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Based on interview and record review it was determined the facility failed to develop and maintain clearly written definitions of its organization and department relationships, and failed to maintain written patient care policies and procedures for the satellite Urgent Care Clinic. Findings include:

During the survey the organizational structure of the Health District and health network was reviewed in detail, including review of the Curry Medical Center, Urgent Care Clinic. That review determined the hospital had failed to develop and maintain clearly written definitions of the organization and authority of the Urgent Care Clinic, and had failed to develop urgent care specific patient care policies and procedures.

Health Network policies and procedures were reviewed, including policies entitled "Urgent Care: Scope of Practice," "Emergency Services," "Performance Improvement Program," "Adverse Event Reporting," "Medication Safety," "Medication Errors," "Health Information: Chart Analysis," "Pharmacy and Therapeutics Committee," "Policy and Procedure Committee," "Standard of Care- Chest Pain or Myocardial Infarction," "New Onset of Chest Pain," "Pediatric Dosing-General Guidelines," "Concentrated Electrolyte Solutions," "Medical Staff By-Laws," and "Medical Staff Credentialing and Privileging."

It was determined that the policies were not department specific for the Urgent Care Clinic. The policies failed to provide a clearly written definition of the organization of the Urgent Care Clinic, and failed to include written patient care policies and procedures specific to the department.

The authority, responsibility, and relationship between the hospital Emergency Department and Urgent Care Clinic was not clear. Hospital policy "Urgent Care: Scope of Practice," failed to define the organization, and relationships between such services. Some policies, such as "Standard of Care- Chest Pain or Myocardial Infarction," "New Onset of Chest Pain," "CVA or Stroke," Pediatric Dosing Guidelines," "Emergency Delivery" and "Concentrated Electrolyte Solutions," were identical for both departments.

In an interview on 3/29/11 at 3:30 PM Staff 5 and Staff 6 acknowledged that policies and procedures specific to the Urgent Care Clinic had not been developed as needed.

Based on record review and interviews of staff, it was determined that the CAH failed to develop policies and procedures with the advice of a group of professional personnel that included one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists as required by this regulation.

Findings are:

See the deficiency under C-0271 whereby the satellite Urgent Care Clinic lacked department-specific policies and procedures. This lack of policies and procedures also reflects the failure of the CAH to develop policies and procedures with the advice of a group of professional personnel that included one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists.

As noted in C-0271, in an interview on 3/29/11 at 3:30 PM the Staff 5 and Staff 6 acknowledged that policies and procedures specific to the Urgent Care Clinic had not been developed as needed.

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Based on interview and record review it was determined the facility failed to ensure that all drugs and intravenous medications for 4 of 12 sampled patients (Patients 2, 5, 10 and 11) were administered in accordance with written, signed orders and accepted standards of practice. Findings include:

1. During the survey the medical records of a sample of 12 patients seen at the Brookings/Curry Medical Clinic between 6/1/10 and 3/15/11 was selected for review. That review revealed that Patients 2, 5, 10 and 11 had been administered drugs, biologicals and/or intravenous medications without a written, signed order from an authorized practitioner and/or not in accordance with accepted standards of practice.

Facility records indicate that Patient 2 was admitted for services at the Urgent Care Clinic on 3/7/11 for "chest pain." According to that record a variety of interventions were provided to the patient including oxygen therapy and placement of an IV.

Record review determined that there were no "practitioner" signed orders for those services. There was no documented, authenticated or dated record of who ordered the IV or oxygen therapy.

2. According to facility records Patient 5 had been seen at the "Brookings Medical Clinic" on 9/9/10, and provided services that included lab tests, IV medication and oxygen. Record review revealed that there was no signed physician/practitioner order for those services. There was no signed, dated order for the IV medication or oxygen.

3. Facility records indicate that Patient 10, a six year old who weighed 42 lbs, had been seen in the "Brookings Medical Clinic" on 6/3/10 and diagnosed with "torticollis," the contracture of the muscles of the neck. At that time Staff 9, a Physician Assistant, wrote a prescription for "liquid Valium, 16 mg, tid for three days. The patient's body weight was not included on the written prescription.

Hospital policy "Pediatric Dosing-General Guidelines" indicates that "all orders for pediatric medication must include the patient's current weight..." Patient 10 was provided a written prescription for Valium that was not in compliance with hospital policy or accepted standards of practice.

4. According to facility records Patient 11 was seen at the Brookings Medical Clinic on 7/30/10 to refill prior medications. The patient's medication record contained in the chart indicated the patient was receiving a variety of "previous" medications including "Lisinopril Oral Tablet, 25 mg po (per os) daily."

Following this visit, Patient 11's medications were refilled by Staff 9 with the written order for "Lisinopril Oral Tablet, 2.5 mg po daily." There was no medication reconciliation or indication of why the dosage was changed from 25 mg to 2.5 mg. The facility failed to ensure that all drugs were administered in accordance with accepted standards of practice.

In an interview on 3/29/11 Staff 5 acknowledged that the medications for Patient's 2, 5, 10 and 11 had not been administered in accordance with hospital policy and accepted standards of practice.

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Based on the review of documentation and interviews with Urgent Care Clinic staff , it was determined that the hospital failed to ensure an effective system of patient records.

Findings include the following:

Please refer to tag C301 reflecting the CAH failed to maintain a clinical records system in accordance with written policies.

Please refer to tag C302 reflecting the CAH failed to maintain a system of clinical records where the records were legible, complete, authenticated, or accurately documented.

Please refer to tag C307 reflecting the CAH failed to maintain, for each patient receiving health care services, a clinical record that included written orders that were dated and signed by the responsible practitioner.

The cumulative effect of the systematic problems related to the clinical record resulted in the CAH's failure to ensure the provision of safe care.

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Based on interview and record review it was determined the facility failed to maintain a clinical record system in accordance with written policies and procedures. Findings include:

1. According to facility policies "Health Information Management," "Chart Analysis," and "Legal Evidence," medical records are to be "complete, accurate and authenticated...", and that "practitioner entries must be signed, including title, date and time." Review of the medical records of a sample of twelve patients seen at the Brookings/Curry Medical Clinic between 6/1/10 and 3/15/11 determined the facility failed to maintain a record system in accordance with those policies.

Record review determined that the reproduced paper copy of the medical record of 8 of 12 patients were not legible (Patients 2, 3, 4, 5, 6, 8, 9 and 12). Refer to Tag C 302, Record Systems, Example 1.

2. Record review determined that the medical records for 4 of 12 patients were not complete and/or accurate (Patients 2, 5, 8 and 10). Refer to Tag C 302, Record Systems, Example 2.

3. Record review determined that the medical record of 3 of 12 patients did not include written, signed physician/practitioner orders for treatments and/or medications (Patients 2, 5 and 10). Refer to Tag C 307, Record Systems.

4. Record review determined that the medical record of 1 of 12 patients (Patient 5) was not accessible. Refer to Tag C 302, Example 6.

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Based on interview and record review it was determined that a legible copy of the electronic medical record could not be reproduced for 8 of 12 sampled patients (Patients 2, 3, 4, 5, 6, 8, 9 and 12), that the medical record for 4 of 12 sampled patients (Patients 2, 5, 8 and 10) were not complete, authenticated, or accurately documented, and the medical record for 1 of 12 patients (Patient 5) was not readily accessible. Findings include:


1. During the survey the medical records of a sample of patients seen at the Brookings/Curry Medical Clinic between 6/1/10 and 3/15/11 was selected for review. A request was made for a reproduced paper copy of the electronic medical record maintained for those patients.

A review of the paper medical records provided by the facility revealed that some sections or portions of the reproduced record for Patients 2, 3, 4, 5, 6, 8, 9 and 12 were not legible. Portions of the electronic record for those patients could not be reproduced in a legible format. From the records it was not clear if the problem was in the quality of the original scanned document, or in the quality of the reproduced, printed document.

The portion of each record that was found to not be legible varied by patient. The typed/stamped name and patient information in the upper left corner of the record was not legible for Patients 2, 3, 4 and 12. Various hand written entry's of nurses notes, physician notes and/or medications for Patients 2, 3, 5, 7, 8, 9 and 12 were not legible without review/input form the original author.

In interview on 3/29/11 Staff 5 acknowledged that portions of the record for Patient 5 did not reproduce well, were not legible and could not be magnified or expanded. Staff 5 expressed that the electronic records were maintained in accordance with industry standards, and could be deciphered with the assistance of the original author.

2. The medical records of a sample of patients seen at the Brookings/Curry Medical Clinic between 6/1/10 and 3/15/11 was selected for review. That review revealed that some entries in the medical record for Patients 2, 5, 8 and 10 had not been timed, dated, and/or authenticated as required.

Facility records indicate that Patient 2 was admitted for services at the Urgent Care Clinic on 3/7/11 for "chest pain." According to that record a variety of services were provided to the patient including physician assessment, IV therapy, an EKG, and discharge planning.

Record review determined that the provision of those services had not been "authenticated" as required. There was no documented, authenticated or dated record of who started the IV or completed the EKG. Although the record stated "MD at bedside," there was no signed record from a physician that indicated what doctor had seen Patient 2, or the outcome of the physician assessment.

3. According to facility records Patient 5 had been seen at the "Brookings Medical Clinic" on 9/9/10, and provided services that included lab tests, IV medication, oxygen, and an EKG test. Record review revealed that there was no signed physician/practitioner order for those services. There was no signed, dated order for the IV medication, oxygen, lab tests or EKG. There was also no documented record of who provided such services.

4. Patient 8 had been admitted to the Urgent Care Clinic on 3/1/11 for "chest pain." According to facility records Patient 8 was provided oxygen, IV therapy and various lab testing. Record review determined that no one had signed for or "authenticated" the provision of IV therapy, oxygen or lab tests. Those sections of the record had not been completed as required.

5. Facility records indicate that Patient 10 had been seen in the "Brookings Medical Clinic" on 6/3/10. Although a variety of nurse and practitioner progress notes had been completed, those notes had not been signed or dated as required. There was no documented record of what practitioner had seen the patient. Although a full assessment had been completed, the assessment had not been dated and/or authenticated as required.

In interview on 3/29/11 the Staff 5 acknowledged that portions of the records for Patients 2, 5, 8 and 10 had not been dated and authenticated as required.

6. Interview and record review determined the facility failed to ensure that 1 of 12 sampled patients (Patient 5) was provided access to information contained in her clinical record as required. Findings include:

According to facility records Patient 5 had been admitted to the Brookings/Curry Medical Clinic for services on 9/9/10. At the time of that admission a variety of documents were generated related to the care and services provided to the patient at the clinic. During a 3/29/11 inspection visit it was revealed that the record included the following documents:

1. A one page (unnamed) face sheet;
2. A one page "CPSI System Clientware" form;
3. A typed, one page "same day care note" from Witness 9;
4. A handwritten one page "Progress Note", unsigned;
5. A one page "Brookings Medical Center Database Tool."

On 10/19/10 Patient 5 completed a written request for records, "Authorization to Release Healthcare Information" related to that clinic visit. That release specifically identified "all hospital records," "clinician office notes," and the records of "Brookings Medical Clinic 9/9/10."

Following that request Patient 5 was provided an array of medical records from both the hospital and Brooking Medical Clinic. However, not all "Brookings Medical Clinic" records that were found in the chart on 3/29/11 were provided.

At the time of the 10/19/10 request Documents 1, 2, 3 and 4 were not provided to the patient. In addition, an incomplete, unsigned copy of Document 5 "Brookings Medical Center Database Tool" was provided to the Patient rather than a complete, final copy.

The facility failed to provide Patient 5 with access to information contained in her clinical records.

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Based on interview and record review it was determined the facility failed to ensure that the medical records for 3 of 12 sampled patients included written orders that were dated and signed by the responsible doctor or health care practitioner (Patients 2, 5 and 10). Findings include:

During the survey the medical records of a sample of patients seen at the Brookings/Curry Medical Clinic between 6/1/10 and 3/15/11 was selected for review. That review revealed that some entries in the chart for Patients 2, 5 and 10 had not been dated and/or authenticated by the responsible practitioner, as required.

Facility records indicate that Patient 2 was admitted for services at the Urgent Care Clinic on 3/7/11 for "chest pain." According to that record a variety of services were provided to the patient including physician assessment at the bedside, IV therapy, an EKG, and discharge to another facility.

Record review determined that there were no "practitioner" signed orders for those services. There was no documented, authenticated or dated record of who ordered the IV, EKG or discharge to another facility. Although the record stated "MD assessment at bedside," there was no signed record from a practitioner that indicated who had seen Patient 2, or the outcome of the physician assessment. The disposition of orders had not been documented in the patient's medical record as required.

According to facility records Patient 5 had been seen at the "Brookings Medical Clinic" on 9/9/10, and provided services that included lab tests, IV medication, oxygen, and an EKG test. Record review revealed that there was no signed physician/practitioner order for those services. There was no signed, dated order for the IV medication, oxygen, lab tests or EKG.

Facility records indicate that Patient 10 had been seen in the "Brookings Medical Clinic" on 6/3/10. Although a variety of practitioner progress notes had been completed, those notes had not been signed or dated as required. There was no documented record of what practitioner had seen the patient. Although a full assessment had been completed, the assessment had not been dated and/or authenticated.

In interview on 3/29/11 the Staff 5 acknowledged that the physician/practitioner orders for Patients 2, 5 and 10 had not been dated and signed by the responsible practitioner as required.

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Based on documentation review, policy and procedure review, and staff interview, it was determined that the facility failed to develop and implement an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH.

Please refer to the deficiency cited at C336 reflecting the CAH failed to ensure an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis, treatment and the treatment outcomes of care furnished in the CAH.

Please refer to the deficiency cited at C339 reflecting the CAH failed to ensure an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners and physicians assistants.

Please refer to the deficiency cited at C342 reflecting the facility failed to take remedial action to address deficiencies identified by the quality assurance program.

Please refer to the deficiency cited at C343 reflecting the facility failed to document the outcome of remedial action to address deficiencies identified by the quality assurance program.


The cumulative effect of the systematic problems related to the quality assurance and the failure to take remedial action resulted in the CAH's failure to ensure the provision of safe care.

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Based on interview and record review it was determined the facility failed to ensure an effective quality assurance program to evaluate the quality of treatment and services furnished in the satellite clinic. Findings include:

As part of the survey, the facility's quality assurance program was reviewed in detail, including review of policies and procedures and interview with staff. Review of those policies, procedures and of the "PIPS" (Performance Improvement and Patient Safety) program determined the quality assurance program was not complete or effective.

Policy review and interview with facility staff revealed that the quality assurance policies and program were not fully developed. In interview on 3/29/11 at approximately 2:30 PM Staff 12 stated that "the current QI (Quality Improvement) policy is in development." Staff 12 further indicated that in the future they would report (QI activities) to the hospital board.

Policy review included review of policies entitled "Performance Improvement and Patient Safety, (PIPS)" "Policy and Procedure Committee," "Medical Staff Bylaws," "Medical Staff Credentialing and Privileging Manual; Allied Health Professionals," "Adverse Event Reporting," "Medication Errors," "Medication Safety," and "Pharmacy and Therapeutics Committee."

That review determined the program policies failed to ensure that quality assurance data was provided to the governing body.

Established facility policies also failed to coordinate the quality improvement activities between the hospital and satellite locations. In an interview on 3/29/11 Staff 5 and Staff 12 presented varied descriptions of their duties and responsibilities regarding the QA program.

The program failed to include a systematic evaluation of the quality of diagnosis and treatment furnished by practitioners. In an interview on 3/29/11 at approximately 3:00 PM, Staff 13 indicated there was no specific written policy regarding the oversight of nurse practitioners or physician assistants.

The policies failed to ensure the facility took appropriate remedial action to address deficiencies identified through the quality assurance program.
There was no written policy that indicated what corrective action would be taken to address any deficiencies, and it was not clear how the facility would document the outcome of remedial actions.

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Based on interview and record review it was determined the facility failed to establish a quality assurance program that evaluated the quality of diagnosis and treatment furnished by nurse practitioners and physician assistants at the satellite clinic. ....(Failure to establish such a system contributed to the occurrence of repeated medication errors by one practitioner)... Findings include:

During the survey it was revealed that the facility employed a number of Nurse Practitioners and Physician Assistants, including Staff 9, 10, 11, 15 and 16. The practitioners furnished care and treatment in a variety of facility settings, including the hospital and satellite clinic.

As part of the survey the facility's quality assurance program was reviewed in detail, including review of policies entitled "Performance Improvement and Patient Safety, (PIPS)" "Policy and Procedure Committee," "Medical Staff Bylaws," "Medical Staff Credentialing and Privileging Manual; Allied Health Professionals," "Adverse Event Reporting," "Medication Errors," "Medication Safety," and "Pharmacy and Therapeutics Committee."

Review of the "PIPS" program and interview with facility staff determined the program did not include a systematic evaluation of the quality of diagnosis and treatment furnished by practitioners. In interview on 3/29/11 at approximately 3:00 PM Staff 13 indicated there was no specific written policy regarding the oversight of nurse practitioners or physician assistants. There was no systematic process to evaluate the quality of care provided by Staff 9, 10, 11, 15 and 16.

Facility policies included no description of a procedure to ensure that a doctor evaluated the quality of care by mid-level practitioners. There was no indication of how the supervising physician was to determine if there were performance problems, or how clinical performance was to be evaluated on an on-going basis. It was not clear what follow-up or corrective actions were to be taken if a problem was identified.

A review of a sample of twelve medical records of patients seen at the satellite clinic revealed that Staff 9 had committed three separate "wrong dosage" medication errors between June and October 2010. Although the first error occurred on 6/3/2010, under facility policy no documented quality intervention or corrective action occurred. Similar "wrong dosage" medications errors by Staff 9 occurred on 7/30 and 9/9/2010.

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Based on interview and record review it was determined the facility failed to take appropriate remedial action to address 2 of 3 sampled deficiencies identified through the quality assurance program. Findings include:

Review of the quality improvement policies determined the facility had developed a specific procedure to be implemented following the identification of an adverse event, including medication errors. That procedure is outlined in policies including "Performance Improvement and Patient Safety, (PIPS)" "Policy and Procedure Committee," Adverse Event Reporting," "Medication Errors," "Medication Safety," and "Pharmacy and Therapeutics Committee."

The policies describe specific procedures to identify and report adverse events, develop and implement corrective actions, and evaluate and monitor the effectiveness of those measures. The policy "Medication Errors" includes specific procedures to be implemented if the adverse event involved a medication error.

According to that policy "all medication error reports will be reviewed by the Medication Use Task Force (MUTF), and categorized by severity...," "...significant error reports will be referred to the Pharmacy and Therapeutics Committee." The policy further indicates that "Reports of actions taken and appropriate follow-up will be made by MUTF to the Pharmacy and Therapeutics Committee" and "Patient Care Evaluation Committee."

The policy "Pharmacy and Therapeutics Committee," indicates that the committee shall "make recommendations for the solutions of problems involved in the appropriate preparing....and administration of medications."

A sample of adverse events was selected for review, including medication error events that occurred on 6/3/10, 7/30/10 and 9/9/2010. Review of the processing of those events revealed the quality improvement procedures outlined in policy had not been followed.

On 6/3/10 a "wrong calculation of dosage" error occurred that involved an out-patient pediatric patient. Patient 10 was prescribed "liquid Valium, 16 mg, tid, for three days" for "torticollis." The prescribed dosage of Valium was approximately ten times the recommended dosage based on the patients body weight. Facility policies on "Medication Safety," and "Pediatric Dosing" were not followed.

Record review revealed the error was identified and reported as planned, but further actions as described by facility policy had not been implemented. There was no documented review of the incident by the MUTF. There was also no documented record of actions taken or reports of appropriate follow-up to the Pharmacy and Therapeutic or Patient Care Evaluation Committees. There was no documented record the "Pharmacy and Therapeutics Committee," made recommendations for the solutions of the dosage calculations problem as planned.

A second medication error event was also reviewed. According to facility records, on 9/9/10 Patient 5 experienced a "wrong dose and method of administration" error. On 9/9/10 Patient 5 was administered the antihypertensive medication Enalapril, 5 mg IV. The recommended dosage of Enalapril was approximately 1.25 mg, IV.

Following the administration of the medication Patient 5 experienced a hypotensive episode, and was transferred to the hospital. Facility policy "Medication Safety" had not been followed.

Record review revealed the error was identified and reported as planned, but further actions as described by facility policy were not implemented. There was no documented review of the incident by the MUTF, and no documented referral of the incident to the Pharmacy and Therapeutics and/or Patient Care Evaluation Committee.

There was also no documented record of the development and implementation of corrective actions, or a process to evaluate and monitor the effectiveness of those measures. The facility failed to implement appropriate remedial action to address deficiencies found through the QA program.

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Based on interview and record review it was determined the facility failed to document the outcome of remedial action taken to address 3 of 3 sampled deficiencies identified through the quality assurance program. Findings include:

As part of the survey, the facility's quality assurance program was reviewed in detail, including review of policies and procedures and interview with staff. The policy "Medication Errors" included specific procedures to be implemented if a medication error occurred.

According to that policy "all medication error reports will be reviewed by the Medication Use Task Force (MUTF), and categorized by severity...," The policy further indicates that "Reports of actions taken and appropriate follow-up will be made by MUTF to the Pharmacy and Therapeutics Committee" and "Patient Care Evaluation Committee."

A sample of adverse events was selected for review, including medication error events that occurred on 6/3/10, 7/30/10 and 9/9/2010. Review of the processing of those events revealed the facility failed to document the outcome of the remedial action taken in response to those events.

On 6/3/10 a "wrong calculation of dosage" error occurred that involved an out-patient pediatric patient. Record review revealed the error was identified and reported as planned, but further actions as described by facility policy had not been implemented. There was no documented record of remedial actions taken or the outcome of those actions. There was no documented record of reports of appropriate follow-up to the Pharmacy and Therapeutic or Patient Care Evaluation Committees.

According to facility records on 7/30/10 Patient 11 experienced a "wrong dose and preparation of dose" error. Record review determined the facility failed to implement written QA procedures related to the incident. Although the incident was identified and reported there was no documented record of the development and implementation of remedial actions, or a process to evaluate and monitor the outcome of those actions.

A medication error that involved Patient 5 was also reviewed. On 9/9/10 Patient 5 experienced a "wrong dose and method of administration" error. Record review revealed the error was identified and reported as planned, but further actions as described by facility policy were not implemented. There was no documented record of the development and implementation of remedial actions, or a process to evaluate and monitor the outcome of those measures.

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