HospitalInspections.org

Based on document review and interview, the hospital failed to ensure that patients received information about whom to contact to file a grievance.

Failure to properly inform patients of their rights places all patients at risk of harm related to their inability to quickly and easily inform people of a grievance.

Findings:

Review of a document on 5/11/2011 entitled "Patient Rights and Responsibilities" revealed that patients were informed by the facility of their right to know the process for submitting a complaint to the hospital or the state agency but the document did not include contact information necessary to file a complaint.

Review of a booklet given to patients admitted to the hospital for overnight care revealed that the process for filing a complaint, both with the hospital and the state agency, was included in the booklet. This booklet was not given to patients utilizing outpatient services.

Administrative staff confirmed that patients utilizing outpatient services were not being given the information needed in order to file a complaint with the hospital or the state agency.




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Based on medical record review, the hospital failed to ensure that restraint or seclusion was only imposed to ensure the immediate physical safety of the patient, a staff member, or others and was discontinued at the earliest possible time for 3 of 5 records reviewed for restraint/seclusion (Patients # 17-19).

Failure to document the required immediate and continued need for restraint/seclusion places patients at risk of harm related to being in restraints/seclusion without an appropriate reason.

Findings:

1. Per observations, Patient #17 was in seclusion while a patient in the Emergency Department (ED) on 4/9/2011. The pre-printed form "Violent/Non-Violent Restraint/Seclusion: Nursing Assessment Tool" showed the patient was assessed by a licensed nurse at 10:45 AM, 12:45 PM and at 2:20 PM. In each of these assessments the licensed nurse indicated that the patient was "not exhibiting" violent behaviors which put the patient's own safety or safety of others at risk, which is directly opposed to the information in the physician's order to seclude the patient.

2. Per record review, Patient #18 was in physical restraints while a patient in the ED on 3/19/2011. The pre-printed form "Violent/Non-Violent Restraint/Seclusion: Nursing Assessment Tool" showed the patient was in physical restraints from 2:15 AM to 5:00 AM The restraint documentation form record did not contain any assessments from a licensed nurse over the entire period the patient was restrained to show that the restraints needed to be in place for the entire time period.

3. Per record review, Patient #20 was admitted on 5/2/2011. The record showed the patient was placed into physical restraints at 10:30 PM until midnight. The restraint documentation form record did not contain any assessments from a licensed nurse over the entire period the patient was restrained to show that the restraints needed to be in place for the entire time period.

All of the examples listed above were verified by administrative staff providing access to the electronic and paper medical record.



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Based on medical record review, the hospital failed to ensure that restraint or seclusion was only imposed when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm for 4 of 5 records reviewed for restraint/seclusion (Patients #17, 18, 20, 21).

Failure to document less restrictive interventions places patients at risk of harm related to being in restraints/seclusion when other lesser restrictive alternatives could have been used.

Findings:

1. Per observations, Patient #17 was in seclusion while a patient in the Emergency Department (ED) on 4/9/2011. The pre-printed form "Violent Restraint New and Renewal Order Set" showed that of the seven (7) less restrictive alternatives printed on the form, only one of the seven was marked as "unsuccessfully attempted". None of the other possible alternatives were listed as not being a viable alternative to the patient's seclusion.

2. Per record review, Patient #18 was in physical restraints while a patient in the ED on 3/19/2011 from 2:15 AM to 5:00 AM. There was no evidence in the record that any less restrictive alternative was tried and/or failed prior to physically restraining the patient.

3. Per record review, Patient #20 was in physical restraints on 5/2/2011 from 10:30 PM to midnight. There was no evidence in the record that any less restrictive alternative was tried and/or failed prior to physically restraining the patient.

4. Per record review, Patient #21 was in physical restraints on 3/29/2011 to 4/7/2011. The initial order obtained on 3/29/2011 at 10 PM did not show evidence that any less restrictive alternative was tried and/or failed prior to physically restraining the patient. The renewal order written on 4/1/2011 did not show evidence that any less restrictive alternative was tried and/or failed prior to physically restraining the patient.

All of the examples listed above were verified by administrative staff providing access to the electronic and paper medical record.



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Based on medical record review, the hospital failed to ensure that a restrained/secluded patient had documentation of a completed order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others and/or was renewed after the initial four (4) hour order for 3 of 5 records reviewed for restraint/seclusion (Patients #17, 18, 20).

Failure to document the required order renewal for restraint/seclusion places patients at risk of harm related to being in restraints/seclusion without a physician order.

Findings:

1. Per observations, Patient #17 was in seclusion while a patient in the Emergency Department (ED) on 4/9/2011. The pre-printed form "Violent Restraint New and Renewal Order Set" showed a physician order was obtained at 11:15 AM. A review of the "Violent/Non-Violent Restraint/Seclusion: Nursing Assessment Tool" showed the patient was in seclusion from 10:30 AM to 4:15 PM. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing that a physician had renewed the original order which expired at 2:30 PM. Thus, the patient was in seclusion for an additional one hour and forty-five minutes without a physician order.

2. Per record review, Patient #18 was in physical restraints while a patient in the ED on 3/19/2011 from 2:15 AM to 5:00 AM. There was no evidence in the record that a physician order had been obtained for the restraint time period.

3. Per record review, Patient #20 was in physical restraints on 5/2/2011 from 10:30 PM to midnight. There was no evidence in the record that a physician order had been obtained for the restraint time period.

All of the examples listed above were verified by administrative staff providing access to the electronic and paper medical record.



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Based on observations and medical record review, the hospital failed to ensure that a restrained/secluded patient had documentation of a face-to-face evaluation within 1 hour after the initiation of the intervention to evaluate: a) the patient's immediate situation; b) the patient's reaction to the intervention; c) the patient's medical and behavioral condition; and d) the need to continue or terminate the restraint or seclusion for 3 of 5 patients in restraints/seclusion (Patients #17, 18, 20).

Failure to document the required face -to-face evaluation to determine whether the patient actually meets the specific criteria for restraint/seclusion places patients at risk of harm related to being inappropriately placed into restraints/seclusion.

Findings:

1. Per observations, Patient #17 was in seclusion while a patient in the Emergency Department (ED) on 4/9/2011. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing that physician or registerd nurse had completed the required face-to-face evaluation within 1 hour after the initiation of the intervention to evaluate the patient for the above identified four (4) specific criteria.

2. Per record review, Patient #18 was in physical restraints while a patient in the ED on 3/19/2011. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing that physician or registerd nurse had completed the required face-to-face evaluation within 1 hour after the initiation of the intervention to evaluate the patient for the above identified four (4) specific criteria.

3. Per record review, Patient #20 was in physical restraints on 5/2/2011. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing that physician or registerd nurse had completed the required face-to-face evaluation within 1 hour after the initiation of the intervention to evaluate the patient for the above identified four (4) specific criteria.

All of the examples listed above were verified by administrative staff providing access to the electronic and paper medical record.



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Based on medical record review, the hospital failed to ensure that documentation existed to show the patient's condition or symptom(s) that warranted the use of the restraint or seclusion for 3 of 5 records reviewed for restraint/seclusion (Patients #18-20).

Failure to document the patient's behaviors, condition and observed symptoms that required restraint/seclusion places patients at risk of harm related to the potential for being restrained/secluded after the behaviors and symptoms have subsided.

Findings:

1. Per record review, Patient #18 was in physical restraints while a patient in the ED on 3/19/2011. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing the patient's condition or symptom(s) that warranted the use of the restraint.

2. Per record review, Patient #19 was admitted on 3/26/2011. The record showed the patient was placed into both arm and leg physical restraints at 6:30 PM and were discontinued at 2:45 AM on 3/27/2011. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing the patient's condition or symptom(s) that warranted the use of leg restraints. The physician order form stated that the patient's behavior which required restraint was "inability to maintain body position; disorientation; and pulling at tubes or other treatment devices". The "Violent/Non-Violent Restraint/Seclusion: Nursing Assessment Tool" showed that the behavior warranting restraint included many possible behaviors and included "pulling at tubes". The record showed that the patient had a "heparin lock" device to be used if the patient needed to have something administered intravenously, but no documentation showing that it was actually being used. No evidence was found in the record to show that the patient had any behaviors requiring both legs to be restrained with the arms.

3. Per record review, Patient #20 was in physical restraints on 5/2/2011. Per review of the patient's electronic and paper-based medical record, no documentation could be found showing the patient's condition or symptom(s) that warranted the use of the restraint.

All of the examples listed above were verified by administrative staff providing access to the electronic and paper medical record.



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I.
Based on observations, the hospital quality assessment and process improvement program failed to adequately monitor the effectiveness and safety of service and quality of care in the Emergency Department (ED) to ensure that patient care supplies were not removed from immediate patient access once they had passed the product manufacturer's expiration date.

Failure to maintain an effective quality assessment program regarding patient care supplies places patients at risk of harm related to possible infections from out dated intravenous fluids and from potential inaccurate diagnostic tests with expired products.

Findings:

1. Per observations in the ED Triage rooms on 4/9/2011 the following was noted: a) two (2) containers of "Multistix 10 SG" (urinalysis), containing 100 test sticks, had an expiration date of 12/2009; b) a bottle of sodium chloride (NaCl) injectable solution had expired in 01/2010; c) two (2) containers of pregnancy testing urine dip sticks had expired in 07/2010 and 10/2010 respectively; d) a 500 ml intravenous fluid bag of Lactated Ringer's solution had expired in 11/2009; and e) several individual "3M Red Dot" ECG pads were found, out of their original package, that prevented knowledge of their expiration date to staff.

2. Per observations in the ED Zone 2 Intravenous Cart the following was noted: a) nine (9) "BacT/Alert PF" blood culture vials had expired on 1/31/2011.

All the above observations were verified by hospital staff present during rounds.


II.
Based on medical record review, the hospital quality assessment and process improvement program failed to adequately monitor patient treatments to ensure that patients received care and treatment as ordered by the physician for 1 of 2 records reviewed for dialysis care (Patient #15).

Failure to ensure to maintain an effective quality assessment program regarding patient care and treatments places patients at risk of harm related to possible problems from care and treatments that were not specifically ordered by the physician.

Findings:

1. Per review of Patient #15's medical record, the record showed a physician order for a "PL-6" dialyzer to be used during the patient's 5/8/2011 hemodialysis treatment. A review of the patient's "Hemodialysis Record" form dated 5/8/2011 revealed that the dialyzer used on the patient was a "F50" type, not the one ordered by the physician. There was no documentation from the dialysis nurse about why the patient did not get the specific dialyzer ordered by the physician. Thus, there was no order from the physician to use the "F50" type dialyzer.

2. The record also showed a physician order for the patient's Blood Flow Rate (BFR) during the patient's 5/8/2011 hemodialysis treatment was to be set at "300". A review of the patient's "Hemodialysis Record" form dated 5/8/2011 revealed that the BFR for the entire treatment time was set at "250". Thus, less blood moved through the dialyzer than was ordered by the physician. There was no documentation from the dialysis nurse about why the patient did not get the specific BFR ordered by the physician. Thus, there was no order from the physician to use a slower treatment setting.



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Based on interview and record review, the facility failed to ensure that a medical history and physical examination (H&P) was documented in the medical record prior to surgery or procedures requiring anesthesia services for 4 of 12 patients reviewed for this requirement (Patients #1-4).

Failure to make the H&P available in the medical record prior surgery to places patients at risk for poor outcomes related to failure of the surgical team to have necessary information about the patient ' s medical condition prior to undertaking a procedure.

Findings include:

The surveyor chose a cross section of medical records from the logs of surgeries and procedures done in other areas of the hospital which used anesthesia services. The surveyor reviewed these records for required components on 5/12/11.

Patient #1 was a 55 year old male who underwent wrist surgery on 4/1/11. Review of the patient ' s medical record failed to demonstrate the presence of an H&P.

Patient #2 was a 13 year old female who had an appendectomy on 11/4/10. Review of the medical record revealed the presence of an H&P which was incomplete. There were blank spaces in the transcription of the H&P which were not addressed by the physician.

Patient #3, an 87 year old male, underwent a cardioversion procedure on 1/10/11. No H&P was found for this patient.

Patient #4 was a 50 year old female who had a colonoscopy and an upper GI endoscopy on 1/14/11. Review of the patient ' s record revealed no documentation of an H&P.

These findings were confirmed by the Quality staff person (#S1) who was assisting with the review of the records.

The surveyor asked Staff #S2, the survey coordinator, for the facility policy and procedure for H&Ps on 5/12/11. She stated that these requirements were in the Medical Staff By-laws. Later on 5/12/11 Staff #S2 stated that she could not find reference to H&Ps in the By-laws.



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Based on medical record review, the hospital failed to fully develop the Fall Risk Assessment tool, for registered nurses, that allowed accurate documentation of the assessment to include the actual assessment score of the six (6) specified criteria in the tool for 4 of 4 records reviewed for assessments (Patients #22, 24, 25, 26).

Failure to document assessments in a way that allows staff to see rationale for over-all scores places patients at risk of harm related to nursing care staff not being aware of potentially increasing problem areas, or of not allowing patients more freedom to exercise activities of daily living in an effort to strengthen themselves before discharge.

Findings:

1. Per record review, Patient #25 was admitted on 5/4/2011. The record contained an Fall Risk Assessment tool that was accomplished each shift by a registered nurse. The format of the tool had a scoring box in one column followed by boxes for each shift assessment that included the "total score" and any interventions to be accomplished based on the patient's score. Per review of the shift scoring boxes, it was noted that only the "total score" was included. There was no identification of which of the six criteria was used to obtain the score. Thus, there was no way to determine if a patient's score in one of the six criteria had improved or declined. This information would be needed by the registered nurse in determining which interventions to initiate or terminate. Assessments were reviewed from 5/4/2011 to 5/7/2011, and on 5/6/2011 the score changed from "85" to "65". There was no documentation in the record to describe which if the six criteria had changed to show the patient's fall risk was declining.

2. Per record review, Patient #26 was admitted on 4/16/2011. The record contained an Fall Risk Assessment tool that was accomplished each shift by a registered nurse. Assessments were reviewed from 5/5/2011 to 5/11/2011. During this time period the score declined twice and was elevated on one shift. There was no documentation in the record to describe which if the six criteria had changed to show the patient's fall risk was improving or declining.

3. Per record review, Patient #24 was admitted on 5/7/2011. The record contained an Fall Risk Assessment tool that was accomplished each shift by a registered nurse. Assessments were reviewed from 5/7/2011 to 5/10/2011. During this time period the score declined twice and was elevated on one shift. There was no documentation in the record to describe which if the six criteria had changed to show the patient's fall risk was improving or declining.

4. Per record review, Patient #22 was admitted on 4/29/2011. The record contained an Fall Risk Assessment tool that was accomplished each shift by a registered nurse. Assessments were reviewed from 4/29/2011 to 5/5/2011. During this time period the score declined twice and was elevated on one shift. There was no documentation in the record to describe which if the six criteria had changed to show the patient's fall risk was improving or declining.

All of the examples listed above were verified by administrative staff providing access to the electronic and paper medical record.



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Based on medical record review, administrative staff interview, and review of policy and procedure, hospital pharmacy services failed to ensure that physician orders for drugs/medications were obtained prior to the patients receiving these drugs/medications for 2 of 2 dialysis/alcohol withdrawal records reviewed (Patients #15-16)

Failure to ensure that drugs/medications are administered only with a physician order places all patients at risk of harm related to the administration of drugs/medications that were not specifically ordered by a physician.

Findings:

1. Per record review, Patient #15 was admitted on 5/7/2011:

a) The record contained a pre-printed form titled "VMC Hemodialysis Orders", last revised 6/5/2008. This form documents physician orders for "Albumin 25% to be administered intravenously in a 50 ml bolus to maintain the patient's blood pressure above 90 mmHg. A review of the patient's "Hemodialysis Record" form dated 5/8/2011 revealed that the patient was given this medication dose at 4:15 PM and again at 5:00 PM. The blood pressure recorded at these times did not provide evidence the blood pressure was below 90 mmHg. There was no documentation from the dialysis nurse about why these intravenous fluids were given at these times. Thus, there was no order from the physician to administer this medication;

b) The record contained a pre-printed form titled "Alcohol Withdrawal Management Order Set", last revised 8/23/2010. This form documents physician orders for "Lorazepam" (an anti-anxiety medication) to be administered to the patient based on a specific assessment from the CIWA Scale. A review of the patient's electronic Medication Administration Record (MAR) and data from the "Pyxis" medication storage and dispensing machine showed the patient received the medication on 5/11/20111 at 5:52 PM. The "Alcohol Withdrawal Assessment Scale-CIWA-Ar" form did not have documentation of the required assessment, prior to administering the medication. Thus, there was no order from the physician to administer this medication.

2. Per record review, Patient #16 was admitted on 5/5/2011. The record contained a pre-printed form titled "VMC Hemodialysis Orders", last revised 6/5/2008. This form documents physician orders for normal saline (.9%) to be administered intravenously in a 200 ml bolus to maintain the patient's blood pressure above 90 mmHg. A review of the patient's "Hemodialysis Record" form dated 5/9/2011 revealed that the patient was given a 200 ml bolus of normal saline at 3:30 PM and again at 4:00 PM. The blood pressure recorded at these times did not provide evidence the blood pressure was below 90 mmHg. There was no documentation from the dialysis nurse about why these intravenous fluids were given at these times. Thus, there was no order from the physician to administer this medication.






21647


Based on interview, record review, and review of policy and procedure, the hospital failed to ensure that nursing staff followed physician's orders for assessments and monitoring of patients receiving pain relieving medication via a Patient Controlled Analgesia (PCA) pump in 2 of 2 records reviewed (Patients #27-28).

Failure to accurately document required assessments places patients at risk of harm related to inadequate control of pain and/or overdosing of medications.

Findings:

1. The hospital's policy entitled "Patient Controlled Analgesia - Adult" (Policy No. N-1085.03; Issued 12/2007; Revised 8/2009) stated that patients receiving pain medication via a patient controlled analgesia (PCA) pump should be assessed when the initial dose is given then monitored every 15 minutes times two, then every 30 minutes times two, then every 2 hours for 24 hours, and then every 4 hours thereafter. The monitoring should include level of sedation, level of consciousness, respiration rate, depth, and quality.

In addition, the policy referred to the use of number scales for evaluating the patient's respiratory rate, sedation level and level of consciousness. There was no evidence in the medical record that nursing staff were using scales and assigning numbers to the patient's respiratory rate, sedation level or level of consciousness.

An interview with the manager of the surgical unit (Staff #12) on 5/11/2011 revealed that the scoring system had been changed to the use of words rather than numbers when documentation was switched from the paper record to the electronic medical record.

2. Review of the medical records of 2 patients who were receiving pain medications via a PCA pump revealed the following:

a. Patient #27 was a 62 year-old patient admitted on 5/8/2011 for treatment of a bowel obstruction. Following a surgical procedure on 5/10/2011 a PCA pump was placed to allow the patient to self administer pain medication. The PCA was started at 6:40 PM. An initial set of assessments were documented at 6:42 PM. Assessments of the patient's respiratory rate and sedation level occurred at 7:20 PM, 7:59 PM, 9:00 PM, 9:30 PM, 1:10 AM on 5/11/2011, 6:00 AM, and 8:32 AM. The assessments were not completed as frequently as required by hospital policy and procedure.

b. Similar findings were found in the medical record of Patient #28.




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Based on medical record review, the hospital failed to ensure that the records contained the actual date and time when staff authenticated their telephone/verbal patient care orders for 5 of 5 records reviewed for signature authentication (Patients #15, 16, 22, 23, 24).

Failure to ensure that medical record documentation shows an authentication of verbal/telephone orders places all patients at risk of receiving or not receiving care as specified by the physician due to an inaccurately transcribed order.

Reference: Per Hospital "Medical Staff Bylaws Final Version", last revised 12/2010, on page 49, section 5.8, it states, "Orders. All orders including verbal orders, must be signed, dated and timed by the ordering practitioner...".

Findings:

1. Per review of Patient #16's medical record, the patient was admitted on 5/5/2011. Per review of the "VMC Hemodialysis Orders" form a telephone order was received from the physician on 5/5/2011 at 00:11 AM. This order had been initialed by the physician but had not been dated or timed. Thus, there was no evidence that the order had been authenticated within 48 hours, as required.

Additional telephone orders were found from 5/5/2011 to 5/8/2011. Four (4) orders had been initialed by the physician but had not been dated or timed. Thus, there was no evidence that the order had been authenticated within 48 hours, as required. Four (4) orders had not been authenticated, as of 5/11/2011.
Two orders had been properly authenticated except they were authenticated four (4) days after they were written.

2. Per review of Patient #22's medical record, the patient was admitted on 4/29/2011. Per review of orders from 4/29/2011 to 5/5/201, thirteen (13) of which were telephone orders. Nine (9) orders had not been authenticated, as of 5/11/2011. Four (4) orders were found that had a physician initial that had not been dated or timed. Thus, there was no evidence that the order had been authenticated within 48 hours, as required.

3. Per review of Patient #23's medical record, the patient was admitted on 5/4/2011. Per review of orders from 5/7/2011 to 5/8/201, five (5) of which were telephone orders. One (1) order had not been authenticated, as of 5/11/2011. Four (4) orders were found that had a physician initial that had not been dated or timed. Thus, there was no evidence that the order had been authenticated within 48 hours, as required.

4. Per review of Patient #15's medical record, the patient was admitted on 5/7/2011. Per review of orders from 5/7/2011 to 5/8/201, seven (7) of which were telephone orders. Six (6) telephone orders had no authentication, as of 5/11/2011. One (1) order was found that had a physician initial that had not been dated or timed. Thus, there was no evidence that the order had been authenticated within 48 hours, as required.

5. Per review of Patient #24's medical record, the patient was admitted on 5/7/2011. Per review of orders, three of three telephone orders had not been authenticated, as of 5/11/2011.



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Based on observation, interview, and record review the facility failed to follow its policy and procedure for possible adverse drug reactions including, but not limited to, timely physician and pharmacy notification.
Failure to complete timely and appropriate communications/reports related to adverse drug reactions places patients at risk for complications related to the drug reaction, risks harm for future adverse events, omits relevant updates of patient medical records and creates circumstances where incidences of adverse reactions cannot be accurately evaluated or prevented.
Findings:

1. Per policy and procedure titled, Suspected Adverse Drug Reaction (ADR) Reporting Program (February 2010), an adverse drug reaction is defined in the policy as " any unintended, undesired, and/or unexpected noxious effect .....that requires a change in therapy .... "
Item #2 states " Upon suspected ADR, notify the prescribing physician to confirm reaction and to take appropriate action " . This communication is to occur by the end of the shift. The next item states, " Contact the clinical pharmacist to assess and evaluate ADR " and assessment documentation should be placed in the patient ' s chart. It also states that initiation of the Adverse Drug Reaction (ADR) Reporting Form should be completed by the " health care provider " .

2a. Midday on 05/10/11 an interview was completed with a Patient #13. The patient had a radical mastectomy on 4-6-11, was discharged on 4-7-11 and was re-admitted to the hospital on 5-8-11 with " progressive wound infection refractory to oral antibiotics " for intravenous antibiotic therapy.

During the interview the patient stated s/he thought s/he had a difficult day on 5-9-11. S/he related that her wound opened and released a large amount of drainage from the surgical site (approximately 300 cc per a nursing note) and also the patient thought she/he had a drug reaction. Related to the patient suspected drug reaction, on 5-9-11 s/he requested medication for nausea because ondansetron (another anti-nausea medication) was not due for around two more hour and symptoms of nausea were recurring. The patient was administered intravenous metoclopromide per physician order for nausea. The patient stated that s/he thought s/he had a drug reaction about 10 minutes after receiving intravenous metoclopramide.
The symptoms that the patient interpreted as a drug reaction were a " heart racing and clammy hands " and a " feeling of anxiety " . S/he reported the symptoms to the registered nurse staff #S8. The registered nurse told her that the uncomfortable effects of the medication would have to wear off with time and that nothing could be done. The patient stated that the symptoms lasted for at least a few hours. The patient did not think the explanation by the registered nurse was adequate enough to provide an understanding of what had occurred and what to expect for treatment.

The registered nurse did obtain an order at 1:30PM (approximately 3.5 hours later) to administer oral Ativan and at 5:30PM the metoclopramide was discontinued in a handwritten order by the physician. The policy required that the health care provider contact the physician by the end of the shift however the patient was not tolerating the symptoms for a significant length of time prior to related physician contact.

2b. On 5-10-11 in a telephone interview with a Medication Safety Officer pharmacist, staff #S9, it was determined that an ADR Report Form had not been filed and that other information related to pharmacist activities were not available online from the previous day. However, Staff #S9 stated that the pharmacist would be responsible for evaluating the patient on the unit and completing an ADR Report Form. It was later noted by the surveyor that the policy does not state that the pharmacist is responsible for completing the ADR Report Form.

In an interview with pharmacy staff on 5-12-11, staff #S9 stated that the nurse had sent an electronic message to the pharmacy (through the order entry system, not the ADR Report Form) and then contacted a pharmacist by phone at around 3:00PM that day. At that time the pharmacist asked the nurse to contact the physician and the pharmacist updated the metoclopramide online as a medication allergy.

The facility failed to follow its procedure and standards of care in several ways: prompt physician notification, proper notification the clinical pharmacist, pharmacist completion of the assessment/documentation of the event and related physician documentation in the patient ' s record. All facility staff members failed to complete an ADR Report Form and the Medication Safety Officer identified the incorrect staff person as responsible for completing form. The patient also expressed dissatisfaction with the manner in which the incident was handled by the facility and the patient remained concerned/uninformed about the care event.


3a. During an interview on 5-11-11 at around 1030am with a registered nurse, Staff #S10, regarding the care of Patient #14, it was discussed that the patient became " disoriented " , " confused " , was " pulling at things " and " trying to get out of bed " on the previous evening shift. These symptoms started after the patient received 0.25mg of oral triazolam for sleep at approximately 9:00PM the previous evening. The evening nurse, Staff #S11, documented the symptoms/events in the progress notes. The symptoms were resolved at the time when Staff #S10 assumed care. Staff #10 acknowledged that if triazolam 0.25 mg were to be administered in the future the patient ' s mentation would likely be affected.

The facility failed to follow its procedures and standards of care in several ways: the physician and pharmacy were not notified about the symptoms related to medication administration at any time or prior to the patient ' s discharge on 5-11-11 at around 1030 am. An ADR Report Form was not completed by facility staff members and the online medical record was not updated as of as of 1030am. The patient and family were not informed about the reaction to the medication prior to discharge from the facility.


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Based on review of hospital documents, the hospital failed to establish an agreement with the blood bank and policies for patient notification consistent with 21 CFR 610.46 and 21 CFR 610.47 timelines. Failure to address timelines in the blood bank agreement and patient notification, increases patient risk of untreated human immunodeficiency virus (HIV) and hepatitis C virus (HCV) from blood and blood components received in the hospital.

Findings:

The hospital agreement with Puget Sound Blood Center did not require notification of the hospital (i) within 3 calendar days if the supplied blood was from a donor testing negative at the time of donation, but reactive on a later donation, (ii) within 45 days of the test of results of follow up testing, and (iii) within 3 calendar days if the supplied blood was collected from an infectious donor.

Hospital Blood Transfusion Recipient and "Look Back Program" policy [effective 7-2009] states "The notification effort ... should continue for 8 weeks." Notification efforts must continue over a period of 12 week.



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Based on observation the hospital failed to ensure that equipment was installed and maintained in a manner to assure the safety of the patients and to prevent possible cross contamination of the hospital's water supply. Failure to install and maintain cross-connection controls on equipment that is attached to the hospital's water supply places the patients at risk for possible exposure to chemical or biological contaminates.

Finding:

1. During the environmental tour of the Birth Center on 5/10/2011 the surveyor observed hand held shower wands with hoses attached in patient tub/shower rooms #2301, #2306, #2309, and #2310 on the C unit and rooms #2346, #2351and #2353 on the E unit. Vacuum breakers were not properly installed on the shower hoses to provide the needed level of protection to prevent possible back siphoning of contaminates into the hospital's water supply.

2. On 5/11/2011 during a tour of the endoscopy unit the surveyor observed that the Medivator scope washer was not provided with a reduce pressure back flow assembly to protect from possible high level cross contamination of the water supply by chemical disinfectants or biological contaminates. CORRECTED DURING THE SURVEY

3. Also, on 5/12/2011 during a tour of the emergency department the surveyor observed a backboard washer unit in the decontamination room that was not provided with a vacuum breaker on the cold water supply line. CORRECTED DURING THE SURVEY




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Based on observation and interview with hospital staff, the hospital failed to maintain ventilation consistent with Center for Disease Control and Prevention (CDC) Guidelines for Environmental Infection Control in Health Care Facilities, 2003, Table B.2 [American Institute of Architects (AIA) Guidelines for Design and Construction of Hospitals and Health-Care Facilities, 2001.

Failure to maintain ventilation relationships and ventilation monitoring consistent with CDC guidelines risks patient infection and compromises the quality of patient care.

Findings:

During a tour of the Sterile Processing Department on 5/11/11, observation of a light weight tissue showed the Decontamination Room ventilation to be positive to the adjacent corridor.

During a tour of the Pathology Laboratory on 5/12/11, observation of a light weight tissue showed the ventilation to be positive to the adjacent corridor.

During an interview on 5/12/11 at 11:30 PM, Staff #13 confirmed the ventilation relationships observed for the Sterile Processing Decontamination Room and the Pathology Laboratory were positive to adjacent spaces and had been corrected.

CORRECTED DURING SURVEY.




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Based on observation and interview, the facility failed to implement and maintain policies and procedures for specific infection prevention issues.

Failure to do so places patients, staff, and visitors at risk for health-care acquired infections, resulting in debility, pain, suffering, extended hospital stays, increased health-care costs, and death.

Findings:

The surveyor observed the following breaches of infection control standards, policies and procedures on 5/9/11 in the main operating room areas:

· Approximately 1:40PM medical staff #MS1 handled patient care items with gloved hands which were contaminated with the patient ' s saliva while establishing a patent airway for the patient during anesthesia induction. Without removing gloves and performing hand hygiene, staff #MS1 proceeded to administer medications intravenously to the patient.
· At about 1:45PM medical staff #MS2 entered the operating room flapping hands to dry them, thereby potentially contaminating them.
· Approximately 1:50PM staff #S3 shook rather than gently spread out sterile drapes in preparation to cover the patient, contrary to standard, and thereby potentially contaminating them.
· Once the drapes were in place, medical staff #MS2 moved the drapes surrounding the surgical site, which conflicts with asepsis standards of practice, and risks contamination of the surgical site.
· Approximately 2:00PM staff #S7 picked up a patient care item which had fallen to the floor and placed it back on a cart, putting it back in a position to be used, rather than discarding the now contaminated item.
· At about 2:50PM staff #S3 lifted the lid of the trash can by hand rather than using foot pedal, then proceeded to make patient contact without performing hand hygiene.
· Staff #S3 also retrieved a pillow which had fallen to the floor, and without cleaning and re-covering it, placed it on the operating room bed, where it was subsequently used for the patient.
· Approximately 3:00PM staff #S3 again lifted the trash can lid by hand, and without doing hand hygiene moved on to several tasks: completing paperwork, moving the trash can by touching the lid, and retrieving the patient transfer stretcher. No hand hygiene was observed when moving between these dirty and clean tasks.

These 5/9/11 peri-operative observations were also observed staff #S4, who was accompanying the surveyor.


On 5/10/11 the surveyor observed the following infection control breaches in the Day Surgery Center:

· Approximately 10:15AM medical staff #MS4 moved repeatedly in very close proximity to a sterile field set up on a Mayo stand, with his back to the field, thereby risking contaminating it, and not following standard aseptic procedures for non-sterile staff.
· At about 10:25AM medical staff #MS5 removed contaminated gloves before proceeding to do paperwork, adjust the heart monitor, and place protective covers over the patient ' s eyes. The surveyor observed no hand hygiene between or after any of these activities. Those staff accompanying the surveyor could not state whether they had observed hand hygiene.
· Approximately 10:35AM staff #S6 completed prepping the patient ' s surgical area and removed gloves without performing hand hygiene. Staff #S6 went on to re-arranges cords on the floor, reposition clean equipment, wrap up and discard the materials used to prep the patient, manipulate a trash bag, and pick up the end of a warm air blowing hose which had dropped to the floor. No hand hygiene was observed when moving from a dirty to a clean task. The hose was not de-contaminated.
· At about the same time the end of an IV tubing hose hit the floor while final preparations for surgery were underway. Staff #S6 picked the tubing up from the floor, and instead of discarding and getting a new set, used it to set up an IV pump and attached it to the IV fluids bag.

These 5/10/11 peri-operative observations were also observed by staff #S5 and medical staff #MS3, who were accompanying the surveyor.



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Based on interview and record review, the facility failed to document post-anesthesia evaluations reflecting current standards of anesthesia care for 10 of 12 patients reviewed who had undergone surgery or procedures requiring anesthesia services (Patients #1-9, 12).

Failure to complete post anesthesia evaluations places patients at risk for poor outcomes related to unrecognized and untreated complications of anesthesia care.

Findings include:

The surveyor chose a cross section of medical records from the logs of surgeries and procedures done in other areas of the hospital which used anesthesia services, and reviewed them for required components.

CMS regulations state that the elements of an adequate post-anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including:

· Respiratory function, including respiratory rate, airway patency, and oxygen saturation;
· Cardiovascular function, including pulse rate and blood pressure;
· Mental status;
· Temperature;
· Pain;
· Nausea and vomiting; and
· Postoperative hydration.

A Quality staff person (#S1), who was assisting with review of the records, stated that for the 10 patients cited, the Anesthesia Record was the form where policy stipulated the post-anesthesia evaluation was to be documented.

The Anesthesia Record form had a box at the bottom, approximately 1 " X 3 " where the post-anesthesia data was designed to be recorded. Certain cues were provided in this box to fill in blanks for vital signs, oxygen saturation, post-operative notes, time, and signature. There were no cues for the remaining parameters outlined above.

Patient #1 was a 55 year old male who underwent wrist surgery on 4/1/11. Review of the patient ' s Anesthesia Record found vital signs and oxygen saturation, but no documentation of assessment of mental status, pain status, nausea or vomiting, and hydration. The notes stated " no cxs " , an abbreviation staff #S1 stated probably meant " no changes " .

Patient #12, a 102 year old female, had surgery on 4/5/11 to remove a clot from her femoral artery. Review of the Anesthesia Record only found the notation " stable " , along with pulse, blood pressure, and oxygen saturation. Missing were entries addressing assessment of temperature, respiratory rate, mental status, pain status, nausea and vomiting, and hydration.

Patient #6 was a 63 year old female who had two surgeries on successive days. On 4/14/11 she underwent an arterial bypass graft procedure in her leg. The only data documented for a post-anesthesia evaluation was " stable " and the patient ' s blood pressure. On 4/15/11 she returned to surgery for amputation of the leg. The post-anesthesia documentation only included the word " stable " , pulse, blood pressure, and oxygen saturation.

Similar gaps in documentation of post-anesthesia evaluations were found when reviewing the records for Patients #2-5, 7-9.

These findings were confirmed by the Quality staff person (#S1) who was assisting with the review of the records. Staff #S1 also reviewed the records examined by the surveyor to confirm that anesthesia notations had not been unexpectedly entered in another area of the record.



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I.
Based on observations, the hospital quality assessment and process improvement program failed to adequately monitor the effectiveness and safety of service and quality of care in the Emergency Department (ED) to ensure that patient care supplies were not removed from immediate patient access once they had passed the product manufacturer's expiration date.

Failure to maintain an effective quality assessment program regarding patient care supplies places patients at risk of harm related to possible infections from out dated intravenous fluids and from potential inaccurate diagnostic tests with expired products.

Findings:

1. Per observations in the ED Triage rooms on 4/9/2011 the following was noted: a) two (2) containers of "Multistix 10 SG" (urinalysis), containing 100 test sticks, had an expiration date of 12/2009; b) a bottle of sodium chloride (NaCl) injectable solution had expired in 01/2010; c) two (2) containers of pregnancy testing urine dip sticks had expired in 07/2010 and 10/2010 respectively; d) a 500 ml intravenous fluid bag of Lactated Ringer's solution had expired in 11/2009; and e) several individual "3M Red Dot" ECG pads were found, out of their original package, that prevented knowledge of their expiration date to staff.

2. Per observations in the ED Zone 2 Intravenous Cart the following was noted: a) nine (9) "BacT/Alert PF" blood culture vials had expired on 1/31/2011.

All the above observations were verified by hospital staff present during rounds.


II.
Based on medical record review, the hospital quality assessment and process improvement program failed to adequately monitor patient treatments to ensure that patients received care and treatment as ordered by the physician for 1 of 2 records reviewed for dialysis care (Patient #15).

Failure to ensure to maintain an effective quality assessment program regarding patient care and treatments places patients at risk of harm related to possible problems from care and treatments that were not specifically ordered by the physician.

Findings:

1. Per review of Patient #15's medical record, the record showed a physician order for a "PL-6" dialyzer to be used during the patient's 5/8/2011 hemodialysis treatment. A review of the patient's "Hemodialysis Record" form dated 5/8/2011 revealed that the dialyzer used on the patient was a "F50" type, not the one ordered by the physician. There was no documentation from the dialysis nurse about why the patient did not get the specific dialyzer ordered by the physician. Thus, there was no order from the physician to use the "F50" type dialyzer.

2. The record also showed a physician order for the patient's Blood Flow Rate (BFR) during the patient's 5/8/2011 hemodialysis treatment was to be set at "300". A review of the patient's "Hemodialysis Record" form dated 5/8/2011 revealed that the BFR for the entire treatment time was set at "250". Thus, less blood moved through the dialyzer than was ordered by the physician. There was no documentation from the dialysis nurse about why the patient did not get the specific BFR ordered by the physician. Thus, there was no order from the physician to use a slower treatment setting.



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Based on medical record review, administrative staff interview, and review of policy and procedure, hospital pharmacy services failed to ensure that physician orders for drugs/medications were obtained prior to the patients receiving these drugs/medications for 2 of 2 dialysis/alcohol withdrawal records reviewed (Patients #15-16)

Failure to ensure that drugs/medications are administered only with a physician order places all patients at risk of harm related to the administration of drugs/medications that were not specifically ordered by a physician.

Findings:

1. Per record review, Patient #15 was admitted on 5/7/2011:

a) The record contained a pre-printed form titled "VMC Hemodialysis Orders", last revised 6/5/2008. This form documents physician orders for "Albumin 25% to be administered intravenously in a 50 ml bolus to maintain the patient's blood pressure above 90 mmHg. A review of the patient's "Hemodialysis Record" form dated 5/8/2011 revealed that the patient was given this medication dose at 4:15 PM and again at 5:00 PM. The blood pressure recorded at these times did not provide evidence the blood pressure was below 90 mmHg. There was no documentation from the dialysis nurse about why these intravenous fluids were given at these times. Thus, there was no order from the physician to administer this medication;

b) The record contained a pre-printed form titled "Alcohol Withdrawal Management Order Set", last revised 8/23/2010. This form documents physician orders for "Lorazepam" (an anti-anxiety medication) to be administered to the patient based on a specific assessment from the CIWA Scale. A review of the patient's electronic Medication Administration Record (MAR) and data from the "Pyxis" medication storage and dispensing machine showed the patient received the medication on 5/11/20111 at 5:52 PM. The "Alcohol Withdrawal Assessment Scale-CIWA-Ar" form did not have documentation of the required assessment, prior to administering the medication. Thus, there was no order from the physician to administer this medication.

2. Per record review, Patient #16 was admitted on 5/5/2011. The record contained a pre-printed form titled "VMC Hemodialysis Orders", last revised 6/5/2008. This form documents physician orders for normal saline (.9%) to be administered intravenously in a 200 ml bolus to maintain the patient's blood pressure above 90 mmHg. A review of the patient's "Hemodialysis Record" form dated 5/9/2011 revealed that the patient was given a 200 ml bolus of normal saline at 3:30 PM and again at 4:00 PM. The blood pressure recorded at these times did not provide evidence the blood pressure was below 90 mmHg. There was no documentation from the dialysis nurse about why these intravenous fluids were given at these times. Thus, there was no order from the physician to administer this medication.






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Based on interview, record review, and review of policy and procedure, the hospital failed to ensure that nursing staff followed physician's orders for assessments and monitoring of patients receiving pain relieving medication via a Patient Controlled Analgesia (PCA) pump in 2 of 2 records reviewed (Patients #27-28).

Failure to accurately document required assessments places patients at risk of harm related to inadequate control of pain and/or overdosing of medications.

Findings:

1. The hospital's policy entitled "Patient Controlled Analgesia - Adult" (Policy No. N-1085.03; Issued 12/2007; Revised 8/2009) stated that patients receiving pain medication via a patient controlled analgesia (PCA) pump should be assessed when the initial dose is given then monitored every 15 minutes times two, then every 30 minutes times two, then every 2 hours for 24 hours, and then every 4 hours thereafter. The monitoring should include level of sedation, level of consciousness, respiration rate, depth, and quality.

In addition, the policy referred to the use of number scales for evaluating the patient's respiratory rate, sedation level and level of consciousness. There was no evidence in the medical record that nursing staff were using scales and assigning numbers to the patient's respiratory rate, sedation level or level of consciousness.

An interview with the manager of the surgical unit (Staff #12) on 5/11/2011 revealed that the scoring system had been changed to the use of words rather than numbers when documentation was switched from the paper record to the electronic medical record.

2. Review of the medical records of 2 patients who were receiving pain medications via a PCA pump revealed the following:

a. Patient #27 was a 62 year-old patient admitted on 5/8/2011 for treatment of a bowel obstruction. Following a surgical procedure on 5/10/2011 a PCA pump was placed to allow the patient to self administer pain medication. The PCA was started at 6:40 PM. An initial set of assessments were documented at 6:42 PM. Assessments of the patient's respiratory rate and sedation level occurred at 7:20 PM, 7:59 PM, 9:00 PM, 9:30 PM, 1:10 AM on 5/11/2011, 6:00 AM, and 8:32 AM. The assessments were not completed as frequently as required by hospital policy and procedure.

b. Similar findings were found in the medical record of Patient #28.




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