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Based on observations, interview, review of the manufacturer's instructions and review of logs maintained by the facility, the provider failed to ensure equipment was maintained at an acceptable level of safety and quality as evidenced by failure to perform maintenance on steam sterilizer used for sterilizing instruments; and failure to ensure inspection, maintenance and testing of their fire alarm and fire sprinkler system in accordance with NFPA 25 and NFPA 72.

The findings include:

On 5/23/19 at approximately 10am, a steam sterilizer (Midmark M9/M11) was observed housed in the area of the hospital once designated as operating room suite.
Concurrent interview with the interim Director of Nursing (DON), who also served as the facility's designated patient safety officer, revealed the equipment was used once or twice a month to steam sterilize instruments from the hospital and the 2 clinics owned and operated by the hospital. She stated the steam sterilization process was conducted by an employee who came in just to perform that duty. The employee responsible for sterilizing the instruments was not available during the survey visit.

Review of the facility document titled "sterilization log sheet 2019" included two entries. An entry dated 1/14/19 that monthly maintenance had been performed and an entry dated 2/3/19 included a start time of 1400 and an end time of 1600 without any further documentation.

Interview conducted with the facility's interim Director of Nursing on 5/23/19 at approximately 11:00am confirmed there not to be any further documentation related to the maintenance of the equipment.

Review of the manufacturer's instructions for the steam sterilizer documented a procedure for weekly maintenance and for monthly maintenance. The instructions documented failure to perform weekly maintenance could result in sterilizer malfunction and failure to perform monthly maintenance could result in the premature failure of sterilizer components.


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On 05/23/2019, a tour of the facility was conducted by the Life Safety Code Inspector and the Maintenance Director. The sprinkler system was observed to display a red tag dated 04/30/2019. This tag indicates the fire system has a critical problem which requires immediate repair. The facility had been issued a letter from sprinkler inspecting company stating the system had five sprinkler heads that were needing replaced. If not replaced, the system may not function in the event of a fire. The facility's fire alarm panel was found to be in "trouble" mode. Further review of documentation identified the fire alarm panel had been in trouble since 12/2018. The facility failed to ensure this essential equipment was maintained in safe operating condition.

Based on interview, review of facility policies and procedures, review of medical executive committee reviews, review of governing body meeting minutes and review of governing body by-laws, the Critical Access Hospital failed to ensure development, review and implementation of policies governing the total operation of the hospital and failed to ensure the provision of quality health care in a safe environment.

Findings:

Review of facility policies and procedures for nursing services, radiology services, respiratory services, infection control and the facility's Quality Assurance Performance Improvement plan revealed the most recent review date of 1/19/2018. A request was made for the facility's annual program review that included review of policies and procedures.

Interview conducted with the administrative assistant on 5/23/19 at 9:30am revealed there was not an annual evaluation conducted. She further stated she was not aware of the requirement to conduct such an evaluation.
In interview with the facility's designated Chief Executive Officer (CEO) on 5/23/19 at 1:20pm, he was informed of the components required for an annual evaluation and confirmed the facility had not conducted a total annual program evaluation.

Interview with the interim Infection Control designee on 5/22/19 at approximately 1pm, revealed instruments were steam sterilized twice monthly by an employee from one of the hospital's medical clinics. Observation of the M9/M11 Steam Sterilizer on 5/22/19 at approximately 1:45pm, in the presence of the interim Infection Control designee (ICD), failed to indicate any biological indicators were being run. A notebook was observed containing a document titled "Sterilization Log Sheet 2019" with designated columns to document date, start and end time of cycle, cycle length, temperature, pressure and operators initials. There were no entries for sterilization cycles on this document for calendar year (CY) 2019 and only 4 entries for CY 2018. The entries failed to indicate temperature or pressure were obtained during the cycle. The temperature and pressure were documented as WNL (Within Normal Limits). Steam sterilization pouches and chemical steam indicator strips were observed in the cabinet housing the sterilizer, but there was no evidence of any biological testing indicators. The interim ICD (Infection Control Designee), at the time of this observation, acknowledged it "probably was not being done" since there were no supplies for the biological testing.

The Center for Disease Control (CDC) recommends a spore test should be used on each sterilizer at least weekly. CDC guidelines for sterilization include the following: Chemical indicators should be used in conjunction with biological indicators, but based on current studies should not replace them because they indicate sterilization at marginal sterilization time and because only a biological indicator consisting of resistant spores can measure the microbial killing power of the sterilization process. Biological indicators measure the sterilization process directly by using the most resistant microorganisms and not by merely testing the physical and chemical conditions necessary for sterilization. Biological indicators are the only process indicators that directly monitor the lethality of a given sterilization process.

Review of the facility's policy and procedure titled "Autoclave" with most recent review date of 1/29/18, documented the procedure for use of the autoclave, but failed to include preparation of instruments prior to the steam sterilization and failed to include biological monitoring testing for use of the steam sterilizer. The procedure documented to start the timer when the temperature reached 262 degrees and to set the timer for 60 minutes. The ICD was not able to provide logs to indicate the instruments had been sterilized (temperature and time) in accordance with the written procedure..

A review of the facility's 2018 Quality Assessment Performance Improvement (QAPI) Plan documented key components included the following: (1) Ongoing monitoring and data collection (2) Problem prevention, identification of problems or potential problems (3) Data Analysis and (4) Identification, implementation and evaluation of corrective actions.

Review of the QAPI indicators for April 2018 through April 2019 revealed the laboratory failed to provide QA data for 7 of the 12 months (September and December 2018; and and January, February, March 2019.) Review of the QAPI indicators revealed radiology failed to provide QA data for January, February and March 2019. Interview with the Radiology Department manager on 5/20/19 at approximately 11am revealed a plan to incorporate ultrasound diagnostic testing that began February 1, 2019 to their current QA program. Medical records failed to provide any Quality Assurance data for 12 of 12 months for their measure of monitoring percentage of incomplete inpatient charts. Review of the QAPI indicators for Plant Operations documents "completion of tasks" as the measure for 2018 and 2019. There is no data submitted for the period of April 2018 through March 2019. Routine, preventative maintenance and testing activities for equipment and fire safety was not included in the QA plan. Interview conducted with the facility's designated interim Plant Operations Manager on 5/23/19 at approximately 12:30pm revealed "completion of tasks" to be related to maintenance work orders. She further stated she needed ideas on what to include in Plant Operations Quality Assurance plan.

Review of Quality Improvement/Patient Safety meeting minutes for January 2019, February 2019, March 2019 and April 2019 failed to include documentation of fire safety issues that been brought to the attention of the provider on 12/11/2018, when the facility's fire alarm company informed the facility their system had 5 sprinkler heads that were in need of replacement to prevent malfunction of the system in the event of a fire. The minutes failed to include the identification of the problem and/or corrective measures implemented.

The facility's QAPI plan documented Medical Staff peer audits to be included and fulfilled by the Medical Staff in accordance with the Medical Staff Case Review Plan. The plan documented chart reviews shall be performed at the Medical Staff meetings and documented in the minutes of the reviewing committee. Chart review criteria included, but was not limited to, mortality reviews, unexpected return Emergency Room visits within 48 hours of prior discharge with same or related diagnosis and patient complaints regarding physician care. An interview was conducted with Director of Medical Records on 5/23/19 at approximately 9:30am, and revealed she was not aware of any process where medical records were reviewed for quality and appropriateness. She stated she reviewed 100% of the medical records, but only looked at diagnoses as it related to coding. An interview with the facility's designated interim Director of Nursing (DON) on 5/23/19 at approximately 1pm revealed she was not aware of any process for conducting peer reviews. She contacted the Emergency Department (ED) via phone and was informed there was periodic discussion at medical staff meetings and they had conducted peer review on specific cases as warranted. The ED Director informed the DON he reviewed charts occasionally, but had done nothing regularly since hurricane Michael, due to physician turnover and moving spaces. Review of Medical Staff committee meetings for 7/24/18, 9/18/18, 11/13/18 and 2/12/19 failed to indicate any documentation of peer review activity. Subsequent interview with the DON on 5/23/19 at approximately 1:10pm revealed 2 complaints from ED patients included a chart review by the ED Director as part of the investigation. No other peer reviews were noted. Interview with the staff member designated as Human Resources Director/Medical Staff Coordinator on 5/23/19 at approximately 1:15pm revealed there had been no peer reviews conducted in the last year.

Review of Governing Body By-Laws with most recent review date of 2/5/19, included "oversees the quality and efficiency of care provided to hospital patients."

Based on interviews, record reviews and policy and procedure reviews, the cumulative effect of the facility's failure to ensure quality assurance activities were implemented in accordance with their written plan and failure to ensure an annual evaluation of their total program was conducted, resulted in NOT meeting the Condition of Participation.

Findings:

A review of the facility's 2018 Quality Assessment Performance Improvement (QAPI) Plan was conducted. The plan documented the purpose of the QAPI program was "to deliver and enhance quality patient care and to improve patient health outcomes accomplished through continuous monitoring, data collection, surveying of customers, identification of problems and potential problems and correction of those problems." Key components of the QAPI plan documented inclusion of the following: (1) Ongoing monitoring and data collection (2) Problem prevention, identification of problems or potential problems (3) Data Analysis and (4) Identification, implementation and evaluation of corrective actions.

Review of the QAPI indicators for April 2018 through April 2019 revealed the laboratory failed to provide QA data for 7 of the 12 months (September through December 2018 and January through March 2019.) Review of the QAPI indicators revealed radiology failed to provide QA data for January, February and March 2019. Interview with the Radiology Department manager on 5/20/19 at approximately 11am, revealed a plan to incorporate ultrasound diagnostic testing that began February 1, 2019 to their current QA program. Medical records failed to provide any Quality Assurance data for 12 of 12 months for their measure of monitoring percentage of incomplete inpatient charts.

Review of the QAPI indicators for Plant Operations documents "completion of tasks" as the measure for 2018 and 2019. There is no data submitted for the period of April 2018 through March 2019. Routine, preventative maintenance and testing activities for equipment and fire safety was not included in the QA plan. Interview conducted with the facility's designated interim Plant Operations Manager on 5/23/19 at approximately 12:30pm revealed "completion of tasks" to be related to maintenance work orders. She further stated she needed ideas on what to include in Plant Operations Quality Assurance plan.

Review of Quality Improvement/Patient Safety meeting minutes for January 2019, February 2019, March 2019 and April 2019 failed to include documentation of fire safety issues that been brought to the attention of the provider on in December 2018. The minutes failed to include the identification of the problem and/or corrective measures implemented.

The facility's QAPI plan documented Medical Staff peer audits to be included and fulfilled by the Medical Staff in accordance with the Medical Staff Case Review Plan. Review of the Medical Staff Case Review Plan documented the Medical Records Department shall be responsible for accumulating and preparing all charts and incidents selected for peer review. The plan documented, "chart reviews shall be performed at the Medical Staff meetings and documented in the minutes of the reviewing committee." Chart review criteria included, but was not limited to, mortality reviews, unexpected return Emergency Room visits within 48 hours of prior discharge with same or related diagnosis and patient complaints regarding physician care.

An interview was conducted with Director of Medical Records on 5/23/19 at approximately 9:30am. She was not aware of any process where medical records were reviewed for quality and appropriateness, but stated she reviewed 100% of the medical records for diagnoses as they related to coding.

An interview with the facility's designated interim Director of Nursing (DON) on 5/23/19 at approximately 1pm revealed she was not aware of any process for conducting peer reviews. She contacted the Emergency Department (ED) via phone and was informed there was periodic discussion at medical staff meetings and they conducted peer review on specific cases as warranted. The ED Director informed the DON he reviewed charts occasionally, but had done nothing regularly since hurricane Michael due to physician turnover and moving spaces.

Review of Medical Staff committee meetings for 7/24/18, 9/18/18, 11/13/18 and 2/12/19 failed to indicate any documentation of peer review activity. Subsequent interview with the DON on 5/23/19 at approximately 1:10pm revealed 2 complaints from ED patients included a chart review by the ED Director as part of the investigation. No other peer reviews were noted.

Interview with the staff member designated as Human Resources Director/Medical Staff Coordinator on 5/23/19 at approximately 1:15pm revealed there had been no peer reviews conducted in the last year.

Review of facility policies and procedures for nursing services, radiology services, respiratory services, infection control and the facility's Quality Assurance Performance Improvement plan revealed the most recent review date of 1/19/2018. A request was made for the facility's annual program review that included review of policies and procedures.

Interview conducted with the administrative assistant on 5/23/19 at 9:30am revealed there was not an annual evaluation conducted. She further stated she was not aware of the requirement to conduct such an evaluation.

In interview with the facility's designated Chief Executive Officer (CEO) on 5/23/19 at 1:20pm, he was informed of the components required in an annual evaluation and confirmed the facility had not conducted an annual total program evaluation.

Based on interview, the Critical Access Hospital failed to conduct a annual evaluation of its total program to include the regulatory requirements.

Findings:

Review of facility policies and procedures for nursing services, radiology services, respiratory services, infection control and the facility's Quality Assurance Performance Improvement plan revealed the most recent review date of 1/19/2018. A request was made for the facility's annual program review that included review of policies and procedures.

Interview conducted with the administrative assistant on 5/23/19 at 9:30am revealed there was not an annual evaluation conducted. She further stated she was not aware of the requirement to conduct such an evaluation.

In interview with the facility's designated Chief Executive Officer (CEO) on 5/23/19 at 1:20pm, he was informed of the components required in an annual evaluation and confirmed the facility had not conducted an annual total program evaluation.

Based on interview, the Critical Access Hospital failed to conduct a annual evaluation of its total program to include the utilization of CAH services, including at least the number of patients served and the volume of services.

Findings:

Review of facility policies and procedures for nursing services, radiology services, respiratory services, infection control and the facility's Quality Assurance Performance Improvement plan revealed the most recent review date of 1/19/2018. A request was made for the facility's annual program review that included review of policies and procedures.

Interview conducted with the administrative assistant on 5/23/19 at 9:30am revealed there was not an annual evaluation conducted. She further stated she was not aware of the requirement to conduct such an evaluation.

In interview with the facility's designated Chief Executive Officer (CEO) on 5/23/19 at 1:20pm, he was informed of the components required in an annual evaluation and confirmed the facility had not conducted an annual total program evaluation.

Based on interview, the Critical Access Hospital failed to conduct a annual evaluation of its total program to include a representative sample of both active and closed records.

Findings:

Review of facility policies and procedures for nursing services, radiology services, respiratory services, infection control and the facility's Quality Assurance Performance Improvement plan revealed the most recent review date of 1/19/2018. A request was made for the facility's annual program review that included review of policies and procedures.

Interview conducted with the administrative assistant on 5/23/19 at 9:30am revealed there was not an annual evaluation conducted. She further stated she was not aware of the requirement to conduct such an evaluation.

In interview with the facility's designated Chief Executive Officer (CEO) on 5/23/19 at 1:20pm, he was informed of the components required in an annual evaluation and confirmed the facility had not conducted an annual total program evaluation.

Based on interview, the Critical Access Hospital (CAH) failed to conduct a annual evaluation of its total program to include a review of the CAH's health care policies.

Findings:

Review of facility policies and procedures for nursing services, radiology services, respiratory services, infection control and the facility's Quality Assurance Performance Improvement plan revealed the most recent review date of 1/19/2018. A request was made for the facility's annual program review that included review of policies and procedures.

Interview conducted with the administrative assistant on 5/23/19 at 9:30am revealed there was not an annual evaluation conducted. She further stated she was not aware of the requirement to conduct such an evaluation.

In interview with the facility's designated Chief Executive Officer (CEO) on 5/23/19 at 1:20pm, he was informed of the components required in an annual evaluation and confirmed the facility had not conducted an annual total program evaluation.