's physician about the aspirin. The patient continued on aspirin and on 7/9/10, MD C noted in Patient's 9 chart, "New onset bleeding/oozing from mouth." On 7/9/10, MD D noted, "Patient oozing from side of mouth and also on aspirin." MD D wrote an order on 7/9/10 to administer intravenous Vitamin K (antidote for Coumadin to reverse the blood thinning effects) due to oozing of the mouth.

b. On 8/3/10 at 1503 hours, Patient 16's medical record was reviewed. Patient 16 was admitted on 6/25/10 and on that day an order was written for Coumadin to be regulated per pharmacy. The pharmacist ordered the daily doses of Coumadin based on the daily INRs. On 7/5/10, Patient 16's physician ordered Lovenox 120 milligrams subcutaneously twice a day and to discontinue the Lovenox when the INR was greater than 2.0. Lovenox is another blood thinning medication that is administered by injection. Blood levels to determine whether the blood is thin enough are not recommended with this medication since the full anticoagulant effect begins within 24 hours of starting. The pharmacist continued to order Coumadin doses daily with a goal of reaching an INR above 2.0 so the Lovenox could be discontinued. Patient 16 continued on both Coumadin and Lovenox from 7/5/10 until 8/3/10 without achieving an INR above 2.0 (30 days). The American College of Chest Physicians - Consensus Report June 2008, 133 (6 Supp) provides a national standard of practice for anticoagulant therapy and addresses Coumadin resistant patients who require higher doses than normal to achieve a therapeutic INR. They also recommend for all general hospitals, that a thromboprophylaxis strategy (to prevent blood clots from forming) be in the form of a written, institutional wide policy. Taking two anticoagulants at the same time increased the risk of bleeding for Patient 16.

On 8/5/10 at 1123 hours, a telephone interview was conducted with Patient 16's physician (MD A). He stated he was unaware the hospital did not have an approved Coumadin protocol. He was wondering why Patient 16 continued on Lovenox for such a long time. He also said, he spoke with the DOP and told him it was OK to increase the dose of Coumadin to 15-20 milligrams a day but this was not done.

On 8/5/10 at 1140 hours, the DOP stated he spoke on the telephone to MD A two to three times over the last month about Patient 16. He stated MD A recommended he increase Coumadin to 15 milligrams. The DOP was asked if he increased the Coumadin dose after his telephone conversation with MD A, he stated he did not increase the dose. The DOP was asked why he didn't but did not answer this question. The pharmacist dosed Coumadin for Patient 16 without the guidance from the physician and without an approved Coumadin protocol. The pharmacist also ordered doses which were too low to achieve an INR of greater than 2.0. Although, the INRs remained below 2.0, the levels of 1.4 and above are considered "low intensity" anticoagulation by the American College of Chest Physicians - Consensus Report June 2008, 133 (6 Supp). The INRs in nine of the 30 days were above 1.4 which put Patient 16 at jeopardy for developing a bleeding episode.

On 8/3/10 at 1630 hours, the Administration was notified of Immediate Jeopardy (IJ) to the health and safety of hospital patients with orders for Coumadin per pharmacy.

On 8/4/10 at 1130 hours, the hospital's written plan of action to abate the IJ was verified as complete and accepted by the survey team. The plan of correction stated, "All patients receiving Coumadin dosing by a pharmacist were immediately switched to physician dosing. Each patient's primary care physician was called to discontinue the order for dosing of Coumadin by the the pharmacist and switched to dosing by physician. All patients' Coumadin dosing will be by the appropriate physician until such time that an adequate, detailed protocol is developed and approved by the medical staff." The IJ was abated on 8/4/10 at 1130 hours.

2. On 8/2/10 at 1019 hours, the DOP was interviewed. He said when patients were discharged from the hospital, there was no routine education provided on discharge medications. He said there was no policy and procedure for providing this education and in most cases no education was provided at all. The California Health and Safety Code, Section 1262.5(e) states, "a hospital must establish and implement a written policy to ensure that each patient receives, at the time of discharge, information regarding each medication dispensed." In March, 2009, the Department of Public Health issued an AFL (All facility letter) to notify the hospitals of the regulation requiring a written discharge medication policy and process requirements pursuant to Health and Safety Code Section 1262.5. The DOP, when asked if he saw this AFL, replied "no."

3. a. On 8/2/10 at 0900, while touring the surgical department, the Malignant Hyperthermia (MH) Cart (a cart containing the required emergency drugs for MH treatment) was found to have an inaccurate account of Dextrose 50% (a medication used to treat low blood sugars).
The California Code of Regulations, Title 22, Section 70263(f)(3), states, "The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

According to the list of contents on the outside of the cart, there should have been Dextrose 50% 50 vials x 2 stored inside. Stored inside the cart was Dextrose 50% 50 ml vials x 2.

b. On 8/2/10 at 1039 hours, while touring the medical/surgical unit, the code blue crash cart was found to have several drugs stored inside that were not listed on the content list taped to the outside of the cart. These drugs included:
Cetacaine Spray - found in drawer 2
Xylocaine Jelly - found in drawer 2
Normal Saline 500 milliliter (ml) intravenous solution - found in drawer 3
Normal Saline 1000 ml intravenous solution - found in drawer 3
Dextrose 500 ml intravenous solution - found in drawer 3

The California Code of Regulations, Title 22, Section 70263(f)(3), states, "The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

The California Department of Public Health issued an all facility letter (AFL) dated February, 2005 and entitled, "The Storage and Use of Emergency Medications," to provide information on the requirements of a code blue crash carts. The AFL states, "A content list must be posted on the outside of the portable container containing emergency medications and equipment. A content list attached to a medication tray that is sealed and placed inside a movable cart doesn't meet the requirements of regulation. The content list must accurately and comprehensively reflect all medications in the cart (i.e. vials of normal saline for injection, tubes of lidocaine jelly, bottles of povidone-iodine solution, large and small volume parenteral solutions, etc)."

In addition, the medication list on the outside of the medical/surgical floor crash cart listed Magnesium Sulfate 10 ml vial stored inside. Inside the code blue drug tray were 5 vials of Magnesium 2 ml.

c. On 8/2/10 at 1423 hours, the code blue crash cart in ICU was found to be missing a list of medications on the outside of the cart. Without a list of medications on the outside of the cart, the healthcare staff would not know what the cart contained. Also, there was no documentation as to when the first drug would expire. In addition, Atropine (a heart mediation) was stored in different concentrations and quantities than what was documented on the list located inside the cart, i.e.. Atropine 4 syringes of 1 milligram/ml instead of 0.5 milligrams/ml which is half the strength.

4. On 8/2/10 at 0949 hours, the main pharmacy's refrigerator was found to contain several types of vaccines. A sample of the types of vaccines found in the refrigerator were:
Meningococcal
Rabies
Tetanus
Diptheria
Hepatitis B
Measles, Mumps and Rubella

Temperature monitoring was being documented once daily on the hospital's temperature log form. In December 2009, the California Department of Public Health issued an AFL (All Facility Letter) to address concerns pertaining to the safe use of medications requiring refrigeration. The AFL states, "To ensure optimal efficacy of vaccines, it is important that careful attention be directed to the handling and storage of these products. The Department has identified a number of facilities that have stored vaccines at excessive temperatures, both heat and cold, outside manufacturers' recommended ranges." The AFL also states, "All medication storage areas must be periodically inspected by qualified staff in accordance with facility policy, standards of practice and/or regulatory requirements to ensure that medications are safely and properly stored. For refrigerators used to store vaccines, the temperature should be monitored and recorded twice a day." The main pharmacy refrigerator that stores vaccines for the hospital was being monitored only once a day.

5. On 8/2/10 at 0925 hours, the PACU refrigerator temperature log for July was only completed for 6 days of the month and there was no documentation of temperatures from July 14 to the end of the month. On 8/2/10 at 0931 hours, the Surgery Director stated there are days when the PACU has no patients so staff was not present to complete the log. Medications contained in the refrigerator were:
Bacitracin 5,000 unit injection - an antibiotic
Anectine injection - a neuromuscular blocker used in surgery
Regular Insulin injection - medication to treat high blood sugar levels
Propofol Emulsion injections - used in anesthesia to induce sleep

*California Code of Regulations, Title 22, Section 70263(q)(6) states, "Drugs shall be stored at appropriate temperatures. Refrigerator temperatures shall be between 36 and 46 degrees F." It's unknown whether medications stored in refrigerators not monitored for temperatures are being stored in the required ranges. If not, their integrity can be compromised and have a significant impact on patient care.

6. On 8/2/10 at 0949 hours, two shelves located in the main pharmacy, were found to contain both oral and topical medications. On one shelf were oral medications, i.e. Phosphosoda, Potassium Iodine while on the same shelf were topical medications, i.e. iodine tincture, and chlorhexidine. Another shelf contained the following oral medications, i.e. castor oil and topical medications, i.e. iodine ointment, and tincture of benzoin.

*California Code of Regulations, Title 22, Section 70263(q)(5) states, "External use drugs in liquid, tablet, capsule or powder form shall be segregated from drugs for internal use."

7. a. On 8/2/10 at 1315 hours, review of Patient 13's medical record revealed three verbal orders taken over the telephone that were not cosigned by the prescriber. The orders were for Clonidine and written on 7/25/10, Nystatin Powder written on 7/25/10, and Tygacil written on 7/9/10.

b. On 8/2/10 at 1455 hours, review of Patient 30's medical record revealed a verbal order taken over the telephone for Potassium Chloride that was written on 7/31/10 at 1300 hours. There was no countersignature by the prescriber.

c. On 8/2/10 at 1511 hours, review of Patient 10's medical record revealed a verbal order taken over the telephone for Coumadin on 7/29/10 without a counter signature by the prescriber.

*California Code of Regulations, Title 22, Section 70263(g) states, "The prescriber or furnisher shall countersign the order within 48 hours."

Based on observation, the hospital failed to ensure that medications stored in the medication room adjacent to nursing station 200 were secure when staff was not present.

Findings:

On 8/3/10 at 0935 hours, the medication room was found unlocked. The medication room was located off a hallway and in close proximity to patient rooms. Staff was not present inside the medication room and the door to the night locker was found open. The night locker contained medications that nurses had access to when the pharmacy was closed. Stored in the night locker were several injectable medications and an extra emergency drug tray.

Based on observation and interview, the hospital failed to remove expired medications from stock, leaving them available for patient use.

Findings:

On 8/2/10 at 0925 hours, during a tour of the PACU (post anesthesia care unit) there were two 1000 milliliter bottles of sterile water for irrigation found to have expired 6/10.

On 8/2/10 at 0949 hours, while touring the hospital's main pharmacy, the medication refrigerator was observed to contain several expired medications, including vaccines. The following were found expired:
*Tetanus and Diphtheria Vaccines - 9 vials expired 2-22-10
*Afluria (Influenza vaccine) - 1 syringe expired 6-30-10
*Cubicin 500 milligram single dose vial opened with no expiration date and used more than once
*IV bag of normal saline 0.45% with potassium - expired 7/25/10
*Doripenem (antibiotic) 250 milligram in sodium chloride 0.9% - expired 7/25/10

On 8/2/10 at 1014 hours, the DOP was notified of the above expired drugs in the pharmacy. The DOP did not comment.

Based on observation, interview and review of hospital documents, the hospital failed to have a system in place to ensure staff wore proper PPE and washed hands in between patients; staff and physicians were screened annually for TB; the hospital was maintained in a sanitary manner; and the contracted service providing dialysis to hospital patients provided documented evidence cultures were obtained monthly on the diaylisis machines. These findings had the potential to create an unsafe environment for patient care and infectious diseases to spread throughout the hospital.

Findings:

1. The P&P Pre-Placement Health Screening, revised 5/28/09, showed a pre-placement physical would be conducted after an offer of employment was extended. The pre placement physical included TB screening for all candidates. In addition, a test for TB would be required yearly.

a. Review of the health record for RT A showed the last documentation of a PPD skin test for TB was dated 7/1/09.

b. Review of the health record for Employee A showed a date of hire of 1/4/10. No documentation of a test for TB was found in the record.

c. Review of the health record for RN A showed a date of hire as 6/28/06. The documentation of a PPD skin test for TB showed the new employee had a positive skin test. A notation on the Employee PPD Tuberculosis Skin Test Record dated 6/26/06, documented the employee was "Bringing copy of CXR which was done a few months ago." The x-ray report provided by the employee was dated 11/30/05.

The Vice President of Human Resources was interviewed on 8/4/10 at 1115 hours. When asked to provide documentation to show Employee A and RT A were tested for TB as required in the hospital's P&P, the Vice President stated these employees "fell through the cracks." She stated the TB tests should have been completed.


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2. A review of the policy and procedure for Tuberculosis screening of physicians, licensed practitioners and/or professional staff dated 11/25/09 revealed: "All members of the medical staff and professional staff (AHP) are required to provide Medical Staff Services with documented TB screening as part of their appointment process and every two (2) years thereafter."

A review of the professional credentials files for MD B, MD I, MD L and the Medical Director revealed that each physician had received TB testing every two years.

Interviews with the Medical Director conducted on 8/3/10 at approximately 1330 hours confirmed that professional staff TB testing was being conducted every two years. The recommendations of the CDC ( Center for Disease Control) were presented and discussed. The Medical Director agreed that the population of patients in the long term acute care hospital were at risk and vulnerable to exposure to tuberculosis. He agreed that annual testing, as recommended by the CDC, Communicable Disease Center, should be adopted.

3. During an onsite visit to the intensive care unit conducted on 8/4/10 at approximately 1458 hours, Lab Tech 1 was observed entering an ICU room. This patient was in isolation with signage instructing all who enter to put on personal protective equipment. Lab Tech 1 was observed entering this room without personal protective equipment.


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4. On 8/2/10, during the initial tour of the ICU, Patient 9 was observed receiving renal dialysis treatment from Dialysis Nurse A,an employee of the contracted dialysis service company. Patient 9 was in contact isolation for MRSA. A warning sign outside the ICU patient cubicle indicated that all persons entering the cubicle should wear gloves upon entering the room, mask if splashes of blood and body fluids are likely and gowns when contact with the patient or contaminated surfaces is anticipated.

Dialysis Nurse A was observed giving direct care to Patient 9 without wearing gloves. In addition, the nurse was not observed to wear a mask or a face covering to protect her in the event of exposure to splashes of the patient's blood. The protective gown she wore was not secured and was open at the back, exposing her uniform at the shoulders and back. According to the ICU staff this same nurse went to other rooms in the hospital to give dialysis treatments after she left this patient.

5. On 8/2/10 at 1030 hours, RT - B was observed giving tracheoscopy care to Patient 9. The therapist was observed to be wearing an isolation gown that was not secured at the neck as designed, to ensure that her uniform was covered and her clothing was protected from contact with infectious agents. The gown did not cover her shoulders and was falling forward exposing the therapist's front neck area, shoulders and back area.

6. The hospital Dialysis Infection Control Policies and preventative maintenance book provided to the hospital from the dialysis company were reviewed on 8/2/10. The P&P documented a routine culture will be drawn on each dialysis machine on a monthly basis and the results will be kept in the appropriate file that is maintained for each individual dialysis machine. A copy of each culture report will be provided to each client hospital on a monthly basis.

Review of the books provided showed cultures were done on the water and dialysate every month from 2006 to 2/28/07. From 2/28/07 to 12/16/09, there was no documented evidence cultures were done on the water and dialysate every month as required. When asked, the hospital ICP was unable to provide documentation to show cultures were done by the company or the hospital during this period of time. The ICP stated he was unaware the cultures had not been done from 2007 to 2009. Documentation of cultures of water and dialysate had resumed monthly on 12/16/09.



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7. On 8/2/10 at 1404 hours, located in the main pharmacy were several rows of boxes containing intravenous medications. The boxes were left sitting on the floor, dusty, and unorganized. There were also boxes stacked in a medication aisle. The boxes contained intravenous medications.

Located in the back room was the laminar flow hood which is used to compound intravenous medications that require sterile procedures and a sterile environment. On the back wall of the laminar flow hood was a filter. Located inside the filter was a brown gooey substance. When the DOP was asked what the substance was, he described it as "gunk."

The pharmacy continued to compound intravenous medications and failed to ensure a sterile compounding environment with "gunk" on the filter. Also, the laminar flow hood was last serviced in January 2010 and required service again by 7/15/10 which, as of 8/2/10, had not been performed.

Based on interviews, a review of 30 open and closed medical records and a review of the minutes from selected committees of the medical staff, the hospital failed to identify and track quality indicators to assess the quality and safety of care being provided to patients in the hospital. The hospital failed to identify issues such as incomplete medical records, the use of unapproved multiple pre-printed medical record forms in use by practitioners on the medical staff, and the need to evaluate and provide a mechanism to authenticate medical staff signatures to provide safety and appropriateness of care for patients. In addition, the hospital failed to identify the pharmacist dosing of Coumadin, a high risk medication, without an approval protocol as a potential patient safety issue.

Findings:

1. On 8/2/10 at 1409 hours, the DOP was interviewed. He stated pharmacists regulated medications in the hospital based on approved hospital protocols. He said pharmacists ordered the medication(s), the doses, the laboratory tests, and if needed adjusted the doses.
The DOP stated, "the protocols were approved by the hospital's pharmacy and therapeutics committee and medical committee before I started working here." The DOP provided a list of medications pharmacists regulated by following hospital protocols. One such medication was Coumadin. Coumadin is frequently prescribed to prevent patients from developing blood clots or when patients were at risk for blood clots to reoccur. The DOP was asked to produce a copy of the hospital's approved protocol pharmacists followed to guide them in regulating Coumadin. After several minutes of searching his files, the DOP said, "I can't find one." He called additional hospital staff to help him search for the protocol but in the end was told by the Director of Medical Staff, there wasn't one.

On 8/2/10 at 1418 hours, the DOP presented other protocols that were approved by the hospital and allowed pharmacists to regulate the following medications: vancomycin (antibiotic to treat severe infections), aminoglycosides (antibiotics to treat severe infections), heparin (blooding thinning medication to treat blood clots) and TPN (total parenteral nutrition - supplies all the nutrients the body needs by intravenous infusion).

On review of the vancomycin protocol, the last date it was reviewed and updated by the P & T committee was December 1997 (13 years ago); a aminoglycoside protocol was last reviewed in December 1997 (13 years ago); the heparin protocol was last reviewed on January 2004 (6 years ago), and the TPN protocol was last reviewed in January 2005 (5 years ago). The protocols were not being reviewed to determine if there were weaknesses or deficiencies that the hospital needed to address.

2. During an interview with the Director of Quality on 8/4/10 at 1315 hours, the Director of Quality stated incomplete discharged patients' medical records had been addressed in QA. When asked if the observations by the survey team of multiple telephone orders not being signed, dated and timed by the physicians in the active record was self identified as an area for improvement, the Director of Quality stated, no, QA was only looking at the incomplete closed records. When the Director of Quality was asked if the staffing issues in the Medical Records department had been identified as a problem, the Director of Quality stated, no. When asked if the four to five week turn around time to complete a discharged patient's medical record was identified as inadequate staffing in the Medical Records department, the Director of Quality stated, no it was not. He stated the time to complete a closed record by the Medical Records department had not been tracked. See A 438.

3. The hospital failed to identify and approve multiple pre-printed medical records forms being used by practitioners on the medical staff. The hospital failed to evaluate and provide a mechanism to authenticate medical staff signatures to provide safety and appropriateness of care for patients. See A 289.

4. The hospital failed to track and identify the use of personal protective equipment by contracted service employees and hospital personnel to ensure patient safety. See A 749.

5. During an interview with the Director of Quality on 8/5/10 at 1100 hours, the Director was asked what issues regarding the use of a contracted service for dialysis care for patients were identified as areas for improvement. The Director stated the QA committee had not tracked any specific dialysis quality indicators. The Director stated the contracted service had provided QA information to the hospital in June for the first two quarters of 2010. When asked, the Director stated he was unaware of any previous submissions. See A 749.

Based on interview and medical record review, the hospital failed to ensure performance improvement activities were implemented for high risk medications such as Coumadin (a blood thinning medication to prevent blood clots from forming). Pharmacists began determining doses of Coumadin for patients in the hospital when they received a prescriber order that read, "Coumadin per pharmacy." There were four patients in the hospital with orders for Coumadin per pharmacy. The DOP, after searching his files and contacting the Director of Medical Staff was unable to produce an approved hospital protocol for Coumadin. Other protocols approved by the hospital's pharmacy and therapeutics committee (P & T) that allowed pharmacists to regulate medication included, i.e. vancomycin, aminoglycosides, heparin, and TPN. These protocols were not being evaluated to determine if dosing errors or adverse events had occurred and, if so, what improvements needed to be made.

Findings:

On 8/2/10 at 1409 hours, the DOP was interviewed. He stated pharmacists regulated medications in the hospital based on approved hospital protocols. He said pharmacists ordered the medication(s), the doses, the laboratory tests, and if needed adjusted the doses.
The DOP stated, "the protocols were approved by the hospital's pharmacy and therapeutics committee and medical committee before I started working here." The DOP provided a list of medications pharmacists regulated by following hospital protocols. One such medication was Coumadin. Coumadin is frequently prescribed to prevent patients from developing blood clots or when patients were at risk for blood clots to reoccur. The DOP was asked to produce a copy of the hospital's approved protocol pharmacists followed to guide them in regulating Coumadin. After several minutes of searching his files, the DOP said, "I can't find one." He called additional hospital staff to help him search for the protocol but in the end was told by the Director of Medical Staff, there wasn't one.

On 8/2/10 at 1418 hours, the DOP presented other protocols that were approved by the hospital and allowed pharmacists to regulate the following medications: vancomycin (antibiotic to treat severe infections), aminoglycosides (antibiotics to treat severe infections), heparin (blooding thinning medication to treat blood clots) and TPN (total parenteral nutrition - supplies all the nutrients the body needs by intravenous infusion).

On review of the vancomycin protocol, the last date it was reviewed and updated by the P & T committee was December 1997 (13 years ago); a aminoglycoside protocol was last reviewed in December 1997 (13 years ago); the heparin protocol was last reviewed in January 2004 (6 years ago), and the TPN protocol was last reviewed in January 2005 (5 years ago). The protocols were not being reviewed to determine if there were weaknesses or deficiencies that the hospital needed to address.

On 8/3/10 at 1322 hours, during an interview, the Medical Director stated he was unaware the hospital did not have an approved Coumadin protocol. He checked with the hospital for an approved protocol but said there wasn't one.

Based on interviews and a review of 30 open and closed medical records, the hospital failed to take action to improve the delinquent completion of medical records. In addition, the hospital failed to take action to improve the accuracy, timeliness and consistency of medical record entries.

Findings:

During an interview with the Director of Medical Records on 8/3/10 at 1500 hours, the Director provided a Performance Improvement Department report for the first two quarters of 2010 for review. Review of the report showed the delinquency rate of 50% for the first quarter and 45% for the second quarter. Actions for both quarters were to "continue to monitor and work on the delinquency rate. Will strongly enforce the P&Ps." When asked to state the specific actions the Medical Records department took to ensure the completeness of the record, she stated she called the physicians' offices and their cell phones to remind them to dictate and/or sign the discharge summary and to complete other deficiencies in the record. The Director stated the P&P of the hospital required the medical record to be completed within 14 days or the hospital privileges of the physician would be suspended. When asked how many physicians had been suspended since she began work here at the beginning of the year, she stated none. The Director stated she reported to the CEO of the hospital regarding the medical record delinquency rate.

The Director of Medical Records was interviewed on 8/4/10 at 0845 hours. The number of delinquent medical records at the time of discharge, which included telephone orders not signed by the physician, was discussed. The Director admitted that medical record delinquency rate was a big problem when she became the director seven months ago. When asked about the observations in the medical records of physician signatures which were illegible, not dated and timed, the Director stated that problem had not yet been approached, the emphasis was on missing signatures and reports in the closed records. When asked about improvement efforts regarding missing signatures in an active record, the Director stated it was the nursing staff's responsibility to tag missing items in an active record.

The Director of Medical Records was then asked to review the different pre-printed progress note forms used by the physicians. The forms included progress notes sent to the hospital via fax transmission, infectious disease pre-printed progress notes and progress notes containing pre-printed notations for the "subjective," "objective findings," "diagnoses" (dx) and lab work. When interviewed, the Director of Medical Records stated the different pre-printed forms had been in use prior to her date of hire. She stated that there was no Forms Committee or any committee of the medical staff that had approved the use of these forms. The Director stated the authentication system for the physician's initials, observed as signatures in the medical records, was not reviewed by an appropriate committee of the medical staff. In addition she was unable to state if the governing body had approved the process for the authentication of these "signatures."

During a follow up interview with the Director of Medical Records on 8/4/10 at 1000 hours, the Director was asked to review the Deficiency Worklist form on the front of Patient 26's closed record. The patient was discharged from the hospital on 6/25/10. The assignment date for the physician's deficiencies was listed as 7/30/10. The Director stated the assigned date was the date the record was completed by the medical records staff. The Director stated the expected turn around time for a record to be completed after discharge was three to five days. The Director was asked why Patient 26's medical record was not completed by the medical records staff for five weeks after discharge. The Director stated the department had only one other full time staff member other than herself. She stated that employee had recently been out on leave for three weeks so they were very behind in completing the discharged medical records.

There was no written documentation in the minutes for QAPI or meetings of the governing body for 2009-2010 to indicate that a plan for quality improvement for the medical records delinquent practices had been addressed with a plan for improvement.

Based on observation, interviews, a review of 30 open and closed medical records, and a review of minutes of the governing body for 2009-2010, the governing body failed to ensure and implement a QAPI program for patient safety, including the reduction of potential medical errors.

Findings:

1. The governing body failed to implement a program to assess and reduce the number of unsigned physician orders noted on open and closed medical records. See A 267 and A 289.

2. The hospital failed to ensure performance improvement activities were implemented for high risk medications such as Coumadin (a blood thinning medication to prevent blood clots from forming) when dosed by a pharmacist. There was no documented evidence provided to show a protocol had been approved by the hospital for the dosing of Coumadin by a pharmacist. Other protocols approved by the hospital's pharmacy and therapeutics committee (P & T) that allowed pharmacists to regulate medication included, i.e. vancomycin, aminoglycosides, heparin, and TPN. These protocols were not being evaluated to determine if dosing errors or adverse events had occurred and, if so, what improvements needed to be made. See A 285.

Based on observation and medical record review, the hospital failed to ensure that two of two patients observed for medication administration received their medications as ordered by their physicians (Patients 3 and 6). This resulted in the potential for unsafe medication treatments.

Findings:

1. On 8/3/10 at 0851 hours, RN D was observed administering medications to Patient 6 during a morning medication pass. One of the medications administered was Flonase Nasal Spray (a medication that helps relieve the nasal allergy symptoms of congestion, sneezing, itching and runny nose). RN D was in Patient 6's room and administering medications when she handed Flonase NS (Nasal Spray) to the patient. Patient 6 administered two sprays to each nostril and handed the medication back to the nurse.
On 8/3/10 at 0948 hours, review of Patient 6's chart revealed an order for Flonase NS twice a day. The physician order did not specify how many sprays the patient should receive. Review of the MAR revealed documentation that Flonase NS should be administered as one spray in each nostril. Patient 6 took 2 inhalations per nostril. There was a discrepancy between the physician order, what the MAR had documented, and what the patient received.

2. On 8/3/10 at 0923 hours, RN D was observed administering medications to Patient 3 during a morning medication pass. Twelve medications were administered by RN D. Review of Patient 3's medical record revealed an order for Folic Acid 1 milligram (mg) daily. The order was written on 7/13/10 and according to the MAR, Patient 3 received a dose each morning at 0900 hours. RN D collected her medications for administration, Folic Acid 1 mg was not included. Patient 3 did not receive his dose of Folic Acid. RN D mistakenly charted on the MAR that Folic Acid was given at 0900.