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Based on review of policy and procedures, documentation review, manufacturer's product recommendations, observations during tour, physician and staff interviews, the hospital's Governing Body failed to have oversight and assure systems were in place to ensure: a competent nursing staff; an effective Quality Assessment and Performance Improvement program; maintenance of the facility; and an effective infection control program to ensure the safety and well being of patients.

The findings include:

1. The Governing body failed to ensure that the Medical Director of the hemodialysis unit provided oversight for the provision of safe quality patient care.

~cross refer to 482.12(a)(5) Governing Body Standard: Tag A0049

2. The Governing Body failed to ensure the services provided under contract were evaluated and performed in a safe and effective manner (contracted Dialysis Services).

~cross refer to 482.12(e)(1) Governing Body Standard: Tag A0084

3. The Governing Body failed to ensure a physician (on-site or on call) provided medical direction of onsite staff (a Qualified RN)conducting assessments for the need of emergency care and failed to evaluate the patient population the hospital routinely cares for in order to anticipate potential emergency care scenarios and develop the policies and procedures that would enable the staff to provide safe and adequate initial treatment of an emergency within the hospital's capabilities.

~cross refer to 482.12(f)(2) Governing Body Standard: Tag A0093

4. The Governing Body failed to implement and maintain an effective Quality Assessment and Performance Improvement program to ensure the safety of patients receiving hemodialysis treatments and procedures which utilize endoscopes.

~cross refer to 482.21 QAPI Condition: Tag A0263

5. The Governing Body failed to ensure the nursing staff were competent in their duties to assure the water treatment systems were operated in a manner that ensure safety for patients receiving hemodialysis.

~cross refer to 482.23 Nursing Services Condition: Tag A0385

6. The Governing Body failed to develop and maintain the facility in a manner to ensure the safety of patients.

~cross refer to 482.41 Physical Environment Condition: Tag A0700

7. The Governing Body failed to have a system in place to ensure the prevention, control and investigation of infections.

~cross refer to 482.42 Infection Control Condition: Tag A0747

Based on observations during tour, policy review, patient procedure log review, inspection of reverse osmosis (RO) equipment, review of hemodialysis water documentation, staff interviews, and manufacturer's product recommendations, the hospital's Quality Assessment and Performance Improvement (QAPI) program failed to monitor and assess the quality of hospital processes to ensure the health and safety of patients receiving hemodialysis treatments and undergoing procedures utilizing endoscopes.

The findings included:

1. The hospital failed to assure the nursing staff provided quality care in a safe and competent manner.

~Cross refer to 482.23 Nursing Services Condition: Tag A0385

2. The hospital failed to ensure facilities, supplies and equipment were maintained to ensure patient safety by failing to ensure the water treatment systems in the hemodialysis unit were operated and water samples were tested in a manner to assure the water used for treatment would be within the required limits for chemical contaminates.

~cross refer to 482.41 Physical Environment Condition: Tag A0700

3. The hospital failed to ensure the water used for patient hemodialysis was tested monthly for bacteria and endotoxins; ensure measures were taken for water culture results that exceeded the set action level and ensure endoscopes were disinfected prior to patient use.

~cross refer to 482.42 Infection Control Condition: Tag A0747

Based on dialysis policy review, dialysis water documentation review, contract staff interview, observation, manufacturer's product instructions review, and administrative staff interview, nursing staff failed to ensure quality patient care was provided in a safe manner.

The finding included:

1) Nursing failed to supervise staff to ensure water used for patient hemodialysis was safe.

~Cross refer to 482.23(b)(3)- Nursing Services Tag A0395

2) Nursing failed to ensure contracted staff for the hemodialysis unit was competent in the technical aspects of hemodialysis care.

~Cross refer to 482.23(b)(3)- Nursing Services Tag A0398

3) Nursing failed to ensure that the RO (reverse osmosis) water systems and dialysate were tested for bacterial/endotoxin growth monthly and that prompt measures were taken by staff when culture/endotoxin growth exceeded set action level.

~Cross refer to 482.42(a)(1) Infection Control Tag A0749 example 1

Based dialysis policy review, dialysis water documentation review, contact staff interview, observations, and manufacturer's product instructions review, the hospital failed to ensure facilities, supplies and equipment were maintained to ensure patient safety by failing to ensure the water treatment systems in the hemodialysis unit were operated and water samples were tested in a manner to assure the water used for treatment would be within the required limits for chemical contaminates.

The findings included:

~Cross refer to 482.41(c)(2) Physical Environment Condition: Tag A0724

Based on policy reviews, dialysis water documentation reviews, staff interviews, observations during tour, Patient Procedure Log reviews and Endoscope Cleaning Log reviews, the hospital failed to have a system in place to ensure the prevention, control and investigation of infections.

The findings included:

The hospital's infection control officer failed to have a system to control infections and communicable diseases by failing to: ensure the water used for patient hemodialysis was tested monthly for bacteria and endotoxins; ensure measures were taken for water culture results that exceeded the set action level and ensure endoscopes were disinfected prior to patient use.

~Cross refer to 482.42(a)(1) Infection Control - Tag A0749.

Based on dialysis policy review, observations during tour, dialysis water documentation review, staff interviews, personnel record reviews, and physician interviews, the Governing Body failed to provide oversight to ensure provision of safe hemodialysis services and quality care.

The findings included:

Review of hemodialysis policy 153-510-010-1, Microbiological Monitoring, (4/4/07) revealed monthly bacteria and endotoxin tests would be obtained for product water and dialysate. Policy review also revealed if a test result exceeds the action level and allowable limit, staff should promptly notify the medical director, nurse manager...and corrective actions implemented.

Observation in the hemodialysis unit on 1/27/2010 at 1000 revealed the unit utilized two portable reverse osmosis (RO) water systems for patient treatment, RO #2, and RO #3 and two hemodialysis machines, #18 and #43A.

Review of the water documentation from 1/09-12/09 revealed no documented evidence that bacteria cultures had been obtained for the product water on RO #2 and RO #3 for 5 of 12 months (3/09, 7/09, 9/09, 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that bacteria cultures had been obtained for the product water on RO #2 and RO #3 for 5 of 12 months (3/09, 7/09, 9/09, 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that endotoxin cultures had been obtained for the product water on RO #2 and RO #3 for 8 of 12 months (1/09, 2/09, 3/09, 4/09, 7/09, 9/09, 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate bacteria cultures had been obtained on hemodialysis machine #18 for 4 of 12 months (3/09, 9/09 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate bacteria cultures had been obtained on hemodialysis machine #43 for 5 of 12 months (3/09, 7/09, 9/09 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate endotoxin cultures had been obtained for hemodialysis machines #18 and #43A on 7 of 12 months (1/09, 2/09, 3/09, 4/09, 7/09, 10/09, 11/09).

Review of the cultures for 5/09 on the RO#2 product water revealed endotoxin growth above the action level of 0.25 EU with a subsequent re-culture which resulted at 0.88 EU without staff follow-up.

Review of the dialysate cultures on hemodialysis machine #18 revealed 2/9/09 bacteria growth of >200 cfu (above allowable limit) which was reported on 2/11/09. Review revealed documented action measures were not implemented regarding the high bacteria growth until 2/16/09, 5 days after results were reported. Review also revealed no documented evidence that the medical director or unit nurse manager of the hemodialysis unit had been notified.

Review of dialysis policy 153-010-041, Water Quality Standards For Hemodialysis (5/15/96), revealed "Free chlorine is potentially toxic due to its high oxidation potential and ability to form chloramines. Effective purification method: Carbon filtration."

Observation on 1/27/2009 at 1000 of the dialysis RN #1 performing the total chlorine test on the water from portable RO #2 (portable reverse osmosis water system that included 2 carbon tanks) revealed the RN tested the water during a patient treatment incorrectly using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips on 2 different attempts (1000 and 1020). Observation revealed patient #13 was dialyzing on RO#2 and ultimately, the water that fed RO#2 after the carbon tanks, when measured correctly, resulted in an unsafe total chlorine level. Observation revealed the reagent strip color change measured 0.1 ppm (parts per million) initially, with further total chlorine testing using a Hach meter that resulted at an even higher level of 0.23 ppm at 1110 and 0.36 ppm at 1125.

Interview with the dialysis RN #1 on 1/27/2010 at 1005 revealed she had been aware that the total chlorine level for RO#2 had been increasing and had informed the contracted biomedical technician 8 days prior (January 19) and informed him that the total chlorine result was 0.05 ppm.

Interview on 1/27/2010 at 1115 with the inventory and compliance supervisor revealed that carbon tanks are safe to use until the total chlorine reached 0.1 ppm. She stated that "we try to re-bed or exchange the carbon tanks at around a total chlorine level of 0.08 ppm to ensure that the chlorine level never reaches 0.1 ppm."

Interview on 1/17/2010 at 1145 with the inventory and compliance supervisor revealed that based on the hospitals current testing methods for identifying levels of total chlorine for the RO water systems, the RPC K100-0118 Ultra-Low Total Chlorine test strips included no method for identifying levels of total chlorine between 0.05 ppm (safe) and 0.1 ppm (unsafe) total chlorine results. Observation revealed the color comparator had no color result for 0.08 ppm, the point that biomedical staff indicated that an action was required. Review of the RPC K100-0118 Ultra-Low Total Chlorine test strips color comparator also revealed that color change between 0.05 ppm (safe levels of chlorine) verses 0.1 ppm (unsafe levels of chlorine) was a very subtle color change.

Review of the personnel records of contracted licensed staff of the hemodialysis unit revealed no documented evidence that 3 of 3 (dialysis RN #1, dialysis RN #2, dialysis RN #3) staff reviewed had competence in performing the total chlorine test using the contracted RPC K100-0118 Ultra-Low Total Chlorine Test Strips. Record review also revealed that 1 of the 3 (dialysis RN #3) contracted hemodialysis staff had no documented evidence that she had been trained in "Nurses Technical Training" (NTT) (skills competence related to hemodialysis water knowledge), and 1 of the 3 (dialysis RN #1) hemodialysis contracted staff most current annual NTT was dated on 4/14/05.

Phone interview on 1/28/2010 at 1030 with Physician #1, the Medical Director of the dialysis unit, revealed that he had no involvement in ensuring the contracted staff was competent in providing safe care. Interview revealed that the Medical Director attends the hospitals MEC (medical executive committee) meeting quarterly to speak to the hemodialysis unit. But, the dialysis topics discussed during the MEC meeting only dealt with the number of patient treatments and not the quality of care.

Interview with the hospitals Chief Clinical Officer (CCO) on 1/27/2010 at 0900 revealed hemodialysis services has been a contracted service for over 7 years and being a member of the Governing Body, "we (the Governing Body) were not aware of the dialysis quality issues," respectively. Interview revealed discussion regarding hemodialysis quality had not occurred. Interview revealed that hemodialysis was a contracted service which from a Governing Body stand point had only been looked from a "customer service verses quality stand point. We felt like they (contracted service) were the experts and would do what was required, and had no idea that it was not being done."

Based on contract reviews and executive leadership staff interviews the Governing Body failed to ensure the services provided under contract were evaluated and performed in a safe and effective manner for 1 of 4 contracted services reviewed (Contracted Dialysis Services).

The findings included:

Review on 01/27/2010 of the hospital's list of contracted services revealed acute Dialysis Services are provided by a contracted service provider.

Interview with executive leadership staff on 01/28/2010 at 0852 revealed the governing body does evaluate the dialysis services contract on a yearly basis. Interview revealed the contract was last reviewed in January 2009. Interview revealed the contract is evaluated only from a customer service point of view. Interview revealed the governing body has not been evaluating the contract from a patient safety and quality of care stand point. Interview revealed there was no available documentation of monitoring of patient care and quality of services provided by the contracted service provider for the dialysis services provided to patients at the hospital.

Based on review of hospital policy and procedures, medical staff bylaws - rules and regulations, medical record reviews and staff interviews the governing body failed to ensure a physician (on-site or on call) provided medical direction of onsite staff (a Qualified RN)conducting assessments for the need of emergency care for 3 of 3 emergency service records reviewed (#35, #36, #37); and failed to evaluate the patient population the hospital routinely cares for in order to anticipate potential emergency care scenarios; and develop the policies and procedures that would enable the staff to provide safe and adequate initial treatment of an emergency within the hospital's capabilities.

The findings included:

A) Review of the current "Medical Staff Rules & Regulations" approved 09/30/2004 and last reviewed on 01/2009 revealed "...1.5 Emergency Services - Stand-Alone Facilities. ...D. A physician shall be available or on call twenty-four (24) hours per day to assist in an emergency. ...G. If, after appropriate medical screening, no emergency is found to exist, the patient's private physician shall be contacted to determine what further treatment is required and where it should be obtained. If the patient has no private physician or the private physician is unavailable, the on-call physician shall be contacted to determine the need for further treatment. ..."

Review of hospital policy "Emergency Services Individuals Seeking" Policy 001-21-004.2, revised February 2009, revealed "...A physician is available or on call twenty four (24) hours per day to assist in an emergency. ...B. Non-Emergencies. If, after appropriate screening, no emergency is found to exist, the patient will be given instructions for follow up care; and directions to a facility for appropriate care if warranted. ..."

Review on 01/27/2010 of the Emergency Services Log from January 2009 to January 2010 revealed fourteen (14) log entries of individuals who presented to hospital staff requiring an assessment to determine the need for emergency care (for various complaints).

Review on 01/27/2010 of policies related to the provision of emergency services for the hospital revealed only one (1) policy (Emergency Services Individuals Seeking) provided by Administrative Management Staff. Further review of the policy revealed, the policy did not contain specific protocols and/or procedures for the treatment of potential emergency care scenarios, specific to the hospital's patient population routinely cared for, that would enable the staff to provide safe and adequate initial treatment of an emergency within the hospital's capabilities.

1. Review of emergency service record for Patient #35, revealed a female patient (age unknown) presented to the hospital staff on 01/19/2010 at 2030 with complaints of Vertigo and Vision Changes. Further record review revealed the patient was assessed for the need of emergency care by a registered nurse (RN). Record review revealed the treatment provided to the patient by the RN was a "wet bath cloth." Further record review revealed a physician was not onsite. Record review failed to reveal documented evidence the RN (who conducted the assessment to recognize if the patient had a need for emergency care) contacted the on-call physician for medical direction and oversight. Further record review failed to reveal any documented evidence: the patient was given instructions for follow up care or the directions to a facility for appropriate care, if warranted; the patient's private physician was contacted to determine what further treatment is required and where it should be obtained; nor the on-call physician was contacted to determine the need for further treatment, if the patient had no private physician or the private physician was unavailable per hospital policy and medical staff rules and regulations.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer (CCO) revealed the hospital does not provide emergency services nor has a dedicated emergency department. Interview revealed individuals who may need emergency services and present to hospital staff are either assessed by a physician (MD) or physician assistant (PA) when onsite, Monday through Friday from 0700 to 1900, or by the Charge Nurse (house supervisor) after hours. Interview revealed an on-call PA or MD is available after hours if needed. Interview revealed the hospital provides "basic support to get 911 here," Interview revealed the on-call PA or MD does not always get notified and/or consulted by the RN performing the assessment for the need of emergency care. Interview revealed there are no protocols in place for the RN to follow regarding specific emergency medical situations. Interview revealed the hospital policy "Emergency Services, Individuals Seeking" (Policy 001-21-004.2, revised February 2009) does not contain protocols for treatment of specific emergency medical situations (i.e. low blood sugar). Interview revealed the leadership has not evaluated the patient population, routinely served by the hospital, in order to anticipate potential emergency care scenarios nor developed specific policies and procedures that would enable the staff to provide safe and adequate initial treatment of an emergency medical condition within the hospital's capabilities. Interview confirmed Patient #35 was evaluated by an RN. Interview confirmed the patient's emergency services record failed to reveal any documented evidence: the patient was given instructions for follow up care or the directions to a facility for appropriate care, if warranted; the patient's private physician was contacted to determine what further treatment is required and where it should be obtained; nor the on-call physician was contacted to provide oversight and medical direction to the RN, or to determine the need for further treatment, if the patient had no private physician or the private physician was unavailable per hospital policy and medical staff rules and regulations.

2. Review of emergency service record for Patient #36, revealed a female patient (age unknown) presented to the hospital staff on 12/16/2009 at 0500 with complaints of Tachycardia (fast heart rate), elevated blood pressure, and feeling bad. Further record review revealed the patient was assessed for the need of emergency care by a registered nurse (RN). Record review revealed the treatment provided by the RN was a "fluid - sent home." Further record review revealed a physician was not onsite. Record review failed to reveal documented evidence the RN (who conducted the assessment to recognize if the patient had a need for emergency care) contacted the on-call physician for medical direction and oversight. Further record review failed to reveal any documented evidence: the patient was given instructions for follow up care or the directions to a facility for appropriate care, if warranted; the patient's private physician was contacted to determine what further treatment is required and where it should be obtained; nor the on-call physician was contacted to determine the need for further treatment, if the patient had no private physician or the private physician was unavailable per hospital policy and medical staff rules and regulations.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer (CCO) revealed the hospital does not provide emergency services nor has a dedicated emergency department. Interview revealed individuals who may need emergency services and present to hospital staff are either assessed by a physician (MD) or physician assistant (PA) when onsite, Monday through Friday from 0700 to 1900, or by the Charge Nurse (house supervisor) after hours. Interview revealed an on-call PA or MD is available after hours if needed. Interview revealed the hospital provides "basic support to get 911 here," Interview revealed the on-call PA or MD does not always get notified and/or consulted by the RN performing the assessment for the need of emergency care. Interview revealed there are no protocols in place for the RN to follow regarding specific emergency medical situations. Interview revealed the hospital policy "Emergency Services, Individuals Seeking" (Policy 001-21-004.2, revised February 2009) does not contain protocols for treatment of specific emergency medical situations (i.e. low blood sugar). Interview revealed the leadership has not evaluated the patient population, routinely served by the hospital, in order to anticipate potential emergency care scenarios nor developed specific policies and procedures that would enable the staff to provide safe and adequate initial treatment of an emergency medical condition within the hospital's capabilities. Interview confirmed Patient #36 was evaluated by an RN. Interview confirmed the patient's emergency services record failed to reveal any documented evidence: the patient was given instructions for follow up care or the directions to a facility for appropriate care, if warranted; the patient's private physician was contacted to determine what further treatment is required and where it should be obtained; nor the on-call physician was contacted to provide oversight and medical direction to the RN, or to determine the need for further treatment, if the patient had no private physician or the private physician was unavailable per hospital policy and medical staff rules and regulations.

3. Review of emergency service record for Patient #37, revealed a female patient (age unknown) presented to the hospital staff on 11/06/2009 at 0540 with complaints of Feeling weak and seeing spots. Further record review revealed the patient was assessed for the need of emergency care by a registered nurse (RN). Record review revealed the treatment provided by the RN was "sat down, ate snack c (with) soda, Pt (patient) assisted to breakroom." Further record review revealed a physician was not onsite. Record review failed to reveal documented evidence the RN (who conducted the assessment to recognize if the patient had a need for emergency care) contacted the on-call physician for medical direction and oversight. Further record review failed to reveal any documented evidence: the patient was given instructions for follow up care or the directions to a facility for appropriate care, if warranted; the patient's private physician was contacted to determine what further treatment is required and where it should be obtained; nor the on-call physician was contacted to determine the need for further treatment, if the patient had no private physician or the private physician was unavailable per hospital policy and medical staff rules and regulations.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer (CCO) revealed the hospital does not provide emergency services nor has a dedicated emergency department. Interview revealed individuals who may need emergency services and present to hospital staff are either assessed by a physician (MD) or physician assistant (PA) when onsite, Monday through Friday from 0700 to 1900, or by the Charge Nurse (house supervisor) after hours. Interview revealed an on-call PA or MD is available after hours if needed. Interview revealed the hospital provides "basic support to get 911 here," Interview revealed the on-call PA or MD does not always get notified and/or consulted by the RN performing the assessment for the need of emergency care. Interview revealed there are no protocols in place for the RN to follow regarding specific emergency medical situations. Interview revealed the hospital policy "Emergency Services, Individuals Seeking" (Policy 001-21-004.2, revised February 2009) does not contain protocols for treatment of specific emergency medical situations (i.e. low blood sugar). Interview revealed the leadership has not evaluated the patient population, routinely served by the hospital, in order to anticipate potential emergency care scenarios nor developed specific policies and procedures that would enable the staff to provide safe and adequate initial treatment of an emergency medical condition within the hospital's capabilities. Interview confirmed Patient #37 was evaluated by an RN. Interview confirmed the patient's emergency services record failed to reveal any documented evidence: the patient was given instructions for follow up care or the directions to a facility for appropriate care, if warranted; the patient's private physician was contacted to determine what further treatment is required and where it should be obtained; nor the on-call physician was contacted to provide oversight and medical direction to the RN, or to determine the need for further treatment, if the patient had no private physician or the private physician was unavailable per hospital policy and medical staff rules and regulations.

Based on restraint policy and procedure review, medical record review, and staff interviews the hospital staff failed to ensure an order for a restraint was obtained for 2 of 5 restraint records reviewed (#1, #16).

The findings included:

Review of hospital policy entitled Restraints, revised 2/2009, revealed under ...2. "Restraint for Acute Medical and Surgical Care" ...c. "Orders for Restraints" ...7. "The physician order should not exceed a period of 24 hours. 8. Continued use of the restraint beyond the first 24 hours is authorized by a physician by issuing a new order if the restraint continues to be clinically justified."

1. Open record review for Patient #1, revealed a 64 year old admitted on 12/12/2009 with a diagnosis of Respiratory Failure, Secondary to Pneumonia. Review of nursing documentation revealed the patient was placed in bilateral wrist restraints on 01/02/2010, 01/03/2010 and 01/09/2010. Further record review failed to reveal documentation of a physician's order for the bilateral wrist restraints applied on 01/02/2010, 01/03/2010 and 01/09/2010. Interview with the director of nursing (DON) on 1/27/2010 at 1400 confirmed these findings as she was unable to provide documentation of physician restraint orders for these dates.

2. Open record review for Patient #16, revealed a 78 year old, admitted on 10/05/2009 with diagnoses of FTT (failure to thrive), and Altered Mental Status. Record review revealed the patient was restrained with multiple forms of restraints (i.e. bilateral wrist restraints, mittens, or 4 bed rails up) from 12/14/2009 through 1/26/2010. Review of nursing documentation revealed the patient was in mitten and 4 side rail restraints on 1/6/2010. Further record review failed to reveal documentation of a physician order for the restraints applied on 01/06/2010. Interview with the DON on 1/27/2010 at 1400 confirmed these findings as she was unable to provide documentation of physician restraint orders for 1/6/2010.

Based on medical record review and administrative staff interview the hospital staff failed to document in the patient's medical record the date and time a death was reported to the Centers for Medicare and Medicaid Services (CMS) for 1 of 1 patient that expired within 24 hours of being released from restraints (#8).

The findings included:

Review of hospital policy entitled "Restraints," revised February 2009, revealed "Any deaths that occur (a) while a patient is in restraints, or (b) within 24 hours of the release of the restraint...are reported to the Centers for Medicare and Medicaid Services (CMS). ...Staff will document in the medical record the date and time of the patients death was reported to CMS."

Closed record review for Patient #8 revealed an 87 year old male admitted on 08/26/2009 for composite resection of the floor of the mouth. The patient subsequently expired on 08/29/2009 while hospitalized. Record review revealed a physician's order dated 08/27/2009 at 1600 to apply bilateral wrist restraints (medical). Further review revealed the restraints were applied on 08/27/2009 at 1650 and removed on 08/28/2009 at 0815. Record review revealed the patient's time of death was documented on 08/29/2009 at 0030 (less than 24 hours after restraint removal). Further review failed to reveal documented evidence in the medical record of the date and time the death was reported to CMS.

Interview on 01/27/2010 at 1415 with Director of Quality and Risk Management revealed, CMS had been notified of Patient #8's death. Further interview revealed the Director was unaware of the regulation requiring the recording of the date and time the death was reported to CMS in the medical record. Interview revealed "I don't document in the medical records."

Based on administrative staff interviews, hospital organizational chart review, physician interviews, contracted staff interviews, dialysis water documentation review, the medical staff failed to have a formalized organizational structure for the provision of safe and quality dialysis services.

The findings included:

1. Interviews on 1/27/2010 and 1/28/2010 with administrative staff, physicians and contracted staff revealed inconsistencies among those interviewed regarding the identification of the physician designated as Medical Director of the hospital's hemodialysis unit and a lack of awareness of water quality issues by the Medical Director.

Interview on 1/27/2010 at 1530 with the hospitals Chief Clinical Officer (CCO) revealed Physician #1 was the Medical Director for the hospital's hemodialysis unit and had been for years.

Review of the hospital organization chart (updated on 3/18/2008) reflected Physician #1 as the Medical Director of Nephrology.

Telephone interview on 1/28/2010 at 1030 with Physician #1 revealed he was "under the impression" that the Medical Director position for the hospital's dialysis unit was a shared position between Physician #1 and Physician #2. Interview revealed that he was not aware that he was the sole Medical Director of the hospital's dialysis unit. He indicated that he was required to attend the hospitals MEC (medical executive committee) meeting quarterly to address hemodialysis unit issues.

Interview on 1/28/2010 at 1015 with the inventory and compliance supervisor with the contracted dialysis service revealed Physician #2 was the Medical Director of the hospital's hemodialysis unit. Interview revealed that Physician #2 had always been the Medical Director of the hospital's dialysis unit and therefore, she seeks his guidance for all identified water issues at the hospital.

Interview with the hospital Chief Executive Officer (CEO) on 1/28/2010 revealed that "I specifically met with Dr.{name}(Physician #1) years ago and he was well aware that he was the Medical Director of the hospitals dialysis unit."

2. Review of the hemodialysis water documentation revealed the water used for patient dialysis treatments was not safe due to increased levels of total chlorine on 1/25/10 and 1/27/10. Reviews revealed that the hospital had no workable system in place for identifying and reporting faulty testing and/or equipment.

Review of TCL-1 (total chlorine log) log revealed if total chlorine result is not below 0.1 ppm, immediate actions required.

Observation in the dialysis unit on 1/27/10 at 1010 revealed Patient #13 was dialyzing on the portable RO #2 (reverse osmosis water system) which tested at an unsafe level of total chlorine 0.1 ppm using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips. Observation revealed the reagent strip color change measured 0.1 ppm (parts per million) and remained above an unsafe level upon subsequent total chlorine testing at 0.23 ppm at 1110 and 0.36 ppm at 1125 using a Hach meter that was borrowed from the nearby out patient dialysis unit.

Review of the TCL-1 for RO #3 revealed on 1/25/10 the total chlorine level measured 0.1 ppm at 0830, 1030 and 1330 and had been used for used for patient dialysis treatment on 1/27/2010. Review revealed no documented evidence that staff identified or acted upon the elevated chlorine test result for 1/25/10.

Interview on 1/27/10 at 1145 with the inventory and compliance supervisor revealed she had not been informed regarding the 0.1 ppm level of total chlorine in the RO#3 water on 1/25/10.

3. Review of the water documentation from 1/09-12/09 revealed no documented evidence that bacteria cultures had been obtained for the product water on RO #2 and RO #3 for 5 of 12 months (3/09, 7/09, 9/09, 10/09, 11/09) and no documented evidence that endotoxin cultures had been obtained for the product water on RO #2 and RO #3 for 8 of 12 months (1/09, 2/09, 3/09, 4/09, 7/09, 9/09, 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate bacteria cultures had been obtained on hemodialysis machine #18 for 4 of 12 months (3/09, 9/09 10/09, 11/09) and no documented evidence that dialysate bacteria cultures had been obtained on hemodialysis machine #43 for 5 of 12 months (3/09, 7/09, 9/09 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate endotoxin cultures had been obtained for hemodialysis machines #18 and #43A on 7 of 12 months (1/09, 2/09, 3/09, 4/09, 7/09, 10/09, 11/09).

Review of the cultures for 5/09 on the RO#2 product water revealed endotoxin growth above the action level of 0.25 EU with a subsequent re-culture which resulted at 0.88 EU without staff follow-up.

Review of the dialysate cultures on hemodialysis machine #18 revealed 2/9/09 bacteria growth of >200 cfu (above allowable limit) which was reported on 2/11/09. Review revealed documented action measures were not implemented regarding the high bacteria growth until 2/16/09, 5 days after results were reported.

Review of the dialysate cultures on hemodialysis machine #18 revealed 2/9/09 bacteria growth of >200 cfu (above allowable limit) which was reported on 2/11/09. Review revealed immediate action had not been implemented rgarding the high results. Review revealed subsequent cultures had been re-drawn on 2/16/09, 5 days after results were reported.

Telephone interview on 1/28/2010 at 1030 with Physician #1, the Medical Director of the dialysis unit, revealed that he was unaware of any dialysis water quality issues. Review of the water documentation that included physician authentication indicating his awareness of the water processes revealed water documentation included the signature of Physician #2 and not Physician #1, the Medical Director of the dialysis unit.

4. Observation on 1/27/2009 at 1000 of dialysis RN#1, a contracted nurse, performing the total chlorine test on the water from portable RO#2 revealed she tested the water sample incorrectly, per manufacturers instructions, using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips on 2 different attempts. Observation on 1/27/2010 at 1000 and at 1020 revealed dialysis RN#1 collected samples of water to be tested for total chlorine in a plastic cup without measuring the amount of collected water. Observation on 1/27/2010 at 1025 revealed administrative staff measured the 1000 and 1020 water samples to determine if dialysis RN #1 had in fact obtained the required 100 cc (cubic centimeters) of water to be tested. Observation revealed the 1000 test measured 80 cc (not enough water) and the 1020 test sample measured 140 cc (too much water). Observation also that revealed dialysis RN #1 failed to obtain the water sample temperature to determine the amount of time the reagent pad needed to be in contact with the water sample for both the 1000 and 1020 total chlorine tests.

Interview with the dialysis RN #1 indicated that her supervisor instructed her on 10/8/09 (the first day of using the Chlorine Test Strips) to keep the test strip in the sampled water for 60 seconds and then read the results, so she didn't see the need to get the temperature of the water sample.

Observation on 1/27/2010 at 1025 of a subsequent chlorine test that had been conducted under the supervision of administrative staff ensuring the correct amount of water was tested for the required amount of time using the RPC K100-0118 Ultra-Low Total Chlorine test strips, revealed a result of 0.1 ppm. Observation revealed the temperature of the fresh sample of RO#2 water was 64 degrees F (Farenheit) which required 30 seconds of contact time.

Review of the personnel records of contracted licensed staff of the hemodialysis unit revealed no documented evidence that 3 of 3 (dialysis RN #1, dialysis RN #2, dialysis RN #3) staff reviewed had competence in performing the total chlorine test using the contracted RPC K100-0118 Ultra-Low Total Chlorine Test Strips. Record review also revealed that 1 of the 3 (dialysis RN #3) contracted hemodialysis staff had no documented evidence that she had been trained in "Nurses Technical Training" (NTT) (skills competence related to hemodialysis water knowledge), and 1 of the 3 (dialysis RN #1) hemodialysis contracted staff most current annual NTT was dated on 4/14/05).

5. Review of the machine log for RO #2 and RO#3 from 7/1/09-to 1/27/2010 revealed all aspects of the portable ROs were not monitored as required.

Review of the dialysis policy 153-020-031, Instructions for Completing form A-RO-1 RO Machine Log (5/15/96), "The purpose of the log is to establish a record of the performance of the RO machines that may be used in the Acute Program. The record may also be used to provide the operating history necessary to resolve problems with the general operation of the water treatment equipment"....daily feed water temperature....-differential pressure-recorded monthly on the day the filter element is changed.

Review of the machine log from 7/09-1/27/10 for RO#2 revealed no documented evidence that the daily feed water temperature had monitored on 113 of 113 treatment days.

Review of the machine log from 7/09-1/27/10 for RO#3 revealed no documented evidence that the daily feed water temperature had monitored on 113 of 113 treatment days.

Review of the RO machine logs from 1/09-1/27/10 for RO #2 revealed no documented evidence that the monthly differential pressure had been monitored on 7 of 7 months.

Review of the RO machine logs from 1/09-1/27/10 for RO #3 revealed no documented evidence that the monthly differential pressure had been monitored on 7 of 7 months.

Interview with the hemodialysis RN #1 on 1/27/2010 at 1005 revealed she had been aware that the total chlorine level for RO#2 had been increasing and had informed the contracted biomedical technician 8 days prior (January 19) and that the total chlorine result was 0.05 ppm, which was higher than normal for RO #2.

6. Observation on 1/27/10 at 1025 revealed that portable RO#2, where Patient #13 had been dialyzing since approximately 0800, had an unsafe level of total chlorine. Interview on 1/27/2010 at 1115 with the inventory and compliance supervisor revealed that carbon tanks are safe to use until the total chlorine reached 0.1 ppm. She stated that "we try to re-bed or exchange the carbon tanks at around a total chlorine level of 0.08 ppm to ensure that the chlorine level never reaches 0.1 ppm."

Observation revealed the color comparator had no color result for 0.08 ppm, the point that biomedical staff indicated an action was required. Review of the RPC K100-0118 Ultra-Low Total Chlorine test strips color comparator also revealed that color change between 0.05 ppm (safe levels of chlorine) verses 0.1 ppm (unsafe levels of chlorine) was a very subtle color change.

Interview on 1/17/2010 at 1145 with the inventory and compliance supervisor revealed that based on the hospitals current testing methods for identifying levels of total chlorine for the RO water systems, the RPC K100-0118 Ultra-Low Total Chlorine test strips included no method for identifying levels of total chlorine between 0.05 ppm (safe) and 0.1 ppm (unsafe) total chlorine results.

The Medical Director of the dialysis unit (Physician #1) stated during a telephone interview on 1/28/2010 at 1030 that he "was not aware of any issues related to water quality."

Based on dialysis policy reviews, dialysis water documentation reviews, contract nursing staff interviews, observations, manufacturer's product instructions review, and administrative staff interviews, the hospital failed to supervise nursing staff to ensure water used for patient hemodialysis was safe.

The findings included:

Review of dialysis policy 153-010-041, Water Quality Standards For Hemodialysis (5/15/96), revealed "Free chlorine is potentially toxic due to its high oxidation potential and ability to form chloramines. Effective purification method: Carbon filtration."

Review of TCL-1 (total chlorine log) log revealed if total chlorine result is not below 0.1 ppm, immediate actions required.

Interview on 1/27/2010 at 1145 with the inventory and compliance supervisor revealed total chlorine tests are conducted prior to each patient treatment and approximately every 4 hours while the patient is receiving hemodialysis.

Observation on 1/27/10 revealed the colors on the reagent strip color comparator that indicated safe color (0.05 ppm) versus unsafe color (0.1 ppm) of total chlorine levels was a very subtle color change. Review of the dialysis policies revealed that there was no policy related to use of the RPC K100-0118 Ultra-Low Total Chlorine Test Strips.

Review of the manufacturer's instructions for using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips revealed the following:

Test Procedure
-Collect a fresh 100 ml sample of water in a plastic cup
-Remove one test strip from its foil package and dip it in the sample for 20 (crossed out) 60 (had been hand written in) seconds.

Important Note:
The 20 (crossed out and 60 had been hand written in) second dip time is for a test sample at approximate room temperature (72-80 degrees)
Water sample at 64 degrees F, dip time=30 seconds.
Water sample at 52 degrees F, dip time=45 seconds
Water sample at 42 degrees F, dip time=60 seconds.

Observation on 1/27/2009 at 1000 of dialysis RN#1, a contracted nurse, performing the total chlorine test on the water from portable RO#2 revealed she tested the water sample incorrectly, per manufacturers instructions, using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips on 2 different attempts. Observation on 1/27/2010 at 1000 and at 1020 revealed dialysis RN#1 collected samples of water to be tested for total chlorine in a plastic cup without measuring the amount of collected water. Observation on 1/27/2010 at 1105 revealed administrative staff measured the 1000 and 1020 water samples to determine if dialysis RN #1 had in fact obtained the required 100 cc (cubic centimeters) of water to be tested. Observation revealed the 1000 test measured 80 cc (not enough water) and the 1020 test sample measured 140 cc (too much water). Observation also that revealed dialysis RN #1 failed to obtain the water sample temperature to determine the amount of time the reagent pad needed to be in contact with the water sample for both the 1000 and 1020 total chlorine tests.

Interview with the dialysis RN #1 indicated that her supervisor instructed her on 10/8/09 (the first day of using the Chlorine Test Strips) to keep the test strip in the sampled water for 60 seconds and then read the results, so she didn't see the need to get the temperature of the water sample.

Observation on 1/27/2010 at 1110 of a subsequent chlorine test that had been conducted under the supervision of administrative staff ensuring the correct amount of water was tested for the required amount of time using the RPC K100-0118 Ultra-Low Total Chlorine test strips, revealed a result of 0.1 ppm. Observation revealed the temperature of the fresh sample of RO#2 water was 64 degrees F (Farenheit) which required 30 seconds of contact time. This test result indicated that the portable RO#2, where Patient #13 had been dialyzing since approximately 0800, had an unsafe level of total chlorine.

Interview on 1/27/2010 at 1110 with the inventory and compliance supervisor and the hospital Quality Director revealed that they verified the total chlorine reagent test strip result as 0.1 ppm for RO #2. Observation revealed that the patient was immediately removed from RO #2 and dialyzed the remainder of his treatment on RO #3. Observation revealed further total chlorine testing for RO#2 using a Hach meter (borrowed from a nearby outpatient dialysis) remained above the safe total chlorine limits at 0.23 ppm at 1110 and 0.36 ppm at 1125.

Interview with the dialysis RN #1 on 1/27/2010 at 1005 revealed she had been aware that the total chlorine level for RO#2 had been increasing since January 19, 2010, and had informed the biomedical technician from the outpatient dialysis unit on January 19 that RO #2 had tested 0.05 ppm. Interview on 1/27/2010 at 1145 with dialysis RN #1 revealed she put patient #13 on RO#2 because "he (the patient) wouldn't have been able to see the TV from where the other portable RO was located."

Interview on 1/27/2010 at 1115 with the inventory and compliance supervisor indicated that although the carbon tanks can be used until the carbon test result reaches 0.1 ppm," they try to re-bed the carbon tanks at 0.08 to ensure that the chlorine level never reaches 0.1 ppm."

Review of the hemodialysis water documentation revealed the water used for patient dialysis treatments was not safe due to increased levels of total chlorine (greater or equal to 0.1 ppm). Review of the TCL-1 for RO #3 revealed on 1/25/10 the total chlorine level measured 0.1 ppm at 0830, 1030 and 1330.

Interview on 1/27/2010 at 1145 with the dialysis RN #1 revealed that RO #3 had been used for patient dialysis treatment on 1/27/2010.

Interview on 1/28/2010 at 0900 with the hospitals CCO, the nurse responsible for the Dialysis unit oversight, revealed she had not been aware of the quality issues in dialysis that surfaced during the survey and did not have any dialysis qualifications such that she would have known what to look for. She stated that she felt like "they (contracted service) were the experts and would do what was required, and had no idea that it was not being done."

Based on manufacturer's product instructions review, observations and staff interviews, the hospital failed to ensure 3 of 3 contracted dialysis staff (dialysis nurses #1, 2, 3) was competent in the technical aspects of hemodialysis care.

The findings included:

Review of the manufacturer instructions for using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips revealed the following:

Test Procedure
-Collect a fresh 100 ml sample of water in a plastic cup
-Remove one test strip from its foil package and dip it in the sample for 20 (crossed out) 60 (had been hand written in) seconds.

Important Note:
The 20 (crossed out and 60 had been hand written in) second dip time is for a test sample at approximate room temperature (72-80 degrees)
Water sample at 64 degrees F, dip time=30 seconds.
Water sample at 52 degrees F, dip time=45 seconds
Water sample at 42 degrees F, dip time=60 seconds.

Observation on 1/27/2009 at 1000 of dialysis RN#1, a contracted nurse, performing the total chlorine test on the water from portable RO#2 revealed she tested the water sample incorrectly, per manufacturers instructions, using the RPC K100-0118 Ultra-Low Total Chlorine Test Strips on 2 different attempts. Observation on 1/27/2010 at 1000 and at 1020 revealed dialysis RN#1 collected samples of water to be tested for total chlorine in a plastic cup without measuring the amount of collected water. Observation on 1/27/2010 at 1105 revealed administrative staff measured the 1000 and 1020 water samples to determine if dialysis RN #1 had in fact obtained the required 100 cc (cubic centimeters) of water to be tested. Observation revealed the 1000 test measured 80 cc (not enough water) and the 1020 test sample measured 140 cc (too much water). Observation also that revealed dialysis RN #1 failed to obtain the water sample temperature to determine the amount of time the reagent pad needed to be in contact with the water sample for both the 1000 and 1020 total chlorine tests.

Interview with the dialysis RN #1 indicated that her supervisor instructed her on 10/8/09 (the first day of using the Chlorine Test Strips) to keep the test strip in the sampled water for 60 seconds and then read the results, so she didn't see the need to get the temperature of the water sample.

Observation on 1/27/2010 at 1110 of a subsequent chlorine test that had been conducted under the supervision of administrative staff ensuring the correct amount of water was tested for the required amount of time using the RPC K100-0118 Ultra-Low Total Chlorine test strips, revealed a result of 0.1 ppm. Observation revealed the temperature of the fresh sample of RO#2 water was 64 degrees F (Farenheit) which required 30 seconds of contact time. This test result indicated that the portable RO#2, where Patient #13 had been dialyzing since approximately 0800, had an unsafe level of total chlorine.

Interview with the dialysis RN #1 on 1/27/2010 at 1005 revealed she had been aware that the total chlorine level for RO#2 had been increasing since January 19, 2010, and had informed the biomedical technician from the outpatient dialysis unit on January 19 that RO #2 had tested 0.05 ppm. Interview on 1/27/2010 at 1145 with dialysis RN #1 revealed she put patient #13 on RO#2 because "he (the patient) wouldn't have been able to see the TV from where the other portable RO was located."

Review of the personnel records of contracted licensed staff of the hemodialysis unit revealed no documented evidence that 3 of 3 staff reviewed had competence in performing the total chlorine test using the contracted RPC K100-0118 Ultra-Low Total Chlorine Test Strips. Record review also revealed that 1 of the 3 contracted hemodialysis staff had no documented evidence that she had been trained in "Nurses Technical Training" (NTT) (skills competence related to hemodialysis water knowledge), and 1 of the 3 hemodialysis contracted staff most current annual NTT was dated on 4/15/09.

Interview with the hospitals CCO on 1/27/2010 at 0900 revealed the dialysis staff did not have documentation reflecting that they had been trained on how to use the Ultra-Low Total Chlorine Test Strips and/or water technical training.

Based on restraint policy and procedure review, medical record review, and staff interviews the hospital staff failed to ensure a restraint order was authenticated (signed, dated, and timed) by the ordering physician and/or authenticated by the ordering physician within 24 hours after the order was written for 2 of 5 restraint records reviewed (#16 & 1).

The findings included:

Review of hospital policy entitled Restraints, revised 2/2009, revealed under ...2. "Restraint for Acute Medical and Surgical Care" ...c. "Orders for Restraints" ...7. "The physician order should not exceed a period of 24 hours. 8. Continued use of the restraint beyond the first 24 hours is authorized by a physician by issuing a new order if the restraint continues to be clinically justified."

1. Open record review for Patient #16, revealed a 78 year old, admitted on 10/05/2009 with diagnoses of FTT (failure to thrive), and Altered Mental Status. Record review revealed nursing documentation the patient had been placed in restraints on 01/08, 01/09, 01/10 and 01/11/2010. Further record review revealed documentation of a physician's order for restraints on 01/08, 01/09, 01/10 and 01/11/2010. Further review of the orders revealed the orders were signed by the physician, however there were no dates or times indicating when the orders were authenticated by the prescribing physician. Continued record review revealed on 01/12/2010 a physician order had been placed in the patient's medical record for the use of restraints. Further review of the restraint order revealed the physician did not authenticate the order until 01/14/2010 (2 days later). Interview with the DON (director of nursing) on 1/27/2010 at 1400 confirmed these findings as she was unable to provide documentation the physician dated and timed the orders written on 01/08, 01/09, 01/10 and 01/11/2010 and authenticated the restraint order within 24 hours for the restraint order obtained on 01/14/2010.

2. Open record review for Patient #1, revealed a 64 year old admitted on 12/12/2009 with a diagnosis of Respiratory Failure, Secondary to Pneumonia. Record review revealed on 12/25/2009 and 12/26/2009, physician orders were placed in the patient's chart by nursing staff for the use of restraints. Further review of the restraint orders revealed the physician did not authenticate the orders until 12/28/2009 (3 and 2 days later respectively). Interview with the DON on 1/27/2010 at 1400 confirmed these findings as she was unable to provide documentation the restraint orders were authenticated within 24 hours after being obtained.

Based on hospital policy, emergency service record reviews, and staff interviews, the hospital staff failed to ensure a complete and accurate medical record for 3 of 3 emergency services records reviewed (#35, #36, #37).

Findings included:

Review of hospital policy "Emergency Services Individuals Seeking" Policy 001-21-004.2, revised February 2009, revealed "...6. An appropriate medical record shall be kept for every patient receiving emergency service....The medical record shall include: ...b. ...who/how transported....d. Description of significant clinical findings. ...f. ...plans for management. g. Condition of the patient on discharge or transfer..."

1. Review of Emergency Services Record for Patient #35, revealed a female patient (age unknown) presented to the hospital staff on 01/19/2010 at 2030 with complaints of Vertigo and Vision Changes. Further record review failed to reveal any available documentation of mode of arrival; description of significant clinical findings; plans for management; nor condition of the patient on discharge or transfer.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #35 did not contain the required documentation as per policy. Interview revealed she was unaware of the required elements to be documented in the emergency service record per the hospital policy.

2. Review of Emergency Services Record for Patient #36, revealed a female patient (age unknown) presented to the hospital staff on 12/16/2009 at 0500 with complaints of Tachycardia (fast heart rate), elevated blood pressure, and feeling bad. Further record review failed to reveal any available documentation of mode of arrival; description of significant clinical findings; plans for management; nor condition of the patient on discharge or transfer.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #36 did not contain the required documentation as per policy. Interview revealed she was unaware of the required elements to be documented in the emergency service record per the hospital policy.

3. Review of Emergency Services Record for Patient #37, revealed a female patient (age unknown) presented to the hospital staff on 11/06/2009 at 0540 with complaints of Feeling week and seeing spots. Further record review failed to reveal any available documentation of mode of arrival; description of significant clinical findings; plans for management; nor condition of the patient on discharge or transfer.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #37 did not contain the required documentation as per policy. Interview revealed she was unaware of the required elements to be documented in the emergency service record per the hospital policy.

Based on Medical Staff Rules and Regulations, hospital policy, emergency service record reviews, and staff interviews, the hospital staff failed to ensure a discharge summary was completed for 3 of 3 emergency service records reviewed (#35, #36, #37).

Findings included:

Review of the current "Medical Staff Rules & Regulations" approved 09/30/2004 and last reviewed on 01/2009 revealed "...I. An appropriate emergency service medical record shall be maintained for all patients presenting for emergency care...The emergency service medical record shall include, but not be limited to, the following: ...vi. Conclusions at termination of treatment including condition, final disposition, and instructions given to the patient and/or family member regarding necessary follow-up care; and vii. Notation that a copy of the record is available to the physician or medical organization providing follow-up care, treatment, and service. ..."

Review of hospital policy "Emergency Services Individuals Seeking" Policy 001-21-004.2, revised February 2009, revealed "...6. An appropriate medical record shall be kept for every patient receiving emergency service....The medical record shall include: ...d. Description of significant clinical findings. e. Diagnosis including condition of patient. f. Treatment given and plans for management. g. Condition of the patient on discharge or transfer. h. Final disposition, including instruction given to the patient and/or family relative to necessary follow-up care. ..."

1. Review of emergency service record for Patient #35, revealed a female patient (age unknown) presented to the hospital staff on 01/19/2010 at 2030 with complaints of Vertigo and Vision Changes. Further record review failed to reveal any available documentation of a description of significant clinical findings; diagnosis including condition of patient; plans for management; condition of the patient on discharge or transfer; final disposition, including instruction given to the patient and/or family relative to necessary follow-up care.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #35 did not contain the required documentation as per policy. Interview revealed she was unaware of the required elements to be documented in the emergency service record per the hospital policy.

2. Review of emergency service record for Patient #36, revealed a female patient (age unknown) presented to the hospital staff on 12/16/2009 at 0500 with complaints of Tachycardia (fast heart rate), elevated blood pressure, and feeling bad. Further record review failed to reveal any available documentation of a description of significant clinical findings; diagnosis including condition of patient; plans for management; condition of the patient on discharge or transfer; final disposition, including instruction given to the patient and/or family relative to necessary follow-up care.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #36 did not contain the required documentation as per policy. Interview revealed she was unaware of the required elements to be documented in the emergency service record per the hospital policy.

3. Review of emergency service record for Patient #37, revealed a female patient (age unknown) presented to the hospital staff on 11/06/2009 at 0540 with complaints of Feeling week and seeing spots. Further record review failed to reveal any available documentation of a description of significant clinical findings; diagnosis including condition of patient; plans for management; condition of the patient on discharge or transfer; final disposition, including instruction given to the patient and/or family relative to necessary follow-up care.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #37 did not contain the required documentation as per policy. Interview revealed she was unaware of the required elements to be documented in the emergency service record per the hospital policy.

Based on hospital policy, emergency service record reviews, and staff interviews, the hospital staff failed to ensure a discharge diagnosis was completed for 3 of 3 emergency service records reviewed (#35, #36, #37).

Findings included:

Review of hospital policy "Emergency Services Individuals Seeking" Policy 001-21-004.2, revised February 2009, revealed "...6. An appropriate medical record shall be kept for every patient receiving emergency service....The medical record shall include: ...e. Diagnosis including condition of patient. ..."

1. Review of emergency service record for Patient #35, revealed a female patient (age unknown) presented to the hospital staff on 01/19/2010 at 2030 with complaints of Vertigo and Vision Changes. Further record review failed to reveal any available documentation of a diagnosis.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #35 did not contain a diagnosis as per policy. Interview revealed she was unaware a diagnosis was required to be documented in the the emergency service record per the hospital policy.

2. Review of emergency service record for Patient #36, revealed a female patient (age unknown) presented to the hospital staff on 12/16/2009 at 0500 with complaints of Tachycardia (fast heart rate), elevated blood pressure, and feeling bad. Further record review failed to reveal any available documentation of a diagnosis.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #36 did not contain a diagnosis as per policy. Interview revealed she was unaware a diagnosis was required to be documented in the the emergency service record per the hospital policy.

3. Review of emergency service record for Patient #37, revealed a female patient (age unknown) presented to the hospital staff on 11/06/2009 at 0540 with complaints of Feeling week and seeing spots. Further record review failed to reveal any available documentation of a diagnosis.

Interview on 01/27/2010 at 0955 with the Chief Clinical Officer revealed the emergency service record for patient #37 did not contain a diagnosis as per policy. Interview revealed she was unaware a diagnosis was required to be documented in the the emergency service record per the hospital policy.

Based on policy and procedure reviews, observations during tour, and staff interviews, the hospital's dietary staff failed to carry out their respective duties in a competent manner to ensure: potentially hazardous foods were not served to patients and were maintained at safe temperatures; opened refrigerated foods were dated and labeled; dry foods were stored in a manner to prevent pest infestation; ventilation screens/filters and hoods were maintained in a clean and sanitary manner; and cookware, plateware, serving utensils were cleaned and stored in a sanitary condition.

Findings included:

1. Observation during tour of the main kitchen on 01/26/2010 at 1155, revealed milk being placed on patient trays was 51 degrees Farenheit. Hospital Dietary Policy entitled "Nutrition Service Role in Infection Control" revised date of 12/2008 under Scope of Practice C revealed "Ensure that food is stored, prepared, and served at proper temperatures in a safe and sanitary manner," under H. Handling and Preparing Foods: 2. revealed "...If foods are to be served cold, they must be kept at temperatures below 40 degrees..." Interview during tour with the dietary manager indicated the milk was not being served at an appropriate temperature and the milk was removed from all patient trays observed.

2. Observation during tour of the main kitchen on 01/26/2010 at 1215, revealed the refrigerator was observed to have gallon containers of condiments that had been opened (i.e. two containers of buttermilk ranch dressing, two containers of creamy french dressing, one container of mayonnaise, one container of banana peppers, two containers of La Choy sweet and sour sauce, one container of mustard, one container of Creamy Caesar dressing, one container of sweet relish, one container of chicken wing sauce and one container of olives) with no dates on the containers to indicate when they had been opened. Hospital Dietary Policy entitled "Leftover Utilization" revised date of 6/2007, "A. Proper storage of leftovers... 6. Label and date leftovers and store according to guidelines." Interview during tour with the dietary manager revealed this was inappropriate storage of opened containers of food.

3. Observation during tour of the main kitchen on 01/27/2010 at 0830, revealed plastic containers used to store rice and flour had lids/covers that would not close tightly, to prevent insects from entering the containers. Hospital Dietary Policy entitled "Nutrition Service Role in Infection Control" revised date of 12/2008 under Scope of Practice C. revealed "Ensure that food is stored, prepared, and served at proper temperatures in a safe and sanitary manner" and under Food storage - dry and refrigerated "...7. Dry products, such as beans, peas, flour, sugar meal rice, etc., are stored in portable bins with tight fitting covers." Interview during tour with the dietary manager revealed this was inappropriate storage of the flour and rice and the containers were replaced with appropriate containers with sealing covers.

4. Observation during the dietary department tour on 01/26/2010 at 1220, revealed the ice machine was observed to have a ventilation screen on the front of the machine which was heavily covered with dust and dirt. Further observation during tour on 01/27/2010 at 0830 it was observed that the ventilation hood over the cooking stoves and food preparation area had dust and mold around the air ventilation screens and condensation was forming around the surfaces of the hood over the stoves and preparation areas. Further observation of the plate warmer revealed plates with dry food particles on them, and dry food particles on the inside of the plate warmer. Further observation revealed drawers containing cooking utensils, large spoons and ladles with dry food particles on them. Review of dietary policy entitled "Nutrition Service Role in Infection Control" revised date of 12/2008 under Procedure B. revealed "Infection transmission reduction methods -- All personnel will comply with all infection control policies and procedures" including the following: "...9. Cleaning and sanitizing of equipment used in food preparation and serving." Interview during tour with the dietary manager confirmed these findings during the tour.

Based on staff interview, dialysis contract review, dialysis policy review, dialysis water documentation review, contact staff interview, observations, and manufacturer's product instructions review, the hospital failed to ensure water treatment systems in the hemodialysis unit were maintained to assure the water used for treatment would be within the required limits for chemical contaminants and failed to ensure staff monitored the temperature of high-level disinfectant in the instrument decontamination room.

The findings included:

1. Interview with administrative staff on 1/27/2010 at 0900 revealed hemodialysis was a contracted service.

Review of the hemodialysis contract dated on 10/7/2003 revealed "Provider (contractor) shall provide equipment necessary to render acute dialysis services...including, but not limited to, portable dialysis machines, water treatment and ancillary equipment ...The services shall be performed ...either duly licensed and qualified nurses or qualified technicians trained in extracorporeal therapy including acute dialysis treatment ...Provider shall maintain equipment it supplies ...in proper working order and be responsible for repairs, upkeep, maintenance and servicing of the equipment. The equipment shall be maintained by Provider Staff in proper operating condition pursuant to the manufacturer's guidelines and applicable industry standards."

Review of dialysis policy 153-010-041, Water Quality Standards For Hemodialysis (5/15/96), revealed "Free chlorine is potentially toxic due to its high oxidation potential and ability to form chloramines. Effective purification method: Carbon filtration."

Review of TCL-1 (total chlorine log) log revealed if total chlorine result is not below 0.1 ppm, immediate actions required.

Interview on 1/27/2010 at 1145 with the inventory and compliance supervisor revealed total chlorine tests are conducted prior to each patient treatment and approximately every 4 hours while the patient is receiving hemodialysis.

Review of TCL-1 (total chlorine log) log revealed if total chlorine result is not below 0.1 ppm, immediate actions required.

Observation on 1/27/2010 at 1000 revealed the total chlorine test conducted by dialysis RN#1 for RO#2 had results than exceeded the safe limit for provision of patient hemodialysis. Observation revealed a total chlorine level of 0.1 ppm.

Observation on 1/27/2010 at 1110 of a subsequent chlorine test that had been conducted under the supervision of administrative staff to ensure the correct technique and procedure had been followed using the RPC K100-0118 Ultra-Low Total Chlorine test strips revealed the total chlorine result indicated that the portable RO#2, where Patient #13 had been dialyzing since approximately 0800, had an unsafe level of total chlorine. Observation revealed a total chlorine level of 0.1 ppm.

Interview with biomedical staff on 1/27/2010 at 1115 also confirmed that the total chlorine test conducted at 1110 on 1/27/2010 for RO#2 had results that exceeded the safe limit for provision of patient hemodialysis as evidenced by subsequent chlorine test results that used a Hach meter (a more accurate chlorine test method) which had been borrowed on 1/27/2010 at 1010 from the out patient dialysis facility that resulted above the safe total chlorine limits at 0.23 ppm at 1110 and 0.36 ppm at 1125. Interview revealed based on the unsafe total chlorine test results, RO #2 should not be used until the attached carbon tanks were replaced.

Interview with the dialysis RN #1, on 1/27/2010 at 1005 revealed she initially became aware that the total chlorine level for RO#2 had increased since January 19, 2010, and had informed the biomedical technician from the out patient dialysis unit on January 19 that RO#2 had tested 0.05 ppm. Dialysis RN #1 stated on 1/27/10 at 1045 that she didn't like to dialyze patients on portable RO equipment when the the carbon tanks tart exhausting "at 0.05 ppm."

Interview on 1/27/2010 at 1115 with the inventory and compliance supervisor revealed that carbon tanks are safe to use until the total chlorine reached 0.1 ppm. She stated that "we try to re-bed or exchange the carbon tanks at around a total chlorine level of 0.08 ppm to ensure that the chlorine level never reaches 0.1 ppm."

Interview on 1/27/2010 at 1145 with the inventory and compliance supervisor of the dialysis contracted service revealed that based on the hospitals current testing methods for identifying levels of total chlorine for the RO water systems, the RPC K100-0118 Ultra-Low Total Chlorine test strips, contained no method for identifying levels of total chlorine between 0.05 ppm (safe) and 0.1 ppm (unsafe) total chlorine results.

Observation revealed the color comparator had no color result for 0.08 ppm, the point that biomedical staff indicated an action was required. Review of the RPC K100-0118 Ultra-Low Total Chlorine test strips color comparator also revealed that color change between 0.05 ppm (safe levels of chlorine) verses 0.1 ppm (unsafe levels of chlorine) was a very subtle color change.

Interview on 1/27/2010 at 1115 with the inventory and compliance supervisor revealed that the RO should have not been used if the total chlorine test resulted in 0.1 ppm. Interview revealed she had not been aware that the carbon tanks for RO#2 were exhausted.

Review of the hemodialysis water documentation revealed the water used for patient dialysis treatments was not safe due to increased levels of total chlorine (greater or equal to 0.1 ppm). Review of the TCL-1 for RO #3 revealed on 1/25/2010 the total chlorine level measured 0.1 ppm at 0830, 1030 and 1330.

Interview on 1/27/2010 at 1145 with the dialysis RN #1 revealed that RO #3 had been used for patient dialysis treatment on 1/27/2010.

2. Interview on 1/27/2010 at 1150 with dialysis RN #1 revealed staff is required to complete the individual log for each of the RO machines for each treatment day it is utilized for patient treatment.

Review of the dialysis policy 153-020-030, Water Treatment Equipment (11/2/05), revealed the primary purpose of the a reverse osmosis machine is to remove from feed water dissolved inorganic solutes, larger organic solutes having a molecular weight greater than 200, and microbiological contaminants such as endotoxins, viruses and bacteria. Review of dialysis policy 153-020-031, Instructions for Completing form A-RO-1 RO Machine Log (5/15/96), "The purpose of the log is to establish a record of the performance of the RO machines that may be used in the Acute Program. The record may also be used to provide the operating history necessary to resolve problems with the general operation of the water treatment equipment".

Review of the machine log for RO#2 and RO#3 from 7/1/09-review of the RO log revealed the following areas were required to be monitored each hemodialysis treatment day:
-Feed water temperature
-pre-filter pressure
-post filter pressure
-final pump pressure
-permeate flow
-concentrate flow
-feed conductivity
-permeate conductivity
-concentrate conductivity
-pH post carbon tank
Review of the RO log revealed the following areas were required to be monitored at:
-pH pre-carbon tank-each operating week
-percent rejection-each operating week
-differential pressure-recorded monthly on the day the filter element is changed

Review of the machine log from 7/09-1/27/10 for RO#2 revealed no documented evidence that the daily feed water temperature had monitored on 113 of 113 treatment days.

Review of the machine log from 7/1/09-1/27/10 for RO#3 revealed no documented evidence that the daily feed water temperature had monitored on 113 of 113 treatment days.

Review of the RO machine logs from 7/1/09-1/27/10 for RO #2 revealed no documented evidence that the monthly differential pressure had been monitored on 7 of 7 months.

Review of the RO machine logs from 7/1/09-1/27/10 for RO #3 revealed no documented evidence that the monthly differential pressure had been monitored on 7 of 7 months.

Interview on 1/27/2010 at 1145 with dialysis RN #1 revealed the temperature of the feed water had not been obtained as required because there wasn't a thermometer available in the dialysis unit.


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3. Review of the manufacturer's package insert for the high-level disinfectant Cidex OPA (a glutaraldehyde solution used to disinfect surgical instruments) revealed, "Directions for Use...A. High Level Disinfection 1. Manual Processing: Immerse device completely...in Cidex OPA Solution for a minimum of 12 minutes at 20 (degrees) C (Celsius) (68 degrees F [Fahrenheit]) or higher to destroy all pathogenic microorganisms....D. Reusage for Disinfection:....1. Monitoring of Germicide:....During the usage of Cidex OPA Solution as a high level disinfectant, it is recommended that a thermometer and timer be utilized to ensure that the optimum conditions are met...."

Observation during tour on 01/27/2010 at 1115 of the decontamination room (scope processing room) revealed Cidex OPA in a basin in the room. Observation revealed no thermometer in the basin of Cidex OPA. Review of the Cidex Test Log located in the decontamination room during tour revealed no documentation that the temperature was monitored.

Interview on 01/27/2010 at 1115 with administrative nursing staff revealed the Cidex OPA was used to disinfect endoscopes used to perform endoscopic procedures on patients. Interview further revealed the administrative nursing staff was unaware of the manufacturer's instructions to monitor the temperature of Cidex OPA Solution to ensure the temperature was 68 degrees Fahrenheit or higher.

Based on policy reviews, dialysis water documentation reviews, staff interviews, observations during tour, Patient Procedure Log reviews and Endoscope Cleaning Log reviews, the hospital's infection control officer failed to have a system in place to control infections and communicable diseases by failing to: ensure the water used for patient hemodialysis was tested monthly for bacteria and endotoxins; ensure measures were taken for water culture results that exceeded the set action level and ensure endoscopes were disinfected prior to patient use.

The Findings included:

1. Review of dialysis policy 153-510-010-1, Microbiological Monitoring, (4/4/07) revealed monthly bacteria and endotoxin tests would be obtained for product water and dialysate. Policy review also revealed if a test result exceeds the action level and allowable limit, staff should promptly notify the medical director, nurse manager...and corrective actions implemented. Policy revealed the following limitations for bacteria/endotoxin growth:

PRODUCT WATER
Bacteria-
action-20 cfu (colony forming units)
allowable limit- 50 cfu
Endotoxin-
action-0.25 EU (endotoxin units)
allowable limit-1 EU

DIALYSATE
Bacteria-
action-20 cfu
allowable limit-200 cfu
Endotoxin-
action-0.06 EU
allowable limit-0.25 EU

Policy review also revealed if a test result exceeds the action level and allowable limit, staff should promptly notify the medical director, nurse manager...and corrective actions implemented.

Observation in the hemodialysis unit on 1/27/2010 at 1000 revealed the unit utilized two portable reverse osmosis (RO) water systems for patient treatment, RO #2, and RO #3 and two hemodialysis machines, #18 and #43A.

Review of the water documentation from 1/09-12/09 revealed no documented evidence that bacteria cultures had been obtained for the product water on RO #2 and RO #3 for 5 of 12 months (3/09, 7/09, 9/09, 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that endotoxin cultures had been obtained for the product water on RO #2 and RO #3 for 8 of 12 months (1/09, 2/09, 3/09, 4/09, 7/09, 9/09, 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate bacteria cultures had been obtained on hemodialysis machine #18 for 4 of 12 months (3/09, 9/09 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate bacteria cultures had been obtained on hemodialysis machine #43 for 5 of 12 months (3/09, 7/09, 9/09 10/09, 11/09).

Review of the water documentation from 1/09-12/09 revealed no documented evidence that dialysate endotoxin cultures had been obtained for hemodialysis machines #18 and #43A on 7 of 12 months (1/09, 2/09, 3/09, 4/09, 7/09, 10/09, 11/09).

Review revealed endotoxin cultures for RO #2 drawn on 5/20/09 with a result of 0.94 EU. Review revealed staff re-drew cultures on 5/22/09 with a result of 0.88 EU on 5/24/09 which was, again, above the action level. Review revealed no documented evidence of follow-up by staff until 6/30/09 when routine monthly cultures were drawn for 6/09. Review also revealed no documented evidence that the medical director or unit nurse manager of the hemodialysis unit had been notified.

Review of the dialysate cultures on hemodialysis machine #18 revealed 2/9/09 bacteria growth of >200 cfu (above allowable limit) which was reported on 2/11/09. Review revealed immediate action had not been implemented rgarding the high results. Review revealed subsequent cultures had been re-drawn on 2/16/09, 5 days after results were reported.

Interview on 1/27/2010 at 1145 with the inventory and compliance supervisor revealed the dialysis unit does not have a workable system in place for obtaining, tracking, trending, reporting and timely acting upon bacteria/endotoxin culture results above the set action levels.

Interview with the Infection Control Nurse on 1/18/2010 at 1015 revealed that she was told every month by RN#1 that there were no problems with bacteria/endotoxin growth in the water used for patient hemodialysis. She stated that unfortunately, because she had relied on the "dialysis expects" to provide her with accurate information, there was no tracking or trending of abnormal dialysis culture results.


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2. Review of current hospital policy entitled "Infection Control: High Level Disinfection" revised June 2004 revealed, "Purpose To insure properly processed, high level disinfected medical equipment to all patients to prevent the transmission of nosocomial pathogens....Procedure A. High level disinfection is appropriate for semi-critical medical equipment....For example, flexible endoscopes...."

Observation during tour of the decontamination (endoscope processing) room on 01/27/2010 at 1115 revealed one endoscope hanging on the wall in an enclosed, clear Plexiglass case. Further observation revealed the endoscope was unlabeled. Interview with administrative nursing staff during the observation revealed the hospital utilized 3 endoscopes for patient procedure, including one for PEG tube insertions, one for bronchoscopies and one for swallow studies. Interview revealed staff disinfect endoscopes after each patient use with a high level disinfectant in the decontamination room. Interview revealed after the endoscopes are dry, staff hang them in the following areas: the one used for PEG tube insertions in the clear case in the decontamination room; the one used for swallow studies in the Rehabilitation Department in a clear case and the one used for bronchoscopies in the Respiratory Therapy Department in a clear case. Interview revealed there was no process at the hospital to label endoscopes as "clean" after they have been disinfected. Interview revealed the administrator knew the observed endoscope was clean "because it's hanging there (in the clear case)". Interview revealed staff should document disinfection on the Cleaning Log for each endoscope whenever it was disinfected.

Observation during tour of the Respiratory Therapy Department on 01/27/2010 at 1130 revealed one bronchoscope (endoscope) hanging on the wall in an enclosed, clear Plexiglass case. Further observation revealed the endoscope was unlabeled. Interview with the Director of Respiratory Therapy during the observation revealed prior to November 2009 there was no process to document bronchoscope disinfection. Interview revealed the hospital initiated a new process in November 2009 in which staff must document each disinfection of the bronchoscope on the Bronchoscope Cleaning Log. Interview revealed there was no process to label the bronchoscope as "clean" after it had been disinfected.

Observation during tour of the Rehabilitation Department on 01/28/2010 at 0900 revealed one endoscope hanging on the wall in an enclosed, clear Plexiglass case. Further observation revealed the endoscope was unlabeled. Interview with a speech therapist during the observation revealed speech therapy staff cleaned the endoscope with a high level disinfectant in the decontamination room and then hang it in the clear case after it was clean. Interview revealed speech therapy staff document each disinfection of the endoscope on the Endoscope Cleaning Log. Interview revealed there was no process to label the endoscope as "clean" after it had been disinfected. Interview revealed, "If it's in the case then it's clean."

Review of Patient Procedure Logs revealed the following:
? Patient #10 had a PEG procedure on 09/23/2009;
? Patient #15 had a PEG procedure on 09/25/2009;
? Patient #38 had a bronchoscopy on 10/01/2009;
? Patient #16 had a PEG procedure on 10/06/2009;
? Patient #26 had a PEG procedure on 10/09/2009;
? Patient #27 had a PEG procedure on 10/23/2009;
? Patient #4 had a PEG procedure on 11/13/2009 (at 0835);
? Patient #28 had a PEG procedure on 11/13/2009 (at 1240);
? Patient #29 had a bronchoscopy on 11/24/2009;
? Patient #16 had a bronchoscopy on 12/14/2009 and
? Patient #30 had a bronchoscopy on 12/30/2009.

Review of Endoscope Cleaning Logs from September 2009 through January 2010 revealed documentation the endoscope used for the insertion of PEG tubes was disinfected on the following dates (no times listed): 09/22/2009, 09/25/2009, 10/23/2009, 10/26/2009 (listed twice), 11/13/2009, 12/02/2009, 12/05/2009, 12/25/2009 and 01/22/2010. Review revealed documentation the bronchoscope was disinfected on 11/24/2009. Review revealed no documentation that the endoscope used for PEG procedures was disinfected before it was used on the following patients:
? Patient #15 on 09/25/2009 (after it was used for Patient #10 on 09/23/2009);
? Patient #26 on 10/09/2009 (after it was used for Patient #16 on 10/06/2009);
? Patient #27 on 10/23/2009 (after it was used for Patient #26 on 10/09/2009) and
? Patient #28 on 11/13/2009 at 1240 (after it was used for Patient #4 on 11/13/2009 at 0835.

Further review revealed no documentation that the bronchoscope was disinfected before it was used on the following patients:
? Patient #29 on 11/24/2009 (after it was used on Patient #38 on 10/01/2009) and
? Patient #30 on 12/30/2009 (after it was used on Patient #16 on 12/14/2009).

Interview with administrative nursing staff on 01/27/2010 at 1415 confirmed there was no documented evidence available that endoscopes were disinfected prior to use on Patient #15 on 09/25/2009, Patient #26 on 10/09/2009, Patient #27 on 10/23/2009, Patient #28 on 11/13/2009, Patient #29 on 11/24/2009 and Patient #30 on 12/30/2009.

Interview on 01/27/2010 at 1430 with the Infection Control nurse revealed the nurse has oversight of the hospital's Infection Control Program. Interview revealed the nurse's oversight of the procedure for the disinfection of endoscopes consisted of ensuring staff performed high level disinfection per policy. Further interview revealed, "I have not evaluated the process to the extent that I have reviewed logs and verified they (endoscopes) were clean before use on patients."

Based on hospital policy review, observations during tour, documentation review, and staff interviews the hospital failed to ensure unauthorized individuals could not can gain access to confidential health information stored in patient medical records by failing to limit access to the Health Information Management (HIM) Department (medical records).

The findings included:

Review of hospital policy titled "Security of the HIM Department," approved May 2006, revealed "Medical records are maintained in the HIM department. The records shall not be left unattended to unauthorized personnel."

Observation during tour on 01/27/2010 at 1400 of the Health Information Management (HIM) Department, revealed the department's main entry door to be secured with a single key lock located in the door handle. Observation revealed the entry door was the only access to the HIM department.

Interview on 01/27/2010 at 1400 with the Health Information HIPPA Officer (HIM Director) revealed the hours of operation for the department are Monday - Friday 0800-1630. The interview revealed at 1700 the office is locked and the department is closed. Further interview revealed the department is accessible after normal hours of operation with a master key for the facility, which will open the HIM department.

Review of a "list" (hand written) provided on 01/28/2010 by the HIM Director, revealed eight (8) master keys issued to Non-HIM personnel in the following departments: Chief Executive Officer (1) ; Chief Clinical Officer(1); Human Resources (1); Risk Manager (1); Infection control (1); Administrative assistant (1); and Senior Director of Business Development (1) and Maintenance (1).

Follow-up interview on January 28, 2010 at 1100 with the HIM Director revealed the policy (Security of the HIM Department) does not identify who is "authorized" to have access to the HIM department. Further interview revealed there is no reason why the HR Director, Risk Manager, or Infection Control Nurse should have access to the HIM department. Interview revealed "others may have keys too that should not." Interview confirmed unauthorized personnel have access to the HIM department after normal hours of operation.