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Based on closed and current patient medical record review, surveyor observations, medical staff by-law review, hospital policy and procedure review and
hospital staff interview and dialysis contract staff interview, this LTAC (Long Term Acute Care) hospital failed to have hemodialysis services provided by a hospital contractor that complied with hospital policies and procedures meeting Medicare Conditions of Participation standards; and meeting the accepted hemodialysis practice standards under AAMI (Association for the Advancement of Medical Instrumentation publication, "Dialysate for Hemodialysis", ANSI (American National Standards Institute)/ AAMI RD 52:2004 and RD 62:2001); National Kidney Foundation (NKF) KDOQI (Kidney Disease Outcomes Quality Initiatives); and CDC (Centers for Disease Control)", "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" (Morbidity and Mortality Weekly Review, Volume 50/No. RR-5.

Findings include:

1) The ANSI/ AAMI RD 62:2001, 4. 4. Fluid Quality, A.4.1.1 sets forth maximum levels of chemical contaminants that can adversely affect dialysis patients. The maximum level of chloramine in dialysate water is .1 mg./L (milligrams per liter). The maximum level of chlorine is .5 mg./L. Chloramine /Chlorine levels in dialysate water that are higher than .1mg/L. damages red blood cells by taking their oxygen content away. Permanent injury and death can occur to body tissues and organs that cannot get oxygen through the transport and transfer of oxygen by red blood cells.

At approximately 8:15 a.m. on 6/30/10, Surveyor 09948 asked Dialysis RN (Registered Nurse) A to demonstrate how chloramine/chlorine testing of water was conducted using the portable R. O.(water purifying) machine, during observation of Patient #1's hemodialysis procedure. Dialysis RN A let R. O. (purified) water run from the outlet valve for approximately 30 seconds, then collected water in a small clear plastic medicine cup and proceeded to dip a test strip into the cup for 15 seconds. Dialysis RN (Registered Nurse) A then compared the test strip to the side of the color coded (white to shades of pale blue) bottle, reading it as negative for chlorine and chloramine contamination. Interview with Dialysis RN (Registered Nurse) A, at this time, reflects that she has not been color-blind tested to ensure that she can read the test strip bottle's color coding safely.

At approximately 10:39 a.m. on 6/30/10 Surveyor 09948 watched Dialysis RN (Registered Nurse) C perform chloramine/chlorine test of water using the portable R. O. machine, during observation of Patient #3's hemodialysis procedure. Dialysis RN C let R. O. (purified) water run from the outlet valve for approximately 1 minute, then held the test strip into the water flow for approximately 2 seconds before comparing it to the side of the color coded (white to shades of pale blue) bottle reading it as negative for chlorine and chloramine contaminates. Interview with Dialysis RN (Registered Nurse) C, at this time, reflects that she has not been color-blind tested to ensure that she can read the test strip bottle's color coding safely.

Surveyor observations of the chlorine/chloramine test strip bottles used by Dialysis RN staff A and C reflect the following: "Hold .1ppm (parts per million) test, Hold strip under slow running stream of test water for 30 seconds. Gently shake off the excess from the strip and compare color blocks". Surveyor observations of dialysis RN staffs A and C show demonstrate that chlorine/chloramine testing was not conducted per manufacturer's instructions, and therefore maximum levels of contaminants that could cause serious injury to Patient #'s 1 and 3 were not accurately assessed before using dialysate water in patient hemodialysis.

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.

2) The ANSI/AAMI RD 52:2004, 5.6 Dialysate proportioning, states that testing of the acid base balance of dialysate by independent methods is recommended as a patient safety precaution. The prepared dialysate must be confirmed to be in a safe pH and conductivity range to be compatible with the patient's blood.

The 6/30/10 record review of Patient #1's "Inpatient Hemodialysis Flow sheet" reflects that there is no independent conductivity nor independent pH testing done on the dialysate to ensure it meets the AAMI safety standards before patient dialysis is initiated.

Interview with Dialysis Nurse C on 6/30/10 at approximately 10:40 a.m. reflects that conductivity reading recorded on the "Inpatient Hemodialysis Flow sheet" are taken directly from the dialysis machine's digital display, and that no pH testing is done by the dialysis machine or dialysis staff to ensure that the pH of the dialysate is compatible with a patient's blood pH.

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.

3) The surveyor review of the contracted dialysis service reflects that it failed to meet standard level requirements under 42 CFR 482-Conditions of Participation for Hospitals in the following areas:

The hospital and contracted dialysis services did not develop and maintain current care plans for dialysis services received. (Reference A0396)

The hospital did not supervise contracted dialysis staff to ensure that services rendered met dialysis standards of practice (NKF KDOQI) and standard level requirements under the Medicare Conditions of Participation. (Reference A0398)

The hospital did not ensure that standard dialysis order set used by their contracted dialysis service had orders that were written for the administration of drugs and biologicals that contained the necessary and required elements to ensure safe administration per hospital policy and the standard level requirements under the Medicare Conditions of Participation. (Reference A0406)

The hospital did not ensure that medical records used by contracted dialysis service are author identified, legible, authenticated, signed and dated by the appropriate staff. (Reference A0450, A0454, and A0457)

The hospital did not ensure that CDC hemodialysis infection control guidelines
were followed during hemodialysis treatment. (Reference A0749)

Based on closed medical record review, hospital policy and procedure, complainant information and staff interview, the LTAC (Long Term Acute Care) hospital failed to safeguard 1 of 7 patient records (Patient # 7) to ensure confidentiality was maintained. This occurred in a total sample of 7 patients reviewed.

Findings include:

Review of material with AC (Anonymous Complainant) O's mailed complaint information reflects that it contains information regarding Patient #7's hospital stay. Review of the complaint information reflects the following patient records for Patient #7 were enclosed:
"Consent to Admission and Treatment, Authorization to Release Information and Assignment of Insurance Benefits" which was signed and dated by Patient #7's POA (Power of Attorney) and hospital staff P on 2/20/10.
"Acknowledgement for AD (Advanced Directives)" detailing that Patient #7 issued an AD, has a DPOAHC (Durable Power of Attorney for Healthcare), and that Patient #7 was notified to provide these documents to the hospital during stay, dated and signed by the patient's POA on 2/24/10.
"Medicare Lifetime Reserve Days" letter stating the date coverage would go into effect, the amount of coinsurance owed of the Lifetime Medicare days were in effect, and the patients wishes to not have hospital stay paid by the Lifetime Reserve days. This was signed and dated by Patient #7's POA on 2/24/10.
"Billing Disclosures to Individuals Involved in Patient's Care/Restrictions in Facility Directory" gives names of two family members and the relationship to Patient #7, and id signed and dated by Patient #7's POA on 2/24/10.
"Medicare Secondary Payer Questionnaire" which gives information on medicare eligibility, services sought, employment status of patient and spouse, and end stage renal disease disability coverage. This was signed and dated by Patient #7's POA on 2/24/10.
"An Important Message from Medicare about your Rights" dated and signed by Patient #7's POA on 2/24/10.
"Patient Rights" statement dated and signed by Patient #7's POA on 2/24/10.
All of the above documents were registration stamp marked with the patient's name, medical record number, date of birth, transferring hospital's medical record number and primary care physician's name.

On 7/7/10 at approximately 10 a.m. the above records were presented to the hospital staff [Chief Operation Officer (CEO) Q and Quality Manager E] and verified as records were from their hospital.

Interview with AC O by telephone on 7/7/10 at approximately 1 p.m. verifies that the above medical records information, mailed with the complaint allegations, was found in the hospital room of a family member (Patient #5), during Patient #5's hospital stay.

On 7/7/10 at approximately 2 p.m. Patient #7's closed records from this hospital stay of 2/20/10 through 3/25/10 were reviewed. It was found by this Surveyor 09948 that the medical records in AC O's possession were actual copies of Patient #7's hospital medical records. AC O had unauthorized access to confidential hospital information of Patient #7.

The 6/30/10 review of hospital policy "Security and Accessibility of Medical Records, revised 1/2/09" reflects "...F. Medical records shall not be left unattended in areas accessible to unauthorized individuals..."

This was verified by Quality Manager E on 6/30/10 at approximately 4 p.m.

Based on medical record review and staff interview, the LTAC (Long Term Acute Care) hospital failed to ensure that 3 of 4 dialysis patients (Patient #'s 1, 2 and 3) had nursing care plans that covered dialysis care; and failed to ensure that these care plans were developed and kept current by the contracted dialysis nursing staff or by hospital nursing staff. This occurred in a total sample of 7 patients.

Findings include:

In interview with Dialysis RN A on 6/30/10 at approximately 8 a.m., she stated that this LTC hospital does not require the contracted dialysis nursing staff to develop or manage dialysis care plans. Dialysis RN A states that to her knowledge that staff is not required to be involved with the interdisciplinary team meetings that define care progress.

Interview with the LTC Quality Improvement Manager E on 6/30/10 at approximately 3 p.m. reflects that there is nothing in the LTC hospital's dialysis contract that requires the contracted dialysis RN staff to provide a nursing care plan for dialysis care, and to her knowledge they are not required to participate in interdisciplinary care plan meeting.

1) The 6/30/10 review of Patient #1's medical record reflects that this patient has no nursing care plan for dialysis services received. As of 6/28/10 Patient #1 has had 17 hemodialysis treatments in the LTC facility. The 6/30/10 record review of the LTC hospital's "Interdisciplinary Team Reports" dated 5/24/10, 6/1/10, 6/7/10, 6/15/10 and 6/21/10 reflects no informational input from the nephrologist or the nephrology team nurses about the progress/"current status" of the hemodialysis treatments.

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.

2) The 6/30/10 review of Patient #2's medical record reflects that this patient has no nursing care plan for dialysis services received. This patient received 22 hemodialysis treatments between 6/13/09 and 7/31/09.

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.




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3) Per record review conducted by Surveyor #03383 on 6/29/10 from 9:00 AM to 11:30 AM:

In-patient Hemodialysis Flow sheets dated 6/15/10, 6/17/10, 6/19/10, 6/22/10, 6/24/10, 6/26/10, and 6/28/10 show Patient #3 received hemodialysis treatments on those days. The Peritoneal Dialysis Record shows Patient#3 received peritoneal dialysis on 6/18/10, 6/19/10, 6/20/10, and 6/21/10. Inpatient Hemodialysis Flow sheets dated 6/17/10 shows Patient #3's BP (blood pressure) could drop as low as 77/45 mmHg (hypotension= low blood pressure); and the Inpatient Hemodialysis Flow sheets dated 6/28/10 shows BP could rise as high as 183/83 mmHg (hypertension= high blood pressure). Hospital staff give Patient #3 Midodrine 10 mg. (medication that help maintain a normal blood pressure ) prior to hemodialysis, with ability to repeat dosage in one hour for systolic BP less than 90 mmHg per physician order. The 24 Hour Record & Plan of Care completed by hospital nursing staff on 6/24/10, 6/25/10, 6/27/10, and 6/28/10 failed to have a dialysis plan of care or include potential complications of hypotension or hypertension or any other complication that may occur during hemodialysis and peritoneal dialysis.

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.

Based on medical record review, hospital policy review, review of National Kidney Foundation (NKF) KDOQI (Kidney Disease Outcomes Quality Initiatives) guidelines, review of contracted dialysis staff employee files and staff interview, the LTAC (Long Term Acute Care) hospital failed to ensure that 1 of 4 dialysis patients (Patient #1) had written orders for dialysis services given by contracted dialysis nursing staff; and failed to ensure that adequate nursing supervision and evaluation was conducted and documented when a change of condition occurred in 1 of 4 dialysis patients (Patient #1); and failed to ensure that necessary post dialysis weights were obtained in 2 of 4 dialysis patients (Patient #'s 1 and 3); and failed to ensure that 7 of 7 contracted dialysis staff (Dialysis RN's A, J, K, L, M and N) and 1 of 1 supervisory RN staff (Acute Dialysis services Director B) were provided with basic hospital orientation. This occurred in a total sample of 7 patients, and in a total sample review of 7 employee files of contracted dialysis staff.

Findings include:

1) The 6/30/10 record review of Patient #1's "Dialysis Acutes Physician's Orders" dated 6/30/10 reflects that Patient #1's hemodialysis treatment is to last 2 hours and 30 minutes. The 6/30/10 record review of the "In-patient Hemodialysis Flow sheet" dated 6/30/10 reflects the hemodialysis treatment started at 8:55 a.m. and lasted until 10:30 a.m. (1 hour and 35 minutes). There was no documented evidence that Dialysis RN A wrote a telephone order to cover the verbal order for early discontinuation of the hemodialysis treatment given to her by Nephrologist D at 10:23 a.m. on 6/30/10 per review of the "Dialysis Acutes Physician's Orders" and the hospital's "Physician's order" sheet.

The 6/30/10 record review of Patient #1's "Dialysis Acutes Physician's Orders" dated 6/21/10 reflects that Patient #1's hemodialysis treatment is to last 3 hours. The 6/30/10 record review of the "In-patient Hemodialysis Flow sheet" dated 6/21/10 reflects the hemodialysis treatment was not started due to 3 hypertensive (abnormally high) blood pressure readings taken before the start of the treatment and recorded on the 6/21/10 hemodialysis treatment sheet. The dialysis staff documenting these high blood pressures, and the telephone call to Nephrologist D about these high blood pressures has illegible initials/signature. This illegible writer records "tx (treatment) cancelled per MD (Nephrologist D)". There was no documented evidence that this writer wrote a telephone order to cover the verbal order for termination of this hemodialysis treatment on the "Dialysis Acutes Physician's Orders" or the hospital's "Physician's order" sheet.

2) The 6/30/10 record review of Patient #1's "In-patient Hemodialysis Flow sheet" reflects the following on 6/14/10:
The handwritten documentation on this treatment sheet is has illegible initials and signature making the hospital contracted dialysis staff writer unidentifiable.
"At 5: 45 p.m. the hemodialysis treatment was started with a blood pressure of 150/86 and heart rate of 112,
At 7:45 p.m. blood pressure is recorded as 109/16, heart rate is 46. The documentation under "comments" written by unidentified dialysis staff states "VSS (vital signs stable)... illegible handwriting...decrease goal".
The next documented entry at 8:15 p.m. reflects blood pressure and pulse as "unable to be obtained". The documentation by the unidentified contract dialysis staff reflects that "Patient is blinking but unresponsive", and that "Staff RN here at (sic) patient, attempting to get manual blood pressure-unable to get but patient is blinking eyes-not responsive to sternal rub".
There is no blood pressure recorded until 8:36 p.m. when the blood pressure was documented as 67/46 with a heart rate of 53. It is recorded in the "comments" that hemodialysis treatment was ended.
The documentation on this sheet states Nephrologist F "was called about the low blood pressures during treatment-will decide tomorrow whether to UF (ultrafiltrate= filter blood) or not." The next blood pressure recorded is 106/62 with heart rate of 125 at 9:50 p.m.

There is no documentation on this flow sheet that reflects what happened to Patient #1 in the 21 minutes (between 8:15 p.m. and 8:36 p.m.) without blood pressure and pulse.

There is no documentation on Patient #1's 6/14/10 "24 hour Patient Record and Plan of Care" to reflect what happened to Patient #1 in this 21 minute period when this change of condition occurred.

Review of the physician's progress notes dated 6/14/10 and 6/15/10 reflects no physician's notes about the change of condition occurring between 8:15 p.m. and 8:36 p.m. on 6/14/10.

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.

3) Record review of 7 randomly selected contracted dialysis staff's hospital-based employee files on 6/30/10 reflects that their employee files have no documented evidence of the hospital staff provided basic orientation (basic orientation to the hospital and the nursing units, hospital emergency procedures, hospital nursing service policies and procedures and hospital safety policies and procedures) to the dialysis staff before the dialysis staff provided hemodialysis treatment to hospital-based patients. This occurred with review of 6 of 6 RN (registered Nurse) staff (Dialysis RN's A, J, K, L, M and N) and 1 of 1 supervisory RN staff (Acute Dialysis services Director B).

This was verified by Quality Improvement Manager E on 6/30/10 at approximately 4 p.m.

4) The NKF KDOQI -CLINICAL PRACTICE GUIDELINES FOR HEMODIALYSIS ADEQUACY, GUIDELINE 5. CONTROL OF VOLUME AND BLOOD PRESSURE states that "There is ample evidence in the non-CKD (chronic kidney disease) population that optimal control of blood pressure influences mortality. In the HD (hemodialysis) population, available evidence indicates that control of a patient's fluid volume influences outcome. Volume and blood pressure are linked; thus, it is important to optimize ultrafiltration and dry weight to control blood pressure in an effort to improve patient outcome". Therefore, post dialysis weight is a method of determining fluid balance after dialysis; and is a measurement of nursing assessment use to identify whether physician prescription weight loss goals/ dry weight goals are met. Dry weight is the estimated weight a patient would be if abnormal fluid build-up due to renal failure was removed.
The 6/30/10 record review of Patient #1's 6/25/10 and 6/28/10 "Graphic Intake and Output Record" and the "Dialysis Acutes Inpatient Hemodialysis Flow sheet" reflects no documentation of post hemodialysis treatment weights.

This was verified by Quality Improvement Manager E on 7/13/10 at approximately 1 p.m.



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5) Per record review conducted by Surveyor #03383 on 6/29/10 from 9:00 AM to 11:30 AM:

The Inpatient Hemodialysis Flow sheets completed by contracted dialysis staff failed to document that a post weight was obtained after Patient #3 received dialysis treatment on 6/22/10 and 6/26/10. The Inpatient Hemodialysis Flow sheets documentation on 6/22/10 and 6/26/10 under the Patient Assessment Post Dialysis section has the word 'graphics' written under "Weight." The Graphic Intake & Output Record for 6/22/10 and 6/26/10 does not have a post weight listed . A post weight was not obtained by dialysis staff or hospital staff on 6/22/10 or 6/26/10.

This was verified by Quality Improvement Manager E on 7/19/10 at approximately 2:30 p.m.

Based on medical record review, hospital policy and procedure and staff interview, the LTAC (Long Term Acute Care) hospital failed to ensure the standard dialysis order set used by their contracted dialysis service had orders that were written for the administration of drugs and biologicals that contained the necessary and required elements to ensure safe administration, these order sets were used in 1 of 4 dialysis patients reviewed (Patient #2), in a total sample of 7 patients.

Findings include:

Review of the "contracted Dialysis Physician's Orders" on 6/30/10 reflects the following:

1) Under "#11." it states "If hypotensive give: 200 ml. of 0.9 Sodium Chloride OR 6 ml. of 23.4% Sodium Chloride over 2-3 minutes. May repeat every 5 minutes, NOT to exceed 3 doses (any combination). Avoid 23.4% Sodium in the last 30 minutes of treatment."

This standing order is not clarified as to whether the 0.9 sodium chloride and or the 23.4% sodium chloride should both be given over 2-3 minutes. This order has no route of administration. There is no specific instruction as to what qualifies as hypotension, if a patient has a BP (blood pressure) that routinely runs lower that normal parameters.

2) Under "#12." it states "Alternate order for hypotension:"
"Give 0.9 Sodium Chloride up to ____ ml." This order is not complete, and is missing route of administration and maximum frequency and the frequency between the dosages.
"23.4 % Sodium Chloride___ml. X (times) ____ doses." This order is not complete, and is missing route of administration and the frequency between the dosages. .
"Albumin 25% up to ____doses." This order is not complete, and is missing the prescribed amount of 25% albumin to be given, the frequency between the dosage and the route of administration. Albumin 25% injection comes in 250 milligrams/milliliter in 20, 50 and 100 ml. vials. Albumin when given increases blood volume therefore increasing blood pressure.
"Mannitol 12.5 grams (gm.) X____doses." This order is not complete, and is missing the prescribed amount of the 12.5 gm. dose of Mannitol, the administration time, the frequency between the dosage and the route of administration. Mannitol is a potent medication that pulls fluid from the tissues into the blood stream to increase blood pressure, and comes in solutions of 15 and 20% that should normally be given over a prescribed amount of time to prevent serious adverse reactions.
(*Information regarding Albumin and Mannitol taken from "Nursing 2008- Drug Handbook").

The 7/12/10 review of the hospital policy "002-G, Orders, Physician, Revised 3/09/09" reflects on page 4 of 8 under "medication policy" that:
"1. A complete medication order consist of:
A. Name of medication
B. Dose of medication
C. Frequency of medication
D. Route of medication
E. Comments /qualifying phases are optional for scheduled medications but are required for PRN (as needed) orders, (i.e., severe pain)
2. Medication name, dose and frequency must be written by physician. Route may be entered by nurse or pharmacist if known. For example, medications only available in one form or physician stated route, but did not write it.(sic) Otherwise, physician must be contacted and clarification order written on order sheet".

This order set was used by the dialysis nursing staff, when they called the nephrologist for verbal orders for individual hemodialysis treatments on the following patients.
Patient #2 had this order set used on June 16, 18, 20, 23, 27 of 2009 and 7/9, 16, 21, 23 of 2009.

Based on medical record review, review of facility dialysis machine disinfection logs and staff interview, the LTAC (Long Term Acute Care) failed to ensure that 2 of 4 dialysis patient's medical records (Patient #1 and 2) had pre and post dialysis nursing assessments that were timed, in a total sample of 7 patients; and failed to ensure that it had a method of author identification for contract dialysis staff using disinfection logs for 2 of 2 hemodialysis machine logs reviewed (Machine #45 and #202), and 2 of 2 water purifying machine logs reviewed (Machine #20 and #15), in a total of 4 hemodialysis and 4 water purifying machines available for patient use.

Findings include:

1) Medical record review of Patient #1's "In-Patient Hemodialysis Flow sheets" dated 6/14/10 through 6/28/10 reflects that the "Patient Assessment Pre-Dialysis" and the "Patient Assessment Post-Dialysis" are not timed as to tell when these assessments occurred in the course of the hemodialysis treatment.

2) Medical record review of Patient #2's "In-Patient Hemodialysis Flow sheets" dated 6/13/09 through 7/31/09 reflects that the "Patient Assessment Pre-Dialysis" and the "Patient Assessment Post-Dialysis" are not timed as to tell when these assessments occurred in the course of the hemodialysis treatment.

3) The 6/30/10 record review of the "contracted Dialysis Acute Services" for June 1 through 30, 2010- (Hemodialysis) Machine #45 reflects that there is no signature identification legend to identify the initials of the contracted dialysis staff that provided disinfectant services to Machine #45.

The 7/7/10 record review of the "Midwest Dialysis Acute Services" for June 1 through 30, 2010- (Hemodialysis) Machine #202 reflects that there is no signature identification legend to identify the initials of the contracted dialysis staff that provided disinfectant services to Machine #202.

4) The 6/30/10 record review of portable R. O. (Reverse Osmosis=water purifier) machine #20 (Semper Pure Checklist) reflects that there is no signature identification legend to identify the initials of the contracted dialysis staff that provided chemical testing and disinfection to Machine #20 (SP#20) for 6/1/10 through 6/30/10.

The 7/7/10 record review of portable R. O. (Reverse Osmosis=water purifier) machine #15 (Semper Pure Checklist) reflects that there is no signature identification legend to identify the initials of the contracted dialysis staff that provided chemical testing and disinfection to Machine #15 (SP#20) for 6/1/10 through 6/30/10.

This was verified by Quality Manager E on 7/19/10 at approximately 2 p.m.

Based on medical record review, hospital policy review and staff interview, the LTAC (Long Term Acute Care) hospital failed to ensure that 2 of 4 dialysis patients (Patient#'s 1 and 2) had verbal telephone orders that were authenticated by the prescribing practitioner or other responsible practitioner, in a total sample of 7 patients.

Findings include:

"The Rules and Regulations of the Medical Staff" in the "2009 Physician Orientation Manual" of the LTC hospital reflects under "D. 3....all orders, including verbal orders, must be dated, timed and authenticated by the prescribing practitioner or another practitioner responsible for the care of the patient, even if the order did not originate with him/her..."

1) The 6/30/10 record review of Patient #1's "Dialysis Acutes Physician Orders" reflects that the following nephrology physicians did not authenticate verbal orders as per hospital policy:

Nephrology Physician D signed name, but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/28/10, 6/23/10, 6/22/10 for hemodialysis treatments given on those dates.

Nephrology Physician D did not authenticate (sign, date nor time) the 6/25/10 telephone orders taken by contract nephrology nursing staff for the hemodialysis treatment given on 6/25/10.

Nephrology Physician F did not authenticate with time, the 6/18/10 telephone orders taken by contract nephrology nursing staff for the hemodialysis treatment given on 6/18/10.

Nephrology Physician F did not authenticate (sign, date nor time) the 6/16/10 telephone orders taken by contract nephrology nursing staff for the hemodialysis treatment given on 6/16/10.

2) The 6/30/10 record review of Patient #2's "Dialysis Acutes Physician Orders" reflects that the following nephrology physicians did not authenticate verbal orders as per hospital policy:

Nephrology Physician D signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/16/09, 6/18/09, 6/20/09, 7/7/09, 7/21/09 and 7/23/09 for hemodialysis treatments given on the these dates.

Nephrology Physician G signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/13/09 for hemodialysis treatment given on this date.

Nephrology Physician H signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/27/09 for hemodialysis treatment given on this date.

Nephrology Physician I signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/30/09 for hemodialysis treatment given on this date.

These examples were verified by Quality Improvement Manger E on 7/19/10 at approximately 2 p.m.

Based on medical record review, hospital policy review and staff interview, the LTAC (Long Term Acute Care) hospital failed to ensure that 2 of 4 dialysis patients (Patient#'s 1 and 2) had verbal telephone orders for hemodialysis services authenticated within a 48 hours of the orders being taken by contracted dialysis nursing staff, in a total sample of 7 patients.

Findings include:

"The Rules and Regulations of the Medical Staff" in the "2009 Physician Orientation Manual" of the LTC hospital reflects under "D. 1. ...All orders dictated over the telephone shall be signed by the appropriately authorized person to whom dictated with the name of the practitioner. The responsible practitioner shall authenticate such orders within the time frame specified by state or if no state law applies the responsible practitioner shall authenticate such order within forty-eight (48) hours and failure to do so shall be brought to the attention of the Medical Staff for appropriate action."

1) The 6/30/10 record review of Patient #1's "Dialysis Acutes Physician Orders" reflects that the following nephrology physicians did not authenticate verbal orders within 48 hours as hospital policy and federal hospital regulations under Appendix A requires:

Nephrology Physician D did not authenticate telephone orders taken by contract nephrology nursing staff on 6/25/10, 6/23/10 and 6/22/10 for hemodialysis treatments given on those dates. There was no date or time documented to show medical review by any allowable practitioner within the 48 hours period.

Nephrology Physician F did not authenticate (sign, date nor time) the 6/16/10 telephone orders taken by contract nephrology nursing staff for the hemodialysis treatment given on 6/16/10.

2) The 6/30/10 record review of Patient #2's "Dialysis Acutes Physician Orders" reflects that the following nephrology physicians did not authenticate verbal orders within 48 hours as hospital policy and federal hospital regulations under Appendix A requires:

Nephrology Physician D signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/16/09, 6/18/09, 6/20/09, 7/7/09, 7/21/09 and 7/23/09 for hemodialysis treatments given on those dates, therefore practitioner authentication of the orders within the 48 hour timeframe cannot be verified.

Nephrology Physician G signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/13/09 for hemodialysis treatment given on this date, therefore practitioner authentication of the orders within the 48 hour timeframe cannot be verified.

Nephrology Physician H signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/27/09 for hemodialysis treatment given on this date, therefore practitioner authentication of the orders within the 48 hour timeframe cannot be verified.

Nephrology Physician I signed name but did not time and date verification of telephone orders taken by contract nephrology nursing staff on 6/30/09 for hemodialysis treatment given on this date, therefore practitioner authentication of the orders within the 48 hour timeframe cannot be verified.

The following examples were verified with Quality Improvement Manager E on 7/19/10 at approximately 2 p.m.

Based on surveyor observations and staff interview, the Infection Control Officer/Preventionist (ICO/ICP) failed to ensure that 1 of 2 the contracted dialysis staff observed (Dialysis Registered Nurse A) met infection control standards of practice guidelines during the delivery of hemodialysis care in 2 of 2 patient care observations (Patient #'s 1 and 2) in a total sample of 4 hemodialysis patients.

Findings include:

On 6/30/10 from 6:54 a.m. through 9:05 a.m. observations were made with Dialysis RN (Registered Nurse) A as she prepared for and performed a hemodialysis treatment on Patient #1. The following infection control issues were identified:

1) At 7:15 a.m. Dialysis RN A was observed to drop the hemodialysis machine tubing with it's white plastic connector, which was not covered and open, on the floor of Patient #1's bathroom. Patient #1 was in contact isolation. Dialysis RN A picked the tubing off the bathroom floor. Dialysis RN A did not glove change or hand wash after contamination of gloves by picking up dialysis tubing off Patient #1's bathroom floor. This open, and potentially contaminated connector was then attached to the portable RO (Reverse Osmosis) machine (attached to the pure water port) which provides the purified water to the dialysis machine through this tubing and connector. Dialysis RN A contaminated the RO connection and potentially contaminated the purified water coming out the RO machine into the hemodialysis machine.

After the connection of the hemodialysis machine to the R.O. machine, Dialysis RN A failed to remove gloves and hand wash, using the same contaminated gloves (used to pick up the contaminated tubing and connector) to apply the clean dialysis blood cassette and tubing (holds patient' blood) to the "clean" hemodialysis machine.

At 7:20 a.m. the R.O. machine "pure water connection" (machine tubing attachment to pure water port on the R.O. machine) was observed to leak water form it's connection. The leakage of purified water out of this port/ connector reflects that it is open and can serve as entry to bacterial contamination.

At 8:23 a.m. a white wash cloth was observed to be wrapped around this leaking connection. Use of the wash cloth wrapped around this connection serves to increase the chance of bacterial entry by giving the bacteria a surface to stick to.

The CDC (Centers for Disease Control)", "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" (Morbidity and Mortality Weekly Review, Volume 50/No. RR-5 and "Recommended Infection Control Practices for Hemodialysis Units at a Glance" states under "Equipment, Supplies and Environmental Surfaces" that "the hemodialysis machine and it's components also can be vehicles for patient to patient transmission of blood borne viruses and pathogenic bacteria. The external surfaces of the machine are the most likely sources for contamination...".

2) At approximately 9 a.m. Dialysis RN A was observed to insert the arterial fistula needle into Patient #1 and check patency with a syringe of normal saline, and repeat the same action with the venous fistula needle. Dialysis RN A then removed gloves, and without benefit of handwashing re-applied clean gloves before connecting the arterial and venous dialysis machine cassette tubing to the patient's arterial and venous needle connectors.

The CDC (Centers for Disease Control)", "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" (Morbidity and Mortality Weekly Review, Volume 50/No. RR-5 and "Recommended Infection Control Practices for Hemodialysis Units at a Glance" states under "Infection Control Precautions for all Patients" that "...Hands should always be washed after gloves are removed and between patients contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items...".

The above observational information was shared with Quality Improvement Manager E on 6/30/10 at approximately 4 p.m. without rebuttal.