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Based on interview, review of infection control documents, review of medical staff and quality assurance committee minutes. review of medical staff by laws, and review of 15 of 15 physician credential files the governing board was ineffective in assuming responsibility for the conduct of the hospital by failing to enforce medical staff by laws and failing to ensure an effective quality assurance/performance program was in place to monitor pharmacy, the infection control program and the performance of the medical staff.
Findings:

1. CROSS REFER to : A-0263, 482.21 QAPI

2. CROSS REFER to: A-0338, 482.22 MEDICAL STAFF

3. CROSS REFER to A-0747 482,42 INFECTION CONTROL

Based on interview, review of quality assurance, medical staff and governing board meeting minutes, review of infection control documents and review of 15 of 15 physician credential files, the Hospital failed to ensure an effective, hospital wide, data driven quality assessment performance improvement program. The hospital held one Quality Assessment meeting in 2009 on November 30th,2009. The meeting did not include data from the Infection Control Program, Pharmacy, Environment of Care, Medical Staff, or contract Dialysis services.
Findings:

1. Review of quality assurance, medical staff and governing body meeting minutes for time period 3/16/09 to date had no reference of quality monitoring for the medical staff.
On 2/24/2010 at 9;20am personnel #16 stated there has been no quality monitoring of the medical staff.. Comittee meeting minutes had no reference to infection control activities or pharmacy.


Surveyor: 12000
2. The Administrator (ID# 50) stated 2/22/10 at 3:30 p.m. that the Hospital sustained damage / flooding due to a Hurricane in September 2008. The Hospital was closed for six months for repairs (9/12/08 to 3/16/09).

3. Record review of a Quality Improvement Meeting dated November 30th, 2009 stated "Second and Third Quarter 2009." The minutes stated "No Reports" for the Infection Control Program, Pharmacy, Environment of Care, or a contract Dialysis service.

4. Interview 2/22/10 at 3:40 p.m. with the Quality Assurance Director (# 52) revealed the only Quality Assurance meeting held in 2009 was the meeting held on November 30th. The Quality Assurance Director stated no information was presented to the Quality Assurance Committee in November 2009 regarding the Infection Control Program, Pharmacy, Environment of Care, or a contract Dialysis service.

5. Record review of the "Organizational Performance Improvement Plan" (Revised October 2009) stated "All Departments monitor the performance of their individual departments. If individual department indicators show a trend towards unacceptable standards, corrective action is immediately taken at a department level. Departmental activities are reported quarterly, according to the reporting calendar, to the Quality Council. Performance improvement activities are reported at least quarterly to the Medical Executive Committee and the Governing Body."



CROSS REFER to: A-0338, 482.22 MEDICAL STAFF

CROSS REFER to: A-0747, 482.42 INFECTION CONTROL

Based on interview, review of Medical Staff Bylaws and review of 15 of 15 physician credential files the medical staff failed to enforce Medical Staff by laws which require monitoring physician performance through the quality assurance program. quarterly and prior to reappointment and physician peer review when there is a variance report.
Findings:

1. Review of Medical Staff Bylaws at Article V Section 5.2.1 Appointment and Reappointment. Section 5.2.5.2 reflected " Ongoing professional practice evaluation is factored into the decision to maintain existing privileges prior to or at time of renewal. Criteria used in ongoing evaluation:
. Review of operative and other invasive procedures
. Blood usage and appropriateness
. Morbidity and mortality data
. Documentation quality
. Procedure specific activity during the past two years
Ongoing evaluation.will be monitored and reported at least quarterly."

However, review of 15 of 15 physician credential files had no evidence of ongoing quality assurance monitoring as required by medical staff bylaws . Personnel ID #16, medical staff coordinator stated at 2:20pm on 2/24/2010 " there are no QA files on the 15 physicians recently re-appointed. There has been no QA monitoring (whatsoever) from initial appointment to date."
Physician ID #s: 1,2,3,4,6,8,9,10,11,12,13,14,15,63,75

Dates of oldest initial appointments were as follows:
#1, 2002
#2, 2001
#3, 2001
#7, 2003
#20, 2003
#21, 1994

2. Review of Medical Staff Bylaws at Article VII Section 1. Peer Review Process.(C) " If physician performance is questioned as a result of an occurrence - variance report, the department chief will review the matter and determine what reflection this has on practitioners competence and clinical privileges."

However, review of an occurrence report. dated 8/20/1009 12:30hrs. Location: OR, reflected the following:
" At the end of the procedure the final sponge count was incorrect. Dr #10 was notified the sponge count was incorrect while he was closing the abdomen, yet, he continued closing the abdomen." Dr. #10 then left the OR. He returned to the OR after X-ray verified a laparotomy sponge was still in the patient's abdomen. Dr. #10 reopened the abdomen and removed the laparotomy sponge.

This incident was not taken to peer review as required by Medical Staff Bylaws. This was verified by personnel #79 at 2:55pm on 2/25/2010 who stated there was no peer review on this incident.

Based on review of documents and interviews, the hospital failed to provide an active program for the prevention, control, and investigation of infections and communicable diseases regarding patients and personnel.

Findings:

1. The hospital reopened, March 16, 2009, after being closed for six months following flood damage and need for repairs. No infection control person(s)/team had monitored the repair, renovation and construction activities. No surveillance/air quality monitoring/environmental quality testing had been performed to assure hospital environment was safe from mold, etc. prior to opening and admitting patients.

2. No infection control surveillance activities had been conducted from hospital's re-opening date of March 16, 2009 to date of this survey.

3. Interview with the administrator (#50) on 2/23/2010 at 10:00 a.m. confirmed no infection control activities had been conducted during the repair, renovation, construction activities. No air quality monitoring had been conducted prior to hospital's re-opening.

4. Three of nine hospital personnel health records reviewed were incomplete for HBsAb (hepatitis B surface antibody) testing and vaccine series to ensure personnel had immunity from hepatitis B. Citing records #38, #39, and #78.

5. Interview on 10/23/2010 at 2:00 p.m. with the HR person (#77) in charge of personnel health records confirmed she was unable to provide evidence confirming Hepatitis B immunity status for these three individuals.

6. Review of three of seven clinical records revealed no surveillance activities conducted of their infections to determine if antibiotic therapy was appropriate or if the patient had acquired a nosocomial infection. Citing patients #26, #27, and #28.

a. Patient #26:
This patient was treated in the Emergency Department for a breast abscess on 09/17/2009. Prior to discharge, a culture was obtained of breast abscess drainage. Patient was discharged on Amoxicillin (a form of penicillin). Results of culture were received on 9/20/2009: "heavy growth of MRSA (Methicillin Resistant Staphylococcus Aureus)". Report also noted that the bacteria was "resistant to penicillin".

b. Patient #27:
This patient was admitted to hospital on 9/29/2009 with a diagnosis of "COPD, CHF, and Asthma". A blood culture was drawn on patient on 9/29/2009. On 10/2/2009, patient was discharged home and given antibiotic Levaquin (levofloxacin) to take at home. On 10/3/2009, the culture report was received and showed Staph infection resistant to levofloxacin.

c. Patient #28:
This patient had multiple admissions:

Admission from 8/28/2009 to 9/1/2009 was secondary to "line sepsis with MRSA (methicillin resistant staphylococcus aureus)". The medical record for this admission reflected complete resolution of infection.

Admission from 9/25/2009 to 9/30/2009 was for a low grade fever. He was sent to hospital by his hemodialysis center.

Admission from 10/21/09 to 10/29/2009 for infected AV graft. Blood culture on this admission was positive for gram positive bacteria. The patient's graft was removed and a new graft inserted.

Admission from 1/4/2010 to 1/6/2010 was for non-functioning right Quentin catheter, hyperkalemia, hypertension, congestive heart failure, and fluid overload. He required two emergency hemodialysis treatments. Patient needed his Quentin catheter removed and a new access put in. Documentation in record noted that patient deferred this action "until the next week" due to commitments. No cultures were noted for this admission.

Admission from 1/26/2010 to 1/30/10 for insertion of new right AV graft. A blood culture for this admission was done and report was received with positive for MRSA. The record noted that this was a suspected line sepsis.

No analysis had been conducted of this patient's infections to determine if patient had acquired some of these infections while in the hospital (nosocomial).

7. Consultant hired to assist with quality assurance reported during interview of 2/23/2010 at 10:30 that an infection can be classified as a nosocomial if it occurs within a thirty day period after patient's discharge.

8. There were no surveillance activities on patients #26 and #27 to ensure the infection control department/person was monitoring culture reports in order to follow-through and see that patients were contacted in order to change their antibiotic prescription to one that patients' bacterial infections were sensitive to.

9. There was no surveillance reports on patient #28 to determine if any of his readmissions within a thirty day or less period were for a nosocomial infection.

10. Interview with the CNO (#53) on 2/25/2010 at 10:30 confirmed that no infection control surveillance activities had occurred on these three patients. She also confirmed that patients #26 and #26 had not been contacted in order to change their antibiotic therapy.

11. Facility's Policy entitled: "Infection Control Program" with "Revised Date of 2/15/2007" had not been implemented.

12. Personnel #52 stated during an interview conducted on 2/22/2010 at 09:45 that she had been hired five months ago. At that time, she had been told she would be over Education, Infection Control, Quality Assurance, Utilization Review, Risk Management, and Case Management.

She also confirmed that the facility had not held any infection control meetings, had not conducted any surveillance activities for infection control and had not analyzed any infection control data received from the laboratory in the form of culture reports and reportable disease reports.

13. There was no surveillance activities over Anesthesia Department to ensure single use/single dose vials were not used multiple times.

Note:
"Single Dose Vials" contain no preservatives whereas "Multiple Dose Vials" are preserved to help retard the growth of bacteria. Bacteria can be inadvertently introduced with the penetration of the stopper by the needle.

Single dose vials such as Propofol and Naloxone, contain no preservatives.

During a tour of the facility's operating room area on 2/23/2010 at 1:30, these two medications (Propofol 20 ml labeled:" single dose vial" and Naloxone 1 ml labeled " single dose vial ") were found in the Operating Room #1's anesthesia cart. Both medication vials had been penetrated and were left on the cart and available for use on the next patient.

Cross Refer to: A0748; A0749, A0750.

14. Infection Control was not integrated into the hospital's Quality Assurance Performance Improvement (QAPI) activities. Governing body failed to ensure that there was an infection control program in place.

Cross Refer to: A0043 (482.12 Governing Body).

Cross Refer to: A0263 (482.21 Quality Assessment and Performance Improvement Program).

Based on observation, interview, and record review the Hospital failed to provide patients with the right to a safe environment. Electrical equipment (defibrillators, ventilators, anesthesia machines, surgical electrical equipment, sonogram machine, etc.) were not checked by a Biomedical company semi-annually per the Hospital's policy. (Departments included: Medical / Surgical unit, Emergency Room, Intensive Care unit, Surgical Suite, and Radiology)

Findings include:

Observation 2/22/10 at 10 a.m. in the following departments (Medical / Surgical unit, Emergency Room, Intensive Care unit, Surgical Suite, and Radiology) revealed all the electrical equipment was last checked by a Biomedical Company for safety in March 2009.

The Director of Nursing (# 53) acknowledged 2/24/10 at 3:30 p.m. the electrical equipment was last checked for safety March 2009. The Director of Nursing (DON) stated that most equipment should be checked semi-annually and the anesthesia machines should be checked quarterly. The DON further stated that the hospital had previously identified this as a problem and is currently working with a new Biomedical Company to check the equipment.

Record review of a Quality Assurance Improvement Meeting dated 2/12/10 stated "Environment of Care: New Biomedical Company being contracted for equipment checks."

Record review of the hospital's "Safety Manual" revealed "Responsibilities - Medical Equipment (no date) stated "Biomedical Engineering: It is the function and responsibility of biomedical engineering, with the nursing and medical staff, to insure the safety and operating effectiveness of medical equipment to be used in patient care."

A policy titled "Scheduled Equipment Maintenance Medical Equipment" (no date) stated "To ensure that medical equipment will perform safely, reliably, accurately, functional testing at regular intervals is necessary."

Based on document reviews and interview, the registered nurse failed to adequately supervise and evaluate the nursing care to assure staff informed the physician when a patient's condition changed.

The registered nurse failed to assure staff followed physician orders for hemodialysis and that weights were obtained on hemodialysis treatments both pre and post treatments.

The registered nurse failed to assure the staff had an order for the Mannitol given by intravenous route to a hemodialysis patient with a low blood pressure.

These problems were noted in one of three death records reviewed (patient #34) and two of three hemodialysis patient records reviewed (Citing #22 and #23) :

FINDINGS:
1. Patient #34:
Patient, a 62 year old female, was admitted on 10/2/2009. Her chief complaint was "abdominal pain". She was admitted through the Emergency Department (ED) to in-patient status. Diagnostic Impression listed on History and Physical (H&P) were: "Acute abdominal pain; acute diverticulitis; hypokalemia; diabetes mellitus; hypertension; End-state renal disease; history of colon and cervical cancer". Physician physical exam on H&P noted patient had "no evidence of shortness of breath......" Physician also noted on H&P: "She was alert, in no major acute distress, still complaining of the abdominal pain especially in the left lower quadrant".

Patient was admitted to room 107 from the ED at 20:45 on 10/2/2009.

Nursing noted that patient was admitted to room 107 alert and oriented X 3 (A&O X3). "KCL IV started at 2100. She was given medication for her abdominal pain at 23:00 hours.

At 04:30 (10/3/2009)she was "sleeping".

At 0500 her pain medication was repeated for abdominal pain.

The following was documented by 7a.m. to 7 p.m. nursing staff on 10/3/2009:
0700: "Received Report from Night Nurse".
07:30: "Pt. calling stating, `She needs oxygen'. Pt. assessment done. New set of vitals done: 120/64, 80, 16. 96% on Room Air. Pt. skin cold and clammy, but patient has fan on high. Placed 2 L. of O2 on patient. She states, `She feels no relief yet'. Repositioned her in bed. Started cleaning Pt. had loose stool".
08:00: Pt. calling again. C/O SOB. Tried to calm patient. Told her to calm down, Repositioned her in bed from slumped position. Put another pillow under her head and reassessed. Pt. Stated that this was better."
09:00: "Gave scheduled medications. Patient stating, `still no relief from oxygen'. Reassessed. Lungs are clear but patient says, `she's wheezing'.
10:15: "Received call that pt. pulse is down to 28. Went to see. Pt. eyes closed and not breathing. Code Blue Button Pushed".

At 10:55: patient was pronounced dead.

There was evidence that physician had been notified at any time of patient's complaints and of her feeling she was getting no relief of symptoms until the code was called.

2. Patient #22:
Physician orders were to provide 1000 units of heparin "bolus" at the beginning of patient's hemodialysis treatment and to instill ("pack") 5000 units into each catheter access port at the end of dialysis. This was to assure catheter did not clot during or between treatments. The hemodialysis nurse failed to provide heparin (bolus or pack) as ordered.

Patient was not weighed post hemodialysis on 2/20/10 as required on the hemodialysis treatment sheet.

She was not weighed pre or post hemodialysis on 2/22/10.

3. Patient #23:
Patient was given Mannitol 25% (50 mls.) intravenously on 2/21/10 for hypotension. There was no order for Mannitol on date record was reviewed (2/25/10). Later, patient's physician stated, during his rounds, that he had given a verbal order for the Mannitol to hemodialysis nurse on 2/21/2010.

Patient was not weighed post hemodialysis treatment on 2/16/2010 as required on the hemodialysis treatment sheet.

No pre dialysis weight was obtained on 2/17/10

No pre and no post weights were obtained on hemodialysis treatment dates of 2/18/10, 2/19/10, 2/21/10, and 2/23/10.

4. Interview with the CNO on 2/25/2010 at 10:30 a.m. confirmed findings in the above clinical records.

Based on record review and interview it was determined that the facility failed to ensure that clinical records were completed within 30 days of discharge.

Findings included:
Clinical records were not completed within 30 days of the patient's discharge. A review of a document entitled "Outstanding Physician Deficiencies" printed on 2/23/10 by HIM Coordinator (# 59) revealed that there were 327 delinquent medical records (incomplete more than 30 days after the patient's discharge).

A review of the Medical Staff Bylaws, Article VIII Rules and Regulations, 8.2 Medical Records stated: "All medical records shall be completed by the attending physician within 30 days of discharge." "If the records are not completed within 30 days the HIM coordinator will notify the Administrator. The Administrator/Designee will notify the responsible physician that his/her admitting/consulting privileges have been suspended until such time as the records are complete."

In an interview on 2/23/10 at 10:00 AM, the HIM Coordinator (# 59) confirmed that there were delinquent medical records per the facility's own report. The HIM Coordinator (# 59) also stated that no physician has been suspended for delinquent medical records.
In an interview on 2/24/10 at 13:14 PM the Administrator (# 50) stated that no physician has had his/her admitting privileges suspended due to delinquent medical records.

Based on observation, interview, and record review the Hospital failed to stock 36 vials of Dantrolene according to their policy regarding Malignant Hyperthermia.

Findings include:

Observation 2/24/10 at 9:30 a.m. in the operating room suite revealed the hospital stocked twelve (12) vials of Dantrolene to treat Malignant Hyperthermia.

A policy titled "Malignant Hyperthermia" dated 1/2007 stated "Drugs and supplies for treating Malignant Hyperthermia shall be readily available. Thirty-six (36) vials of Dantrolene are stocked."

The Pharmacist (# 54) acknowledged 2/24/10 at 9:45 a.m. the Hospital currently had only 12 vials of Dantrolene in stock.

Based on observation, interview, and record review the Hospital failed to ensure that medications in the operating room pharmacy were not expired and failed to ensure that previously opened vials of medication in the operating room anesthesia cart were dated or discarded once opened.

Findings include:

Observation 2/23/10 at 1:30 p.m. in the operating room suit revealed two expired medications inside the locked pharmacy room. (Nitroglycerin 250ml expired 9/1/09 and Bupivacaine 30ml expired 12/1/09)

Further observation of operating room #1 suite revealed an anesthesia cart contained the following medications: Two vials of medication were previously opened and labeled "single dose vial" (Propofol 20ml and Naloxone 1ml).

The Operating room director (# 56) acknowledged 2/23/10 at 2 p.m. that multiple use vials of medication should be dated when first opened.

Record review of a Pharmacy policy titled "Single Dose Vial Protocol" dated 1/2007 stated "The singe dose vial shall be discarded immediately after single dose is withdrawn. It will not be used on more than one patient."

Record review of another pharmacy policy titled "Multi-dose Vial Protocol" dated 1/2007 stated "The vial shall be labeled with the date and initials of the person opening the vial and shall be discarded after thirty days from opening."

Based on record review and interview the hospital pharmacy services failed to be integrated into a hospital-wide quality assurance and performance improvement committee in order to track, trend, and analyze medication errors.

Findings:

Record review of a Quality Improvement Meeting dated November 30th, 2009 stated "Second and Third Quarter 2009." The minutes stated "Safety/Risk Management: a.)needle sticks, b.)Medication Variances, c.)Adverse Drug Reaction, d.)other: "No Report Given."

Record review of Pharmacy Policies and Procedure Number 1118.01, revised date 1/2007, Subject: Performance Improvement stated: "The pharmacy shall participate in facility-wide performance improvement activity. The Pharmacy director shall report his/her findings to the P & T [Pharmacy and Therapeutics] Committee for appropriate action."

In an interview on 2/23/10 at 1:30 PM the Pharmacy Director (# 54) stated "We don't have a separate P & T [Pharmacy and Therapeutics] Committee. We are just reporting directly to the MEC [Medical Executive Committee]."
However, review of Medical Executive Committee meeting minutes for 3/19/09, 8/3/09, 8/15/09, 9/3/09, 9/24/09, 10/8/09, 11/2/09, 12/10/09, and 12/29/09 revealed no documentation of a pharmacy report.

Based on review of the facility ' s dietary policies and procedures, observations, and interviews with personnel, it was determined that the Director of Food and Dietary Services (# 35) failed to be responsible for the daily management of the dietary services in that food items with expired dates were available for use and dietary personnel failed to follow their own policies and procedures (i.e.: 1 of 1 reach-in refrigerator contained foods that were not dated, previously opened food items were not dated, food products were stored without a secure lid, and the refrigerator temperature was not documented 7 of 22 days).
Findings:

Review of Dietary Policy # D-1, approved 11/13/08, Subject: Storage and Rotation Procedures stated: " Only food products may be stored in the refrigerators, properly covered and contents labeled and dated in container. " However, observation of the food prep area on 2/22/10 at 1:10 PM revealed the following:

1. 10 individual servings of cooked spaghetti, not dated
2. 1 individual serving of cooked fish, not dated
3. 7 individual servings of cooked cauliflower, not dated
4. 5 individual servings of cucumber slices, not dated
5. 5 individual servings of jello, not dated
6. 1 individual serving of pineapple dessert, not dated
7. 1 1-gallon container of mayonnaise previously opened and half full, not dated as to when it was opened.
The Dietary Manager (# 35) confirmed these findings.

Review of Dietary Policy # D-1, approved 11/13/08, Subject: Storage and Rotation Procedures stated: " Storage of food after initial use should be done in plastic storage containers with lids which are secure. " However, observation of the food prep area on 2/22/10 at 1:10 PM revealed the following: an opened container of dry mashed potato mix was under the counter. The container was loosely covered with foil instead of a secure lid.

Observation on 2/22/10 at 1:10 PM of the reach-in refrigerator in the kitchen revealed five 1/2 pint cartons of chocolate milk that expired 2/21/10. Observation on 2/22/10 at 1:10 PM of the walk-in refrigerator in the kitchen revealed fourteen 1/2 pint cartons of chocolate milk that expired 2/21/10.

Review of Dietary Policy (no policy number or date) subject: Dietary Preventive Maintenance Plan stated: " Log on refrigerator/freezer readings: Temperature is taken three times a day by dietary personnel and recorded on log. "

Review of the Temperature Log for February 2010 revealed no recording of temperatures for February 3rd, 4th, 13th, 14th, 17th, 18th, or 22nd.

Based on review of documents and interviews, no person or team had been designated in writing as being the responsible for developing and implementing infection control policies to control infections and communicable diseases.

Findings:

1. Facility's Policy entitled: "Infection Control Program" with "Revised Date of 2/15/2007" had not been implemented.

The policy stated under IV. A.: "The infection control practitioner oversees the hospital-wide program for surveillance, prevention and control of infections. Representative from other services and disciplines, including physicians will be consulted as needed, in addition.........."

The policy stated under IV. B. 3.:
"Development of standard criteria for defining nosocomial infections and a system for collecting and analyzing the data".

And, the policy continued at #4:
"Ongoing collection, review and analysis of data pertaining to nosocomial infections, risk factor, and as needed, special studies that relate to infection prevention and control".

Personnel #52 stated during an interview conducted on 2/22/2010 that she had been hired five months ago. At that time, she had been told she would be over Education, Infection Control, Quality Assurance, Utilization Review, Risk Management, and Case Management.

She confirmed that the facility had not held any infection control meetings, had not conducted any surveillance activities for infection control, and had not analyzed any infection control data received from the laboratory in the form of culture reports and reportable disease reports.

Governing Body meeting minutes did not reflect the designation of anyone or any team to be responsible for infection control.

The personnel file for #52 did not have any job description/notation that reflected she had been designated as the infection control practitioner and therefore responsible for the development and implementation of policies governing infections and communicable diseases.

Based on document reviews and interviews, the facility failed to analyze, investigate and control infections and communicable diseases of patients and personnel.

Nosocomial and community acquired infections were not being tracked/analyzed.

Patients were discharged home on antibiotics that were resistant to the bacterial infections the patients had.

Personnel were not monitored to assure vaccines they had received for Hepatitis B were effective.

FINDINGS:

1. FINDINGS REGARDING PATIENT INFECTIONS AND CULTURE REPORTS:

a. All bacterial culture reports (wound, sputum, blood, etc.) and reportable disease lab reports, from date of hospital's opening (March 16, 2009) to current date were contained in two file folders. One folder contained all reports for 2009 (over 100 reports) and another folder reports for 2010.

b. No method had been employed by hospital's infection control to analyze these reports.

c. As a result, patients' infections and bacterial culture reports were not being monitored to determine if patients had a nosocomial infection and/or were on antibiotics that were sensitive to the antibiotic they had been sent home on. This was noted in three of seven clinical records reviewed. Citing Patients #26, #27, and #28.

d. The facility had no written definition of a nosocomial infection.

e. The consultant hired to assist with quality assurance reported during the interview of 2/23/2010 at 10:30 that the hospital could identify an infection as a nosocomial if it occurred within a thirty day period after patient's discharge.

2. FINDINGS REGARDING PATIENTS (#26, #27, and #28):

a. Patient #26:
This patient was treated in the Emergency Department for a breast abscess on 09/17/2009. Prior to her discharge, a wound culture was obtained from the abscess site. Patient was discharged on Amoxicillin (a form of penicillin).

Results of culture were received on 9/20/2009: "heavy growth of MRSA (Methicillin Resistant Staphylococcus Aureus)".

Report also noted that the bacteria was "resistant to penicillin".

There was no documented evidence that the patient had been contacted regarding culture findings and that she was on an antibiotic that was resistant to the bacterial infection the patient had.


b. Patient #27:
This patient was admitted to hospital on 9/29/2009 with a diagnosis of "COPD, CHF, and Asthma". A blood culture was drawn on patient on 9/29/2009. On 10/2/2009, patient was discharged home on antibiotic Levaquin (levofloxacin) to take at home. On 10/3/2009, the culture report was received and showed Staph infection resistant to levofloxacin.

There was no documented evidence that the patient had been contacted regarding culture findings and that she was on an antibiotic that was resistant to the bacterial infection she had.

Note:
There was no designated infection control person responsible for follow through after analyzing culture reports to ensure patients #26 and #27 were contacted so that antibiotics could be changed if needed.


c. Patient #28 (multiple admissions):

First admission from 8/28/2009 to 9/1/2009 was "secondary" to "line sepsis with MRSA (methicillin resistant staphylococcus aureus)". The medical record for this admission reflected "complete resolution" of infection by discharge date.

Admission from 9/25/2009 to 9/30/2009 was for a low grade fever. He was sent to hospital by his hemodialysis center.

Admission from 10/21/09 to 10/29/2009 for infected AV graft. Blood culture on this admission was positive for gram positive bacteria. The patient's graft was removed and a new graft inserted.

Admission from 1/4/2010 to 1/6/2010 was for non-functioning right Quentin catheter, hyperkalemia, hypertension, congestive heart failure, and fluid overload. He required two emergency hemodialysis treatments. Patient needed his Quentin catheter removed and a new access put in. Documentation in record noted that patient deferred this action "until the next week" due to his personal commitments. No cultures were noted for this admission.

Admission from 1/26/2010 to 1/30/10 for insertion of new right AV graft. A blood culture for this admission was done. The culture report was positive for MRSA.

No analysis had been conducted of this patient's infections to determine if patient had acquired some of these infections while in the hospital (nosocomial).

There were no surveillance reports on patient #28 to determine if any of his readmissions within thirty day periods or less period were for a nosocomial infection.

3. Interview with the CNO (#53) on 2/25/2010 at 10:30 confirmed that no infection control surveillance activities had occurred on these three patients. She also confirmed that patients #26 and #26 had not been contacted in order regarding their antibiotic therapy.

4. FINDINGS REGARDING PERSONNEL:
a. Three of nine hospital personnel health records reviewed were incomplete for HBsAb (hepatitis B surface antibody) testing and vaccine series to ensure personnel had immunity from hepatitis B. Citing records for personnel #38, #39, and #78.

b. Written policy on "Hepatitis B Vaccination Consent Form/Record" stated: "Post vaccination testing: 1-2 months after final dose. If anti-HBs less than 10, complete a second three dose vaccine series and determine if HbsAg-positive".

c. Personnel #38:
Personnel (food services aide) received her hepatitis series beginning 2/11/2008 (initial, one month, five months). No post surface antibody test had been done as per written policy to assure she had achieved immunity from Hepatitis B.

d. Personnel #39:
Personnel (a cook) signed form stating she wanted hepatitis B series. However, her file showed no evidence she had received the series and no evidence a hepatitis B surface antibody had been drawn on her to show immunity from Hepatitis B.

e. Personnel #78:
Personnel (insurance verifier) signed consent and had the Hepatitis B series. No post test had been done to determine if she had achieved immunity from her series of the Hepatitis B vaccine.

f. Interview on 10/23/2010 at 2:00 p.m. with the HR person (#77) in charge of personnel health records confirmed she was unable to provide evidence confirming Hepatitis B immunity status for these three individuals.

Based on review of documents and interviews, the hospital/infection control failed to maintain a log of incidents related to infections and communicable diseases.

FINDINGS:

All bacterial culture reports (wound, sputum, blood, etc.) and reportable disease lab reports, from date of hospital's opening (March 16, 2009) to current date were contained in two file folders. One folder contained all reports for 2009 (over 100 reports) and another folder reports for 2010.

Reports were not in any type of order in the file folders.

No method had been employed by hospital's infection control to analyze these reports or put them in any order or log.

Interview with Personnel #52 on 2/22/2010 at 09:45 confirmed that no log had been maintained.

Based on document reviews and interviews, the hospital staff failed to notify the OPO (LifeGift) so that OPO could determine medical suitability for organ donation as per hospital's written policy. This was noted in 3 of 3 death record reviewed. Citing records #32, #33, #34.

Findings:

Written policy entitled "Organ/Tissue Donation" stated at #1: "The Nurse will notify the OPO of all deaths......".

Patient #32 died on 12/09/2009 and the nurse noted that it was "N/A" to notify the OPO on the "LifeGift-Organ Donation Center Routine Notification of Death" form.

Patient #33, the "LifeGift-Organ Donation Center Routine Notification of Death" form was not completed for date of death and the nurse noted "N/A" for notifying LifeGift on this form also.

Patient #34: No "LifeGift-Organ Donation Center Routine Notification of Death" form was completed and placed on chart.

Personnel #53 was unable to provide evidence of compliance when interviewed on 2/24/2010 at 9:00 a.m.