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ONE HOSPITAL DRIVE

LEWISBURG, PA 17837

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0166

Based on review of facility policies, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure patient care plans were updated to include the use of restraints for four of four restraint patient records reviewed (MR74, MR75, MR76 and MR77)

Findings include:

On April 24, 2017, a request was made for a listing of patients who required the use of restraints. This listing was provided 30 minutes prior to the planned exit conference on April, 27, 2017. The survey exit was delayed while these records were reviewed on April 27, 2017.

Review on April 27, 2017, of the facility policy "Physical Restraints/Chemical Restraints," last reviewed December 18, 2016, revealed "Standard: Evangelical Community Hospital is committed to: 1. Preventing, reducing, and striving to eliminate the use of restraint(s). 2. Preserving the individual's safety and dignity when restraint(s) are used. 3. The use of alternative methods as preferred interventions. 4. Raising awareness among staff about when the restraint(s) can be used and their potential effects on individuals. 5. Carrying out organizational responsibility to facilitate the discontinuation of restraint(s) as soon as possible. 6. Preventing emergencies that have the potential to lead to the use of restraint(s). 7. Maintaining the safety of patients, visitors and staff members. 8. Preventing interruption of necessary therapeutic measures. ... Implementation: 1. Initiate the Restraint Nursing Care Plan ..."

Review on April 27, 2017, of MR74 revealed this patient was admitted to the hospital on December 26, 2016, and discharged on December 31, 2016. This patient received a chemical restraint at 7:30 PM on December 26, 2016. Review of MR74 revealed no restraint nursing care plan.

Review on April 27, 2017, of MR75 revealed this patient was admitted to the hospital on December 26, 2016, and discharged on January 17, 2017. This patient was placed in bilateral wrist restraints at 6:36 PM on December 29, 2016. Review of MR75 revealed no restraint nursing care plan.

Review on April 27, 2017, of MR76 revealed this patient was admitted to the hospital on October 5, 2016, and discharged on October 13, 2016. This patient was placed in bilateral wrist restraints at 11:30 AM on October 5, 2016. Review of MR76 revealed no restraint nursing care plan.

Review on April 27, 2017, of MR77 revealed this patient was admitted to the hospital on October 4, 2016, and discharged on October 8, 2016. This patient was placed in bilateral wrist restraints at 4:28 PM on October 4, 2016. Review of MR77 revealed no restraint nursing care plan.

An interview with EMP31 conducted at approximately 2:20 PM on April 27, 2017, confirmed MR74, MR75, MR76 and MR77 did not have a restraint nursing care plan.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on a review of facility documents and staff interviews (EMP), it was determined the facility failed to ensure each quality indicator selected was related to improvement of health outcomes; failed to ensure the frequency of data collection was specified for each quality indicator; and failed to ensure data collected was measured, analyzed and tracked for performance.

Findings include:

1) Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance," last reviewed January 1, 2017, revealed "Statement of Commitment and Authority The Board of Directors, Medical Staff and Hospital Administration of the Evangelical Community Hospital affirm their commitment and responsibility for maintaining and improving the quality of care in the hospital. ... Scope of QA Monitoring Functions ... Hospital Departments Hospital departments will design effective mechanisms for reviewing and evaluating the quality of patient care and appropriateness of services each provides. Written summaries of quality activities will be submitted to the Director of Clinical Quality and Patient Safety on a quarterly basis. ..."

Review on April 27, 2017, of the facility provided list of hospital departments revealed the following: Acute Rehabilitation, Ambulatory Surgical Center, Anesthesia, Cardiac Rehabilitation, Cardiovascular Services, Breast health, Orthopedic, Central Supply, Echocardiogram, Endoscopy, Housekeeping, Imaging, Infection Control, Infusion Center, Intravenous, Laboratory, Nuclear Medicine, Nursing Services (Intensive Care/Coronary Care, Labor and Delivery, Medical, Obstetrics, One Day Surgery, Pediatrics, Step Down and Surgical patient care units) Nutrition Services, Pain, Pharmacy, Plant Engineering, Pulmonary Rehabilitation, Rehabilitation, Respiratory Therapy, Sleep Center, Operating Room, Urgent Care Center, Utilization Review, Vascular and Wound.

Review on April 27, 2017, of the facility provided Quality Improvement projects revealed the following departments reported on Quality activities during 2016: Nutrition Services, Nuclear Medicine and Emergency Department.

Review on April 27, 2017, of the facility provided Quality Improvement projects revealed the following departments reported on Quality activities during 2017: Third Floor Medical, Surgical Services, Intensive Care, Emergency Department, Central Services, Laboratory, Rehab Services, Cardiopulmonary Services and Intravenous Therapy.

A request was made of EMP26 on April 27, 2017, for documentation indicating how the facility selected the departmental quality indicators. No documentation was provided.

Interview with EMP26 on April 27, 2017, at approximately 10:30 AM revealed there was no documentation the departmental quality indicators selected were related to the improvement of patient health outcomes. EMP6 revealed departments selected their own quality indicators and may or may not be patient care related.

2) Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance" last reviewed January 1, 2017, revealed "... Statement of Purpose The purpose of the performance improvement program is to provide efficient and effective mechanisms for identifying, reporting, evaluating and monitoring all aspects of patient care. All activities in the Hospital, both clinical and non-clinical, are processes that can be continuously improved. ..."

A request was made of EMP26 on April 27, 2017, for a policy, procedure or guideline for facility staff to follow regarding the frequency of data collection for quality assurance indicators. No policy, procedure or guideline was provided.

Interview with EMP26 on April 27, 2017, at approximately 10:45 AM confirmed there was no defined frequency of data collection for each quality indicator selected for review. EMP6 revealed this employee was not aware of how departments collected data or the frequency of the data collection.

3) Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance" last reviewed January 1, 2017, revealed "... Responsibility ... Performance Enhancement Committee The primary duties of the PEC shall be in medical care evaluation, performance improvement and patient safety activities as follows: ... Actively be involved in the measurement, assessment, and improvement of activities of practitioner performance in the Hospital as defined in the Medical Staff Bylaws. ... Identify and analyze system failures that adversely affect patient care and/or patient safety. Recommend, implement, monitor, and document corrective actions to rectify the identified system failures. ..."

A request was made of EMP26 on April 27, 2017, for documentation the facility's quality assurance indicators selected by facility departments were measured, analyzed and tracked for performance over time. No documentation was provided.

Interview with EMP26 on April 27, 2017, at approximately 11:15 AM confirmed there was no documentation the data collected by the facility departments was measured, analyzed and tracked for performance. EMP26 revealed this employee was not able to provide documentation of the data utilized by facility staff to collect, measure, analyze and track data.

Repeat deficiency cited July 25, 2014

Cross reference
482.21(b)(2)(ii), (c)(1), (c)(3) Quality Improvement Activities
482.21(d) Qapi Performance Improvement Projects
482.21 Qapi Governing Body
482.21(e)(1), (e)(2), (e)(5) Qapi Executive Responsibilities

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to measure the success and track the performance of the quality improvement projects in facility departments to ensure improvement of the program activities.

Findings include:

Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance" last reviewed January 1, 2017, revealed "... Statement of Purpose The purpose of the performance improvement program is to provide efficient and effective mechanisms for identifying, reporting, evaluating and monitoring all aspects of patient care. All activities in the Hospital, both clinical and non-clinical, are processes that can be continuously improved. ..."

Review on April 27, 2017, of the facility provided list of hospital departments revealed the following: Acute Rehabilitation, Ambulatory Surgical Center, Anesthesia, Cardiac Rehabilitation, Cardiovascular Services, Breast health, Orthopedic, Central Supply, Echocardiogram, Endoscopy, Housekeeping, Imaging, Infection Control, Infusion Center, Intravenous, Laboratory, Nuclear Medicine, Nursing Services (Intensive Care/Coronary Care, Labor and Delivery, Medical, Obstetrics, One Day Surgery, Pediatrics, Step Down and Surgical patient care units) Nutrition Services, Pain, Pharmacy, Plant Engineering, Pulmonary Rehabilitation, Rehabilitation, Respiratory Therapy, Sleep Center, Operating Room, Urgent Care Center, Utilization Review, Vascular and Wound.

Interview with EMP26 on April 26, 2017, at approximately 11:35 AM confirmed the facility did not measure the success and track the performance of the quality improvement projects in facility departments to ensure improvement of the program activities.

Cross reference
482.21(a),(b)(1), (b)(2)(i), (b)(3) Data Collection and Analysis
482.21(d) Qapi Performance Improvement Projects
482.21 Qapi Governing Body
482.21(e)(1), (e)(2), (e)(5) Qapi Executive Responsibilities

QAPI PERFORMANCE IMPROVEMENT PROJECTS

Tag No.: A0297

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure the quality improvement program reflected the scope and complexity of the hospital's services.

Findings include:

Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance" last reviewed January 1, 2017, revealed no documentation the facility developed and implemented quality improvement activities which reflected the scope and complexity of the facility's services and operations.

Review on April 27, 2017, of the facility provided list of hospital departments revealed the following: Acute Rehabilitation, Ambulatory Surgical Center, Anesthesia, Cardiac Rehabilitation, Cardiovascular Services, Breast health, Orthopedic, Central Supply, Echocardiogram, Endoscopy, Housekeeping, Imaging, Infection Control, Infusion Center, Intravenous, Laboratory, Nuclear Medicine, Nursing Services (Intensive Care/Coronary Care, Labor and Delivery, Medical, Obstetrics, One Day Surgery, Pediatrics, Step Down and Surgical patient care units) Nutrition Services, Pain, Pharmacy, Plant Engineering, Pulmonary Rehabilitation, Rehabilitation, Respiratory Therapy, Sleep Center, Operating Room, Urgent Care Center, Utilization Review, Vascular and Wound.

Interview with EMP26 on April 27, 2017, confirmed there was no documentation the facility developed and implemented quality improvement activities which reflected the scope and complexity of the facility's services and operations.

Cross reference
482.21(a),(b)(1), (b)(2)(i), (b)(3) Data Collection and Analysis
482.21(b)(2)(ii), (c)(1), (c)(3) Quality Improvement Activities
482.21 Qapi Governing Body
482.21(e)(1), (e)(2), (e)(5) Qapi Executive Responsibilities

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure the Quality Improvement program monitoring was performed for all services provided under contract with an outside company.

Findings include:

Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance" last reviewed January 1, 2017, revealed no documentation the Quality Improvement program included monitoring of all services provided under contract with an outside company.

Review on April 27, 2017, of the facility provided list revealed the following services were provided to the hospital through contract: interventional cardiology, tele-critical care medicine services; tele-psychiatry, tele-stroke and pediatric, neurologic and radiology services.

Interview with EMP26 on April 27, 2017, at approximately 2:30 PM confirmed interventional cardiology, tele-critical care medicine services; tele-psychiatry, tele-stroke and pediatric, neurologic and radiology services were services provided to the hospital through contract. EMP26 confirmed these contracted services were not monitored through the quality improvement program.

Cross reference
482.21(a),(b)(1), (b)(2)(i), (b)(3) Data Collection and Analysis
482.21(b)(2)(ii), (c)(1), (c)(3) Quality Improvement Activities
482.21(d) Qapi Performance Improvement Projects
482.21(e)(1), (e)(2), (e)(5) Qapi Executive Responsibilities

QAPI EXECUTIVE RESPONSIBILITIES

Tag No.: A0309

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure the Board had ultimate oversight and responsibility for the Quality Assurance program and failed to ensure all departments selected and reported distinct improvements projects annually.

Findings include:

Review on April 27, 2017, of the facility's "Plan For Improving Organizational Performance" last reviewed January 1, 2017, revealed "Statement of Commitment and Authority The Board of Directors, Medical Staff and Hospital Administration of the Evangelical Community Hospital affirm their commitment and responsibility for maintaining and improving the quality of care in the hospital. While maintaining ultimate authority, the Board of Directors has authorized the medical Staff and Hospital Administration to accept and discharge these obligations. ... Responsibility Board of Directors Ultimate oversight responsibility Review the quality plan annually Review/act on QA/QI information reported by Administration Recommend potential QA/QI activities Demonstrate leadership, commitment and vision by supporting QA/QI activities and modeling Core Values ... Responsibility ... Quality Assessment Manager Work closely with the chairman of the PEC and PIC to provide integration and coordination of quality improvement and associated resource management activities of committees, departments and services. Receives reports from committees, departments, and services as appropriate. ..."

1) A request was made of EMP26 on April 27, 2017, for documentation the facility's Board of Directors reviewed, approved or recommended any quality assurance or quality improvement activities for 2015, 2016 and 2017. No documentation was provided.

Review on April 27, 2017, of the facility's "Board of Directors Bylaws," last adopted June 1, 2015, revealed no documentation indicating the Board had ultimate oversight and responsibility for the Quality Assurance program.

Interview with EMP26 and EMP27 on April 27, 2017, at approximately 2:45 PM confirmed the Board of Directors Bylaws contained no documentation indicating the Board had ultimate oversight and responsibility for the Quality Assurance program.

2) Review on April 27, 2017, of the facility provided list of hospital departments revealed the following: Acute Rehabilitation, Ambulatory Surgical Center, Anesthesia, Cardiac Rehabilitation, Cardiovascular Services, Breast health, Orthopedic, Central Supply, Echocardiogram, Endoscopy, Housekeeping, Imaging, Infection Control, Infusion Center, Intravenous, Laboratory, Nuclear Medicine, Nursing Services (Intensive Care/Coronary Care, Labor and Delivery, Medical, Obstetrics, One Day Surgery, Pediatrics, Step Down and Surgical patient care units) Nutrition Services, Pain, Pharmacy, Plant Engineering, Pulmonary Rehabilitation, Rehabilitation, Respiratory Therapy, Sleep Center, Operating Room, Urgent Care Center, Utilization Review, Vascular and Wound.

Review on April 27, 2017, of the facility provided Quality Improvement projects revealed the following departments reported on Quality activities during 2016: Nutrition Services, Nuclear Medicine and Emergency Department.

Review on April 27, 2017, of the facility provided Quality Improvement projects revealed the following departments reported on Quality activities during 2017: Third Floor Medical, Surgical Services, Intensive Care, Emergency Department, Central Services, Laboratory, Rehab Services, Cardiopulmonary Services and Intravenous Therapy.

Interview with EMP26 on April 27, 2017, at approximately 11:50 AM confirmed the above list of hospital departments and the hospital departments that reported Quality Improvement (QI) projects for 2016 and 2017. EMP26 revealed there was no set reporting time frame for departmental QI projects. EMP26 revealed requests were sent to each department for their QI project reports, and departments were not compliant in providing the QI department with the QI projects.

Cross reference
482.21(a),(b)(1), (b)(2)(i), (b)(3) Data Collection and Analysis
482.21(b)(2)(ii), (c)(1), (c)(3) Quality Improvement Activities
482.21(d) Qapi Performance Improvement Projects
482.21 Qapi Governing Body

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on review of facility documents, observation, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure expired medications were removed from a delivery room on the obstetrical unit and failed to ensure the medication cabinet in a delivery room was locked.

Findings included:

1) Review on April 24, 2017, of the facility "Pharmacy Policy Manual," revised November 2016, revealed "1.1 Subject: The Philosophy of the Pharmacy Department. A. The primary goal of the Pharmacy Department is to provide a broad range of modern, high quality pharmaceutical services to the patients of the Evangelical Community Hospital in an efficient, cost-effective, personalized and compassionate manner. The department will maintain and uphold the policies of Evangelical Hospital with respect to patient rights and confidentiality. ... 1.6 Subject: Drug Procurement, Storage and Control. ... C. Stocking. ... F. Outdated Drugs and Return Goods a. The Medicare Conditions of Participation and the Pennsylvania Department of Health Hospital Regulations prohibit the use of expired or outdated medications. b. Outdated and damaged drugs must be removed from drug supplies intended for patient use by pharmacy or nursing personnel and sent to the inpatient pharmacy. c. No drug may be administered to a patient after its labeled expiration date. When an expiration date is stated only in terms of month and year, the intended expiration date is the last day of the stated month. ..."

Observation on April 24, 2017, at 10:35 AM, of room 3201 (a delivery room) revealed a locked drawer containing 2 vials of Vitamin K (medication that assists the blood to clot) labeled with an expiration date of December 2016.

Interview with EMP3 on April 24, 2017, at 10:35 AM confirmed the locked drawer containing 2 vials of Vitamin K labeled with an expiration date of December 2016 and that it was the nurses' responsibility to check the drawers for expired medications.

Review on April 24, 2017, of MR11 revealed MR11 was delivered in room 3201 and received Vitamin K on April 20, 2016.

Interview with EMP3 on April 24, 2017, at 1:30 PM confirmed MR11 was delivered in room 3201 and received Vitamin K on April 10, 2016. EMP3 revealed MR11 may have received expired Vitamin K.

2) Review on April 24, 2017, of the facility policy "Medication Administration," dated last reviewed/revised January 12, 2017, revealed "Standard: The Medication Administration Policy utilized on the nursing units allows for appropriate transcription, requisition, charging, storage, administration, and charting of medications by qualified nursing personnel. The administration of medications includes the right patient, right drug, right dose, right route, and right time. Policy: ... Section IV Administration of Medications 1. Administration of Medications Using Medication Cart A. The medication cart shall be kept locked when not in use. ... "

Observation on April 24, 2017, at 10:30 AM, of room 3200 revealed an unlocked cabinet above the sink. The cabinet was open with two vials of Pitocin (medication used to strengthen contractions during childbirth), one vial of Ephedrine (medication used to treat low blood pressure), a bottle of Xylocaine (solution used as a local anesthetic), and 18 gauge needles.

Interview with EMP3 on April 24, 2017, at 10:30 AM confirmed the cabinet above the sink was open and unlocked. The cabinet contained two vials of Pitocin, one vial of Ephedrine, a bottle of Xylocaine, and 18 gauge needles. EMP3 revealed the cabinet was to be locked when not in use.

CONTENT OF RECORD: FINAL DIAGNOSIS

Tag No.: A0469

Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure medical records were completed 30 days following discharge for four of 19 medical records reviewed (MR78, MR79, MR80 and MR81).

Findings include:

Review on April 26, 2017 of facility's "Medical Staff Bylaws," last revised March 24, 2017, revealed "Rules [and] Regulations ... 7. The Hospital's Health Information Services Department shall be responsible for monitoring timely completion of medical record and report to the Chair of the Medical Records Committee and President of the Medical Staff any practitioner with incomplete medical records in the Department for more than fifteen days following discharge. The Director of Health Information Services shall notify the practitioner of this deficiency by letter. If the medical records are not completed within fifteen days of the mailing date of the letter, disciplinary action shall be taken by the Executive Committee ... 8. After a letter is sent to the practitioner indicating that he or she has fifteen (15) days in which to complete delinquent medical records and he or she does not comply within the prescribed time, a fine of $25.00 per day will be assessed until the delinquent records are completed and ready to be filed. The daily fine will be assessed for a maximum of fifteen (15) days or a total of $375.00. If at the end of thirty (30) days following the fifteen-day (15) period specified in the letter to the practitioner from the President of the Medical Staff the practitioner still does not have his or her delinquent medical records completed, suspension from the Medical Staff shall be automatic. Failure to pay the fine within thirty (30) days of the billing date shall also result in automatic suspension from the Medical Staff. The check for payment of a fine is to be made payable to Evangelical Community Hospital. Privileges will be reinstated immediately upon completion of medical records and payment of fines. Failure to comply with the medical record completion requirements will be reported to PEC and Credentialing Committee. 9. A medical record is considered complete when it is ready to be filed, i.e. there are no deficiencies and all required signatures are included. ...".

Review on April 26, 2017 of facility's "Incomplete over 30" lists, listing the delinquent medical records over 30 days on April 25, 2017, revealed four medical records incomplete. Documentation noted MR78 at 41 days, MR79 at 33 days, MR80 at 40 days and MR81 at 35 days.

Interview with EMP9 on April 26, 2017, at approximately 12:00 PM, confirmed the "Incomplete over 30" list with four medical records incomplete as of April 25, 2017. MR78 noted at 41 days. MR79 noted at 33 days. MR80 noted at 40 days. MR81 noted at 35 days. EMP9 revealed practitioners are sent letters or emailed when they have delinquent medical records. They are fined per day. They do not lose admitting privilege until after 45 days per the Medical Bylaws.

Interview with EMP9 on April 27, 2017, at 1:50 PM, revealed the practitioners are notified weekly of delinquent medical records from day one through day thirty. The practitioners receive a letter via email or fax to their office through the hospital system. The practitioner's office is called and EMP9 talks to the Director of the office. The office Director is made aware of the delinquent medical records. After 30 days and up to 15 days, the practitioner is fined. After 45 days, the practitioner is referred to the Medical Staff director and the practitioner's privileges become involved.

FIRE CONTROL PLANS

Tag No.: A0714

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to ensure fire drills were completed in all outpatient sites.

Findings include:

Review on April 25, 2017, of the facility's "Fire Evacuation Policy and Procedure" policy, no review date, revealed "Policy This policy ensures that Evangelical Community Hospital meets the standards for evacuation contained in the current Life Safety Code and other applicable laws and regulations. ... Fire Evacuation Drills Hospital wide evacuation drills are conducted once quarterly with the local fire department attending one drill annually. Drills are conducted for two reasons: first, drills allow personnel to practice how they will respond to an evacuation (training), and second, drills reinforce safety education (education) to ensure that drills provide the maximum benefit, personnel should respond as if there were as actual emergency. ..."

Review on April 25, 2017, of the facility's fire drills for Physical Therapy of Evangelical in Williamsport revealed no documentation the facility completed a fire drill during the first quarter in 2016.

Review on April 25, 2017, of the facility's fire drills for Physical Therapy of Evangelical in Mt. Pleasant Mills revealed no documentation the facility completed fire drills during the first and third quarters in 2016.

Review on April 25, 2017, of the facility's fire drills for Physical Therapy of Evangelical in Mifflinburg revealed no documentation the facility completed fire drills during 2016.

Review on April 25, 2017, of the facility's fire drills for Physical Therapy of Evangelical in Middleburg revealed no documentation the facility completed a fire drill during the first quarter in 2017.

Review on April 25, 2017, of the facility's fire drills for Strawbridge Laboratory in Northumberland revealed no documentation the facility completed fire drills during 2016 and 2017.

Review on April 25, 2017, of the facility's fire drills for Milton Laboratory in Milton revealed no documentation the facility completed fire drills during 2016 and 2017.

Review on April 25, 2017, of the facility's fire drills for Physical Therapy of Evangelical in Meadow Green revealed no documentation the facility completed a fire drill during the first quarter in 2017.

Interview with EMP16 on April 25, 2017, at approximately 3:15 PM confirmed the facility did not complete fire drills quarterly in all outpatient sites.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on review of facility documents, observation and staff interview (EMP), it was determined the facility failed to ensure temperature and humidity requirements were monitored in the post-anesthesia care unit.

Findings include:

A policy for maintaining and monitoring temperatures and relative humidity in the surgical suite, including the post-anesthesia care unit, was requested from the facility. No policy was provided.

Review of "The Guidelines for the Design and Construction of Hospitals and Outpatient Facilities," 2014 edition, revealed the recovery room temperature was to be maintained between 72 - 78 degrees Fahrenheit and relative humidity between 20 and 60 percent.

Tour of the post-anesthesia care unit revealed no log of temperature and humidity readings for the area.

An interview with EMP32 conducted at approximately 1:30 PM on April 25, 2017, revealed post-anesthesia care staff do not monitor the temperature and humidity levels in the post-anesthesia care unit.

An interview with EMP33 conducted at approximately 10:30 AM on April 26, 2017, confirmed temperature and humidity levels were not monitored in the post-anesthesia care unit.

An interview with EMP27 conducted at approximately 2:30 PM on April 27, 2017, confirmed the facility did not have a policy for maintaining and monitoring temperatures and relative humidity in the surgical suite which included the post-anesthesia care unit.

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on review of facility policies and observation, it was determined the facility failed to ensure suction tubing and oral catheters were contained in their sterile packaging prior to use in the post-anesthesia area of the hospital and in the ambulatory surgery center.

Findings include:

A request was made for the facility's policy related to suctioning. EMP27 stated the facility followed Lippincott procedures and provided the following document.

Review on April 25, 2017, of the facility provided "Lippincott Procedures-Oropharyngeal suctioning, neonatal," date last revised November 11, 2016, revealed "Introduction Oropharyngeal suctioning is the removal of secretions from the oropharynx through a suction catheter inserted through the mouth. ... Implementation. ... Check the suction pressure by occluding the end of the connection tubing. Perform hand hygiene. Put on gloves and, as needed other personal protective equipment to comply with standard precautions. Open the suction catheter and attach it to the connection tubing. ..."

1) Observation on April 25, 2017, of the post-operative care unit in the hospital revealed four patient bays with the oral suction catheter packages open and catheters attached to the suction tubing. In one patient bay, the suction catheter was no longer in the package and was open to the air. These oral catheters were exposed to potential environmental contaminants.

Interview on April 25, 2017, with EMP8 at 1:15 PM confirmed it was routine practice in the post-operative care unit to open the sterile package and attach the oral suction catheters to the suction tubing. The suction tubing was attached to the suction canister in each patient bay area.

Review of the oral suction catheter packaging revealed this product was sterile while in the package.

Interview with EMP8 confirmed the oral suction catheter packaging stated the catheter was sterile while in the package.

2) Observation at 10:00 AM, on April 27, 2017, of the pre-operative area in the Ambulatory Surgery Center revealed eight bays with the suction tubing and oral suction catheter packages open and attached to the suction canister.

Observation at 10:15 AM, on April 27, 2017, of the post-operative area in the Ambulatory Surgery Center revealed 13 bays with the suction tubing and oral suction catheter packages open and attached to the suction canister.

Review of the suction tubing packaging revealed this product was sterile while in the package.

Interview with EMP34 at 10:15 AM on April 27, 2017, confirmed the eight pre-operative bays and the 13 post-operative bays had the suction tubing and oral suction catheter packages open and attached to the suction canister. EMP34 also confirmed the suction tubing packaging stated this product was sterile while in the package.

3) Observation on April 27, 2017, of the cardiac catheterization laboratory post procedure recovery area revealed suction tubing and oral suction catheters were kept in their sealed sterile packages and placed next to the suction canisters in each patient bay.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on review of facility documents, personnel files (PF), observation, and staff interview (EMP), it was determined the facility failed to ensure the Hepatitis B vaccination series were completed for three of 21 personnel files reviewed ((PF13, PF18 and PF21), failed to ensure antiseptic solutions were labeled with a beyond use date, and failed to ensure carts containing patient care items were covered.

Findings include:

1) Review on April 27, 2017 of facility's "Exposure Control Plan For Evangelical Community Hospital," last reviewed July 2016, revealed "Section I I. Purpose of the Plan: The purpose of the OSHA Bloodborne Pathogen Standard CFR 1910.1030 and the Exposure Control Plan (ECP) is to reduce occupational exposure to bloodborne pathogens. These include but not limited to hepatitis B virus, hepatitis C virus ... Section IV A. General All ECH employees recognize that even with good adherence to all of these exposure prevention practices, exposure incidents can occur. As a result, a Hepatitis B Vaccination Program, as well as procedures for post-exposure evaluation and follow-up has been implemented should exposure to bloodborne pathogens occur. Evangelical ensures that all medical evaluations and procedures including the hepatitis B vaccines and post-exposure evaluation and follow-up, including prophylaxis, are: Made available at no cost the employee. Made available to the employee at a reasonable time and place. Performed by/under the supervision of a licensed physician or other licensed healthcare professional. Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place. ... Hepatitis B Vaccination ... B. Hepatitis B Vaccination Program 1. All employees who have been identified as having exposure to blood or OPIM will be offered the Hepatitis B vaccine at no cost to the employee. 2. The vaccine will be offered within 10 working days of their initial assignment to work involving the potential for occupational exposure to blood or OPIM unless the employee has previously had the vaccinations and the Hepatitis B antibody test demonstrates sufficient immunity or the employee is allergic to the vaccine. 3. If a routine booster is indicated by the antibody titer levels post vaccination series, a routine booster of the vaccine will be administered at no cost to the employee. If the titer is in the non-therapeutic level (0), the complete series will be repeated at no cost the employee and a follow up titer will be drawn. 4. If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Services at a future date, such booster dose(s) shall be made available to the employees at no cost. 5. The Employee Health Nurse is responsible for setting up and operating Hepatitis B vaccination program. ..."

Review on April 27, 2017, of PF13 revealed the Hepatitis B antibody titer dated November 2, 2016, was below 5.0 (not immune). It was recommended to repeat the series of injections. There was no documentation PF13 was informed of the recommendation to repeat the Hepatitis B series.

Review on April 27, 2017, of PF18 revealed PF18 received two of the three injections in the Hepatitis B vaccine series (August 17, 2016, and September 12, 2016).

Review on April 27, 2017, of PF21 revealed PF21 received one of the three injections in the Hepatitis B vaccine series (June 22, 2016).

Interview with EMP35 on April 27, 2017, at approximately 1:45 PM, confirmed the Hepatitis B vaccines were not completed for PF13, PF18 and PF21. EMP35 revealed they provided the employee a card with the information to call and set up a time for the vaccines. EMP35 confirmed they provided no further follow-up with the employee.

2) Review on April 26, 2017 of facility's "Pharmacy Policy Manual", last revised November 2016, revealed "1.1 Subject: The Philosophy of the Pharmacy Department. A. The primary goal of the Pharmacy Department is to provide a broad range of modern, high quality pharmaceutical services to the patients of the Evangelical Community Hospital in an efficient, cost-effective, personalized and compassionate manner. The department will maintain and uphold the policies of Evangelical Hospital with respect to patient rights and confidentiality. ... 1.7.1 Medication Expiration Dates Policy: All medications will be assigned a beyond use date when they are opened. No medication will be used after it has reached its beyond use date. Purpose: To define beyond use dates for opened medication containers so that drug sterility and stability will be maintained. Assigning Beyond Use Dates (BUD): ... 9. Antiseptic Solutions (eg Hydrogen Peroxide, alcohol, Dakin's Solution) i. Upon first use of an antiseptic solution the container will be labeled with a beyond use date. The beyond use date will be 90 days or per manufacturer's expiration date, whichever comes first. If contamination is suspected the product should be discarded. ii. When pouring antiseptic solutions into another container it should be done in a manner to prevent the original container from being contaminated ...".

Observation on April 24, 2017, of the Step-Down Unit (SDU) revealed a spray bottle containing alcohol. There was no documentation of the beyond use date. There were two open 16-ounce bottles of betadine solution. There was no documentation of the beyond use date. One bottle of betadine solution was in the medication room cabinet and one bottle of betadine solution was in the storage room cabinet.

Interview with EMP2 on April 24, 2017, confirmed the spray bottle containing alcohol with no documentation of beyond use date. EMP2 revealed the alcohol was transferred from the manufacture bottle into the spray bottle to use when cleaning the telemedicine monitoring equipment. EMP2 confirmed there were two open 16-ounce bottles of betadine solution with no documentation of the beyond use date.

3) Request made on April 24, 2017 for a facility policy for the storing of patient care items on the patient care carts. No policy was provided.

Observation on April 24, 2017, at 10:25 AM on the second floor revealed a patient care cart in the hallway with unpackaged/exposed patient disposable undergarments. The disposable undergarments were on the bottom shelf of the patient care cart. The bottom shelf was not covered. The top shelf was covered. The top shelf contained packaged and unpackaged/open patient items.

Interview with EMP2 on April 24, 2017, at 10:25 AM, confirmed the carts in the hallway on the second floor with unpackaged/exposed patient disposable undergarments on the bottom uncovered shelves.