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Based on observation and interview, the Critical Access Hospital failed to confirm that the contracted Pharmacy Director (Staff Member #4) was currently licensed as a Registered Pharmacist.

Failure to ensure that all professional healthcare staff members are currently licensed risks provision of services by unqualified individuals.

Findings:

On 8/16/2011 at 9:45 AM, it was observed that the Washington State license for the contracted Pharmacy Director had been posted on the wall of the hospital's pharmacy. The expiration date for this license was May 8, 2011.

An interview with the Human Resources Director (Staff Member #5) revealed that the hospital had not verified that the Pharmacy Director's license had been renewed

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Based on interview the facility failed to complete a technical and engineering review of all medical equipment for the purpose of determining that the equipment will function safely.

Failure on the part of the facility to ensure that equipment will function safely puts patients and staff at risk of injury.

Findings include:

1. On 8/18/2011 the surveyor located two pieces of patient equipment that lacked inventory control and/or service tags (Xterra exercise bike and Govo 7007ES lift). A review of the facility's equipment inventory list by the surveyor and Staff Member #7 failed to show that the above mentioned equipment had been inventoried for the purpose of facilitating preventative maintenance.


2. On 8/18/2011 the surveyor interviewed Staff Member #7 to determine if two pieces of patient equipment (Xterra exercise bike and Govo 7007ES lift) had been safety checked prior to being put into service. The surveyor was informed that the equipment had not been checked.

Based on interview the facility failed to have a system in place that would assure the safety of patients, staff and visitors of the facility during non-medical emergencies. More specifically, the facility failed to have a plan in place that would protect vital supplies of emergency fuel and water.

Findings include:

1. On 8/16/2011 during discussions with the Maintenance Supervisor (Staff member #7) the surveyor was informed that informal agreements had been made with local suppliers for emergency fuel and water but no written agreements had been entered into to assure their delivery if needed during an emergency.

Based on observations made during the course of the survey the facility failed to meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association.

Findings include:

Refer to deficiencies written in the MEDICARE RE-CERTIFICATION SURVEY CRITICAL ACCESS HOSPITAL (FIRE LIFE SAFETY SURVEY) dated 8/16/2011 - 8/18/2011.

Based on observation the facility failed to comply with the requirements of the Life Safety Code, NFPA 101, 2000 edition, Chapter 19.3.2.7.

Refer to deficiencies written in the MEDICARE RE-CERTIFICATION SURVEY CRITICAL ACCESS HOSPITAL (FIRE LIFE SAFETY SURVEY) dated 8/16/2011through 8/18/2011 (Tag K-0211).

ITEM #1 - PATIENT RIGHTS

Based on interview and review of patient rights information, the the Critical Access Hospital failed to develop a process for informing patient's of their rights according to State hospital regulations.

Failure to inform patients of their rights limits the patient's ability to exercise those rights

Reference: WAC 246-320-141: Hospitals must: (2) Provide each patient a written statement of patient rights from subsection (1) of this section;

Findings:

On 8/16/11 at 10:00 AM, an interview with the Chief Nursing Officer (Staff Member #1) revealed that all patients were given a handout to read entitled "Patient Rights and Responsibilities" when admitted to the hospital for inpatient and outpatient care. Review of the contents of this form revealed it did not include all of the patient's rights identified in current hospital regulations.

The form did not inform patients that they had the right that they had the right to be treated and cared for with dignity and respect [WAC 246-320-141(1)(a); the right for communication [WAC 246-320-141(1)(b)]; the right to be protected from neglect [WAC 246-320-141(1)(c)]; and the right to complain about their care without fear of retribution or denial of care [WAC 246-320-141(1)(e)].


ITEM #2 - PATIENTS IN RESTRAINTS

Based on record review, interview, and review of policies and procedures, the Critical Access Hospital failed to follow its policy and procedure for restraining patients in accordance with to State hospital regulations for 3 of 3 patient records reviewed (Patients #5, #6, #7).

Failure to follow established utilization guidelines for restraints risks physical and psychological harm, loss of dignity, and violation of patient rights.

References:
WAC 320-246-226
Hospitals must: (3) Adopt, implement, review and revise patient care policies and procedures designed to guide staff that address: (f) Use of physical and chemical restraints or seclusion consistent with CFR 42.482.

42 CFR 482.13(e) Standard: Restraint or seclusion.
(3) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm.

(4) The use of restraint or seclusion must be--
(ii) Implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law.

(5) The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under Sec. 482.12 (c) and authorized to order restraint or seclusion by hospital policy in accordance with State law.

(8)(i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:
(B) 2 hours for children and adolescents 9 to 17 years of age;

(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order.

Findings

1. The hospital's policy and procedure entitled "Restraint Use" (Effective 8/28/2007) stated that when patients were placed in restraints for behavioral reasons (potential threat to harm self or others), the following was required:

a. The physician's restraint order was to include the type of restraint used and the number of extremities to be restrained.

b. The maximum duration for restraining patients for behavioral reasons was limited to two hours for children and adolescents 9 to 17 years of age.

c. The patients was to be monitored continuously by a staff member. Documentation of the following was to be documented in the patient's record every 15 minutes:
1) Signs of injury associated with applying the restraint
2) Nutrition and hydration
3) Circulation and range of motion in the extremities
4) Vital signs as appropriate
5) Hygiene and elimination
6) Physical and psychological status and comfort
7) Readiness for discontinuation of restraint

2. Review of the records of three patients who had been restrained during their hospitalization revealed the following:

a. Patient #5 was a 22 year-old patient with autism who had been admitted to the emergency department (ED) on 5/6/2011 for treatment of confusion and agitation. The patient became combative at 10:20 PM, and the ED physician ordered that the patient be placed in "soft restraints".

The physician's order was not specific as to the number of extremities to be restrained. The nursing documentation did not indicate that number of extremities that were restrained. The nursing documentation did not include observations of the patient's condition every 15 minutes as specified under #1(c) above.

b. Patient #6 was a 49 year-old patient who had been admitted to the ED on 5/9/2011 for a mental health evaluation for agitation, combativeness, and psychosis. The patient was placed in soft wrist restraints at 6:15 PM.

The patient's record did not include a physician's order for the soft wrist restraints.

c. Patient #7 was a 14 year-old patient who had been admitted to the ED on 1/1/2011 for treatment of alcohol intoxication. The patient had been placed in soft 4 point restraints by the ambulance transport team and was agitated on admission.

The patient's record did not include a physician's order for the 4-point restraints. The nursing documentation did not include observations of the patient's condition every 15 minutes as specified under #1(c) above. There was no documentation of when the patient was released from the restraints.

Patient #7 was readmitted on 3/25/2011 for treatment of alcohol intoxication. The patient became agitated and tried to remove her intravenous line at 10:00 PM and was placed in 4-point soft restraints. The patient was then admitted to the acute care unit for observation.

The ED physician's order for "soft restraints" was not specific as to the number of extremities to be restrained. The admitting physician's order read "Soft restraints - Remove in morning when patient cooperative". The order was not renewed every 2 hours as required by hospital policy.

The patient's record indicated the patient was in 4 point restraints from 10:00 PM to 12:50 AM. The patient's record read "Duct tape was taken off wrist restraints at 22:50 by MD verbal order." Duct tape is not a safe restraining device.

The patient's record indicated the patient slept while in restraints from 11:05 PM to 11:50 PM and from 12:20 AM to 1:50 AM. The wrist restraints were removed at 1:50 AM. The record did not indicate why the patient was not released after the behavior that necessitated the restraints had ceased. The record did not indicate that the patient had been released from restraints at the earliest possible time.

3. An interview on 8/18/2011 at 11:50 AM with the hospital's Chief Nursing Officer (Staff Member #1) confirmed that the hospital's restraint policy and procedure had not been followed for the patients identified above.


ITEM #3 - RESTRAINT TRAINING

Based on interview, the Critical Access Hospital failed to provide ongoing education and training in the proper and safe use of restraints as required by State hospital regulations.

Failure to do so places patients at risk for inadequate care and injury related to restraint use.

References:
WAC 320-246-226 Hospitals must: (3) Adopt, implement, review and revise patient care policies and procedures designed to guide staff that address: (f) Use of physical and chemical restraints or seclusion consistent with CFR 42.482

42 CFR 482.13(f) Standard: Restraint or seclusion
Staff training requirements. (1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion--

(i) Before performing any of the actions specified in this paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospital policy.

Findings:

1. . The hospital's policy and procedure entitled "Restraint Use" (Effective 8/28/2007) stated that competency of all hospital staff involved with restraint use would be demonstrated, and documented during initial orientation and annually thereafter.

2. An interview on 8/17/2011 at 1:30 PM with the hospital's Chief Nursing Officer (Staff Member #1) revealed that the hospital's restraint training program involved online education and testing of competency. There was no method for staff members to physically demonstrate their knowledge of the safe application of restraints.


ITEM #4 - HEPATITIS B VACCINATION

Based on interview and review of occupations health records, the Critical Access Hospital failed to provide evidence that hepatitis B vaccination was offered to 3 of 8 staff members reviewed according to Washington Administrative Code (Staff Members #2, #3, #4).

Failure to vaccinate employees against hepatitis B risks hepatitis B infection when exposed to blood and body fluids.

Reference: WAC 296-823-130 Bloodborne Pathogens
Employers must make hepatitis B vaccination available to employees; employees who refuse vaccination must sign a declination statement.

Findings:

Review of the occupational health records of eight hospital staff members revealed that 3 of the 8 records did not include evidence that the employee had been offered hepatitis B vaccination. The files did not include a declination statement that documented the offering of vaccination by the hospital and refusal of the vaccine by the employee.

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ITEM #1 - PHARMACY POLICIES AND PROCEDURES

Based on interview and review of policies and procedures, the Critical Access Hospital failed to review, approve, and adopt policies and procedures developed and implemented by the telepharmacy contractor.

Failure to review and approve policies and procedures risks pharmaceutical services being out of compliance with Medicare conditions of participation and standards for contracted services.

Findings:

Review of the policy and procedure manual for the pharmacy revealed that the manual had been developed by the telepharmacy contractor. There was no evidence that the hospital had reviewed and approved the contents of the pharmacy manual.

An interview with the hospital's contracted clinical pharmacist (Staff Member #3) on 8/16/2011 at 9:45 AM confirmed the lack of evidence that the policies and procedures had not been reviewed and approved by hospital administration.


ITEM #2 - CONTROLLED SUBSTANCE ACCOUNTABILITY

Based on interview, review of policies and procedures, and review of the narcotics count log, the Critical Access Hospital failed to ensure that narcotics were counted by two nursing staff members according to pharmacy policy.

Failure to verify that narcotics are secure and accounted for risks diversion of narcotics and unsafe healthcare.

Findings:

1. The pharmacy telepharmacy contractor's policy and procedure entitled "Controlled Substances - Pharmacy" (No effective date) stated that controlled substances were to be counted according to the controlled substance policy of the remote hospital site.

2. During an interview on 8/16/2011 at 9:45 AM, the hospital's contracted clinical pharmacist (Staff Member #3) stated that twice weekly two nursing staff members were to count the actual number of narcotic drugs in the automated drug dispensing machine (Pyxis) and verify that this number matched the narcotic count as recorded by the machine. Nurses were to document the narcotics count on the Acute Care Pyxis Control Inventory log.

3. Review of the Acute Care Pyxis Control Inventory log on 8/16/2011 revealed that this count had not been performed for 12 of 16 weeks between 5/8/2011 and 8/72011.


ITEM #3 - REMOVAL OF DRUGS FROM THE PHARMACY WHEN THE PHARMACIST IS ABSENT

Based on review of pharmacy logs and interview, the Critical Access Hospital failed to ensure that pharmacy telepharmacy contractor verified that the correct medications had been removed by nursing staff in absence of he pharmacist according to Washington State pharmacy regulations.

Failure to verify that the correct medications had been removed from the pharmcy risks nondetection of medication errors.

Reference: WAC 246-873-050 Absence of a pharmacist:
(2)(b) The stock container of the drug or similar unit dose package of the drug removed shall be left with a copy of the order of the authorized practitioner to be checked by a pharmacist, when the pharmacy reopens, or as soon as is practicable.

Findings:

Review of the log of medications removed from the pharmacy by nursing staff when the pharmacist was not present revealed that a pharmacist had not initialed the log to verify that the correct medication had been removed from the pharmacy since 3/9/2011.

During an interview on 8/16/2011 at 9:45 AM, the hospital's contracted clinical pharmacist (Staff Member #3) stated that he had verified that the medications removed from the hospital pharmacy were the correct medications. He stated he had not initialed the log to document the verification process.

Based on interview and review of infection control documents, the Critical Access Hospital failed to develop and implement infection control policies consistent with current guidelines published by the Centers for Disease Control and Prevention (CDC).

Failure to implement infection control and prevention policies that are based on current research increases the risk of infection in patients and others.

References: CDC Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 2007; CDC/Healthcare Infection Control Practices Advisory Committee, Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006

Findings:

1. The hospital's policy and procedure entitled "Infection Control Plan" (Effective 12/5/2007; Reviewed 12/10/2010) stated that policies and procedures for infection control and prevention would be based on "relevant contemporary infection control research, including practical measures show[n] empirically to be useful in reducing the risk of infection."

Review of hospital policies and procedure for infection control and prevention revealed they did not include direction for implementation of contact, airborne and droplet isolation precautions. Precautions for care of patients with no known infection were referred to as "universal precautions", a term that has been discontinued by the CDC.

The hospital's policy and procedure entitled "Methicillin Resitant Staphylococccus Aureus" (MRSA) had been wrttien in 1997 and had not been updated since that time to reflect current CDC guidelines. The policy stated that patients with MRSA should be cared for using "universal precautions". CDC guidelines state such patients should be cared for using contact precautions.

2. The hospital's policy and procedure entitled "Infection Control Plan" (Effective 12/5/2007; Reviewed 12/10/2010) stated that surveillance policies, procedures, and methodologies would differentiate between hospital-acquired infections and community-acquired infections.

The hospital's policy and procedure entitled "Surveillance and Reporting" (Effective 11/28/2007; Reviewed 11/27/2010) did not identify how hospital-acquired infections would be differentiated from community-acquired infections.

3. An interview with the hospital's Chief Nursing Officer (Staff Member #1) and infection preventionist (Staff Member #2) on 8/17/2011 at 8:30 AM confirmed that the hospital's infection control and prevention policies and procedures had not been updated according to current CDC guidelines.

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Based on interview the facility failed to ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices. More specifically, the facility's dietary services were not being provided under the direction of an individual who by experience or training would be deemed qualified for the position.

Failure on the part of the facility to appoint an individual having the necessary experience or training in managing a food and dietetic services program puts patients at risk of not having nutritional needs properly met.

Findings include:

1. On 8/18/2011 the surveyor interviewed the individual (Staff Member #1) assigned duties as the director of food and nutrition services. During the interview the surveyor was informed that he/she lacked the background and training that is required to hold the position.

Based on interview and review of hospital policies and procedures, the Critical Access Hospital failed to ensure that hospital policies and procedures were reviewed annually by a professional group that included a physician, a member that was not a member of the CAH staff and physician's assistants that worked in the Emergency Department.

Failure to include all members of the professional group when reviewing policies and procedures risks implementation of procedures that do not meet current standards of practice
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Findings:

1. The hospital's policy and procedure entitled "Policy Management" (Reviewed February 2008) stated that on an annual basis, all non-clinical policies were to be reviewed and approved by the department manager/director and the Chief Executive Officer. All clinical policies were to be reviewed and approved annually by the department manager/director, the Medical Director, and the Chief Executive Officer. The Rural Healthcare Quality Network would provide review oversight "as appropriate".

The policy did not specify which policies would be reviewed by the Rural Healthcare Quality Network

2. Review of non-clinical policies revealed the following:

a. The Environment of Care policies and procedures had not been reviewed since 6/24/2001.

b. The Dietary Department policies and procedures for had not been reviewed since 7/1/2009.

3. Review of clinical policies revealed the following:

a. The Infection Control policies and procedures had been reviewed in November 2010 by the Infection Control Coordinator (Staff Member #2). There was no evidence that the manual had been reviewed by the Medical Director, the Chief Nursing Officer, and the Chief Executive Officer.

b. The Emergency Department policies had been reviewed in January 2011 by the Chief Nursing Officer and the Chief Executive Officer. There was no evidence that the manual had been reviewed by the Medical Director.

c. An interview with the Chief Nursing Officer on 8/16/2011 confirmed that these clinical policies and procedures had not been reviewed according to facility policy.

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Based on interview, the Critical Access Hospital failed to perform a program evaluation according to the regulatory requirements for Critical Access Hospitals.

The purpose of the program evaluation is to determine whether the utilization of services was appropriate, that established policies were followed, and if any changes are needed.

Reference: 42 CFR 485.641(a)
[The evaluation includes review of] (1)(i)The utilization of CAH services, including at least the number of patients served and the volume of services; (ii) A representative sample of both active and closed clinical records; and (iii) The CAH's health care policies.

Findings:

An interview with the hospital administrator on 8/18/2011 at 8:30 AM revealed that the hospital had had not performed a Critical Access Hospital program evaluation since 2009.

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Based on interview and review of quality assurance documentation, the Critical Access Hospital failed to develop a hospital-wide quality assurance plan.

Failure to develop and implement a hospital-wide quality assurance plan limits the hospital's ability to identify problems and develop action plans to improve patient care services.

Findings:

On 8/17/2011 at 11:00 AM, an interview with the Chief Nursing Officer (Staff Member #1) and the hospital's quality program coordinator (Staff Member #6) revealed that individual hospital department had developed their own quality assurance data collection methods and performance improvement projects.

Review of quality assurance program documentation during the interview confirmed that individual department conducted quality assurance and performance improvement in isolation. There was no evidence of inter-departmental collaboration to improve patient outcomes.

The Chief Nursing Officer and the quality improvement coordinator stated that the hospital did not have a written quality assurance/performance improvement plan.

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Based on review of the hospital's list of healthcare contractors and interview, the Critical Access Hospital failed to develop a process for evaluating the performance of contractors who provided clinical services to hospital patients.

Failure to determine whether contractors meet all Medicare conditions of participation and standards risks provision of ineffective and unsafe healthcare to patients.

Findings:

On 8/16/2011 at 9:00 AM during the entrance conference, surveyors received a list of contracted patient care services that included telepharmacy, mobile MRI and mammography, physical and occupational therapy, a reference laboratory, a dietician, a social worker, and a local restaurant that provided meals to patients.

An interview with the hospital administrator on 8/18/2011 at 8:30 AM revealed that the hospital had had not developed a process for evaluating the performance of these patient care contractors.

Based on interview, record review, and review of the Critical Access Hospital's patient rights information, the hospital failed to inform long-term care (swing bed) patients of their rights when admitted to the hospital according to 42 CFR 483.10(b)(3) through (6) for 4 of 4 swing-bed patient records reviewed (Patient #1, #2, #3, #4).

Failure to inform patients of their rights limits the patient's ability to exercise those rights

Reference: ?483.10(b) Notice of Rights and Services -
(1) The facility must inform the resident both orally and in writing in a language that the resident understands of his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility. The facility must also provide the resident with the notice (if any) of the State developed under section 1919(e)(6) of the Act. Such notification must be made prior to or upon admission and during the resident's stay. Receipt of such information, and any amendments to it, must be acknowledged in writing;

Findings:

On 8/16/2011 at 1:30 PM, an interview with the hospital's Chief Nursing Officer (Staff Member #1) revealed that patients were given a handout to read entitled "Patient Rights and Responsibilities" when admitted to the hospital in swing-bed status for long-term care.

Review of 4 swing bed patient records on 8/16/2011 and 8/18/2011 confirmed that the hospital's patient rights handout had been given to these patients for the patient to read and sign.

This handout did not include the rights of swing bed patients as identified at 42 CFR 483.10(b)(3 through 6)), which include the right to choose a MD/DO (?483.10(d)); the right to work or not work (?483.10(h)); the right to privacy in sending and receiving mail (?483.10(i)); the right to retain and use personal possessions (?483.10(l)); and the right to share a room with a spouse (?483.10(m)).

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Based on review of hospital policies and procedure and interview, the Critical Access Hospital failed to ensure that their long-term care activities program director met the professional requirements identified in the regulation.

Failure to develop and implement an activities program that is directed by a qualified professional impairs the hospital's ability to provide and meaningful and therapeutic healthcare environment for long-term care patients.

Findings:

1. Review of the hospital's policy and procedure entitled "Patient Activities/Activities Program" (Revised January 2011) stated that the hospital's swing bed activities program would be directed by a qualified professional according to the regulation.

2. During an interview on 8/16/2011 at 1:30 PM, the hospital's Chief Nursing Officer (Staff Member #1) stated that she was functioning as the activities program director. The interview revealed that the Chief Nursing officer did not have the qualifications to be the director of this program.
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