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Based on observation, interview, and record review, the hospital failed to ensure the GB was responsible for the conduct of the hospital as evidenced by:

1. The quality of services provided by the medical staff was not ensured through proctoring and performance evaluation. Cross Reference A- 0050.

2. The quality of contracted services was not been ensured through quality review of contracted blood bank and laboratory services. Cross Reference A- 0083 and A- 0084.

3. The rights of patients to be free of potentially unnecessary restraints was not promoted and protected. Cross Reference A- 0187 and A- 0283 #4.

4. The quality improvement program did not provide quality oversight of all hospital services and processes. Cross Reference A- 0263.

5. The quality of care supplied by the medical staff was not ensured. Cross Reference A- 0338.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.

Based on observation, record review and staff interview, the hospital failed to protect and promote the patient's right with regard to respect, dignity, comfort and physical safety as evidenced by:

1. There was the potential for the use of unnecessary physicial restraints for patients when the hosptial's P&P was not implemented for complete assessment and complete signatures by the physicians, and documentation of less restrictive measures tried by nursing. Cross Reference A- 0164, A- 0165, A- 0168, and A- 0187.

2. The hospital failed to ensure infection control measures to prevent and control infections were in place and implemented in the hospital. This resulted in the potential for the spread of infections throughout the hospital. Cross Reference A- 0747.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment.

Based on observation, interview and record review, the hospital failed to implement and maintain a data-driven program designed to maximize the quality of care and safety of services provided to the patients as evidenced by:

1. Failure to implement an effective, ongoing, data-driven QAPI program. Cross Reference A- 0273.

2. Failure to identify opportunities to improve data quality or institute changes that will lead to improvement in patient care. Cross Reference A- 0283.

3. Failure to ensure pressure ulcer prevention and treatment measures were analyzed and tracked, and preventive actions and feedback systems were put in place with staff involved in pressure ulcer prevention and treatment to minimize the risk of pressure ulcers for patients in the hospital. Cross Reference A- 0286.

4. Failure to monitor, track, and trend wound care patient charts for completeness and thoroughness of wound documentation. Cross Reference A- 0438.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment.

Based on interview and document review, the hospital failed to ensure the medical staff was organized and operating under its bylaws as evidenced by:

1. The medical staff was not reappraised to ensure the quality of services rendered. Cross Reference A- 0340.

2. The basis for granting medical staff member's temporary privileges was not completed as defined in the Medical Staff Bylaws. In addition, the medical staff members were not submitting information for TB screening annually. Cross Reference A- 0353.

3. Medical staff members were not completing medical records per requirements in the Bylaws and the rules and regulations. Cross Reference A- 0353 and A- 0358.

The cumulative effect of these systemic failures of the quality of services supplied by the medical staff resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.

Based on observation, interview, and record review, the hospital failed to have an effective, organized nursing service to provide quality care to patients as evidenced by:

1. Failure to ensure the needs of two of 63 sampled patients (Patients 69, and 113) were met regarding wound care and investigation of falls. Cross Reference A- 0392.

2. Failure to demonstrate a well-organized nursing service when RNs were not aware a P&P to address dislodged G tubes existed and when nursing staff were not provided the guidance of a P&P to manage situations such as tube feeding dislodgment. Cross Reference A- 0386.

3. Failure to ensure the RN responsible for the care of the patient directly conducted the shift assessment and reviewed the care plans prior to delegating the care of four of the four patients reviewed assigned to LVNs (Patients 71, 72, 73, and 74); supervised the repositioning every two hours for Patients 63, 73, 74, 75, 94, 95, 96, 97, 98, 100, 108, 109, and 110; and supervised and evaluated the nursing care of two of 63 sampled patients (Patients 61 and 78) when essential wound assessments were not available at admission to multidisciplinary staff and a speech therapy screening not provided as assessed. Cross Reference A- 0395.

4. Failure to ensure the care plan was individualized and implemented for seven of 63 sampled patients (Patients 63, 75, 87, 94, 100, 108, and 109) for chest tube care and prevention/healing of pressure ulcers. Cross reference A- 0396.

5. Failure to ensure safe use of medications when nurses administered medications via G tube to two of the two patients observed during medication pass observations (Patients 83 and 104). Cross Reference A- 0405.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment to the patients.

Based on observation, record review, and staff interview, the hospital failed to have an effective infection control program providing safe and quality patient care as evidenced by:

1. Three of the seven members of the medical staff reviewed did not cooperate with TB screening and were not placed on suspension creating the increased risk of the spread of infections to patients using the hospital. Cross Reference A- 0353 #2.

2. The hospital failed to ensure the infection control designee(s) implemented P&Ps for handwashing, wearing of PPE, and TB screening of medical staff; failed to ensure manufacturer's directions were followed by the dietary, housekeeping, and engineering departments for cleaning of all ice machines in the hospital; and failed to have infection control oversight in the surgical services department. Cross Reference A- 0748.

3. The hospital failed to ensure infection control measures to prevent and control infections were in place and implemented in the hospital. Cross Reference A- 0749.

4. The hospital failed to ensure infection control practice was maintained in the surgical services area. Cross Reference A- 0951.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment.

Based on interview and record review, the GB did not ensure selection criteria outlined in the Medical Staff Bylaws was applied to seven of the seven physician files reviewed (MDs 1, 8, 9, 11, 12, 13, and 14). There was no documented performance evaluation of the physicians prior to reappointment and reprivileging, and for two physicians, MDs 11 and 13, there was no evidence of proctoring. These failures created the risk of substandard services being provided by the medical staff.

Findings:

1. The Governing Board Bylaws (undated), page 11, read in part, "The Medical Staff shall conduct a continuing review and appraisal of the quality of professional care rendered in the Hospital, and shall report such activities and their results to the Board. The Medical Staff shall make recommendations regarding the Medical Staff and report same to the Board concerning: ...evaluations of overall patient care performed by the Medical Staff ..."

The Medical Staff Bylaws (undated), page 74, read in part, "By adopting these Bylaws, the Medical staff has delegated to the MEC authority to carry out the following responsibilities on its behalf: to provide effective mechanisms to monitor and evaluate the quality of patient care and the clinical performance of all individuals with Medical Staff or AHP Privileges within the hospital, to ensure all Practitioners provide care at a consistent level of quality."

During a review on 2/27/12, of the credential files of MD 1, reappointed on 1/2012; MD 8, reappointed on 2/20/11; MD 9, reappointed on 4/2010; MD 11, reappointed on 9/30/11; MD 12, appointed on 6/24/11; MD 13, reappointed on 11/30/11; and MD 14, reappointed on 1/31/2011, the files did not contain information about the quality of the services rendered by the physicians. There was no information about the professional performance and judgment of the physicians in carrying out the privileges granted.

In an interview with the CEO on 3/1/13 at 0945 hours, he stated physician performance evaluations had not been pursued.

In a second interview with the CEO on 3/1/13 at 1145 hours, he stated he had trusted the medical staff processes were in place; however, he had not verified the process until recently. The CEO stated the data he received regarding the medical staff processes was found inaccurate.

2. The Medical Staff Bylaws (undated), page 19, read in part, "All initial appointees to the Medical Staff will be assigned to the Provisional Staff category. All Provisional Staff Members will be subject to a period of proctoring, or will be required to provide evidence of satisfactory completion of proctoring at another local institution, in accordance with the procedures set forth in the Rules."

a. The credential file of MD 11 was reviewed on 2/27/13 at 1100 hours. The file showed the physician was appointed initially in October, 2009, to provisional status. MD 11 was subsequently reappointed to active status but the file did not contain evidence of proctoring.

b. The credential file of MD 13, initially appointed in November, 2009, and subsequently reappointed, did not contain evidence of proctoring.

During a concurrent interview with the Medical Staff Coordinator, she concurred there was no documentation of proctoring in the files for MDs 11 and 13. The Coordinator stated she was not sure about the basis for appointing the physician to active status. The Coordinator stated there were 35 or 40 physicians on the medical staff with the same issue.

In an interview with the CEO on 3/1/13 at 0945 hours, he stated physician performance evaluations had not been pursued. Proctoring would have to be obtained for physicians without evidence of proctoring.

Based on interview and document review, the GB failed to ensure the CEO was responsible for managing the hospital as evidenced by:

1. Activities and audit tools for wound prevention were ineffective over a period of 18 months. Hospital administration failed to develop effective interventions in response to their determination that quality data submitted collected (e.g. clinical records, audits, reports) from nursing staff with the lack of RN supervision for the interventions and care delivered to the patients by the LVN. CNAs, RNs, RN Managers, a Wound Care Coordinator RN, a Senior Clinical RN, and the Interim CCO systematically submitted data related to pressure ulcer prevention that was not consistently documented. The hospital's failure placed patients at risk for harm from preventable pressure ulcers. Cross Reference A- 0273 #1.

2. Failure to ensure the RN responsible for the care of the patient directly conducted the shift assessment and reviewed the care plan prior to delegating the care of patients assigned to LVNs and supervised the repositioning of patients every two hours. Cross Reference A- 0395 #1 and #2.

3. The hospital's P&P for the use of physical restraints was not implemented for complete assessment and complete signatures by the physicians resulting in the potential use of unnecessary restraints. Cross Reference A- 0168.

4. The hospital failed to ensure infection control measures to prevent and control infections were in place and implemented in the hospital. This resulted in the potential for the spread of bacteria and disease throughout the hospital. Cross Reference A- 0749.

5. The quality of services provided by the medical staff was not ensured through proctoring and performance evaluation. Cross Reference A- 0050.

6. The quality of contracted services was not been ensured through quality review of contracted blood bank and laboratory services. Cross Reference A- 0083 and A- 0084.

7. Medical staff members were not submitting information for TB screening annually. Cross Reference A- 0353.

Findings:

In an interview with the CEO on 2/27/13 at 1520 hours, the CEO stated he was aware RNs were not ensuring the care plan was implemented regarding repositioning of patients and retarding pressure ulcers. The problem had been ongoing for 18 months. Repositioning was an issue identified in a previous department survey The CEO stated the hospital had done "education, purchased equipment, had leadership changes, audit and re-audits." The CEO stated the problem was "lack of a team approach." The CEO stated he and the Director of Quality Management began hearing reports of 100 percent compliance on the nursing manager audits in January, 2013. The CEO stated, "We questioned credibility of those numbers." The CEO stated independent teams were formed to conduct separate audits. "I come in myself every morning and have a meeting with the nursing staff."

In a meeting with the GB of the hospital on 3/1/13 at 1100 hours, the CEO fully acknowledged issues with the medical staff and the contracted services for lab and x-ray. The CEO stated they were in process of putting fixes into place. The CEO also was aware the use of physical restraints was higher than he would like; however, he stated the hospital did not have enough CNAs at this time to use as sitters for patients as an alternative to restraints.

Based on interview and record review, the governing body did not ensure the safety of services provided by the contracted blood bank. Notifications regarding potentially tainted blood were not communicated by the blood bank to the hospital, creating the increased risk of infectious disease due to tainted blood products.

Findings:

The hospital's P&P, Look Back Program, revised on 8/10/12, read in part, "(Hospital name) has a Blood Bank Services agreement with (blood bank name) ...that governs the procurement, transfer and availability of blood and blood products. The agreement requires that the blood bank service will promptly notify the hospital of a donor testing positive for HIV or HCV."

During a review, on 2/25/13 at 0930 hours, of hospital blood bank communications, the records about possibly tainted blood were found incomplete.

For the unit of blood number W125611200104, a notification was received from the contracted blood bank on 4/4/12, indicating possible hepatitis B contamination. No confirmatory result was found.

For the unit of blood number W125612103618, an initial notification of potentially tainted blood was received on 12/17/12. No confirmatory result had been received.

For the unit of blood number W12561410436, a letter dated 1/12/13, indicated confirmatory testing for the blood showed it was negative for the potential contaminant, hepatitis C. However, the letter referred to an initial notification letter sent on 1/16/13, regarding that unit of blood. The letter was not found in the lab binder where the notifications were stored.

During an interview with the Lab Supervisor on 2/25/13 at 0930 hours, he stated the confirmatory test results were not received by the hospital. The Supervisor stated the confirmatory test results were possibly sent elsewhere as he sometimes received results intended for other facilities.

The document, Clinical Contract Evaluation, contained nine ratings for the blood bank. For each rated issue, the blood bank was given a "3" or "meets standard." The "comments" section of the form was blank, and it was signed by the CEO on 1/9/13. There was no documentation that the communication problems with the blood bank had been reviewed and considered as part of the quality assurance of the contracted provider.

Based on interview and record review, the contracted laboratory services, obtained through the hospital's corporate organization, were not subject to quality assurance by the hospital's GB or quality assurance program, creating the risk of substandard laboratory services.

Findings:

The Bylaws of the hospital (2007), read in part on page 8, "The Board shall have the responsibility to monitor and evaluate the quality of patient care within the Hospital..."

During a review of laboratory results in the medical records of sampled patients from 2/25/13 through 2/28/13, delays in the availability of laboratory results were seen.

During a review of the medical record of Patient 67 on 2/25/13, a laboratory result was dated 2/22/13 at 1336 hours. However, a note at the top of the page showed the result was verified at 1435 hours, nearly an hour later.

In a concurrent interview with the IT staff, he stated he thought the 1435 hours time was the time the result was available to clinicians.

During an interview with the Contract Lab Director on 2/25/13 at 1400 hours, he stated the lab test results appeared in one computer system, were then verified, and transferred to the clinical computer system. The Director stated the time to verification had not been assessed. The Director stated if the contracted laboratory staff needed to spend time to call regarding critical lab results, verification of other lab results could be delayed. The Contract Lab Director stated there were concerns expressed by physicians about the reporting time of the laboratory results. The Director stated the morning specimens were to be received by 0600 hours, and to be resulted by 0800 hours, but was unsure of the number of results reported by 0800 hours. The Director stated there had been no drills down to determine lab reporting times for the hospital.

In an interview with the Lab Consultant on 2/26/13 at 1450 hours, he stated the quality council did not request information about the timeliness of the labs. There had been no study of the time the results were available.

During an interview with the CEO and the Lab Consultant on 2/25/13 at 1400 hours, they stated there was no monitoring done regarding the time from the blood being drawn until the lab results were reported.

Based on record review, the hospital failed to ensure one of 63 sampled patients (Patient 105) was informed about the risks and options associated with sedation prior to a GI procedure, creating the risk of poor health outcome for that patient.

Findings:

On 2/25/13 at 0920 hours, Patient 105 was observed in the OR for a GI procedure. Patient 105 was alert and awake upon arrival in the OR. During the procedure, MD 3 verbally ordered versed and fentanyl (sedative, anesthetic medications). RN 17 administered the medications to the patient via the patient's IV access.

Review of Patient 105's Physician Patient Assessment Prior to Procedure Plan form did not show documentation by the physician as to whether the patient was appropriate for the procedure and the sedation options and risks had been discussed with the patient. These areas on the form were left blank.

Based on observation, one of 63 sampled patients (Patient 109) was not provided privacy during personal care.

Findings:

The 2 E nursing unit was toured on 2/25/13 at 1530 hours, with the CCO. While walking down the hallway, a nurse was observed through the open door to the room giving care to Patient 109. The patient was turned on his right side facing away from the doorway with his bare backside exposed while the nurse provided hygiene care. The privacy curtain had not been fully closed, allowing staff and visitors in the hallway to observe the patient receiving care.

Based on observation, interview, and record review, the hospital failed to ensure patients received care in a safe setting when:

1. The hospital's P&P for the use of physical restraints was not implemented for complete assessment and complete signatures by the physicians resulting in the potential use of unnecessary restraints.

2. The hospital failed to ensure infection control measures to prevent and control infections were in place and implemented in the hospital. This resulted in the potential for the spread of infection throughout the hospital.

Findings:

1. Physical restraints were used for patients contrary to the hospital's P&P requiring the need for the restraints to be assessed and documented by the physician on a daily basis for four of the seven patients reviewed for physical restraints (Patients 63, 64, 67, and 123). Cross Reference A- 0168.

2.a. There was no surveillance of the EVS services conducted on the night shift by the hospital's Infection Control Practitioners. Cross Reference A- 0749 #1.

b. On 2/25/13 at 1137 hours, the sterile processing area was toured with the ORT and Director of Surgical Services. Documentation on the LMA Record Card showing the dates of use were reviewed (a device used to open a patient's airway). The Laryngeal Mask manufacturer recommended LMA airways be used a maximum of 40 times. The manufacturer's warranty indicated the LMA airway is reusable and warranted for forty uses or a period of one year from the date of purchase (whichever is the earlier).

Documentation on the seven LMA Record Cards showed the purchase dates ranged from 2004 to 2006. During interview, the ORT and the Director of Surgical Services were not aware of the manufacturer's recommendations.

c. On 2/25/13 at 1100 hours, the ORT was interviewed regarding sterile processing for surgical instruments. The ORT stated biological indicators were run every week and for every load of sterile processing. The ORT stated, after the processing was completed, the ORT put the processed biological indicator and the control in an incubator overnight. The ORT read the final result the next morning and documented the result on the record.

Reviews of the Sterilizer Record for the month of February 2013, showed biological indicators were utilized in the sterile processes seven times. The results were documented on the Sterilizer Record.

Review of the manufacturer's recommendation for the use of the biological indicators showed the indicator should be incubated for 48 hours for visual change readout. A color change to yellow indicated surviving spores and a positive result.

d. Medical staff, hospital staff, and visitors were observed not washing hands and not wearing proper PPE. Cross Reference A- 0749 #4, #5, #19 b and c, #20, #21, #23, and #24 a.

e. Safe practices for the use of syringes to withdraw medications from single use vials were not followed by one RN observed during a procedure. Cross Reference A- 0749 #11.

f. The ice machines in the hospital were not cleaned and sanitized per manufacturer's directions. Cross Reference A- 0749 #15.

g. Food Service Workers in the kitchen were observed not washing hands between clean and dirty tasks and not sanitizing the carts used to transport meals to the nursing units per hospital P&P. Cross Reference A- 0749 #16.

h. Three of the seven members of the medical staff reviewed did not cooperate with TB screening and were not placed on suspension creating the increased risk of the spread of infection to patients using the hospital. Cross Reference A- 0749 #13.

i. Infection control practice was not maintained in the surgical services area. Cross Reference A- 0951.

Based on interview and record review, the hospital failed to ensure restraints were used only when less restrictive methods were tried and proved ineffective. The hospital records for two of the seven patients reviewed with restraints (Patients 67 and 123) did not show that a sitter, as an alternate to a restraint, was attempted before implementing the physical restraints, creating the risk of unnecessary restraint and poor health outcomes for those patients.

Findings:

The hospital's P&P, Use of Physical or Chemical Restraints, revised on 8/12, read in part, "The Hospital ...uses interventions to prevent the use of restraints and eliminate their use at the earliest possible time." and "When restraints are required, the least restrictive restraint will be used and safely applied after determining that other methods will not be effective."

1. During a review of the medical record of Patient 67 on 2/25/13, the record contained three pre-printed forms titled, 24 Hour Restraint Order and Flow Sheet. The medical record did not show the use of a sitter, as a less restrictive method, was tried prior to initiating physical restraints on the patient.

2. The medical record of Patient 123 was reviewed on 2/26/13. Forty eight restraint forms for various dates from 7/10 through 9/18/12, were reviewed. The record did not show the use of a sitter was attempted prior to initiating physical restraints on the patient.

In an interview with MD 3 on 3/1/13 at 1010 hours, he stated ideally the hospital should be restraint free; however, the hospital did not make sitters available. MD 3 stated the medical staff had repeatedly requested sitters be made available.

In a concurrent interview with the CEO, he stated the hospital had avoided using sitters. In a second interview with the CEO on 3/1/13 at 1130 hours, he stated there were not enough CNAs available at this time to use as sitters.

In an interview with the Senior Director of Clinical Operations on 3/1/13 at 1110 hours, she stated the restraint rate had crept up and was high.

During an interview with the Director of Quality Management on 3/1/13 at 1320 hours, he provided restraint use data dated from September and December, 2012. The Director stated the data indicated the hospital did not meet its goals for restraints in September or December. The data showed higher restraint use in December, compared to September.

Based on interview and record review, the hospital failed to ensure the least restrictive method of restraint was selected to minimize the use of restraints for one of seven patients reviewed with restraints (Patient 64), creating the risk of unnecessary restraints for that patient.

Findings:

The hospital's P&P, Use of Physical or Chemical Restraints, dated 8/12, read in part, "When restraints are required, the least restrictive restraint will be used and safely applied after determining that other methods will not be effective."

Patient 64's medical record was reviewed on 2/28/13. Documentation on the 24 Hour Restraint Order and Flow Sheet form showed the Patient 64 had both right and left hand mitten restraints applied from 11/21 to 11/25/12, to prevent the patient from pulling at tubes/lines.

On 3/1/13 at 1100 hours, during an interview, RN 1, the Nursing Manager of ICU reviewed the Patient 64's record. RN 1 stated the staff should have initiated other less restrictive measures for the patient before using restraints. The staff could place the patient in the wheelchair at the nearby nursing station for direct observation. However, the Manager stated she did not see documentation that was implemented for this patient.

Based on observation, interview, and medical record review, the hospital failed to ensure the P&P for requiring a completed physician's order and assessment for the use of physical restraints was implemented for four of the seven patients reviewed for physical restraints (Patients 63, 64, 67, and 123). This resulted in the potential for the unnecessary use of restraints for patients.

Findings:

The hospital's P&P, Use of Physical Restraints, revised on 8/12, showed the purpose of the policy was to delineate the responsibilities and procedural steps to be followed by the clinical and medical staff for the use of restraints in compliance with hospital policy, Joint Commission Standards and the Medicare COPs.

The physician must examine the patient as soon as possible when notified that restraint use is indicated, but no later than 24 hours after the initiation of non-emergent restraint use. Telephone orders may only be used for the first episode of restraint based on nursing assessment. If a telephone order is needed the clinical justification and events leading to restraint use must be documented at the time the telephone order is countersigned.

The need for restraints for the patient must be continuously reevaluated and orders to renew the use of restraints must be entered at least once each calendar day. Medical staff were to document the events leading to the use.

Restraint use required an order by a physician or licensed independent practitioner (LIP) responsible for the patient's care and authorized to order the restraint use. The results of the physician's comprehensive assessment must be documented in the Electronic Medical Record or paper medical record.

1. Patient 63 was observed on 2/25/13 at 1135 hours, in the supine position in bed. The patient was wearing bilateral wrist restraints tied to each side of the bed.

The medical record for Patient 63 was reviewed with RN 13. The patient was admitted to the hospital on 2/23/13. A telephone physician's order dated 2/23/13 at 1830 hours, was written by the RN. In the Physician Assessment area was the statement "I have completed a comprehensive face to face assessment on this patient...It is my conclusion the use of alternative measures poses greater risk to patient safety than the risk of restraints." The check boxes provided for the physician to document the reasons for the use and the type of the restraint were filled in by the RN obtaining the telephone order. There was no physician's countersignature on the order to show the physician had conducted a face to face assessment of the patient within the 24 hour time period.


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2. Patient 64's medical record was reviewed on 2/28/13. The documentation on the 24 Hour Restraint Order and Flow Sheets dated 11/21/12 to 11/25/12, showed the patient had right and left mitten restraints applied to prevent the patient from pulling the tube/lines. Review of the 24 Hour Restraint Order and Flow Sheets showed the area for physicians to document the Physician Assessment was left blank for the dates of 11/21, 11/22, 11/23, 11/24, and 11/25/12, and there was no documented evidence the physician performed a face to face assessment of the patient for the use of restraints on those dates.


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3. During a review of the medical record of Patient 67 on 2/25/13, three pre-printed forms titled 24 Hour Restraint Order and Flow Sheet were reviewed. The top of the form contained a section for the physician to document an order by completing the check boxes and by filling in blanks. The possible orders included, Initial Episode, Continued Order, New Episode, and Discontinue, followed by spaces to supply signature, printed name, date, and time. One such form in Patient 67's record contained a telephone order for restraints dated 11/29/12 at 1730 hours, with no countersignature. A second form contained a physician's signature, but there was no printed name, date or time for the order. A third restraint form had a physician's signature, printed name, and the date 12/2/12, but no time. There was no documentation of an order for a restraint. That section of the form was left blank.

4. The medical record of Patient 123 was reviewed on 2/26/13. There were 48 restraint forms for various dates from 7/10/12 through 9/18/12, reviewed. The Physician Order portion was not completed for 21 of 48 restraint forms.

During an interview with the CNO on 2/26/13 at 1400 hours, she reviewed the restraint forms for Patient 123 and confirmed the forms should have been completed by the physician.

Based on interview and record review, the hospital failed to ensure two of seven patient records reviewed for restraints (Patients 67 and 123) were free from unnecessary restraints when documentation of an assessment for the restraints was not found for .

Findings:

The hospital's P&P, Use of Physical or Chemical Restraints, revised on 8/12, read in part, "The Hospital ...uses interventions to prevent the use of restraints and eliminate their use at the earliest possible time." and "The physician must examine the patient as soon as possible when notified that restraint use is indicated, but no later than 24 hours after the initiation of non-emergent restraint use."

During a review of the medical record of Patient 67 on 2/25/13, the record contained three pre-printed forms titled 24 Hour Restraint Order and Flow Sheet. The top of the forms contained a section for the physician to document in check boxes and fill in blanks for the physician assessment. That section of the form included the language, "I have completed a comprehensive face to face assessment on this patient including evaluation for elevated temperature, hypoxia, hypoglycemia, electrolyte imbalance, and adverse drug reaction. It is my conclusion the use of alternative measures poses greater risk to pt. safety than the risk of using restraints. This is due to" followed by four choices with check boxes, "Patient pulls at lines/tubes/drains, Fall risk & patient attempts to amb (ambulate) without assist, Risk for self harm, Other." At the bottom of the section were spaces to supply signature, printed name, date, and time. The lower portion of the page provided space for nursing documentation.

1. Review of the 24 Hour Restraint Order and Flow Sheet forms in Patient 67's record showed a telephone order for restraints dated 11/29/12 at 1730 hours. A second form contained a physician's signature, but the sections for physician's assessment and type of restraints were left blank, and there was no printed name, date or time for the order. A third restraint form for Patient 67 had a physician signature, printed name, and the date 12/2/12, but no time and there was no documentation of a physician assessment, order for restraint or selection of type of restraints-those sections of the form were left blank.

The physician's initial assessment was found on the H&P document, dated 12/1/12, more than 24 hours after restraints were implemented on 11/29/12.

None of the three forms had a signature or name of the nurse completing the form on the Nursing Clinical Observations section of the form.

2. The medical record of Patient 123 was reviewed on 2/26/13, and contained 48 restraint forms for various dates from 7/10/12 through 9/18/12. The Physician Assessment portion of the form was not completed for 28 of 48 restraint forms.

During an interview with the CCO on 2/26/13 at 1400 hours, she reviewed the restraint forms and confirmed the forms should have been completed by the physician.

Based on observation, interview, and record review, the hospital failed to implement an effective, ongoing, data-driven QAPI program as evidenced by:

1. Activities and audit tools for wound prevention were ineffective over a period of 18 months. Hospital administration failed to develop effective interventions in response to their determination that quality data submitted collected (e.g. clinical records, audits, reports) from nursing staff with the lack of RN supervision for the interventions and care delivered to the patients by the LVN. CNAs, RNs, RN Managers, Wound Care Coordinator RN, a Senior Clinical RN, and the Interim CCO systematically submitted data related to pressure ulcer prevention that was not consistently documented. The hospital's failure placed the patients at risk for harm from preventable pressure ulcers.

2. There was no evaluation of the Dietary Department staffs' competencies except at the time of their annual reviews and there were no performance improvement activities for the food service part of the department to establish ongoing improvement activities related to patient safety or patient satisfaction.

3. The QA program did not track and trend data that reflected important patient care processes, such as the timeliness of laboratory and radiology results, infection control practices in the surgical suite, and the discharge processes.

4. Incomplete medical records regarding none or delayed physicians' signatures on the Attestation of Wound forms completed by the WCN to document their acknowledgements of their patients' wounds. In addition, the Medical Records Department had not performed quarterly QA for the 3rd and 4th quarters of 2012.

5. The infection control designee(s) failed implemented P&Ps for handwashing and wearing of PPE.

6. There was no review of discharge processes or post-discharge outcomes. Cross Reference A- 0468.

Findings:

1. The hospital failed to ensure the RN responsible for the care of the patient directly conducted the shift assessment and reviewed the care plans prior to delegating the care of the patients assigned to LVNs; supervised the repositioning of the patients every two hours; and supervised and evaluated the nursing care for the patients when essential wound assessments were not available at admission to multidisciplinary staff. Cross Reference A- 0395.

The hospital failed to ensure the care plan was individualized and implemented regarding prevention/healing of pressure ulcers. Cross reference A- 0396.




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In the prior CMS Complaint Validation Survey, exit date of 10/23/13, the hospital was cited for failing to reposition patients with known pressure ulcers. The plan of correction included "ongoing monitoring by Nurse Managers of patient repositioning to ensure effective offloading techniques are being utilized. Identified deficiencies are addressed and remediation provided."

On 2/27/13 at 1200 hours, RN 10 and hospital administrators were interviewed regarding the implementation of patient care plans related to nursing assessments and positioning patients to prevent pressure ulcers. The Clinical Educator RN stated she oversaw nursing education. The RN described the hospital's progress on repositioning patients as, "We are on the last 10 percent of perfection." "We've done education ... observations...audits."

The CEO stated, "We've purchased wedges. We have a daily meeting at to go over nursing manager audits. We look at the effectiveness of offloading (removing pressure where pressure sores are likely to form). We look at documentation."

RN 10 was unable to explain why the patient observations with the surveyor did not reflect nursing documentation. RN 10 was asked if the patients observed on the 2 W tour were positioned appropriately. RN 10 stated, "Not to a certain extent. How's that for an answer?"

In an interview with the CEO and Director of Quality Management on 2/27/13 at 1520 hours, the CEO stated, RNs are not ensuring the care plan was implemented regarding repositioning and retarding pressure ulcers. The problem has been ongoing for 18 months. The CEO stated the hospital had done "education, purchased equipment, had leadership changes, audit and re-audits." The CEO stated the problem was "lack of a team approach." The CEO indicated RNs perceived "repositioning patients" was a nursing assistant's responsibility," "It's a CNA job" ... "It's tedious."

The CEO elaborated both he and the Director of Quality Management began hearing reports of 100 percent compliance on the nursing manager audits in January 2013. The issue was identified on a previous CMS survey." The CEO stated, "We questioned credibility of those numbers." The CEO indicated nursing leadership "threw out the bad ones" and "culled data." The CEO stated, I know darned well it was due to [name corresponded with the former Director of Nurses]." The CCO [Former Chief Clinical Officer] was given a chance to fix it. She left five weeks ago."

In the same interview, the Director of Quality Management described how the quality team was not getting 100 percent of the raw data. The Director described how the hospital intervened to provide an independent double check of the nurse manager audits. The Director stated, "We were seeing different results in the tracker" The Director indicated the two staff doing the independent double checks "noticed the data didn't match." The Director discussed hospital leadership's decision to transition from relying on the nurse manager's audits to depending on the quality department's audits. The CEO stated, The Director "is in here all the time checking on this. I come in myself every morning at 0700 hours, and have a meeting with the nursing staff."

During a follow-up interview with the Director of Quality Management on 2/27/13 at 1330 hours, The Director was asked to provide the actual audit tool and the raw QA data that was entered into the computer by the nurse managers.

On 2/27/13 at 1615 hours, the Director of Quality Management stated he was unable to provide the raw QA data regarding the correct positioning of patients. The Director stated the nurse manager "did not know he needed to keep data." When asked how the QA data could be validated, he stated it could not be.


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2. In an interview with the Director of Dietary on 2/28/13 at 0900 hours, and concurrent review of performance indicators for 2012, revealed the dietary department was submitting data on multiple processes within the department. The Director of Dietary acknowledged all of the quality indicators of the department met departmental set thresholds. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of staff competencies except at the time of their annual reviews. The Director stated there were no performance improvement activities for the food service part of the department to establish ongoing improvement activities related to patient safety or patient satisfaction.



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3.a. In an interview with MD 3 on 3/1/13 at 1015 hours, he stated x-ray results were sometimes provided late in the mornings, and some physicians were complaining the results were too late to be useful. MD 3 stated the X-ray results were sometimes not provided until the afternoon, and this did not allow the physicians to implement timely interventions.

b. During a review of laboratory results in the medical records of sampled patients from 2/25/13 through 2/28/13, delays in the availability of laboratory results were found.

During a review of the medical record of Patient 67 on 2/25/13, a laboratory result was dated 2/22/13 at 1336 hours. However, a note at the top of the page showed the result was verified at 1435 hours, nearly an hour later.

In a concurrent interview with the IT staff, he stated he thought the 1435 hours time was the time the result was available to clinicians.

During an interview with the Contract Lab Director on 2/25/13 at 1400 hours, he stated the lab test results appeared in one computer system and were then verified and transferred to the clinical computer system. The Director stated the time to verification had not been assessed. The Director stated if the contracted laboratory staff needed to spend time to call regarding critical lab results, verification of other lab results could be delayed. The Director stated there were concerns expressed by physicians about the reporting time of the laboratory results. The Director stated the morning specimens were to be received by 0600 hours, and to be resulted by 0800 hours, but he was unsure of the number of results reported by 0800 hours. The Director stated there was no drill down to determine lab reporting times for the hospital.

In an interview with the Lab Consultant on 2/26/13 at 1450 hours, he stated the quality council did not request information about the timeliness of the labs. The Lab Consultant stated there was no study of the time the results available.

During an interview with the CEO and the Lab Consultant on 2/25/13 at 1400 hours, they stated there was no monitoring done of the time from the blood being drawn from a patient until the lab results were reported.

In an interview with the Director of Quality Management at 3/1/13 at 1015 hours, he stated the department had not done studies of the timeliness of laboratory and radiology results. The Director stated the department was not aware of the radiology timeliness concerns.

In a concurrent interview with the CEO, he stated he was taking care of concerns about late laboratory results personally, and had not been reporting the concerns to the quality department.

4. The hospital's failure to maintain complete and accurate medical records was previously cited under COPs for Medical records, Nursing Services, QAPI, and GB during the CMS Complaint Validation survey, exit date of 10/23/12. At that time multiple attestations of wound forms incompletely filled out by the WCN were faxed to doctor's offices. The forms contained wound assessments which included photographs of pressure ulcers, location, and current stage/status. The forms required the physicians' signatures to signify acknowledgments of the wound status; however, the photos were blacked out in the fax process making it impossible to determine the actual wound status. Despite the blacked out pictures, the attestation of wound forms were being faxed back to the hospital signed by physicians.

Per the hospital's submitted plan of correction with a completion date of 11/25/12, the Nurse Manager and WCN were to notify relevant physicians for any areas of the patient charts requiring completion. All wound care nurses and physicians would receive education on the importance of accurate and complete documentation. There would be daily ongoing monitoring of wound care patient charts. The Quality Department would be auditing 30 charts per month for completeness, accuracy, and thoroughness of wound documentation. The data was reported to the QA council, MEC, and GB.

On 2/25/13, a Full Medicare Validation survey was initiated. Again, per the hospital's P&P on Wound Assessment and Classification, a Wound Care Status Report form would be completed on all patients admitted with wounds, on a weekly basis, a change in wound status, new wounds, and at discharge. The Wound Care Coordinator would assess every new admission with wound(s) within 72 hours of admission. The primary care physician would acknowledge assessment and document a management plan discussion with patient/family in the progress notes.

Per review of 14 patients with pressure ulcers (Patients 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, and 89) on 2/28/13, no attestation of wound form was faxed to the physician to obtain their signatures; however, all 14 medical records had incomplete attestation of wound forms filled out by the WCN. The photographs of the wounds were attached but the location, description and staging of the wounds was inconsistently documented and the forms were not signed by the physicians. The lack of signatures was noted to be as late as 12/12, a few weeks away from the completion date of the plan of correction.

On 2/27/13 at 1335 hours, in an interview with the Wound Care Manager, she stated she did not know she was to notify the physician to sign the attestation of wound form. The Manager stated she was not aware who created the form, but the intention of the form was to describe the wound status to the doctor.

During the QAPI meeting conducted on 3/1/13 at 1000 hours, the QAPI Chairman/MD Director stated the hospital had difficulty resolving the issue of incomplete attestation of wound forms. The physicians kept forgetting to sign the forms, especially when the forms were not tabbed/marked by nurses for MD signatures.


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5. The hospital failed to ensure the infection control designee(s) implemented P&Ps for handwashing and wearing of PPE. Cross Reference A- 0951 #3 and #4.

In an interview with the Director of Quality Management on 3/1/13 at 0900 hours, he stated there had been no observations/monitoring of handwashing and the use of PPE during surgical procedures.

6. The hospital failed to ensure the discharge summary was completed according to the hospital's P&P. Cross Reference A- 0468.

During a review of the quality committee minutes for 2012, on 2/26/13, no review of discharge processes or post-discharge outcomes was seen.

In an interview with the Director of Quality Management on 3/1/13 at 1045 hours, he stated there were no quality department follow-up of post discharge outcomes and adequacy of discharge processes.

Based on interview and record review, the hospital failed to identify opportunities to improve data quality or institute changes that will lead to improvement in patient care as evidenced by:

1. The P&T Committee, a medical staff committee, received quality data which identified areas needing improvement in prescription order entry errors and record-keeping of scheduled drugs; however, that data was not analyzed and no actions were taken. This failure placed all patients at risk from preventable medication errors (e.g. wrong patient, wrong drug, wrong dose, omitted dose) and treatment delay.

2. The hospital failed to maintain accurate records for the disposition of all Scheduled II medications. The audit tool was not developed in accordance with all the documentation requirements stipulated in the hospital's CS policies. The Medication Safety Committee and P&T minutes showed no indication that the data quality was questioned. The hospital's failure to maintain a system to ensure control of the drug supply impaired their ability to detect drug diversion and potential medication errors (e.g. wrong patient, wrong medication, and/or missed doses).

3. The hospital failed to identify opportunities in improvement of availability of medications after hours in the night locker when Pharmacist Call Back reports indicated IV electrolyte supplements and other medications were available in the hospital but not available in the hospital's distribution system for nurses to administer for eight of 63 sampled patients (Patients 94, 105, 115, 116, 117, 118, 120, and 121) who required medications after hours.

4. The use of physical restraints in the hospital was not studied, creating the risk of excessive restraint use and poor health outcomes.

Findings:

1. Ongoing quality assurance reports and medication error reports were reported to the P&T related to transcription errors (a subtype of prescription order communication errors) by nurses as described below. This type of medication error occurred when nurses transcribed telephoned physicians orders into the hospital's ProTouch (a Computer Physician Order Entry system).

A review of medication error summary reports dated between 1/1/12 and 12/31/12, showed transcription errors were the most frequently occurring medication error. A review of the monthly totals detail showed this was a trend throughout the year with no significant improvement. The percentage of transcription errors as part of total errors detailed by month follows:

- January (42.9%)
- February (76.5%)
- March (43.8%)
- April (60%)
- May (50%)
- June (76.9%)
- July (64.7%)
- August (83.3%)
- September (75%)
- October (54%)
- In November and December, there were a total of six errors reported for the inclusive 60 day period; no transcription errors were reported.

On 2/27/13 at 1200 hours, in an interview, the DPH stated 107 of 177 reported errors in 2012, were transcription errors by nurses.

On 2/28/13 at 1045 hours, in an interview, MD 6 (Physician, P&T member) acknowledged attending Medication Safety Committee meetings and P&T where data collected from medication variance reports showed nursing staff was responsible for virtually all transcription errors. The DPH explained the errors occurred when nurses entered telephone orders into ProTouch. The DPH and MD 6 were unable to describe how the hospital intervened to reduce this most frequently occurring medication error type. MD 6 stated physicians were not entering their own orders in many cases. MD 6 elaborated "Orders are entered directly by 20-30 percent of physicians" despite the CPOE system having been "implemented for more than ten years." MD 6 stated "We don't really have a goal right now for physicians." The DPH stated "We (pharmacists) are entering all the orders we can but we are not here all the time."

2. The FDA guidelines all CSs as Schedule II, III, IV or V, according to their relative potential for abuse. Of all drugs legally and commercially available for use to treat diseases, Schedule II drugs are those associated with the greatest potential for abuse. Examples of Schedule II drugs include cocaine, morphine, and Dilaudid. The hospital failed to act upon ongoing quality assurance reports and audits to P&T related to incomplete and inaccurate scheduled drug records completed by nursing and pharmacy staff as follows:

On 01/25/12 at 1415 hours, during an interview and concurrent record review, the DPH described the hospital's process for maintaining CSAR. Samples of CSARs, audits, and reports to P&T Committee (a medical staff committee with oversight of safe medication use in the hospital) were reviewed and included all nursing units ICU, 3 E, 2 E, and 2 W as follows:

- "A detailed record of all scheduled drugs was maintained daily on each of four the nursing units ICU, 3 E, 2 E and 2 W."
- "Whenever inventory was added to unit stock, a pharmacy technician was required to date the entry and obtain a nurse co-signature upon delivery."
- "Whenever a nurse wasted a partial medication dose he must obtain a co-signature from another nurse."
- "Whenever a dose was removed from inventory, a nurse must record the full name of the patient, the date and time dispensed/administered and his signature."
- "A shift count (physical inventory of all scheduled drugs) must be conducted every morning and night, and the count must be verified and documented by two nurses."
- "A nurse manager was required to document with his signature that the CSAR is complete and accurate."
- "CSARs were transported to the main pharmacy countertop where a technician completed an audit of each form to identify incomplete entries."
- "A pharmacist reviewed the audits daily and forwarded them to the DPH."

A review of the CSARs identified the following discrepancies:

A review of Schedule II records dated 2/24/13, showed the 2 E unit had missing dates for six of 19 opportunities. Five of these were nursing errors and one was a pharmacy error associated with an addition to inventory. One time was incomplete.

A review of Schedule II records dated 2/24/13, showed the 3 E unit had missing dates for seven of 19 opportunities. The unit name was missing. One of three scratch errors was not documented correctly (a single line through the error with the nurse's initial). A pharmacy technician omitted a delivery date for additional inventory.

A review of Schedule II records dated 2/24/13, showed the 2 W unit had missing dates for six of 20 opportunities. The patient's name was incomplete for three entries. The shift count was missing. A pharmacy technician omitted a delivery date for additional inventory.

A review of Schedule II records dated 2/24/13, showed the ICU had missing dates for six of 20 opportunities. The patient's name was incomplete for three entries. The shift count was missing. A pharmacy technician omitted delivery dates twice for additional inventory.

A review of CSARs for the 2 W, 3 E, ICU and 2 E units for the inclusive period 2/21/13 through 2/23/13, showed a pharmacist failed to document he verified the accuracy and completeness of a single record.

On 01/25/12 at 1415 hours, during an interview, the DPH acknowledged redundancies in the hospital's policies for maintenance of the CS records. The DPH stated the audit tool "could be improved" as it did not include items such as a requirement for pharmacist verification on the CSAR. The DPH was unable to explain how the hospital's quality assurance reporting to the P&T Committee failed to prevent an ongoing problem with CS record-keeping. The DPH was unable to describe why the hospital had not held nursing and pharmacy staff accountable for maintaining accurate and complete records according to their policies.

The CCO and the P&T Chair were unavailable for interview during the survey.

On 2/28/13 at 1045 hours, in an interview, MD 6 (Physician, P&T member) acknowledged he was present at the Medication Safety Committee meetings where members discussed quality data for CS. MD 6 acknowledged there were many redundancies in the CSAR documentation process to ensure completeness and accuracy. The DPH and MD 6 acknowledged neither the redundancies nor the audit tool sufficiently identified the irregularities. Both agreed complete accurate records must be maintained in order to identify missed doses of pain medication as a result of drug diversion and prevent loss of control of the drug supply.

A review of the audit tool showed it was not developed in accordance with all the documentation requirements stipulated in the hospital's CS policies. A review of the Medication Safety Committee and P&T minutes showed no indication that the data quality was questioned.

3. On 2/26/13 at 1500 hours, during an observation of the Night Locker medication storage area with the DPH and the RDPH, a log of Pharmacist Calls Documentation records showed Patient 94, Patient 105, Patient 115, Patient 116, Patient 117, Patient 118, Patient 120, and Patient 121 required medications after hours.

In an interview at that time, the DPH indicated, "A pharmacist was called to return to the hospital to provide the medication(s) for a nurse to administer." The DPH stated it took a pharmacist "about thirty minutes to come to the hospital" to provide mediations not stocked in the night locker. The DPH stated some of the medications were in short supply and "a decision was made not to distribute these to the night locker." The DPH stated some of the mediations "had to be compounded by a pharmacist." The RDPH stated not all the medications identified on the Pharmacist Calls Documentation log were in short supply, specifically two anti-seizure medications and selected electrolyte supplements.

The RDPH offered that increasing par levels or standardizing doses could prevent future occurrences. Neither the DPH nor the RDPH was able to state if the hospital had investigated whether or not the patients in the logs experienced preventable treatment delays (missing dose medication errors).

On 2/28/13 at 1045 hours, in an interview, MD 6 (Physician, P&T member) acknowledged the hospital did not have a process to identify opportunities in improvement of availability of medications after hours in the night locker. MD 6 indicated Pharmacist Call Back reports were included in the quality data in Medication Safety Committee meeting minutes; however, he never associated those reports with potential drug unavailability issues.

MD 6 reviewed a sample of 17 medications accessed from the night locker with the DPH and both agreed most of them were not currently in short supply. The DPH indicated intravenous electrolyte supplements and all other medications were available in the hospital's Main Pharmacy, just not available in the hospital's distribution system for nurses to administer after hours.

On 2/28/13 at 1055 hours, in an interview, MD 6 and the DPH discussed the impact of not having medications available to nursing staff to administer to patients after hours. MD 6 stated the Medication Safety Committee reviewed quality reports including the Pharmacist Calls Documentation logs. MD 6 indicated when the data was presented, it was not framed in a way that emphasized the potential patient care issue of drug unavailability; rather, it was presented as "how many times a pharmacist had to come in" after hours. MD 6, stated "When the data was presented we accepted this as the main issue."


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4. The hospital's P&P, Use of Physical or Chemical Restraints, revised on 8/12, read in part, "The Hospital...uses interventions to prevent the use of restraints and eliminate their use at the earliest possible time." and "Restraint use requires an order by a physician or LIP responsible for the patient's care and authorized to order restraint use." and "When restraints are required, the least restrictive restraint will be used and safely applied after determining that other methods will not be effective." and "The physician must examine the patient as soon as possible when notified that restraint use is indicated, but no later than 24 hours after the initiation of non-emergent restraint use. "

During a review of the medical records of Patients 67 and 123 on 2/25 and 2/26/13, the medical records did not contain complete documentation to support the necessity of restraints. Both physician and nursing documentation about the specific circumstances requiring restraint, the condition of the patient, and about the type of restraint required were frequently missing. Cross Reference to A- 187.

In an interview with MD 3 on 3/1/13 at 1010 hours, he stated ideally the hospital should be restraint free, but the hospital did not make sitters available.

In a concurrent interview with the CEO, he stated the hospital had avoided having sitters.

In a second interview with the CEO on 3/1/13 at 1130 hours, he stated there were not enough CNAs available at this time to use as sitters.

In an interview with the Senior Director of Clinical Operations on 3/1/13 at 1110 hours, she stated the restraint rate had crept up and was high.

The Governing Body meeting minutes for September through December, 2012, were reviewed. The minutes did not contain data regarding restraint usage in the hospital. The December 2012 meeting minutes contained a report from the Patient Care and Safety committee with a grid that contained the topic, "restraint freedom," but there was no data presented on the grid for that topic and no findings, analyses, recommendations, actions or follow-up for that information.

During an interview with the Director of Quality Management on 3/1/13 at 1320 hours, the Director provided additional data. The Director stated the data indicated the hospital did not meet its goals for minimizing the use of restraints in September or December. The data showed higher restraint use in December, compared to September.

The Director of Quality Management reviewed the Governing Body meeting minutes and stated the restraint data should not be blank. Restraint data should have been included in the data shown to the governing body. The Director reviewed the other minutes and stated that he was unable to find restraint data in the Governing Body meeting minutes.

In an interview with the Director of Quality Management on 3/1/13 at 1130 hours, he stated there had been no request by the GB for study of why the restraint use rate was so high.

Based on observation, interview, and record review, the QAPI program failed to ensure pressure ulcer prevention and treatment measures were analyzed and tracked and preventive actions and feedback systems were put in place with staff involved in pressure ulcer prevention and treatment to minimize the risk of pressure ulcers for patients in the hospital.

Findings:

The hospital's P&P, Investigating Serious and Sentinel Events, revised on 6/11, read in part, (hospital name) is committed to providing quality health care to its patients and to responding promptly to adverse events that may affect patient safety." and "Promoting patient safety requires that every event be treated seriously and prompt action taken to protect the patient at the center of the event as well as other patients who, without action, could also be at risk."

In an interview with the Chairman of the Board on 3/1/13 at 1110 hours, he stated increased rates of pressure ulcers had been first noted and presented to the GB in August, 2012.

In an interview with the Director Quality Management on 2/27/13 at 1545 hours, he stated as a part of pressure ulcer prevention and treatment, patient repositioning to offload the affected areas of skin was being undertaken. The Director stated data on correct repositioning of patients was collected starting in December, 2012. However, the Director stated the repositioning data received from the units starting in January, 2013, indicated correct repositioning compliance rates of around 100%. The Director stated the data had not appeared credible, and hence he began performing an independent audit of the repositioning of the patients to offload pressure ulcers. The Director discovered the rates of correct repositioning were below the rates documented by the nurse managers, initially in the 65-70% range. He stated he and the CEO were performing their own audits and providing on-the-spot education for staff members who were not correctly repositioning the patients.

In a second interview with the Director Quality Management on 3/1/13 at 1010 hours, he stated the documentation of repositioning was not effective and needed to be changed.

During an interview with the Senior Director of Clinical Operations on 3/1/13 at 1110 hours, she stated that nurse managers had been put in place, but had not been allowed to act as educators to help reduce the incidence of pressure ulcers.

In an interview with the Wound Care Manager on 2/27/13 at 1415 hours, she stated the wound care team was responsible for seeing all wounds in the hospital, for providing care plans and for obtaining treatment orders from the physicians. The Manager stated the wound care team had not been involved in audits of the numbers or sizes of pressure ulcers developed in the hospital. The Manager stated she had not met with representatives of the quality department and had not received any feedback from the quality department. The Manager stated her staff had new ideas about wound care, but the ideas were not brought forward for review.

In an interview with the Director Quality Management on 3/1/13 at 0900 hours, he concurred that the wound care team was not involved in the root cause analyses that were performed for pressure ulcers.

Based on interview and record review, the medical staff did not ensure the selection criteria outlined in the Medical Staff Bylaws was applied to seven of the seven physician files reviewed (MDs 1, 8, 9, 11, 12, 13, and 14). There was no documented performance evaluation of the physicians prior to reappointment and reprivileging, and for two physicians, MD 11 and MD 13, there was no evidence of proctoring. These failures created the risk of substandard services being provided by the medical staff.

Findings:

1. The Governing Board Bylaws (undated), page 11, read in part, "The Medical Staff shall conduct a continuing review and appraisal of the quality of professional care rendered in the Hospital, and shall report such activities and their results to the Board. The Medical Staff shall make recommendations regarding the Medical Staff and report same to the Board concerning: ...evaluations of overall patient care performed by the Medical Staff ..."

The Medical Staff Bylaws (undated), page 74, read in part, "By adopting these Bylaws, the Medical staff has delegated to the MEC authority to carry out the following responsibilities on its behalf: to provide effective mechanisms to monitor and evaluate the quality of patient care and the clinical performance of all individuals with Medical Staff or AHP Privileges within the hospital, to ensure all Practitioners provide care at a consistent level of quality."

During a review on 2/27/12, of the credential files of MD 1, reappointed on 1/2012; MD 8, reappointed on 2/20/11; MD 9, reappointed on 4/2010; MD 11, reappointed on 9/30/11; MD 12, appointed on 6/24/11; MD 13, reappointed on 11/30/11; and MD 14, reappointed on 1/31/2011, the files did not contain information about the quality of the services rendered by the physicians. There was no information about the professional performance and judgment of the physicians in carrying out the privileges granted.

In an interview with the CEO on 3/1/13 at 0945 hours, he stated physician performance evaluations had not been pursued.

In a second interview with the CEO on 3/1/13 at 1145 hours, he stated he had trusted the medical staff processes were in place; however, he had not verified the process until recently. The CEO stated the data he received regarding the medical staff processes was found inaccurate.

2. The Medical Staff Bylaws (undated), page 19, read in part, "All initial appointees to the Medical Staff will be assigned to the Provisional Staff category. All Provisional Staff Members will be subject to a period of proctoring, or will be required to provide evidence of satisfactory completion of proctoring at another local institution, in accordance with the procedures set forth in the Rules."

a. The credential file of MD 11 was reviewed on 2/27/13 at 1100 hours. The file showed the physician was appointed initially in October, 2009, to provisional status. MD 11 was subsequently reappointed to active status but the file did not contain evidence of proctoring.

b. The credential file of MD 13, initially appointed in November, 2009, and subsequently reappointed, did not contain evidence of proctoring.

During a concurrent interview with the Medical Staff Coordinator, she concurred there was no documentation of proctoring in the files for MDs 11 and 13. The Coordinator stated she was not sure about the basis for appointing the physician to active status. The Coordinator stated there were 35 or 40 physicians on the medical staff with the same issue.

In an interview with the CEO on 3/1/13 at 0945 hours, he stated physician performance evaluations had not been pursued. Proctoring would have to be obtained for physicians without evidence of proctoring.

Based on interview and record review, the medical staff failed to enforce its rules and regulations as evidenced by:

1. Members of the medical staff were appointed to temporary staff appointments and privileges were provided to physicians not meeting criteria in the bylaws.

2. Three of the seven members of the medical staff reviewed did not cooperate with TB (a contagious disease) screening and were not placed on suspension, creating the increased risk of the spread of infection to patients using the hospital.

3. The medical staff did not follow hospital policy for completing assessments and orders for the use of physical restraints for two of seven patients reviewed for restraints (Patients 67 and 123).

4. The medical record was not complete and accurate for two of 63 sampled patients (Patients 107 and 111).

Findings:

1. The Medical Staff Bylaws (undated), page 38, read in part, "Temporary Privileges may be granted on a case-by-case basis in only two categories of circumstances: When there is an important patient care need that mandates an immediate authorization to practice for a limited period of time and sufficient information to establish current licensure and competence to perform the Privileges requested while full credentials information is verified and approved." and "When a new applicant for Medical staff membership and/or Privileges is waiting for review and recommendation by the MEC and approval by the Governing Body, the CEO may grant Temporary Privileges upon recommendation of the President of the Medical Staff for a period not to exceed 120 days..." and on page 39, "Temporary Privileges are not to be granted routinely in the following situations: ...the Medical Staff Office or CVO is unable to verify all data in sufficient time to ensure completed processing of a reappointment application before the expiration date; the MEC does not meet in time to assure completion of the reappointment process before the expiration date; or the Governing Body does not meet in time to ensure approval of reappointment and renewal of Privileges before the expiration date."

a. The credential file of MD 8 was reviewed. Documentation showed the MD was appointed to the medical staff in January, 2003. A form, Initial Appointment, Reappointment, Provisional Review and Removal of Proctoring, signed by the credentialing committee chair and the executive director, documented reappointment to the medical staff category of "consulting" on 2/21/11, for the period from 2/21/11 to 2/20/13. There was no evidence of reappointment to prior to the expiration of consulting staff appointment on 2/20/13. The file also contained a document titled, Temporary Privileges Notification/Approval dated 2/20/13, granting temporary privileges from 2/20/13 to 4/18/13, to MD 8.

b. Review of the credential file of MD 14 showed the physician was initially appointed in January, 2004, and was reappointed as a courtesy staff member on 4/4/11, for the period 1/31/11 to 1/30/13. There was no evidence of reappointment as a courtesy staff member prior to the expiration of the appointment on 1/30/13. The file also contained a document titled Temporary Privileges Notification/Approval dated 1/30/13, granting temporary privileges from 1/30/13 to 3/15/13 to MD 14.

During an interview with the Medical Staff Coordinator on 2/26/13, she stated the medical staff were temporarily reappointed as they were not comfortable with documentation in the files and wanted to make sure all documents were current.

During an interview with the CEO on 3/1/13 at 0945 hours, he stated the Medical Staff Department documentation in the computer system had been overridden by a previous employee in the medical staff's office making it appear the medical staff processes were completed when they had not been.

2. The 2010 Medical Rules, page 8, read in part, "TB Screening will be performed for all physicians/AHPs per CDC guidelines. The Two-Step Screening Process for all initial appointments to the Medical Staff. Annual TB Screening Questionnaire for all Medical Staff ..." and "Physicians will be automatically suspended if TST Report is not received upon expiration date. Physicians may not admit, schedule surgeries, or consult any new patients."

During a review of seven medical staff (MDs 1, 4, 5, 6, 7, 8, and PA 1), the health data for TB screening tests was not found complete within the past year for MD 1, MD 6, and PA 1.

The Infection Control PI Measures 2012, included the performance measure and number of MD annual TB screening tests completed. The graphic data showed 289 of 508 annual TB screening tests for medical staff members were completed in 2012 or 57% of the total.

In an interview with the Infection Control RN on 2/27/13 at 1040 hours, she stated she was trying to get the medical staff members to cooperate with TB screening tests as set forth in the infection control plan, but had limited success so far.

During a review of the physician suspension lists for December, 2012, and January, 2013, MD 1, MD 13, and PA 1 were not listed as suspended. None of the physicians on the suspension list were listed as suspended due to failure to comply with TB screening.

3. The 2010 Medical Staff Rules and Regulations, page 4, read in part, "The responsible LIP shall be accountable for the preparation of a complete and legible medical record for each patient." and on page 5, "All clinical entries in the patient medical record shall be accurately dated, timed and authenticated."

The hospital's P&P, Use of Physical or Chemical Restraints, revised on 8/12, read in part, "The Hospital ...uses interventions to prevent the use of restraints and eliminate their use at the earliest possible time." and "Restraint use requires an order by a physician or LIP responsible for the patient's care and authorized to order restraint use." and "When restraints are required, the least restrictive restraint will be used and safely applied after determining that other methods will not be effective." and "The physician must examine the patient as soon as possible when notified that restraint use is indicated, but no later than 24 hours after the initiation of non-emergent restraint use."

a. During a review of the medical record of Patient 67 on 2/25/13, the record contained three pre-printed forms titled, 24 Hour Restraint Order and Flow Sheet. The top of the forms contained a section for the physician to document in the check boxes and fill-in blanks for the physician's assessment, type of order, and type of restraint, followed by spaces to supply their signature, printed name, date, and time.

One such form in Patient 67's record contained a telephone order for restraints dated 11/29/12 at 1730 hours. A second form contained a physician's signature but the sections for the physician's assessment and type of restraint were left blank. There was no printed name, date or time for the order.

A third restraint form for Patient 67 had a physician's signature, printed name, and the date of 12/2/12, but no time. There was no documentation of a physician's assessment, order for the restraint, or selection of type of restraints. Those sections of the form were left blank.

The physician's initial assessment was found on the H&P document, which was dated 12/1/12, more than 24 hours after restraints were implemented on 11/29/12. None of the three forms had a signature or name of nurse completing the form on the Nursing Clinical Observations section of the form.

b. The medical record of Patient 123 was reviewed on 2/26/13, and contained 48 restraint forms for various dates from 7/10/12 through 9/18/12. The Physician's Assessment portion of the form was not completed for 28 of 48 restraint forms. The Physician's Order portion was not completed for 21 of 48 restraint forms.

During an interview with the CCO on 2/26/13 at 1400 hours, she reviewed the restraint forms and confirmed the forms should have been completed by the physician.


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4. The Medical Staff Bylaws, Article V, the Clinical and Practice Privileges showed the contents of the medical record shall be pertinent and current and include: summary of discharge note. V11, Discharge Summary showed a discharge summary shall be dictated for all patients hospitalized over 48 hours. The responsible practitioners shall authenticate all discharge summaries.

The Medical staff Rules and Regulations showed "Delinquent health information records are those that are incomplete for any reason after fourteen (14) days following discharge of the patient (v.16a)." " If the record remains incomplete at the end of the 14 days grace period, the Administrator will notify the physician in writing via letter or FAX that his/her privileges to admit patient, perform surgical procedures, provide new consultations have been temporarily suspended until the delinquent record(s) have been completed (v.16d)."

a. Patient 107's medical record reviewed on 2/28/13, showed the patient was admitted on 12/10/12, and discharged on 1/14/13. There was no documentation the physician had signed the Discharge Summary as of review date, 2/28/13, six weeks after a suspension note was sent out by the medical staff to MD 7.

b. Patient 111's medical record reviewed on 2/28/13, showed the patient expired on 1/3/13. Documentation of a Notification of Suspension form dated 1/15/13, showed MD 7 was notified of incomplete patients' medical records that included Patient 111's Discharge Summary. On 2/8/13, MD 7 dictated the "Expiration Summary;" however, MD 7 had not signed off on the document as of review date, 2/28/13, six weeks after the suspension note was sent out to MD 7 by the Medical Staff.

Based on interview and record review, the hospital failed to ensure an attending physician completed documentation of a medical H&P examination for two of 63 sampled patients (Patients 67 and 103) within 24 hours after admission in accordance with the hospital's P&P as described in the Medical Staff Bylaws. This failure placed the patient at risk for treatment delay in the event the patient had a new or existing condition requiring intervention.

Findings:

The Medical Staff Bylaws showed "A complete history and physical examination shall, in all cases, be dictated and on the chart within 24 hours of admission." The Bylaws also stipulated "A previous H&P that is legible, may be used if it was performed within 30 days prior to admission, with an updated progress note or addendum within twenty-four (24) hours of inpatient admission or prior to surgery." and "The responsible LIP shall be accountable for the preparation of a complete and legible medial record for each patient."

1. A review of Patient 103's medical record showed the patient was admitted to the hospital on 2/21/13.

A review of the two-page document titled, History and Physical showed all activities for the time span between 2/21/13 at midnight to 2/26/13 at 2332 hours. The document showed a section, "Original entry with all addenda:" with a comment, "history and physical performed;" however, there was no evidence of an original entry or addenda of a completed H&P in the medical record.

On 2/26/13 at 1120 hours, in an interview and concurrent record review, the Medical Records staff was unable to provide evidence of documentation of a H&P in the medical record within the time period inclusive of 30 days prior to admission to 24 hours after admission (1/22/13 to 2/22/13). The staff confirmed the H&P did not meet the hospital's requirement.

An addendum signed and dated by MD 1 on 2/25/13 at 2004 hours, showed "Original entry with all addenda: history and physical, performed." In the body of the second entry was a comment, "This is an addendum to the H and P I had previously performed outside the hospital." There were blank spaces in the categories of "Reason for Admission," "History of Present Illness," "Past Surgical History," "Medications," "Review of Symptoms" and "Impression." Also in the body of the second entry was a comment, "Full addendum and extensive H and P will be dictated, (blank space) which has been obtained from the family and from the records."

On 2/26/13 at 1125 hours, in an interview, the Medical Records staff was unable to explain why there were blank spaces in the addendum to the H&P on 2/25/13. The staff stated perhaps "the doctor mumbles." The staff stated, upon further consideration, perhaps the issue was with the transcriptionist and the problem was not isolated to the doctor. MD 1 was unavailable for interview.


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2. The medical record of Patient 67 was reviewed. An Admission Face Sheet indicated the patient was admitted on 11/29/12 at 1625 hours. The medical record also contained an H&P dictated by the physician on 12/1/12 at 0053 hours, more than 32 hours after admission.

In an interview with the IT staff on 2/26/13 at 1150 hours, he stated the patient must be seen within 24 hours and confirmed the H&P examination was not completed within 24 hours of admission.

Based on observation, record review, and interview, the hospital failed to demonstrate a well-organized nursing service when RNs were not aware a P&P to address dislodged G tubes existed and when nursing staff were not provided the guidance of a P&P to manage situations such as tube feeding dislodgment, creating the risk of poor quality patient care.

Findings:

On 2/26/13 at 1100 hours, Patient 81 was observed in the patient's bedside accompanied by RNs 1 and 2, both Nurse Managers. A hissing, sucking sound was heard by the surveyor. RN 2 was asked to lift the abdominal dressing to expose the G tube. The G tube was found dislodged from the abdominal insertion site with the balloon inflated. The feeding pump was turned off, the insertion site was partially covered, and the dislodged G tube was discarded.

RNs 1 and 2 obtained a large urinary catheter. The tip of the catheter was lubricated with sterile water and inserted into the G tube insertion site to maintain the abdominal stoma leading to the stomach. The balloon of the catheter was inflated with 30 ml of air to keep the catheter in place. RN 2 was to notify the relevant physician to report the event and obtain an order to confirm the location of the catheter via x-ray. The site was covered and secured by tape over a 4 x 4 gauze.

After the dressing was applied, the RNs were asked to provide a P&P for dislodged G tube. RNs 1 and 2 looked at each other and stated the hospital did not have one. The RNs stated, "Considering the number of patients on tube feeding in this hospital, we don't remember having a policy to guide us how to manage dislodged feeding tubes. Somehow we functioned through experience." The event was documented in Patient 81's nursing notes and the physician was informed of the event after the replacement tube was inserted. There was no further documentation done.

After three days, on 3/1/13 at 1130 hours, the CCO provided a written P&P on Enteral Nutrition, revised on 2/13, involving different feeding tubes and a variety of liquid nutrition. The P&P included troubleshooting and precautions for tube feeding. An example was a dislodged G tube.

The P&P also showed the inadvertent removal of a G tube called for a replacement tube to be reinserted within four hours as the stoma could close rapidly. The physician should be notified immediately to obtain orders to temporarily replace the feeding tube with a urinary catheter. The catheter should be the the largest that snugly fit. If it was loose, replace with a bigger one. With the balloon deflated, apply a little water based lubricant to the balloon part of the tube inserting it smoothly in to tract. The possibility to insert the replacement tube into peritoneal cavity was discussed. The balloon of the catheter was to be inflated with water. If the balloon takes 5 ml, inflate with 4.5 ml. If the balloon takes 10 ml, inflate with 7 ml. The placement of the catheter should be confirmed via x-ray. All the problems, interventions, and assessments should be included in the nursing notes and a Change of Condition pathway via Protouch (computer charting). An event report should also be completed.

Based on observation, interview, and record review, the hospital failed to ensure the needs of two of 63 sampled patients (Patients 69 and 113) were met regarding wound care and investigation of falls, creating the risk of poor quality patient care.

Findings:

1. Patient 69 was observed in bed on 2/28/13 at 0900 hours. The patient had heel protector boots in place on the lower extremities. RN 10, the Nurse Manager of the 2 E unit, lifted the bed covers and noted bloody discharge on the space between the patient's left 4th and 5th toes. The bloody discharge stained the surface of the boots. No dressing was observed on the patient's foot. CNA 20 and RN 20 stated the patient had been repositioned by the staff an hour ago.

Review of the Weekly Wound Care Assessment dated 2/27/13, showed Patient 69 was identified with skin breakdown between the 4th and 5th toes of the left foot. An aseptic dressing was applied. The WCN contacted the physician and received a telephone order to apply an oil Emulsion and secure it with a gauze and a Kerlix roll gauze. The dressing should be changed every other day and PRN.

Review of Patient 69's nursing care documentation with RN 10 showed the patient was seen by the wound care team on 2/28/13. Review of the nursing documentation did not show the nurse had reapplied a dressing to the patient's 4th and 5th toe wound as ordered by the physician.

2. Review of hospital documents on 2/28/13, showed Patient 113 had an unwitnessed fall from bed with an injury on 12/5/12. Review of the Fall Investigation report dated 12/5/12, showed documentation the patient received anti-anxiety, narcotic, and antihistamine medications in the past 72 hours. The patient's fall risks included confusion, disorientation, incontinence, generalized weakness, and a prior fall in the last six months. The patient's prior fall occurred during this hospitalization.

The report showed documentation the team determined Patient 113's fall was related to the patient's psychiatric/cognitive status. Documentation on the report showed it was "forwarded to the Director of Quality Management on: (blank)." No date was entered.

On 3/1/13 at 1310 hours, during an interview the the Director of Quality Management stated a RCA was not done for Patient 113's fall investigation. The Director stated the patient sustained a small skin laceration and the fall did not meet the criteria to require an investigation. However, the Director was unable to show documented evidence the patient's fall was thoroughly investigated to prevent further falls.

Based on interview and record review, the hospital failed to ensure the RN responsible for the care of the patient:

1. Directly conducted the shift assessment and reviewed the care plan prior to delegating the care of four of the four patients reviewed assigned to LVNs (Patients 71, 72, 73, and 74). In addition, for Patients 71 and 72, when the patients experienced a change in condition, there was no documentation to show the RN supervised the interventions and care delivered to the patients by the LVN. This resulted in the potential for harm to the patients as decisions were made and executed regarding delivery of care on the basis of an assessment.

2. Supervised the repositioning every two hours for Patients 63, 73, 74, 75, 94, 95, 96, 97, 98, 100, 108, 109, and 110. Cross Reference A- 0396 #2.

3. Supervised and evaluated the nursing care for Patient 78 who did not receive adequate nutrition support with medical nutrition therapy when critical and essential wound assessments were not available at admission to multidisciplinary staff.

4. Supervised the care for Patient 61 who did not receive a speech therapy screening.

Findings:

1. RN 12 was interviewed on 2/26/13 at 1035 hours. RN 12 stated she was the Charge Nurse for the 2 E unit today. Review of the staffing assignment sheets for the unit showed an LVN was assigned to care for four patients on the unit for the day shift of 2/26/13. The assignment sheet showed each of the four patients assigned to the LVN were also assigned a supervising RN.

RN 14 was interviewed on 2/26/13 at 1045 hours. The RN confirmed she was assigned to supervise the care of Patient 71, who was assigned to an LVN today. When asked her responsibilities when assigned to supervise an LVN, RN 14 stated she would "briefly" check the patient in the morning; however, she may not acknowledge and co-sign the LVN's assessment documentation until later in the day. RN 14 stated the LVN documented the assessment "data" gathered for the patient. When asked what the "data" entailed, RN 14 stated the LVN listened to the patient's lungs, heart, and bowel sounds and documented the findings. RN 14 stated she evaluated the patient's care plan also, but she was under the impression this could be done anytime during the shift.

RN 15 was interviewed on 2/26/13 at 1130 hours. The RN stated the LVN assessed the patients assigned to them and documented the assessment. RN 15 stated when assigned to supervise an LVN she also assessed the patient; however, her assessment was not documented as she acknowledged and co-signed the assessment documented by the LVN.

The CCO was interviewed on 2/26/13 at 1345 hours. The CCO confirmed an LVN gathering "data" did not include the LVN conducting a system assessment of a patient; a head to toe assessment of the patient's neurological, respiratory, and cardiac systems, bowel and urinary function, extremities and condition of the skin. The CCO confirmed the RN was expected to conduct and document the assessment for the patients assigned to the care of an LVN, not to co-sign an assessment for which there was no documentation to show they themselves performed.

a. The medical record for Patient 71 was reviewed on 2/26/13 at 1430 hours with the CCO and RN 12. The patient was assigned to an LVN for the day shifts of 2/25 and today, 2/26/13.

Review of the shift assessment dated 2/25/13 showed documentation the full systems assessment for Patient 71 was completed and documented by the LVN at 0800 hours. The RN co-signed she acknowledged the LVN's assessment at the end of the 12 hour shift at 1859 hours. When asked, RN 12 was unable to locate any additional RN documentation.

Review of the shift assessment dated 2/25/13 showed documentation the full systems assessment for Patient 71 was completed and documented by the LVN at 0800 hours. In addition, the LVN documented Patient 71 experienced a change of condition at 0830 hours. The patient was receiving oxygen via a device attached to a tracheostomy tube (a curved tube that is inserted into a hole made in the neck and windpipe). The patient's blood oxygen saturation level decreased and the patient was restarted on mechanical ventilation.

Review of the nursing notes with RN 12 did not show documented evidence the RN assigned to supervise the care of Patient 71 had assessed or was involved in the care of the patient.

b. The medical record for Patient 72 was reviewed on 2/26/13 at 1500 hours, with the CCO and RN 12. The patient was assigned to an LVN on the day and night shifts of 2/24/13 and 2/25/13, and the day shift of 2/26/13.

For the day shift on 2/24/13, the LVN documented an assessment of Patient 72 at 0921 hours. The sole documentation by the RN was an acknowledgement of the assessment at 1635 hours.

For the night shift on 2/24/13, the LVN documented an assessment of Patient 72 at 2330 hours. RN 12 was unable to locate RN documentation regarding the patient's assessment for the shift.

For the day and night shifts on 2/25/13, the LVNs documented their assessments of Patient 72 at 0800 and 2000 hours. For the day shift, the sole RN documentation was an acknowledgement of the assessments at 1837 hours, and for the night shift at 0315 hours.

Review of the nursing documentation for the day shift 2/26/13, showed the LVN assessed Patient 72 at 0800 hours. Documentation by the LVN showed the patient had a change of condition at 0745 hours, when his blood sugar level decreased to 66 mg/dl (normal fasting levels are 70-130 mg/dl), requiring administration of IV Dextrose. Although documentation showed the RN administered the IV medication to Patient 72, RN 12 was unable to locate documentation to show the RN assessed the patient at the time of the change of condition or after the medication was administered.

c. The medical records for Patients 73 and 74 were reviewed on 2/26/13 at 1530 hours, with the CCO.

Review of the shift assessments for the day shift 2/26/13, showed Patient 73 was assessed by the LVN at 0835 hours, and Patient 74 was assessed by the LVN at 0906 hours. The CCO was unable to locate documentation to show the RN(s) assigned to supervise the LVN who had assessed the patients at this point in the shift.

2. The European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel (EPUAP/NPUAP) guidelines for the prevention of pressure ulcers showed "Reposition frequency will be determined by the individual's tissue tolerance, his/her level of activity and mobility, his/her general medical condition, the overall treatment objectives, and assessment of individual's skin condition".

Guidelines developed by the EPUAP/NPUAP for the treatment of pressure ulcers showed "The schedule for repositioning the patient should be based on the degree to which the individual is at risk for developing pressure ulcers and on the response of the tissue to pressure. Thus, the higher the risk for additional pressure ulcer and the longer the duration of reactive hyperemia, the more frequently the patient should be repositioned."

The guidelines also showed "establishing turning frequency based on the characteristic of support surface and the individual's response and written repositioning schedules should be developed even when patients are using a pressure-reducing support surface."

EPUAP/NPUAP guidelines for the prevention of pressure ulcers defined a Stage I pressure ulcer as non-blanchable erythema. The NPUAP guidelines stated "Avoid positioning the individual on bony prominence's with non-blanchable erythema."

These guidelines would direct staff to avoid positioning a patient in a supine position if the patient had a Stage I pressure ulcer to the patient's back or buttocks area.

During an interview with RN 13 and the CCO on 2/25/13 at 1440 hours, they stated a turning diagram was posted over the bed of each patient in the hospital. The clock type wheel was divided into six different two hour clock periods which indicated the correct position of the patient during that time period. For example, at 0800 and 2000 hours, the patient was positioned to the left side. At 1000 and 2200 hours, the patient was turned to the right side. At 1200 and 0000 hours, the patient was positioned supine (on the back). The clock periods rotated in that order.

The CCO stated if patients had skin breakdown the color wheel was individualized to show the patient was not to be turned on to the site of the pressure ulcer. For example, if the patient had a sacral pressure ulcer, the clock wheel showed the patient was to be turned every two hours to the left or right sides only.

The CCO stated patients who were alert and able to turn themselves had "self-turn" written on a sign over the bed.

During an interview with CNA 19 on 2/26/13 at 1055 hours, the CNA stated many of the patients required the help of two staff to reposition. The CNA stated it was sometimes difficult to get the licensed nurses to help with the turning, fifty percent of the time she turned the patients by herself.

During an interview with RN 14 on 2/26/13 at 1045 hours, the RN stated turning could be late by a half hour to an hour. The RN stated most of the patients needed total care and required two staff to turn them. The RN stated she shared a CNA with other licensed nurses and the CNA could have nine or ten patients.

a. An initial tour of the 2 E and 2 W units was conducted on 2/25/13 beginning at 0900 hours, with RN 4. According to the turning wheel, all patients who were not "self-turn" should be positioned on their left sides at this time. Six patients were observed positioned in the supine position or positioned with a pillow under their shoulders; however, their lower back and buttocks remained in contact with the mattress.

b. The 2 E and 2 W units were toured with the CCO on 2/26/13 beginning at 1000 hours. Per the CCO there were 60 patients on the two units. According to the turning wheel, all patients who were not "self-turn" should be positioned either on their right or left sides at this time. Twenty patients were observed in the supine position or they were positioned with a pillow under their shoulders; however, their lower back and buttocks remained in contact with the mattress.

The medical records for two of the above twenty patients observed not correctly positioned (Patients 73 and 74) were reviewed on 2/26/13 beginning at 1430 hours, with the CCO and RN 12. Documentation for Patients 73 and 74 showed they were turned to the right side just prior to 1000 hours. The documentation for Patients 73 and 74 showed they were also turned to the right side, both at 1000 hours, documented by the same CNA (these patients were not in the same room). The CCO was unable to explain why the CNA's documentation did not match the observations of the patients. The CCO stated the CNAs were expected to document the turning in real time. RN 12 stated between she and the Nurse Manager, one of them makes rounds every hour to check on the positioning of the patients.

When interviewed on 2/27/13 at 1045 hours, CNA 14 stated staff was expected document in the electronic record at the bedside at the time the patient was turned. When asked to demonstrate how to document a turn, the procedure took less than a minute.

c. The 2 E unit was toured with the CEO on 2/27/13 at 0915 hours. According to the turning wheel, all patients who were not "self-turn" should be positioned their left sides at this time. Five of the 16 patients observed were observed positioned in the supine position or they were positioned with a pillow under their shoulders; however, their lower back and buttocks remained in contact with the mattress.

Patient 110 was observed with the CEO at 1015 hours. The patient was observed in bed turned slightly to her right side with a wedge pillow behind her back. The patient's lower back and buttocks remained in contact with the mattress. The head of the bed was elevated approximately 30 degrees.

CNA 14 was interviewed on 2/27/13 at 1016 hours. The CNA stated she had just turned Patient 110 on to her side with the help of OT 1. The CNA entered the patient's room with the surveyor and OT 1. CNA 14 confirmed the patient was not completely turned on to her right side.

The staff was asked to demonstrate the repositioning of Patient 110. The staff attempted to turn the patient's left shoulder to the right and position the wedge behind her upper back; however, the patient rolled right back into the supine position. The staff did not lower the head of the bed before attempting to reposition the patient; they did not attempt to pull the patient's hips and shoulders towards them as she was rolled to the right; and they did not place a pillow between her legs.

RN 11 was interviewed on 2/27/13 at 1045 hours. The RN stated Patient 110 was her patient. The RN entered the patient's room with the surveyor. When asked to reposition the patient, RN 11 attempted to turn the patient on to her side and placed the wedge behind her back. The patient appeared uncomfortable and rolled back into the supine position. The RN did not lower the head of the bed before attempting to reposition the patient; did not attempt to pull the patient's hips and shoulders towards her as she was rolled to the right; and did not place a pillow between her legs.


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d. On 2/27/13 at 1035 hours, during a tour of the 2 W unit with the Nurse Manager of 2 W, RN 10, Patient 95 was observed lying on her back in bed with the head of bed raised 30 degrees. Patient 95 stated "My bottom is on the bed. I do my best. It's hard to turn." The diagram on the wall above her head showed between the hours of 1000 and 1200 hours, Patient 95 should be positioned on her side.

e. On 2/27/13 at 1045 hours, during a tour of the 2 W unit with RN 10, Patient 96 was lying on his back in bed. Patient 96 confirmed "My backside is touching the bed." The diagram on the wall above Patient 96's head indicated between the hours of 1000 and 1200, the patient should have been positioned on his side.

f. On 2/27/13 at 1055 hours, during a tour of the 2 W unit with RN 10, Patient 97 was lying on his back in bed. The diagram on the wall above Patient 97's head indicated between the hours of 1000 and 1200, the patient should have been positioned on his side.

g. On 2/27/13 at 1105 hours, during a tour of the 2 W unit with RN 10, Patient 98 was lying on her back in bed. RN 10 confirmed the patient "was not properly positioned on her side. Her coccyx (tailbone) is in contact with the bed." The diagram on the wall above her head indicated between the hours of 1000 and 1200, the patient should be positioned on her side. RN 10 was unable to explain why all the patients who should be positioned on their side were on their back. RN 10 acknowledged the RNs were responsible for ensuring the patient's care plans were implemented. RN 10 stated he was responsible for ensuring RNs on his unit were supervised. RN 10 stated "There is a lag time. They will get to them eventually."

h. On 2/27/13 at 1115 hours, during a tour of the 2 W unit with RN 2 and RN 10, the Nurse Manager, Patient 94 was observed lying in bed on his back. Patient 94 stated, "I feel like the joint is sticking on the bone. It hurts." RN 10 stated, "He should have a wedge. This patient is self-turn. He has had hip replacements." Patient 94 stated, "Someone was in here a while ago. They put it (the wedge, a device used to maintain a position that keeps weight off the patient's backside) in the cabinet." RN 10 assessed Patient 94's backside and stated, "Redness." RN 10 called in RN 9, who was assigned to Patient 94. RN 9 stated, "At 0830 hours, I put lotion on his buttocks and scrotum for redness. I did not notice the upper area. He has skin breakdown now. This is a brand new wound. He didn't have it before." RN 9 denied putting the wedge in the cabinet. RN 9 stated, "Physical Therapy was here earlier." RN 9 called the Nurse Manager and the WCC to perform an assessment.

On 2/27/13 at 1119 hours, in an interview, RN 10 said he was uncertain how many patients required assistance with repositioning according to their care plans. RN 10 stated, "I would have to print out a roster or go in their rooms. Anyone who has the turning clock has a care plan for turning." RN 10 stated Patient 94 was "self-turn."

A review of Patient 94's repositioning documentation by nursing staff showed Patient 94 was repositioned appropriately, without fail, exactly on time (to the minute), from 2/27/13 at 0800 hours to 2/28/13 at 0400 hours.

On 2/27/13 at 1340 hours, in an interview, Wound Care Manager stated, skin rounds for patients without documented skin breakdown were assessed every Wednesday.

Review of WCN's progress note for Patient 94, dated 2/27/13 at 1258 hours, showed the patient denied any pain and was able to self-position; however, he stated he had a hip surgery in the past and was careful when turning. The patient was instructed the sacral area was pink but blanchable with no broken areas; but the patient was instructed not to lie on his back for long times. The WCN documented the patient was assisted to reposition to left side with the body wedge.

An analysis of WCN's progress note did not show documentation of the length, width, and depth of the wound. The WCN failed to stage the wound as a (e.g. stage I pressure ulcer) in the patient's medical record.

A review of the photograph of Patient 94's buttocks showed a measuring tape dated 2/27/13. Written on the tape in black marker were annotations for Patient 94's room number and medical record number. The approximate area of pink skin, according to the photographs and surveyor observations, was a wound eight cm by 10 cm in size.

In the prior CMS Complaint Validation Survey, exit date of 10/23/13, the hospital was cited for failing to reposition patients with known pressure ulcers. The plan of correction included "ongoing monitoring by nurse managers of patient repositioning to ensure effective offloading techniques are being utilized. Identified deficiencies are addressed and remediation provided."


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3. Review of the medical record for Patient 78 showed the patient was admitted on 2/21/13 with diagnoses of CVA (stroke) and dementia.

The patient's admission diet order was Glucerna 1.2 at 40 ml per hour providing 58 grams protein.

Review of the nursing admission assessment dated 2/21/13, did not show the patient was assessed with wounds on the nursing admission documentation.

Review of the nutrition assessment dated 2/22/13 at 1300 hours, showed Patient 78's assessed protein need was at 58 grams based on 1 to 1.3 grams protein per kg. The patient's weight was 116.5 pounds. The patient was assessed at moderate nutritional risk and the plan was to see the patient again in one to two weeks. There was no documentation to show the patient was assessed to require additional protein for wound healing.

Review of the weekly wound assessment for Patient 78 by the WCN dated 2/22/13 entered at 1700 hours, showed the patient had a community acquired Stage 3 pressure ulcers on the sacrum and elbow and an Unstagable pressure ulcer on the right heel at the time of admission.

During a concurrent interview RD 1 stated the nursing admission assessment did not document the presence of Patient 78's wounds. RD 1 stated she did not include nutrition therapy to address the three wounds because she did not see them in the admission assessment. RD 1 stated for Stage 3 pressure ulcers, the patient would get 1.5 to 1.8 grams of protein per kg and vitamin C and zinc supplements. RD 1 stated Patient 78 should have been assessed to require 79 to 95 grams protein.

4. Review of the medical record for Patient 61 showed the patient was admitted to the hospital on 2/11/13.

Review of the nursing admission assessment dated 2/11/13 at 1548 hours, showed a nursing admission assessment for Speech Therapy Screening to be started that day. However, there was no documentation in the medical record the speech therapy screening was conducted.

In an interview on 2/25/13 at 1430 hours, the Rehab Director stated the speech screen order had not been completed. The computer order entry system only sent an order for Speech Evaluations to the Speech Therapy Department; however, for a "speech screen" order, the therapist must go through the new admissions to double check for this order.

Based on observation, staff interview, and record review, the hospital failed to ensure the care plan was individualized and implemented for seven of 63 sampled patients (Patients 63, 75, 87, 94, 100, 108, and 109) as evidenced by:

1. Patient 87 was transferred to from ICU to the step-down unit without a care plan to manage the patient's chest tube. Failure to have a care plan could potentially lead to chest tube leak, bleeding, and infection.

2. Observations of Patients 63, 75, 94, 100, 108, and 109 showed the patients were not correctly repositioned every two hours as directed by their care plans. This failure resulted in the potential for the patients' pressure ulcers to worsen, prevent healing, and further development of additional pressure ulcers.

Findings:

1. On 2/28/13 at 1100 hours, Patient 87 was observed with a chest tube to low continuous suction. Review of the medical record showed the patient had three chest tubes while in the ICU. When the patient was transferred to 3 E Telemetry Unit, the chest tubes were reduced to one. Further review of the record showed a care plan was not developed to guide staff in the management of the chest tube.

On 2/28/13 at 1115 hours, Patient 87's care plan was reviewed with RN 1. RN 1 was unable to locate the care plan for the patient's chest tube since the patient's transfer from ICU.


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2. The EPUAP/NPUAP guidelines for the prevention of pressure ulcers showed "Reposition frequency will be determined by the individual's tissue tolerance, his/her level of activity and mobility, his/her general medical condition, the overall treatment objectives, and assessment of individual's skin condition".

Guidelines developed by the EPUAP/NPUAP for the treatment of pressure ulcers showed "The schedule for repositioning the patient should be based on the degree to which the individual is at risk for developing pressure ulcers and on the response of the tissue to pressure. Thus, the higher the risk for additional pressure ulcer and the longer the duration of reactive hyperemia, the more frequently the patient should be repositioned."

The guidelines also showed "establishing turning frequency based on the characteristic of support surface and the individual's response and written repositioning schedules should be developed even when patients are using a pressure-reducing support surface."

EPUAP/NPUAP guidelines for the prevention of pressure ulcers defined a Stage I pressure ulcer as non-blanchable erythema. The NPUAP guidelines stated "Avoid positioning the individual on bony prominence's with non-blanchable erythema."

These guidelines would direct staff to avoid positioning a patient in a supine position if the patient had a Stage I pressure ulcer to the patient's back or buttocks area.

During an interview with RN 13 and the CCO on 2/25/13 at 1440 hours, they stated a turning wheel diagram was posted over the bed of each patient in the hospital. The clock type wheel was divided into six different two hour clock periods which indicated the correct position of the patient during that time period. For example, at 0800 and 2000 hours, the patient was positioned to the left side. At 1000 and 2200 hours, the patient was turned to the right side. At 1200 and 0000 hours, the patient was positioned supine. The clock periods rotated in that order.

The CCO stated if the patients had skin breakdown the color wheel was individualized to show the patient was not to be turned on to the site of the pressure ulcer. For example, if the patient had a sacral pressure ulcer, the clock wheel showed the patient was to be turned every two hours to the left or right sides only.

The CCO stated the patients who were alert and able to turn themselves had "self-turn" written on the turning clock over the bed.

a. Patient 63 was observed on 2/25/13 at 0940 hours. The patient was positioned supine with bilateral wrist restraints tied to each side of the bed. The turning wheel posted over the patient's bed showed the patient should be positioned on his left side at this time.

Patient 63 was observed again on 2/25/13 at 1135 hours. The patient remained positioned supine with bilateral wrist restraints tied to each side of the bed. The turning wheel posted over the patient's bed showed the patient should be positioned on his right side at this time.

The medical record for Patient 63 was reviewed with RN 13 and the CCO on 2/25/13 at 1410 hours. The patient was admitted to the hospital on 2/23/13, for continued care to treat an infection and to receive wound care for an Unstageable pressure ulcer [full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed. Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined] on the left heel.

Review of the care plan for Patient 63 showed a care plan was developed for potential impaired skin integrity and for actual impaired skin changes. The care plan showed the patients heels were to be off loaded (not touching a surface); however, the care plan did not indicate the location of the pressure as the left heel. The care plan did not include interventions to turn and reposition the patient every two hours to prevent further skin breakdown.

Further review of the care plan did not show a care plan was developed to address the use of physical restraints for Patient 63 with interventions planned for the use of less restrictive measures.

Patient 63 was observed again on 2/25/13 at 1520 hours, with the CCO. The turning wheel over the bed showed the patient should be on the left side at this time. The patient's left shoulder was partially turned to the left and a pillow placed behind his back; however, the patient's sacral area remained in contact with the bed. A pillow was placed under the patient's feet; however, the pillow was flat and did not elevate the heels, which were in contact with the mattress.

b. Patient 75 was observed on 2/26/13 at 1002 hours. The patient was positioned supine. A pillow was placed under the bilateral heels; however, the pillow was flat and the heels were in contact with the bed. The turning wheel posted over the patient's bed showed the patient should be positioned on her left side until 1000 hours, and then turned to the right side at that time. The turning wheel showed the patient was not to be positioned supine.

Patient 75 was observed again on 2/26/13 at 1540 hours. The patient was positioned turned slightly to the right with a flat pillow under the left shoulder; however, the patient's sacral area remained in contact with the bed. A pillow was placed under the bilateral heels; however, the pillow was flat and the heels were in contact with the bed. The CCO confirmed the positioning of Patient 75 and requested the Nurse Manager have staff reposition the patient correctly.

The medical record for Patient 75 was reviewed beginning on 2/27/13. The patient was admitted to the hospital on 10/30/12, with diagnoses which included brain injury, dependence on mechanical ventilation, and multiple pressure ulcers.

The admission wound assessment dated 10/31/12, for Patient 75 showed the patient had a Stage 3 pressure ulcer (full thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscles are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling) on the coccyx .

Review of the care plan developed to address Patient 75's skin breakdown on admission showed the patient was to be turned every two hours; however, it was not until 11/7/12, the care plan was revised to show the patient was not to be positioned on the back.

Review of nursing documentation showed Patient 75 was not turned for six hours on the night shift of 11/2/12; for four hours on the night shift of 11/4/12; and for 10 hours on the night shift of 1/17/13.

The Wound Care assessment dated 1/13/13, showed Patient 75's Stage 3 coccyx pressure ulcer progressed to a Stage 4 (full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling). The pressure ulcer measured 12 cm by 12 cm in size.

Review of the most recent Wound Care Assessment dated 2/24/13, showed Patient 75's coccyx pressure ulcer had worsened and was assessed as Unstageable, measuring 14 cm by 13 cm in size.

c. Patient 109 was observed on 10/26/13 at 1003 hours, with the CCO. The patient was positioned supine in bed. The turning wheel over the bed showed the patient should be positioned either on the left or the right side at this time of day.

The medical record for Patient 109 was reviewed on 2/27/13. The Wound Care Assessment dated 2/24/13 showed the patient had a hospital acquired Stage 3 pressure ulcer on the mid upper back, measuring 0.3 cm by 0.3 cm in size. The WCN recommended repositioning as an intervention.

Review of the care plan developed to address the patient's skin care integrity showed to position the patient on the left or right side only as the wound was at the mid back.

d. Patient 108 was observed on 10/26/13 at 1004 hours, with the CCO. The patient was positioned supine in bed. The turning wheel over the bed showed the patient should be positioned either on the left or the right at this time of day and the patient should not have been in the supine position after 0800 hours.

The medical record for Patient 108 was reviewed on 2/27/13. The Wound Care Assessment dated 2/24/13, showed the patient had a hospital acquired Stage 2 pressure ulcer (partial thickness loss of skin presenting as a shallow open ulcer with a red pink wound bed which may also present as an intact or open/ruptured serum-filled blister) on the right posterior heel, measuring 4 cm by 6.2 cm in size.

Review of the care plan developed to address the patient's skin care integrity showed to reposition the patient every two hours.


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e. On 2/27/13 at 1115 hours, during a tour of the 2 W unit with RN 2 and RN 10, the Nurse Manager, Patient 94 was observed lying in bed on his back. Patient 94 stated, "I feel like the joint is sticking on the bone. It hurts." RN 10 stated, "He should have a wedge. This patient is self-turn. He has had hip replacements." Patient 94 stated, "Someone was in here a while ago. They put it (the wedge) in the cabinet." RN 10 assessed Patient 94's backside and stated, "Redness." RN 10 called in RN 9, who was assigned to Patient 94. RN 9 stated, "At 0830 hours, I put lotion on his buttocks and scrotum for redness. I did not notice the upper area. He has skin breakdown now. This is a brand new wound. He didn't have it before." RN 9 denied putting the wedge in the cabinet. RN 9 stated, "Physical Therapy was here earlier." RN 9 called the Nurse Manager and the WCC to perform an assessment.

On 2/27/13 at 1119 hours, in an interview, RN 10 said he was uncertain how many patients required assistance with repositioning according to their care plans. He said, "I would have to print out a roster or go in their rooms. Anyone who has the turning clock has a care plan for turning." RN 10 stated Patient 94 was "self-turn."

A review of Patient 94's care plan dated 2/15/13 at 0800 hours, showed a care plan to address, "Potential impaired skin integrity ..." The desired outcome was, patient will maintain intact skin integrity as measured by "NO SKIN BREAKDOWN." Interventions listed to reposition every two hours PRN and assess and inspect skin every shift. There was an annotation to pay careful attention to the sacral/coccyx area. The plan showed the patient was on bedrest except for bathroom privileges.

A review of Patient 94's repositioning documentation by nursing staff showed Patient 94 was repositioned appropriately, without fail, exactly on time (to the minute), from 2/27/13 at 0800 hours to 2/28/13 at 0400 hours.

On 2/27/13 at 1340 hours, in an interview, Wound Care Manager stated skin rounds for patients without documented skin breakdown are assessed every Wednesday. We are working on better individualizing the care plans.


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f. Review of the medical record for Patient 100 showed the patient was admitted to the hospital on 12/30/12. The Wound Care Admission Assessment showed the patient was admitted with an existing Stage III sacral pressure ulcer. On 1/6/13, the patient's sacral pressure ulcer progressed to Unstageable.

A care plan developed for potential impaired skin integrity related to Braden scale prevention dated 12/31/12, showed the interventions including to reposition elevated bilateral lower extremities, use skin protection, and monitor areas for redness. The care plan did not show measures to off load pressure by not placing the patient in the supine position where the sacral pressure ulcer site was located.

Review of the repositioning documentation from 12/30/12 to 1/29/13, showed documentation the patient was positioned supine on the site of the sacral pressure ulcer 26 times from 12/30/12-1/7/13. On 1/7/13, documentation showed Patient 100's sacral pressure ulcer progressed from Stage III to Unstageable.

Review of the repositioning documentation from 1/7/13 to 1/17/13, show Patient 100 was positioned supine on the site of the sacral pressure ulcer 32 times.

On 2/27/13 at 1300 hours, during an interview the Wound Care Manager she stated the Wound Care RN's assessed patients with wound care needs and initiated care plans; however, the wound care team did not have a chance to follow up the implementation of the care plan interventions.

Based on observation, interview, and record review, the hospital failed to ensure safe use of medications when the RNs administered medications via G tube (G tube inserted into a patient's stomach allowed for direct instillation of medication into the gastrointestinal system for patients who cannot ingest the drug orally) to two of the two patients observed during medication pass observations (Patients 83 and 104). For Patient 104, the RN failed to flush the G tube with water after administering a medication in accordance with the hospital's P&P and standards of practice. For Patient 83, the RN did not administer a medication via the route ordered by the physician and did not measure and track the amount of water used as flush during medication administration.

Findings:

On 2/28/13, review of the hospital's P&P, Gastrostomy Tube Drug Instillation, revised on 7/7/12, showed the G tube placement was verified by measuring the external tube length, aspirating and testing pH, or using another recommended method determined by the hospital.

To check for the patency of the G tube, release the clamp and instill at least 15 ml of water into the tube through a syringe. If the water flowed easily, the tube was patent. If it flowed slowly, raise the funnel to increase the pressure. If the water did flow properly, stop the procedure and notify the doctor.

The medications should not be mixed together, must be diluted appropriately, and must be administered separately.

The diluted solid or liquid medication should be poured into the syringe or funnel. Tilt the G tube to allow air to escape as the fluid flowed downward. Flush the tube again with at least 15 ml of water, taking into account the patient's volume status. Repeat with the next medication. Flush the tube one final time with at least 15 ml of water.

1. On 2/27/13 at 0905 hours, during a medication pass observation, RN 8 was not observed to flush a dose of lacosamide (an anticonvulsant) 150 milligrams with water after administering the medication via a G tube to Patient 104. Note: If the medication is not flushed through the tube it may not reach the stomach or the bloodstream.

On 2/27/13 at 0915 hours, in an interview, RN 8 acknowledged the purpose of the flush was to "clear out medication in there." RN 8 stated she did not realize she had diluted the medication with water rather than flushing the medication through the G tube with water as she intended.


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2. On 2/26/13 at 1000 hours, the Nurse Manager of the ICU stated instilling air via syringe while auscultating the stomach could determine the placement of the feeding tube.

On 2/26/13 at 1005 hours, RN 20, was observed to administer five medications to Patient 83 who had a G tube. Using a 50 ml syringe with a catheter tip, fluid was pulled back from the end of the G tube suggesting tube feeding residual. There was no air instilled to confirm the placement of the G-tube.

Each medication was diluted in a 30 ml medication cup of water. Each medication was pushed by the syringe during instillation instead of letting the medication flow via gravity from a funnel. Each medication was followed with 30 ml water flush pushed down by the syringe. There was no funnel used throughout the time the medication was passed.

At the end of the procedure, RN 20 was asked how much water was instilled down through the G tube. RN 20 remembered the amount of water used to dilute the pills but not the amount of water used to flush down the medications. When asked why the placement of the G tube was not confirmed prior to medication administration, RN 20 stated instilling air to confirm placement was true on NG tube but not on G tube.

On 2/26/13 at 1130 hours, reconciliation of the medication orders showed one of the medications administered to Patient 83 via G tube was ordered by the physician to be given by mouth, not by G tube.

Based on interview and record review, the hospital failed to ensure the complilation and retrieval of medical record data for quality assurance activities for the 3rd and 4th quarters of 2012.

Findings:

On 2/28/13 at 1325 hours, during an interview, the Director of Health Information Services stated the Medical Records Department had not performed quarterly quality assurance for the 3rd and 4th quarters of 2012. The Director stated she was new to the job and there was no explanation given.

Based on interview and record review, the hospital failed to maintain complete and accurate patient records when 15 of the 15 patients reviewed with pressure ulcers (Patients 61, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, and 89) had blank signatures of the physicians to signify acknowledgements of their patients current wound status. This failure could potentially lead to patient neglect and significantly affect physician's reinstatement per Medical Staff Bylaws.

Findings:

The hospital's failure to maintain complete and accurate medical records was previously cited under COPs for Medical records, Nursing Services, QAPI, and GB during the CMS Complaint Validation survey, exit date of 10/23/12. At that time multiple attestations of wound forms incompletely filled out by the WCN were faxed to doctor's offices. The forms contained wound assessments which included photographs of pressure ulcers, location, and current stage/status. The forms required the physicians' signatures to signify acknowledgments of the wound status; however, the photos were blacked out in the fax process making it impossible to determine the actual wound status. Despite the blacked out pictures, the attestation of wound forms were being faxed back to the hospital signed by physicians.

Per the hospital's submitted plan of correction with a completion date of 11/25/12, the Nurse Manager and WCN were to notify relevant physicians for any areas of the patient charts requiring completion. All wound care nurses and physicians would receive education on the importance of accurate and complete documentation. There would be daily ongoing monitoring of wound care patient charts. The Quality Department would be auditing 30 charts per month for completeness, accuracy, and thoroughness of wound documentation. The data was reported to the QA council, MEC, and GB.

On 2/25/13, a Full Medicare Validation survey was initiated. Again, per the hospital's P&P on Wound Assessment and Classification, a Wound Care Status Report form would be completed on all patients admitted with wounds, on a weekly basis, a change in wound status, new wounds, and at discharge. The Wound Care Coordinator would assess every new admission with wound(s) within 72 hours of admission. The primary care physician would acknowledge assessment and document a management plan discussion with patient/family in the progress notes.

1. The medical records of Patients 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, and 89 were reviewed on 2/28/13. All 14 medical records had incomplete attestation of wound forms filled out by the WCN and there were no physicians' signatures to prove their acknowledgements. The lack of signatures was noted to be as late as 12/12, a few weeks after the completion date of the plan of correction for the prior survey. Photographs of the wounds were attached, but the location, description, and staging of the wounds were inconsistently documented by the WCN and the forms were not signed by the physicians.


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2. The medical record for Patient 61 was reviewed on 2/25/13 at 1045 hours, with RN 4. The patient was admitted to the hospital on 2/11/13, to receive care for non-healing diabetic ulcers on the left foot.

The Physician Attestation of Wound forms dated 2/12 and 2/19/13, showed the WCN's photographs of Patient 61's two wounds taken on admission and at the first weekly assessment. The area for Physician Verification did not contain a signature by the physician to show the physician was aware of the wound's condition and healing progress.

On 2/27/13 at 1335 hours, in an interview with the Wound Care Manager, she stated she was not aware she was to notify the physician to sign the attestation of wound form. The Manager stated she was not aware who created the form, but the intention of the form was to describe the wound status to the doctor.

During the QAPI meeting conducted on 3/1/13 at 1000 hours, the QAPI Chairman/MD Director admitted the hospital had difficulty resolving the issue of incomplete attestation of wound forms. The physicians kept forgetting to sign the forms, especially when the forms were not tabbed/marked by nurses for MD signatures. Despite admission to incomplete medical records, there was no incidence a physician was suspended due to incomplete/delinquent medical records per Medical Staff Rules and Regulation. There was no evidence the physicians were notified by the Nurse Manager and WCN to complete the medical records.

Based on interview and record review, the hospital failed to ensure the medical records for three of seven patients reviewed for use of restraints (Patients 64, 100, and 107) were completed by the physicians with an assessment of the patients for the restraints and the date and time of their signatures on the form.

Findings:

1. Review of Patient 64's medical record was conducted on 2/28/13, and showed the following:

a. The patient had a condition change on 12/22/12 at 0848 hours. The Resuscitation Record showed the patient was intubated at 0830 hours. The final documentation showed the resuscitation ended at 0910 hours. However, review of the Code Blue Record dated 12/22/12, documented the Time of Arrest as 0848 hours. The Time Stopped as 0910 hours. There was no documented evidence of "Intubation."

On 2/28/13 at 1000 hours, during an interview, RN 1, the Nurse Manager of ICU reviewed the record. RN 1 confirmed the documentation did not correlate. The RN stated she was aware the Code Blue Record did not have all the information for Code Blue. The hospital was in the process of making a new form.

b. The hospital's P&P titled Use of Physical or Chemical Restraints dated 8/12, showed restraint use required an order by a physician or LIP responsible for the patient's care and authorized to order the restraint use. Documentation was required to show the results of a comprehensive assessment in the Electronic Medical Record or paper medical record.

For the medical staff and LIP, the physician must examine the patient as soon as possible when notified that restraint use is indicated, but no later than 24 hours after the initiation of non-emergent restraint use. For patients with violent of self-destructive behavior, a face-to- face examination must be made within one hour from the time the restraint was initiated. The need for restraints for the patient must be continuously reevaluated and orders to renew the use of restraints must be entered at least once each calendar day. The medical staff and LIP were to document the events leading to the use.

Review of the for 24 Hour Restraint Order and Flow Sheet showed Patient 64 had restraints applied from 11/21 to 11/25/12. Review of the 24 Hour Restraint Order and Flow Sheet showed the following:

- There was an area for physicians to document "Physician Assessment- I have completed a comprehensive face to face assessment on this patient including evaluation for elevated temperature, hypoxia, hypoglycemia, electrolyte imbalance, & adverse drug reaction. This is my conclusion the use of alternative measures poses greater risk to patient's safety than the risk of using restraints." The area was left blank on the forms dated 11/21, 11/22, 11/23, 11/24, and 11/25/12.

- The area for documentation of "Physician Order for Initial Episode/Continued Order/ New Episode/Discontinue" showed the area was left blank on 11/21 and 11/22/12.

- The area to document the type of the restraint(s) was left blank on 11/21 and 11/2212.

- The area to document the physician's signature, date, and time, showed on 11/21/12, the form was not dated and timed; on 11/24/12, the physician's name was not printed and there was no date and time of the signature; and on 11/2512, the signature was not dated and timed.

- The area for documentation of the restraint activities showed right and left mittens were used for Patient 64 from 11/21 to 11/25/12, to prevent the patient from pulling at the tubes/lines.

On 3/1/13 at 1100 hours, during an interview with RN 1, the Nursing Manager of ICU, the medical record of Patient 64 was reviewed. RN 1 stated the staff implemented other less restrictive measures before using restraints on patients. The staff would place patients in the wheelchair in front of the nurses' station for direct observation; however, the RN did not see documentation this was implemented for Patient 64. The RN 1 further stated, without a valid physician's order, the nursing staff should not utilize any restraint for the patients.

On 2/28/13 at 1335 hours, during an interview, the Director of Health Information stated the Medical Records Department was responsible to check the completion of the forms. The hospital had a policy for medical staff to finish records on time and further discipline for non-compliance of the rules. However, there was no documented evidence the Medical Record Department conducted quality assurance for incomplete records for the 3rd and 4th quarterly 2012.

On 3/1/13 at 0950 hours, during MEC interview, the Medical Director stated the hospital had sent out notices and suspension lists to notify the medical staff for non-compliance of completing patients' records. The Medical Director stated the MEC could not do anything more.

2. Review of Patient 107's medical record was conducted on 2/28/13, and showed the following:

a. The Code Status Orders showed the physician signed and dated the order; however, the documentation for "printed physician name and time" was left blank.

b. The Physician Attestation of Wound form showed the wound care team posted three photos of the patient's wound on 1/10/13. The area for physician signature showed the date and time of the signature was left blank.

3. Review of Patient 100's medical record was conducted on 2/28/13, and showed the following:

a. The 24 Hour Restraint Order and Flow Sheet dated 1/26/13, showed the physician signed, dated, and timed the form; however, the areas for the Physician Assessment was not filled out.

b. The Physician Attestation of Wound form dated 1/25/13, showed a physician's signature; however, the date and time were left blank.

Based on record review and interview, the hospital failed to ensure the discharge summary was completed according to the hospital's P&P for two of 63 sampled patients (Patients 107 and 111).

Findings:

The Medical Staff Bylaws, Article V, the Clinical and Practice Privileges showed the contents of the medical record shall be pertinent and current and include: summary of discharge note. V11, Discharge Summary showed a discharge summary shall be dictated for all patients hospitalized over 48 hours. The responsible practitioners shall authenticate all discharge summaries.

The Medical staff Rules and Regulations showed "Delinquent health information records are those that are incomplete for any reason after fourteen (14) days following discharge of the patient (v.16a)." " If the record remains incomplete at the end of the 14 days grace period, the Administrator will notify the physician in writing via letter or FAX that his/her privileges to admit patient, perform surgical procedures, provide new consultations have been temporarily suspended until the delinquent record(s) have been completed (v.16d)."

a. Patient 107's medical record reviewed on 2/28/13, showed the patient was admitted on 12/10/12, and discharged on 1/14/13. There was no documentation the physician had signed the Discharge Summary as of review date, 2/28/13, six weeks after a suspension note was sent out by the medical staff to MD 7.

b. Patient 111's medical record reviewed on 2/28/13, showed the patient expired on 1/3/13. Documentation of a Notification of Suspension form dated 1/15/13, showed MD 7 was notified of incomplete patients' medical records that included Patient 111's Discharge Summary. On 2/8/13, MD 7 dictated the "Expiration Summary;" however, MD 7 had not signed off on the document as of review date, 2/28/13, six weeks after the suspension note was sent out to MD 7 by the Medical Staff.

Based on interview and record review, the hospital failed to maintain accurate records for the disposition of all Scheduled II medications on 16 of 16 records from four of four nursing units (2 E, 2 W, ICU, and 3 W) between 2/21/13 and 2/24/13. The hospital's failure to maintain a system to ensure control of the drug supply impaired their ability to detect drug diversion and potential medication errors (e.g. wrong patient, wrong medication, and/or missed doses).

The FDA guidelines showed all CSs as Schedule II, III, IV or V, according to their relative potential for abuse. Of all drugs that are legally and commercially available for use to treat diseases, Schedule II drugs are those associated with the greatest potential for abuse. Examples of Schedule II include cocaine, morphine, and Dilaudid.

Findings:

The hospital's P&P, Medication Management (Storage) Patient Care and Safety, dated 3/12, showed "A pharmacist or pharmacy technician will retrieve the previous day's CSAR ...each morning and review for discrepancies or omissions. Any discrepancy will be brought to the attention of the pharmacist. The pharmacist will alert the nurse manager/nursing supervisor ...to reconcile. Under the quality assurance/audits section of the policy, it showed "the DOP and the CCO will verify compliance with this P&P in the pharmacy and nursing departments on a monthly basis. The policy noted "Compile the results of the controlled substance audits and present to the P&T Committee.

The hospital's P&P, Controlled Substances: Management and Administration Outside the Pharmacy (Nursing Units), revised on 6/11, showed:

"The DOP/PIC (Director of Pharmacy/Pharmacist in Charge) will report all issues pertaining to the daily audit of the controlled substance record keeping to the P&T Committee for review, recommendations, and follow-up of any identified ongoing problems or trends indicating problems or potential problems."

Under the section for Receipt of Controlled Substances on Patient Care Units, "The nurse will do the following: Record addition of the drug to stock on the CSAR with co-signature of the pharmacy personnel delivering the controlled substance.

Under the section for Record-keeping, "On nursing units without an ADM, a manual CSAR must be kept for all receipts of controlled substances into floor stock, as well as removal from stock for administration to a patient and a record of wastage." Note: the hospital does not have ADMs and uses CSARs exclusively in all nursing units.

Under the section for Narcotic Count, "Two licensed nurses (the outgoing and oncoming shift) will conduct a controlled drug inventory at each shift change ... " The two authorized nurses must visually inspect and count each scheduled drug and verify the quantity matches the record on the CSAR ..." "If using a manual CSAR form, the two authorized nurses must visually inspect the CSAR form for completion and appropriate documentation at the time of the count." Both nurses must sign, time and date the CSAR ...thereby indicating that the count was made and that the record is complete and accurate. If any discrepancy is identified, staff must remain on duty until the discrepancy is resolved ....Documentation on the CSAR ...is considered incomplete if any of the following are noted: lacks full names of patient or nurse signature, waste lacks witnesses, signature, and/or reason for wastage, errors not marked out correctly with strike through and re-entry of correct information."

Under the section for Removal From Stock and Documentation of Administration and Wastage, "removal of a controlled substance must be recorded on CSAR... at the time is removed from inventory by the nurse who will administer the medication. Record the date, time of administration, patient name, room number, dose, and nurse's signature ..."

Under the section for Documentation of Partial Doses, Wasted Doses and Wastage of Overfill, "If partial doses are given ... In this case a second nurse must co-sign the CSAR ...and witness the waste."

Under the Daily/Audit Procedures: "Nursing managers or designee will audit the CSAR for their assigned unit on a daily basis and forward the CSAR to the pharmacy. CSAR reports will be audited for the following: Presence of all required signatures ...Presence of all required dispensing information including date and time, patient name, dose/partial dose/waste and, inventory count ...Record of waste not related to partial dose and explanation ....Accuracy of records. A pharmacist or pharmacy technician will review the CSAR ...daily or on the next business day if the pharmacy has been closed. The pharmacist will alert the nurse manager/nursing supervisor of any noted discrepancies and/or omission and work with the nurse manager/supervisor to reconcile."

On 01/25/12 at 1415 hours, during an interview and concurrent record review, the DPH described the hospital's process for maintaining CSAR. Samples of CSARs, audits, and reports to P&T Committee were reviewed and included all nursing units ICU, 3 E, 2 E, and 2 W as follows:

- "A detailed record of all scheduled drugs was maintained daily on each of four the nursing units ICU, 3 E, 2 E and 2 W."
- "Whenever inventory was added to unit stock, a pharmacy technician was required to date the entry and obtain a nurse co-signature upon delivery."
- "Whenever a nurse wasted a partial medication dose he must obtain a co-signature from another nurse."
- "Whenever a dose was removed from inventory, a nurse must record the full name of the patient, the date and time dispensed/administered and his signature."
- "A shift count (physical inventory of all scheduled drugs) must be conducted every morning and night, and the count must be verified and documented by two nurses."
- "A nurse manager was required to document with his signature that the CSAR is complete and accurate."
- "CSARs were transported to the main pharmacy countertop where a technician completed an audit of each form to identify incomplete entries."
- "A pharmacist reviewed the audits daily and forwarded them to the DPH."

A review of the CSARs identified the following discrepancies:

A review of Schedule II records dated 2/24/13, showed the 2 E unit had missing dates for six of 19 opportunities. Five of these were nursing errors and one was a pharmacy error associated with an addition to inventory. One time was incomplete.

A review of Schedule II records dated 2/24/13, showed the 3 E unit had missing dates for seven of 19 opportunities. The unit name was missing. One of three scratch errors was not documented correctly (a single line through the error with the nurse's initial). A pharmacy technician omitted a delivery date for additional inventory.

A review of Schedule II records dated 2/24/13, showed the 2 W unit had missing dates for six of 20 opportunities. The patient's name was incomplete for three entries. The shift count was missing. A pharmacy technician omitted a delivery date for additional inventory.

A review of Schedule II records dated 2/24/13, showed the ICU had missing dates for six of 20 opportunities. The patient's name was incomplete for three entries. The shift count was missing. A pharmacy technician omitted delivery dates twice for additional inventory.

A review of CSARs for the 2 W, 3 E, ICU and 2 E units for the inclusive period 2/21/13 through 2/23/13, showed a pharmacist failed to document he had verified the accuracy and completeness of a single record.

On 2/28/13 at 1045 hours, in an interview, MD 6 (Physician, P&T member) acknowledged he was present at the Medication Safety Committee meetings where members discussed quality data for CSs. MD 6 acknowledged there were many redundancies in the CSAR documentation process to ensure completeness and accuracy. The DPH and MD 6 acknowledged neither the redundancies nor the audit tool sufficiently identified the irregularities. The DPH stated the audits were very time-consuming for the pharmacy staff. The DPH said it was important to "maintain controlled drug records to ensure there is a record that the drugs are getting to the patients." The DPH was unable to explain why the hospital's audit system did not detect missing information in the controlled substance records prior to the survey. The DPH stated "The CSARs are the permanent record. They have to be documented."

Based on observation and interview, the hospital failed to distribute drugs in accordance with applicable standards when 19 topical medications were stored in a haphazard manner (co-mingled) in the Main Pharmacy. The hospital's failure had the potential to cause patient harm from preventable medication errors such as retrieval of the wrong medication from co-mingled stock.

Findings:

According to the American Society of Health-System Pharmacists, a nationally recognized professional organization, in the publication Minimum Standard for Pharmacies in Hospitals, indicated "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ..." (Reference: www.ashp.org).

On 2/25/13 at 1415 hours, during a tour of the Main Pharmacy, 25 topical medications were observed stored in a crowded manner in a 14 inch by 16 and one-half inch plastic bin marked "miscellaneous topicals on the bottom shelf of stock in the Main Pharmacy."

On 2/25/13 at 1420 hours, during an interview the DPH and CP 1 both stated "This looks crowded." The DPH explained the medications were probably crowded in the bin "waiting return because they were infrequently used," but acknowledged they were not sequestered or labeled for return. The staff confirmed the medications were not stored properly as required by state and federal requirements and standards of practice.

Based on interview and record review, the hospital failed to ensure supervision of two of 14 CPs (CP 3 and CP 4) assigned IV medication compounding duties. The CPs failed to complete annual media fill tests prior to assignment to prepare CSP as required by hospital policy. A media fill test is used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile products without microbial contamination (Reference: United States Pharmacopeia (USP), General Chapter 797, Pharmaceutical Compounding , definitions section, page 29). The hospital's failure placed patients receiving intravenous medications at risk for hospital-acquired bloodborne infections as a direct result of contamination introduced by poor aseptic technique.

Findings:

On 2/25/13 at 1500 hours, in an interview, the DPH stated the hospital employed 14 CPs. The DPH stated all were required to pass a media fill competency for Compounded Sterile Products at least annually. The DPH explained the media fill competency test required a CP to prepare a sterile product using aseptic technique and a sample was sent to the laboratory to incubate for 14 days. If the result was negative and the CP passed a written test, "they were considered competent" to work in the Compounding Area.

The hospital did not provide a policy that specifically addressed compounding competencies related to media fill tests. In lieu of a policy, the DPH stated the hospital "used USP 797 standards."

A review of the competency records of the CPs indicated the DPH, CP 3, CP 4, and CP 5 had not completed a media fill test.

On 2/25/13 at 1505 hours, the DPH acknowledged CP 3 had been on staff for "three years" and CP 4 had been on staff for "two years."

Based on interview and record review, the hospital failed to ensure complete records regarding potentially tainted blood products were maintained and failed to document notification of the Laboratory Director, per hospital policy, creating the risk of patients not being informed of a risk of infectious disease from a transfusion.

Findings:

The hospital's P&P Look Back Program reviewed 8/10/12, read in part, "The transfusion service shall have a process to identify recipients of blood or components from donors who are subsequently found to have infection with HIV or HCV and to notify the recipient's physician and if appropriate, the recipient as specified in FDA regulation and recommendations." and "If the blood or blood components were transfused, the blood bank technologist will submit to the laboratory manager or designee, the identification of the patient who received the unit." and the Laboratory Manger or designee will notify the Director of Quality and Risk Management and the Laboratory's Medical Director."

During a review on 2/25/13 at 0930 hours, hospital blood bank communications of the records about possibly tainted blood were incomplete as follows:

- For the unit of blood number W125611200104, a notification was received from the contracted blood bank on 4/4/12, indicating possible hepatitis B contamination and advising confirmatory results were to follow. No confirmatory result was found.

- For the unit of blood number W125612103618, an initial notification of potentially tainted blood was received on 12/17/12, that read in part, "We will notify you regarding the subsequent test results." No confirmatory result were found.

- For unit W12561410436, a letter from the blood bank dated 1/17/13, indicated confirmatory testing for the blood showed it was negative for the potential contaminant, hepatitis C. However, the letter referred to an initial notification letter sent 1/16/13, regarding that unit of blood. A letter for that date was not found in the lab binder where the notifications were stored.

- For the unit of blood number W125612103618, the letter dated 12/17/12, read the unit, "was found to have a reactive screening test for a significant infectious disease marker". The bottom of the form contained the name of the patient who received the unit, and the date of transfusion (5/2/12), along with the handwritten note indicating it was faxed to the blood bank on 1/14/13. There was no documentation indicating the Laboratory Director had been informed.

During an interview with the Lab Supervisor on 2/25/13 at 0930 hours, he stated the lab had not received the confirmatory blood testing notifications for the letters received dated 4/4/12 and 12/17/12. The Lab Supervisor stated when he received the initial notification letters, he determined whether the blood had been transfused into a patient, then faxed the patient's name back to the blood bank. The Lab Supervisor stated the language in the initial letter from the blood bank, "Please be assured that the donated blood was tested and found non-reactive/negative for all required viral markers," assured that disease was not found. After he reviewed the hospital's P&P, the Lab Supervisor stated he also notified the Lab Director when he received a tainted blood notification. However, the Lab Supervisor was unable to provide any documentation to show the Lab Director was informed about the blood bank notifications dated 4/4/12 and 12/17/12.

Based on food storage and food production and service observations, dietary staff interview, and dietary document review, the hospital failed to ensure the Food and Dietetic Service Director developed and monitored written procedures and staff practices for safe handling of dishes and handwashing practices according to standards of practice for operational processes. Failure to develop and monitor standardized procedures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

Findings:

During review of selected departmental P&P related to identified deficient practices in dietetic services, it was noted that policies did not consistently provide sufficient procedural guidance that reflected current standards of practice or the department had not developed procedural guidance for all functions.
a) There was no documented monitoring of safe cool down of potentially hazardous foods when prepared from ambient temperature.
b) There was no policy to ensure the milkshake stored frozen was held per manufacturer's directions of 14 days thawed.
c) There was no policy to ensure the liquid pasteurized egg product was stored thawed in accordance with the manufacturer's directions.
d) The label and dating guide did not provide information on all products used including shredded cheese.
e) Ensure staff competencies for glove use, handwashing and handling clean sanitized dishes.

1. An interview with the Director of Dietary on 2/28/13 at 0900 hours, and concurrent review of performance indicators for 2012, revealed the dietary department was submitting data on multiple processes within the department.

The Director of Dietary acknowledged all of the quality indicators of the department were meeting departmental set thresholds. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of staff competencies except at the time of their annual reviews. She stated there was no performance improvement activities for the food service part of the department to establish ongoing improvement activities related to patient safety or patient satisfaction.

2. Staff files were reviewed on 2/28/13 at 0900 hours, for Food Service Workers 1 and 2 and Cook 2. All of their annual performance appraisals showed acceptable standards for all of the evaluated areas including handwashing.

The in-service document provided for Kitchen Safety and Practicing Personal Hygiene presented 9/19/12 and 6/13/12, were reviewed. These handouts did not reference the hospital policies to ensure staff was knowledgeable in the specific food service policies they were expected to follow for handwashing, glove use and department safety policies.

In an interview with the Food Service Manager on 2/25/13, starting at approximately 1030 hours, the Manager stated the staff was in-serviced on handwashing two months ago with Infection Control. The Manager stated there was a sign posted at the handwashing sinks with a detailed procedure. The Manager stated he was responsible for monitoring staff compliance to the handwashing procedures on a day to day basis.

The Food Service Manager provided a weekly "Kitchen Inspection form" on 2/28/13 at 1030 hours. In a concurrent interview, the Food Service Manager stated this was the weekly kitchen inspection he used to ensure the staff competencies. Review of this form did show any staff observations to ensure competencies in the areas of handwashing, clean dish handling, and glove use. This form was specific for equipment, storage, and production.

3. On 2/25/13 starting at 0900 hours, there were defrosted milkshake 4 ounce cartons and quart cartons of liquid pasteurized egg in the walk in refrigerator. The Food Service Manager stated they did not know how long these product could be stored refrigerated but thought there was a Julian code. The eggs had a stamp date of 11/12. Review of the Food Storage Guide did not show a storage period for the thawed liquid egg or the thawed milkshake.

On 2/28/13 at 0900 hours, the Food Service Manager showed a carton of the milkshake that stated "to be used in 14 days thawed." The Director of Dietary sated the date on the liquid egg product was for storage to 11/19/2013. There was no manufacturer's verification as to whether this date was the storage date, "frozen," or how long the product could be safely kept when in thawed state.

4. On 2/25/13 starting at 0900 hours, two bags of shredded yellow cheese were observed in the walk-in refrigerator with a pack date of 1/29/12. The Food Service Manager stated this would be in the Food Storage Guide.

The Food Storage Guide did not have "shredded" cheese. An Internet page dated 2/25/13, was provided for review showed unopened shredded cheese was good for two months.

The information for products holding time and safe storage times was not consistently available to staff to ensure products were not served to patient after their expiration dates.

Based on interview and document review, the hospital failed to ensure regular and therapeutic menus met nutritional components to meet the current nutritional standards including the RDA and DRI of the Food and Nutrition Board of the National Research Council. This had the potential for patients in the hospital not to receive adequate nutrition or meet the estimated dietary allowances for all nutrients.

Findings:

On 2/26/13 at 1500 hours, the non-select nutrient analysis was reviewed with the Director of Dietary.

Review of the Organization Plan for Delivery of Patient Care, Treatments, and Services dated 2012, stated the age of patient was from young adult to geriatric. The Director of Quality Management stated on 2/29/13 at 0800 hours, "young adult" was defined as 18 years old.

Review of the menu analysis provided for therapeutic and regular diets showed the analysis was for one age and gender of male 51 years+. There was no analysis of all ages and gender groups defined in the RDA, which included both males and females ages 19- 24, 25-50 and 51 +.

Review of the nutrient categories showed there was no analysis for Iodine, biotin, molybdenum, or fluoride components of the DRI/RDA profile of nutrients. .

It was noted for the nutrients provided, there were nutrients such as vitamin E and Vitamin D, for the male 51 + were below the current national standard. For these vitamins the menu provided 46 to 58 percent of DRI. There was no analysis for other age and gender groups to compare.

Additionally, the analysis demonstrated the fiber for the 4 week cycles, averages of the non-select regular diet contained 15 to 23 grams of fiber. The DRI for fiber range is from 25 to 48 grams per day. The hospital's menus were inadequate in fiber depending on the age and gender. Similar levels of fiber were found in the 4 gram sodium diet and limited concentrated sweets menus.

The Director of Dietary, in concurrent interview, acknowledged the menus had not been fully analyzed for all gender and age groups serviced by the hospital nor had they fully analyzed the independent nutrient deficit.

The provisions of the DRI, which include the RDA's Adequate Intake and Acceptable Macronutrient distribution range under the aegis of the Institute of Medicine, are used to evaluate nutritional adequacy of patient menus. The menus used were not evaluated to ensure they met the required nutrients, nor were deficiencies noted in the diet manual when it was not possible to meet the DRI/RDA such as in the instance of a clear liquid diet.

Based on observation, interview, and document review, the hospital failed to have a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice. Lack of current and comprehensive diet manual that reflected the hospital-developed diets may result in inaccurate guidance to dietary and hospital staff when following physician ordered diet to meet the nutritional need of the patient and further compromising medical status.

Findings:

On 2/26/13 starting at 1500 hours, the Dietary Work Sheet which represented the physician ordered diets showed diets as "Cardiac," "Diabetic," "Carbohydrate Control diet," and "Renal Diet."

Review of the patient menus generated for patient meal service identified the diets as "Low Fat/Low Cholesterol," "Limited Concentrated Sweets," 80 gram protein, 3 gram K (potassium), and 2 to 3 gram NA (sodium).

Review of the hospital diet manual showed it did not contain a diet as "80 gram protein, 3 gram K (potassium), 2 to 3 gram NA (sodium)." The Renal diet section was a conceptual guidance of principles of renal diet plans.

In an interview with the Director of Dietary on 2/26/13 starting at 1500 hours, the Director acknowledged the diet terminology did not match. The Director stated there were two computer systems, one to enter the diet and the other to print patient diets, as well as the diet manual, and the two did not contain the same diet terms. The Director stated they knew there was a problem but they only addressed future plans to address and there were no immediate plans to ensure the patient ordering systems, the diet manual and the menus all used consistent terminology and definitions.

The diet manual would ensure the diets offered met the current standards of practice and included a comprehensive description of the therapeutic diets offered, by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet, and sample menu plans and standard of practice references.

The diet manual had some elements, but not all elements were present for each routinely ordered diet which would allow the hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare the patients diets.

Based on observation, interview, and document review, the hospital failed to ensure the food supply was adequate based on the hospital's developed plan. Failure to ensure adequate food supply for patients and staff may result in further compromising nutritional status.

Findings:

On 2/25/13 starting at 1530 hours, the hospital's disaster preparedness plan for dietetic services was reviewed. The hospital had been committed to provision of safe food and water in the amounts necessary for adequate nutrition and hydration for patients, staff, volunteers, and visitors, to the extent possible ... to keep on hand ready-to-serve food, medical nutritionals, water, disposables, and cleaning chemicals to meet patient's nutritional and food service needs, as well as staff/visitors for 96 hours to a seven day period. The plan did not specify in writing the number of patients, staff/visitors to plan for. The Director of Dietary in concurrent interview stated this plan was for three days and total 300 patients, staff/visitors.

The hospitals disaster menu consisted of one Emergency Menu; Example 1 for Days 1 to 3 and Emergency Menu Example 2 for Days 1 to 4. The Emergency Menu Example 2 included canned entrees such as beef stew, fruits, and vegetables. Two meals were specified as chicken noodle casserole, but there was no canned product on hand with that title.

Review of the hospital's inventory revealed there was inadequate supply of the entree. For example, the hospital designated a 6-ounce serving of beef stew. The inventory consisted of 3 cases which would equate to approximately 288 servings. This item was designated to be served for two meals.

In a concurrent interview the Director of Dietary acknowledged the menus were a general guideline and could not state how the chicken with noodles would be prepared when the hospital was without utilities like electricity, gas and water. The Director stated they had not established a written policy which included the number of persons (patient, staff/visitor) they planned to serve. The Director acknowledged they had not developed specific emergency menus based on non-perishable food items to ensure the hospital maintained adequate supplies as specified on the plan for the 96 hours to 7 days in the policy.

Based on observation, interview, and document review, the hospital failed to ensure the emergency water supply was adequate to meet the hydration needs and patient care needs for the hospital's licensed bed counts well as staff required to care for patient needs. This failure put patient and staff at risk of dehydration in the event of a disaster that required to hospital to shelter in place with no outside resources available.
Findings:

On 2/25/13 starting at 1530 hours, the hospital's disaster preparedness plan for dietetic services was reviewed. The hospital's waster supply consisted of 250 gallons of bottled water (5 gallon containers) stored in maintenance room.

Review of the P&P, Disaster Planning, dated 6/11, stated for an emergency that interrupts the supply of safe drinking water. The P&P basically directed staff to fill containers with water and directions to use a chlorine solution to disinfect water. The plan stated water needed was based on one gallon of drinkable water per person/per day for use by Nutrition Services Department for cooking and beverages.

An additional document was provided on 2/27/12 at 0900 hours, delineating hospital water supply plan provided by the Environment of Care Director for Hospital Division. This document was not in policy or integrated into the hospital wide emergency plan.

Based on observation and interview, the hospital failed to ensure proper storage and prompt disposal of trash with the potential of transmission of communicable disease or odor.

Findings:

The FDA's Food Code 2009, showed waste should be stored, located, and disposed in a manner that will not permit the transmission of communicable disease or odor, create a nuisance or provide a breeding place for or food source for insects, rodents and vermin (Various small animals or insects, such as rats or cockroaches, that are destructive, and injurious to health). Outside receptacles must be constructed with tight fitting lids to prevent the scattering of the garbage and refuse by birds, the breeding of flies, or the entry of rodents. Thorough and proper cleaning of garbage storage areas and receptacles so that unsanitary conditions are eliminated.

The hospital's P&P, Safety and Sanitation, dated 6/11, showed the "dumpsters must be kept closed at all times when not in use."

On 2/ 25/13 starting at 0920 hours, six open trash dumpsters were observed overflowing with trash in a room at the end of the receiving dock. Lids were observed to be unusable and located between the dumpsters making it impossible to secure the closure of the bins. There was one dumpster outside the enclosure and six bins inside the room at the end of the dock. The trash room was secured by a sliding door at the end which had 2 to 3 inch opening at bottom which permitted access insects, rodents and vermin. The floor around the bins had gloves, trash, and pine needles accumulated.

The Director of Dietary stated in a concurrent interview, the trash area was the responsibility of the Engineering and Housekeeping Departments. The Director acknowledged the trash was overflowing and required more frequent pick up.

Based on observation and interview, the hospital failed to maintain equipment at an acceptable level of safety and quality. Sanitary outlets for dialysis hook-ups were found corroded and opened with the potential for poor infection control. There was no documentation of tracking of the correction action for OR rooms out of range for temperature and humidity or a follow-up evaluation.

Findings:

1. On 2/25/13, during the initial tour of the hospital accompanied by RN 1, several patients were reported receiving dialysis treatments.

On 2/28/13 at 0900 hours, the ICU and the stepdown units were inspected with the Director of Quality Management. In two ICU rooms, the dialysis inlet and outlet ports sticking out beside the sink were observed. The ports were made of rubberized tips and were well covered with rubber caps. Inspection of two additional rooms showed the inlet and outlet dialysis ports were made of corroded spouts, opened with no cap covers, making it difficult to sanitize. The Director of Quality Management acknowledged the finding.


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2. Review of Surgery Daily Temperature Humidity Record guidelines showed staff were to:
* enter time and initial in the correct box for the observed temperature and humidity daily.
* Place an initial above or below the bold box indicated the temperature or humidity was outside the special range. If the temperature or humidity was out of range:
1. Notify Engineering
2. Document the corrective action in the space provided at the bottom of the record.

On 2/25/13 at 0925 hours, the surgical services area was toured with the Manager of Surgical Services. According to the Manager, a scheduled GI procedure would be moved to one of the operating rooms if the humidity of the GI Lab was not in an accepted range. The Engineering Department was made aware of the problem at that time and corrective action was initiated.

The Surgery Daily Temperature Humidity Record for five ORs was reviewed. The documentation showed for the month of February 2013, the daily temperature and humidity was out of range in various days for five of five of the ORs. The "Problem" areas documented the problems; however, the area for "Action Taken" showed only two entries for "adjusting temperature."

On 2/28/13, the Plant Operations Director provided documented evidence for outside service orders. The Director also stated there was no documentation of tracking of the corrective action for those OR rooms out of range for temperature and humidity or follow up evaluation.

Based on observation, interview, and record review, the hospital failed to ensure the infection control designee(s) implemented P&Ps for handwashing, wearing of PPE, and TB screening of medical staff; failed to ensure manufacturer's directions were followed by the dietary, housekeeping, and engineering departments for cleaning of all ice machines in the hospital; and failed to have infection control oversight in the surgical services department.

Findings:

1. According to AORN recommendation, a sterile field established in advance of a procedure should be monitored continuously because sterility is event-related. The purpose of monitoring the sterile field is to observe for, or prevent, an event leading to contamination of the sterile field. These events may be caused by personnel, falling objects, or other means such as insects.

On 2/25/13 at 1020 hours, a GI procedure was observed in the OR room. The patients was placed in the OR room on a gurney for the procedure positioned on the lateral side. During the procedure, MD 3 used an endoscope to evaluate the patient's GI status and asked for an enteral feeding tube from the circulating RN 17. RN 17, opened the first sterile package of the feeding tube set, placed the package on a type of table used in patient rooms, and handed the enteral feeding tube to MD 3.

MD 3 tried to insert the tube into the patient but was unsuccessful. MD 3 requested a second package of an enteral feeding tube to be opened. RN 17 opened the second sterile package and placed the opened package on the end of patient's gurney next to the patient's feet.

A concurrent interview with the Manager of Surgical Services revealed the Manager was not aware a patient room table was in the OR. The Manager stated the OR should have more than enough instrument tables for staff to use during a surgical procedure. The Manager stated she was responsible for the staff's competence and had made direct observations on their performance.

On 3/1/13 at 0900 hours, during an interview, the Infection Control RN was informed of above findings. The Infection Control RN stated she did not perform infection control surveillance on the surgical services.

2. During an interview with the Infection Control RN on 2/28/2013 at 0915 hours, the RN stated infection control staff reviewed policies related to infection control. The RN did not specify how they ensured the manufacturer's directions were followed by the dietary, housekeeping, and engineering departments for cleaning of all ice machines in the hospital. Cross Reference A- 0749 #15.

Hand hygiene was not performed by one medical staff after removing gloves following a procedure. PPE was not properly used in the OR by one medical staff. Cross Reference A- 0951 #3 and #4.

3. Review of the The Infection Control PI Measures 2012, included the performance measure and number of MD's annual TB screening tests completed. The graphic data showed 289 of 508 annual TB screening tests for medical staff members were completed in 2012, or 57% of the total.

In an interview with the Infection Control RN on 2/27/13 at 1040 hours, she stated she had been trying to get the medical staff members to cooperate with TB screening as set forth in the infection control plan, but with limited success. Cross Reference A- 0749 # 13.

Based on observation, interview, and record review, the hospital failed to ensure infection control measures to prevent and control infections were in place and implemented in the hospital. This resulted in the potential for the spread of infection throughout the hospital.

Findings:

1. The hospital's P&P, Terminal Cleaning of Patient Rooms, effective date of 6/11, showed terminal cleaning is completed before another patient is admitted or transferred to that room. The steps taken in the cleaning procedure and the products used are selected and implemented in a manner to reduce risks of disease transmission among patients.

On 2/28/13 at 1400 hours, during an interview, the Plant Operations Director stated he provided oversight for the hospital's EVS as a contractor. The Director stated informal processes were in place to inspect of the cleaning of patient rooms. The evaluation process looked at the cleanliness of the rooms as well as the disinfection process. The Director stated the hospital's Infection Control Practitioners were responsible for the disinfection process.

On 2/28/13 at 1500 hours, during an interview the Infection Control RN, she stated surveillance of the EVS services was not conducted on the night shift.

2. On 2/25/13 at 1137 hours, the sterile processing area was toured with the ORT and Director of Surgical Services. Documentation on the LMA Record Card showing the dates of use were reviewed. The Laryngeal Mask manufacturer recommended LMA airways be used a maximum of 40 times. The manufacturer's warranty indicated the LMA airway is reusable and warranted for forty uses or a period of one year from the date of purchase (whichever is the earlier). Documentation on the seven LMA Record Cards showed the purchase dates ranged from 2004 to 2006. During interview, the ORT and the Director of Surgical Services were not aware of the manufacturer's recommendations.

3. According to AORN, edition 2010, the Recommended Practices for Sterilization in the Perioperative Practice Setting:
- Recommendation IV showed PCDs should be used with routine process monitoring devices (i.e., chemical indicators, biological indicators, physical monitoring devices). Process challenge and process monitoring devices provide information to demonstrate that conditions for sterilization have been met.
- Recommended Practices for sterilization in the Perioperative Practice Setting, Recommendation XIV showed accurate and complete records are required for process verification and are used in sterilizer malfunction analysis. Documentation established accountability. Documentation should include the assigned lot number; contents of each load, and result of physical, chemical and biological monitors.

On 2/25/13 at 1100 hours, the ORT was interviewed regarding sterile processing for surgical instruments. The ORT stated biological indicators were run every week and for every load of sterile processing. The ORT stated, after the processing was completed the ORT put the processed biological indicator and the control in an incubator overnight. The ORT read the final result the next morning and documented the result on the record.

Reviews of the Sterilizer Record for the month of February, 2013, showed biological indicators were utilized in the sterile processes seven times. The results were documented on the Sterilizer Record.

Review of the manufacturer's recommendation for the use of the biological indicators showed the indicator should be incubated for 48 hours for visual change readout. A color change to yellow indicated surviving spores and a positive result.

4. The CDC guidelines for Hand Hygiene in Health-Care Settings dated 11/25/02, showed to decontaminate hands after removing gloves.

On 2/25/13 at 1135 hours, MD 3 was observed at the end of a procedure. MD 3 removed a pair of gloves used during the procedure. MD 3 picked up the patient's medical record, walked out of the OR room, then came back to the OR room to pick up his personal cellular phone, and proceeded to the dictation room. MD did not wash his hands.

5. On 2/25/13 at 1020 hours, a GI procedure to insert a GT was observed in the OR. MD 3 walked in the room wearing a surgical mask. MD 3's facial hair was not fully covered. During the procedure, while managing the endoscopic equipment, the endoscope almost came in contact with the MD's uncovered facial hair.

MD 3 wore a zip-up one piece whole body coverall with a front zipper to the neck over his street clothes (bunny suit) while performing the procedure. Prior to the procedure MD 3 unzipped the bunny suit, took his cellular phone from the pocket of his clothes, and pulled the zipper approximately three inches below the collar of his shirt. The collar of his shirt was outside of the bunny suit. MD 3 maneuvered the endoscope in and out, and back and forth to view the patient's GI system during the procedure. The endoscope almost touched the collar of MD 3's shirt during a couple of the maneuvers.

6. The CDC guidelines, May, 2011, Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care, showed patient care facilities should establish P&P for routine cleaning and disinfection of environmental surfaces as part of their infection prevention plan.

The CDC recommended the responsibility for routine cleaning and disinfection of environmental surfaces should be assigned to appropriately trained HCP. Cleaning procedures should be periodically monitored or assessed to ensure they are consistently and correctly performed. EPA-registered disinfectants or detergents/disinfectants with label claims for use in healthcare should be selected for disinfection. Disinfectant products should not be used as cleaners unless the label indicates the product is suitable for such use. Healthcare professionals should follow manufacturer's recommendations for use of products selected for cleaning and disinfection (e.g., amount, dilution, contact time, safe use, and disposal)

a. On 2/25/13 at 1137 hours, the ORT was observed for decontamination of a used endoscope. The ORT mixed the enzymatic agent with two gallons of water to clean the scope. The ORT stated the dirty scope was not fully immersed in the solution and added more water to the mixed solution. The ORT was not able to state how much water she added. Review of the manufacturer's recommendation showed one ounce of the enzymatic agent was to be mixed with one gallon of water.

b. On 2/25/13 at 1145 hours, the Materials Management Clinical Clerk was interviewed regarding disinfection for used patient care equipment which included IV pumps, enteral feeding pumps, compression sequential stocking pumps, and suction pumps. The Clerk stated he mixed one pump of the disinfectant (one ounce) in a brown colored plastic bin filled halfway with water. The Clerk stated he believed the mixture in the bin was one gallon. The Clerk was asked to measure the water using a measuring device. The mixture measured five gallons.

The manufacturer's instruction for the disinfectant showed to add a half gallon of the disinfectant to one gallon water. When asked, the Clerk stated his infection control training was two years ago. He was unable to recall if he was provided an in-service training for the proper mixture of disinfectant.

7. On 2/25/13 at 1020 hours, the GI instrument processing room was toured with the Manager. The ceiling vent had heavy dust. The Manager stated the EVS department was responsible for the cleaning.

8. On 2/23/13 at 1050 hours, an anesthesia cart was observed in the surgical services area. The drawers of the cart were dusty where the patient care equipment and medications were stored. According to the Manager of Surgical Service the RNs were responsible for the cleaning of the cart.

9. On 2/23/13 at 1145 hours, the Central Supply Department was toured with the Materials Management Manager. The following was observed:

- In the area used for disinfection of dirty patient care equipment, the ceiling vent was dusty and there were black stains on the ceiling board.

- The countertop where disinfectants and cleaning supplies were stored was discolored and the floor was sticky and did not appear clean.

- In the clean equipment storage room, the floor was sticky and the area used to store pumps ready for patient use was dusty. Two pieces of equipment did not have tags to show the equipment was cleaned/disinfected. The Materials Management Manager stated the equipment belonged to the Respiratory Department. The Manager was not aware the equipment was stored in the room.

- A wound care supply cart was parked in the clean equipment room. The drawers with tape, safety pins, and wound care ointment were dirty and sticky. The Manager stated the Wound Care Team was responsible for their own cart. The Manager stated this cart was the most often used cart by the Wound Care Team on the patient units.

10. On 2/28/13 at 1000 hours, the 2 E unit was toured. MD 4 put on a mask and entered a patient's room. MD 4 noted the patient was not in the room and quickly exited the room. A sign indicating the patient was on contact isolation was posted outside the door. The sign indicated staff and visitors entering the room should don a gown and gloves. When interviewed on 2/28/13, MD 4 stated he was not familiar with the hospital's isolation precaution practices. MD 4 stated the hospital had sent out flyers for meeting, but the meeting was not mandatory.

11. According to an APIC position paper titled Safe Injection, Infusion, and Medication Vial Practices in Health Care, published in the American Journal of Infection Control in April, 2010, single-use or single-dose vials should be used whenever possible. The article also showed a recommendation to discard all open vials, IV solutions, and prepared or opened syringes. The article adds, the use of safe injection practices is critical to prevent microbial contamination of products administered to patients.

A GI procedure was observed in the OR on 2/25/13 at 1020 hours. RN 16 provided conscious sedation for the patient. RN 16 labeled one syringe "versed." The RN withdrew the medication versed twice from different vials while using the same syringe and administered the medication into the patient's IV at a different time. In addition, RN 16 labeled another syringe for "fentanyl." RN 16 used the syringe to withdraw the medication twice and administered the medication into the patient by IV push. RN 16 used a 10 ml pre-filled normal saline syringe to flush the patient's IV access port after the versed and fentanyl were administered; however the RN used the same syringe of normal saline to enter the patient's IV access port four different times.

12. According to AORN recommendation, a sterile field established in advance of a procedure should be monitored continuously because sterility is event-related. The purpose of monitoring the sterile field is to observe for, or prevent, an event leading to contamination of the sterile field. These events may be caused by personnel, falling objects, or other means such as insects.

On 2/25/13 at 1020 hours, a GI procedure was observed in the OR room. The patients was placed in the OR room on a gurney positioned on the lateral side. During the procedure, MD 3 used an endoscope to evaluate the patient's GI status and asked for an enteral feeding tube from the circulating RN 17. RN 17, the circulator, opened the first sterile package of the feeding tube set, and placed the package on a type of table used in patient rooms, and handed the enteral feeding tube to MD 3. MD 3 tried to insert the tube into the patient but was unsuccessful. MD 3 requested a second package of an enteral feeding tube to be opened. RN 17 opened the second sterile package and placed the opened package on the end of patient's gurney next to the patient's feet.

A concurrent interview with the Manager of Surgical Services revealed the Manager was not aware a patient room table was in the OR. The Manager stated the OR should have more than enough instrument tables for staff to use during a surgical procedure. The Manager stated she was responsible for the staff's competence and had made direct observations on their performance.

On 3/1/13 at 0900 hours, during an interview, the Infection Control RN was informed of above findings. The Infection Control RN stated she did not perform Infection Control surveillance on the surgical services.


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13. The hospital's Infection Control Plan 2012 Evaluation and 2013 Goals read in part, "The Infection Control Department collaborates with all services across the continuum of care to design and implement the Annual Plan. The Plan and its supporting mechanisms are based on evidence-based practice, sound epidemiological principles, current scientific knowledge, HAI research and accepted guidelines from resources such as: 1. CDC."

According to the Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Settings, 2005. The CDC guidelines recommended health care settings conduct initial and ongoing (preferably annual) evaluations of the risk for transmission of TB.

The hospital's 2010 Medical Rules, page 8, read in part, "TB Screening will be performed for all physicians/AHP's per CDC guidelines. Two-Step Screening Process for all initial appointments to the Medical Staff. Annual TB Screening Questionnaire for all Medical Staff ..." and "Physician will be automatically suspended if TST Report is not received upon expiration date. Physicians may not admit, schedule surgeries, or consult any new patients."

During a review of seven medical staff members (MDs 1, 4, 5, 6, 7, 8, and PA 1), the health data and screening for TB within the past year were not found for MD 1, MD 6, and PA 1.

Review of the The Infection Control PI Measures 2012, included the performance measure, number of MD annual TB screens completed. The graphic data showed 289 of 508 annual TB screens for medical staff members was completed in 2012, or 57% of the total.

In an interview with the Infection Control RN on 2/27/13 at 1040 hours, she stated she had tried to get the medical staff members to cooperate with tuberculosis screening as set forth in the infection control plan, but with limited success.



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14. Review of the hospital's P&P, Infection Prevention and Control Practices, dated 11/20/12, showed "To detect and identify Clostridium difficile and take appropriate contact precautions. To prevent the risk of transmission of Clostridium difficile by direct or indirect contact."

On 2/25/12 starting at 1420 hours, the medical record for Patient 61 was reviewed. Patient 61 was admitted on 2/11/13, with diagnosis of MRSA (methicillin-resistant-Staphylococcus Aureus, a type of staph bacteria resistant to certain antibiotics) infection in the foot. Documentation showed Patient 61 was ambulatory in room and in the hall.

On 2/25/13, Patient 61 was moved to another room. Patient 61 was placed in a room with Patient 90 from 2/23/12 to 2/25/13.

Review of the medical record for Patient 90 showed the patient was admitted on 2/11/13, with loose stools. The patient tested positive for C diff (Clostridium difficile, a species toxin causes pseudomembranous enterocolitis) on 2/19/13. The patient was on isolation with enhanced contact precautions. Lab results confirmed the patient was positive for C diff on 2/19/13 at 1318 hours.

On 2/25/12, Patient 90 remained in Patient 61's room, Patient 90 remained positive for the C diff infection.

In a concurrent interview with RN 4 and the Infection Control RN, the staff stated there had been an emergency and Patient 90 (positive for C diff) was moved into the room with Patient 61 (no C diff); however the Infection Control RN stated that it was not appropriate to cohort a patient positive with a C diff infection with a patient who did not have the infection.

On 2/26/13 at approximately 1500 hours, the Infection Control RN stated she talked to the House Supervisor responsible for the room change on 2/25/13. The Supervisor stated she was told both Patients 61 and 90 had MRSA, which was the reason they were place in the same room. The Infection Control RN acknowledged it was a mistake to place a highly contagious patient with the C diff organism in the same room with a patient who was not infected with C diff. Patient 61 would be at risk of contacting the C diff infection.

15.a. On 2/25/13 starting at 0900 hours, the bin ice machine in the kitchen had a black substance on the bottom of the door when wiped with a white paper towel. There was an accumulation of white scaly substance on the left exterior edge of the ice machine bin. The Food Service Manager stated once the bin was empty it was cleaned once a month with soap and water. The Manager stated the last date cleaned was 2/13/13. The Manager was not able to explain the black substance in the interior of the ice machine or the white substance on the exterior side. There was a sticker on the ice machine to instruct the bin be cleaned with soap and water, but there was no indication this was from the manufacturer.

Review of the manufacturer's direction for the bin ice machine on 2/27/13 at 1050 hours, showed it included directions to sanitize the storage bin with a solution of water and sanitizer (1 ounce liquid household bleach and 2 gallons of warm potable water).

The clear plastic scoop holder for the ice machine had white scale substance on the interior. The Food Service Manager could not state when or how frequently the scoop holder was cleaned and sanitized. There was no policy provided to direct the cleaning and sanitizing of the scoop holder.

b. Review of the preventative maintenance forms for the four chute ice machines located on patient floors showed an ice machine procedure to clean the water system with an ice machine cleaner (formula to remove scale deposits).

In an interview the Director of Plant Operations on 2/27/13 at 1050 hours, the Director stated the ice machines were both cleaned to remove scale and then sanitized; however, he did not provide evidence the sanitizing step was meeting the manufacturer's directions. The Director stated the ice machine procedures needed to be complete with all directions for cleaning and sanitizing per the manufacturer's directions.

Review of the manufacturer's direction for patient area ice machines included using an ice machine cleaner chemical to clean the scale and a sanitizing solution such as one ounce of household bleach mixed with 2 gallons of water.

c. On 2/26/13 starting at 1200 hours, the chute ice machine on the 2 E unit had white substance on the plastic ice delivery chute. In a concurrent interview with the Director of Dietary, she stated the housekeeping department was responsible for the exterior cleaning of the ice machines.

During an interview with the Director of Plant Operations on 2/27/13 at 1050 hours, the Housekeeping monthly cleaning schedule for the ice machines exterior cleaning was provided. The document was titled Scheduled Cleaning Ice Machine/Refrigerator. There was one sign-off for each week. No procedures were included on the sign off form.

Review of the hospital's P&P, Utilities Management (no date of review), showed "It is the policy of the hospital to maintain and operate all equipment in accordance with the manufacturer's recommendations...Accordingly, there is a scheduled maintenance system which is used to schedule, monitor, and document the testing and maintenance of Ice Machines at periodic intervals.

There was no policy provided to specify how the exterior of the ice machine was to be cleaned.

Review of the manufacturer's directions for one of the manufacturer's brands specified weekly cleaning of the dispenser grille and drain pan: to remove the grill and wash with solution A (200 ppm chlorine content concentration) and pour 1 cup household bleach in the drain pan, followed by one gallon of hot water to flush the drains. The dispenser was to be cleaned with a nonabrasive cleaner. The second brand specified the ice chute would be removed, washed, and sanitized. The sink was to be flushed with hot water and wiped with a sanitizer. The splash panel was to be wiped with a sanitizer.

There was no documentation the manufacturer's directions followed to ensure the ice machines were maintained sanitary.

During an interview with the Infection Control RN on 2/28/2013 at 0915 hours, the RN stated infection control staff reviewed policies related to infection control. The RN did not specify how they ensured the manufacturer's directions were followed by the dietary department, housekeeping and engineering parts of the ice machines.

16. During an observation in the kitchen on 2/25/13 starting at 1020 hours, the following was observed:

a. Food Service Worker 1 and Food Service Worker 2 were observed scrapping the patient trays returned to the kitchen for washing.

Food Service Worker 1, wearing the same disposable gloves used to scrap the dirty dishware, hosed down the tray transportation cart with water. Then, with same gloved hands wiped away the excess water and placed the cart in the kitchen for reloading with patient lunch trays.

Food Service Worker 2 changed gloves, but without washing hands proceeded to handle the clean sanitized dishes to be put away. Food Service Worker 2 left the clean side to throw an item into the trash. With gloved hands she touched the trash and directly returned to the clean dishes, handling the sanitized bowls for patient use.

b. Cook 1 and Food Service Worker 1 were observed hand washing with only a soap application and immediate rinse of the soap.

c. Dishwashing staff did not put on clean aprons when leaving the dirty dish area and handling clean sanitized dishes.

During an interview on 2/25/13 starting at approximately 1030 hours, with the Area Director of Infection Control the kitchen observations were reviewed. The Area Director stated all staff should wash their hands between changing gloves. The Area Director stated the Food Service Staff should wash hands and put on clean gloves before touching the clean and sanitized dishes. The Area Director confirmed the brief hand washing observed did not following the hospital's P&P which should include a 20 second wash before the soap was rinsed off.

During a interview with the Food Service Manager on 2/25/13 starting at approximately 1030 hours, he stated staff was in-serviced on hand washing two months ago with Infection Control. There was a sign posted at the hand washing sinks with a detailed procedure. He stated he was responsible for monitoring staff compliance to the hand washing procedures on a day to day basis.

Review of the participant in-service handout dated 9/19/12, showed the CDC "reports there are 5000 cases and 76 million cases of food borne illness annually. Proper personal hygiene is critical to ensure safety of food we prepare daily. Proper hand washing is the MOST IMPORTANT thing you can do." "Proper hand washing includes washing hands, wrist and lower arms for 20 seconds with hot water and soap, rub vigorously and clean between fingers and under nails. Rinse thoroughly and use paper towel to turn off spigot."

The in-service was attended by Food Service Worker 1 and Cook 2.

The policy, Safety and Sanitation, dated 6/2011, showed "the person who is working in the dirty dish area cannot handle any of the clean dishes unless he washes and sanitizes his hands thoroughly before handling. Contamination of clean dishes results from working from dirty to clean without proper hand washing. The person putting away clean dishes must have clean hands and clean apron." The policy also showed "Food transport carts must be washed and sanitized before clean dishes are stored. Spray bottles with proper dilution should be specified on the cleaning procedure."


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17. On 2/25/13 at 0930 hours, during the initial tour of the ICU accompanied by RN 1, the ICU Nurse Manager, eight of 16 ICU patients observed were in contact isolation. During observation of a patient room, the housekeeper and the RT donned isolation gowns and gloves when they entered the room. However, when the primary nurse for the patient was asked why the patient was on contact isolation precautions, the primary nurse was unable to provide the reason for the isolation. Unable to name the infectious microorganism when reviewing the patient's record, the primary nurse stood up and reversed the sign by the patient's door claiming it was a mistake.

18. During the initial tour of the 3 E Telemetry unit on 2/25/13 at 1030 hours, the following was observed:

a. Two patient basins were observed stacked on top of each other in the shared bathroom of room of two patients. Only one of the basins was labeled. An irrigation syringe and bottle on the common bedside table was also not labeled.

b. Three patient basins were found stacked on top of each other in a shared two patient room. Two basins were labeled for one of the patient's but none for the other patient.

c. During inspection of Patient 77's bedside area, the main IV tubing was not labeled containing the date, time, and initial of the RN who changed the tubing. The finding was acknowledged by the assigned RN 2 and RN 1.

d. In a patient room with a posted sign for contact isolation precautions, two flowering cymbidium plants were observed on the bedside table. A Christmas tree remained standing beside the television. Per CNA 21, the plants were brought in by patient's family members on Chinese New Year and were with the patient during the transfer from one room to another.

On 2/27/13 at 1100 hours, during an interview, the Infection Control RN was asked the hospital's P&P on flowers and personal objects in isolation rooms that were unable to be disinfected. The RN stated the hospital did not have a P&P to address possible contaminated objects in a patient's environment unable to be disinfected which served as indirect hosts for contamination.

19. On 2/27/13 at 1000 hours, the following was observed:

a. Patient 81's pressure ulcer on the bilateral heels was observed with RN 21. The patient was on contact isolation precautions. RN 21 stated the black heel protectors used by the patient were taken home by the patient's family member when they needed to be washed. The nurses did not inform the family member she might be spreading the infection to her home.

b. In the room of a patient on contact isolation precaution, ambulance staff exited the room. The staff took off their isolation gowns but kept the gloves on and did not wash their hands. The staff pushed the patient's gurney towards the elevator, past the nurses' station without any nursing staff monitoring the break in the infection control process.

c. In the patient room where a contact isolation sign was posted, a visitor was noted wearing an isolation gown but with no gloves. RN 1 had to remind the visitor to wear gloves.

20. During observation of a G tube insertion procedure on 2/26/13 at 1530 hours, in an ICU room, the room was prepared and cleaned by six staff all wearing scrub attire. The surgeon washed his hands, documented in the patient's chart, and then donned a sterile gown and sterile gloves without hand washing. The sterile drape was already spread out before the surveyor was able to inform the surgical technician the surgeon was wearing a golf hat without a surgical cover cap.

The golf hat was taken off by the circulating RN and replaced by a surgical cap.

21. On 2/26/13 at 1100 hours, while standing at the nurses' station on the 3 E Telemetry unit, a visitor was observed exiting an patient's isolation room wearing a yellow isolation gown. The visitor walked towards the elevator and passed the nurse station. None of the nursing staff noticed the visitor until the Nurse Manager, RN 2, observed the visitor in the waiting room.

22. At 1130 hours, an RN was observed with a cart containing a glucometer and supplies and moved it from one isolation room to another, parking the cart outside the door. The RN did not disinfect the glucometer after leaving the isolation rooms prior to entering the next. RN 1 acknowledged the break in infection control process.

23. On 2/28/13 at 1630 hours, while the surveyors were walking towards the parking lot, a person in street clothes came out of the lobby wearing a yellow isolation gown to smoke out in the front garden. None of the passing hospital staff who saw the person made any comments.

On 3/1/13 at 1000 hours, when discussed during QAPI meeting, the Infection Control RN 2 stated the hospital's P&P allowed patients and visitors to smoke outside with yellow isolation gowns.


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24. The 2 E unit was toured on 2/25/13 beginning at 0900 hours, with the Nurse Manager, RN 4.

a. A visitor was observed inside Patient 90's room wearing a mask and gown, but no gloves. The visitor was walking around in the room, touching the patient's bed and bed linens. A hospital staff was in the room caring for the patient's roommate. The sign outside the door of the room indicated the patients were on contact isolations precautions requiring staff and visitors to wear a gown and gloves when entering the room.

When interviewed, Patient 90's visitor stated he was not aware he needed to wear gloves. When asked, the visitor stated hospital staff had not instructed him on wearing PPE and the importance of hand washing after their removal and before leaving the room.

When interviewed, RN 4 stated Patient 90 was on contact isolation precautions due to a foot infection from a multi-drug resistant organism.

b. In a patient room, equipment boxes for the bed air mattress and the anti-embolic stockings were on the floor at the foot of the patient's bed. When asked, RN 4 stated the equipment should be hooked on the end of the bed, not sitting on the floor.

25. The 2 E unit was toured on 2/26/13 at 1000 hours, with the CCO. In a patient room, the equipment box for the bed air mattress was on the floor at the foot of the patient's bed. The CCO stated patient care equipment should not be placed on the floor and requested staff hook the box on the end of the bed.

Based on observation, interview, and record review, the hospital failed to ensure surgical services were provided for the patient as evidenced by:

1. LMAs were available for patient use six to eight years past the manufacturer's warranty for safety.

2. Staff failed to ensure the result reading of sterile processing biological indicators was followed per the manufacturer's guidelines.

3. Hand hygiene was not performed by one medical staff after removing gloves following a procedure.

4. PPE was not properly used in the OR by one medical staff (MD 3).

5. The manufacturer's recommendation for mixing of a disinfectant solution was not followed by staff cleaning a endoscope.

6. The GI instrument processing room was dusty and dirty.

7. The drawers of an anesthesia cart in the surgical services area were dusty where the patient care equipment and medications were stored.

8. The standard of practice for the use of syringes was not followed by staff during a GI procedure.

9. Sterile items for use during a procedure in the OR were placed on the gurney at the foot of the patient and on a type of table used in patient rooms.

Findings:

1. On 2/25/13 at 1137 hours, the sterile processing area was toured with the ORT and Director of Surgical Services. Documentation on the LMA Record Card showing the dates of use were reviewed. The Laryngeal Mask manufacturer recommended LMA airways be used a maximum of 40 times. The manufacturer's warranty indicated the LMA airway is reusable and warranted for forty uses or a period of one year from the date of purchase (whichever is the earlier). Documentation on the seven LMA Record Cards showed the purchase dates ranged from 2004 to 2006. During interview, the ORT and the Director of Surgical Services were not aware of the manufacturer's recommendations.

2. On 2/25/13 at 1100 hours, the ORT was interviewed regarding sterile processing for surgical instruments. The ORT stated biological indicators were run every week and for every load of sterile processing. The ORT stated, after the processing was completed the ORT put the processed biological indicator and the control in an incubator overnight. The ORT read the final result the next morning and documented the result on the record.

Reviews of the Sterilizer Record for the month of February, 2013, showed biological indicators were utilized in the sterile processes seven times. The results were documented on the Sterilizer Record.

Review of the manufacturer's recommendation for the use of the biological indicators showed the indicator should be incubated for 48 hours for visual change readout. A color change to yellow indicated surviving spores and a positive result.

3. According to the CDC guidelines for Hand Hygiene in Health-Care Settings dated 11/25/02, showed to decontaminate hands after removing gloves.

On 2/25/13 at 1135 hours, MD 3 was observed at the end of a procedure. MD 3 removed a pair of gloves used during the procedure. MD 3 picked up the patient's medical record, walked out of the OR room, then came back to the OR room to pick up his personal cellular phone, and proceeded to the dictation room. MD did not wash his hands.

4. On 2/25/13 at 1020 hours, a GI procedure to insert a GT was observed in the OR. MD 3 walked in the room wearing a surgical mask. MD 3's facial hair was not fully covered. During the procedure, while managing the endoscopic equipment, the endoscope almost came in contact with the MD's uncovered facial hair.

MD 3 wore a zip-up one piece whole body coverall with a front zipper to the neck over his street clothes (bunny suit) while performing the procedure. Prior to the procedure MD 3 unzipped the bunny suit, took his cellular phone from the pocket of his clothes, and pulled the zipper approximately three inches below the collar of his shirt. The collar of his shirt was outside of the bunny suit. MD 3 maneuvered the endoscope in and out and back and forth to view the patient's GI system. The endoscope almost touched the collar of MD 3's shirt during a couple of the maneuvers.

5. On 2/25/13 at 1137 hours, the ORT was observed for decontamination of a used endoscope. The ORT mixed the enzymatic agent with two gallons of water to clean the scope. The ORT stated the dirty scope was not fully immersed in the solution and added more water to the mixed solution. The ORT was not able to state how much water she added. Review of the manufacturer's recommendation showed one ounce of the enzymatic agent was to be mixed with one gallon of water.

6. On 2/25/13 at 1020 hours, the GI instrument processing room was toured with the Manager. The ceiling vent had heavy dust. The Manager stated the EVS department was responsible for the cleaning.

7. On 2/23/13 at 1050 hours, an anesthesia cart was observed in the surgical services area. The drawers of the cart were dusty where the patient care equipment and medications were stored. According to the Manager of Surgical Service, the RNs were responsible for the cleaning of the cart.

8. According to an APIC position paper titled Safe Injection, Infusion, and Medication Vial Practices in Health Care, published in the American Journal of Infection Control in April, 2010, single-use or single-dose vials should be used whenever possible. The article also showed a recommendation to discard all open vials, IV solutions, and prepared or opened syringes. The article added the use of safe injection practices is critical to prevent microbial contamination of products administered to patients.

A GI procedure was observed in the OR on 2/25/13 at 1020 hours. RN 16 provided conscious sedation for the patient. RN 16 labeled one syringe "versed." The RN withdrew the medication versed twice from different vials while using the same syringe and administered the medication into the patient's IV at a different time. In addition, RN 16 labeled another syringe for "fentanyl." RN 16 used the syringe to withdraw the medication twice and administered the medication into the patient by IV push. RN 16 used a 10 ml pre-filled normal saline syringe to flush the patient's IV access port after the versed and fentanyl were administered; however, the RN used the same syringe of normal saline to enter the patient's IV access port four different times.

9. According to AORN recommendation, a sterile field established in advance of a procedure should be monitored continuously because sterility is event-related. The purpose of monitoring the sterile field is to observe for, or prevent, an event leading to contamination of the sterile field. These events may be caused by personnel, falling objects, or other means such as insects. Taping the door shut is not acceptable because it does not prevent all events from occurring or provide a means to observe the occurrence.

On 2/25/13 at 1020 hours, a GI procedure was observed in the OR room. The patients was placed in the OR room on a gurney for the procedure positioned on the lateral side. During the procedure, MD 3 used an endoscope to evaluate the patient's GI status and asked for an enteral feeding tube from the circulating RN 17. RN 17, the circulator, opened the first sterile package of the feeding tube set, placed the package on a type of table used in patient rooms, and handed the enteral feeding tube to MD 3. MD 3 tried to insert the tube into the patient but was unsuccessful. MD 3 requested a second package of an enteral feeding tube to be opened. RN 17 opened the second sterile package and placed the opened package on the end of patient's gurney next to the patient's feet.

A concurrent interview with the Manager of Surgical Services revealed the Manager was not aware a patient room table was in the OR. The Manager stated the OR should have more than enough instrument tables for staff to use during a surgical procedure. The Manager stated she was responsible for the staff's competence and had made direct observations on their performance.

On 3/1/13 at 0900 hours, during an interview, the Infection Control RN was informed of above findings. The Infection Control RN stated she did not perform infection control surveillance on the surgical services.

Based on observation, interview, and record review, the hospital failed to ensure respiratory care services were provided per physician's order for one of 63 sampled patients (Patient 105).

Findings:

On 2/25/13 at 0820 hours, a GI procedure was observed in the OR. RT 1 was in the room providing respiratory services for Patient 105. The patient was administered oxygen via nasal cannula by RT 1. Observation showed seven liters per minute was administered. RT 1 monitored the patient during the procedure.

During an interview at the close of the procedure, RT 1 stated the physician verbally ordered six liters of oxygen per minute to be administered via nasal cannula to Patient 105.

Review of Patient 105's Invasive Procedures with Moderate Sedation form showed the RT documented the patient received six liters of oxygen per minute via nasal cannula.