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On the days of the hospital Validation Survey based on observations, interviews, record reviews, and review of hospital policies and procedures,the governing body failed to ensure the safety of those patients in the hemodialysis unit .

The findings include:

Cross Reference to A 0063: The governing body in accordance with hospital policy failed to ensure that specific patient care requirements of the Hemodialysis Unit were met.

Cross reference to A 0144: The facility failed to ensure the Hemodialysis patient's right to receive care in a safe setting.

Cross Reference to A 0265: The facility failed to ensure an ongoing program that shows measurable improvement in indicators for hemodialysis for which there is evidence that it will improve health outcomes.

Cross Reference to A 0285: The facility failed to set priorities for its performance improvement activities that focus on a high-risk problem-prone areas (Hemodialysis); consider the incidence, prevalence, and severity of problems in those areas; and affect patient safety.

Cross Reference to A 0314: The facility failed to ensure that clear expectations for safety were established for the Hemodialysis unit.

On the days of the hospital Validation Survey based on observations, interviews, record reviews, review of hospital policy and procedure, and facility log review, the governing body failed to ensure that specific patient care requirements of the Hemodialysis Unit were met.

The findings include:

Cross Reference A 0392: The facility failed to provide nursing care to all patients as needed for the hospital's Hemodialysis Unit.

Cross Reference A 0396: The facility failed to ensure a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care in the hemodialysis unit.

On the days of the hospital Validation Survey based on observations, interviews, record reviews, review of hospital policy and procedure, and facility log review, the facility failed to ensure the Hemodialysis patients right to receive care in a safe setting.

The findings include:

Cross Reference to A 0386: The facility failed to ensure a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care in the hemodialysis unit.

Cross Reference to A 0392: The facility failed to provide nursing care to all hemodialysis patients as needed.


27544


On the days of the Validation Survey based on observation, interview and facility record review, the hospital failed to ensure that emergency equipment(Ambu bag and airways) were present in the Imaging Department at Summerville and Moncks Corner Medical Centers. The Summerville Medical Center failed to ensure that an evacuation diagram was posted in the Emergency Room.

The findings are:

On 03-29-10 a tour was conducted of the Imaging Department of the Summerville Medical Center. Observation revealed that there was not a pediatric airway or Ambu bag present in the Code Cart nor was one available throughout the department.
An interview conducted with the Supervisor on 03-29-10 at 1400 revealed that the Imaging Department treats both children and adults, he/she explains that the department provides adult emergency equipment, but depends on the Emergency Room to respond with pediatric Ambu bag and airways.

A tour was conducted of the Moncks Corner Medical Center on 03-30-10. Observation of the crash cart revealed absence of an adult Ambu bag. This was confirmed with the Medical Imaging Coordinator on 03-30-10 at 1610.

Facility record review on 03-29-10 of form titled Adult Crash Cart 2010 Inventory Checklist Trident Health System reads, "Drawer 6 Airways; small/ medium 1 each ...Ambu bag 1..."

On the days of the hospital Validation survey based on observations, facility policy review, record reviews, facility log reviews, a review of the Clinical Effectiveness Plan for 2009 - 2010, and interview, the facility failed to ensure an ongoing program that shows measurable improvement in indicators, for hemodialysis, for which there is evidence that it will improve health outcomes.

The findings include:

On 3/30/10, a review of the hospital's Clinical Effectiveness Plan for 2009 - 2010 revealed that the Hemodialysis Unit was not included in the hospital's quality management plan. On 3/30/10, a review of the hospital's Quality Management Plan had no measurable improvement indicators related to staff performance or proficiency for monitoring the water quality in the hemodialysis unit which could impact patient health outcomes.

On 3/31/10 at 1500 based on observations, record reviews, review of hospital policies and procedures, and staff interviews, it was determined that an Immediate Jeopardy existed on the Hemodialysis Nursing Unit as a result of 5 of 5 staff nurses' failure to accurately process a water sample in the hemodialysis for the presence of Chlorine/Chloramine.

Review of the Clinical Effectiveness Council Minutes dated 1/13/10, 2/10/10, and 3/10/10 failed to identify criteria specific to monitoring the effectiveness of care and services for patient on the hemodialysis unit.

On 4/1/2010 at 1300, an interview was conducted with the AVP (Associate Vice President) QM (Quality Management related to the hospital's Clinical Effectiveness Plan for 2009 - 2010. The AVP QM verified that the Hemodialysis Unit was under the direction of the Critical Care department. The AVP QM reported that the Critical Care Department had not selected any criteria from the Hemodialysis Unit for review. The Vice President of Quality Management reported presently there was no ongoing Performance Improvement Actions for the hemodialysis Unit related to Quality of the Water testing for Chlorine/Chloramine or staff proficiency.

On the days of the hospital Validation survey based on hospital policy review, record reviews, facility log reviews, a review of the Clinical Effectiveness Plan for 2009 - 2010, and interview, the facility failed to ensure an ongoing program that shows measurable improvement in indicators, for hemodialysis, for which there is evidence that it will identify and reduce medical errors.

The findings include:

On 3/30/10, a review of the hospital's Quality Management Plan revealed there were no measurable improvement indicators related to staff performance or proficiency for monitoring the water quality in the hemodialysis unit which result in patient health outcomes. This was evident in the observation in the hemodialysis unit of inaccurate performance of the water for the presence of Total Chlorine/Chloramine Test, and failure of staff to provide safe nursing care and services within their scope of practice by following physician orders, clarifying physician orders for Normal Saline and heparin administration , and reporting incidents of patient hypotensive episodes during treatment to the physician . The Vice President of Quality reported presently there was no ongoing Performance Improvement Actions for the hemodialysis unit related to Quality of the Water testing and/or staff proficiency.

On the days of the hospital Validation survey based on observations, facility policy review, record reviews, facility log reviews, a review of the Clinical Effectiveness Plan for 2009- 2010 and interview, the facility failed to measure, analyze, and track quality indicators and other aspects of performance that assess process of care, hemodialysis services and operations.

The findings include:

On 3/30/10, a review of the hospital's Clinical Effectiveness Plan for 2009 - 2010 revealed there were no measures, analysis, or tracking of the water cultures, water analysis, and water quality. There was no measure, analytics, and tracing of staff performance or proficiency for monitoring the water quality and operations. On 4/1/10 at 1300, the AVP(Associate Vice President) QM (Quality Management) verified that the hemodialysis unit was not monitored under the hospital's Clinical Effectiveness Plan 2009 - 2010 for the above indicators.

On the days of the hospital Validation Survey based on observations, interviews, record reviews, facility log reviews, review of facility policies and procedures, and review of the hospital's Clinical Effectiveness Plan for 2010, the facility failed to set priorities for its performance improvement activities that focus on a high-risk, problem-prone areas (Hemodialysis); consider the incidence, prevalence, and severity of problems in those areas; and affect patient safety.

The findings include:

On 3/30/10, a review of the hospital's Clinical Effectiveness Plan for 2009 - 2010 revealed that the Hemodialysis Unit was not included in the hospital's plan. On 3/30/10, a review of the hospital's Quality Management Plan for 2009 - 2010 had no measurable improvement indicators related to staff performance or proficiency for monitoring the water quality which result in health outcomes.

On 3/31/10 at 1500 based on observations, record reviews, review of hospital policies and procedures and staff interviews, it was determined that an Immediate Jeopardy existed on the Hemodialysis Unit as a result of 5 of 5 staff nurses' failure to accurately process a water sample for Chlorine/Chloramine presence.

Review of the Clinical Effectiveness Council Minutes dated 1/13/10, 2/10/10, and 3/10/10 did not identify any criteria specific to monitoring the effectiveness of care and services for patients on the hemodialysis unit.

On 4/1/10 at 1300, the AVP(Associate Vice President) QM (Quality Management) verified that the hemodialysis unit was not monitored under the hospital's Clinical Effectiveness Plan for 2009 - 2010. The Vice President of Quality Management reported presently there was no ongoing Performance Improvement Actions for the Dialysis Unit related to Quality of the Water or staff proficiency.

On the days of the hospital Validation survey based on observations, facility policy review, record reviews, facility log reviews, a review of the hospital's Clinical Effectiveness Plan for 2009 - 2010 and interview, the facility failed to ensure that the hospital- quality assessment and performance improvement efforts address priorities for improved quality of care and that all improvement actions are evaluated.

The findings include:

On 3/30/2010, a review of the hospitals Clinical Effectiveness Plan for 2009 - 2010 showed no indicators for the assessment of the quality of patient care and performance of monitoring of the water treatment system on the hemodialysis unit for the presence of Chlorine/Chloramine. The Vice President of Quality Management reported presently there was no ongoing Performance Improvement Actions for the Dialysis Unit related to Quality of the Water or staff proficiency.

On the days of the hospital Validation Survey based on observations, facility policy review, record reviews, facility log review, a review of the Clinical Effectiveness Plan for 2009 -2010 and interview, the facility failed to ensure that clear expectations for safety were established for the Hemodialysis unit.

The findings included:

On 3/31/10 at 1500, based on observations, record reviews, review of hospital policies and procedures and staff interviews, it was determined that an Immediate Jeopardy existed on the Hemodialysis Nursing Unit as a result of 5 of 5 staff nurses' failure to accurately process a water sample for Chlorine/Chloramine presence. On 4/2/10, based on observations, hospital policy and procedure review, hospital Clinical Effectiveness Plan, and review of physician orders, it was determined that Immediate Jeopardy existed in the hospital's Hemodialysis Unit related to nurses practicing outside their scope of practice related to but not limited to: not following physician orders, not clarifying unclear physician orders for heparin administration and normal saline infusion for hypotensive episodes in patients, no treatment protocols, lack of necessary policies and procedures to address issues related to testing of water in the dialysis unit, no supervisory/administrative staff or nurse educator who were knowledgeable in hemodialysis procedures.

On the days of the hospital Validation Survey based on observations, interviews, record reviews, and review of hospital policies and procedures, the hospital failed to ensure that patients received care and services in accordance with the hospital's policies and procedures and Standards of Practice on the hemodialysis unit.

The findings include:

Cross Reference A 0392: The facility failed to provide nursing care to all patients as needed (Hemodialysis) and for 6 of 11 patients who had records were reviewed for care and
services, and for 3 of 3 hemodialysis nurses (RN #5, RN #7, and RN #3) who failed to accurately perform testing on the hemodialysis unit's water for the presence of Chlorine/Chloramine.

Cross reference to A 0396: The facility failed to ensure a well organized service with a plan of administrative authority and delineation of responsibilities for patient care in the hemodialysis unit.

Cross Reference A 0405: The hospital failed to ensure that all drugs and biologicals were administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, and in accordance with approved medical staff policies and procedures.

Cross Reference to A 0285: The facility failed to set priorities for its performance improvement activities that focus on a high-risk, problem-prone areas (Hemodialysis); consider the incidence, prevalence, and severity of problems in those areas; and affect patient safety.

On the days of the hospital Validation survey based on observations, facility policy review, record reviews, facility log reviews, personnel record reviews, and staff interviews, the hospital failed to ensure a well organized service with a plan of administrative authority and delineation of responsibilities for patient care in the hemodialysis unit.

The findings include:

On 4/1/10, a review of the hospital's personnel files verified that the Director of the Hemodialysis Unit and the Health Educator for the Hemodialysis Unit had no previous dialysis experience.

Cross Reference A0144: The facility failed to ensure the Hemodialysis patient's right to receive care in a safe setting.

Cross Reference A0392: The facility failed to provide nursing care to all patients as needed (Hemodialysis) and for 6 of 11 patients whose records were reviewed for care and services, and for 3 of 3 hemodialysis nurses (RN #5, RN #7, and RN #3) who failed to accurately perform testing on the hemodialysis unit's water for the presence of Chlorine/Chloramine.




27669

On 3/30/10 at 1140, an interview was conducted with the Nurse Director of the hospital's hemodialysis unit. The hemodialysis Nurse Director reported that he/she did not have any previous dialysis experience, and/or dialysis training necessary for the direction of the hemodialysis unit. The hemodialysis Nurse Director verified that he/she had no knowledge of Chlorine/Chloramine testing of the water. The hemodialysis Nurse Director reported that employees of the hemodialysis unit were all long-term employees of the hospital with numerous years of hemodialysis experience. On 4/1/10, a review of the hemodialysis Nurse Director's personnel file confirmed that the dialysis unit's Nurse Director had no previous dialysis experience.

On 4/1/10 at 1745, an interview was conducted with the hemodialysis unit Health Educator. The hemodialysis unit Health Educator verified that he/she had no previous hemodialysis experience. The Health Educator reported, "I'm not able to initiate or terminate a patient's treatment from beginning to end. I have no knowledge of how to do that process". On 4/2/10, a review of the personnel files revealed that the Health Educator for the Hemodialysis Unit had no previous hemodialysis experience.

On the days of the hospital Validation survey based on observations, facility policy review, record reviews, facility log reviews, and interview, the facility failed to provide nursing care to all patients as needed (Hemodialysis) and for 6 of 11 patients (Patient #46, 48, 49, 42, 43, and 44), for 2 of 2 patients on the medical surgery unit (Patient #55 and 56) whose records were reviewed for care and services, and for observation of 3 of 3 hemodialysis nurses (RN #5, RN #7, and RN #3) who failed to accurately perform testing on sample water for Chlorine/Chloramine presence, observation of 2 of 5 hemodialysis nurses who were observed incorrectly performing procedures (Hemodialysis RN #5 and 6), and 4 of 4 medical surgical nurses (RN #4, 5, 6, and 14) observed at the unit's pediatric crash cart, and 1 of 1 nurse (Medical Surgical RN #2) implementing blood transfusions on the medical surgical unit.

The findings include:

On 4/2/10 at 1030, a review of Patient # 46's medical record revealed the sixty-one year old female was admitted on 1/24/10 with diagnoses of End Stage Renal Disease, Hypertension, Seizure Disorder, lower Gastrointestinal Bleed, status/ post Cerebrovascular Accident with expressive Aphasia, and Hyperkalemia. The patient's Hemodialysis Record (HD) dated 2/3/10 showed staff documented the administration of 200 milliliters (ml.) of Normal Saline with nursing comments of the patient moaning and diaphoretic with a blood pressure of 137/79 at 0405. There was no physician order for the administration of normal saline, and there was no documentation of physician notification of the patient's symptoms.

The patient 's HD record dated 2/12/10 showed staff documented a patient blood pressure of 116/63 at 1015 with 200 ml. of normal saline given. Nursing commented that the patient was moaning with low pressure, and normal saline was administered. There was no documentation of physician notification of the patient's hypotensive episode, and no physician order for the administration of normal saline for hypotension.

The patient's HD record dated 2/17/10 showed staff documented a heparin maintenance dose throughout treatment of 2500 units. At 0815, nursing documented a patient blood pressure of 78/28 with 200 ml. of normal saline given for blood pressure; at 0820, the nurse documented the patient's blood pressure was 82/48 with 200 ml. of normal saline given for blood pressure support; and at 0845, the patient's blood pressure was documented as 86/42 with 200 ml. of normal saline given for blood pressure support. A maintenance dose of 2500 units of heparin was administered throughout the patient's dialysis treatment with no documentation of clotting problems although the physician order dated 2/8/10 included heparin 1000- 2000 units of heparin, and a physician order dated 2/16/10 included " ... up to 2000 units heparin prn (as needed) for clotting". There was no order for the administration of normal saline for hypotension and no documentation of physician notification of the patient's hypotensive episodes.

The patient's HD record dated 2/25/10 showed staff documented the administration of 1000 units of heparin with the most recent heparin order dated 2/20/10 for 1500 units of heparin load dose.

The patient's HD record dated 2/27/10 showed staff documented the administration of 2200 units of heparin with the most recent heparin order, dated 2/26/10, for 1500 units of heparin load dose. The patient's blood pressure at 0800 was 88/32 with 100 ml. bolus of normal saline given. There was no physician order for normal saline for the hypotensive episode, and no documentation of physician notification of the hypotensive episode.

The patient's HD record dated 3/2/10 showed staff documented illegible units of heparin maintenance given with the most recent heparin order, dated 2/26/10 for 1500 units of heparin load dose.

The patient's HD record dated 3/4/10 showed staff documented 5000 units of heparin at 0715 with the most recent heparin order, dated 2/26/10 for 1500 units of heparin load dose.
The patient's HD record dated 3/6/10 showed staff documented 5000 units of heparin at 1050 with the most record heparin order, dated 2/26/10 for 1500 units of heparin load dose.
The patient's HD record dated 3/9/10 showed staff documented heparin, amount illegible, at 1050 with the most record heparin order, dated 2/26/10 for 1500 units of heparin load dose.
The patient's HD record dated 3/11/10 showed staff documented 1900 units of heparin given throughout treatment with the most record heparin order, dated 2/26/10 for 1500 units of heparin load dose.
The patient's HD record dated 3/13/10 showed staff documented 2600 units of heparin given throughout treatment with the most record heparin order, dated 2/26/10 for 1500 units of heparin load dose.
The patient's HD record dated 3/16/10 showed staff documented 1500 units of heparin given at 0749, with the most record heparin order, dated 2/26/10 for 1500 units of heparin load dose.
The patient's HD record dated 3/18/10 showed staff documented heparin given , amount illegible.
The patient's HD record dated 3/2010 showed staff documented heparin given , amount illegible.
The patient's HD record dated 3/22/10 showed staff documented heparin given , amount illegible.
The patient's HD record dated 3/25/10 showed staff documented 2300 units of heparin given throughout treatment, with the most recent heparin order dated 2/26/10 for 1500 units of heparin load dose.

The patient's HD record dated 3/30/10 showed staff documented 2000 units of heparin given at 0726, with the most recent heparin order dated 2/26/10 for 1500 units of heparin load dose and on 3/25/10, and an order for 2000 units of heparin for clotting. There was no documentation of clotting problems. The patient's blood pressure was 85/53 at 0800; 99/30 at 0830. There was no documentation of physician notification or nursing comments regarding the low blood pressure.

The patient's HD record dated 4/1/10 showed staff documented 1000 units of heparin given at 0805 with the most recent heparin order dated 2/26/10 for 1500 units of heparin load dose and on 3/25/10, a physician order for 2000 units of heparin prn for clotting. There was no staff documentation of clotting problems. At 0930, the patient's blood pressure was 127/74, and the nursing comments included "Pointing at belly and moaning- gave normal saline bolus for cramps". There was no order for normal saline for hypotension and no documentation of physician notification of the patient's symptoms.

Review of hospital policy, "Dialysis Documentation", revised 5/09, read, " ... Implementation: 1. Nursing and medical orders are carried out accurately and appropriately, and in compliance with established hospital and departmental policies and procedures. 2. Nursing intervention, in the event of complications or of emergencies, are prompt, appropriate and based on established policies and procedures. 3. Documentation of all nursing interventions will be done on the Hemodialysis Record. unexpected occurrences should be documented in detail ..."

Review of hospital policy, "Order Types and Clarification of Orders", effective 3/07/07, read, "... Responsibility: Registered / licensed professionals approved to receive practitioner orders per scope of practice, SC State Law and approval from the Medical Executive Committee...No treatments or medication (including over-the-counter medications) are to be given without an order from an authorized practitioner ... Vague, non-specific, or illegible orders are not to be carried out. The nurse, pharmacist, etc. should call the involved practitioner for a more specific and detailed order before nay medication can be given or order can be carried out. Examples: Heparin ordered in amounts other than in "unit dosage....".





28630

On 4/2/2010 at 1200, a review of Patient #42's chart showed the Hemodialysis Treatment Order Set by the physician on 3/25/2010 at 1050, reads, "Duration of 3 hours The dialysis bath: Potassium 2 and Calcium 2, the dose of Bicarb had 'standard' circled, Blood Flow Rate (BFR) 350 ml/min (milliliters/minute), and Dialysis Flow Rate (DFR) at 800 mL/min, fluid removal of 2 (Kilograms)Kg. Dialysis Temperature had standard circled. No systemic heparin, 0.9% Sodium Chloride 1-2 liters PRN (as needed) during dialysis for priming and Heparin 5000 units/ml vial) instill 1.9 ml into venous catheter and there was no dose of heparin specified for the arterial catheter post every hemodialysis." The physician's order called for a bath with Potassium 2 and Calcium 2 .

Review of the hemodialysis record dated 3/25/10 showed the Nurse documented the Bath as Potassium 2 and Calcium 2.5. Review of the hemodialysis record showed there was no patient post assessment completed for Intake and Output. The patient's vital signs recorded at 0818 was 163/73. The hemodialysis record showed the patient's blood pressure steadily decreased until 1030 when the patient's blood pressure reading was 87/54. There was no notation that the physician was called about the patient's hypotension. The nurse recorded that he/she changed the patient's UF goal from 2 Kg as ordered to 1.5 Kg. There was no physician's order on the patient's chart that showed the nurse obtained a physician order to decrease the patient's UF goal.

Review of Patient #42's hemodialysis record showed physician orders for heparin flush that read no systemic heparin. The physician order further reads, "Heparin 5000 units/ml vial but the Instill __ mL into venous catheter and __Ml into arterial catheter post every hemodialysis" was blank for physician orders recorded on 3/4/2010, 3/6/2020. 3/9/2010, 3/11/2010, 3/13/2010, 3/17/10, and 3/25/2010. On 3/4/2010, the patient's hemodialysis record completed by Nursing staff showed the heparin dosages to store cath was written at two different values: arterial was 2.1 and 1.9 and venous was 2.1 and 1.9. There was no physician order or protocol related to the change. The patient's hemodialysis record dated 3/9/2010, 3/11/2010, and 3/13/2010 showed nursing documentation that Heparin 1.9 ml was given to flush arterial and venous catheter lumens. There was no physician's order on the patient's chart or hospital protocol. Patient #42's hemodialysis record dated 3/13/10 showed staff recorded a dialysate bath containing 3 K (potassium) and no Calcium. Review of the physician's order for this hemodialysis treatment, read, "Dialysate Bath Potassium 3 and Calcium 2"
.
Patient #42's hemodialysis record dated 3/20/2010 showed the patient's blood pressure readings at 1130 was 88/51. The patient received 100 cc (cubic centimeters) of Normal Saline at 1149 for "BP" (blood pressure) because the patient's blood pressure recording at 1149 was 76/43. Documentation on the hemodialysis flow sheet showed on 3/20/10 at 1200 Noon, the patient's blood pressure was recorded as 75/45 and 300 cc Normal Saline was infused related to blood pressure support. The nurse documented on the hemodialysis flow sheet at 1415, "large clot in venous chamber- new system ^". At 1431, the nurse documented " TX (treatment) c (with) new set up". There were no physician orders for the Normal Saline administered for the patient's hypotension. There was no documentation that the physician was notified of the patient's hypotensive episodes. The hemodialysis record had no documentation that the physician was notified that the patient's dialyzer had clotted or for additional orders to resume dialysis treatment.

On 3/23/2010 at 0810, Patient #42's hemodialysis record showed the patient's blood pressure was 67/44. The patient was given 200 ml of saline. Twenty minutes later at 0820, the patient's blood pressure was 74/52 and the patient was given another 300 ml of Normal Saline. There was no notation on 3/23/2010 in the hemodialysis record that the physician was informed of the patient's hypotension. The last physician order for Normal Saline was written on 3/13/2010 for dialysis but did not indicate the amount of Normal Saline to be given to the patient. The hospital had no protocols pertaining to hypotensive episodes.

Review of Patient #42's Hemodialysis Record showed that on 3/25/2010, the nurse wrote that the bath prescription was Potassium 2 and Calcium 2.5. However, a review of the medical orders showed the Physician did not write a Potassium or Calcium bath order on 3/23/2010. On 3/25/2010 at 1050, the physician order for the bath was for a Potassium 2 and Calcium 2 bath.

Patient #42's hemodialysis record dated 3/30/2010 showed the patient's blood pressure reading at 0703 was 74/40. The patient received 200 cc Normal Saline. Patient #42's blood pressure reading at 0709 was 63/59 and at 0730, the patient's blood pressure reading was 95/54. The last physician order for Normal Saline was written and signed on 3/13/2010 but the physician's order did not state the volume of Normal Saline to be given. There was no documentation that the physician was notified of the patient's hypotensive episodes.

Review of Patient #43's chart showed the patient had a diagnoses of Hypertension and End Stage Renal Disease and received hemodialysis on Monday, Wednesday, and Friday. The chart showed physician dialysis order written on 03/23/2010, reads, "for dialysis on 3/24/2010, 3:35 time, 2K (Potassium)/2 Ca (Calcium) bath, no heparin, 2-3 Kg (kilogram) fluid removal, max blood flow'. On 3/25/2010, the hemodialysis nursing record showed "Blood Pressure support NS" (Normal Saline). There was no physician order for Normal Saline on the patient's chart.

On 3/25 for 3/26, Physician Orders for Patient #43's dialysis, reads, "3.5 hr, 2K, 2 Ca, 2-2 UF (ultrafiltration), no heparin". An additional order written for 3/26/2010, reads, "change dialysate to 1 (one) K for 1 (one) hour, and then, 2 K for 2.5 hours. UF for 6 Kgs.". Review of the patient's hemodialysis record for 3/26/2010 showed the amount of Potassium added to the bath but did not show the amount of Calcium added to the bath. The hemodialysis continuation sheet showed a 1 K bath was started at 1036 to run for one hour. The hemodialysis record showed the 2 K bath was not hung until 1200 which showed the 1 K bath ran on the patient for one hour and 24 minutes. The patient's blood pressure was recorded as 84/52 at 1300. The patient's blood pressure was recorded as 83/57 at 1330. The patient was given 250 ml of Normal Saline. There was no physician order on the patient's chart for Normal Saline. The hemodialysis record had no documentation that the physician was notified of the patient's hypotensive episodes.

On 3/27/2010, the physician's dialysis orders for Patient #43 read, "Hemodialysis 3/29. 2K, 2.5 Ca, 3 hrs (hours), no (symbol) heparin". Review of the patient's hemodialysis record for 3/27/10 showed the Bath that was recorded on the hemodialysis record did not include the Calcium prescription. The patient's blood pressure readings on 3/27/2010 were 92/53 at 1200; 89/50 at 1230; 87/47 at 1300; and 70/50 at 1330. There was no documentation on the patient's hemodialysis record that the patient's physician was notified of the patient's low blood pressure reading.

Review of Patients #43's "Physician Order Sheet Hemodialysis" dated 3/31, reads, "3 hr, 2K 2.5, 2 Kg UF, symbol (no) heparin". Review of the patient's hemodialysis record dated 3/31/10 showed no documentation that the ordered Calcium was added to the bath as prescribed by the patient's physician.

On 4/2/2010 at 0945, a review of Patient #44's chart showed the 89 year old had a history of Hypertension and End Stage Renal Disease. The following physician's orders for hemodialysis were written on 3/22/10 at 1000 for the patient's dialysis treatment on 3/23/2010, that reads, "HD orders for 3/23/2010, 330, UF (symbol zero with a line through it), 2K, 2 Ca, heparin 1000/500, pre and post BUN (Blood Urea Nitrogen)". Additional physician telephone orders for hemodialysis were written on 3/23/2010 at 1140 and reads, "0.9% Sodium Chloride 1-2 liters prn (as needed) during HD, Heparin 1000 units /cc (cubic centimeter) 1,000 unit bolus - 500 units per hour maintenance during HD. Heparin 5000 units/cc. Instill 2.4 ml in arterial and 2.6 ml in venous lumen of permcath post HD".

The patient's hemodialysis record dated 3/23/2010 showed nursing staff documented the dialysate bath had 2 K and 2.5 Ca which was not the dose of calcium ordered by the physician. The patient's hemodialysis record showed for BP (Blood Pressure) support, Normal Saline was administered for hypotension, but there was no physician order or protocol for Normal Saline to be used to support low blood pressure during the patient's dialysis treatment. On 3/23.2010 at 1400, review of Patient #44's chart showed the nurse documented a blood pressure of 83/50, and wrote "(decrease arrow) BP 'Feels bad' NS bolus". The nurse documented that 500 ml of Normal Saline was administered. The patient's hemodialysis record showed when the patient's blood pressure was rechecked at 1405, the blood pressure was recorded at 114/64. The Nurse wrote "VSS" (vital signs stable) in the nursing notes. There was no documentation that the patient's physician was notified of the patient's symptoms, and there was no physician order for the Normal Saline in the patient's chart. On 3/23/2010 at 1523, the Hemodialysis continuation sheet showed the patient had an episode of hypotension and altered consciousness lasting from 1523 to 1625. The note does not specify when the physician was notified of the patient's symptoms or when the order for an additional 500 milliliters of Normal Saline was received.

On 3/29/2010 at 0715, Patient #44's chart revealed that the patient's physician gave a telephone order to "use previous dialysis orders". Review of the previous physician orders written on Dialysis Treatment Order Set dated 3/26/2010 at 1232 showed a physician order for a bath with Potassium 2 and Calcium 2. The patient's Hemodialysis Record showed the nurse recorded the Bath as Potassium 2 and Calcium 2.5.

On 3/31/2010 at 1050, a review of Patient # 56's chart revealed the patient was admitted to Mother-Baby (post partum) unit on 3/29/2010 following a Vaginal Delivery of a baby girl. Review of the the Postpartum Admission Assessment showed the Post Partum Admission Assessment was not completed within four hours of admission per hospital policy. The finding was confirmed by Registered Nurse (RN) #9 on 3/31/10 at 1050.

Hospital policy on Assessment and Reassessment of Patients, Effective 12-02-1997, page nine, reads "The RN will complete the nursing admission assessment as soon as possible upon patient arrival to the nursing unit but shall not exceed the time frame appropriate to the acuity of the patient (see Appendix B). Patient condition upon arrival may warrant immediate assessment. Quick Reference for Unit Specific Assessment/Reassessment Criteria, Appendix B (page 48). Mother-Baby Admission Completed and Documented. Transfer from L&D (Labor and Delivery): within 4 (four) hours of admission".


On 3/29/2010 and 3/30/2010, random staff interviews of four Registered Nurses (RN # 4, RN #5, RN #6 and RN #14) who were on duty on the medical surgical third floor which provides telemetry service to patients were unable to describe the use of the Pediatric Color Coded Crash Cart. Three of the four RNs were unable to locate or assemble the laryngoscope in the crash cart. On 3/30/2010 at 1100, RN #9 who was on duty on the Mother-Baby unit was unable to locate the Crash Cart on the unit.

Position Description for the Med/Surg/614 Registered Nurse, Age of Patients Served, reads "This position requires competency in providing service and/or care for the age groups indicated. The staff member must be able to demonstrate the knowledge and skills necessary to provide care, based on physical, psycho/social, educational, safety, and related criteria, appropriate to the age of the patients served in his/her assigned service area. The skills and knowledge needed to provide such care may be gained through education, training or experience. Ages: 13-18 years Adolescent...". Policy Competency Assessment, Effective date 2/2008, Approved by the CEO. page 2, Procedure, reads, " Facility Competency Assessment Program Includes: All facility employees will participate in an ongoing competency assessment program designed specifically for each area or department and position. This program... (bullet 4) Includes ongoing competency assessment, which provides regular opportunities for review of infrequently used but necessary skills, or of high-risk, low-volume or problem-prone skills. It also includes training for new equipment or technology, training for policy/procedure changes, and annual assessment. (Bullet 6) reads "Ensures that patient care staff is competent to provide care to the patient population served in their department".

On 3/29/2010 at 1445, a random observational tour of the third floor showed a patient located in Room 306 with a diagnosis of Gastrointestinal Bleed had a unit of blood hanging with a time recorded as 1420 for the time that the blood was hung. Further inspection of the unit of blood that was hung at 1445, revealed that the clamp between the unit of blood and the intravenous drip chamber on the infusion set was closed which obstructed the flow of blood through the blood tubing set to the patient. No blood product was observed in the tubing. During an interview on 3/29/10 at 1445, RN #2 reported that the blood was running per the physician's order. After a second inquiry about the blood infusion, RN #2 went to the patient's room and verified that the clamp on the blood infusion set had never been opened. RN #2 reported that the clamp should be opened when starting a blood transfusion on a patient. The findings were reviewed with Clinical Director on 3/30/2010. Review of the Patient's Record on 3/30/2010 showed the blood was initiated at 1420 but observation showed the clamp on the infusion set was not opened until 30 minutes after the blood unit was hung.

Hospital Policy, Blood and Blood Products: Transfusion of and Distribution from Blood Bank, Effective 08-01-2002, Procedure 3. Transfusing Blood Products, (bullet seven), reads "To start the transfusion of blood product: .... Open clamp under blood pack and begin transfusion. Regulate rate of infusion by adjusting clamp or tubing or IV (intravenous) settings".

On 3/30/2010 at 1515, during an interview with Patient #55, observation showed RN #2 secured the tape of an intravenous line that had been inserted in the patient's right forearm. RN #2 stated that the patient was to have a blood transfusion. Review of the patient's chart on 3/30/10 at 1530 revealed Patient #55 had a history of Sickle Cell Anemia and Avascular Necrosis of the left hip. The patient's chart revealed that the patient had a Left Hip Replacement performed on 3/29/2010. Patient #55's chart had a physician order recorded on 3/30/2010 at 0717 for the transfusion of two (2) units of packed red blood cells (PRBCs) because the patient's hemoglobin was 7.3 gm/dl. The physician order was reviewed and initialed by hospital staff at 1000. Observation of the patient at 1500 revealed that the blood transfusion had not been started. RN #2 reported that when the lab was called to obtain the patient's blood at 1530, he/she discovered the patient had no blood available for pick up because the patient had had no recent Type and Cross Match ordered. RN #2 reported that it had been a busy day and that was the cause of the delay in initiating the transfusion. On 3/31/2010, a review of the patient's chart showed the blood was initiated at 1715. The Clinical Director confirmed that a delay in treatment had occurred.

Hospital policy, Title, Blood and Blood Products: Transfusion of & Distribution from Blood Bank, Effective 8-01-2002, reads, "Responsibility RN or MD: (first bullet) Obtaining products from Blood Bank. Procedure reads "1. 'Prior to' Obtaining Blood Product from the Blood Bank (Bullet one) reads Verify that the blood product order has been received and completed by the Blood Bank and is available for 'pick up'. This is easily accomplished by accessing 'Nursing Main Menu...in Meditech. Select 'printing options' then 'View Available Blood Products by Patient'. Type in the patient information and Meditech will display any products that are ready to be issued for transfusion. NOTE: Orders for RBCs (Red Blood Cells). Patient's Blood Bank specimen and corresponding blood recipient wristband are good for three (3) days that is until midnight of the third day post draw".










27669

On 3/30/10 at 1140, upon arrival in the hemodialysis Unit, the Nurse Director of the hemodialysis unit reported not having any previous hemodialysis experience, training, or completed any skill competencies for the hemodialysis unit. He/she reported no knowledge of performing the sample water chlorine/chloramine testing. The hemodialysis unit Director reported that employees of the hemodialysis unit were all long-term employees of the hospital with numerous years of hemodialysis experience. On 4/1/10, a review of the personnel files verified the Director of Hemodialysis unit had no previous hemodialysis experience, having completed skill competencies, or an annual competency.

On 4/1/10 at 1745, the Health Educator reported that he/she had no previous hemodialysis experience, no available skilled competencies of proficiency in hemodialysis nursing, and no annual competencies. The Health Educator reported receiving minimal training and orientation to hemodialysis when he/she first started the educator role. The Health Educator reported, "I'm not able to initiate or terminate a patient's treatment from beginning to end. I have no knowledge of how to do that process". On 4/2/10, a review of the personnel files verified the Health Educator for the Hemodialysis Unit had no previous hemodialysis experience.

On 4/1/10 at 0745, a random observation in the hemodialysis unit showed Registered Nurse (RN) #5 administering an initial bolus of 500 milliliters (mL) of Normal Saline (NS) to a patient for a blood pressure (B/P) reading via dialysis machine of 64/44. Then, RN #5 administered an additional 200 mL of NS. After administering a total of 700 mL of NS, RN #5 obtained the patient's B/P which was a reading of 96/61. During an interview with RN #5 on 4/1/10 at 0745, RN #5 reported that there was no hospital policy and procedure and/or standing/written/verbal physician orders with the parameter limits for administering a Normal Saline bolus for a patient's hypotensive episodes during a patient's hemodialysis treatment. Review of the patient's medical record showed RN #5 administered a 500 mL bolus of NS, and then, an additional 200 mL of NS. There was no physician order or protocol for the administration of the Normal Saline for patient's hypotensive episodes in the patient's medical record. The dialysis record for 4/1/2010 had no documentation that the physician was notified of the patient's hypotensive events.

On 4/1/10 at 1100, a random observation of RN #6 preparing a bath for a dialysis treatment showed RN #6 adding Potassium 10.4 grams in a powdered form to a pre-mixed jug of unknown fluid of 2 milliequalivents/liter (mEq/L) of Potassium(K+) and 2.5 mEq/L of Calcium (Ca++) Acid concentrate. During an interview with hemodialysis RN# 6, RN #6 reported, "I don't know if there is a hospital policy and procedure for mixing or adding additional potassium to the acid concentrate. I was taught when I came to work here that this was how it should be done by the nurse that trained me. I remember there use to be a big policy and procedure manual awhile back. I think the jug has 2 gallons of 2K+ 2.5 Calcium in it. I obtain an accudose packet of the K+, add to this jug, and shake gently until mixed to get a 3.5 K+, 2.5 Calcium." On 4/1/10 at 1100, a review of the the Directions For Use (DFR), reads, "...Increase Potassium by: 1mEu/L When added to: 3.78 Liters (1 gallon) of Acid Concentrate...Directions: Add contents to 3.78 liters of acid concentrate. Mix completely. Fill out Edlaw Concentrate Adjustment Label and affix to concentrate container...". On 4/1/10 at 1110, the hemodialysis Nurse Director reported, "I've searched and I was not able to find a hospital policy for adding K+ to acid concentrate. The Nurse Director attempted to fill an empty jug similar in size to the jug used by RN #6 with water from the sink using an empty gallon jug which resulted in the filling of the jug with 3-4 gallons of water to obtain the approximate amount of 2 K 2.5 Ca in the jug used by RN #6 to add K powder in the earlier observation.

On 4/2/10 at 1030, a review of Patient #48's chart showed the patient was admitted to the hospital with diagnoses of End Stage Renal Disease, Urinary Tract Infection, and Hypertensive Urgency, and hemodialysis. The patient's chart showed physician orders written on 3/5/10 at 1120 for duration of 3 hours, 2 K+ (Potassium) 2.5 Calcium bath, Blood Flow Rate of 400, an Estimated Dry Weight (EDW) of 91. 5 Kilograms (Kgs), and a Dialysis Flow Rate of 800. Hemodialysis treatment record dated 3/12/10 showed the patient's dialysis treatment was initiated at 0810, and the patient's blood pressure was recorded as 129/55. On 3/12/10 at 1000, staff recorded a blood pressure of 83/39, and staff charted that 200 ml (milliliters) of normal saline was administered for blood pressure support. The nurse wrote "Recheck BP (Blood Pressure) - 74/36 - NS for BP support". On 3/12/10 at 1005 , staff recorded a blood pressure of 79/38, and recorded that staff administered 200 ml of Normal Saline. The nurse wrote "NS for BP support". Staff recorded the patient's blood pressure at 1007 as 102/44. On 3/12/10 at 1105, staff charted a patient blood pressure of 96/42. Staff wrote "Tx (treatment) terminated 8 min (minutes) early". Review of the patient's chart showed no physician orders for the administration of normal saline for hypotensive episodes. There was no documentation that the physician had been notified of the patient's hypotensive episodes on 3/12/10. Review of the patient's hemodialysis orders on the Initial Dialysis Treatment Order set shows "Heparin (1000 units/mL vial): administer loading dose of 1000 units and then infuse 500 units/hr (hour)". Review of hemodialysis orders recorded on the Physician order forms dated 3/5/10, 3/8/10, 3/9/10, 3/11/10, 3/12/10, and 3/15/10 show no orders for heparin. On 3/18/10, the physician orders read, "up to 2000 units heparin prn clotting". Physician orders dated 3/28/10 at 0800 read, "heparin 2000 IV load". Physician orders written on 3/22/10 have no orders for heparin. Physician orders written for 3/26/10 read, "1000 - 2000 units heparin prn clotting". Physician orders for dialysis dated 3/29/10 at 1030 and 3/31/10 at 0610 show no orders for heparin. Review of the patient's hemodialysis treatment sheets dated 3/8/10, 3/12/10, 3/15/10 showed the patient received 1.0 units heparin when the treatment was initiated when none had been ordered. Review of the hemodialysis treatment record dated 3/17/10 showed the patient received 2.0 heparin when the treatment was initiated. Review of the patient's hemodialysis treatment sheet dated 3/24/10 showed the patient received 1.0 units heparin when treatment initiated. Review of the patient's hemodialysis treatment sheet dated 3/26/10 at 1313 showed the patient received 50 units heparin when treatment initiated, 1000 units heparin at 1430, 1800 units heparin at 1500, and 2000 units heparin at 1530 for a total of 4850 heparin units. The patient's hemodialysis treatment sheet dated 3/2?/10 and 3/30/10 showed the patient received 1.0 unit heparin. Review of the patient's dialysis flow sheet dated 3/31/10 showed the patient received a 2000 unit bolus. There was no evidence that the patient received the 500 unit/hour maintenance dose of heparin that was in the original dialysis orders or any documentation that staff contacted the physician to clarify the physician's orders regarding heparin.

Review of Patient #49's hemodialysis chart revealed that the patient was admitted to the hospital with a chief compliant of necrosis of the ascending colon. Review of the patient's past medical history showed the patient was on renal hemodialysis. Review of the physician's hemodialysis orders dated 3/18/10 at 0936 showed "2. Dialysis orders 3/19; 3hrs (hours); 3 K (Potassium)/2.5 Ca (Calcium) bath; no heparin; 1 - 2 kg fluid r

On the days of the hospital's Validation survey based on interviews, record reviews, and review of hospital policies and procedures, the hospital failed to ensure that all drugs and biologicals were administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, and in accordance with approved medical staff policies and procedures.

The findings included:

On 3/30/10 at 0930, a random observation showed Registered Nurse (RN) #1 administering Lasix 40 milligrams (mgs) intravenous (IV) push to a random patient in the Emergency Department over 45 seconds. During an interview on 3/30/10 at 0930 as to the appropriate length of time interval to administer Lasix 40 mgs intravenously, RN#1 reported, "I just know slowly". Review of the Nursing 2010 Drug Handbook located in the medication area read, "Lasix should be administered IV push for over 1 to 2 minutes". The findings were confirmed by the Emergency Department Nurse Director.

On 4/1/10 at 0745, random observation in the dialysis unit showed RN #5 administering an initial bolus of 500 milliliters (mL) of Normal Saline (NS) to Patient #1 for a blood pressure (B/P) reading via dialysis machine of 64/44. Then, RN #5 administered an additional 200 mL of NS. After administering a total of 700 mL of NS, RN #5 obtained the patient's B/P which was 96/61. During an interview with RN #5 on 4/1/10, RN #5 reported that there was no hospital policy and procedures and/or standing/written/verbal physician orders with the parameter limits for administering a Normal Saline bolus for hypotensive episodes during a patient's dialysis treatment. Review of Patient #1's medical record showed RN #5 administered a 500 mL bolus of NS, then, administered an additional 200 mL of NS. There was no physician order or protocol for the administration of Normal Saline for hypotensive episodes in the patient's medical record. The dialysis record for 4/1/2010 had no documentation that the physician was notified of the patient's hypotensive event.

On 4/1/10 at 1100, random observation of RN #6 preparing a bath for a dialysis treatment showed staff adding Potassium 10.4 grams powdered form to a pre-mixed jug of unknown fluid of 2 milli-equalivents/liter (mEq/L) of Potassium(K+) and 2.5 mEq/L of Calcium (Ca++) Acid concentrate. During an interview with dialysis RN# 6, he/she reported, "I don't know if there is a hospital policy and procedure for mixing or adding additional potassium to the acid concentrate. I was taught when I came to work here that this was how it should be done by the nurse that trained me. I remember there use to be a big policy and procedure manual awhile back. I think the jug has 2 gallons of 2 K+, 2.5 Calcium in it. I obtain an accudose packet of the K+, add to this jug, and shake gently until mixed to get a 3.5 K+, 2.5 Calcium." On 4/1/10 at 1100, a review of the the Directions For Use (DFR), reads, "...Increase Potassium by: 1mEu/L When added to: 3.78 Liters (1 gallon) of Acid Concentrate...Directions: Add contents to 3.78 liters of acid concentrate. Mix completely. Fill out Edlaw Concentrate Adjustment Label and affix to concentrate container...". On 4/1/10 at 1110, the Hemodialysis Nurse Director reported, "I've searched and I was not able to find a hospital policy for adding K+ to acid concentrate. The Nurse Director attempted to fill an empty jug similar in size to the jug used by RN #6 with water from the sink using an empty gallon jug which resulted in the filling of the jug with 3-4 gallons of water to obtain the approximate amount of 2 K, 2.5 Ca in the jug used by RN #6 to add K powder in the earlier observation.

Review of the facility's drug reference, "Nursing 2010 Drug Administration", reads, "Furosemide (Lasix)... Administration... I.V...For direct injection, give over 1 to 2 minutes...".

Review of the facility's policy, "IV Push Medications", revised/reviewed: 5/5/08, reads, "...Procedure...The nurse must have knowledge of the use and efforts of all IV push medications prior to administration. This includes any monitoring specific to the medication. Persons administering medications via IV Push should consult appropriate drug information references when necessary...".


Cross Reference to A 0405: The hospital failed to ensure that all drugs and biologicals were administered by or under supervision of nursing or other personnel in accordance with Federal and State laws and regulations, and in accordance with approved medical staff policies and procedures, and practitioner's orders.

On the days of the hospital Validation survey based on interviews, record reviews, and review of hospital policies and procedures, the hospital failed to ensure that all drugs and biologicals were administered by or under supervision of nursing or other personnel in accordance with Federal and State laws and regulations, and in accordance with approved medical staff policies and procedures for 6 of 11 hemodialysis patient records reviewed. )Patient #46, 42, 43, 44, 48, and 49)

The findings include:

On 4/2/10 at 1030, a review of Patient # 46's medical record revealed a sixty-one year old female admitted on 1/24/10 with diagnoses of End Stage Renal Disease, Hypertension, Seizure Disorder, lower Gastrointestinal Bleed, status/ post Cerebrovascular Accident with expressive Aphasia, and Hyperkalemia. The patient's Hemodialysis Record dated 2/3/10 showed documentation on 2/3/10 at 0405 that the patient received 200 ml. (milliliters) of Normal Saline. Nursing recorded that the patient was moaning and diaphoretic with a blood pressure of 137/79. There was no physician order in the patient's chart on 2/3/10 for the administration of normal saline. There was no documentation that staff had notified the physician of the patient's symptoms. There was no evidence that staff protocols in place for the management of the symptoms.
The patient's hemodialysis record dated 2/12/10 showed staff documented the patient's blood pressure as 116/63 at 1015 with 200 ml. of normal saline administered. Nursing recorded that the patient was moaning with low pressure, and the normal saline was administered. There was no physician order for the administration of normal saline, and no documentation of physician notification of the patient's symptoms.
The patient's hemodialysis record dated 2/17/10 showed staff documented a heparin maintenance dose throughout the patient's treatment of 2500 heparin units. Review of the patient's chart showed no physician order for a heparin maintenance dose. At 0815, the record showed nursing documented the patient's blood pressure as 78/28 with 200 ml. of normal saline given for blood pressure. On 2/17/10 at 0820, staff documented the patient's blood pressure was 82/48 with 200 ml. of normal saline given for blood pressure support. On 2/14/10 at 0845, staff documented the patient's blood pressure was 86/42 with 200 ml. of normal saline given for blood pressure support. The patient's chart showed a maintenance dose of 2500 units of heparin was administered throughout the dialysis treatment with no documentation of clotting problems. The physician order dated 2/8/10 showed heparin 1000- 2000 units of heparin, and a physician order dated 2/16/10 showed " ... up to 2000 units heparin prn (as needed) for clotting". The patient's record revealed there was no physician order for the administration of normal saline for hypotension, no physician order for a heparin maintenance dose, and no documentation of physician notification of the patient's symptoms
The patient's hemodialysis record dated 2/25/10 showed staff documented the administration of 1000 units of heparin with the most recent physician order dated 2/20/10 was written for 1500 units of heparin load dose.
The patient's hemodialysis record dated 2/27/10 showed staff documented the administration of 2200 units of heparin. The most recent heparin physician order dated 2/26/10 was written for 1500 units of heparin load dose. On 2/27/10 at 0800, staff recorded the patient's blood pressure was 88/32 with a 100 ml. bolus of normal saline given. The patient's record showed there was no physician order for normal saline, and no staff documentation of physician notification of the patient's symptoms.
The patient's hemodialysis record dated 3/2/10 showed staff documentation of the units of heparin maintenance given was illegible. The patient's record showed the most recent physician order dated 2/26/10 was for 1500 units of heparin load dose. There was no physician order for a maintenance dose.
The patient's hemodialysis record dated 3/4/10 showed staff documented 5000 units of heparin administered at 0715 on 3/4/10. The patient's record showed the most recent physician order dated 2/26/10 was for 1500 units of heparin load dose.
The patient's hemodialysis record dated 3/6/10 showed staff documented 500 units of heparin administered at 1050 on 3/6/10. The patient's record revealed the most recent physician order was dated 2/26/10 for 1500 units of heparin load dose.
The patient's hemodialysis record dated 3/9/10 at 1050 showed staff documentation for the heparin dose amount was illegible. The most recent physician order dated 2/26/10 was for 1500 units of heparin load dose.
The patient's hemodialysis record dated 3/11/10 showed staff documented 1900 units of heparin given throughout the patient's treatment. The most record physician order dated 2/26/10 was for 1500 units of heparin load dose. The was no physician order for a maintenance dose of heparin.
The patient's hemodialysis record dated 3/13/10 showed staff documented 2600 units of heparin was given throughout the patient's treatment. The most recent physician order dated 2/26/10 was for 1500 units of heparin load dose. The was no physician order for a maintenance dose of heparin.
The patient's hemodialysis record dated 3/16/10 at 0749 showed staff documented 1500 units of heparin was given at 0749. The most recent physician order dated 2/26/10 was for 1500 units of heparin load dose. There was no physician order for a maintenance dose of heparin.
The patient's hemodialysis record dated 3/18/10 showed staff documentation of the heparin dose given was illegible.
The patient's hemodialysis record dated 3/20/10 showed staff documentation of the heparin dose given was illegible.
The patient's hemodialysis record dated 3/22/10 showed staff documentation of the heparin dose given was illegible.
The patient's hemodialysis record dated 3/25/10 showed staff documentation that 2300 units of heparin was given throughout the patient's treatment. The most recent physician order was dated 2/26/10 for 1500 units of heparin load dose. There was no physician order for a heparin maintenance dose.
The patient's hemodialysis record dated 3/30/10 at 0726 showed staff documentation that 2000 units of heparin was given. The most recent physician order dated 2/26/10 was for 1500 units of heparin load dose. On 3/25/10, a physician order for 2000 units of heparin prn (as needed) for clotting was written. There was no documentation in the patient's record of clotting problems. The patient's blood pressure was recorded as 85/53 on 3/30/10 at 0800 and 99/30 at 0830 on 3/30/10. There was no documentation of physician notification of the patient's symptoms or nursing documentation regarding the low blood pressure.
The patient's hemodialysis record dated 4/1/10 showed staff documented 1000 units of heparin was given at 0805. The most recent physician order dated 2/26/10 was for 1500 units of heparin load dose. On 3/25/10, a physician order was written for 2000 units of heparin prn for clotting. There was no documentation in the patient's chart of clotting problems. On 4/1/10 at 0930, staff documented the patient's blood pressure was 127/74. Review of nursing comments showed "Pointing at belly and moaning- gave normal saline bolus for cramps". There was no physician order for normal saline for hypotension, and no documentation of physician notification of the patient's symptoms.

Review of hospital policy, "Dialysis Documentation", revised 5/09, read, " ... Implementation: 1. Nursing and medical orders are carried out accurately and appropriately, and in compliance with established hospital and departmental policies and procedures. 2. Nursing intervention, in the event of complications or of emergencies, are prompt, appropriate and based on established policies and procedures. 3. Documentation of all nursing interventions will be done on the Hemodialysis Record. unexpected occurrences should be documented in detail ..."

Review of hospital policy, "Order Types and Clarification of Orders", effective 3/07/07, read, "... Responsibility: Registered / licensed professionals approved to receive practitioner orders per scope of practice, SC State Law and approval from the Medical Executive Committee...No treatments or medication (including over-the-counter medications) are to be given without an order from an authorized practitioner ... Vague, non-specific, or illegible orders are not to be carried out. The nurse, pharmacist, etc. should call the involved practitioner for a more specific and detailed order before nay medication can be given or order can be carried out. Examples: Heparin ordered in amounts other than in "unit dosage....".







27669

On 4/2/10 at 1030, a review of Patient #48's chart showed showed physician orders written on 3/5/10 at 1120 for duration of 3 hours, 2 K+ (Potassium) 2.5 Calcium bath, Blood Flow Rate of 400, an Estimated Dry Weight (EDW) of 91. 5 Kilograms (Kgs), and a Dialysis Flow Rate of 800. Hemodialysis treatment record dated 3/12/10 showed the patient's dialysis treatment was initiated at 0810, and the patient's blood pressure was recorded as 129/55. On 3/12/10 at 1000, staff recorded a blood pressure of 83/39, and staff charted that 200 ml (milliliters) of normal saline was administered for blood pressure support. The nurse wrote "Recheck BP (Blood Pressure) - 74/36 - NS for BP support". On 3/12/10 at 1005 , staff recorded a blood pressure of 79/38, and recorded that staff administered 200 ml of Normal Saline. The nurse wrote "NS for BP support". Staff recorded the patient's blood pressure at 1007 as 102/44. On 3/12/10 at 1105, staff charted a patient blood pressure of 96/42. Staff wrote "Tx (treatment) terminated 8 min (minutes) early". Review of the patient's chart showed no physician orders for the administration of normal saline for hypotensive episodes. There was no documentation that the physician had been notified of the patient's hypotensive episodes on 3/12/10.
Review of the patient's hemodialysis orders on the Initial Dialysis Treatment Order set shows "Heparin (1000 units/mL vial): administer loading dose of 1000 units and then infuse 500 units/hr (hour)". Review of hemodialysis orders recorded on the Physician order forms dated 3/5/10, 3/8/10, 3/9/10, 3/11/10, 3/12/10, and 3/15/10 show no orders for heparin. On 3/18/10, the physician orders read, "up to 2000 units heparin prn clotting". Physician orders dated 3/28/10 at 0800 read, "heparin 2000 IV load". Physician orders written on 3/22/10 have no orders for heparin. Physician orders written for 3/26/10 read, "1000 - 2000 units heparin prn clotting". Physician orders for dialysis dated 3/29/10 at 1030 and 3/31/10 at 0610 show no orders for heparin. Review of the patient's hemodialysis treatment sheets dated 3/8/10, 3/12/10, 3/15/10 showed the patient received 1.0 units heparin when the treatment was initiated when none had been ordered. Review of the hemodialysis treatment record dated 3/17/10 showed the patient received 2.0 heparin when the treatment was initiated. Review of the patient's hemodialysis treatment sheet dated 3/24/10 showed the patient received 1.0 units heparin when treatment initiated. Review of the patient's hemodialysis treatment sheet dated 3/26/10 at 1313 showed the patient received 50 units heparin when treatment initiated, 1000 units heparin at 1430, 1800 units heparin at 1500, and 2000 units heparin at 1530 for a total of 4850 heparin units. The patient's hemodialysis treatment sheet dated 3/2?/10 and 3/30/10 showed the patient received 1.0 unit heparin. Review of the patient's dialysis flow sheet dated 3/31/10 showed the patient received a 2000 unit bolus. There was no evidence that the patient received the 500 unit/hour maintenance dose of heparin that was in the original dialysis orders or any documentation that staff contacted the physician to clarify the physician's orders regarding heparin.

Review of Patient #49's hemodialysis chart revealed physician's hemodialysis orders dated 3/18/10 at 0936 showed "2. Dialysis orders 3/19; 3hrs (hours); 3 K (Potassium)/2.5 Ca (Calcium) bath; no heparin; 1 - 2 kg fluid removal; max blood flow".
Review of the patient's hemodialysis record dated 3/19/10 at 1615 showed the dialysis nurse recorded the patient's blood pressure as 152/60 and recorded that 300 cc Normal Saline was infused. The dialysis nurse note, reads, "confused, HR ^^, NS (Normal Saline) bolus."
The patient's heart rate was recorded as 134. Review of the patient's chart showed there was no physician order to administer Normal Saline for an elevated heart rate, and no hospital protocols for the administration of Normal Saline for elevated heart rates. There was no documentation that the patient's physician was notified of the increased heart rate or confusion. The dialysis treatment record showed the patient's heart rate was 128 at 1620 and 133 at 1700.

Review of the physician orders in the patient's chart dated 3/25/10 at 0740 showed "4. Hemodialysis orders 3/26; 3 hrs; 3K/2.5 Ca Bath; no heparin; 2 kg UF". Review of the patient's hemodialysis treatment sheet dated 3/26/10 showed the nurse recorded at 1600 that the patient's blood pressure was 105/51 and 100 cc Normal Saline was administered. The nurse recorded "(arrow down) BP UF off NS bolus." Review of the patient's chart showed there was no physician order for to administer Normal Saline for a hypotensive episode, and no hospital protocols for the administration of Normal Saline for hypotensive episodes. There was no documentation that the patient's physician was notified of the patient's hypotensive episode.

Review of the physician orders dated 3/29/10 at 1845 reads, "Hemodialysis 3/29; 4 k 2.5 Ca; 3 hr; 1-2 kg UF; 0 heparin". Review of the patient's hemodialysis treatment sheet dated 3/29/10 at 14(illegible) showed the patient's blood pressure was 73/57. The nurse documented that 300 ml (milliliters) of Normal Saline was infused. The nurse note, reads, "alert, (arrow down) BP NS". The nurse documented the patient's blood pressure at 1500 as 83/43 and "feels better". The patient's blood pressure was documented as 94/50 but the time was not charted when the blood pressure was taken. Review of the patient's chart showed there was no physician order to administer Normal Saline for a hypotensive episode, and no hospital protocols for the administration of Normal Saline for hypotensive episodes. There was no documentation that the patient's physician was notified of the patient's hypotensive episode.

Review of the physician's orders dated 3/30/10 at 1500, reads, "Hemodialysis 3/31; 3 hrs; 4K 2.5 Ca; 1-2 kg UF; ) heparin". Review of the patient's hemodialysis treatment sheet dated 3/31/10 at 0756 revealed that the patient's blood pressure was 83/44. The nurse recorded "alert". The nurse recorded the blood pressure at 0800 was 81/45 and recorded "(arrow down) Goal to 800 BP low". The nurse recorded the patient's blood pressure at 0827 as 83/47 and wrote 200 Normal Saline for blood pressure support in the nursing comment section. Review of the patient's chart showed there was no physician order to administer Normal Saline for a hypotensive episode, and no hospital protocols for the administration of Normal Saline for hypotensive episodes.











28630

On 4/2/2010 at 1200, a review of Patient #42's chart showed the Dialysis Treatment Order Set by the physician recorded on 3/25/2010 at 1050, reads, "Duration of 3 hours The dialysis bath: Potassium 2 and Calcium 2, the dose of Bicarb had 'standard' circled, Blood Flow Rate (BFR) 350 ml/min (milliliters/minute), and Dialysis Flow Rate (DFR) at 800 mL/min, fluid removal of 2 (Kilograms)Kg. Dialysis Temperature had standard circled. No systemic heparin, 0.9% Sodium Chloride 1-2 liters PRN (as needed) during dialysis for priming and Heparin 5000 units/ml vial) instill 1.9 ml into venous catheter and there was no dose of heparin specified for the arterial catheter post every hemodialysis." The physician's order called for a bath with Potassium 2 and Calcium 2 .
Review of the hemodialysis record dated 3/25/10 showed the Nurse documented the Bath as Potassium 2 and Calcium 2.5. Review of the hemodialysis record showed there was no patient post assessment completed for Intake and Output. The patient's vital signs recorded at 0818 was 163/73. The hemodialysis record showed the patient's blood pressure steadily decreased and by 1030, the blood pressure reading was 87/54. There was no notation written that the physician was called about the patient's hypotension. The nurse recorded that he/she changed the patient's UF goal from 2 Kg as ordered to 1.5 Kg. There was no physician's order on the patient's chart that showed the nurse obtained a physician order to decrease the patient's UF goal.
Review of Patient #42's hemodialysis record showed physician orders written for heparin flush that read no systemic heparin but the physician order further reads, "Heparin 5000 units/ml vial but the Instill __ mL into venous catheter and __Ml into arterial catheter post every hemodialysis" was blank for physician orders recorded on 3/4/2010, 3/6/2020. 3/9/2010, 3/11/2010, 3/13/2010, 3/17/10, and 3/25/2010. On 3/4/2010, the patient's hemodialysis record completed by Nursing staff showed the heparin dosages to store cath was written at two different values: arterial was 2.1 and 1.9 and venous was 2.1 and 1.9 but there was no physician order or protocol related to the change. The patient's hemodialysis records dated 3/9/2010, 3/11/2010, and 3/13/2010 showed nursing documentation that Heparin 1.9 ml was given to flush arterial and venous catheter lumens but there was no physician's order on the patient's chart or hospital protocol. Patient #42's hemodialysis record dated 3/13/10 showed staff recorded a dialysate bath containing 3 K (potassium) and no Calcium. Review of the physician's order for this hemodialysis treatment, read, "Dialysate Bath Potassium 3 and Calcium 2".
Patient #42's hemodialysis record dated 3/20/2010 showed the patient's blood pressure readings at 1130 was 88/51, and the patient received 100 cc (cubic centimeters) of Normal Saline at 1149 for "BP" (blood pressure) because the patient's blood pressure recording at 1149 was 76/43. Documentation on the hemodialysis flow sheet showed that on 3/20/10 at 1200 Noon, the patient's blood pressure was recorded as 75/45 and 300 cc Normal Saline was infused related to blood pressure support. The nurse documented on the hemodialysis flow sheet at 1415, "large clot in venous chamber- new system ^". At 1431, the nurse documented " TX (treatment) c (with) new set up". There were no physician orders for the Normal Saline administered for the patient's hypotension. There was no documentation that the physician was notified of the patient's hypotensive episodes. The hemodialysis record had no documentation that the physician was notified that the patient's dialyzer had clotted or for additional orders to resume dialysis treatment.
On 3/23/2010 at 0810, Patient #42's hemodialysis record showed the patient's blood pressure was 67/44 and that the patient was given 200 ml of saline. Twenty minutes later at 0820, the patient's blood pressure was 74/52 and the patient was given another 300 ml of Normal Saline. There was no notation on 3/23/2010 in the hemodialysis record that the physician was informed of the patient's hypotension. the last physician order for Normal Saline was written on 3/13/2010 for dialysis but did not indicate the amount of Normal Saline to be given to the patient and the hospital had no protocols pertaining to hypotensive episodes.
Review of Patient #42's Hemodialysis Record showed that on 3/25/2010, the nurse wrote in the record that the bath prescription was Potassium 2 and Calcium 2.5. However, review of the medical orders showed the Physician did not write a Potassium or Calcium bath order on 3/23/2010 and on 3/25/2010 at 1050, the physician order for the bath was for a Potassium 2 and Calcium 2 bath.
Patient #42's hemodialysis record dated 3/30/2010 showed the patient's blood pressure reading at 0703 was 74/40 and the patient received 200 cc Normal Saline. Patient #42's blood pressure reading at 0709 was 63/59 and at 0730, the patient's blood pressure reading was 95/54. The last physician order for Normal Saline was written and signed on 3/13/2010 but the physician's order did not state the volume of Normal Saline to be given. There was no documentation that the physician was notified of the patient's hypotensive episodes.

Review of Patient #43's chart showed the patient who was diagnosed with Hypertension and End Stage Renal Disease was on hemodialysis on Monday, Wednesday, and Friday had the following physician dialysis order written on 03/23/2010: "for dialysis on 3/24/2010, 3:35 time, 2K (Potassium)/2 Ca (Calcium) bath, no heparin, 2-3 Kg (kilogram) fluid removal, max blood flow'. On 3/25/2010, the hemodialysis nursing record showed nursing documentation of "Blood Pressure support NS" (Normal Saline), although there was no physician order for Normal Saline.
Physician Orders written for Patient #43 on 3/25 for 3/26 dialysis reads, "3.5 hr, 2K, 2 Ca, 2-2 UF (ultrafiltration), no heparin". Additional order for 3/26/2010, read, "change dialysate to 1 (one) K for 1 (one) hour, and then, 2 K for 2.5 hours. UF for 6 Kgs. Review of the patient's hemodialysis record for 3/26/2010 showed the amount of potassium added to the bath but not the amount of Calcium. The hemodialysis continuation sheet showed the 1 K bath was started at 1036 to run for one hour. The hemodialysis record showed the 2 K bath was not hung until 1200 which showed the 1 K bath ran on the patient for one hour and 24 minutes. The patient's blood pressure was recorded as 84/52 at 1300 and then, the patient's blood pressure was recorded as 83/57 at 1330. The patient was given 250 ml of Normal Saline but there was no physician order on the patient's chart for Normal Saline. The hemodialysis record had no documentation that the physician was notified of the patient's hypotensive episodes. On 3/27/2010, the physician's dialysis orders for Patient #43 read, "Hemodialysis 3/29. 2K, 2.5 Ca, 3 hrs (hours), no (symbol) heparin". Review of the patient's hemodialysis record on 3/27/10 showed the Bath that was recorded on the hemodialysis record did not include the Calcium prescription. The patient's blood pressure readings on 3/27/2010 were 92/53 at 1200; 89/50 at 1230; 87/47 at 1300; and at 70/50 at 1330. There was no documentation on the patient's hemodialysis record that the patient's physician was notified of the patient's low blood pressure reading. Review of Patients #43's "Physician Order Sheet Hemodialysis" dated 3/31, reads, "3 hr, 2K 2.5, 2 Kg UF, symbol (no) heparin". review of the patient's hemodialysis record dated 3/31/10 showed no documentation that the ordered Calcium was added to the bath as prescribed by the patient's physician.

On 4/2/2010 at 0945, a review of Patient #44's chart showed the 89 year old who had a history of Hypertension and End Stage Renal Disease had the following physician's orders for hemodialysis written on 3/22/10 at 1000 for the patient's dialysis treatment on 3/23/2010 that reads, "HD orders for 3/23/2010, 330, UF (symbol zero with a line through it), 2K, 2 Ca, heparin 1000/500, pre and post BUN (Blood Urea Nitrogen)". Additional physician telephone orders for hemodialysis written on 3/23/2010 at 1140, reads, "0.9% Sodium Chloride 1-2 liters prn during HD, Heparin 1000 units /cc (cubic centimeter) 1,000 unit bolus - 500 units per hour maintenance during HD. Heparin 5000 units/cc. Instill 2.4 ml in arterial and 2.6 ml in venous lumen of permcath post HD". The patient's hemodialysis record completed on 3/23/2010 during the patient's treatment by the nursing staff documented the dialysate bath had 2K and 2.5 Ca, which was not the dose of calcium ordered by the physician. The patient's hemodialysis record showed for BP (Blood Pressure) support, Normal Saline was to be administered for hypotension but there was no physician order or protocol for Normal Saline to be used to support low blood pressure during the patient's dialysis treatment. On 3/23.2010 at 1400, review of Patient #44's chart showed the nurse documented a blood pressure of 83/50, and wrote "(decrease arrow) BP 'Feels bad' NS bolus". The nurse documented that 500 ml of Normal Saline was administered. The patient's hemodialysis record showed when the patient's blood pressure was rechecked at 1405, the blood pressure was recorded at 114/64, and the Nurse wrote "VSS" (vital signs stable) in the nursing notes. There was no documentation that the patient's physician was notified and there was no physician order for the Normal Saline in the patient's chart. On 3/23/2010 at 1523, the Hemodialysis continuation sheet showed the patient had an episode of hypotension and altered consciousness lasting from 1523 to 1625. The note does not specify when the physician was notified of the patient's symptoms or when the order for an additional 500 milliliters of Normal Saline was given. On 3/29/2010 at 0715 , Patient #44's chart revealed that the patient's physician gave a telephone order to "use previous dialysis orders". Review of the previous physician orders written on Dialysis Treatment Order Set dated 3/26/2010 at 1232 showed a physician's order called for a bath with Potassium 2 and Calcium 2 but the Nurses Hemodialysis Record recorded the Bath as Potassium 2 and Calcium 2.5.

On the days of the hospital Validation survey based on record review and interview, the facility failed to record a report for every transfusion reaction per facility policy for 1 of 70 open patient records reviewed for care and services.

The findings are:

On 3/30, 2010, a review for Patient #27's record showed the patient has a diagnosis of Sickle Cell Anemia. On March 31, 2010 at 1530, review of the Physician progress note dated March 27, 2010 revealed "Had a bad time with transfusion", and "Pain was better until the transfusion reaction", "Anemia post transfusion with transfusion reaction". In an interview with the Nurse Manager on March 31, 2010 at 1530, the Nurse Manager confirmed that the Physician had approved a "High Risk transfusion with least incompatible units". During an interview on March 31, 2010 at 1610, the Nurse Manager confirmed that no Suspect Transfusion Reaction Report had been completed on the incident. Facility policy, entitled, "Blood and Blood Products: Transfusion of and Distribution from Blood Bank", under "Transfusion Reaction", reads, "Send the following to the Blood Bank without delay: Completed Suspect Transfusion Reaction Form.....".

On the days of the hospital Validation Survey based on interview, clinical record review, and hospital policy and procedure review, the facility failed to ensure all patient clinical records were complete by way of date and time of the physician's authentication of verbal orders for 1 of 17 closed records (Patient # 3) and 1 of 11 dialysis patient records. (Patient #46)

The findings include:

A record review conducted on 3/29/10 at 1435 revealed Patient #3 was admitted to the facility on 2/7/10 with the diagnosis of Alcoholic Hepatitis. On 2/8/10, the chart showed three verbal physician orders were received but the physician did not date or time the orders when he/she authenticated the verbal orders. Hospital Policy M-71, titled, "What A Record Needs To Be Completed", reads, "...Policy...All entries written in the medical record must be authenticated (signed, dated, and timed). If not, it is considered incomplete...". The findings were verified by Registered Nurse #1 on 3/29/10 at 1500.



21307

On 4/2/10 at 1030, a review of Patient # 46's medical record revealed a sixty-one year old female admitted on 1/24/10 with diagnoses of End Stage Renal Disease, Hypertension, Seizure Disorder, lower Gastrointestinal Bleed, status/ post Cerebrovascular Accident with expressive Aphasia, and Hyperkalemia. Review of the patient's Hemodialysis record dated 3/2/10 showed staff documentation of the heparin units of the Heparin maintenance dose was illegible. The most recent Heparin order in the patient's chart was dated 2/26/10 for 1500 units of heparin load dose with no heparin maintenance dose ordered. Review of the patient's Hemodialysis record dated 3/9/10 showed staff documented the heparin units administered at 1050, but the dose of the Heparin units administered was illegible. The most recent record of the physician's heparin order in the patient's chart was dated 2/26/10 for 1500 units of heparin load dose. Review of the patient's Hemodialysis record dated 3/18/10, 3/20/10, and 3/22/10 showed staff documented the heparin units administered but the dose of the heparin administered was illegible.

Review of hospital policy, "Order Types and Clarification of Orders", effective 3/07/07, read, "... Responsibility: Registered / licensed professionals approved to receive practitioner orders per scope of practice, SC State Law and approval from the Medical Executive Committee...No treatments or medication (including over-the-counter medications) are to be given without an order from an authorized practitioner ... Vague, non-specific, or illegible orders are not to be carried out. The nurse, pharmacist, etc. should call the involved practitioner for a more specific and detailed order before nay medication can be given or order can be carried out. Examples: Heparin ordered in amounts other than in "unit dosage....".

On the days of the hospital Validation Survey based on interview, record review, and hospital policy review, the facility failed to ensure that all verbal physician orders were authenticated within a 48 hour timeframe for 3 of 17 closed patient records. (Patient #9, 36, and 37)

The findings include:

A clinical record review conducted on 3/31/10 at 1300 revealed Patient #9 was admitted to the facility on 1/14/10 with the diagnosis of Urinary Tract Infection. On 1/16/10, a telephone order for discharge was taken from the physician but was not authenticated by the physician until 1/26/10 which was out of the 48 hour timeframe. The findings were verified by Registered Nurse #1 on 3/31/10 at 1300.

Facility Policy, M-71, titled, "What A Record Needs To Be Completed", reads, "...Policy...DOCTORS ORDERS All orders must be authenticated by the responsible physician. Each record must have an authenticated discharge order. If there is none, ask for one. All orders signed by a medical student must be authenticated by the attending physician. All orders are to be signed within 48 hours. VO/TO {Verbal Orders/Telephone Orders} can only be taken by qualified personnel (RN's, dietitians, Pharm-D's, respiratory therapist, physical therapist and occupational therapist)...".



22313

Record review on April 1, 2010 at 0900 for Patient #37 showed a physician telephone order dated January 5, 2010 that was authenticated by the physician on March 8, 2010 which was over 2 months later.
Record review on April 1, 2010 at 0930 for Patient #36 revealed a physician telephone order dated February 26, 2010 at 1510 that was authenticated by the physician on March 3, 2010 at 0600 which was 5 days later.

Facility Medical Records policy, entitled, "What a Record Needs to be Completed", under "Doctors orders", reads, "All orders are to be signed within 48 hours". The Director of Nursing confirmed the findings in an interview on April 1, 2010 at 1030.

On the days of the hospital Validation Survey based on interview, record review, and hospital policy review, the facility failed to ensure that patient discharge summaries were authenticated within 30 days of the patients discharge for 2 of 17 closed patient records reviewed for completion of chart after patient discharge. (Patient #7 and 8)

The findings include:

A clinical record review conducted on 3/31/10 at 1120 revealed Patient #7 was admitted to the facility on 12/26/09 and discharged on 1/4/10 with the diagnosis of Pneumonia. The discharge summary was authenticated by the physician on 2/24/10 which was outside the 30 day timeframe. A clinical record review conducted on 3/31/10 at 1315 revealed Patient #8 was admitted to the facility on 1/17/10 and discharged on 1/21/10 with the diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The discharge summary was authenticated by the physician on 3/1/10 which is outside the 30 day timeframe. The findings were verified by Registered Nurse #6 on 3/31/10 at 1345. Facility Policy, M-71, titled, "What A Record Needs To Be Completed", reads, "...Policy...All dictated reports must be authenticated within a period of time not to exceed thirty (30) following discharge...".

On the days of the hospital Validation survey based on observation and interview, the facility failed to ensure adherence to proper routine storage and prompt disposal of biohazard waste (overfilled sharps containers in the Emergency Department).

The findings included:

On 3/29/10 at 1120, observations during the environmental tour of the facility's Emergency Department (ED) conducted with the Emergency Department Nurse Director and Assistant Chief Nursing Officer revealed an overfilled biohazard Sharp container on the emergency crash cart in Room #30 which was the supply room in the fast track area of the Emergency Department. The Sharp container was noted to have contaminated scissors, syringes, and empty vials of medications sticking out of the top of the Sharp container. During an interview with the ED Director on 3/29/10 at 1120, the ED Director reported that environmental services was responsible for changing Sharp containers when the containers were three fourth full.

Review of hospital policy, "System-Wide Infection Control Policy", revised 2/4/08 and 6/2/09, read, "...Infection Transmission Reduction Methods: ...When applicable to their department, all personnel will comply with: ...10. Proper handling of biohazardous waste and sharps...Education:...All personnel will complete annual review of infection control practices to include standard precautions, OSHA Bloodborne Pathogens Standard and Respiratory Protection Plan. Additional in-services and consultation with infection control are provided as needed..."
Review of hospital policy, "Waste Management Plan", revised 5/16/05, "...Environmental Services Department personnel, under the direction and supervision of the Environmental Services Director, are responsible for cleaning and maintenance of the equipment utilized...Decontamination methods included: ...Sharps waste shall be contained in "Sharps Containers" which are rigid, puncture resistant when sealed, labeled "Sharps Waste" or "Biohazardous Waste" with the international biohazard symbol. Three-quarters (3/4) full sharps containers shall be taped closed or tightly lidded. Sharps containers are placed in red bags by Environmental Services Department personnel for processing. Sharps waste is disposed of in sharps containers as close to site of use as possible...Bio-hazardous waste is obtained from, in-house areas, by Environmental Services Department personnel: twice per shift on days and evenings. Once per shift on evenings and nights. More often if necessary...".

On the days of the hospital Validation survey based on observation and interview, the facility failed to ensure that equipment and supplies were maintained at an acceptable level of safety and quality in the
Hospital's kitchen related to storage of supplies and on the 4th Floor Medical Surgical Unit (unsecured oxygen tanks).

The findings are:

A tour of the Dietary Department at the Hospital was conducted on March 29, 1020 at 1000 with the Department Director. During the tour, it was noted that a cardboard box of food was on the floor of the main refrigerator unit (no identification numbers). The Director conducting the tour reported that the box of food "just hadn't been put up yet". A tour of the Dietary Department at the hospital's kitchen revealed a box of food in the main refrigerator unit (no identification numbers) sitting directly upon the floor of the unit. The Director acknowledged that boxes of food were directly placed on the floor in the large refrigerator unit and not on the shelves. Facility policy, entitled, "Food Storage Areas", reads, "Adequate shelving is provided to prevent over crowding of foods and to promote circulation of air". Further, "Shelving is at least 6 inches from the floor and 18 inches from the ceiling." Facility policy, entitled, "Food Safety and Infection", reads, "Food will be stored at least 6 inches above the floor (or on easily moveable dollies) and at least 2 inches away from he walls and 18 inches from the ceiling".

During a tour of the 4th floor Medical Surgical nursing unit at the Hospital on March 30, 2010 at 1430 revealed two E-size oxygen tanks were in Room 426 on the floor beside the door. The two tanks were not in a holder and were unsecured. There were many visitors observed in the patient's room including children, and the patient was in an oversized electric wheelchair and observed moving about the door area. Facility policy, entitled, "Respiratory: Cylinders", reads, "Free standing cylinders must be properly chained or secured in an appropriate cylinder cart, base, or area. During an interview with the Nurse Manager of the Medical Surgical unit on March 30, 2010 at 1440, the Nurse Manager verified the oxygen tanks were unsecured.


27544

A tour of the Summerville Imaging Department was conducted on 03-29-10 with the Imaging Supervisor. Observation of Room 4 revealed 2 Xray table pads on the floor. This was confirmed with the Supervisor on 03-29-10 at 1145.
Observation of the Mammography suite revealed multiple plastic wrapped packages of linen that was approximately 18 inches from the ceiling and several packages that were unwrapped scattered in the room. An area behind a closed curtain in the hallway revealed multiple open bags of soiled linen. This was confirmed with the Mammography Technician on 03-29-10 at 1430.

Review of hospital policy and procedure titled Linen Operation reads, " Policy; All linens will be stored, handled, transported and processed in a manner that prevents the transmission of microorganisms to other patients and areas. Procedure; Soiled Linen; Soiled linen will be stored in separate, well ventilated areas in covered linen hampers or carts.... Clean Linen; Clean linens will be transported to patient care areas by use of covered carts..."

On the days of the hospital Validation survey based on observations, interviews, and review of hospital policies and procedures, the staff failed to ensure proper handwashing hygiene in the Dialysis unit and the Emergency Department, and the use of proper personal protective equipment (gloving and wearing of mask during central venous care) in the Dialysis unit and the Emergency Department of the facility.


The findings included:

On 3/29/10 at 1120, an environmental tour of the facility's Emergency Department (ED) conducted with the Emergency Department Nurse Director, and Assistant Chief Nursing Officer revealed an overfilled biohazard Sharp container on the emergency crash cart in Room #30 (supply room in the fast track area of the Emergency Department). The Sharp container was noted to have contaminated scissors, syringes, and empty vials of medications sticking out of the top of the Sharp container. During an interview with the ED Director, he/she reported that environmental services was responsible for changing Sharp containers when three fourth full.

On 3/29/10 at 1130, an Emergency Medical Doctor (MD) #1 was observed leaving an examination room in the ED and walking in the hallway of the emergency department wearing gloves. On 3/29/10 at 1140, Registered Nurse #3 was observed leaving a patient room with one hand gloved. RN #3 obtained supplies from the clean supply area at the nursing station in the ED, and then, returned to the patient's room. The observations were confirmed with the Assistant Chief Nursing Officer and the Nursing Director of the Emergency Department on 3/29/10 at 1145.

On 3/30/10 at 1010, in the Emergency unit, Emergency Department Registered Nurse (RN)#2 was observed administering two medications via intravenous to a patient in the Emergency unit. RN #2 performed hand hygiene prior to preparing or administrating the medications to the patient. After administering the medications to the patient, RN #2 was observed performing hand washing for 7 seconds total while constantly holding his/her hands under the running water. After completing handwashing and drying his/her hands with a paper towel, RN #2 used his/her bare hands to turn off the water faucet. During an interview on 3/30/10 at 1010, RN#2 reported that handwashing should be performed for at least 2 minutes, and that he/she should have perform handwashing prior to administering the intravenous medication to the patient.

On 3/30/10 at 1445, during random observations of a physical therapy session for a random patient therapy session in the Intensive Care Unit, Physical Therapist #1 was observed washing his/her hands for a total of 20 seconds constantly while holding his/her hands under the running water. During an interview, Physical Therapist #1 reported that handwashing should be performed at least 2 minutes.

On 4/1/10 at 0745, random observations on the hemodialysis unit showed RN #5 touched the patient's dialysis delivery system without gloves. Then, RN #5 administered a bolus of Normal Saline to Random Patient #1 without performing hand hygiene in between tasks.

On 4/1/10 at 0750, random observations showed RN #6 initiated a dialysis treatment for random Patient #2 with a Central Venous Catheter (CVC). RN #6 was wearing a facial mask, but he/she did not place a mask on the patient. On 4/1/10 at 1025, random observation showed RN #6 terminated a dialysis treatment for Patient #1 with a Central Venous Catheter (CVC). RN #6 was wearing a facial mask, but he/she did not place a mask on the Patient #1.

Review of facility's policy, "System-Wide Infection Control Policy", revised 2/4/08 and 6/2/09, read, "...Infection Transmission Reduction Methods: ...When applicable to their department, all personnel will comply with: ...8. Hand Hygiene Policy. 9. Aseptic sterile technique...Education:...All personnel will complete annual review of infection control practices to include standard precautions, OSHA Bloodborne Pathogens Standard and Respiratory Protection Plan. Additional in-services and consultation with infection control are provided as needed..."
Review of facility's policy, "Hand Hygiene Policy", revised/reviewed: 11/8/06 and 6/2/09, read, "...Handwashing will be performed with soap and water to remove dirt, organic material and transient microorganisms. Hand antisepsis will be performed with an alcohol-containing antiseptic hand rub to remove or destroy transient microorganisms when hands are already clean...Definitions...Antiseptic Handwashing Washing hands with water and soap or detergents containing an antiseptic agent. Antiseptic hand Rub: Applying an antiseptic hand-rub product to all surfaces of the hands to reduce the number of microorganisms present. Decontaminate Hands: To reduce bacterial counts on hands by performing antiseptic hand rub or antiseptic handwashing...Hand Hygiene: Washing hands with plain (i.e., non-antimicrobial) soap and water...Procedure...2. Indications for handwashing and hand antisepsis...b. If hands are not visibly soiled, use alcohol-based hand rub for routine decontaminating hands...i. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. j. Decontaminate hands after removing gloves...3. Hand-Hygiene Technique...c. When washing hands with soap and water, wet hands first with water, apply an amount of product recommended by manufacturer to hands, and rub hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers, Rinse hands with water and dry thoroughly with a disposable towel. Use the towel to turn off the faucet...".

On the days of the Validation Survey based on interview and facility record review, the hospital failed to ensure that the preparation of radiopharmaceuticals were compounded under the direct supervision of a qualified physician or pharmacist.( Imaging Department of Summerville and Trident Hospitals)

The findings are:


On 03-29-10 at 1420 an interview with the Imaging Supervisor reveals that there is monthly oversight by the physician to provide direct supervision of the nuclear technician when preparing radiopharmaceuticals. The technicians are rotated and receive oversight approximately 2 times a year. The Supervisor explains that the radiopharmaceuticals are received in unit dose form, but there are times when a stat test or after hours when a physician is not available, that a radiopharmaceutical must be prepared by a nuclear technician.

Review of the form titled Working Under the Direct Supervision of an Authorized User reads, ".. physician signature indicates physical presence during radiopharmaceutical kit preparation by Nuclear Medicine Technologist.."denotes that direct supervision took place for Jan-.10, Feb.-10, Mar-10 at Trident Hospital. There is no physician signature. On another form there is a physician signature for January.

Review of form titled Daily Report Kit Preparation reads, "...MAA Kit- Tc04 User name-Nuclear Medicine Technologist #1 dated 01-20-10, 02-02-10, 02-05-10, and on 02-12-10 by Supervisor.

Review of hospital policy and procedure did not produce a policy regarding supervision of preparation of radiopharmaceuticals by the nuclear technician.

On the days of the hospital Validation Survey based on interview, record review, and hospital policy review, the facility failed to ensure services provided are based through physician orders for 1 of 17 closed patient records and 2 of 68 open patient records reviewed. (Patient # 9, 40, and 41)

The findings include:

A record review conducted on 3/31/10 at 1325 revealed Patient #9 was admitted to the facility on 1/19/10 and discharged on 1/22/10 with the diagnosis of Septicemia. Upon admission on 1/19/10, the patient was placed on 3 L (liters) of O2 (oxygen) NC (nasal cannula), but the patient's admission physician orders did not include an order for O2. A physician order for O2 was written on 1/21/10. Facility Policy A.PCS.50.50.150a, titled, "Oxygen (O2) Therapy", reads, "...Policy: All patients receiving oxygen must have an order...". The findings were verified by Registered Nurse #6 on 3/31/10 at 1345.

A record review conducted on 4/1/10 at 1015 revealed Patient #40 was admitted to the sleep lab on 3/28/10 with the diagnosis of Sleep Disturbance. The sleep lab form, titled, "Referrals And Authorizations Referral Details" showed the type of service requested (polysomnography), but there was no physician signature.

A record review conducted on 4/1/10 at 1025 revealed Patient #41 was admitted to the sleep lab on 1/20/10 and 3/24/10 with the diagnosis of Sleep Disturbance. The sleep lab form, titled, "Referrals And Authorizations Referral Details" showed the type of service requested (polysomnography), but there was no physician signature.

An interview with Sleep Lab Director and Polysomnologist #1 on 4/1/10 at 1030 revealed all referrals for a sleep study from that particular insurance provider were accepted as physician orders and the referrals were sent without a physician's signature.

Facility Policy, A.SLP.50.00.500.0, titled, "Patient Testing Records, Storage and Retrieval of", reads, "...Procedure...Folders will contain the patient's test results, video consent, history, subjective sleep questionnaire, physician orders...".