Patrick Horine, Chief Executive Officer, Det Norske Veritas Healthcare, Inc./DNV Healthcare US, has provided Compass Clinical Consulting with a list of the top 15 challenging standards cited in DNV surveys from June to December 2012. The results are listed in order of frequency, with life safety management issues being the standard most often cited as noncompliant. The life safety non-conformities were related to the Life Safety Code (LSC) and National Fire Protection Agency requirements (NFPA) such as egress, doors, and penetrations.

As you review the DNV list, you will notice similarity between numbers 9 and 14. Mr. Horine explained that they are essentially the same. However, he says, “One is related to the specific data or indicators not being in place, [and] the second is related to the process associated with the review of such information at the time of reappointment.”

The Joint Commission’s report of the top five standards for 2012, which was issued earlier this year, differs from DNV’s top 15 challenging standards only in the rank order—not in content. Also, TJC lists the specific EP, while DNV’s list is more topic based.

When conducting mock surveys for hospitals and health system components, Compass Clinical Consulting found similar results to TJC’s most frequently cited standards and DNV’s list of challenging standards. [Read more about TJC's most frequently cited standards and tips to improve compliance here.]

DNV’s Hospital Top 15 Challenging Standards

1. Life Safety Management – Various issues not meeting LSC and NFPA requirements
2. Medical Record Content – Dating and timing of medical record entries/orders
3. Anesthesia Services – Incomplete/missing pre/post anesthesia evaluations
4. Care Plan – Incomplete or not updated Plan of Care for the patient
5. Verbal Orders – Missing/delayed authentication of verbal/telephone orders
6. Medication Security – Medications storage and labeling issues
7. Infection Control – Activities related to surveillance issues and monitoring
8. Informed Consent – Missing elements of the Informed Consent
9. Medical Staff – Missing/limited quality/performance data for practitioners (Quality Profile)
10. Restraint and Seclusion – timeframes of orders and incomplete documentation
11. Advance Directives – Missing documentation regarding patient’s Advance Directive – not present in the record or not following process when requested by a patient
12. Staffing Management (Orientation) –  Not including contracted staff or students in the process
13. Quality Management (Measure, Monitoring, and Analysis) – Not implementing a documented process of evaluation of all organized services
14. Medical Staff (Performance Data) – Not implementing a documented process that generates a quality profile for each medical staff member to be used for evaluation as part of appointment and reappointment
15. Governing Body (Contracted Services) – Not having a current list or not including scope/nature of service

TJC’s Hospital Top Five Challenging Standards

1. RC.01.01.01 – The hospital maintains complete and accurate medical records for each individual patient.
2. LS.02.01.20 – The hospital maintains the integrity of the means of egress.
3. LS.02.01.10 – Building and fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat.
4. IC.02.02.01 – The hospital reduces the risk of infections associated with medical equipment, devices, and supplies.
5. EC.02.03.05 – The hospital maintains fire safety equipment and fire safety building features.

About DNV Healthcare

DNV Healthcare was approved by the Centers for Medicare and Medicaid Services (CMS) in 2008 as an accreditation organization. Currently, 288 hospitals are accredited by DNV Healthcare. DNV’s approach to the survey process is similar to that of other accrediting bodies in that the surveys are unannounced, and accreditation is awarded for three years. The survey process differs, though, in that annual reviews are conducted to gauge the hospital’s response to implementation of its action plans from the triennial accreditation survey. To the extent possible, one of the surveyors from the accreditation survey will serve as a coach to the hospital’s team for the next two reviews. This continuity helps to ensure a collaborative approach to accreditation. Surveys are conducted using the Nationally Integrated Accreditation of Health Organizations Standards (NIAHO) which is an integration of the CMS Conditions of Participation (CoPs) standards with the International Standardization Organization (ISO) 9001 standards.

Call to Action

It should be obvious that hospitals need to pay attention to managing Environment of Care compliance. The days when the Environment of Care received little attention are gone. With all the focus on clinical transformation, hospitals must remember that management resources, in addition to capital, must be invested in ensuring a safe clinical environment. Details make the difference, and what you don’t know may hurt you. Consider getting an outsider’s assessment of your hospital’s readiness.

Image credit: iStockphoto / Thinkstock

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This final article in our series on the Joint Commission’s Sentinel Event Alert alarm-equipped medical device safety examines alarm sensor recommendations, acoustics of patient care areas, the priorities driving alarm technology, and the sharing of alarm-related information. Catch up on the Joint Commission’s previous six recommendations and Compassville Hospital’s assessment of compliance and action plan in Part I and Part II.

Let’s wrap up the fictional Compassville Hospital’s assessment of compliance with the recommendations listed in the Joint Commission Sentinel Event Alert and their action plan.

Recommendation 7. To help reduce nuisance alarm signals, change single-use sensors (for example, ECG leads) according to manufacturer’s recommendations, unless contraindicated.

Assessment Findings: The clinical staff on the safety team reported that sometimes single use devices, such as ECG leads and pulse oximeter probes, were used for extended periods of time or less than ideal situations without being replaced. Thus the sensor for the device was less effective in picking up readings outside the set parameters. For example the clinical staff reported that a patient may sweat profusely thus causing the ECG electrode not to adhere to the skin properly and producing artifact signals. More frequent changes of the electrode would improve the signal and decrease nuisance alarms.

Actions: Include information on how to determine when a sensor may be failing in the education program.

Recommendation 8. Assess whether the acoustics in patient care areas allow critical alarm signals to be audible.

Assessment Findings: As part of their preventative maintenance program, the biomed department conducted checks on whether alarms were audible in various areas of the hospital during peak and off-peak hours. Areas identified as producing weak signals or low audible alarms were discussed with the clinical manager and at the safety committee.

Actions: The safety committee asked biomed to investigate whether amplifiers can be used to strengthen alarm signals; request funds and install if/when approved. Consider hardwiring the medical device alarm to the nurses’ pagers/phones. Informing the clinical managers of any “hot spots” where signals were weak, so patient on medical devices with alarms would not be placed in those areas until a more permanent solution could be found.

Recommendation 9. Re-establish priorities for the adoption of alarm technology; the priority-setting process should drive technology adoption rather than allowing technology to drive the process.

Assessment Findings: There were no established principles for adopting alarm technology.

Actions: Taking advantage of a report produced by the Healthcare Technology Foundation, Compassville’s safety team developed several characteristics to consider when purchasing new equipment with alarms. For example, one characteristic was to determine how easy it was to set the alarm, while another characteristic was to rate the device according to its ability to produce different alarm tones to signify priorities.

Recommendation 10. Establish a cross-disciplinary team that includes representation from clinicians, clinical engineering, information technology, and risk management, to address alarm safety and the potential impact of alarm fatigue in all patient care areas. Establish a process for continual improvement and constant optimizing of alarm system policies and configurations. Review trends and patterns in alarm-related events to identify opportunities for improving alarm use. Implement an alarm system management policy, including the periodic review of alarm coverage processes and systems, and the development of realistic, implementable strategies to address vulnerabilities.

Assessment Findings: Not all key stakeholders had been involved in previous decisions related to purchasing medical devices with alarms.

Actions: Compassville Hospital formed a multidisciplinary team includes representation from clinical area, biomed, information technology, and risk management to regularly review incidents related to medical devices with alarms as well as to provide input regarding purchasing of new devices.

Recommendation 11. Share information about alarm-related incidents, prevention strategies, and lessons learned with appropriate organizations, such as AAMI, ECRI Institute, the FDA, and The Joint Commission.

Assessment Findings: Compassville Hospital regularly reported alarm-related incidents to appropriate organizations, but had not shared any lessons learned.

Actions: Compassville Hospital will share lessons learned from alarm-related incidents within the hospital and with appropriate organizations.

For more information about how your organization can develop an action plan or if you have questions, please contact our office at (513) 241.0142 or send us an email.

Related Articles:

• It’s Time to Sound the Alarm About Medical Device Safety
• Alarm-Equipped Medical Device Safety Alert, Part II

The post Alarm-Equipped Medical Device Safety Alert, Part III appeared first on Hospital Accreditation & Compliance Journal.

According to the Joint Commission’s report, the most challenging requirements for 2012 were the following:

• RC.01.01.01. The hospital maintains complete and accurate medical records for each individual patient.
• LS.02.01.20. The hospital maintains the integrity of the means of egress.
• LS.02.01.10. Building and fire protection features are designed and maintained to minimize the effects of fire, smoke, and heat.
• IC.02.02.01. The hospital reduces the risk of infections associated with medical equipment, devices, and supplies.
• EC.02.03.05. The hospital maintains fire safety equipment and fire safety building features.

(The Joint Commission, March 13, 2013)

Turning Challenges into Wins

How can hospitals use this information in 2013? Knowing areas that have been problematic for others allows organizations to conduct their own assessments to determine if these areas are vulnerabilities for them. In medicine, prevention is better than cure—and the same is true with compliance efforts. It’s much easier to correct deficiencies found during a self-assessment or mock survey when you have the time and resources to do so, than it is to correct them when you’re under deadlines for a rapid response.

Let’s examine these challenging standards and discuss how to turn them into “wins.”

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The first letter, issued on April 5, 2013, instructed State Agencies to limit the on-site investigations to “those allegations that, if substantiated, would likely result in a finding of Condition-level deficiency or Immediate Jeopardy.”

 The second letter, issued on April 19, 2013, provided clarification regarding post-complaint survey procedures for deemed providers/suppliers.  The letter stated, “A full survey of a deemed provider/supplier after a complaint survey with Condition-level findings will be made on a selective rather than an automatic basis.”  The letter went on to state that deemed providers and suppliers found on a complaint investigation to have Condition-level noncompliance (including cases where the noncompliance rises to the level of Immediate Jeopardy (IJ)) are still subject to a full survey. However, a full-survey may not be required in every such case.  Immediate Jeopardy findings will continue to result in the organization being placed on a 23- or 90-day termination track.

Hospitals should not interpret these survey and certification letters to mean that they will not be subjected to a survey in response to a complaint. On the contrary, State Agencies will likely scrutinize complaints in order to identify any that might result in a Condition-level deficiency or Immediate Jeopardy.  Hospitals should remain on their guard and take a hard look at their internal systems, such as variance reports and performance improvement data, which are used to identify conditions and situations that potentially place patients at risk of harm or could result in a violation of patients’ rights.  Condition-level deficiencies and findings of Immediate Jeopardy are often the result of a violation of patient rights (e.g., failure to protect and promote patient rights) and life safety code violations (e.g., failure to protect the patient from fire hazards).

When such conditions are identified, taking a “plan of correction” approach will not only protect patients from harm and promote patients’ rights, but the organization will also be better positioned to respond to a complaint survey that could potentially result in a Condition-level deficiency or a finding of Immediate Jeopardy. A “plan of correction” approach means the organization conducts an analysis of the event or situation to identify any policy, procedure, or practice that is the likely cause of a “failure to protect or promote patient rights” issue and develop a plan to correct the situation. Often, policies need to be developed or revised, staff members need to be educated on the new or revised policy, and a measurement system needs to be put into place to ensure that the change was effective and sustained.

Responsibility for oversight of the corrective action process should be assigned to a member of senior leadership to ensure that the action plan is followed through to completion and that results are reported to the hospital’s quality committee and the governing body.

Image credit: AbleStock.com / Thinkstock

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In Part I of this series, “It’s Time to Sound the Alarm About Medical Device Safety,” we began to examine The Joint Commission’s (TJC) guidelines for medical device safety in hospitals focusing on the safety of alarm-equipped medical devices. In Part II, we continue our examination of these recommendations—including guidelines for alarm settings and processes for safe alarm management and response in high-risk areas—as we follow along with Compassville Hospital’s action plan.

Let’s continue with our assessment of the fictional Compassville Hospital’s compliance with the recommendations listed in the Joint Commission Sentinel Event Alert and their action plan.

Recommendation 3. Establish guidelines for alarm settings on alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions; include identification of situations when alarm signals are not clinically necessary.

Assessment Findings: Although Compassville Hospital has a policy/procedure on “Alarm Management,” it did not address situations when alarm signals were not clinically necessary. The critical care staff indicated that when patients were dying and the patients’ wishes were not to be resuscitated (DNR), they would turn the alarms off while the families/friends were present. Alarms were not needed in this situation, as the staff were only providing comfort measures.

Actions: Compassville’s “Alarm Management” policy/procedure was revised to address turning off alarms when patients were DNR and families/friends were present.

Recommendation 4. Establish guidelines for tailoring alarm settings and limits for individual patients. The guidelines should address situations when limits can be modified to minimize alarm signals and the extent to which alarms can be modified.

Assessment Findings: When the team regrouped two weeks later to present their findings, they discussed the job aid attached to the “Alarm Management” policy/procedure, which contained a list of medical devices with alarms and the recommended settings.

Actions: The Compassville Hospital team updated the job aid listing the medical devices and alarm setting to include guidance from the manufacturer, literature, and evidence-based practices to include how to customize the settings for individual patients. Here’s an example:

By default, the manufacturer sets the cardiac upper limits as 120 and the lower limits as 50. To accommodate a patient who presents with a lower pulse as his/her baseline, the nurse and physician would determine the appropriate parameters for the patient and then set the alarms accordingly (e.g., 10% above and 10% below the patient’s admission heart rate).

Recommendation 5. Inspect, check, and maintain alarm-equipped devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on criteria such as manufacturers’ recommendations, risk levels, and current experience.

Assessment Findings: Compassville Hospital’s biomed department has an electronic system that identifies all of the medical devices in use in the hospital. Preventative maintenance (PM) checks are performed as recommended by the manufacturer, and the biomed department has a 98% compliance rate of performing PMs on time.

Actions: No further actions were needed.

Recommendation 6. Provide all members of the clinical care team (as defined by the organization) with training on the organization’s process for safe alarm management and response in high-risk areas (as identified by the organization), and on the safe use of the alarmed medical devices on which they rely. Also provide ongoing training on new alarmed medical devices and updates to alarmed medical devices, and ensure that new members of the clinical care team receive training on the alarmed medical devices on which they rely.

Assessment Findings: Education regarding alarms was provided to new hires during orientation as part of equipment training. However, there was no emphasis on managing alarms.

Actions: The education department updated its education program to include updated information in the “Alarm Management” policy/procedure as well as some stories of how alarms had been successfully used to prevent harm in order to emphasize how to respond to alarms. The program will roll out to specified clinical staff including physicians, nurse practitioners, and physicians’ assistants.Because the policy/procedure reflected changes in the existing process for managing alarms, the education department announced a schedule in which the education staff would take the “Education on the Go” cart around to the high-risk clinical areas. Additionally, the program will be included in the training for new hires.

The third and final article in this series will wrap up Compassville Hospital’s assessment of compliance with TJC’s Sentinel Event Alert on alarm-equipped medical devices and the corresponding action plan.

The post Alarm-Equipped Medical Device Safety Alert, Part II appeared first on Hospital Accreditation & Compliance Journal.

On April 8, 2013, the Joint Commission issued a Sentinel Event Alert on medical device alarm safety in hospitals. This series of articles examines how to improve safety related to alarm-equipped medical devices and thereby improve an organization’s ability to provide safe, quality care.

Have you ever bought a new car with all the latest bells and whistles and then, when you got it home, thought, “I don’t remember how to use this feature. It looked so easy when the salesperson demonstrated it to me. Oh well, I guess I don’t really need it”?

The same thing happens in healthcare. A new piece of equipment is purchased, sometimes in response to an event that occurred in the hospital, or even to prevent the occurrence of such an event. But then, when it’s in-serviced to the staff, it appears so complicated or has so many features that the staff cannot remember all the details on how the equipment works. As a result, some of the main selling features intended to prevent adverse events or sound alarms when a dangerous conditions approach end up going unused.

For example, some medical equipment comes with computer memory boards and can provide forced stops to prevent errors or sound alarms when certain parameters are reached.

But how do you know what parameters should be used when setting alarms? Can you set all of the same types of equipment to a prescribed upper and lower limit for all patients? How can you ensure that staff can hear and respond to the alarms – especially when the majority of alarms don’t require interventions? These were some of the questions posed by the staff at the fictional Compassville Hospital as they read the Joint Commission (TJC) Sentinel Event Alert # 50, Medical Device Alarm Safety In Hospitals.

In this series, we will join Compassville Hospital as they assess their compliance with the 11 strategies recommended by TJC to improve safety related to using alarm-equipped medical devices. By following TJC’s recommendations in the Sentinel Event Alert, hospitals can create an action plan summarizing an assessment of their organization’s current level of compliance similar to the one developed by Compassville Hospital. If not found to be compliant, the organization can then determine what barriers exist and how/if/when they can be addressed. Action steps and due dates can then be assigned to the appropriate organizational leaders.

Medical Device Safety Action Plan

Here’s an example of an action plan for the fictional Compassville Hospital:

Recommendation 1. Leadership ensures that there is a process for safe alarm management and response in high-risk areas (as identified by the organization).

Assessment Findings: One of the agenda items on Compassville Hospital’s safety committee was to discuss the recent Sentinel Event Alert on medical device alarm safety. The risk management department brought information from past incidents in which equipment had been involved and summarized whether any events were related to alarm use. Additionally, the biomed engineer reported on equipment repairs due to staff reports of alarm failures. A clinical nurse specialist provided examples of near-miss situations in the critical care unit where alarms had not been set correctly, had been turned off completely, or had been tuned out due to staff fatigue of hearing so many alarms sounding throughout the shift. Compassville Hospital has a policy/procedure on “Alarm Management” which had been reviewed a couple of years earlier.

Actions: After hearing the various reports, the safety committee formed a multidisciplinary team to update their policy/procedure.

Recommendation 2. Prepare an inventory of alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions, and identify the default alarm settings and the limits appropriate for each care area.

Assessment Findings: Compassville Hospital’s biomed department together with the clinical staff compiled an inventory of all the medical devices used in the hospital that contained alarms.

Actions: Due to the large number of medical devices with alarms, the biomed department and clinical staff decided to focus first on high-risk clinical conditions and high-risk areas. High-risk clinical conditions were those associated with life safety, such as ventilators, defibrillators, cardiac monitors, etc. High-risk areas were determined to be emergency department, critical care, surgery, and post-anesthesia care, cardiac cath lab, and telemetry.

Next, the team began researching the manufacturer’s guidelines for setting alarms. Additionally, the clinical nurses contacted the quality management and librarian to ascertain if there were any evidence-based practices related to alarm settings based on the patients’ clinical presentation. The team agreed to report back in two weeks with a summary of their findings.

The assessment continues in Part II of this series, where Compassville Hospital will examine guidelines for alarm settings and its process for safe alarm management and response in high-risk areas.

Image credit: iStockphoto / Thinkstock

The post It’s Time to Sound the Alarm About Medical Device Safety appeared first on Hospital Accreditation & Compliance Journal.

Here’s an example of how these standards can differ:

CMS Tag A-0131, §482.13(b)(2), relates to informed consent.  Although this is a single CMS CoP, it cross-references with 27 TJC standards/elements of performance (EPs) as described below. Many EPs vary significantly from the original intent of the CMS CoPs regarding informed consent.

• LD.04.02.01, EP 4 concerns leaders addressing conflicts of interest.

Tag A-0131 concerns informed consent, not conflict of interest.

• RI.01.01.01, EP 10 concerns allowing patients to obtain and amend health information that has been disclosed to others.

Tag A-0131 does not address amending personal health information.

• RI.01.01.03, EP 1, EP 2, and EP 3  relate to providing information in a language the patient can understand, including the use of translation services or other mechanisms to address speech or hearing impairments.

By nature of the definition of informed consent, would it not preclude that in order for a patient to give consent, he/she must understand what he/she is consenting to?

• RI.01.02.01, EP 1, EP 2, EP 3, EP 6, EP 7, EP 8, EP 20, and EP 21  address the patient’s right to have his/her physician notified of his/her admission; right to received written information regarding the right to refuse care/treatment/service as permitted by law; hospital must respect patient’s rights to refuse care; involvement of surrogate decision-maker when patient is unable to make decisions; hospital must respect surrogate decision-makers decisions as permitted by law; involvement of patient/family/surrogate decision-maker in patients’ care; and right to be informed of outcomes which make affect future healthcare decisions including any unanticipated outcomes relating to sentinel events.

Tag A-0131 concerns informed consent, not notification of physicians regarding admission.

• RI.01.03.01, EP 1, EP, 2, EP 3, EP 4, EP 5, EP 6, EP 7, EP 9, EP 11, and EP 13 relate to the hospital having a policy on informed consent; policy must specify what care/treatment/services requires informed consent; when exceptions to obtaining informed consent are permitted; description of the informed consent process; how informed consent is to be documented in the patient’s record; and when a surrogate-decision may give informed consent; informed consent process must include a discussion about proposed care/treatment/service, potential benefits, risks, side effects, likelihood of achieving goals/potential problems that might occur during recuperation;, reasonable alternatives and associated risks/benefits/side effects to not receiving the proposed care; and that informed consent is obtained in accordance with policy, except in emergencies prior to surgery.

This standard most closely resembles Tag A-0131.

• RI.01.05.01, EP 1, EP 5, PE 6, and EP 13  address having policies on advance directives, forgoing/withdrawing life-sustaining treatment, and withholding resuscitation; requirement for hospital to implement its advance directive policies; provision of written information to patients; and that hospital honors advance directives in accordance with law and regulation and its capabilities.

Tag A-0131 concerns informed consent, not advance directives.

It would seem an easier way to cross-reference TJC standards/elements of performance to the CMS CoPs would be to simply state them as they are originally worded in the CMS manual and then add any TJC standards that would augment the TJC standard/element of performance.

Read more:

• CMS and TJC Survey Preparation – Is There a Difference?

Image credit: iStockphoto / Thinkstock

The post How TJC Interprets CMS CoPs – Example of Differences appeared first on Hospital Accreditation & Compliance Journal.

What Hospital Leaders Can Expect

As people become more familiar with this source, www.hospitalinspections.org, hospital executives can expect inquiries from the press, public figures, lawyers, and patients about these reports. If you have ever read a CMS report of deficiencies, you know it does not paint a pretty picture. That’s because CMS views the Conditions of Participation as minimum standards of care to protect patients from harm.

To the trained eye, the violation is not always as extreme as it may sound; unfortunately, neither the public nor members of the news media are familiar with or understand the CMS Conditions and the inspection reporting process. There may be a tendency to over-report, misinterpret, and simply “make news” of violations information; furthermore, the inability of the public and the media to differentiate between minor and major findings may be problematic for hospitals. And because the corrective action submissions are not yet available, concern may arise that the conditions cited continue uncorrected. In short, this database could be a public relations problem for many hospitals, including some of the best known in the country.

In addition to meeting the public’s desire to know, CMS hopes that making this information public will generate more attention within the C-suite toward ensuring full, continuous compliance with the CMS Conditions of Participation. If hospitals attend to this goal as they have to other initiatives, there should be fewer new reports being entered into this database. But hospitals should be aware that increased CMS surveillance of compliance (site inspections) is likely to increase, creating more exposure to adverse findings.

How Hospital Leaders Can React

While there always was a duty to ensure compliance, the penalty for permitting even minor infractions has just increased, and responsible leaders who protect their hospital’s reputation should be aware of this new risk. Although what is past is done, the key to addressing this risk is a well-designed management system that can assure full and continuous compliance. Simply assuming compliance will not get you the results you want.

The first step is to be aware of the requirements. The Conditions of Participation can be found on the CMS website. These requirements even tell you how CMS surveys for compliance.

Next, make sure you have policies and procedures that comply with federal requirements. But just having the policies and procedures is not enough—you must assure that the policies and procedures are implemented in practice. Remember that compliance is about consistency, which means that you must establish measurement systems that review many observations. Education and competencies are not enough, nor is it enough to review 30 charts when there were 200 charts (based on sampling theory, there is no reason to assume “no error” with 30 charts when you need 100% compliance).

Patient grievances are an important source for initiating investigation into potential compliance problems as many CMS inspections originate with a patient or family complaint. Satisfying the patient, while necessary, may not be sufficient for making sure that you are prepared for a CMS complaint visit. Some grievances may indicate system failures that show poor implementation of policies and procedures.

Finally, it may be useful to bring in outsiders, such as consultants, to conduct an assessment of your hospital’s compliance. Like an accounting audit, an outside compliance audit may uncover practices that are not compliant but have gone undetected by internal reviews—possibly due to inadequate internal surveillance systems or misunderstanding of the requirements for compliance. In either case, experts in conducting compliance assessments can uncover potential areas of noncompliance before surveyors do, which allows for remediation and can prevent serious patient harm or adverse outcomes.

As with readmissions, hospital leaders should consider greater focus on ensuring compliance. If not, the new CMS website presents new hazards for noncompliant hospitals: reputation damage and potential litigation exposure.

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The next step is to identify where the gaps are in your own organization—before surveyors find them.

Know where the gaps are in your organization

To identify gaps in your program or in compliance, you need to know where to look and what to look for.  The steps outlined below provide a roadmap for completing your gap analysis.

1. Make a list of every area, department, service, and location to be surveyed.

The first step in identifying gaps is to understand the scope of what will be surveyed. Make sure you have a complete list of all services and locations to be surveyed. Check with the person responsible for submitting your application for accreditation, as the application must list all areas subject to being surveyed.

2. For every area listed on the application, determine whether any cleaning, disinfection, or sterilization of equipment is being performed in the area.

For cleaning of the environment and patient-care equipment, provide the clinical staff with a poster or one-page reference that lists the cleaning products to be used, the types of equipment or surfaces they are to be used on, and any special instructions for using the products.

If sterilization procedures are performed, schedule a site visit to directly observe their practices. Sterilization procedures may be performed using steam sterilization, plasma, or Ethylene Oxide (EO) gas. Be especially alert to the use of tabletop steam sterilizers in clinics and offices.  Whenever possible, remove the guesswork and post easy-to-read-and-follow instructions above or near where the procedures are being carried out. For sterilization procedures, pay particular attention to the following:

a. Transport and decontamination of soiled instruments, including attire, use of PPE, transport containers, movement from dirty to clean, clean area is dedicated to processing and no other items are stored in this area.

b. Assembly and packaging of instruments for processing (use of peel-packs, hinged instruments open).

c. Quality control documentation, including documentation of mechanical indicators that show time and temperature, chemical indicators for every package, and biological indicators at least weekly – most organizations test daily.

d. Storage of sterilized items (in appropriate packaging, in a location that prevents damage to the package, solid bottoms on wire rack shelving).

e. Competency training and assessment programs for sterilization procedures.

If high-level disinfection (soaking something at a specific temperature for a specific time) is performed, schedule a site visit to directly observe their practices. Whenever possible, remove the guesswork and post easy-to-read-and-follow instructions above or near where the procedures are being carried out. Ensure that there is a clock or other timing device available when the timing of a step is critical. For high-level disinfection procedures, verify the following:

a. The soak solution is prepared according to the manufacturer’s instructions, is discarded on or before the expiration date, and is tested with the quality control strips just as the manufacturer states before the solution is used. The strip must remain in the solution for a specific period of time and a specific amount of time must elapse before it is read.  The strips must be stored in a container that kept closed when not in use. The strips must be the correct test strips for the solution being used.  The wrong strips have been found in areas even when the department ordered the correct test strips – make sure the strips match the solution. All quality control results must be recorded on the log.

b. The log contains every required element, according to AAMI standards. Construct the log so there is a place to record every element.  These elements are:

i. The assigned lot number or other means of identification, including chemical sterilizer, processor or soaking container identification and cycle number.

ii. The general contents of the load.

iii. The patient’s name and medical record number, if applicable

iv. The procedure, physician, and if applicable, serial number or identification of the item.

v. The date that the original container of LSC/HLD was opened, the use-life of the open container, the date the product was activated or diluted, the date that the activated, diluted or ready-to-use solution was poured into the secondary container; and the reuse-life of the solution.

vi. The number or other identification of the chemical sterilizer, processor or soaking container.

vii. The date and time of the cycle.

viii. The time, temperature, and if applicable, chemical concentration of the exposure phase of the sterilization or high-level disinfections cycle.

ix. The quality control monitoring results.

x. The signature or other identification of the operator.

c. The staff can verbalize and demonstrate the correct procedure, including quality control testing, processing the instrument, moving from dirty to clean areas and packaging or storing processed items.

3. For every area listed on the application, determine whether the area should be included in the organization’s surveillance plan, and if so, how surveillance will be performed in the area (type and frequency).

For each type of surveillance being conducted, your plan should reflect what data will be reported to the committee and how often. For example, surveillance may include review of water testing results for a therapy pool or dialysis unit or reporting of communicable diseases identified in outpatient clinics or appropriate follow-up testing and treatment for syphilis or HIV testing in psychiatric populations. If an area is not included in the surveillance plan, explain the rationale in your surveillance plan.

4. For every area listed on the application, verify that there is a process for monitoring hand hygiene compliance in that area.

Ensure that compliance monitoring captures the disciplines providing care in this area. Provide department- or site-specific feedback on performance to the area as soon as possible. For areas with compliance levels that are lower than desired, schedule a meeting with the director or manager to discuss the results and develop a performance improvement plan.

 5. For every area listed on the application, verify that Infection Control education and training is specific to the area.

This also applies to departments and services within the hospital, including the medical staff and other independent licensed practitioners. Infection Control information may be contained in the unit- or site-specific orientation material, but do not assume that the material contains the correct and necessary information. Conduct a careful and thorough review of every unit-specific or site-specific orientation and fill in any gaps. Remedial education may be necessary for current employees if the education initially received was deficient.

With the ever-increasing amount of time needed to meet the requirements for external reporting of infection data, ICPs often find it difficult to maintain visibility in all patient care areas. Many ICPs find it helpful to identify IC liaisons or champions in patient care areas to lend a hand with the monitoring of key practices. Having clear, well-articulated Infection Control policies and procedures and user-friendly monitoring tools will help these champions and liaisons to be the extended “eyes and ears” of Infection Control.

The current level of scrutiny of Infection Control processes is not likely to abate in the near future.  Time spent in patient care and support settings must be managed efficiently and effectively to adequately assess, and if necessary, correct patient care practices.

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