HospitalInspections.org

A. Based on observation, document review, and interview, it was determined that the facility failed to ensure that there was an effective governing body responsible for the conduct of the hospital as an institution as evidenced by the lack of compliance with the following Conditions of Participation:

482.23--Nursing Services
482.42--Infection Control

These were repeat condition level deficiencies.

A. Based on observation, document review, and interview, it was determined that the facility failed to ensure that contracted services were provided in a safe and effective manner.

Findings include:

1. In an interview on 1/20/10 at 10:00 AM, Staff #s 1 and 4 stated that the facility has a contract to provide acute hemodialysis services to their inpatients.

2. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for September 2009 to present for machine ID #s 132239 and 132631 indicated that the facility was not able to adequately track hemodialysis cleaning and disinfection procedures in order to ensure the control of infections and communicable diseases.

3. Review of inpatient hemodialysis flowsheets provided dated 12/14/09 through 12/18/09 indicated that information was missing or inaccurate, which did not allow the facility to accurately track what patients used what hemodialysis machines, in order to ensure the control of infections and communicable diseases.

4. On 1/20/10 at 1:30 PM, in the presence of Staff #4, contracted Staff #7 was observed to terminate hemodialysis on a patient by decannulating the patient and placing the used cannulas in the sharps container. Staff #7 was wearing a short-sleeved scrub top with skin exposed on the arms bilaterally. Staff #7 was not wearing a fluid resistant gown, full face shield or mask, as per policy.

5. On 1/20/10 at 1:45 PM, in the presence of Staff #4, contracted Staff #7 was observed to touch the hemodialysis machine at the bedside of the patient noted above that had just received a HD treatment. Staff #7 was not wearing gloves while touching the HD machine and proceeded to then touch paperwork without performing hand hygiene in between. This is not in accordance with infection control policies.

6. Staff #4 confirmed the findings and observations noted above in an interview on 1/20/10 at 2:15 PM.

7. As evidenced by the findings noted above, the governing body failed to ensure that the contracted hemodialysis services were performed in a safe and effective manner.

THIS IS A REPEAT DEFICIENCY

A. Based on document review and interview, it was determined that the facility failed to ensure that patients received care in a safe setting.

Findings include:

ED=Emergency Department
CVA=cerebrovascular accident
q or Q=every
RN=Registered Nurse
LPN=Licensed Practical Nurse
TELE=telemetry
pt=patient
oob=out of bed

1. Review of Medical Record #15 indicated that this 90-year old patient presented to the ED on 12/25/09 and was triaged at 20:31 with the chief complaint of possible stroke, with slurred speech and drooping of the right side of the face. Neurological examination in the ED indicated that the patient had weakness in the right arm, hand, leg and foot. Nursing assessment documented on 12/25/09 at 20:20 indicated that the patient had partial hemianopia and a history of macular degeneration with central visual loss.

Physician Orders in Medical Record #15 dated and timed 12/26/09 at 0005 stated to admit the patient to the "Stroke Unit" with a diagnosis of CVA. Patient #15 was transferred to the "Stroke Unit" on 12/26/09 at approximately 02:00.

Review of Medical Record #15 indicated that the patient did not receive care in a safe setting as evidenced by the following:

a. On 12/26/09 at 08:00, an LPN assessed Patient #15 to have a Fall Risk of 19. Greater than 10 is considered high risk.

b. On 12/26/09 at 10:00 AM, an LPN documented that, "pt is confused."

c. On 12/26/09 at 19:20, a technician found Patient #15 on the floor. The nursing staff failed to provide a safe environment for this 90-year old patient admitted with a CVA, right-sided weakness, and visual impairment that was confused and had a High Fall Risk score of 19.

2. The findings noted above were discussed with and confirmed by Staff #s 17 and 2 on 1/22/10 at 2:40 PM.

Reference #1: Facility policy #ADM 277, Supportive Observation for Patient Safety, in the Intermittent Supportive Observation section stated that, "1) This level of observation is appropriate when patients are potentially, but not immediately, a safety risk. Observation should be more frequent than q2 hours for patients at low or moderate fall risk and more frequent than q1 hour for patients with high fall risk...7) a. An Acute Observation Record will be initiated..."

3. Review of Medical Record #15 lacked evidence that this patient with a High Fall Risk score of 19 was observed more frequently than q1 hour and that an Acute Observation Record had been initiated, in accordance with the policy in Reference #1.

4. Review of Medical Record #14 indicated that this patient presented to the ED on 12/9/09 and was triaged at 11:26 with the chief complaint of unresponsiveness. Patient #14 was diagnosed with acute alcohol intoxication. ED History of Present Illness indicated that the patient had been recently admitted to this facility on 10/27/09 for syncope and paroxysmal supraventricular tachycardia, and was discharged on 11/1/09.

12/9/09 ED record Disposition section stated, "ADMIT TO TELE, Condition: GUARDED."

Nursing assessment for the inpatient telemetry unit dated and timed 12/9/09 at 15:30 PM indicated that the patient was "arousable," and that the level of consciousness was, "Lethargic/Somnolent." Patient #14 was assessed to have a Johns Hopkins Fall Risk Score of 10 (moderate risk).

Review of Medical Record #14 indicated that the patient did not receive care in a safe setting as evidenced by the following:

a. On 12/9/09 at 17:10 PM, an RN noted, "pt found standing in room, bleeding from his left eyebrow. states he tried to get oob and fell..." The nursing staff failed to provide a safe environment for this patient admitted with acute alcohol intoxication and a history of syncope who had an altered mental state and a moderate fall risk score.

5. Review of Medical Record #14 lacked evidence that an Acute Observation Record had been initiated prior to this patient's fall, in accordance with the policy in Reference #1.

6. The findings noted above were discussed with and confirmed by Staff #s 17 and 2 on 1/22/10 at 2:40 PM.

7. Review of the Performance Improvement data related to falls for January 2009 through December 2009 indicated that the facility exceeded the national benchmark of less than 3.8 patient falls per 1000 patient days for 10 out of 12 months of 2009 (All months except August and October). Patient falls per 1000 patient days for the facility that exceeded the national benchmark in 2009 ranged from 4 to 6.2 patient falls per 1000 patient days. This was confirmed by Staff #1 in an interview on 1/22/10 at 3:00 PM.

a. The facility failed to ensure that patients at risk for falls received care in a safe setting.

A. Based on document review and interview, it was determined that the facility failed to ensure that the quality assurance/program improvement program showed measurable improvement in reducing the number of patient falls.

Findings include:

1. Review of the Performance Improvement data related to falls for January 2009 through December 2009 indicated that the facility exceeded the national benchmark of less than 3.8 patient falls per 1000 patient days for 10 out of 12 months of 2009 (All months except August and October).

Patient falls per 1000 patient days for the facility that exceeded the national benchmark in 2009 were as follows:

January: 4.8
February: 5
March: 4.7
April: 5.2
May: 4.7
June: 4.2
July: 6.2
September: 4.8
November: 4
December: 5

2. Review of the Performance Improvement/Risk Management Council monthly meeting minutes for January, 2009 through October, 2009 indicated the following:

a. For the topic of "Falls," the minutes for January, March, April, May, June, and July, the column titled "Action" stated, "Monthly data reports."

b. For the topic of "Falls," the minutes for September and October, the column titled "Action" stated, "Continue to monitor."

c. For the topic of "Falls," the minutes for January indicated that, "new bed alarms are in place." For the minutes of April, May, and June, further interventions to prevent falls included, "re-education regarding bed alarms." In July, as noted above, the fall rate increased to 6.2 per 1000 patient days.

3. The findings noted above were confirmed by Staff #1 in an interview on 1/22/10 at 3:00 PM.

4. As evidenced by the findings noted above, the facility failed to show measurable improvement in reducing the number of patient falls.

THIS IS A REPEAT CONDITION

A. Based on document review and interview, it was determined that the hospital failed to have a well-organized and supervised nursing service, as evidenced by the lack of compliance with the following regulations:

482.23(b)(3)--The facility failed to ensure that registered nurses supervised and evaluated the nursing care of each patient.
482.23(c)(2)--The facility failed to ensure that all orders for drugs were documented and signed by a practitioner who is authorized by hospital policy, and in accordance with State law, to write orders and who is responsible for the care of the patient.

THIS IS A REPEAT DEFICIENCY

A. Based on document review and interview, it was determined that the facility failed to ensure that registered nurses (RNs) supervised and evaluated the nursing care of patients that received intrathecal analgesia, in accordance with prescriber orders.

Findings include:

BP=blood pressure
q=every
h=hour
x=times
RR=respiratory rate
LOC=level of consciousness
<=less than
mg=milligram
pt=patient
VS=vital signs

Reference #1: Facility Physician Order form "Pain Management Infusion Orders" stated that, "Epidural and Intrathecal Monitoring/Additional Orders: Monitoring (underlined)
1. Temperature, Pulse and BP q1hx4, then q4hx5, then per routine
2. Assess level of consciousness q1hx4, then q4hx5, then q shift and while awake..."

1. Review of 3 of 3 Medical Records (#s 5, 6, and 7) of patients that received intrathecal Duramorph for Caesarean sections indicated that the RNs failed to supervise and evaluate the vital signs and LOC in accordance with prescriber orders noted in Reference #1. Evidence and examples are as follows:

a. On 1/22/10 at 12:25 PM, the surveyor reviewed the Pain Management Infusion Order forms in Medical Record #s 5, 6, and 7 with the Chief of Anesthesia, Staff #15. Staff #15 indicated that the anesthesia staff complete that order form, including the date and time of the orders, while the patient is in the operating room. Staff #15 stated that the orders are to be implemented upon the patient's arrival on the post-partum unit.

b. In an interview on 1/22/10 at 2:00 PM, Staff #s 16 and 2 confirmed that the Pain Management Infusion Orders were to be implemented upon the patient's arrival on the post-partum unit. Staff #16 indicated that there were separate orders for monitoring vitals signs in the recovery room that were more frequent than those ordered on the Pain Management Infusion Order form.

c. Review of Medical Record #7 indicated that this patient received 0.3 mg of Duramorph intrathecally on 12/16/09 at 9:00 AM, with Pain Management Infusion Orders dated and timed 12/16/09 at 9:24 AM. Patient #7 arrived on the post-partum unit on 12/16/09 at 12:45 PM. Temperature, Pulse, Blood Pressure, and Level of Consciousness were documented upon Patient #7's arrival on the post-partum unit on 12/16/09 at 12:45 PM. Review of Medical Record #7 indicated that vital signs and LOC were performed at the following times, not in accordance with the Pain Management Infusion Orders noted in the Medical Record, as outlined in Reference #1:

(i). Temperature, Pulse, and Blood Pressure were next assessed on 12/16/09 at 15:00, 2 hours and 15 minutes later.

(ii). Temperature, Pulse, and Blood Pressure were next assessed on 12/16/09 at 22:00, 7 hours later. The BP was 118/64.

(iii). Temperature, Pulse, and Blood Pressure were next assessed on 12/17/09 at 07:30, 9.5 hours later. The BP was 98/63.

(iv). Although the RN documented "pain evaluations" for this patient, Medical Record #7 lacked evidence of formal evaluations of this patient's LOC that were recorded in the neurological section of the nursing assessments for the remainder of the patient's hospital stay. "Pain evaluations" did not demonstrate assessment of whether the patient was awake, alert, and oriented to person, place and time. Patient #7 was discharged on 12/20/09 at 12:30 PM.

(v). The findings noted above were confirmed by Staff #s 16 and 2 on 1/22/10 at 2:20 PM.

d. Review of Medical Record #5 indicated that this patient received 0.3 mg of Duramorph intrathecally on 12/17/09 at 7:15 AM, with Pain Management Infusion Orders dated and timed 12/17/09 at 7:15 AM. Patient #5 arrived on the post-partum unit on 12/17/09 at 10:45 AM. Temperature, Pulse, Blood Pressure, and LOC were assessed upon Patient #5s arrival on the post-partum unit on 12/17/09 at 10:45 AM. Patient #5s BP at 10:45 AM was 94/51. Review of Medical Record #5 indicated that vital signs and LOC were performed at the following times, not in accordance with the Pain Management Infusion Orders noted in the Medical Record, as outlined in Reference #1:

(i). Temperature, Pulse, and Blood Pressure were next assessed on 12/17/09 at 12:30, 1 hour and 45 minutes later.

(ii). Temperature, Pulse, and Blood Pressure were next assessed on 12/17/09 at 16:18, 5 hours and 48 minutes later.

(iii). Temperature, Pulse, and Blood Pressure were assessed on 12/17/09 at 23:45. The BP was 98/56. The BP was next assessed on 12/18/09 at 06:30, 6 hours and 45 minutes later, after an episode of unresponsiveness as outlined below. The BP was 79/45.

(iv). Although the RN documented "pain evaluations" for this patient, Medical Record #5 lacked evidence of formal evaluations of this patient's LOC that were recorded in the neurological section of the nursing assessments. Nursing note dated and timed 12/18/09 at 06:25 stated, "answered pt call bell pt sitting in chair unable to verbally respond. (Staff name omitted) RN into room to assist. smelling salts waved under pt nose. pt responded immediately. pt verbalized feeling better. VS taken. placed pt back to bed..."

(v). The findings noted above were confirmed by Staff #s 16 and 2 on 1/22/10 at 2:20 PM.

e. Review of Medical Record #6 indicated that this patient received 0.25 mg of Duramorph intrathecally on 12/8/09 at 9:30 AM, with Pain Management Infusion Orders dated and timed 12/8/09 at 9:30 AM. Patient #6 arrived on the post-partum unit on 12/8/09 at 13:00. Temperature, Pulse, Blood Pressure, and LOC were assessed upon Patient #6s arrival on the post-partum unit on 12/8/09 at 13:00. Review of Medical Record #6 indicated that vital signs and LOC were performed at the following times, not in accordance with the Pain Management Infusion Orders noted in the Medical Record, as outlined in Reference #1:

(i). Temperature, Pulse, and Blood Pressure were next assessed on 12/8/09 at 15:45, 2 hours and 45 minutes later.

(ii). Temperature, Pulse, and Blood Pressure were next assessed on 12/8/09 at 20:30, 4 hours and 45 minutes later.

(iii). Although the RN documented "pain evaluations" for this patient, Medical Record #6 lacked evidence of formal evaluations of this patient's LOC that were recorded in the neurological section of the nursing assessments. "Pain evaluations" did not demonstrate assessment of the patient's level of consciousness and whether the patient was awake, alert, and oriented to person, place and time.

(iv). The findings noted above were confirmed by Staff #s 16 and 2 on 1/22/10 at 2:20 PM.

B. Based on document review and interview, it was determined that the facility failed to ensure that registered nurses (RNs) supervised and evaluated the nursing care of patients requiring neurologic checks and fall assessments, in accordance with prescriber orders, facility policy and procedures, and standards of practice.

Findings include:

ED=Emergency Department
CVA=cerebrovascular accident
neuro=neurologic
q or Q=every
x=times
RN=Registered Nurse
LPN=Licensed Practical Nurse

Reference #1: Policy # NUR-N-0012, Neurologic Checks, in the POLICY section stated that, "A physician orders neurological checks designating frequency of checks on the physician order sheet. Neurological checks are to be documented as ordered..."

1. Review of Medical Record #15 indicated that this 90-year old patient presented to the ED on 12/25/09 and was triaged at 20:31 with the chief complaint of possible stroke, with slurred speech and drooping of the right side of the face. Neurological examination in the ED indicated that the patient had weakness in the right arm, hand, leg and foot. Nursing assessment documented on 12/25/09 at 20:20 indicated that the patient had partial hemianopia and a history of macular degeneration with central visual loss.

Physician Orders in Medical Record #15 dated and timed 12/26/09 at 0005 stated to admit the patient to the "Stroke Unit" with a diagnosis of CVA and "neuro check Q2 x 4 hours, then Q4 x 12 hours." Patient #15 was transferred to the "Stroke Unit" on 12/26/09 at approximately 02:00.

Review of Medical Record #15 indicated that the RN failed to supervise and evaluate the patient as evidenced by the following:

a. A neuro check was documented on 12/26/09 at 08:00. The next neuro check was documented on 12/26/09 at 14:00, 6 hours later. This is not in accordance with the doctor's order for 4 hours, and not in accordance with the policy in Reference #1.

b. On 12/26/09 at 04:15 AM, an RN assessed Patient #15 to have a Johns Hopkins Fall Risk Score (Fall Risk) of 9. A score of 6-10 is considered moderate risk. On 12/26/09 at 08:00, (3 hours and 45 minutes later) an LPN assessed Patient #15 to have a Fall Risk of 19. Greater than 10 is considered high risk.

The RN at 04:15 AM failed to accurately assess Patient #15s fall risk, as evidenced by the following:

(i). The RN indicated that the patient was receiving one category of high fall risk medication. The patient was receiving two categories of high fall risk medications, antihypertensives and diuretics.

(ii). The RN indicated that the patient had no patient care equipment. The patient had a foley catheter. (The LPN at 08:00 indicated that the patient had two or more unspecified items of patient care equipment.)

(iii). In the "Mobility" category, the RN failed to include Patient #15s previously identified visual impairment.

c. On 12/26/09 at 10:00 AM, an LPN documented that, "pt is confused." On 12/26/09 at 19:20, a technician found Patient #15 on the floor. The nursing staff failed to adequately supervise this 90-year old patient admitted with a CVA, right-sided weakness, and visual impairment that was confused and had a High Fall Risk score of 19.

2. The findings noted above were discussed with and confirmed by Staff #s 17 and 2 on 1/22/10 at 2:40 PM.

Reference #2: Facility policy #ADM 277, Supportive Observation for Patient Safety, in the Intermittent Supportive Observation section stated that, "1) This level of observation is appropriate when patients are potentially, but not immediately, a safety risk. Observation should be more frequent than q2 hours for patients at low or moderate fall risk and more frequent than q1 hour for patients with high fall risk...7) a. An Acute Observation Record will be initiated..."

3. Review of Medical Record #15 lacked evidence that this patient with a High Fall Risk score of 19 was observed more frequently than q1 hour and that an acute observation record had been initiated, in accordance with the policy in Reference #2.

4. Review of the Performance Improvement data related to falls for January 2009 through December 2009 indicated that the facility exceeded the national benchmark of less than 3.8 patient falls per 1000 patient days for 10 out of 12 months of 2009 (All months except August and October). Patient falls per 1000 patient days for the facility that exceeded the national benchmark in 2009 ranged from 4 to 6.2 patient falls per 1000 patient days. This was confirmed by Staff #1 in an interview on 1/22/10 at 3:00 PM.

a. The facility failed to ensure that RNs adequately supervised and evaluated the nursing care for patients in order to prevent patients from falling.

C. Based on document review and interview, it was determined that the facility failed to ensure that registered nurses (RNs) supervised and evaluated the nursing care of hemodialysis patients in accordance with policy and procedure, and standards of practice.

Findings include:

HD=hemodialysis
RN=Registered Nurse

Reference #1: Dialysis Policy #FMS-CS-IS-I-505-045A, FMS Inpatient Services Documentation Guidelines, in the Accuracy section stated, "Step 1. Record precisely, truthfully and completely to document an accurate presentation of the care delivered to each patient."

In the Legibility section, this policy stated, "Step 4. Always sign your full name and title after a notation."

In the Format section , this policy stated, "Step 7. Do not allow a space on the inpatient treatment record to be BLANK at the request of anyone..."

1. Review of Acute Hemodiaysis Flow Sheet forms for inpatients at the facility that received HD treatments between 12/14/09 and 12/18/09 evidenced that RNs failed to implement the policy in Reference #1. In some cases, these violations of policy resulted in the inability to determine what patient was dialyzed on what machine, resulting in an infection control concern. Examples of RNs failure to follow the policy in Reference #1 are as follows:

a. HD Flow Sheets for Patient #s 22 and 38 dated 12/14/09 lacked evidence of the dialysis machine #. The # recorded in this space was the model number of the dialysis machine.

b. HD Flow Sheet for Patient #29 dated 12/14/09 lacked information in the following areas (they were blank) "TIME OFF, TOTAL HOURS, LITERS PROCESSED, TOTAL FLUID REMOVED."

c. HD Flow Sheet for Patient #28 dated 12/14/09 lacked an RN signature, date, and time.

d. HD Flow Sheet for Patient #34 dated 12/15/09 lacked evidence of the dialysis machine #. This area was blank.

e. HD Flow Sheet for Patient #20 dated 12/16/09 lacked evidence of the dialysis machine #. This area was blank.

f. HD Flow Sheet for Patient #25 dated 12/17/09 lacked information in the following areas (they were blank) "MACHINE #, MACHINE CONDUCTIVITY, BICART (sic) CONDUCTIVITY, DIALYSATE CONDUCTIVITY, DIALYSATE pH, Temp, Bleach Neg, Autotest Passed, Alarm Test Passed, Alarms Set."

g. HD Flow Sheet for Patient #33 dated 12/18/09 lacked evidence of the dialysis machine #. This area was blank.

2. The findings noted above were confirmed by Staff #4 in an interview on 1/20/10 at 2:15 PM, and by Staff #s 12 and 13 on 1/21/10 at 2:15 PM.

THIS IS A REPEAT DEFICIENCY

A. Based on document review and interview, it was determined that the facility failed to ensure that medications other than influenza and pneumococcal polysaccharide vaccines were ordered, documented, and signed by an authorized practitioner.

Findings include:

ED=Emergency Department
resp=respiratory
RN=Registered Nurse
w/=with
mg=milligram
kg=kilogram
PO=by mouth
PR=per rectum
>=greater than

Reference #1: Emergency Department Policy # ES-055, Emergency Department Standing Orders, in the PROCEDURE section stated that,
"1. Emergency Department nurses are empowered to initiate standing orders to facilitate rapid treatment of patients.
1. (sic) Standing orders should be initiated upon the initial nursing assessment after triage and should not be delayed for physician evaluation."

1. Attached to the policy in Reference #1 was a table titled, "Emergency Department Approved Nursing Standing Orders." In an interview on 1/20/10 at 11:50 AM, Staff #3 stated that this table was the "protocol" that had been approved by the ED medical staff.

In the section labeled "asthma," this protocol stated, "resp treatments." At the bottom of the page, this table stated, "Resp Treatments = Albuterol with Atrovent," and "These protocols can be initiated by the triage or primary nurses at any time."

a. The protocol noted above lacked evidence of a dosage for the Albuterol and Atrovent. Staff #3 stated that the dosages for these medications would appear on the computer in the order set accessed by the RN. Staff #3 provided the computerized order set for a patient presenting to the ED with a "Respiratory" concern. This order set included, but was not limited to, the following options for respiratory medications in a section titled "Nursing Orders":

"Albuterol Nebulizer Unit Dose"
"Albuterol w/Atrovent Unit Dose Nebulizer"
"Xopenex Nebulizer Unit Dose"
"Xopenex w/Atrovent Unit Dose Nebulizer"

(i). The policy, protocol, and order sets did not clarify when to administer which of these different respiratory treatments, allowing the RN to choose which medications to order.

2. Attached to the policy in Reference #1 was a table titled, "Emergency Department Approved Nursing Standing Orders." In an interview on 1/20/10 at 11:50 AM, Staff #3 stated that this table was the "protocol" that had been approved by the ED medical staff.

At the bottom of the page, this table stated, "Tylenol for fever: Adult 650mg PO/PR or Child 15mg/kg PO/PR,"
"Motrin for fever: Adult 400mg PO or Child 10mg/kg PO for Fever >101," and
"These protocols can be initiated by the triage or primary nurses at any time."

(i). The protocol for Tylenol did not define what temperature constituted a "fever."

(ii). The protocol did not clarify when to administer Tylenol versus Motrin for the same indication of "fever," allowing the RN to choose which medication to order.

3. The protocols attached to Reference #1 lacked evidence of a requirement to assess contraindications based on the particular medication to be ordered and administered via the protocol.

4. As evidenced by the findings noted above, the facility had physician-approved hospital policies and protocols in place for drugs other than influenza and pneumococcal polysaccharide vaccines.

THIS IS A REPEAT DEFICIENCY

A. Based on document review and interview, it was determined that the facility failed to ensure that all orders, including verbal orders, were dated, timed, and authenticated by the ordering practitioner.

Findings include:

ED=Emergency Department
RN=Registered Nurse
mg=milligram
IV=intravenous
IVPB=intravenous piggyback
IVP=intravenous push
CBC=Complete Blood Count

1. Review of ED Medical Records for order authentication indicated that it could not be determined whether verbal orders for medications, orders for observation levels, and orders for laboratory testing were authenticated and by whom. Examples are as follows:

a. Medical Record #4 contained verbal orders for Reglan and Zofran entered and administered by the RN caring for the patient. Medical Record #4 lacked evidence that these verbal orders for medication had been authenticated by the ordering practitioner, ED physician Staff #18.

b. Medical Record #4 contained a verbal order for a "Pregnancy Test Serum" entered by the RN. Medical Record #4 lacked evidence that this verbal order for laboratory testing had been authenticated by the ordering practitioner, ED physician Staff #18.

c. In an interview on 1/20/10 at 11:50 AM, Staff #3 indicated that PEPA was the abbreviation for "Protocol for Emergency Physician Associates," and that the nurses in the ED may order certain tests and medications based upon this physician-approved protocol.

Medical Record #2 contained orders for the following laboratory testing and observation level, entered by the RN as per "PEPA":

"Salicylate Level"
"Observation 1:1 (Suicidal/High Risk)"
"Acetaminophen Level"
"Alcohol Ethyl"
"Comprehensive Metabolic Panel"
"CBC"

Medical Record #2 lacked evidence that these orders for laboratory testing and observation level had been authenticated by the "ordering practitioner," or a practitioner authorized to write orders.

2. In interviews on 1/20/10 at 11:50 AM and 3:00 PM, Staff #s 3 and 8, respectively, stated that by practice, the ED physician authenticates the entire ED record, including all of the contents and the orders contained within it by placing a "digital signature" in the ED record.

a. Medical Record #4 contained digital signatures for two (2) ED physicians, Staff #s 18 and 19. It could not be determined which prescriber had authenticated which orders.

b. Medical Record #2 contained a digital signature for an ED physician and for the RN caring for the patient.

Medical Record #4 lacked evidence of a digital signature for the RN caring for the patient.

In interviews on 1/20/10, 1/21/10, and 1/22/10, Staff #s 1, 2, 3, 8, and 14 were unable to explain under what circumstances an RN is required to place a digital signature on a Medical Record and what the RNs digital signature represented.

c. Upon request, Staff #s 1, 2, 3, 8, and 14 were unable to provide a facility policy and procedure outlining how all orders, including verbal orders, in an ED Medical Record were authenticated.

d. Upon request, Staff #s 1, 2, 3, 8, and 14 were unable to provide a facility policy and procedure that indicated what a digital signature represented and what staff members are required to place a digital signature on the Medical Record.

THIS IS A REPEAT CONDITION

A. Based on interview, observation, and document review, it was determined that the facility failed to ensure that there was a sanitary environment, and that there was an active program for the prevention, control, and investigation of infections and communicable diseases as evidenced by the lack of compliance with the following regulations:

482.42(a)--The facility failed to ensure that policies governing control of infections and communicable diseases in hemodialysis patients were developed and implemented.
482.42(a)(1)--The infection control officer failed to ensure that the facility staff developed and adhered to a system for controlling infections.

A. Based on observation, document review, and interview, it was determined that the facility failed to ensure that policies governing control of infections and communicable diseases in hemodialysis patients were developed and implemented.

Findings include:

PPE=Personal Protective Equipment
HD=hemodialysis

Reference #1: Dialysis policy #FMS-CS-IC-II-155-080A, Personal Protective Equipment, in the General Policy section stated that, "Personal protective equipment such as a full face shield or mask and protective eyewear with full sideshield, fluid-resistant gowns and gloves will be worn to protect and prevent employees from blood or other potentially infectious materials to pass through to or reach the employee's skin, eyes, mouth, other mucous membranes, or work clothes when performing procedures during which spurting or spattering of blood might occur (e.g. during initiation and termination of dialysis...)..."

The "Exposure Task List" table in this policy indicated that for terminating HD, gloves, fluid resistant gown, and full face shield or mask and protective eyewear with full side shield were required PPE.

The "Exposure Task List" table in this policy indicated that when touching any part of the dialysis machine or equipment at the dialysis station gloves are to be worn and hand hygiene is to be performed.

1. On 1/20/10 at 1:30 PM, in the presence of Staff #4, Staff #7 was observed to terminate hemodialysis on a patient by decannulating the patient and placing the used cannulas in the sharps container. Staff #7 was wearing a short-sleeved scrub top with skin exposed on the arms bilaterally. Staff #7 was not wearing a fluid resistant gown, full face shield or mask as per policy in Reference #1.

2. On 1/20/10 at 1:45 PM, in the presence of Staff #4, Staff #7 was observed to touch the hemodialysis machine at the bedside of the patient noted above that had just received a HD treatment. Staff #7 was not wearing gloves while touching the HD machine and proceeded to then touch paperwork without performing hand hygiene in between. This is not in accordance with the infection control measures noted in Reference #1.

3. Staff #4 confirmed the findings and observations noted above in an interview on 1/20/10 at 2:15 PM.

Reference #2: Dialysis Policies #FMS-CS-IS-I-510-020A, Acid Clean and Chemical Disinfection, and #FMS-CS-IS-I-510-019A, Acid Clean and Heat Disinfection in the Policy sections stated that, "Chemical disinfection or heat disinfection must also be performed before treatment any time the machine has not been used for more than 48 hours."

4. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for December 2009 to present for machine ID #s 132239 and 132631 indicated the following examples that the policies noted in Reference #2 were not implemented:

a. The forms stated, "If Machine is not used with (sic) 72 hours, bleach before using and document."

(i). This is not in accordance with the 48 hours indicated in the policies.

(ii). The policies indicated that chemical or heat disinfection may be performed prior to the treatment if the machine has not been used for more than 48 hours. The form indicated that only bleach disinfection (chemical) was acceptable.

b. The logs lacked evidence of the time of the heat or chemical disinfection was performed. Machine #s 132239 and 132631 had numerous periods where the machines were not used for more than 48 hours at a time. It could not be determined whether the heat or chemical disinfection had occurred prior to initiating treatments or at the end of the treatment day. Compliance with the disinfection policies could not be determined.

c. The findings noted above were confirmed by Staff #7 in an interview on 1/20/10 at 1:50 PM, by Staff #4 in an interview on 1/20/10 at 2:15 PM, and by Staff #s 12 and 13 on 1/21/10 at 2:15 PM.

Reference #3: Dialysis Policy #FMS-CS-IS-I-510-020A, Acid Clean and Chemical Disinfection, in the Policy section stated that, "Inpatient hemodialysis machines must be chemically disinfected weekly and whenever indicated by culture results or other designated situations."

5. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for September 2009 to present for machine ID #s 132239 and 132631 indicated the following examples that the policy noted in Reference #3 was not implemented:

a. Machine #132239 was chemically disinfected with bleach on 9/21/09. The next bleach disinfection was noted on 10/2/09, 11 days later.

b. Machine #132239 was chemically disinfected with bleach on 10/3/09. The next bleach disinfection was noted on 10/20/09, 17 days later.

c. Machine #132239 was chemically disinfected with bleach on 10/20/09. The next bleach disinfection was noted on 11/2/09, 13 days later.

d. Machine #132239 was chemically disinfected with bleach on 11/2/09. The next bleach disinfection was noted on 11/27/09, 25 days later.

e. Machine #132239 was chemically disinfected with bleach on 12/2/09. The next bleach disinfection was noted on 12/14/09, 12 days later.

f. Machine #132631 was chemically disinfected with bleach on 9/21/09. The next bleach disinfection was noted on 9/29/09, 8 days later.

g. Machine #132631 was chemically disinfected with bleach on 10/9/09. The next bleach disinfection was noted on 10/27/09, 18 days later.

h. Machine #132631 was chemically disinfected with bleach on 11/2/09. The next bleach disinfection was noted on 11/11/09, 9 days later.

i. Machine #132631 was chemically disinfected with bleach on 11/11/09. The next bleach disinfection was noted on 11/23/09, 12 days later.

j. Machine #132631 was chemically disinfected with bleach on 11/23/09. The next bleach disinfection was noted on 12/9/09, 16 days later.

k. The findings noted above were confirmed by Staff #7 in an interview on 1/20/10 at 1:50 PM, by Staff #4 in an interview on 1/20/10 at 2:15 PM, and by Staff #s 12 and 13 on 1/21/10 at 2:15 PM.

Reference #4: Dialysis Policy #FMS-CS-IC-II-155-110A, Cleaning and Disinfection, in the Policy section stated to, "Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment."

6. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for September 2009 to present for machine ID #s 132239 and 132631 indicated the following examples that the policy noted in Reference #4 was not implemented:

a. Machine #132631 lacked evidence that external cleaning was performed after treatments on 9/19/09 at 6:40 AM and 10:15 AM, on 9/30/09 at 11:30 AM, on 10/6/09 at 7:00 AM and 9:45 AM, on 11/13/09 at 11:30 AM, on 11/20/09 at 9:30 AM, on 11/23/09 at 8:00 AM, on 12/11/09 at 0900, 1100, and 1515, on 12/14/09 at 1500, on 12/22/09 at 1300, on 12/23/09 at 1445, and on 12/24/09 at 1300.

b. Machine #132239 lacked evidence that external cleaning was performed after treatments on 9/19/09 at 11:00 AM, on 9/22/09 at 6:45 AM, on 10/3/09 at 0930, on 10/5/09 at 1130, on 11/13/09 at 0835, on 12/14/09 at 1600, on 12/16/09 at 1740, and on 12/31/09 at 2:30 PM.

c. The findings noted above were confirmed by Staff #7 in an interview on 1/20/10 at 1:50 PM, by Staff #4 in an interview on 1/20/10 at 2:15 PM, and by Staff #s 12 and 13 on 1/21/10 at 2:15 PM.

Reference #5: Dialysis Policies #FMS-CS-IS-I-510-020A, Acid Clean and Chemical Disinfection, and #FMS-CS-IS-I-510-019A, Acid Clean and Heat Disinfection in the Acid Cleaning of the Fresenius 2008K machine sections stated that, "Step 5. Following the machine prompt, "CONNECT WANDS". 1. Connect the RED Wand line to the Acid connecrate (sic) loop or vinegar jug 2. Connect the blue bicarb line to the vinegar jug."

Reference #6: Dialysis Policies #FMS-CS-IS-I-510-020A, Acid Clean and Chemical Disinfection, and #FMS-CS-IS-I-510-019A, Acid Clean and Heat Disinfection in the Policy sections stated that, "The hemodialysis machine must be acid rinsed and heat disinfected at the end of each treatment day...except on the day of chemical disinfection."

7. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for December 2009 to present for machine ID #s 132239 and 132631 indicated a column heading that stated, "Wands Bleached (Mon and Fri)."

Review of these machine logs lacked evidence that the wands for machine #132239 were bleached on 12/21/10 (a Monday that the machine was used) and 1/13/10 (a Wednesday the machine was used following a Monday the machine was not in use).

a. The policy in Reference #3 indicated that chemical disinfection (with bleach) was to occur weekly and whenever indicated by culture results or other designated situations. Bleaching of the machine was listed on the machine monitoring logs to be done on Wednesdays or with an unknown or positive hepatitis status. This is not on Mondays and Fridays as indicated on the machine monitoring logs for the wands.

b. The policies in Reference #s 5 and 6 address connecting the Wands during the acid cleaning, not bleaching the wands on Mondays and Fridays, as indicated on the machine monitoring logs.

c. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for September 2009 to December 2009 for machine ID #s 132239 and 132631 indicated a column heading that stated, "Wands (2)." In this column, the dialysis personnel were noting the number of wands as "1" or "2," or a check mark. These monitoring logs lacked evidence of whether the wands were being bleached two times a week on Mondays and Fridays, as indicated on the machine monitoring log forms beginning in December, 2009.

d. Upon request on 1/20/09 and 1/21/09, Staff #s 4, 12, and 13 were unable to provide a policy and procedure regarding the required frequency for bleaching or disinfection of the wands.

e. The findings noted above were confirmed by Staff #7 in an interview on 1/20/10 at 1:50 PM, by Staff #4 in an interview on 1/20/10 at 2:15 PM, and by Staff #s 12 and 13 on 1/21/10 at 2:15 PM.

Reference #7: Dialysis Policy #FMS-CS-IS-I-510-009A, Diasafe(R) Filter Integrity Testing, in the Background section stated that, "The Diasafe(R) and Diasafe (R) Plus filters are intended to enhance the dialysate fluid to reduce the level of bacteria and endotoxin in the dialysate."

In the Policy section, this policy stated that, "Diasafe(R) and Diasafe(R) Plus filters will be tested Bi-Weekly (every other week)."

8. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for September 2009 to December 2009 for machine ID #s 132239 and 132631 lacked evidence that the Diasafe filters were tested.

THIS IS A REPEAT DEFICIENCY

A. Based on document review and interview, it was determined that the facility failed to ensure that the infection control officer developed a system for identifying and controlling infections and communicable diseases of patients and personnel related to hemodialysis treatments.

Findings include:

HD=hemodialysis

1. On 1/20/10 at 12:00 Noon, review of "Dialysis Machine Monitoring Log" forms for September 2009 to present for machine ID #s 132239 and 132631 indicated the following examples that the facility was not able to adequately track hemodialysis cleaning and disinfection procedures in order to ensure the control of infections and communicable diseases:

a. Machine #132239 had 2 "Dialysis Machine Monitoring Log" forms for the week of 12/13/09 to 12/19/09. These two forms had conflicting information that would indicate that more than one patient was being dialyzed with the same machine at the same time.

Hemodialysis Treatment Flow Sheets for 12/14/09 through 12/18/09 were requested from the contracted dialysis service and the facility's Medical Record Department. Comparison of the Dialysis Machine Monitoring Logs for machine #132239 and the HD flow sheets provided indicated the following:

(i). The 2 machine logs indicated that on 12/14/09, three (3) patients were dialyzed using machine #132239. The HD flow sheets indicated that two (2) patients (#s 28 and 35) were dialyzed on machine #132239 on 12/14/09. The third patient could not be identified.

(ii). The 2 machine logs indicated that on 12/15/09, two (2) patients were dialyzed using machine #132239. The HD flow sheets indicated that one (1) patient (#41) was dialyzed on machine #132239 on 12/15/09. The second patient could not be identified.

(iii). The 2 machine logs indicated that on 12/16/09, three (3) patients were dialyzed using machine #132239. The HD flow sheets indicated that one (1) patient (#19) was dialyzed on machine #132239 on 12/16/09. The second and third patients could not be identified.

(iv). The 2 machine logs indicated that on 12/17/09, two (2) patients were dialyzed using machine #132239. The HD flow sheets indicated that one (1) patient (#21) was dialyzed on machine #132239 on 12/17/09. The second patient could not be identified.

(v). The 2 machine logs indicated that on 12/18/09, three (3) patients were dialyzed using machine #132239. The HD flow sheets indicated that two (2) patients (#s 19 and 23) were dialyzed on machine #132239 on 12/18/09. The third patient could not be identified.

b. Review of HD flowsheets provided dated 12/14/09 through 12/18/09 indicated that information was missing or inaccurate, which did not allow the facility to accurately track what patients used what HD machines, in order to ensure the control of infections and communicable diseases. Examples are as follows:

(i). Two flowsheets dated 12/14/09 for Patient #s 22 and 38 indicated the machine # as "2008 K2." This was the model number of the type of machine used, not the machine ID #. It could not be determined what machine was used to dialyze these patients.

(ii). One flowsheet dated 12/15/09 for Patient #34, one flowsheet dated 12/16/09 for Patient #20, one flowsheet dated 12/17/09 for Patient #25, and one flowsheet for 12/18/09 for Patient #33 lacked entries in the machine # area. It could not be determined what machine was used to dialyze these patients.

(iii). One flowsheet dated 12/18/09 for Patient #26 indicated the machine # as "2634." According to the list of machine ID #s provided by the contracted dialysis service, this machine # does not exist at this facility. It could not be determined what machine was used to dialyze this patient.

(iv). One flowsheet dated 12/18/09 for Patient #35 indicated the machine # as "2031." According to the list of machine ID #s provided by the contracted dialysis service, this machine # does not exist at this facility. It could not be determined what machine was used to dialyze this patient.

2. The findings noted above were confirmed by Staff #7 in an interview on 1/20/10 at 1:50 PM, by Staff #4 in an interview on 1/20/10 at 2:15 PM, and by Staff #s 12 and 13 on 1/21/10 at 2:15 PM.