HospitalInspections.org

Based on interview, review of grievance files and review of documents, it was determined that the hospital failed to establish and implement a process for the effective operation of the grievance process, and to review and resolve grievances, including a mechanism for timely referral of patient concerns regarding quality of care. The hospital's failure to do so resulted in 4 of 9 patients/complainants not receiving complete and timely resolution of grievances with appropriate clinical referrals and investigation, and potentially placed all patient/complainants who filed grievances at risk for same.

Findings include:

A total of 9 grievance files were reviewed. The files were reviewed for compliance to Federal regulatory requirements, compliance with the hospital's own policy and procedure for processing grievances and for the appropriate referral for further investigation of complaint issues.

Patient #18
The patient's grievance, received on 2/10/2011, had to do with an extended wait for pain relief while in the hospital's Emergency Department (ED).

Review of the patient's ED medical record revealed that the physician documented her/his assessment at 14:45 and the RN documented her/his assessment at 15:35. The record documented that the patient received the initial dose of pain and anti-nausea medication at 17:49, 3 hours after being originally seen by the physician. The patient returned several hours after discharge and was again medicated for nausea/vomiting and anxiety.

The grievance file contained no documentation that the grievance had been reviewed by a person with a clinical background, who was qualified to evaluate the care provided to the patient in the ED. Review of the hospital's policy and procedure for processing grievances revealed the following:
"IV. GRIEVANCE RESERARCH/DETERMINATION OF ACTION/FOLLOWUP:
1. In cooperation with a Clinical or Department Manager or Director, the Patient Advocate is primarily responsible for facilitating and monitoring follow-up on patient grievances..."

The final letter to the complainant, signed by the Patient Advocate, was dated 2/24/2011.

Patient #22
Review of the file revealed that a grievance was received from the patient/representative on 5/6/2011 regarding her/his treatment in the hospital's ED. On 5/30/2011, a letter signed by the Patient Advocate was sent to the patient. The letter did not state what steps had been taken to investigate the patient's concerns, nor did the letter identify any actions taken as a result of the hospital's investigation as required by Federal regulation and hospital policy.

Patient #23
Review of the file revealed that a 6-page, typewritten grievance was received from the patient/representative regarding multiple aspects of the patient's nursing and medical care while in the hospital. The file indicated that the grievance had been received on 5/4/2011, but the date on the file had been changed, by an unknown person, to document that the grievance had been received on 5/18.

The grievance process "worksheet" revealed that the area of concern had been identified as "MD attitude", however a review of the letter of complaint revealed multiple issues around medical and nursing practice. The review did not document that the complainant's concerns about the hospitalist's refusal to obtain a cardiac consult on a patient with a cardiac history or administer specific medications.

The file also did not contain evidence that the issues regarding "zeroing beds" [to assure correct patient weights were obtains]; widely fluctuating patient weight or what appeared to be a lack of nursing assessment to identify potential cardiac complications (increased heart rate, increased work of breathing, fluid retention) had been addressed.

The file did contain an email from a RN who had reviewed the case and the nurse identified several issues, such as the need to be "...more open and transparent" in regard to physician communications] as well as issues with medication reconciliation.

When asked why the case had not been referred to the hospital's Peer Review group, supervisor of QA stated on 7/27/2011, that the Medical Director of the hospitalist group in the hospital had decided not to take the issues to the hospital's Peer Review group, but to instead address the issue of requesting consultations from other physicians, within the hospitalist group.

An acknowledgement letter was sent to the patient on 5/18, and another letter stating that the hospital's review of the issues was not yet complete was sent on 6/13/2011. A resolution letter was sent to the patient on 6/28, but did not state what steps had been taken to correct the identified issues.

The case was referred by the Department of Health to the State's Professional Review Organization for a peer review of the medical care provided to the patient.

Patient #24
Review of the grievance file revealed that an email had been received from the patient on 5/27/2011. The letter noted concerns over long wait times for call lights to be answered, lack of assistance with personal hygiene for 3 days, and the development of a potential hospital-acquired infection (HAI) 2 days after the patient's discharge.

No acknowledgement letter was present in the grievance file, but the final, resolution letter, dated 6/2/2011 was in the file and stated in part:

Regarding the long wait time for lights to be answered...
"...when patients ask for "self-cleaning items" and have the ability to move without medical assistance "staff will leave to provide the patient with privacy".

Regarding not being given items for self-hygiene...
"each nurse is to round on their patients every hour and ask if there is anything else they can do or provide before they leave the room. If at any time you wanted a wash cloth or your sheets changed your nurse would have complied with your request".

Regarding the development of sores on legs which appeared 2 days after the patient left the hospital...
The letter to the patient stated that the QA staff had requested medical records from the patient's primary care physician, and that doctor had noted that the lesions were a recurring concern. The letter also stated "...since the sores appeared after your discharge, one cannot be certain that they are a result of the care you received here..."

A response letter dated 6/16/2011 was received from the patient. The letter stated that the patient disagreed with the statements in the resolution letter, with specific rationale as to why, and requested a review by the Director of Quality Improvement.

No response to the patient's request for further investigation and referral of the grievance was found in the file, and the case was noted to be closed out.

The Supervisor of QA stated that staff in the QA department had made the request for the patient's medical records from the primary care physician, had read the medical records and made their own determination that the skin lesions were not HAIs. The Supervisor confirmed that neither the Patient Advocate and/or the Supervisor had clinical backgrounds.

The Supervisor also confirmed that the case had not been referred to the Infection Control program, nor had the case been referred on to the Quality Committee, as the patient had requested and in compliance with the hospital's own policy.

The Supervisor confirmed that the case was closed in error, and should have been sent to the Quality Assurance Committee, but had been "missed".

On 6/15/2011, the QA Supervisor was asked to describe her/his role in the complaint and grievance process. The Supervisor stated that s/he had written the grievance policy and the former Director of Quality Assurance/Risk Management (DQRM) had reviewed the policy. The Supervisor also stated that s/he helped supervisor, guide and train the Patient Advocate.

The QA Supervisor further stated that the Patient Advocate had previously reported to the DQRM, but another person with a RN Project Manager background had been hired into the department.

The Supervisor stated that the Patient Advocate was to bring every complaint and grievance to the Supervisor for review and that the Supervisor reviewed the initial [acknowledgement] letters. The Supervisor stated s/he was responsible to identify clinical issues, identify cases that should be referred to Peer Review and Risk Management and confirm that the correct referrals for review/investigation had occurred.

On 6/24/2011, the RN Project Manager (PM) was interviewed about her/his role in the grievance process. The PM stated that s/he had been hired into her/his role about 6 months prior, and had been hired because s/he was a RN. The PM stated that every grievance was discussed with either the QA Supervisor or the PM.

The PM stated that s/he was to deal with any grievances that contained clinical issues. S/he looked at the grievance, and the Patient Advocate then "talks to managers and patients", and did, on occasion, take the PM with her/him to interview patients. The PM stated that there were no written guidelines for the Patient Advocate that s/he was aware of.

When asked who made the final determination to close a case, the Supervisor stated that the Patient Advocate made the decision, but either the Supervisor or the RN Project Manager would review the final letter.

The Supervisor acknowledged that there were not written instructions to guide the Patient Advocate in that process.

A 6/16/2011 interview with the Patient Advocate revealed that the Patient Advocate did not have a clinical background and had been in her/his role at the hospital for approximately 6 months. The Patient Advocate stated that s/he did not have guidelines on how to process complaint and grievances other than the grievance policy.

Based on interview, document review and review of medical records it was determined that the hospital failed to ensure that all patients had the right to participate in the development of his or her plan of care. The hospital's failure to do so resulted in 1 non-English speaking patient not being provided an opportunity to participate in her/his care, and potentially deprived all patients who might have limited or absent capacity to read, write and/or understand English, of the same right.

Findings include:

Review of the hospital document "Patient Rights and Responsibilities" revealed that the hospital informed patients of the following:

"As the patient, or his or her legal representative, you have the right to:

-Receive safe care in a safe setting.
-Be informed of your current health status and prognosis, so you may make informed decisions regarding your healthcare and be involved in care planning and treatment.
-Be included in your pain management by being provided with education on pain and treatment options.
-Be involved in developing and implementing a plan to control your pain and have your pain regularly assessed..."

The document did not note that patients/their representatives have the right to be involved in all aspects of their care, not only pain management.

As a patient at Stevens Hospital it is expected you will:

-Provide information about your past illnesses, hospitalizations, medications and other health matters that may be pertinent to your care.
Request additional explanation if you do not understand what yo are being asked to sign.
Communicate your concerns to your doctors and the hospital staff, especially if you are concerned about pain and pain management.
-Inform your doctor and other care givers if you will have difficulty in following their prescribed treatment..."

The document did not describe how non-English speaking, blind, illiterate or other persons unable to read, understand or speak English would be able to exercise those rights.

Review of the hospital's Policy and Procedure "Interpreter Services" revealed the following directions:

"PURPOSE:
To ensure that patients who have limited proficiency in English and deaf and hearing impaired patients are able to communicate...regarding their medical conditions and treatment options.
SCOPE:
This policy applies to all areas within Stevens/Edmonds involved in direct patient care or related to patient care, such as financial services.
This policy pertains to patients who do not speak English; have limited English proficiency...
POLICY:
Swedish/Edmonds will take reasonable steps to ensure that persons with Limited English Proficiency (LEP) have meaningful access and an equal opportunity to participate..."

Review of the medical record of Patient #1 (complaint #32080), who was a primarily non-English speaking person, revealed that the "multidisciplinary care plan and education" document noted "none" as barriers to the plan, although "speech/language" was noted to be Italian. The medical record, including the "multidisciplinary" plan of care, was reviewed in the company of the Nurse Manager (NM) of the nursing unit where Patient #1 received care.

The NM confirmed the the plan of care did not note how the primarily non-English speaking patient would be able to communicate and/or participate in her/his plan of care, or would be able to communicate her/his needs or be adequately educated regarding her/his care issues, nor did any part of the record indicate that the services of an interpreter had been utilized, per hospital policy.

Reference also the deficiency written under Tag A0396, Nursing Care Plan

Based on interview, review of medical records and review of hospital documents, it was determined that the hospital failed to ensure that all patients received care in a safe setting. The hospital's failure to do so resulted in multiple patient safety issues as identified in the body of this report, and placed all patients of the hospital at risk for harm or potentially death.

Findings include:

Medical Staff Bylaws Incomplete
On 6/15/2011, the Chief Nurse Executive (CNE) was asked to provide documentation as to who had been designated by the Medical Staff as qualified to issue orders. "Bylaws of the Medical Staff of Swedish Edmonds and Rues and Regulations 2011" were reviewed. Although the Bylaws identified who was qualified to receive verbal orders, there was no evidence that the medical staff had qualified which staff were allowed to issue orders, written or verbal. The CNE and supervisor of Quality Assurance confirmed that the bylaws did not contain that information, and that there was not a separate policy or procedure regarding the issue.

On 6/24/2011, the Director of the Pharmacy was asked how the pharmacy staff knew which providers were authorized to issue orders, and therefore, which orders the pharmacy could legitimately accept. The Director stated that the pharmacy was provided with a list of which staff had privileges at the hospital and the pharmacy information technician then built the information into the pharmacy computer system.

The hospital's failure to determine which staff was qualified to issue orders placed all patients of the hospital at risk for receiving inappropriate or inaccurate medications, services or procedures.


Failure to Process and Investigate Two Potential Nosocomial Infections
Reference Citation written under Tag A 0120


Lack of a Scope of Services Statement for Radiologic Services
Reference Citation written under A0529


Medication Error Policy & Procedure Not Available to Hospital Staff
The complainant for Patient #1 (complaint #32080) stated on 6/6/2011 that the patient had not been given the proper medication at the hospital, specifically Mellaril, which in turn led to the patient's psychiatric decline and subsequent death.

The medical record for Patient #1 was reviewed in the company of the Nurse Manager (NM) of the care unit where the patient received care. The NM confirmed that the patient's physician had ordered Mellaril, an antipsychotic medication, but patient had not received the ordered Mellaril for 2 days. The NM also confirmed that the medical record documented that the failure to administer the medication had been identified by the patient's family and brought to the attention of the nursing staff by the patient's family, while the patient was still in the hospital.

On 6/24/2011, staff in the department of Quality Assurance (QA) was asked to provide the policy and procedure for medication errors. The QA supervisor and the QA project manager were unable to access the policy on the hospital's intranet.

On 6/24/2011, the Director of Pharmacy was asked if the policy and procedure regarding medication errors was online and available to hospital staff. The Director stated that the policy had not been available to hospital staff previously, and had only been available on the hospital intranet to the pharmacy staff. The Director also confirmed that the medication error for Patient #1 had not been sent to the pharmacy via a medication error report, and therefore, the reason for the medication error had not been investigated.

The hospital's failure to develop and implement a system of checks and balances regarding medication orders, as well as a medication error policy and procedure which was available to all staff, may have contributed to the unreported and uninvestigated medication errors related to Patient #1, and an unknown number of other patients.


Medication Orders Written in Cursive
Review of patient medical records revealed that 5 of 5 inpatient medical records and 1 of 3 surgery patient medical records (Patients #1, 2, 10, 13, 14, 15 and 16) contained medication orders which were written in cursive.

Five (5) inpatient medical records were reviewed in the company of the Nurse Manager for the nursing care area where the patients had received care. The NM acknowledged that all 5 records contained medication orders which were written in cursive.

On 7/22/2011, 3 medical records of patients currently in the Operating Room were reviewed. One (1) of 3 (Patient #10) medical records was found to contain medication orders in cursive; that order was reviewed with the NM of the operating room, who acknowledged that the physician's order for medications had been written in cursive.

Review of the hospital's Policy and Procedure "Prescribing and Ordering - General Practices" revealed the following directions:
"...All medication orders must be hand printed, typewritten or electronically generated. State law considers cursive writing to be illegible and not a legal prescription..."

The hospital policy also referenced the Washington State Board of Pharmacy requirement...


RCW 69.41.010 Definitions.As used in this chapter, the following terms have the meanings indicated unless the context clearly requires otherwise:(13) "Legible prescription" means a prescription or medication order issued by a practitioner that is capable of being read and understood by the pharmacist filling the prescription or the nurse or other practitioner implementing the medication order. A prescription must be hand printed, typewritten, or electronically generated.

On 6/24/2011, the Director of the Pharmacy was asked how the pharmacy managed the Board of Pharmacy requirement that all medication orders be hand-printed, typewritten or electronically generated. The Director stated that the pharmacy did not specifically screen for medication orders in cursive. The Director also stated that s/he accepted orders in a "mixed style" if s/he could read the orders, because to not do so "would bring medical management and care to a grinding halt in this hospital."

On 6/16/2011, the Chief Medical Officer stated that there had been discussion with the Medical Staff regarding the use of cursive to write medication orders, but the hospital "may have to take harsher steps" to resolve the ongoing issue.

The hospital's failure to develop and implement a process to ensure that medication orders were not written in cursive, and that such orders were not accepted by the pharmacy, placed all patients of the hospital at risk for receiving incorrect medications.
"Resume" Orders for Medications
Review of the medical records for 5 former inpatients (all had been surgical patients) revealed that 2 patients (#14 & #15) had post-operative orders for "resume" medications. The medical records were reviewed in the company of the Nurse Manager for the nursing care area where the patients had received care. The NM acknowledged that the medication orders under review were written to "resume" prior medications.

Review of the hospital's policy and procedure "Prescribing & Ordering - General Practices", revealed the following direction:

"..Renewal: The use of the terms "renew", "repeat", "resume" and "continue" in reference to previous orders are not acceptable and represent an incomplete order".

Review of the hospital's policy "Physician Practitioner Orders" revealed the following direction:

"PROCEDURE:
5. Cancellation of orders:
All existing orders for patients shall be canceled [sic] when the patient is transferred to a higher level of nursing care of the operating room. Orders must be rewritten upon their return to the nursing floor".

Also reviewed was an email from the Director of Pharmacy to a person at the surgeons practice group, dated June 14, 2011. The email stated:

"...Medication orders have required elements; those that do not contain those elements "may" be considered incomplete.

Another section of the policy specifies that we do not allow use of the terms "renew", "resume", or "continue" - but it should be noted that this was intended to prevent the use of blanket statements or orders. By this I mean orders such as 'continue pre-op medications" or "resume home medications.

Physicians are required to "rewrite" all medications when patients are transferred to a higher level of care or to the OR...

This query has demonstrated that there is currently a gap between policy and practice for post-operative orders. I intend to recommend that this policy be modified to reflect our current practice as stated above; I believe that it adequately ensure post-operative review and restart of medications..."

The Director of Pharmacy stated on 6/24/2011 that the issue of "resume" orders would be brought to the "P&T" [pharmacy and therapeutics] committee the upcoming Monday [6/27/2011].

The hospital's failure to follow it's own policies regarding the use of "renew", "resume" or "continue" orders placed all patients transferred within the hospital at risk for receiving incorrect medications.


Failure to Implement A Consistent Process for Medication Reconciliation
Review of the medical record for Patient #1 (complaint #32080) revealed that on 6/24/2011, the patient's family alerted nursing staff that the patient had not received her/his Mellarill [an antipsychotic medication].The nurse subsequently placed a call to the patient's physician and an order was received for Mellaril on 2/24/2011 at 7:12 pm. The medical record, reviewed in the company of the Nurse Manager (NM) for the nursing unit where the patient received care, revealed that the patient received the first dose of the medication at 9 pm the same day.

Further review of the medical record revealed that the "medication reconciliation" form, completed on 2/17/2001 by a "pre-op" nurse, did note that the patient took "Mellaril 50 mg. bid [twice daily]". The form contained a column in which the ordering practitioner could choose to continue the medication as before, change the medication order or discontinue the medication. None of the columns had been checked off for any of the medications, and the form had not been signed.

The NM stated that the patient's physician was supposed to check off one of the choices in the columns and sign the form, and then the list would be treated as a physician order and faxed to the pharmacy. That had not happened for Patient #1; however, a dictated clinic summary note from the surgeon had been faxed to the hospital and stamped "scanned". The clinic summary note contained a list of medications the patient had taken and "routine meds to be resumed post-operatively", but Mellaril was not on either list. The note had a signature beside "RN signature", but it was not clear if the RN represented the hospital or the clinic. The note was dated 2/22/2011 at 0955 [9:55 am].

The NM also stated that the surgeon for Patient #1 was the only physician s/he knew of who routinely faxed clinic summary notes to be utilized as medication reconciliation information.

On 6/24/2011, the Director of the Pharmacy stated that the pharmacy had not received the "medication reconciliation" list for Patient #1.

On 6/16/2011, the Chief Medical Officer stated that the Medical Staff "may not be clear" regarding all requirements pertaining to medication reconciliation.

Review of the hospital's policy and procedure "Medication Reconciliation" revealed the following:

Throughout the body of the policy and procedure, there were multiple uses of the words "should" and "may" including the following:

"PROCEDURE
Admission
1. The MRF should be initiated by the first nurse to encounter the patient during provision of care. This may be...during preadmission....
d. All written lists should be scanned to pharmacy...
3. An effort should be made to verify...that the list is as accurate as possible.
4. Besides being a medication list, the form may also be used as an order form....
The prescriber may initial this if desired, but it is not required...
7. The completed MRF/order should be scanned to Pharmacy...

On 6/24/2011, the Director of the Pharmacy acknowledged that the use of "should" and "may" could be confusing, and could potentially lead physicians and staff to believe that directions regarding processes relative to medication reconciliation were optional.


Incomplete Assessment and Investigation of Patient Falls
Review of medical records revealed an incomplete assessment and investigation of 9 of 11 documented patient falls. All medical records were reviewed in the company of the QA Supervisor and the QA Project Manager for evidence of a nursing assessment post-fall, notification of family and/or physician and vitals signs per the hospital's Fall Prevention Program and Fall Management" policy and procedure.

Patient #1
Interview with the complainant revealed that when the patient fell, there had been 2 nurses in the same room, but they had been helping the other patient in the room. The complainant stated that the patient was very sedated because of her/his pain. The complainant also stated that the patient had reported calling out for help because s/he could not tolerate sitting on the commode any longer, but help was not available.

The complainant stated that when the patient fell, s/he struck her/his head and shoulder during the fall and sustained a "goose egg" above the left ear. The complainant stated that the physician, who was in the room shortly after the fall, did not examine the patient and, in fact, did not even cross the room to evaluate the patient. The physician reportedly asked the patient if s/he wanted an X-ray, but the patient declined. The complainant stated that the patient "...just wanted to leave because [s/he] was afraid", not because s/he was not injured.

Review of the medical record revealed that the patient had had vital signs checked once after the fall, which was not in compliance with the hospital's fall prevention policy and procedure.

Review of the physician's discharge summary revealed the following documentation: "...did have a fall while sitting on the commode slumped to the ground and bonked [her/his] head on the plastic side rails...no loss of consciousness, no change in mental status, and has had no other injury. I discussed this with the family. We decided not to work this up further since there was no evidence of injury".

Review of the incident report and medical record did not indicate that the reason for the fall had been investigated, including why a sedated patient was left alone on a commode; nor had the lack of vital signs per policy, post-fall, been identified as an issue; nor had the physician's lack of documented assessment post-fall been identified as a potential care issue.

Patient #26:
The incident report documented that the patient became dizzy, grabbed a nearby wheeled cart and slipped and fell.
The medical record contained evidence that the patient's blood sugar had not been re-checked until 4 hours after the initial blood sugar of 66 was identified, and that the patient had had vital signed checked only once after the fall.

Review of the incident did not address the the potential environmental hazard of a wheeled cart left in a patient care area, nor did the review identify the low blood sugar as a potentially contributing factor to the fall, nor was the lack of follow-up on the low blood sugar identified as an issue.

Patient #28
The incident report documented that the patient had been standing at the bedside attempting to urinate, and had fallen when s/he attempted to pull the privacy curtain. Review of the patient's medical records revealed that the patient did not have post-fall vital signs taken per policy.
No further actions were documented, except that the therapy supervisor "educated staff" about the need to activate the bed alarm.

Review of the incident did not identify the open privacy curtain as a contributing factor to the fall, but did note that the patient's bed alarm "...alarm was not reactivated-this is a common problem."


Patient #29
The incident report documented that the patient had been found down.
Review of the patient's medical record revealed that the patient's vital signs had been checked only once, not every 4 hours for 4 times, per the hospital's policy for unwitnessed falls.

The review of the incident did not identify the lack of vital signs, nor did the review identify the apparent lack of nursing assessment to identify the lack of anti-skid socks on the patient, prior to the patient's fall. The lack of the anti-skid socks was identified after the patient had already fallen, and then the anti-skid socks were placed on the patient.

Patient #30
The incident report documented that the patient had fallen while being assisted to the commode by 2 nursing assistants. Review of the medical record revealed that the patient did not receive a nursing assessment post-fall, nor were the patient's vital signs checked, both required per hospital policy.

The review of the incident did not identify either omission, nor did the review identify that the patient, who had a diagnosis of Guillan-Barre [a disease in which the patient's immune system attacks the patient's nervous system and muscles, which can cause unsteadiness, weakness and paralysis] as possibly needing specialized assistance with ambulation and/or transfers.

Patient #31
The incident report documented that the patient had fallen during a transfer, assisted by 2 RNs. Review of the medical record revealed that the patient had had vital signs taken only once, which was not in compliance with the hospital's fall policy.

Review of the incident did not identify lack of vital signs per policy as an issue. The review also did not identify that the patient, who was heavy and could bear weight on only one side, may not have been adequately assessed for safe ambulating and transfers.

Patient #32
The incident report documented that the patient had fallen off of a treatment table/bed in the Emergency Department. Review of the patient's medical record revealed that the patient had not had her/his vital signs taken after the fall.

Review of the incident did not identify the lack of vitals signs as an issue, nor did the review contain an evaluation of why the patient fell off of the table in the first place, particularly since, at the time of the fall, the patient had been attended by a sitter.

On 7/27/2011, the CNE stated that the hospital had not developed a policy and procedure regarding the utilization of safety straps on operating room beds, procedure tables or gurneys, although the "cath lab [cardiac catheterization laboratory] was "auditing use of safety belts".


Patient #33
Review of the incident report revealed that the patient fell on her/his head and sustained a hematoma [bruise]. The incident report stated that the patient had not had a chair alarm in use. Medical record review revealed that the patient did not receive vital sign checks per the hospital policy.

Review of the incident did not identify the lack of vital signs as an issue, although the patient had sustained a head injury, nor did the review identify why the patient had not had a chair alarm in use.

Patient #34
Review of the incident report revealed that the patient had been at the bedside with a walker when her/his legs "gave out", and the patient fell to the floor on one knee. Review of the patient's medical record revealed that the patient, who had been admitted for back surgery, had no documented assessment by a RN after the fall, nor was there any documentation that the patient's vital signs were taken.


In June, 2010, in response to a substantiated allegation that a sedated patient had fallen off of a procedure table, the hospital was cited as follows:
"The VPPCS [Vice President Patient Care Services] and the DRMQI [Director of Risk Management/Quality Improvement] acknowledged that there had not been a complete evaluation of the "why and how" of any of the incidents under review, and that there was not a process in place to ensure that each incident was evaluated and analyzed, with the appropriate subsequent policies and procedures and staff trainings...

The hospital's plan of correction stated: "...managers of all areas of the hospital have a means of rapidly receiving notification of incidents so that they may investigate, evaluate and analyze them..."

The hospital's progress report stated:
...Safety straps have been installed on procedure tables, and staff have been trained in their use...

Ongoing random spot checks (audits) of "completed" incident reports to ensure that events are adequately reviewed and analyzed for the "How and Why" components before being closed out in the system."

The progress report of stated that the Director of Quality/Risk Management would be responsible for the actions; however, the CNE stated during the current investigation that the Director of Quality/Risk Management was no longer with the hospital and the position had not been replaced. The CNE stated that the incident reports were currently evaluated by the Quality Assurance RN Project Manager. Interview with the RN Project Manager confirmed that s/he currently reviewed incident reports.

The hospital's failure to fully implement the plan of correction and progress report for deficiencies identified in 2010 may have contributed to continued patient falls, in part because falls subsequent to the 2010 investigation had not been thoroughly evaluated and analyzed for contributing causes.


Non-English Speaking Patient Not Provided with Translator Services
Review of the hospital document "Patient Rights and Responsibilities" revealed that the hospital informed patients of the following:

"As the patient, or his or her legal representative, you have the right to:

-Receive safe care in a safe setting.
-Be informed of your current health status and prognosis, so you may make informed decisions regarding your healthcare and be involved in care planning and treatment.
-Be included in your pain management by being provided with education on pain and treatment options.
-Be involved in developing and implementing a plan to control your pain and have your pain regularly assessed..."

The document did not note that patients/their representatives have the right to be involved in all aspects of their care, not only pain management.

As a patient at Stevens Hospital it is expected you will:

-Provide information about your past illnesses, hospitalizations, medications and other health matters that may be pertinent to your care.
Request additional explanation if you do not understand what yo are being asked to sign.
Communicate your concerns to your doctors and the hospital staff, especially if you are concerned about pain and pain management.
-Inform your doctor and other care givers if you will have difficulty in following their prescribed treatment..."

The document did not describe how non-English speaking, blind, illiterate or other persons unable to read, understand or speak English would be able to exercise those rights.

Review of the hospital's Policy and Procedure "Interpreter Services" revealed the following directions:

"PURPOSE:
To ensure that patients who have limited proficiency in English and deaf and hearing impaired patients are able to communicate...regarding their medical conditions and treatment options.
SCOPE:
This policy applies to all areas within Stevens/Edmonds involved in direct patient care or related to patient care, such as financial services.
This policy pertains to patients who do not speak English; have limited English proficiency...
POLICY:
Swedish/Edmonds will take reasonable steps to ensure that persons with Limited English Proficiency (LEP) have meaningful access and an equal opportunity to participate..."

Review of the medical record of Patient #1 (complaint #32080), who was a primarily non-English speaking person, revealed that the "multidisciplinary care plan and education" document noted "none" as barriers to the plan, although "speech/language" was noted to be Italian. The medical record, including the "multidisciplinary" plan of care, was reviewed in the company of the Nurse Manager (NM) of the nursing unit where Patient #1 received care.

The NM confirmed the the plan of care did not note how the primarily non-English speaking patient would be able to communicate and/or participate in her/his plan of care, or would be able to communicate her/his needs or be adequately educated regarding her/his care issues, nor did any part of the record indicate that the services of an interpreter had been utilized, per hospital policy and statement of patient rights.

Further review of the medical record revealed that on 2/25/2011, a Case Manager met with the patient and daughter and "...both agreeable to d/c [discharge] to [skilled nursing facility]". The note from the Case Manager did not note how the patient was able to participate in that decision.

Review of the "admission profile and current history" information was obtained from the patient's son. The "anesthesia and medical" documented that "pt. consented via Italian speaking son".

No documented evidence was found that the patient had been provided a translator to assure that her/his nursing admission assessment was accurate and complete, or that the patient had been able to participate in her/his own care planning, or was able to receive education about her/his health status and prognosis or any other aspect of her/his care. No documented evidence found that the patient, who underwent orthopedic surgery and then was discharged to a place other than home, where s/he had been living with a son, was involved in her/his postdischarge care planning.

Lack of Plan of Care for Nursing
Reference citation written under Tag A-0396

Lack of Defined Process for Referral and Investigation of Clinical Issues in Grievances
Reference citation written under Tag A0120


Failure to Process Patient/Complainant Concern about Medical Care
Reference deficiency written under Tag A0120


Failure to Present Patient/Complainant Concern About Medical Care to Peer Review
Reference deficiency written under Tag A0120

Based on interview, review of medical records and review of hospital documents, it was determined that the hospital failed to set priorities for its performance improvement activities that focused on high-risk, high-volume, or problem-prone areas and to consider the incidence, prevalence, and severity of problems in those areas. The hospital's failure to do so resulted in a lack of Quality Assurance/Process Improvement plans in the Pharmacy and the Infection Control program to assure same.


Lack of Quality Assurance/Process Improvement Plan for Pharmacy

The medical record for Patient #1 was reviewed in the company of the Nurse Manager (NM) of the care unit where the patient received care. The NM confirmed that the patient's physician had ordered Mellaril, but the patient had not received the ordered Mellaril for 2 days. The NM also confirmed that the medical record documented that the failure to administer the medication had been identified by the patient's family and brought to the attention of the nursing staff by the patient's family, while the patient was still in the hospital.

On 6/24/2011, staff in the department of Quality Assurance (QA) was asked to provide the policy and procedure for medication errors. The QA supervisor and the QA project manager were unable to access the policy on the hospital's intranet.

On 6/24/2011, the Director of Pharmacy was asked if the policy and procedure regarding medication errors was online and available to hospital staff. The Director stated that the policy had not been available to hospital staff previously, and was only available on the hospital intranet to the pharmacy staff. The Director also confirmed that the medication error for Patient #1 had not been brought to the attention of the pharmacy via a medication error report, and therefore, the reason for the medication error had not been investigated.

On 6/24/2011, the Director of Pharmacy stated that the pharmacy did not have a specific "QA" [quality assurance] plan. S/he stated that the pharmacy did not routinely monitor, track and trend such issues as medication orders written in cursive or orders to "resume" previous medications.

The Director provided a report on "Where Medications are Being Documented", that had been completed 2/8/2011. The report contained the scope of the project and 2 graphs as to where medications were documented. No narrative was found to explain the rationale for the project, the process utilized, the results of the process or who owned the process.

The Director provided the hospital's "Pharmacy Department Dashboard" which was a compilation of statistics.

The Director also provided 2 additional documents, both unsigned and undated. One document was entitled "Data-Driven Medication Safety Changes" and the second was "Pharmacy & Medication Safety at Swedish Edmonds". The second document listed 3 "ongoing measures", but did not note why those measures had been chosen, who was responsible for the process, who would be involved in the process, how the process was to be accomplished, or what the goals and objectives were.

No narrative was found as to what quality concerns were identified for the Pharmacy Department, which indicators would be tracked, what the goals and objectives would be, or other rationale or documentation.

The "Swedish Edmonds Year 2011 Performance Improvement - Patient Safety Plan" was also reviewed. The Plan gave an oversight of purpose, scope, authority, organization and responsibility. The Plan was not found to contain a specific reference to the Pharmacy Department, but did state in part:

"IV. Performance Improvement Improvement Objectives
The objectives of the Performance Improvement Program are to:
-Ensure a safe environment for patient, staff and visitors
-Reduce safety risks and hazards within the organization
-Improve patient care processes...

These objectives are accomplished through the use of:
...
Risk/patient safety review of trends through incident reports, grievances, medication misadventure reports..."

Review of the policy and procedure "Stevens Hospital Pharmacy - Medication Management", dated 6/24/2011 revealed the following directions:

"POLICY:
The organization has a process to respond to actual or potential medication errors. All actual or potential errors identified will be documented through the hospital's risk management system...

All medication error reports will be reviewed by Pharmacy director and categorized according to severity, type, cause and drug class involved..."

The lack of a defined Quality Improvement/Process Improvement Plan for the Pharmacy Department may have contributed to the hospital's failure to identify issues with medication orders, medication reconciliation issues, post-operative orders or other issues related to the Pharmacy Department.


Lack of a Quality Assurance/Process Improvement Plan for Infection Control Program

On 7/27/2011, the Manager of the Infection Control program stated that there was not a quality assurance/process improvement plan for the department. However, the Manager provided the "Swedish/Edmonds Infection Prevention Program Plan 2011" which contained the following sections:

-Purpose
-Scope
"...Determine the type and scope of surveillance and investigation activities including the criteria for defining healthcare-associated infections..."

-Risk Assessment Summary
-Prioritized Risks
"8. Exposure of patients and staff to...other communicable diseases..."

-Data Collection and Analysis
-Thresholds/Benchmarks
-Action
-Evaluation and Improvement
-Reporting Structure and Responsibilities

The "Swedish Edmonds Year 2011 Performance Improvement - Patient Safety Plan" was also reviewed. The Plan gave a oversight of purpose, scope, authority, organization and responsibility.

The Plan stated:

IV. Performance Improvement Objectives
The objectives of the Performance Improvement Program are to:
-Ensuring a safe environment for patient, staff and visitors
-Reduce safety risks and hazards within the organization
-Improve patient care processes...

These objectives are accomplished through the use of:
...infection control surveillance and monitoring of Hospital Acquired Infections (HAI)...."

The Infection Control Manager provided a list of potential sources of information regarding HAIs. Included in the list were physicians' offices and the hospital's Quality Assurance/Process Improvement department.
The Manager stated that the hospitals asked physicians to self-report by calling or writing to the hospital, but there were no guidelines or directions for the physicians regarding how, why or when to do so.

The Manager also stated that another challenge in identifying potential nosocomial infections was that all laboratory results did not go through the hospital's laboratory because the hospital utilized multiple laboratories; therefore, there was no way to assure that all abnormal laboratory results were reviewed.

The Manager also confirmed that allegations made regarding 2 patients (Patient #2 and #24) about potential HAIs had not been received by the Infection Control program, and the lack of intra-departmental communication on the allegations had not been identified until the investigator was onsite.

Conversation with the Quality Assurance/Process Improvement staff (Quality Assurance Supervisor and Patient Advisor) revealed that the QA/PI staff had made independent determinations about the potential HAIs and replied directly to the patients regarding their determinations.

The Infection Control Program Manager confirmed that there were no written processes to provide checks and balances and/or to assure that the Infection Control program received the appropriate information from any of the identified potential sources of that information. The Manager also stated that there were no written guidelines or documentation regarding the process for how of when physicians were to report back to the hospital when patient infections were identified post-discharge from the hospital.

The lack of a defined Quality Improvement/Process Improvement Plan for the Infection Control program may have contributed to the hospital's failure to identify issues related to HAIs.

Based on interview and review of medical records it was determined that the hospital failed to ensure that the nursing staff developed, and kept current, a nursing care plan for each patient. The hospital's failure to do so resulted in 7 of 7 patients whose medical records were reviewed, not having a nursing care plan and subsequently not having nursing care needs identified and 1 non-English speaking patient not having a nursing care plan that identified her/his needs relative to the language barrier.

Findings include:

On 6/15/2011, the Chief Nursing Executive (CNE) was asked to provide the hospital's policy and procedure for nursing care plans. The CNE stated that the hospital did not have a policy specifically for nursing care plans, but utilized a "multi-disciplinary" plan.

Review of 7 "multi-disciplinary" care plans revealed that none of the care plans specifically called out nursing care needs such as assessments for pain, nutrition/hydration needs, functional status, teaching deficits, psychosocial needs, or other needs that would appropriately be assessed by nursing staff.

Review of the medical record of Patient #1 (complaint #32080), who was a primarily non-English speaking person, revealed that the "multidisciplinary care plan and education" document noted "none" as barriers to the plan, although "speech/language" was noted to be Italian. The medical record, including the "multidisciplinary" plan of care, was reviewed in the company of the Nurse Manager (NM) of the nursing unit where Patient #1 received care.

The NM confirmed the the plan of care did not note how the primarily non-English speaking patient would be able to communicate and/or participate in her/his plan of care for nursing issues, or would be able to communicate her/his needs or be adequately educated regarding her/his nursing care issues.

Review of the hospital document "Patient Rights and Responsibilities" revealed that the hospital informed patients of the following:

"As the patient, or his or her legal representative, you have the right to:

-Be informed of your current health status and prognosis, so you may make informed decisions regarding your healthcare and be involved in care planning and treatment.
-Be included in your pain management by being provided with education on pain and treatment options.
-Be involved in developing and implementing a plan to control your pain and have your pain regularly assessed..."


As a patient at Stevens Hospital it is expected you will:
-Communicate your concerns to your doctors and the hospital staff, especially if you are concerned about pain and pain management.
-Inform your doctor and other care givers if you will have difficulty in following their prescribed treatment..."


Reference also the deficiency written under Tag A0130

Based on interview and review of hospital documents, it was determined that the hospital failed to identify professionally approved standards for safety and personnel qualifications. The hospital's failure to develop a Scope of Services for the department, and to assure that the Medical Staff had identified which staff was qualified to use the radiologic equipment and administer procedures, placed all patients who received radiologic services at the hospital at risk for not receiving services appropriate to their age and condition and/or for receiving services from persons who had not been determined qualified to provide such services.

Findings include:

On 7/21/2011 the Chief Nurse Executive (CNE) was asked to provide the Scope of Services for the Radiology Department and also to provide documentation that the Medical Staff had designated who was qualified to use the radiologic equipment and administer procedures. The CNE stated that a Scope of Services for the department did not exist and was being developed.

A newly developed Scope of Services was subsequently provided and noted to not identify the patient population to be served. The CNE acknowledged the lack of identified patient population, and also that the Medical Staff had not yet approved and signed the Scope of Services.

On 7/27/2011, the CNE stated that the Scope of Services was being revised to "more closely align with downtown", which would include identifying the patient population to be served.

The CNE was also asked to provide the position description for the physician who was responsible for operations in the Radiologic department. S/he provided an undated and unsigned document "Medical Director Duties" which stated in part:
"The Medical Director shall be responsible for...
b.Direct and oversee the Department's compliance with generally accepted medical standards, the Standards of JCAHO and the American College of Radiology, licensure standards of the state....
e. Coordinate, supervise and evaluate all Professional Radiology Services provided in the Department...
i. Oversee, monitor and evaluate the quality and appropriateness of radiology services through a quality assurance program. This shall include a systematic review of quality, safety, efficiency and appropriateness of radiology services rendered at District through District's quality assurance programs.

As of the last on-site day of the 7/27/2011, a complete Scope of Services, identifying the scope of services and identifying which staff was determined qualified to use equipment and perform procedures, signed by the Medical Staff, was not available.

Based on interview, review of grievance files and review of documents, it was determined that the hospital failed to establish and implement a process for the effective operation of the grievance process, and to review and resolve grievances, including a mechanism for timely referral of patient concerns regarding quality of care. The hospital's failure to do so resulted in 4 of 9 patients/complainants not receiving complete and timely resolution of grievances with appropriate clinical referrals and investigation, and potentially placed all patient/complainants who filed grievances at risk for same.

Findings include:

A total of 9 grievance files were reviewed. The files were reviewed for compliance to Federal regulatory requirements, compliance with the hospital's own policy and procedure for processing grievances and for the appropriate referral for further investigation of complaint issues.

Patient #18
The patient's grievance, received on 2/10/2011, had to do with an extended wait for pain relief while in the hospital's Emergency Department (ED).

Review of the patient's ED medical record revealed that the physician documented her/his assessment at 14:45 and the RN documented her/his assessment at 15:35. The record documented that the patient received the initial dose of pain and anti-nausea medication at 17:49, 3 hours after being originally seen by the physician. The patient returned several hours after discharge and was again medicated for nausea/vomiting and anxiety.

The grievance file contained no documentation that the grievance had been reviewed by a person with a clinical background, who was qualified to evaluate the care provided to the patient in the ED. Review of the hospital's policy and procedure for processing grievances revealed the following:
"IV. GRIEVANCE RESERARCH/DETERMINATION OF ACTION/FOLLOWUP:
1. In cooperation with a Clinical or Department Manager or Director, the Patient Advocate is primarily responsible for facilitating and monitoring follow-up on patient grievances..."

The final letter to the complainant, signed by the Patient Advocate, was dated 2/24/2011.

Patient #22
Review of the file revealed that a grievance was received from the patient/representative on 5/6/2011 regarding her/his treatment in the hospital's ED. On 5/30/2011, a letter signed by the Patient Advocate was sent to the patient. The letter did not state what steps had been taken to investigate the patient's concerns, nor did the letter identify any actions taken as a result of the hospital's investigation as required by Federal regulation and hospital policy.

Patient #23
Review of the file revealed that a 6-page, typewritten grievance was received from the patient/representative regarding multiple aspects of the patient's nursing and medical care while in the hospital. The file indicated that the grievance had been received on 5/4/2011, but the date on the file had been changed, by an unknown person, to document that the grievance had been received on 5/18.

The grievance process "worksheet" revealed that the area of concern had been identified as "MD attitude", however a review of the letter of complaint revealed multiple issues around medical and nursing practice. The review did not document that the complainant's concerns about the hospitalist's refusal to obtain a cardiac consult on a patient with a cardiac history or administer specific medications.

The file also did not contain evidence that the issues regarding "zeroing beds" [to assure correct patient weights were obtains]; widely fluctuating patient weight or what appeared to be a lack of nursing assessment to identify potential cardiac complications (increased heart rate, increased work of breathing, fluid retention) had been addressed.

The file did contain an email from a RN who had reviewed the case and the nurse identified several issues, such as the need to be "...more open and transparent" in regard to physician communications] as well as issues with medication reconciliation.

When asked why the case had not been referred to the hospital's Peer Review group, supervisor of QA stated on 7/27/2011, that the Medical Director of the hospitalist group in the hospital had decided not to take the issues to the hospital's Peer Review group, but to instead address the issue of requesting consultations from other physicians, within the hospitalist group.

An acknowledgement letter was sent to the patient on 5/18, and another letter stating that the hospital's review of the issues was not yet complete was sent on 6/13/2011. A resolution letter was sent to the patient on 6/28, but did not state what steps had been taken to correct the identified issues.

The case was referred by the Department of Health to the State's Professional Review Organization for a peer review of the medical care provided to the patient.

Patient #24
Review of the grievance file revealed that an email had been received from the patient on 5/27/2011. The letter noted concerns over long wait times for call lights to be answered, lack of assistance with personal hygiene for 3 days, and the development of a potential hospital-acquired infection (HAI) 2 days after the patient's discharge.

No acknowledgement letter was present in the grievance file, but the final, resolution letter, dated 6/2/2011 was in the file and stated in part:

Regarding the long wait time for lights to be answered...
"...when patients ask for "self-cleaning items" and have the ability to move without medical assistance "staff will leave to provide the patient with privacy".

Regarding not being given items for self-hygiene...
"each nurse is to round on their patients every hour and ask if there is anything else they can do or provide before they leave the room. If at any time you wanted a wash cloth or your sheets changed your nurse would have complied with your request".

Regarding the development of sores on legs which appeared 2 days after the patient left the hospital...
The letter to the patient stated that the QA staff had requested medical records from the patient's primary care physician, and that doctor had noted that the lesions were a recurring concern. The letter also stated "...since the sores appeared after your discharge, one cannot be certain that they are a result of the care you received here..."

A response letter dated 6/16/2011 was received from the patient. The letter stated that the patient disagreed with the statements in the resolution letter, with specific rationale as to why, and requested a review by the Director of Quality Improvement.

No response to the patient's request for further investigation and referral of the grievance was found in the file, and the case was noted to be closed out.

The Supervisor of QA stated that staff in the QA department had made the request for the patient's medical records from the primary care physician, had read the medical records and made their own determination that the skin lesions were not HAIs. The Supervisor confirmed that neither the Patient Advocate and/or the Supervisor had clinical backgrounds.

The Supervisor also confirmed that the case had not been referred to the Infection Control program, nor had the case been referred on to the Quality Committee, as the patient had requested and in compliance with the hospital's own policy.

The Supervisor confirmed that the case was closed in error, and should have been sent to the Quality Assurance Committee, but had been "missed".

On 6/15/2011, the QA Supervisor was asked to describe her/his role in the complaint and grievance process. The Supervisor stated that s/he had written the grievance policy and the former Director of Quality Assurance/Risk Management (DQRM) had reviewed the policy. The Supervisor also stated that s/he helped supervisor, guide and train the Patient Advocate.

The QA Supervisor further stated that the Patient Advocate had previously reported to the DQRM, but another person with a RN Project Manager background had been hired into the department.

The Supervisor stated that the Patient Advocate was to bring every complaint and grievance to the Supervisor for review and that the Supervisor reviewe

Based on interview, review of medical records and review of hospital documents, it was determined that the hospital failed to ensure that all patients received care in a safe setting. The hospital's failure to do so resulted in multiple patient safety issues as identified in the body of this report, and placed all patients of the hospital at risk for harm or potentially death.

Findings include:

Medical Staff Bylaws Incomplete
On 6/15/2011, the Chief Nurse Executive (CNE) was asked to provide documentation as to who had been designated by the Medical Staff as qualified to issue orders. "Bylaws of the Medical Staff of Swedish Edmonds and Rues and Regulations 2011" were reviewed. Although the Bylaws identified who was qualified to receive verbal orders, there was no evidence that the medical staff had qualified which staff were allowed to issue orders, written or verbal. The CNE and supervisor of Quality Assurance confirmed that the bylaws did not contain that information, and that there was not a separate policy or procedure regarding the issue.

On 6/24/2011, the Director of the Pharmacy was asked how the pharmacy staff knew which providers were authorized to issue orders, and therefore, which orders the pharmacy could legitimately accept. The Director stated that the pharmacy was provided with a list of which staff had privileges at the hospital and the pharmacy information technician then built the information into the pharmacy computer system.

The hospital's failure to determine which staff was qualified to issue orders placed all patients of the hospital at risk for receiving inappropriate or inaccurate medications, services or procedures.


Failure to Process and Investigate Two Potential Nosocomial Infections
Reference Citation written under Tag A 0120


Lack of a Scope of Services Statement for Radiologic Services
Reference Citation written under A0529


Medication Error Policy & Procedure Not Available to Hospital Staff
The complainant for Patient #1 (complaint #32080) stated on 6/6/2011 that the patient had not been given the proper medication at the hospital, specifically Mellaril, which in turn led to the patient's psychiatric decline and subsequent death.

The medical record for Patient #1 was reviewed in the company of the Nurse Manager (NM) of the care unit where the patient received care. The NM confirmed that the patient's physician had ordered Mellaril, an antipsychotic medication, but patient had not received the ordered Mellaril for 2 days. The NM also confirmed that the medical record documented that the failure to administer the medication had been identified by the patient's family and brought to the attention of the nursing staff by the patient's family, while the patient was still in the hospital.

On 6/24/2011, staff in the department of Quality Assurance (QA) was asked to provide the policy and procedure for medication errors. The QA supervisor and the QA project manager were unable to access the policy on the hospital's intranet.

On 6/24/2011, the Director of Pharmacy was asked if the policy and procedure regarding medication errors was online and available to hospital staff. The Director stated that the policy had not been available to hospital staff previously, and had only been available on the hospital intranet to the pharmacy staff. The Director also confirmed that the medication error for Patient #1 had not been sent to the pharmacy via a medication error report, and therefore, the reason for the medication error had not been investigated.

The hospital's failure to develop and implement a system of checks and balances regarding medication orders, as well as a medication error policy and procedure which was available to all staff, may have contributed to the unreported and uninvestigated medication errors related to Patient #1, and an unknown number of other patients.


Medication Orders Written in Cursive
Review of patient medical records revealed that 5 of 5 inpatient medical records and 1 of 3 surgery patient medical records (Patients #1, 2, 10, 13, 14, 15 and 16) contained medication orders which were written in cursive.

Five (5) inpatient medical records were reviewed in the company of the Nurse Manager for the nursing care area where the patients had received care. The NM acknowledged that all 5 records contained medication orders which were written in cursive.

On 7/22/2011, 3 medical records of patients currently in the Operating Room were reviewed. One (1) of 3 (Patient #10) medical records was found to contain medication orders in cursive; that order was reviewed with the NM of the operating room, who acknowledged that the physician's order for medications had been written in cursive.

Review of the hospital's Policy and Procedure "Prescribing and Ordering - General Practices" revealed the following directions:
"...All medication orders must be hand printed, typewritten or electronically generated. State law considers cursive writing to be illegible and not a legal prescription..."

The hospital policy also referenced the Washington State Board of Pharmacy requirement...


RCW 69.41.010 Definitions.As used in this chapter, the following terms have the meanings indicated unless the context clearly requires otherwise:(13) "Legible prescription" means a prescription or medication order issued by a practitioner that is capable of being read and understood by the pharmacist filling the prescription or the nurse or other practitioner implementing the medication order. A prescription must be hand printed, typewritten, or electronically generated.

On 6/24/2011, the Director of the Pharmacy was asked how the pharmacy managed the Board of Pharmacy requirement that all medication orders be hand-printed, typewritten or electronically generated. The Director stated that the pharmacy did not specifically screen for medication orders in cursive. The Director also stated that s/he accepted orders in a "mixed style" if s/he could read the orders, because to not do so "would bring medical management and care to a grinding halt in this hospital."

On 6/16/2011, the Chief Medical Officer stated that there had been discussion with the Medical Staff regarding the use of cursive to write medication orders, but the hospital "may have to take harsher steps" to resolve the ongoing issue.

The hospital's failure to develop and implement a process to ensure that medication orders were not written in cursive, and that such orders were not accepted by the pharmacy, placed all patients of the hospital at risk for receiving incorrect medications.
"Resume" Orders for Medications
Review of the medical records for 5 former inpatients (all had been surgical patients) revealed that 2 patients (#14 & #15) had post-operative orders for "resume" medications. The medical records were reviewed in the company of the Nurse Manager for the nursing care area where the patients had received care. The NM acknowledged that the medication orders under review were written to "resume" prior medications.

Review of the hospital's policy and procedure "Prescribing & Ordering - General Practices", revealed the following direction:

"..Renewal: The use of the terms "renew", "repeat", "resume" and "continue" in reference to previous orders are not acceptable and represent an incomplete order".

Review of the hospital's policy "Physician Practitioner Orders" revealed the following direction:

"PROCEDURE:
5. Cancellation of orders:
All existing orders for patients shall be canceled [sic] when the patient is transferred to a higher level of nursing care of the operating room. Orders must be rewritten upon their return to the nursing floor".

Also reviewed was an email from the Director of Pharmacy to a person at the surgeons practice group, dated June 14, 2011. The email stated:

"...Medication orders have required elements; those that do not contain those elements "may" be considered incomplete.

Another section of the policy specifies that we do not allow use of the terms "renew", "resume", or "continue" - but it should be noted that this was intended to prevent the use of blanket statements or orders. By this I mean orders such as 'continue pr

Based on interview, review of medical records and review of hospital documents, it was determined that the hospital failed to set priorities for its performance improvement activities that focused on high-risk, high-volume, or problem-prone areas and to consider the incidence, prevalence, and severity of problems in those areas. The hospital's failure to do so resulted in a lack of Quality Assurance/Process Improvement plans in the Pharmacy and the Infection Control program to assure same.


Lack of Quality Assurance/Process Improvement Plan for Pharmacy

The medical record for Patient #1 was reviewed in the company of the Nurse Manager (NM) of the care unit where the patient received care. The NM confirmed that the patient's physician had ordered Mellaril, but the patient had not received the ordered Mellaril for 2 days. The NM also confirmed that the medical record documented that the failure to administer the medication had been identified by the patient's family and brought to the attention of the nursing staff by the patient's family, while the patient was still in the hospital.

On 6/24/2011, staff in the department of Quality Assurance (QA) was asked to provide the policy and procedure for medication errors. The QA supervisor and the QA project manager were unable to access the policy on the hospital's intranet.

On 6/24/2011, the Director of Pharmacy was asked if the policy and procedure regarding medication errors was online and available to hospital staff. The Director stated that the policy had not been available to hospital staff previously, and was only available on the hospital intranet to the pharmacy staff. The Director also confirmed that the medication error for Patient #1 had not been brought to the attention of the pharmacy via a medication error report, and therefore, the reason for the medication error had not been investigated.

On 6/24/2011, the Director of Pharmacy stated that the pharmacy did not have a specific "QA" [quality assurance] plan. S/he stated that the pharmacy did not routinely monitor, track and trend such issues as medication orders written in cursive or orders to "resume" previous medications.

The Director provided a report on "Where Medications are Being Documented", that had been completed 2/8/2011. The report contained the scope of the project and 2 graphs as to where medications were documented. No narrative was found to explain the rationale for the project, the process utilized, the results of the process or who owned the process.

The Director provided the hospital's "Pharmacy Department Dashboard" which was a compilation of statistics.

The Director also provided 2 additional documents, both unsigned and undated. One document was entitled "Data-Driven Medication Safety Changes" and the second was "Pharmacy & Medication Safety at Swedish Edmonds". The second document listed 3 "ongoing measures", but did not note why those measures had been chosen, who was responsible for the process, who would be involved in the process, how the process was to be accomplished, or what the goals and objectives were.

No narrative was found as to what quality concerns were identified for the Pharmacy Department, which indicators would be tracked, what the goals and objectives would be, or other rationale or documentation.

The "Swedish Edmonds Year 2011 Performance Improvement - Patient Safety Plan" was also reviewed. The Plan gave an oversight of purpose, scope, authority, organization and responsibility. The Plan was not found to contain a specific reference to the Pharmacy Department, but did state in part:

"IV. Performance Improvement Improvement Objectives
The objectives of the Performance Improvement Program are to:
-Ensure a safe environment for patient, staff and visitors
-Reduce safety risks and hazards within the organization
-Improve patient care processes...

These objectives are accomplished through the use of:
...
Risk/patient safety review of trends through incident reports, grievances, medication misadventure reports..."

Review of the policy and procedure "Stevens Hospital Pharmacy - Medication Management", dated 6/24/2011 revealed the following directions:

"POLICY:
The organization has a process to respond to actual or potential medication errors. All actual or potential errors identified will be documented through the hospital's risk management system...

All medication error reports will be reviewed by Pharmacy director and categorized according to severity, type, cause and drug class involved..."

The lack of a defined Quality Improvement/Process Improvement Plan for the Pharmacy Department may have contributed to the hospital's failure to identify issues with medication orders, medication reconciliation issues, post-operative orders or other issues related to the Pharmacy Department.


Lack of a Quality Assurance/Process Improvement Plan for Infection Control Program

On 7/27/2011, the Manager of the Infection Control program stated that there was not a quality assurance/process improvement plan for the department. However, the Manager provided the "Swedish/Edmonds Infection Prevention Program Plan 2011" which contained the following sections:

-Purpose
-Scope
"...Determine the type and scope of surveillance and investigation activities including the criteria for defining healthcare-associated infections..."

-Risk Assessment Summary
-Prioritized Risks
"8. Exposure of patients and staff to...other communicable diseases..."

-Data Collection and Analysis
-Thresholds/Benchmarks
-Action
-Evaluation and Improvement
-Reporting Structure and Responsibilities

The "Swedish Edmonds Year 2011 Performance Improvement - Patient Safety Plan" was also reviewed. The Plan gave a oversight of purpose, scope, authority, organization and responsibility.

The Plan stated:

IV. Performance Improvement Objectives
The objectives of the Performance Improvement Program are to:
-Ensuring a safe environment for patient, staff and visitors
-Reduce safety risks and hazards within the organization
-Improve patient care processes...

These objectives are accomplished through the use of:
...infection control surveillance and monitoring of Hospital Acquired Infections (HAI)...."

The Infection Control Manager provided a list of potential sources of information regarding HAIs. Included in the list were physicians' offices and the hospital's Quality Assurance/Process Improvement department.
The Manager stated that the hospitals asked physicians to self-report by calling or writing to the hospital, but there were no guidelines or directions for the physicians regarding how, why or when to do so.

The Manager also stated that another challenge in identifying potential nosocomial infections was that all laboratory results did not go through the hospital's laboratory because the hospital utilized multiple laboratories; therefore, there was no way to assure that all abnormal laboratory results were reviewed.

The Manager also confirmed that allegations made regarding 2 patients (Patient #2 and #24) about potential HAIs had not been received by the Infection Control program, and the lack of intra-departmental communication on the allegations had not been identified until the investigator was onsite.

Conversation with the Quality Assurance/Process Improvement staff (Quality Assurance Supervisor and Patient Advisor) revealed that the QA/PI staff had made independent determinations about the potential HAIs and replied directly to the patients regarding their determinations.

The Infection Control Program Manager confirmed that there were no written processes to provide checks and balances and/or to assure that the Infection Control program received the appropriate information from any of the identified potential sources of that information. The Manager also stated that there were no written guidelines or documentation regarding the process for how of when physicians were to report back to the hospital when patient infections were identified post-discharge from the hospital.

The lack of a defined Quality Improvement/Process Improvement Plan for the Infection Control program may have contributed to the hospital's failure