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Based on review of hemodialysis (HD) contracts, HD policies and procedures, water culture reports and staff interviews, the facility's governing body failed to ensure oversight of the hemodialysis contracted services by failing to ensure water culture reports for four out of twelve months were reviewed by the hemodialysis medical director.

Finding include:

Review of a contract between the hospital and the HD provider effective 06/01/2009 on 04/06/2011 revealed "Exhibit 3.13 Items Provided by Company (HD contracted service)...6. Water Quality Analysis Supplies."

Review on 04/06/2011 of the HD policy "Dialysate Culture Policy" revised 03/2010 revealed the policy had been provided by the contracted service. Review revealed "Policy:...2. The AFA (Acute Facility Administrator)/designee, Biomed Services and Medical Director, if applicable review all dialysate culture results monthly."

Review of the HD water culture logs from March 2010 - February 2011 failed to reveal a review of the culture results by the AFA, Biomed Service or Medical Director on May 2010 or June 2010. Further review failed to reveal a review of the culture results by the Medical Director on October 2010 or November 2010.

Interview with facility nurse management staff on 04/07/2011 at 0950 revealed this staff member is the facility's liaison with the HD contracted service. Interview revealed there were months with missing physician reviews. Interview revealed this may have been during a transition between HD medical directors. Interview revealed the facility's governing body failed to ensure oversight of the contracted service by failing to ensure oversight of the water quality utilized for HD treatments in the facility and provided by the contracted service.

Based on hospital policy review, grievance file reviews, and staff interviews the hospital failed to review, investigate, and resolve each patient's grievance within a reasonable time frame for 3 of 3 grievance files reviewed (#47, #48, #49).

The findings include:

Review of current hospital policy "Patient Complaint/Grievance Reporting," Policy: H-05-13, revised 02/23/2010 revealed "...Procedure: ...II. Within 24 hours of receipt, the grievance will be forwarded to the Department Director for review by the Patient Representative. ...III. The Department Director will review the grievance, document action/resolution and forward the completed patient complaint/grievance form to the Patient Representative within seven business days. ...IV. The patient or patient's designee filing the grievance, will be informed of the findings of the investigation. Such report will be made in writing, by the Patient Representative within 60 business days from the date the grievance is filed. The notice will contain the steps taken on behalf of the patient to investigate the grievance, with whom the grievance was discussed, the results of the grievance process with date of completion, the name and phone number of a contact person. ..."

1. Review on 04/06/2011 of a grievance file containing a "Patient Concern Form" for Patient #47 revealed a grievance was received by the hospital on 02/01/2011 (64 days since receipt) from the patient's representative (mother) concerning quality of care issues at the hospital. Review revealed a copy of the grievance was sent (no date noted) to the Emergency Department (ED) Nursing Director and the ED Medical Director (former) for investigation. Review of a typed note (not dated) from the ED Nursing Director revealed "...This concern as stated refers to patient care by provider. I feel this issue should be addressed by physician. Please share this concern with Dr.___(former ED Medical Director)..." Review of the "Patient Concern Form" revealed handwritten notes by the ED Medical Director (former) dated 03/07/2011 (34 days after grievance submission) and 03/17/2011 (44 days after grievance submission). Further review revealed "Date Completed: (blank)" and "Completed By: (blank)." Further review of the grievance file revealed no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further review revealed no documentation of a written letter of resolution sent to the patient or patient's representative.

Interview on 04/06/2011 at 1348 with the Director of Marketing and Customer Service revealed he oversees the hospital's grievance process. Interview revealed complaints are usually called into a complaint line. Interview revealed the complaint line is checked daily by one of four hospital Patient Representatives. Once a compliant is received the complaint is sent to the appropriate department Director or Medical Director within 24 hours for investigation. Interview revealed the department Director or Medical Director has 7 business days to complete the investigation. Interview revealed once the investigation is completed the findings are submitted back to the hospital's Patient Representative department and a written response is sent to the patient and/or patient's representative within 60 days. Interview revealed the grievance file for Patient #47 was considered open (64 days after grievance receipt) because there was not a copy of the written response sent to the patient and/or patient's representative in the grievance file. Interview confirmed no documentation of the date (within 24 hours after receipt) the grievance was submitted to the ED Nursing Director or ED Medical Director (former) for investigation. Interview confirmed the ED Nursing Director nor the ED Medical Director (former) had not completed the investigation within the 7 business days per policy. Interview confirmed a written response had not been sent to the patient and/or patient's representative within in 60 days per policy. Interview confirmed the grievance file contained no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further interview revealed the Director of Marketing and Customer Service was unaware of the CMS guidelines for appropriate timeframes for the investigation and provision of a written response to a grievance. Interview confirmed the hospital's grievance policy did not comply with CMS requirements. Interview confirmed the hospital failed to review, investigate, and resolve Patient #47's grievance within a reasonable time frame.

2. Review on 04/06/2011 of a grievance file containing a "Patient Concern Form" for Patient #49 revealed a grievance was received by the hospital on 03/02/2011 (35 days after receipt) from the patient concerning quality of care issues at the hospital. Review revealed a copy of the grievance was sent (no date noted) to the ED Medical Director (former) for investigation and to Risk Management. Review of the grievance file revealed no documentation as of 04/06/2011 (35 days after receipt) of an investigation into Patient #49's grievance. Further review revealed no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further review revealed no documentation of a written letter of resolution sent to the patient or patient's representative. Review of hospital documentation not contained in the grievance file and presented after-the-fact revealed an electronic mail dated 03/31/2011 at 0914 (29 days after receipt) to the ED Medical Director (former) that revealed "Dr.___ just wanted to touch base and see if you have looked at this concern." Review of a typed note (not dated) revealed "...On Friday, April 1st (30 days after receipt) spoke with medical director's office. Administrative assistant advised that new ED Medical Director should be starting Monday, April 5th. Any unresolved complaint can be shared with him."

Interview on 04/06/2011 at 1348 with the Director of Marketing and Customer Service revealed he oversees the hospital's grievance process. Interview revealed complaints are usually called into a complaint line. Interview revealed the complaint line is checked daily by one of four hospital Patient Representatives. Once a compliant is received the complaint is sent to the appropriate department Director or Medical Director within 24 hours for investigation. Interview revealed the department Director or Medical Director has 7 business days to complete the investigation. Interview revealed once the investigation is completed the findings are submitted back to the hospital Patient Representative department and a written response is sent to the patient and/or patient's representative within 60 days. Interview revealed the grievance file for Patient #48 was considered open (35 days after receipt) because there was not a copy of the written response sent to the patient and/or patient's representative in the grievance file. Interview confirmed no documentation of the date (within 24 hours after receipt) the grievance was submitted to the ED Medical Director (former) for investigation. Interview confirmed no documentation of the findings of an investigation into the grievance. Interview confirmed the ED Medical Director (former) had not completed the investigation within the 7 business days per policy. Interview confirmed the grievance file contained no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Interview confirmed no written letter of resolution had been sent to the complainant as of 04/06/2011. Further interview revealed the Director of Marketing and Customer Service was unaware of the CMS guidelines for appropriate timeframes for the investigation and provision of a written response to a grievance. Interview confirmed the hospital's grievance policy did not comply with CMS requirements. Interview confirmed the hospital failed to review, investigate, and resolve Patient #49's grievance within a reasonable time frame.

3. Review on 04/06/2011 of a grievance file containing a "Patient Concern Form" for Patient #48 revealed a grievance was received by the hospital on 03/08/2011 (29 days prior to review date) from the patient's representative (mother) concerning quality of care issues at the hospital. Review revealed a copy of the grievance was sent (no date noted) to the ED Medical Director (former) for investigation. Review of the grievance file revealed no documentation as of 04/06/2011 (29 days since receipt) of an investigation into Patient #48's grievance. Further review revealed no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further review revealed no documentation of a written letter of resolution sent to the patient or patient's representative. Review of hospital documentation not contained in the grievance file and presented after-the-fact, revealed a typed note (not dated) that revealed "03/21/2011 (13 days after receipt) - Sent reminder regarding (Patient #48) complaint. 3/31/2011 (23 days after receipt) - Spoke to (staff name) and told her Dr.___(former ED Medical Director) had not responded to this complaint. This was his last scheduled day. (staff name) said to give a copy to the new director, Dr.___. 04/04/2011 (27 days after receipt) - Gave a copy of the original complaint to (staff name). She said she would have DR.___ go over the complaint and process with Dr.___(new ED Medical Director)."

Interview on 04/06/2011 at 1348 with the Director of Marketing and Customer Service revealed he oversees the hospital's grievance process. Interview revealed complaints are usually called into a complaint line. Interview revealed the complaint line is checked daily by one of four hospital Patient Representatives. Once a compliant is received the complaint is sent to the appropriate department Director or Medical Director within 24 hours for investigation. Interview revealed the department Director or Medical Director has 7 business days to complete the investigation. Interview revealed once the investigation is completed the findings are submitted back to the hospital Patient Representative department and a written response is sent to the patient and/or patient's representative within 60 days. Interview revealed the grievance file for Patient #48 was considered open (29 days after receipt) because there was not a copy of the written response sent to the patient and/or patient's representative in the grievance file. Interview confirmed no documentation of the date (within 24 hours after receipt) the grievance was submitted to the ED Medical Director (former) for investigation. Interview confirmed no documentation of the findings of an investigation into the grievance. Interview confirmed the ED Medical Director (former) had not completed the investigation within the 7 business days per policy. Interview confirmed the grievance file contained no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Interview confirmed no written letter of resolution had been sent to the complainant as of 04/06/2011. Further interview revealed the Director of Marketing and Customer Service was unaware of the CMS guidelines for appropriate timeframes for the investigation and provision of a written response to a grievance. Interview confirmed the hospital's grievance policy did not comply with CMS requirements. Interview confirmed the hospital failed to review, investigate, and resolve Patient #48's grievance within a reasonable time frame.

Based on hospital policy review, grievance file reviews, and staff interviews the hospital failed to provide written notice of the resolution of a grievance for 1 of 3 grievance files reviewed (#47).

The findings include:

Review of current hospital policy "Patient Complaint/Grievance Reporting," Policy: H-05-13, revised 02/23/2010 revealed "...Procedure: ...IV. The patient or patient's designee filing the grievance, will be informed of the findings of the investigation. Such report will be made in writing, by the Patient Representative within 60 business days from the date the grievance is filed. The notice will contain the steps taken on behalf of the patient to investigate the grievance, with whom the grievance was discussed, the results of the grievance process with date of completion, the name and phone number of a contact person. ..."

Review on 04/06/2011 of a grievance file containing a "Patient Concern Form" for Patient #47 revealed a grievance was received by the hospital on 02/01/2011 (64 days since receipt) from the patient's representative (mother) concerning quality of care issues at the hospital. Review revealed a copy of the grievance was sent (no date noted) to the Emergency Department (ED) Nursing Director and the ED Medical Director (former) for investigation. Review of a typed note (not dated) from the ED Nursing Director revealed "...This concern as stated refers to patient care by provider. I feel this issue should be addressed by physician. Please share this concern with Dr.___(former ED Medical Director)..." Review of the "Patient Concern Form" revealed handwritten notes (of the investigation) by the ED Medical Director (former) dated 03/07/2011 (34 days after grievance submission) and 03/17/2011 (44 days after grievance submission). Further review revealed "Date Completed: (blank)" and "Completed By: (blank)." Further review of the grievance file revealed no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further review revealed no documentation of a written notice of resolution sent to the patient or patient's representative as of 04/06/2011 (64 days after grievance received).

Interview on 04/06/2011 at 1348 with the Director of Marketing and Customer Service revealed he oversees the hospital's grievance process. Interview revealed complaints are usually called into a complaint line. Interview revealed the complaint line is checked daily by one of four hospital Patient Representatives. Once a compliant is received the complaint is sent to the appropriate department Director or Medical Director within 24 hours for investigation. Interview revealed the department Director or Medical Director has 7 business days to complete the investigation. Interview revealed once the investigation is completed the findings are submitted back to the hospital's Patient Representative department and a written response is sent to the patient and/or patient's representative within 60 days. Interview revealed the grievance file for Patient #47 was considered open (64 days after grievance received) because there was not a copy of the written response sent to the patient and/or patient's representative in the grievance file. Interview confirmed no documentation of the date (within 24 hours after receipt) the grievance was submitted to the ED Nursing Director or ED Medical Director (former) for investigation. Interview confirmed the ED Nursing Director nor the ED Medical Director (former) had not completed the investigation within the 7 business days per policy. Interview confirmed a written response had not been sent to the patient and/or patient's representative within 60 days per policy. Interview confirmed the grievance file contained no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further interview revealed no documentation of a written letter of resolution in the grievance file for Patient #47. Further interview revealed the Director of Marketing and Customer Service was unaware of the CMS guidelines for appropriate timeframes for the investigation and provision of a written response to a grievance. Interview confirmed the hospital's grievance policy did not comply with CMS requirements. Interview confirmed the hospital failed to review, investigate, and resolve Patient #47's grievance within a reasonable time frame and provide a written letter of resolution.

Based on hospital policy review, medical record review and staff interview, the hospital staff failed to ensure a time limited restraint order was obtained for 1 of 3 sampled patients who were restrained for the management of violent or self-destructive behaviors (#10).

The findings include:

Review of current hospital policy "Restraint and Seclusion" Policy: D-50-D42, revised 01/11 revealed, "...V. PHYSICAL RESTRAINT AND/OR SECLUSION FOR BEHAVIORAL HEALTH REASONS A. Requirements for All Settings 1. Initiation of Restraint. ...b. The initial and all subsequent restraint orders shall expire in: * 4 hours for patients 18 years of age and older. ..."

Closed record review on 04/07/2011 for Patient #10 revealed a 46 year-old female who presented to the hospital's emergency department on 02/21/2011 with a diagnosis of Alcohol Intoxication and was subsequently discharged in the custody of police the same day.

Review of a Physician's Restraint Order Form (ATTACHMENT C) revealed "A. Reason - based on Nursing Assessment: (check all that apply) ...5. [check mark on a line] Other: Patient very ETOH (alcohol), kicking, pulling, threatening to bite staff" hand written on a line {Violent or Self-Destructive Behaviors}.

Further review revealed a verbal physician's order for restraint obtained by a registered nurse with a "Start Date" 02/21/2011 (hand written), a "Start/Order Time" 1845 (hand written), "Type Restraint" RW (right wrist) LW (left wrist) soft (hand written), "Reason for Restraint" ETOH, threatening nurses-to kill them (hand written). Further review revealed no documentation of an age appropriate time limited order for the restraint.

Consequently, record review revealed the patient was placed into bilateral soft limb holders (2 point wrist restraints) for the management of violent or self-destructive behaviors on 02/21/2011 from 1845 to ~2235 (3 hours 50 minutes) without an age appropriate time limited physician's order. Furthermore, the preprinted directions on the Physician's Restraint Order Form (ATTACHMENT C) directs the staff to obtain a time limited order only for "Use of 4-point restraints whether soft wrist & ankle or TAT requires: ...3) physician order renewal every 4 hours" and not for 2 point restraints used for the management of violent and self-destructive behaviors.

Interview on 04/07/2011 at 1545 with emergency department nursing management staff revealed an age appropriate time limited order is required for the use of restraints for the management of violent or self-destructive behaviors. Interview revealed documentation by the nurse on the Physician's Restraint Order Form (ATTACHMENT C) dated 02/21/2011 at 1845 for Patient #10 revealed the patient was restrained for the management of violent or self-destructive behaviors. Interview revealed the nurse documenting the order and restraint should have used the behavioral health restraint forms instead of the medical-surgical restraint forms. Interview revealed the verbal physician's order obtained by the nurse indicated a start date and start/order time. Interview revealed the nurse failed to document a stop date and stop time. Interview revealed the order should have been time limited to no more than four hours. Interview confirmed the order for restraint was not time limited to four hours.

Based on hospital policy review, medical record review and staff interview, the hospital staff failed to monitor and assess a restrained patient per hospital policy for 1 of 3 patients sampled who were restrained for the management of violent or self-destructive behaviors (#10).

The findings include:

Review of current hospital policy "Restraint and Seclusion" Policy: D-50-D42, revised 01/11 revealed, "...V. PHYSICAL RESTRAINT AND/OR SECLUSION FOR BEHAVIORAL HEALTH REASONS A. Requirements for All Settings ...5. Monitoring: a. a competent registered nurse shall assess the patient at the initiation of restraint or seclusion and every 15 minutes thereafter. b. The assessment shall include the following, unless it is inappropriate for the type of restraint or seclusion employed. *Signs of any injury associated with applying restraint or seclusion *Nutrition and hydration *Circulation and range of motion in the extremities *Vital signs *Hygiene and elimination *Physical and psychological status and comfort * Readiness for discontinuation of restraint or seclusion ..."

Closed record review on 04/07/2011 for Patient #10 revealed a 46 year-old female who presented to the hospital's emergency department on 02/21/2011 with a diagnosis of Alcohol Intoxication and was subsequently discharged in the custody of police the same day.

Review of a Physician's Restraint Order Form (ATTACHMENT C) revealed "A. Reason - based on Nursing Assessment: (check all that apply) ...5. [check mark on a line] Other: Patient very ETOH (alcohol), kicking, pulling, threatening to bite staff" hand written on a line {Violent or Self-Destructive Behaviors}. Further review revealed a verbal physician's order for restraint obtained by a registered nurse on 02/21/2011 at 1845. Review of nursing documentation revealed the patient was placed into bilateral soft limb holders (2 point wrist restraints) for the management of violent or self-destructive behaviors on 02/21/2011 from 1845 to ~2235 (3 hours 50 minutes). Review of a Restraint Management Plan of Care Medical & Post-Surgical (ATTACHMENT D) form revealed the patient was assessed by a registered nurse at 1845 (initiation of restraint), 2015 (30 minutes later); and 2215 (120 minutes later). Further record review failed to reveal any available documentation a registered nurse assessed and monitored the patient every 15 minutes for the required elements after the initiation of the restraints until release per policy.

Interview on 04/07/2011 at 1545 with emergency department nursing management staff revealed when restraints are used for the management of violent or self-destructive behaviors, the patient is to be assessed and monitored every 15 minutes after initiation of restraint and thereafter until released from restraint. Interview revealed documentation by the nurse on the Restraint Management Plan of Care Medical & Post-Surgical (ATTACHMENT D) form revealed no available documentation the nurse monitored and assessed the patient every 15 minutes per policy. Interview confirmed Patient #10 was restrained for the management of violent or self-destructive behaviors. Interview confirmed the patient should have been monitored and assessed every 15 minutes until the restraints were released for the elements required in the policy. Interview confirmed the nurse failed to follow hospital policy.

Based on hospital policy review, medical record review, and staff interview the physician or other licensed independent practitioner conducting the face-to-face evaluation within 1 hour after the initiation of restraint and/or seclusion failed to evaluate one or more of the following required elements: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint for 3 of 3 sampled patients restrained and/or secluded for the management of violent or self-destructive behaviors (#10, #9, #36).

The findings include:

Review of current hospital policy "Restraint and Seclusion" Policy: D-50-D42, revised 01/11 revealed, "...V. PHYSICAL RESTRAINT AND/OR SECLUSION FOR BEHAVIORAL HEALTH REASONS A. Requirements for All Settings ...2. One-hour face-to-face assessment: The physician or LIP shall perform a face-to-face assessment of the patient's physical and psychological status within 1 hour of the initiation of the restraint. ..."

1. Closed record review on 04/07/2011 for Patient #10 revealed a 46 year-old female who presented to the hospital's emergency department (ED) on 02/21/2011 with a diagnosis of Alcohol Intoxication and was subsequently discharged in the custody of police the same day. Review of a Physician's Restraint Order Form (ATTACHMENT C) revealed "A. Reason - based on Nursing Assessment: (check all that apply) ...5. [check mark on a line] Other: Patient very ETOH (alcohol), kicking, pulling, threatening to bite staff" hand written on a line {Violent or Self-Destructive Behaviors}. Further review revealed a verbal physician's order for restraint obtained by a registered nurse on 02/21/2011 at 1845. Review of nursing documentation revealed the patient was placed into bilateral soft limb holders (2 point wrist restraints) for the management of violent or self-destructive behaviors on 02/21/2011 from 1845 to ~2235 (3 hours 50 minutes). Review of ED physician documentation revealed a medical screening exam was conducted at 1900 (15 minutes after the initiation of restraint). Further record review revealed no documentation the ED physician evaluated Patient #10 within one-hour after the restraint initiation for one or more of the following required elements specific to restraints: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint.

Interview on 04/07/2011 at 1545 with ED nursing management staff revealed the nursing staff does not conduct the one hour face-to-face evaluation in the emergency department for patients who have been restrained and/or secluded for the management of violent or self-destructive behaviors. Interview revealed the ED physician conducts the evaluation. Interview revealed the physicians document the findings on a "T-Sheet" or "T-Sheet" progress note. Interview confirmed there was no available documentation the ED physician assessed all of the required elements of a one hour face-to-face evaluation including: the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and the need to continue or terminate the restraint for the restraint initiated on 02/21/2011 at 1845 for Patient #10.

2. Closed record review on 04/07/2011 for Patient #9 revealed a 23 year-old female admitted to the hospital's behavioral health unit under involuntary commitment petition on 01/06/2011 with a diagnosis of Schizoaffective Disorder, Bipolar Type versus Bipolar Disorder. The patient was subsequently discharged on 01/08/2011. Review of a Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI) dated 01/07/2011 at 1835 revealed a physician's order for mechanical restraint and seclusion for Verbal/Physical Threat, Physically Assaultive, and Imminent danger to self/other. Further record review revealed the patient was placed into mechanical restraint and/or seclusion on 01/07/2011 from 1830 to 2010 (110 minutes). Further review revealed documentation of a "Face to face evaluation completed by: (Physician Signature on line) Date: 01/07/2011 (hand written on line) Time: 1915 (hand written on line)." Further record review revealed no documentation of the findings of the physician's one-hour face-to-face evaluation of Patient #9 conducted on 01/07/2011 at 1915 for the following required elements specific to restraints: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint.

Telephone Interview on 04/07/2011 at 1600 with the Behavioral Health Medical Director (a Psychiatrist) revealed a face-to-face assessment is conducted by a physician within one hour, on the unit, after a patient is placed into restraint and/or seclusion. Interview revealed after the face-to-face is conducted the physician immediately signs, dates, and times the Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI). Interview revealed he does not generally document his findings of the one-hour face-to-face exam. Interview revealed he may address the findings of his assessment in a progress note the next day. Interview revealed he was unaware of the four elements required by regulation to be evaluated and documented in the medical record regarding one-hour face-to-face assessments.

Interview on 04/07/2011 at 1615 with an Information Systems Clinical Analyst confirmed no available documentation of the required elements for the one-hour face-to-face evaluation, including: the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and the need to continue or terminate the restraint for the restraint initiated on 01/07/2011 at 1915 for Patient #9.

3. Closed record review on 04/07/2011 for Patient #36 revealed a 57 year-old male admitted to the hospital's behavioral health unit under involuntary commitment petition on 10/28/2010 with a diagnosis of Bipolar Disorder, NOS (not otherwise specified). The patient was subsequently discharged on 11/05/2010. Review of a Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI) dated 10/30/2010 at 1335 revealed a physician's order for seclusion for Verbal/Physical Threat, Physically Assaultive, and Imminent danger to self/other. Further review revealed the patient was placed into seclusion on 10/30/2010 from 1335 to 1345 (10 minutes). Further review revealed documentation of a "Face to face evaluation completed by: (Physician Signature on line) Date: 10/30/2010 (hand written on line) Time: 1339 (hand written on line)." Further record review revealed no documentation of the findings of the physician's one-hour face-to-face evaluation conducted on 10/30/2010 at 1339 for the following required elements specific to restraints: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint.

Telephone Interview on 04/07/2011 at 1600 with the Behavioral Health Medical Director (a Psychiatrist) revealed a face-to-face assessment is conducted by a physician within one hour, on the unit, after a patient is placed into restraint and/or seclusion. Interview revealed after the face-to-face is conducted the physician immediately signs, dates, and times the Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI). Interview revealed he does not generally document his findings of the one-hour face-to-face exam. Interview revealed he may address the findings of his assessment in a progress note the next day. Interview revealed he was unaware of the four elements required by regulation to be evaluated and documented in the medical record regarding one-hour face-to-face assessments.

Interview on 04/07/2011 at 1615 with a Information Systems Clinical Analyst confirmed there was no available documentation of the required elements for the one-hour face-to-face evaluation, including: the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and the need to continue or terminate the restraint for the restraint initiated on 10/30/2010 at 1335 for Patient #36.

Based on review of hemodialysis (HD) policies and procedures, HD medical records and staff interview, staff failed to ensure a complete HD order was obtained prior to initiation of treatment for 3 of 3 records reviewed (#29, #28, #27).

Findings include:

Review on 04/07/2011 of HD policy "Physician Order Policy" revised 09/2010 revealed the policy was provided by the HD contracted service. Review revealed "i. HD prescription includes: treatment duration and frequency, dialyzer type, blood flow rate (BFR), dialysate flow rate (DFR), body weight parameters, anticoagulation therapy and, as applicable, sodium modeling, UF (Ultra Filtration) profile, and dialysate temperature."

1. Closed record review on 04/07/2011 for Pt (patient) #29 revealed a 53 year old admitted 03/14/2011 for hypoglycemia and CKD (chronic kidney disease - dialysis dependent). Review revealed the patient received a HD treatment on 03/14/2011 and 03/16/2011. Review revealed a telephone verbal order received by a staff Registered Nurse (RN) on 03/14/2011 at 1805 "Hemodialysis change: run (symbol for with) K+ bath of 1.0 for 2 hours then K+ bath of 2.0 for remainder of HD treatment." Further review revealed a handwritten order by the HD physician on 03/15/2011 at 1230 "Dialysis tomorrow (symbol for with) same outpt (outpatient) HD orders - Take off 3-4kg."

Interview with nurse management staff on 04/07/2011 at 1530 revealed a complete HD prescription order, as per the HD policy, should be received prior to initiation of treatment. Review revealed the only orders written for the patient's HD treatments were as above. Review revealed the orders were incomplete and failed to address: dialyzer type, treatment time and frequency, BFR, DFR and body weight parameters.

2. Closed record review on 04/07/2011 for Pt #28 revealed a 59 year old admitted 01/10/2011 for hyperkalemia (elevated blood potassium level) and shortness of breath. Review revealed a telephone verbal order received by a HD LPN (Licensed Practical Nurse) on 01/10/2011 at 1900 "Stat HD 3-1/2* (three hours thirty minutes treatment time), BFR 400, DFR 800, 0K bath x 1*, 1K x 2-1/2* (start treatment with zero potassium dialysis solution for one hour then to a one potassium dialysis solution for two and one half hours), Rem (remove) 3-5kg". Review of the HD treatment record for 01/10/11 revealed the patient was administered heparin 2000 Units (a blood-thinner or anticoagulant medication) when the HD treatment was initiated at 2055. Further review failed to revealed a physician's order for the anticoagulant medication administered at the initiation of the HD treatment.

Interview with nurse management staff on 04/07/2011 at 1530 revealed a complete HD prescription order, as per the HD policy, should be received prior to initiation of treatment. Review revealed the telephone order received by the HD LPN failed to also include: the dialyzer type and anticoagulant therapy.

3. Open record review on 04/07/2011 for Pt #27 revealed a 49 year old admitted 04/06/2011 for multiple pulmonary masses, pneumonia, hypoxia, diabetes type II, hypertension and end stage renal disease, requiring hemodialysis. Review revealed a telephone verbal order received by a hemodialysis licensed practical nurse (LPN) on 04/05/2011 at 1600 "HD for tomorrow (4/6): 3*30" (three hours thirty minutes treatment time), BFR (blood flow rate) 400-500, DFR (dialysate flow rate) 800, K 3.0/Ca 2.5 (dialysate type), Hep (heparin - a blood thinner medication) 2000 U (Unit) bolus, Attempt to rmve (remove) 2-3 kg (kilograms)".

Interview with nurse management staff on 04/07/2011 at 1530 revealed a complete HD prescription order, as per the HD policy, should be received prior to initiation of treatment. Review revealed the telephone order received by the HD LPN failed to also include the dialyzer type.

Based on review of facility hemodialysis (HD) contracts, HD staff job descriptions, facility policies and procedures, North Carolina (NC) Board of Nursing (BoN) Position Statements, NC Administrative Code Rules, personnel files, HD medical records, observations during tour and staff interviews, the facility failed to provide supervision to contract HD nursing staff as required by the scope of practice for the Licensed Practical Nurse (LPN) in the state of NC for three of three HD records reviewed (#27, #28, #29).

Findings include:

Review of a contract between the facility and a HD service provider effective 06/01/2009 on 04/06/2011 revealed "3.9 Staff. Company (HD service provider) shall provide properly trained and qualified non-physician personnel (the "Staff"), which may include but is not limited to, registered nurses, licensed practical nurses and dialysis technicians practicing under the supervision of Company's registered nurses, in adequate numbers to provide the ordered services..."

Review on 04/07/2011 of a job description for the "Acute Licensed Practical Nurse (Acute LPN) effective 05/2007 revealed the job description was provided by the contracted HD service. Review revealed "Essential Duties and Responsibilities...Perform duties under the supervision of a Registered Nurse in accordance with State regulations, (Company) policy, Acute Facility policy and the (Company) Acute Service agreement with the Acute Facility."

Review on 04/07/2011 of facility Nursing policy "Patient Assessment Standard" revised 11/2010 revealed "Policy: A Registered Nurse assesses the patient's need for nursing care...The LPN may complete the Admission History."

Review on 04/07/2010 of NC BoN Position Statement "Dialysis - Role of Unlicensed Assistive Personnel (UAP) - Position Statement for RN, LPN and UAP Practice" revised 05/2009 revealed "Issue: Hemodialysis and Peritoneal Dialysis in Acute Settings - Clients requiring dialysis in acute care settings are unstable because of either acute renal failure or chronic renal failure complicated by other acute health problems...Note: To support the provision of safe, effective nursing care throughout the dialysis process...monitoring the client throughout the dialysis process must be performed by the appropriate level of licensee and consistent with the scope of practice, including assignment and supervision."

Review on 04/07/2011 of NC BoN Position Statement "Delegation and Assignment of Nursing Activities - Position Statement for RN and LPN Practice" revised 01/2010 revealed "RN Role in Assignment and Delegation...Maintains overall accountability for the coordination and delivery of nursing care to the individual client or group of clients for whom the RN has accepted responsibility; Assesses client's status, determines clinical competence of licensed and unlicensed personnel, and identifies variables in each practice setting prior to permitting any staff to assign or delegate nursing activities; Indicates through policy, procedure, and plans of care what nursing activities and tasks may appropriately be completed by each level of licenses or unlicensed personnel based on scope of practice..." Further review revealed "LPN Role in Assignment and Delegation...RN supervision is continuously available, on-site if necessary, as determined by client needs." Further review revealed "Notes...An agency's chief nursing officer is responsible for establishing those policies, procedures, practices, and channels of communication, which provide the framework in which assignment and/or delegation may be carried out..."

Review on 04/07/2011 of NC BoN Position Statement "LPN Scope of Practice - Clarification - Position Statement for LPN Practice" effective 01/2010 revealed "LPN Scope of Practice in all steps of the nursing process is limited and focused because, by law, it is a dependent and directed scope of practice. LPN practice requires assignment or delegation by and performance under the supervision, orders, or directions of a registered nurse (RN), dentist, or other person authorized by State law to provide the supervision." Further review revealed "Planning...For the LPN, planning includes the participation in the identification of the client's needs related to the findings of the nursing assessment...Identification of nursing interventions and goals for review by the RN." Further review revealed "It is beyond the scope of practice to assign nursing responsibilities to RNs...Therefore, it is beyond LPN scope of practice to be responsible for the following activities...orientation and teaching of nursing staff, validation of competence."

Review of NC Administrative Code (NCAC) Rule 21 NCAC 36 .0225 "Components of Nursing Practice for the Licensed Practical Nurse" effective 01/2010 revealed "(a) The licensed practical nurse shall accept only those assigned nursing activities and responsibilities...which the licensee can safely perform. That acceptance shall be based upon the variables in each practice setting which include...(3) the stability of each client's clinical condition." Further review revealed "(3) The degree of supervision required for the performance of any assigned or delegated nursing activity by the licensed practical nurse when implementing nursing care is determined by variables which include, but are not limited to...(B) stability of the client's clinical condition, which involves both the predictability and rate of change...When a client's condition is unpredictable or unstable, the licensed practical nurse participates in the performance of the task under close supervision of the registered nurse or other person(s) authorized by law to provide such supervision; (C) complexity of the nursing task which is determined by depth of scientific body of knowledge upon which the action is based and by the task's potential threat to the client's well-being. When a task is complex, the licensed practical nurse participates in the performance of the task under close supervision of the registered nurse or other person(s) authorized by law to provide such supervision..."

Personnel file review for Staff #15 revealed the staff is provided by the contracted service and is a licensed practical nurse (LPN).

Personnel file review for Staff #16 revealed the staff is provided by the contracted service and is a registered nurse (RN).

Personnel file review for Staff #17 revealed the staff is provided by the contracted service and is a licensed practical nurse (LPN).

1. Open record review on 04/07/2011 for Pt #27 revealed a 49 year old admitted 04/06/2011 for multiple pulmonary masses, pneumonia, hypoxia, diabetes type II, hypertension and end stage renal disease, requiring hemodialysis. Review revealed the patient was assessed and monitored by Staff #15 during HD treatment on 04/06/2011.

Observation during tour of the HD unit on 04/06/2011 at 1015 and during the HD treatment for Pt #27 revealed Staff #15 (a LPN) and Staff #16 (a RN) were present. Interview with Staff #16 during tour revealed this was the staff member's first day in the hospital and the staff member was being oriented by Staff #15 to the acute HD program at the facility. Interview revealed the HD LPN was orienting and validating the competence of the new HD RN.

2. Closed record review on 04/07/2011 for Pt #28 revealed a 59 year old admitted 01/10/2011 for hyperkalemia (elevated blood potassium level) and shortness of breath. Review revealed the patient was assessed and monitored by Staff #17 during HD treatment on 01/10/11.

3. Closed record review on 04/07/2011 for Pt #29 revealed a 53 year old admitted 03/14/2011 for hypoglycemia and CKD (chronic kidney disease - dialysis dependent). Review revealed the patient was assessed and monitored by Staff #17 during HD treatments on 03/14/2011 and 03/16/2011.

Interview the chief nursing officer (CNO) of the facility on 04/07/2011 at 0950 revealed the HD treatments in the facility have always been provided under contract with the current company. Interview revealed the primary care providers for HD treatments currently in the facility are LPNs. Interview revealed the HD treatments "used to be performed by a registered nurse (provided by the contracted service)." Interview revealed there are no RNs in the facility who are competent to perform and monitor HD treatments and supervise the LPNs performing HD treatments. Interview revealed the HD LPNs assess, monitor and perform the HD treatments in the facility independently and without supervision by a RN. Review of the NC BoN Position Statements and LPN Scope of Practice Rules during interview revealed the HD LPNs were practicing outside their Scope of Practice and without supervision by a RN.

Review of facility Medical Staff Bylaws, HD (Hemodialysis) records and staff interview, staff failed to ensure verbal orders for HD treatments were authenticated by the ordering physician for 1 of 2 closed HD records reviewed (#28).

Findings include:

Review of current Medical Staff Bylaws on 04/07/2011 revealed "Section D: Conduct of Care...B. Orders...All verbal orders must be dated, timed and authenticated promptly by the ordering practitioner within 48 hours."

1. Closed record review on 04/07/2011 for Pt #28 revealed a 59 year old admitted 01/10/2011 for hyperkalemia (elevated blood potassium level) and shortness of breath. Review revealed a telephone verbal order received by a HD LPN (Licensed Practical Nurse) on 01/10/2011 at 1900 "Stat HD 3-1/2* (three hours thirty minutes treatment time, BFR [Blood Flow Rate] 400, DFR [Dialysis Flow Rate] 800, 0K bath x 1*, 1K x 2-1/2* (dialysate type start treatment with zero potassium for one hour then to a one potassium for two and one half hours), Rem (remove) 3-5kg". Review revealed the ordering physician authenticated the order on 02/04/2011 (three weeks and four days after the order was obtained).

Interview with nurse management staff on 04/07/2011 at 1530 revealed verbal orders should be authenticated within 48 hours. Interview revealed the HD treatment verbal orders for Patient #28 was not authenticated within the required 48 hour time frame.

Based on policy review, observation and staff interview the hospital dietary staff failed to ensure a clean and sanitary environment for the safe handling of food and equipment use in the dietary services area.

Findings include:

Review on 04/07/2011 of hospital Shelf Life Guidelines, revised 11/22/2010, revealed a list of products that once opened some products would last from 3 to 4 days, others 5 to 7 days, some products as much as a month. However without the producted being dated when opened there was no way of knowing when to discard the products.

1. Observation during the dietary tour on 04/06/2011 at 1015 revealed the following opened and undated products in the dry storage and refrigerated areas:
? Spices
? Peanut Granules
? Breading Seasoning
? Graham Cracker Crumbs
? Barley
? Red Hot Sauce
? Brown Seasoning Sauce
? Sesame Oil
? Lime Juice
? Molasses
? Relishes
? Dressings
? Macaroni Salad
? Whipping Cream
? Gallon of Milk
? Frozen package of meat with a hole in the bag

2. Further observation of dietary on 04/06/2011 at 1015 revealed the following expired foods:
? Goldfish Cheddar Crackers expired on 02/28/2011
? Five chocolate health shakes expired on 04/05/2011
? Mayonnaise dated 01/30/2011
? Mayonnaise dated 03/01/2011
? A-1 Sauce dated 01/27/2011
? Red Hot Sauce dated 03/02/2011

3. Final observation of dietary on 04/06/2011 at 1045 revealed two containers used to store powdered sugar did not have a cover that completely sealed the products while in storage.

Interview on 04/06/2011 with the Dietary Manager who was present at the time of the tour indicated the opened products should have been dated and the expired products should not have been on the shelves. Further interview revealed staff would need continued training on policies regarding these issues. Interview further revealed there was no specific dietary policy regarding spices, however agreed there needed to be policies in place to monitor.

Based on observations as referenced in the Life Safety Report of Survey completed 04/07/2011, the hospital staff failed to develop and maintain the facilities in a manner to ensure the health and safety of patients, staff, and visitors.

The findings include:

1. The hospital failed to develop and maintain a safe physical plant and overall safe environment to assure the safety and well being of patients.

~cross-refer to 482.41(a) Physical Environment: Maintenance of Physical Plant - Standard Tag A0701.

2. The hospital failed to assure the safety of patients, staff, and visitors by failing to ensure the essential electrical system was maintained to provide emergency power and lighting to critical and appropriate areas of the hospital during outages of normal power.

~cross-refer to 482.41(a)(1) Physical Environment: Emergency Power and Lighting - Standard Tag A0702.

3. The hospital failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association to assure the safety and well being of patients.

~cross-refer to 482.41(b) Physical Environment: Life Safety from Fire - Standard Tag A0709.

4. The hospital failed to ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association.

~cross-refer to 482.41(b)(1)(2)(3) Physical Environment: Life Safety from Fire - Standard Tag A0710.

5. The hospital failed to ensure that alcohol based hand rub dispensers were located away from an ignition source.

~cross-refer to 482.41(b)(9) Physical Environment: Alcohol-Based Hand Rub Dispensers - Standard Tag A0716.

6. The hospital failed to ensure supplies and equipment were maintained to ensure an acceptable level of safety and quality by failing to: A) ensure high-level disinfectant solution used in surgical services was not expired and was at the appropriate concentration; B) label enzymatic cleaning solution used in surgical services; C) ensure the accurate temperature monitoring of contrast solutions placed in a warmer. D) ensure responses to action-level cultures involving HD (hemodialysis) machines were logged and within 48 hours of being reported.

~cross-refer to 482.41(c)(2) Physical Environment: Facilities, Supplies, Equipment Maintenance - Standard Tag A0724.

Based on observations as referenced in the Life Safety Report of Survey completed 04/07/2011, the hospital failed to develop and maintain a safe physical plant and overall safe environment to assure the safety and well being of patients.

The findings include:

Building 01
A. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Access Doors to the smoke duct detectors for visual inspection was not provided to several of the smoke duct detectors installed in the HVAC units on the 3rd floor mechanical area.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 067.

B. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [Behavioral Health] The findings include that the residential dryer in the laundry area did not have a noncombustible dryer vent.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 068.

C. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [Fifth Floor] The findings include there was an unapproved space heater being utilized in the office next to oncology.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 070.

D. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [Behavioral Health] The findings include the door to the nurse's station opened into the egress corridor neither without opening 180 degrees to the wall nor had a door closure installed to keep the door closed after being opened.

2) [Labor and Delivery Room (LDR)] The findings include the wheel chair storage in alcove that were protruding into the egress corridor and not stored properly.

3) [LDR] The findings include the storage of two planters in the egress corridor.

4) [LDR] The findings include the keypad/bio readers were protruding into the corridor more that seven inches.

5) Corridor door to the janitor's closet next to room 281 swings into the corridor without a listed closure and the door does not swing 180 degrees but leaves a projection of approximately 18" into the corridor.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 072.

E. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Oxygen cylinders stored in the clean works room 1st floor near the nurse station were not separated, full from empty and were not properly labeled full or empty.

2) H-size tanks stored in the bulk oxygen area were not individually secured or cover in order to be protected from the environment.

3) Full and Empty signs were not posted in oxygen storage areas on fourth and second floors. (Fourth floor across from room 467 & second floor clean utility room)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 076.

Based on observations as referenced in the Life Safety Report of Survey completed 04/07/2011, the hospital failed to assure the safety of patients, staff, and visitors by failing to ensure the essential electrical system was maintained to provide emergency power and lighting to critical and appropriate areas of the hospital during outages of normal power.

The findings include:

Building 01
Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Type 1 EES Emergency Power Generators did not crank and Transfer load within the required 10 Seconds. (Generators 1, 2, and 4)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 145.

Based on observations as referenced in the Life Safety report of survey completed 04/07/2011, the hospital failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association to assure the safety and well being of patients.

The findings include:

Building 01
A. Life Safety Surveyor observation on Wednesday, 04/06/201 revealed:

1) The exit corridor on 3rd floor was not constructed smoke tight. (Exit Corridor between the two mechanical rooms)

2) The inside corridor wall of the storage closet located next to the large clean linen room was not maintained in order to provide a one hour fire resistance rating for the area. (Ground Floor West)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 012.

B. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) The findings include the door to the medical perpetration room in the behavioral health portion of the 5th floor did not have a door closure for the top portion of the door that can be opened by the staff. (Behavioral Health)

2) The findings include the door to the office next to the Oncology office had unsealed holes near the door hardware that were not properly sealed. (Fifth Floor)

3) The corridor door to patient room 135 did not close, latch and seal when checked. (1st floor)

4) The corridor doors to the mechanical room near the elevators were not smoke tight when closed. (3rd floor)

5) The first set of corridor door to the mechanical room on the left side of hall on 3rd floor were not self-closing.

6) Corridor Door to the second floor nursing lounge, near room 271, does not have positive latching. (11:00 AM)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 018.

C. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Access to the exit, in the stairwell from OR & Outpatient, did not have a hinge on the directional barrier or a sign that says "no exit". The way to reach the exit is not readily apparent to the occupants. 7.10.1.4 (2:45 PM)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 022.

D. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [ADON's office area] The findings include the smoke wall above the cross corridor smoke doors had unsealed penetrations at the area where the smoke wall meets the door frame. (This area is located where the new MRI was brought through the corridor)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 025.

E. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) The findings include both sets of cross corridor smoke doors to enter and exit the ICU had gaps greater than 1/8 of an inch. (ICU)

2) The Fire/Smoke door from ground floor PACU to ER, in the four hour wall, did not have positive latching. (2:00 PM)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 027.

F. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) The Supply Room corridor door for the Laboratory was not self closing. (Ground Floor West)

2) There was soiled linen stored in alcoves across from room 463 and room 475. (10:20 AM)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 029.

G. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Lower Level, Out-Patient- Same Day Surgery, Numerous doors to Baths, storage, etc. required 2 hand motion to exit the rooms.

2) Lower Level, Out-Patient- Same Day Surgery, Exit discharge - There was no hard surface discharge path to a safe public way.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 032.

F. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [Behavioral Health] The findings include the key lock door release for the egress from that space is not located in the vicinity of the locked door. The key lock is at the door nearest to the nurse's station.

2) [Fifth Floor] The findings include not all staff that are assigned to the fifth floor carry keys for egress through the behavioral health area.

3) [Dietary] The findings include the exit discharge path from the required exit on the North wall did not have a solid path (easily maintained in inclement weather) other than grass or soil to the public way.

4) [Dietary] The findings include the freezer, cooler and produce cooler did not have a means of egress from each space that could be found from inside in all levels of light.

5) [Loading dock] The findings include the loading dock did not have fall protection installed at the truck loading and unloading area.

6) [Dietary] The findings include the facility is utilizing special locking arrangements but did not have full sprinkler coverage nor detection in the freezer, cooler and produce cooler.

7) [Fifth Floor] The findings include the facility is utilizing special locking arrangements but did not have full sprinkler coverage nor detection in the closet of the Oncology office.

8) [Decontamination room] The findings include the facility is utilizing special locking arrangements but did not have full sprinkler coverage nor detection in the hopper room.

9) [Dietary] The findings include the facility is utilizing special locking arrangements but did not have full sprinkler coverage nor detection in the freezer, cooler and produce cooler.

10) [First Floor] The findings include the facility is utilizing special locking arrangements but did not have full sprinkler coverage nor detection in the Viewing room.

11) [Behavioral Health] The findings include the facility is utilizing special locking arrangements but did not have full sprinkler coverage nor detection in the closet in room 565.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 032.

G. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Stairwell from Outpatient Clinic - Lower Level to 1st Floor: There was no Exit Direction Sign to the exit Discharge.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 047.

H. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [Dietary] The findings include the exit sign located on the south wall did not give the proper direction for exiting. The exit sign directed persons in that space to the right where there was no required exit.

2) [Behavioral Health] The findings include there was no exit directional sign leading from the nurses station door to the required exit at the stairwell in the locked unit.

3) An exit directional sign was not provided for in the hall outside the laboratory storage room to the exit corridor. (Ground Floor West)

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 047.

Based on observations as referenced in the Life Safety Report of survey completed 04/07/2011, the hospital failed to ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association.

The findings include:

Building 01
A. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) During the inspection and testing of the facility fire alarm system, that consisted of multiple components, the automatic dialer component, when placed in trouble from phone line failure, located in the main electrical room, did not send a trouble signal to the fire alarm control panel (FACP) located at the ER main communications. The main electrical room, where the automatic dialer component was located, gave an audible trouble signal, however, the main fire alarm control panel (FACP), located at the ER main communications, showed all systems were normal. There was not a visual and audible signal at the main communications area.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 052.

B. Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) Lower Level - Outpatient - Same Day Surgery Clinic - Two Electrical/IT closets had no sprinkler coverage as required.

~ cross refer to NFPA 101 Life Safety Code Standard - Tag K 056.

Based on observations as referenced in the Life Safety Report of survey completed 04/07/2011, the hospital failed to ensure that alcohol based hand rub dispensers were located away from an ignition source.

The findings include:

Building 01
Life Safety Surveyor observation on Wednesday, 04/06/2011 revealed:

1) [Labor and Delivery Room] The findings include the soiled utility room had an alcohol based hand rub that was installed above the light receptacle which is an ignition source.

~ cross-refer to Life Safety Code Standard - NFPA 101, Tag K0211.

Based on policy review, manufacturer's instructions review, water culture and HD machine action logs, observation, and staff interview the hospital failed to ensure supplies and equipment were maintained to ensure an acceptable level of safety and quality by failing to: A) ensure high-level disinfectant solution used in surgical services was not expired and was at the appropriate concentration; B) label enzymatic cleaning solution used in surgical services; C) ensure the accurate temperature monitoring of contrast solutions placed in a warmer. D) ensure responses to action-level cultures involving HD machines were logged and within 48 hours of being reported.

The findings include:

A) Review of current hospital policy entitled "Disinfection with High-Level Disinfectants" dated 09/2009 revealed, "All equipment and instruments used in the Operating Room that cannot withstand steam autoclaving and when time does not allow for gas sterilization, must receive high-level disinfectant prior to their use in a procedure....II. Pour contents into a plastic soak pan. III. Inscribe on a label the date that the solution is activated and expiration date....To insure that the appropriate concentration of high-level disinfectant is present and to guard against dilution, the solution will be tested with Test Strips prior to each usage. These results will be documented in a log book along with the initials of the person performing the test."

Review of manufacturer's instructions entitled "Cidex OPA (brand name)...high level disinfectant for semi-critical medical devices" attached to a container of Cidex in a storage room in the surgical services department during tour on 04/06/2011 at 1000 revealed, "Usage:...Record the date the solution was poured out of the original container into a secondary container in a log book...or on a label affixed to the secondary container. The solution in the secondary container can be used for a period up to 14 days. The product must be discarded after 14 days even if the CIDEX OPA Solution The Strip indicates a concentration above the MEC (Minimum Effective Concentration)....Monitoring of Germicide: During reuse, it is recommended that the CIDEX OPA Solution be tested with CIDEX OPA Solution Test Strips prior to each use. This is to ensure that the Minimum Effective Concentration (MEC) of ortho-phthalaldehyde is present...."

Observation on 04/06/2011 at 1000 during tour of the surgical suite revealed a semi-restricted (proper surgical attire required) hallway that circled the area where the operating rooms are located. Observation revealed a covered container of Cidex on top of a cart in the hallway. Observation revealed the container was labeled "mixed - 2/21/11...expires - 3/7/11" (expired 30 days prior to observation). Further observation revealed a black notebook labeled "Cidex Log" on the bottom of the cart. Review of instructions in the log book revealed, "Solution must be checked daily or before each case it is used for." Review of the log revealed pages with columns labeled date, pass, fail, and nurse/tech(nician) checking. Review of the log revealed an entry dated 07/05/2010, which was initialed by a staff member. Review of the 07/05/2010 log entry revealed no check mark under either the pass or fail column. Review of the log revealed no other entries. Review revealed no documentation the Cidex solution had been checked to ensure effective levels of concentration since 07/05/2010 (9 months prior to observation).

Interview on 04/06/2011 at 1000 during tour of the surgical suite with the Director of Surgical Services revealed Cidex solution should be checked to ensure effective levels of concentration before each use. Interview revealed, "This is the only Cidex (solution) we have....It is all of our responsibility to check it." Interview revealed the Cidex was not used often because most instruments were sterilized by the sterile processing department. Interview revealed, "We have 2 Ureteroscopes. (name of physician) uses them for Ureteroscopy. That is all we use Cidex for now....Its probably been a couple of weeks since we used one." Interview confirmed the observed Cidex solution was expired and should have been discarded. Interview confirmed there was no available documentation that Cidex solution had been checked to ensure effective levels of concentration since 07/05/2010 (9 months prior to observation).

B) Review of current hospital policy entitled "Decontamination of Surgical Instrument Before Leaving the Operating Room" dated 09/2009 revealed, "...The OR (operating room) housekeeper will have available a large plastic container filled with appropriate concentration of Enzymatic Detergent per manufacturer's recommendation. The container will be labeled BIO-HAZARD...."

Observation on 04/06/2011 at 1000 during tour of the surgical suite revealed a semi-restricted (proper surgical attire required) hallway that circled the area where the operating rooms are located. Observation revealed 3 covered orange containers labeled "Enzol (enzymatic detergent)" and 8 covered blue containers labeled "Cidex (high-level disinfectant solution)". Observation revealed none of the containers were labeled "BIO-HAZARD". Interview with the Director of Surgical Services during the observation revealed all of the observed containers (orange and blue) contained Endozime (enzymatic detergent). Interview revealed staff used the containers of Endozime to soak used surgical instruments in before they are sent to the sterile processing department. Interview revealed the containers labeled "Cidex" were used because they were "the right size" for soaking instruments. Interview confirmed none of the 11 observed containers of enzymatic detergent were labeled "BIO-HAZARD". Further interview revealed patients are taken to and from the operating rooms through the observed hallway.



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C. During the tour of the Radiology Department on 04/07/2011 at 1030 it was observed that a warmer for contrast solutions was being used, with no visiable temperature thermometer inside the warmer. The only temperature check that was being indicated was a green light on the front of the warmer that indicated the temperature was normal and the staff were recording "normal" for the warmer temperature. It was observed in another room the same warmer was being used, however this warmer had a thermometer strip inside the warmer to give an accrurate reading, even though the temperature log showed normal. When asked what normal was suppose to represent the staff had to go and look it up in the manufacture's product information. Normal was suppose to represent 36 to 37 C. Interview with the Department manager during this tour indicated they should be monitoring the actual temperature for accuracy.



25021

D) Review on 04/07/2011 of HD (Hemodialysis) policy "Dialysate Culture Policy" revised 03/2010 revealed the policy was provided by the contracted HD service in the facility. Review revealed "7. Interpreting culture results: Action level: 50-199 cfu/ml (colony forming units per milliliter)...8. Required responses...Single site at or above the action level: reculture the site(s)...If repeat sampling is at or above the action level...enter Troubleshooting Mode."

Review of cultures obtained from the HD machine #2 revealed on 09/05/2010 a culture result of 60 cfu/ml was reported (10 cfu/ml above minimum action level). Review revealed a handwritten note by the contracted service biomedical technician "Redraw". Further review of cultures revealed on 02/05/2011 a culture result of 110 cfu/ml was reported (60 cfu/ml above minimum action level). Review revealed a handwritten note by the contracted service biomedical technician dated 02/08/2011 (three days after the result was reported) "Redraw". Further review of cultures revealed on 02/13/2011 a culture result of 50 cfu/ml was reported (at the minimum action level). Review revealed a handwritten note by the contracted service biomedical technician dated 02/16/2011 (one day after the result was reported) "pulled from service, redraw culture". Further review of cultures revealed on 02/20/2011 a culture result of 70 cfu/ml was reported (20 cfu/ml above minimum action level). Review revealed no documentation of action taken on the culture result. Further review of cultures revealed on 02/25/2011 a culture result of <10 cfu/ml was reported (below minimum action level). Review revealed a handwritten note by the contracted service biomedical technician (no date) "Followup".

Review of the Equipment Maintenance Record for HD machine #2 from April 2010 to current date failed to reveal any documentation of any action taken for the action-level cultures reported on 09/05/2010, 02/05/2011, 02/13/2011 or 02/20/2011.

Review of cultures obtained from the HD machine #5 revealed on 09/05/2010 a culture result of 100 cfu/ml was reported (50 cfu/ml above minimum action level). Review revealed a handwritten note by the contracted service biomedical technician "Redraw" (no date).

Review of the Equipment Maintenance Record for HD machine #5 from April 2010 to current date failed to reveal any documentation of any action taken for the action-level cultures reported on 09/05/2010.

Interview by phone with biomedical technician staff from the contracted service on 04/06/2011 at 1425 revealed both machines were disinfected and recultured in response to the action-level cultures reported on 09/05/2010. Interview revealed the technician had notes with her (at another site) she was referencing as to the actions taken. Interview revealed "I should have written these in the log." Further interview revealed on 02/08/11, HD machine #2 was disinfected in response to the action-level culture reported on 02/05/2011 and cultures were redrawn (response to action-level cultures three days after reported). Interview revealed when the cultures were still at action-level when reported on 02/13/2011, the machine was again disinfected and cultures redrawn (response three days after report of action-level cultures) Interview revealed on 02/21/2011, the HD machine #2 was pulled from service in response to the action-level culture on 02/20/2011, a higher-level disinfection process was performed with maintenance on the pyrogen filter. Further interview revealed the machine was put back into service on 02/28/2011 after the normal culture result was received on 02/25/2011. Interview revealed the technician failed to log the maintenance performed on machine #2 in the maintenance log and failed to log the machine was out of service from 02/21/2011 through 02/28/2011. Further interview revealed response to action-level cultures should be accomplished within 48 hours of the culture result. Interview revealed the response for the action-level cultures on 02/05/2011 and 02/13/2011 were outside of the 48 hour response and were not performed in the accepted timeframe.

Based on policy review, observation, and staff interview the hospital's infection control officer failed to implement measures to prevent and control infections by failing to: A) ensure the semi-restricted area immediately adjacent to each operating room was free of dirty equipment, supplies, and dust; B) ensure medications and clean supplies were segregated from contaminated areas.

The findings include:

A) Review of current Operating Room (OR) policy entitled "Traffic Control" dated 09/2009 revealed, "POLICY: Prescribed patterns to control flow of personnel, patients, and material to, from and within the operating room will be strictly adhered to. To ensure patient and personnel safety. To create and maintain as clean an environment as possible within the operating room. To prevent cross-contamination of restricted, semi-restricted, and unrestricted area. PROCESS: I. Traffic Control Zones: All work flow, staff and patient traffic patterns, and materials handling must follow an unidirectional course from an unsterile to an aseptic environment state, and then to an unsterile environment or disposition as defined: A. Intermediate Zone: Areas serving as intermediate access between unrestricted corridors. Included are patient holding area, PACU (Post Anesthesia Care Unit), locker and offices with access. B. Semi-restricted zone: This includes the OR, offices in the vicinity, clean storage area, and inner corridors off operating/induction rooms. Personnel must wear scrub attire, cap and shoe covers...."

Observation on 04/06/2011 at 1000 during tour of the surgical suite revealed a semi-restricted (proper surgical attire required) hallway that circled the area where the operating rooms are located. Observation revealed a door led from the semi-restricted hallway directly into each operating room. Observation revealed the the following equipment and supplies were in the semi-restricted hallway: (6) stretchers, (2) floor cleaning machines and their chargers, (11) covered containers of Endozime (enzymatic detergent used for cleaning surgical instruments) on carts, (1) covered container of Cidex (high-level disinfectant) on a cart, (2) bins of trash, (1) intravenous infusion pump, (2) c-arm (Xray) machines and their monitors, (1) mini c-arm machine, several pieces of equipment used for spinal surgeries (such as special bed frames, etc.), (2) mop pails with mops, and several brooms. Observation revealed the Director of Surgical Services picked up a black notebook from the bottom of the "Cidex" cart located outside of OR #4 and opened it for the surveyor. Observation revealed a thick layer of dust on the notebook. Observation revealed dust flew through the air in the semi-restricted hallway when the Director opened the notebook.
A surgical procedure (c-section) was in progress in OR #4 at the time of observation.

Interview on 04/06/2011 at 1000 during the observation of the semi-restricted hallway with the Director of Surgical Services revealed patients were taken through the hallway and directly into the operating rooms for surgery. Interview revealed after surgery, patients were taken back through the hallway and into PACU. Interview revealed some of the items stored in the hallway were dirty and some were clean. Interview revealed the observed brooms, mops, and mop pails were used to clean operating rooms between surgical cases. Interview revealed the observed intravenous infusion pump was dirty. Interview revealed some of the observed stretchers were clean and others had been used to transport patients from the holding area to the OR that morning. Interview revealed items were stored in the semi-restricted hallway because there was not enough space in the surgical suite to store all equipment and supplies. Interview revealed items in the semi-restricted hallway should be clean. Interview confirmed the Cidex notebook, intravenous infusion pump, trash bins, brooms, mops, and mop pails were not clean.

Interview on 04/07/2011 at 1110 with the Infection Control Practitioner (ICP) revealed the ICP made rounds in the OR 2-4 times per year. Interview revealed during rounds the ICP had identified infection prevention concerns with storage in the semi-restricted hallway outside of OR rooms. Interview revealed, "Its been an issue for years. As we accumulate more things we don't have places to store the equipment, so more ends up in the hall....(The Director of Surgical Services) and I have discussed the (concern with) dirty and clean equipment mixed (in the hallway). One of the main issues we need to resolve is the mop buckets in the hall. We identified that as an issue at the end of last year when one of our orthopedic surgeons mentioned it to us." Interview revealed no changes had been implemented to ensure dirty items were not kept in the semi-restricted hallway. Interview revealed, "I don't think we have a good solution at this point. We need to find another place to keep them. I'm not sure where that's going to be."


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B) Review of facility policy "Infection Prevention Guidelines" revised 0/16/2009 on 4/07/2011 revealed "E. Utility rooms should segregate clean and dirty procedures."

Review of hemodialysis policy "Infection Control in the Hospital Dialysis Setting" revised 9/2010 on 04/07/2011 revealed "Hospital Dialysis Setting Hygiene - 26. Sinks should be easily accessible and readily available in the treatment area...Hand washing sinks should be dedicated only for hand washing purposes and remain clean. Avoid placing, cleaning or draining used items in hand washing sinks. Used or contaminated items should be handled in designated utility sinks...29. If a common supply cart is used to store clean supplies in the hospital dialysis setting, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. 30. Clean area should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled."

Observation during tour of the acute hemodialysis (HD) area on 04/06/2011 at 1015 revealed the area had two rooms each with one patient station. Observation revealed the entry to the area from the main hallway was into Station A and to the left past a storage cabinet and a sink, was a entry way into Station B. Observation revealed a patient currently receiving a HD treatment in the bed in Station B. Observation revealed a storage area with a shelving unit in the Station B area. Observation revealed the shelving unit contained dialysate solution in jugs (a clean supply used for HD treatments) and one shelf below was stored a jug-container of bleach solution. Interview during tour with HD staff revealed the bleach being stored with the dialysate was used to disinfect the HD machine after the treatment had ended. Interview revealed staff were storing clean supplies used for HD treatments in the same storage room as supplies used to decontaminate dirty items.

Further observation during tour of the acute HD area revealed the area had one sink in the Station B room and one sink in the Station A room. Observation revealed no designation "clean" or "dirty" sinks areas. Interview with HD staff during tour revealed both sinks were used for handwashing as well as draining potentially contaminated items. Observation revealed a locked drawer under the sink in Station A contained medications used for HD treatments. Further observation revealed there is no designated clean area for preparation of medications.

Further observation during tour of the acute HD area revealed a common supply cart against the wall of Station A and within 2 feet of the station where a patient would receive HD treatments. Interview during tour revealed staff have concerns regarding space in the unit. Interview revealed patients receive HD treatments in their bed and when the bed and HD equipment are in place in Station A, there is approximately less than 2 feet of space on the side of the bed adjacent to the common supply cart in Station A and approximately less than three feet of space from the foot of the bed and the sink area in Station A Interview revealed "we do not have sufficient space."

Based on policy review, manufacturer's instructions review, water culture and HD machine action logs, observation, and staff interview the hospital failed to ensure supplies and equipment were maintained to ensure an acceptable level of safety and quality by failing to: A) ensure high-level disinfectant solution used in surgical services was not expired and was at the appropriate concentration; B) label enzymatic cleaning solution used in surgical services; C) ensure the accurate temperature monitoring of contrast solutions placed in a warmer. D) ensure responses to action-level cultures involving HD machines were logged and within 48 hours of being reported.

The findings include:

A) Review of current hospital policy entitled "Disinfection with High-Level Disinfectants" dated 09/2009 revealed, "All equipment and instruments used in the Operating Room that cannot withstand steam autoclaving and when time does not allow for gas sterilization, must receive high-level disinfectant prior to their use in a procedure....II. Pour contents into a plastic soak pan. III. Inscribe on a label the date that the solution is activated and expiration date....To insure that the appropriate concentration of high-level disinfectant is present and to guard against dilution, the solution will be tested with Test Strips prior to each usage. These results will be documented in a log book along with the initials of the person performing the test."

Review of manufacturer's instructions entitled "Cidex OPA (brand name)...high level disinfectant for semi-critical medical devices" attached to a container of Cidex in a storage room in the surgical services department during tour on 04/06/2011 at 1000 revealed, "Usage:...Record the date the solution was poured out of the original container into a secondary container in a log book...or on a label affixed to the secondary container. The solution in the secondary container can be used for a period up to 14 days. The product must be discarded after 14 days even if the CIDEX OPA Solution The Strip indicates a concentration above the MEC (Minimum Effective Concentration)....Monitoring of Germicide: During reuse, it is recommended that the CIDEX OPA Solution be tested with CIDEX OPA Solution Test Strips prior to each use. This is to ensure that the Minimum Effective Concentration (MEC) of ortho-phthalaldehyde is present...."

Observation on 04/06/2011 at 1000 during tour of the surgical suite revealed a semi-restricted (proper surgical attire required) hallway that circled the area where the operating rooms are located. Observation revealed a covered container of Cidex on top of a cart in the hallway. Observation revealed the container was labeled "mixed - 2/21/11...expires - 3/7/11" (expired 30 days prior to observation). Further observation revealed a black notebook labeled "Cidex Log" on the bottom of the cart. Review of instructions in the log book revealed, "Solution must be checked daily or before each case it is used for." Review of the log revealed pages with columns labeled date, pass, fail, and nurse/tech(nician) checking. Review of the log revealed an entry dated 07/05/2010, which was initialed by a staff member. Review of the 07/05/2010 log entry revealed no check mark under either the pass or fail column. Review of the log revealed no other entries. Review revealed no documentation the Cidex solution had been checked to ensure effective levels of concentration since 07/05/2010 (9 months prior to observation).

Interview on 04/06/2011 at 1000 during tour of the surgical suite with the Director of Surgical Services revealed Cidex solution should be checked to ensure effective levels of concentration before each use. Interview revealed, "This is the only Cidex (solution) we have....It is all of our responsibility to check it." Interview revealed the Cidex was not used often because most instruments were sterilized by the sterile processing department. Interview revealed, "We have 2 Ureteroscopes. (name of physician) uses them for Ureteroscopy. That is all we use Cidex for now....Its probably been a couple of weeks since we used one." Interview confirmed the observed Cidex solution was expired and should have been discarded. Interview confirmed there was no available documentation that Cidex solution had been checked to ensure effective levels of concentration since 07/05/2010 (9 months prior to observation).

B) Review of current hospital policy entitled "Decontamination of Surgical Instrument Before Leaving the Operating Room" dated 09/2009 revealed, "...The OR (operating room) housekeeper will have available a large plastic container filled with appropriate concentration of Enzymatic Detergent per manufacturer's recommendation. The container will be labeled BIO-HAZARD...."

Observation on 04/06/2011 at 1000 during tour of the surgical suite revealed a semi-restricted (proper surgical attire required) hallway that circled the area where the operating rooms are located. Observation revealed 3 covered orange containers labeled "Enzol (enzymatic detergent)" and 8 covered blue containers labeled "Cidex (high-level disinfectant solution)". Observation revealed none of the containers were labeled "BIO-HAZARD". Interview with the Director of Surgical Services during the observation revealed all of the observed containers (orange and blue) contained Endozime (enzymatic detergent). Interview revealed staff used the containers of Endozime to soak used surgical instruments in before they are sent to the sterile processing department. Interview revealed the containers labeled "Cidex" were used because they were "the right size" for soaking instruments. Interview confirmed none of the 11 observed containers of enzymatic detergent were labeled "BIO-HAZARD". Further interview revealed patients are taken to and from the operating rooms through the observed hallway.



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C. During the tour of the Radiology Department on 04/07/2011 at 1030 it was observed that a warmer for contrast solutions was being used, with no visiable temperature thermometer inside the warmer. The only temperature check that was being indicated was a green light on the front of the warmer that indicated the temperature was normal and the staff were recording "normal" for the warmer temperature. It was observed in another room the same warmer was being used, however this warmer had a thermometer strip inside the warmer to give an accrurate reading, even though the temperature log showed normal. When asked what normal was suppose to represent the staff had to go and look it up in the manufacture's product information. Normal was suppose to represent 36 to 37 C. Interview with the Department manager during this tour indicated they should be monitoring the actual temperature for accuracy.



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D) Review on 04/07/2011 of HD (Hemodialysis) policy "Dialysate Culture Policy" revised 03/2010 revealed the policy was provided by the contracted HD service in the facility. Review revealed "7. Interpreting culture results: Action level: 50-199 cfu/ml (colony forming units per milliliter)...8. Required responses...Single site at or above the action level: reculture the site(s)...If repeat sampling is at or above the action level...enter Troubleshooting Mode."

Review of cultures obtained from the HD machine #2 revealed on 09/05/2010 a culture result of 60 cfu/ml was reported (10 cfu/ml above minimum action level). Review revealed a handwritten note by the contracted service biomedical technician "Redraw". Further review of cultures revealed on 02/05/2011 a culture result of 110 cfu/ml was reported (60 cfu/ml above minimum action level). Review revealed a handwritten note by the contracted service biomedical technician dated 02/08/2011 (three days after the result was reported) "Redraw". Further review of cultures revealed on 02/13/2011 a culture result of 50 cfu/ml was reported (at the minimum action level). Review revealed a handwritten note by the contracted service biomedical technician dated 02/16/2011 (one day after the result was reported) "pulled from service, redraw culture". Further review

Based on policy review, observation, and staff interview the hospital's infection control officer failed to implement measures to prevent and control infections by failing to: A) ensure the semi-restricted area immediately adjacent to each operating room was free of dirty equipment, supplies, and dust; B) ensure medications and clean supplies were segregated from contaminated areas.

The findings include:

A) Review of current Operating Room (OR) policy entitled "Traffic Control" dated 09/2009 revealed, "POLICY: Prescribed patterns to control flow of personnel, patients, and material to, from and within the operating room will be strictly adhered to. To ensure patient and personnel safety. To create and maintain as clean an environment as possible within the operating room. To prevent cross-contamination of restricted, semi-restricted, and unrestricted area. PROCESS: I. Traffic Control Zones: All work flow, staff and patient traffic patterns, and materials handling must follow an unidirectional course from an unsterile to an aseptic environment state, and then to an unsterile environment or disposition as defined: A. Intermediate Zone: Areas serving as intermediate access between unrestricted corridors. Included are patient holding area, PACU (Post Anesthesia Care Unit), locker and offices with access. B. Semi-restricted zone: This includes the OR, offices in the vicinity, clean storage area, and inner corridors off operating/induction rooms. Personnel must wear scrub attire, cap and shoe covers...."

Observation on 04/06/2011 at 1000 during tour of the surgical suite revealed a semi-restricted (proper surgical attire required) hallway that circled the area where the operating rooms are located. Observation revealed a door led from the semi-restricted hallway directly into each operating room. Observation revealed the the following equipment and supplies were in the semi-restricted hallway: (6) stretchers, (2) floor cleaning machines and their chargers, (11) covered containers of Endozime (enzymatic detergent used for cleaning surgical instruments) on carts, (1) covered container of Cidex (high-level disinfectant) on a cart, (2) bins of trash, (1) intravenous infusion pump, (2) c-arm (Xray) machines and their monitors, (1) mini c-arm machine, several pieces of equipment used for spinal surgeries (such as special bed frames, etc.), (2) mop pails with mops, and several brooms. Observation revealed the Director of Surgical Services picked up a black notebook from the bottom of the "Cidex" cart located outside of OR #4 and opened it for the surveyor. Observation revealed a thick layer of dust on the notebook. Observation revealed dust flew through the air in the semi-restricted hallway when the Director opened the notebook.
A surgical procedure (c-section) was in progress in OR #4 at the time of observation.

Interview on 04/06/2011 at 1000 during the observation of the semi-restricted hallway with the Director of Surgical Services revealed patients were taken through the hallway and directly into the operating rooms for surgery. Interview revealed after surgery, patients were taken back through the hallway and into PACU. Interview revealed some of the items stored in the hallway were dirty and some were clean. Interview revealed the observed brooms, mops, and mop pails were used to clean operating rooms between surgical cases. Interview revealed the observed intravenous infusion pump was dirty. Interview revealed some of the observed stretchers were clean and others had been used to transport patients from the holding area to the OR that morning. Interview revealed items were stored in the semi-restricted hallway because there was not enough space in the surgical suite to store all equipment and supplies. Interview revealed items in the semi-restricted hallway should be clean. Interview confirmed the Cidex notebook, intravenous infusion pump, trash bins, brooms, mops, and mop pails were not clean.

Interview on 04/07/2011 at 1110 with the Infection Control Practitioner (ICP) revealed the ICP made rounds in the OR 2-4 times per year. Interview revealed during rounds the ICP had identified infection prevention concerns with storage in the semi-restricted hallway outside of OR rooms. Interview revealed, "Its been an issue for years. As we accumulate more things we don't have places to store the equipment, so more ends up in the hall....(The Director of Surgical Services) and I have discussed the (concern with) dirty and clean equipment mixed (in the hallway). One of the main issues we need to resolve is the mop buckets in the hall. We identified that as an issue at the end of last year when one of our orthopedic surgeons mentioned it to us." Interview revealed no changes had been implemented to ensure dirty items were not kept in the semi-restricted hallway. Interview revealed, "I don't think we have a good solution at this point. We need to find another place to keep them. I'm not sure where that's going to be."


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B) Review of facility policy "Infection Prevention Guidelines" revised 0/16/2009 on 4/07/2011 revealed "E. Utility rooms should segregate clean and dirty procedures."

Review of hemodialysis policy "Infection Control in the Hospital Dialysis Setting" revised 9/2010 on 04/07/2011 revealed "Hospital Dialysis Setting Hygiene - 26. Sinks should be easily accessible and readily available in the treatment area...Hand washing sinks should be dedicated only for hand washing purposes and remain clean. Avoid placing, cleaning or draining used items in hand washing sinks. Used or contaminated items should be handled in designated utility sinks...29. If a common supply cart is used to store clean supplies in the hospital dialysis setting, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. 30. Clean area should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled."

Observation during tour of the acute hemodialysis (HD) area on 04/06/2011 at 1015 revealed the area had two rooms each with one patient station. Observation revealed the entry to the area from the main hallway was into Station A and to the left past a storage cabinet and a sink, was a entry way into Station B. Observation revealed a patient currently receiving a HD treatment in the bed in Station B. Observation revealed a storage area with a shelving unit in the Station B area. Observation revealed the shelving unit contained dialysate solution in jugs (a clean supply used for HD treatments) and one shelf below was stored a jug-container of bleach solution. Interview during tour with HD staff revealed the bleach being stored with the dialysate was used to disinfect the HD machine after the treatment had ended. Interview revealed staff were storing clean supplies used for HD treatments in the same storage room as supplies used to decontaminate dirty items.

Further observation during tour of the acute HD area revealed the area had one sink in the Station B room and one sink in the Station A room. Observation revealed no designation "clean" or "dirty" sinks areas. Interview with HD staff during tour revealed both sinks were used for handwashing as well as draining potentially contaminated items. Observation revealed a locked drawer under the sink in Station A contained medications used for HD treatments. Further observation revealed there is no designated clean area for preparation of medications.

Further observation during tour of the acute HD area revealed a common supply cart against the wall of Station A and within 2 feet of the station where a patient would receive HD treatments. Interview during tour revealed staff have concerns regarding space in the unit. Interview revealed patients receive HD treatments in their bed and when the bed and HD equipment are in place in Station A, there is approximately less than 2 feet of space on the side of the bed adjacent to t

Based on hospital policy review, grievance file reviews, and staff interviews the hospital failed to review, investigate, and resolve each patient's grievance within a reasonable time frame for 3 of 3 grievance files reviewed (#47, #48, #49).

The findings include:

Review of current hospital policy "Patient Complaint/Grievance Reporting," Policy: H-05-13, revised 02/23/2010 revealed "...Procedure: ...II. Within 24 hours of receipt, the grievance will be forwarded to the Department Director for review by the Patient Representative. ...III. The Department Director will review the grievance, document action/resolution and forward the completed patient complaint/grievance form to the Patient Representative within seven business days. ...IV. The patient or patient's designee filing the grievance, will be informed of the findings of the investigation. Such report will be made in writing, by the Patient Representative within 60 business days from the date the grievance is filed. The notice will contain the steps taken on behalf of the patient to investigate the grievance, with whom the grievance was discussed, the results of the grievance process with date of completion, the name and phone number of a contact person. ..."

1. Review on 04/06/2011 of a grievance file containing a "Patient Concern Form" for Patient #47 revealed a grievance was received by the hospital on 02/01/2011 (64 days since receipt) from the patient's representative (mother) concerning quality of care issues at the hospital. Review revealed a copy of the grievance was sent (no date noted) to the Emergency Department (ED) Nursing Director and the ED Medical Director (former) for investigation. Review of a typed note (not dated) from the ED Nursing Director revealed "...This concern as stated refers to patient care by provider. I feel this issue should be addressed by physician. Please share this concern with Dr.___(former ED Medical Director)..." Review of the "Patient Concern Form" revealed handwritten notes by the ED Medical Director (former) dated 03/07/2011 (34 days after grievance submission) and 03/17/2011 (44 days after grievance submission). Further review revealed "Date Completed: (blank)" and "Completed By: (blank)." Further review of the grievance file revealed no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further review revealed no documentation of a written letter of resolution sent to the patient or patient's representative.

Interview on 04/06/2011 at 1348 with the Director of Marketing and Customer Service revealed he oversees the hospital's grievance process. Interview revealed complaints are usually called into a complaint line. Interview revealed the complaint line is checked daily by one of four hospital Patient Representatives. Once a compliant is received the complaint is sent to the appropriate department Director or Medical Director within 24 hours for investigation. Interview revealed the department Director or Medical Director has 7 business days to complete the investigation. Interview revealed once the investigation is completed the findings are submitted back to the hospital's Patient Representative department and a written response is sent to the patient and/or patient's representative within 60 days. Interview revealed the grievance file for Patient #47 was considered open (64 days after grievance receipt) because there was not a copy of the written response sent to the patient and/or patient's representative in the grievance file. Interview confirmed no documentation of the date (within 24 hours after receipt) the grievance was submitted to the ED Nursing Director or ED Medical Director (former) for investigation. Interview confirmed the ED Nursing Director nor the ED Medical Director (former) had not completed the investigation within the 7 business days per policy. Interview confirmed a written response had not been sent to the patient and/or patient's representative within in 60 days per policy. Interview confirmed the grievance file contained no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further interview revealed the Director of Marketing and Customer Service was unaware of the CMS guidelines for appropriate timeframes for the investigation and provision of a written response to a grievance. Interview confirmed the hospital's grievance policy did not comply with CMS requirements. Interview confirmed the hospital failed to review, investigate, and resolve Patient #47's grievance within a reasonable time frame.

2. Review on 04/06/2011 of a grievance file containing a "Patient Concern Form" for Patient #49 revealed a grievance was received by the hospital on 03/02/2011 (35 days after receipt) from the patient concerning quality of care issues at the hospital. Review revealed a copy of the grievance was sent (no date noted) to the ED Medical Director (former) for investigation and to Risk Management. Review of the grievance file revealed no documentation as of 04/06/2011 (35 days after receipt) of an investigation into Patient #49's grievance. Further review revealed no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Further review revealed no documentation of a written letter of resolution sent to the patient or patient's representative. Review of hospital documentation not contained in the grievance file and presented after-the-fact revealed an electronic mail dated 03/31/2011 at 0914 (29 days after receipt) to the ED Medical Director (former) that revealed "Dr.___ just wanted to touch base and see if you have looked at this concern." Review of a typed note (not dated) revealed "...On Friday, April 1st (30 days after receipt) spoke with medical director's office. Administrative assistant advised that new ED Medical Director should be starting Monday, April 5th. Any unresolved complaint can be shared with him."

Interview on 04/06/2011 at 1348 with the Director of Marketing and Customer Service revealed he oversees the hospital's grievance process. Interview revealed complaints are usually called into a complaint line. Interview revealed the complaint line is checked daily by one of four hospital Patient Representatives. Once a compliant is received the complaint is sent to the appropriate department Director or Medical Director within 24 hours for investigation. Interview revealed the department Director or Medical Director has 7 business days to complete the investigation. Interview revealed once the investigation is completed the findings are submitted back to the hospital Patient Representative department and a written response is sent to the patient and/or patient's representative within 60 days. Interview revealed the grievance file for Patient #48 was considered open (35 days after receipt) because there was not a copy of the written response sent to the patient and/or patient's representative in the grievance file. Interview confirmed no documentation of the date (within 24 hours after receipt) the grievance was submitted to the ED Medical Director (former) for investigation. Interview confirmed no documentation of the findings of an investigation into the grievance. Interview confirmed the ED Medical Director (former) had not completed the investigation within the 7 business days per policy. Interview confirmed the grievance file contained no documentation the hospital informed the patient or the patient's representative that the hospital was still working to resolve the grievance and that the hospital would follow-up with a written response within a stated number of days. Interview confirmed no written letter of res

Based on hospital policy review, medical record review, and staff interview the physician or other licensed independent practitioner conducting the face-to-face evaluation within 1 hour after the initiation of restraint and/or seclusion failed to evaluate one or more of the following required elements: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint for 3 of 3 sampled patients restrained and/or secluded for the management of violent or self-destructive behaviors (#10, #9, #36).

The findings include:

Review of current hospital policy "Restraint and Seclusion" Policy: D-50-D42, revised 01/11 revealed, "...V. PHYSICAL RESTRAINT AND/OR SECLUSION FOR BEHAVIORAL HEALTH REASONS A. Requirements for All Settings ...2. One-hour face-to-face assessment: The physician or LIP shall perform a face-to-face assessment of the patient's physical and psychological status within 1 hour of the initiation of the restraint. ..."

1. Closed record review on 04/07/2011 for Patient #10 revealed a 46 year-old female who presented to the hospital's emergency department (ED) on 02/21/2011 with a diagnosis of Alcohol Intoxication and was subsequently discharged in the custody of police the same day. Review of a Physician's Restraint Order Form (ATTACHMENT C) revealed "A. Reason - based on Nursing Assessment: (check all that apply) ...5. [check mark on a line] Other: Patient very ETOH (alcohol), kicking, pulling, threatening to bite staff" hand written on a line {Violent or Self-Destructive Behaviors}. Further review revealed a verbal physician's order for restraint obtained by a registered nurse on 02/21/2011 at 1845. Review of nursing documentation revealed the patient was placed into bilateral soft limb holders (2 point wrist restraints) for the management of violent or self-destructive behaviors on 02/21/2011 from 1845 to ~2235 (3 hours 50 minutes). Review of ED physician documentation revealed a medical screening exam was conducted at 1900 (15 minutes after the initiation of restraint). Further record review revealed no documentation the ED physician evaluated Patient #10 within one-hour after the restraint initiation for one or more of the following required elements specific to restraints: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint.

Interview on 04/07/2011 at 1545 with ED nursing management staff revealed the nursing staff does not conduct the one hour face-to-face evaluation in the emergency department for patients who have been restrained and/or secluded for the management of violent or self-destructive behaviors. Interview revealed the ED physician conducts the evaluation. Interview revealed the physicians document the findings on a "T-Sheet" or "T-Sheet" progress note. Interview confirmed there was no available documentation the ED physician assessed all of the required elements of a one hour face-to-face evaluation including: the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and the need to continue or terminate the restraint for the restraint initiated on 02/21/2011 at 1845 for Patient #10.

2. Closed record review on 04/07/2011 for Patient #9 revealed a 23 year-old female admitted to the hospital's behavioral health unit under involuntary commitment petition on 01/06/2011 with a diagnosis of Schizoaffective Disorder, Bipolar Type versus Bipolar Disorder. The patient was subsequently discharged on 01/08/2011. Review of a Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI) dated 01/07/2011 at 1835 revealed a physician's order for mechanical restraint and seclusion for Verbal/Physical Threat, Physically Assaultive, and Imminent danger to self/other. Further record review revealed the patient was placed into mechanical restraint and/or seclusion on 01/07/2011 from 1830 to 2010 (110 minutes). Further review revealed documentation of a "Face to face evaluation completed by: (Physician Signature on line) Date: 01/07/2011 (hand written on line) Time: 1915 (hand written on line)." Further record review revealed no documentation of the findings of the physician's one-hour face-to-face evaluation of Patient #9 conducted on 01/07/2011 at 1915 for the following required elements specific to restraints: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint.

Telephone Interview on 04/07/2011 at 1600 with the Behavioral Health Medical Director (a Psychiatrist) revealed a face-to-face assessment is conducted by a physician within one hour, on the unit, after a patient is placed into restraint and/or seclusion. Interview revealed after the face-to-face is conducted the physician immediately signs, dates, and times the Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI). Interview revealed he does not generally document his findings of the one-hour face-to-face exam. Interview revealed he may address the findings of his assessment in a progress note the next day. Interview revealed he was unaware of the four elements required by regulation to be evaluated and documented in the medical record regarding one-hour face-to-face assessments.

Interview on 04/07/2011 at 1615 with an Information Systems Clinical Analyst confirmed no available documentation of the required elements for the one-hour face-to-face evaluation, including: the patient's immediate situation; reaction to the intervention; medical and behavioral condition; and the need to continue or terminate the restraint for the restraint initiated on 01/07/2011 at 1915 for Patient #9.

3. Closed record review on 04/07/2011 for Patient #36 revealed a 57 year-old male admitted to the hospital's behavioral health unit under involuntary commitment petition on 10/28/2010 with a diagnosis of Bipolar Disorder, NOS (not otherwise specified). The patient was subsequently discharged on 11/05/2010. Review of a Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI) dated 10/30/2010 at 1335 revealed a physician's order for seclusion for Verbal/Physical Threat, Physically Assaultive, and Imminent danger to self/other. Further review revealed the patient was placed into seclusion on 10/30/2010 from 1335 to 1345 (10 minutes). Further review revealed documentation of a "Face to face evaluation completed by: (Physician Signature on line) Date: 10/30/2010 (hand written on line) Time: 1339 (hand written on line)." Further record review revealed no documentation of the findings of the physician's one-hour face-to-face evaluation conducted on 10/30/2010 at 1339 for the following required elements specific to restraints: the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint.

Telephone Interview on 04/07/2011 at 1600 with the Behavioral Health Medical Director (a Psychiatrist) revealed a face-to-face assessment is conducted by a physician within one hour, on the unit, after a patient is placed into restraint and/or seclusion. Interview revealed after the face-to-face is conducted the physician immediately signs, dates, and times the Behavioral Health-Restrictive Intervention Order Sheet (ATTACHMENT EI). Interview revealed he does not generally document his findings of the one-hour face-to-face exam. Interview revealed he may address the findings of his assessment in a progress note the next day. Interview revealed he was unaware of the four elements required by regulation to be evaluated and documented in the medical record regarding one-hour face-to-face assessments.

Interview on 04/07/2011 at 1615 with a Information Systems Clinical Analyst confirmed there was no available documentation of the required elements for the one-hour face-to-face evaluation, including: the pa

Based on review of facility hemodialysis (HD) contracts, HD staff job descriptions, facility policies and procedures, North Carolina (NC) Board of Nursing (BoN) Position Statements, NC Administrative Code Rules, personnel files, HD medical records, observations during tour and staff interviews, the facility failed to provide supervision to contract HD nursing staff as required by the scope of practice for the Licensed Practical Nurse (LPN) in the state of NC for three of three HD records reviewed (#27, #28, #29).

Findings include:

Review of a contract between the facility and a HD service provider effective 06/01/2009 on 04/06/2011 revealed "3.9 Staff. Company (HD service provider) shall provide properly trained and qualified non-physician personnel (the "Staff"), which may include but is not limited to, registered nurses, licensed practical nurses and dialysis technicians practicing under the supervision of Company's registered nurses, in adequate numbers to provide the ordered services..."

Review on 04/07/2011 of a job description for the "Acute Licensed Practical Nurse (Acute LPN) effective 05/2007 revealed the job description was provided by the contracted HD service. Review revealed "Essential Duties and Responsibilities...Perform duties under the supervision of a Registered Nurse in accordance with State regulations, (Company) policy, Acute Facility policy and the (Company) Acute Service agreement with the Acute Facility."

Review on 04/07/2011 of facility Nursing policy "Patient Assessment Standard" revised 11/2010 revealed "Policy: A Registered Nurse assesses the patient's need for nursing care...The LPN may complete the Admission History."

Review on 04/07/2010 of NC BoN Position Statement "Dialysis - Role of Unlicensed Assistive Personnel (UAP) - Position Statement for RN, LPN and UAP Practice" revised 05/2009 revealed "Issue: Hemodialysis and Peritoneal Dialysis in Acute Settings - Clients requiring dialysis in acute care settings are unstable because of either acute renal failure or chronic renal failure complicated by other acute health problems...Note: To support the provision of safe, effective nursing care throughout the dialysis process...monitoring the client throughout the dialysis process must be performed by the appropriate level of licensee and consistent with the scope of practice, including assignment and supervision."

Review on 04/07/2011 of NC BoN Position Statement "Delegation and Assignment of Nursing Activities - Position Statement for RN and LPN Practice" revised 01/2010 revealed "RN Role in Assignment and Delegation...Maintains overall accountability for the coordination and delivery of nursing care to the individual client or group of clients for whom the RN has accepted responsibility; Assesses client's status, determines clinical competence of licensed and unlicensed personnel, and identifies variables in each practice setting prior to permitting any staff to assign or delegate nursing activities; Indicates through policy, procedure, and plans of care what nursing activities and tasks may appropriately be completed by each level of licenses or unlicensed personnel based on scope of practice..." Further review revealed "LPN Role in Assignment and Delegation...RN supervision is continuously available, on-site if necessary, as determined by client needs." Further review revealed "Notes...An agency's chief nursing officer is responsible for establishing those policies, procedures, practices, and channels of communication, which provide the framework in which assignment and/or delegation may be carried out..."

Review on 04/07/2011 of NC BoN Position Statement "LPN Scope of Practice - Clarification - Position Statement for LPN Practice" effective 01/2010 revealed "LPN Scope of Practice in all steps of the nursing process is limited and focused because, by law, it is a dependent and directed scope of practice. LPN practice requires assignment or delegation by and performance under the supervision, orders, or directions of a registered nurse (RN), dentist, or other person authorized by State law to provide the supervision." Further review revealed "Planning...For the LPN, planning includes the participation in the identification of the client's needs related to the findings of the nursing assessment...Identification of nursing interventions and goals for review by the RN." Further review revealed "It is beyond the scope of practice to assign nursing responsibilities to RNs...Therefore, it is beyond LPN scope of practice to be responsible for the following activities...orientation and teaching of nursing staff, validation of competence."

Review of NC Administrative Code (NCAC) Rule 21 NCAC 36 .0225 "Components of Nursing Practice for the Licensed Practical Nurse" effective 01/2010 revealed "(a) The licensed practical nurse shall accept only those assigned nursing activities and responsibilities...which the licensee can safely perform. That acceptance shall be based upon the variables in each practice setting which include...(3) the stability of each client's clinical condition." Further review revealed "(3) The degree of supervision required for the performance of any assigned or delegated nursing activity by the licensed practical nurse when implementing nursing care is determined by variables which include, but are not limited to...(B) stability of the client's clinical condition, which involves both the predictability and rate of change...When a client's condition is unpredictable or unstable, the licensed practical nurse participates in the performance of the task under close supervision of the registered nurse or other person(s) authorized by law to provide such supervision; (C) complexity of the nursing task which is determined by depth of scientific body of knowledge upon which the action is based and by the task's potential threat to the client's well-being. When a task is complex, the licensed practical nurse participates in the performance of the task under close supervision of the registered nurse or other person(s) authorized by law to provide such supervision..."

Personnel file review for Staff #15 revealed the staff is provided by the contracted service and is a licensed practical nurse (LPN).

Personnel file review for Staff #16 revealed the staff is provided by the contracted service and is a registered nurse (RN).

Personnel file review for Staff #17 revealed the staff is provided by the contracted service and is a licensed practical nurse (LPN).

1. Open record review on 04/07/2011 for Pt #27 revealed a 49 year old admitted 04/06/2011 for multiple pulmonary masses, pneumonia, hypoxia, diabetes type II, hypertension and end stage renal disease, requiring hemodialysis. Review revealed the patient was assessed and monitored by Staff #15 during HD treatment on 04/06/2011.

Observation during tour of the HD unit on 04/06/2011 at 1015 and during the HD treatment for Pt #27 revealed Staff #15 (a LPN) and Staff #16 (a RN) were present. Interview with Staff #16 during tour revealed this was the staff member's first day in the hospital and the staff member was being oriented by Staff #15 to the acute HD program at the facility. Interview revealed the HD LPN was orienting and validating the competence of the new HD RN.

2. Closed record review on 04/07/2011 for Pt #28 revealed a 59 year old admitted 01/10/2011 for hyperkalemia (elevated blood potassium level) and shortness of breath. Review revealed the patient was assessed and monitored by Staff #17 during HD treatment on 01/10/11.

3. Closed record review on 04/07/2011 for Pt #29 revealed a 53 year old admitted 03/14/2011 for hypoglycemia and CKD (chronic kidney disease - dialysis dependent). Review revealed the patient was assessed and monitored by Staff #17 during HD treatments on 03/14/2011 and 03/16/2011.

Interview the chief nursing officer (CNO) of the facility on 04/07/2011 at 0950 revealed the HD treatments in the facility have always been provided under contract with the current company. Interview revealed the primary care providers for HD treatments currently in the facility are LPNs. Interview revealed the HD trea