Department of Health Licensing Survey Meeting the minimum standards

Presented in cooperation with the Rural Healthcare Quality Network Speaker: Richard A. Bryan, BSN, RN, CCM Vice President, Healthcare Risk Management Arthur J. Gallagher & Co. of Washington, Inc.

Department of Health Licensing Survey Meeting the minimum standards Agenda Introduction: Where the rules are located (WACs & RCWs), Guide to Surveyors Hospital Survey Process: High level review of the steps the surveyors take Top Ten Findings: What they mean to you Who has the “rock in their pocket”: Assessing who, within the organization, should be responsible for specific areas of survey readiness and preparation (it may not be the most obvious person if you really want to pass Wrap up and questions

“It is the doctrine of war to not assume the enemy will not come, but rather to rely on one’s readiness to meet him; not to presume that he will not attack, but rather make one’s self invincible.” Sun Tzu, The Art of War

RCW 70.41.030 Standards and rules. The department shall establish and adopt such minimum standards and rules pertaining to the construction, maintenance, and operation of hospitals, and rescind, amend, or modify such rules from time to time, as are necessary in the public interest, and particularly for the establishment and maintenance of standards of hospitalization required for the safe and adequate care and treatment of patients. To the extent possible, the department shall endeavor to make such minimum standards and rules consistent in format and general content with the applicable hospital survey standards of the joint commission on the accreditation of health care organizations. The department shall adopt standards that are at least equal to recognized applicable national standards pertaining to medical gas piping systems. [1995 c 282 § 1; 1989 c 175 § 127; 1985 c 213 § 17; 1971 ex.s. c 189 § 9; 1955 c 267 § 3.] NOTES: Effective date -- 1989 c 175: See note following RCW 34.05.010. Savings -- Effective date -- 1985 c 213: See notes following RCW 43.20.050

RCW 70.41.130 Denial, suspension, revocation, modification of license -- Procedure. The department is authorized to deny, suspend, revoke, or modify a license or provisional license in any case in which it finds that there has been a failure or refusal to comply with the requirements of this chapter or the standards or rules adopted under this chapter. RCW 43.70.115 governs notice of a license denial, revocation, suspension, or modification and provides the right to an adjudicative proceeding. [1991 c 3 § 335; 1989 c 175 § 128; 1985 c 213 § 22; 1955 c 267 § 13.] NOTES: Effective date -- 1989 c 175: See note following RCW 34.05.010. Savings -- Effective date -- 1985 c 213: See notes following RCW 43.20.050.

RCW 70.41.170 Operating or maintaining unlicensed hospital or unapproved tertiary health service -- Penalty. Any person operating or maintaining a hospital without a license under this chapter, or, after June 30, 1989, initiating a tertiary health service as defined in RCW 70.38.025(14) that is not approved under RCW 70.38.105 and 70.38.115, shall be guilty of a misdemeanor, and each day of operation of an unlicensed hospital or unapproved tertiary health service, shall constitute a separate offense. [1989 1st ex.s. c 9 § 612; 1955 c 267 § 17.] NOTES: Effective date -- Severability -- 1989 1st ex.s. c 9: See RCW 43.70.910 and 43.70.920.

Chapter 246-320 WAC HOSPITAL LICENSING REGULATIONS Provides a framework for the Department of Health Surveyors to inspect hospitals. It also Provides hospitals with the rules!

WAC 246-320-025 On-site licensing survey.    The purpose of this section is to provide annual on-site survey requirements in accordance with chapter 70.41 RCW. (1) The department will:      (a) Conduct at least one on-site licensing survey each calendar year to determine compliance with the provisions in chapter 70.41 RCW and this chapter;      (b) Notify the hospital in writing of state survey findings;      (c) Contact the hospital to discuss the findings of an on-site licensing or joint commission on accreditation of health care organizations (JCAHO) survey when appropriate; and      (d) Not conduct the annual on-site licensing survey when requested by a hospital accredited by JCAHO in accordance with subsections (2) and (3) of this section….

Department of Health Licensing Survey Meeting the minimum standards There is a compelling reason for minimum standards!

Department of Health Licensing Survey Meeting the minimum standards Our communities expect more from us!

Department of Health Licensing Survey State Operations Manual – Survey Protocol

Department of Health Licensing Survey Hospitals must comply! “Should an individual or entity (hospital) refuse to allow immediate access upon reasonable request to either a State Agency or CMS surveyor, the Office of the Inspector General (OIG) may exclude the hospital from participation in all Federal healthcare programs in accordance with 42 CFR §1001.1301.”

Department of Health Licensing Survey Survey Process Team Arrives Entrance Conference On-Site Team Meeting Sample Selection Information Gathering/Investigations Survey Locations Observation Interviews Document Review Completion of Hospital/CAH Medicare Database Worksheet Team Discussion Determination of Severity of Deficiencies Exit conference Closure Post Survey – Plan of Correction

Department of Health Licensing Survey Arrival “The entire survey team should enter the hospital together. Upon arrival, surveyors should present their identification. The team coordinator should announce to the Administrator, or whoever is in charge, that a survey is being conducted. If the Administrator (or person in charge) is not onsite or available (e.g., if the survey begins outside normal daytime Monday-Friday working hours), ask that they be notified that a survey is being conducted. Do not delay the survey because the Administrator or other hospital staff is/are not on site or available.”

Department of Health Licensing Survey Entrance Conference “The entrance conference sets the tone for the entire survey. Be prepared and courteous, and make requests, not demands. The entrance conference should be informative, concise, and brief; it should not utilize a significant amount of time. Conduct the entrance conference with hospital administrative staff that is available at the time of entrance.”

Department of Health Licensing Survey Entrance Conference During the entrance conference, the Team Coordinator will arrange with the hospital administrator, or available hospital administrative supervisory staff if he/she is unavailable to obtain the following: - A location (e.g., conference room) where the team may meet privately during the survey; - A telephone for team communications, preferably in the team meeting location; - A list of current inpatients, providing each patient’s name, room number, diagnosis(es), admission date, age, attending physician, and other significant information as it applies to that patient.

Department of Health Licensing Survey Entrance Conference The team coordinator will explain to the hospital that in order to complete the survey within the allotted time it is important the survey team is given this information as soon as possible, and request that it be no later than 3 hours after the request is made. SAs may develop a worksheet to give to the facility for obtaining this information; - A list of department heads with their locations and telephone numbers; - A copy of the facility’s organizational chart; - The names and addresses of all off-site locations operating under the same provider number; - The hospital’s infection control plan; - A list of employees; - The medical staff bylaws and rules and regulations; - A list of contracted services; and - A copy of the facility’s floor plan, indicating the location of patient care and treatment areas;

Department of Health Licensing Survey Information Gathering/Investigation General Objective The objective of this task is to determine the hospital’s compliance with the Medicare CoP through observations, interviews, and document review. Guiding Principles Focus attention on actual and potential patient outcomes, as well as required processes. Assess the care and services provided, including the appropriateness of the care and services within the context of the regulations. Visit patient care settings, including inpatient units, outpatient clinics, anesthetizing locations, emergency departments, imaging, rehabilitation, remote locations, satellites, etc. Observe the actual provision of care and services to patients and the effects of that care, in order to assess whether the care provided meets the needs of the individual patient. Use the interpretive guidelines and other published CMS policy statements to guide the survey. Use Appendix Q for guidance if Immediate Jeopardy is suspected.

Department of Health Licensing Survey Information Gathering/Investigation The objective of this task is to determine the hospital’s compliance with the Medicare CoP through observations, interviews, and document review. Focus attention on actual and potential patient outcomes, as well as required processes. Assess the care and services provided, including the appropriateness of the care and services within the context of the regulations. Visit patient care settings, including inpatient units, outpatient clinics, anesthetizing locations, emergency departments, imaging, rehabilitation, remote locations, satellites, etc. Observe the actual provision of care and services to patients and the effects of that care, in order to assess whether the care provided meets the needs of the individual patient.

Department of Health Licensing Survey Survey Locations For hospitals with either no or a small number of off-campus provider-based locations, survey all departments, services, and locations that bill for services under the hospital’s provider number and are considered part of the hospital.

Department of Health Licensing Survey Patient Sample Size and Selection Review the patient list provided by the hospital and select patients who represent a cross-section of the patient population and the services provided Minimum of 30 inpatient records. For small general hospitals (this reduction does not apply to surgical or other specialty hospitals) with an average daily census of 20 patients or less, the sample should not be fewer than 20 inpatient records, provided that number of records is adequate to determine compliance. To conduct an initial survey of a hospital there must be enough inpatients currently in the hospital and patient records (open and closed) for surveyors to determine whether the hospital can demonstrate compliance with all the applicable CoP.

Department of Health Licensing Survey Patient Review A comprehensive review of care and services received by each patient in the sample should be part of the hospital survey. A comprehensive review includes observations of care/services provided to the patient, patient and/or family interview(s), staff interview(s), and medical record review.

Department of Health Licensing Survey Observations Surveyors are encouraged to make observations, complete interviews, and review records and policies/procedures by stationing themselves as physically close to patient care as possible. When conducting observations, particular attention should be given to the following: - Patient care, including treatments and therapies in all patient care settings; - Staff member activities, equipment, documentation, building structure, sounds and smells; - People, care, activities, processes, documentation, policies, equipment, etc., that are present that should not be present, as well as, those that are not present that should be present; - Integration of all services, such that the facility is functioning as one integrated whole; - Whether quality assessment and performance improvement (QAPI) is a facility- wide activity, incorporating every service and activity of the provider and whether every facility department and activity reports to, and receives reports from, the facility’s central organized body managing the facility-wide QAPI program; and Storage, security and confidentiality of medical records.-

Department of Health Licensing Survey Interviews Interviews provide a method to collect information, and to verify and validate information obtained through observations. Informal interviews should be conducted throughout the duration of the survey… Staff interviews should gather information about the staff’s knowledge of the patient’s needs, plan of care, and progress toward goals. Problems or concerns identified during a patient or family interview should be addressed in the staff interview in order to validate the patient’s perception, or to gather additional information. Patient interviews should include questions specific to the patient’s condition, reason for hospital admission, quality of care received, and the patients knowledge of their plan of care. For instance, a surgical patient should be questioned about the process for preparation for surgery, the patient’s knowledge of and consent for the procedure, pre-operative patient teaching, post-operative patient goals and discharge plan.

Department of Health Licensing Survey Document Review Document review focuses on a facility’s compliance with the CoP. Patient’s clinical records, to validate information gained during the interviews, as well as for evidence of advanced directives, discharge planning instructions, and patient teaching. This review will provide a broad picture of the patient’s care. Plans of care and discharge plans should be initiated immediately upon admission, and be modified as patient care needs change. Closed medical records may be used to determine past practice, and the scope or frequency of a deficient practice. Closed records should also be reviewed to provide information about services that are not being provided by the hospital at the time of the survey Personnel files to determine if staff members have the appropriate educational requirements, have had the necessary training required, and are licensed, if it is required; Credential files to determine if the facility complies with CMS requirements and State law, as well as, follows its own written policies for medical staff privileges and credentialing;

Department of Health Licensing Survey Document Review Maintenance records to determine if equipment is periodically examined and to determine if it is in good working order and if environmental requirements have been met; Staffing documents to determine if adequate numbers of staff are provided according to the number and acuity of patients; Contracts, if applicable, to determine if patient care, governing body, QAPI, and other CoP requirements are included; and Policy and procedure manuals. When reviewing policy and procedure manuals, verify with the person in charge of an area that the policy and procedure manuals are current;

Department of Health Licensing Survey Completion of Medicare Database Worksheet Arrange an interview with a member of the administrative staff to update and clarify information from the provider file. The Hospital/CAH Medicare Database Worksheet will be used to collect information about the hospital’s services, locations, and staffing by Medicare surveyors during hospital surveys. The worksheet will be completed by the surveyors using observation, staff interviews, and document review. The worksheet will not be given to hospital staff to complete. The worksheet is used to collect information that will later be entered into the Medicare database. During the interview clarify any inconsistencies from prior information or information gathered during the survey.

Department of Health Licensing Survey Team Discussion Meeting The team’s preliminary decision-making and analysis of findings assist it in preparing the exit conference report. Based on the team’s decisions, additional activities may need to be initiated. At this meeting, the surveyors will share their findings, evaluate the evidence, and make team decisions regarding compliance with each requirement. Proceed sequentially through the requirements for each condition appropriate to the facility as they appear in regulation. For any issues of noncompliance, the team needs to reach a consensus. Decisions about deficiencies are to be team decisions, with each member having input.

Department of Health Licensing Survey Determining the Severity of Deficiencies The regulations at 42 CFR 488.26 state, “The decision as to whether there is compliance with a particular requirement, condition of participation, or condition for coverage, depends upon the manner and degree to which the provider or supplier satisfies the various standards within each condition.” When noncompliance with a condition of participation is noted, the determination of whether a lack of compliance is at the Standard or Condition level depends upon the nature (how severe, how dangerous, how critical, etc.) and extent (how prevalent, how many, how pervasive, how often, etc.) of the lack of compliance. The cited level of the noncompliance is determined by the interrelationship between the nature and extent of the noncompliance.

Department of Health Licensing Survey Determining the Severity of Deficiencies A deficiency at the Condition level may be due to noncompliance with requirements in a single standard or several standards within the condition, or with requirements of noncompliance with a single part (tag) representing a severe or critical health or safety breach. Even a seemingly small breach in critical actions or at critical times can kill or severely injure a patient, and represents a critical or severe health or safety threat. A deficiency is at the Standard level when there is noncompliance with any single requirement or several requirements within a particular standard that are not of such character as to substantially limit a facility’s capacity to furnish adequate care, or which would not jeopardize or adversely affect the health or safety of patients if the deficient practice recurred.

Department of Health Licensing Survey Determining the Severity of Deficiencies When a deficient practice (noncompliance) is determined to have taken place prior to the survey and the hospital states that it has corrected the deficient practice/issue (noncompliance), issues for the survey team to consider would include: • Is the corrective action superficial or inadequate, or is the corrective action adequate and systemic? • Has the hospital implemented the corrective intervention(s) or action(s)? • Has the hospital taken a QAPI approach to the corrective action to ensure monitoring, tracking and sustainability? The survey team uses their judgment to determine if any action(s) taken by the hospital prior to the survey is sufficient to correct the noncompliance and to prevent the deficient practice from continuing or recurring. If the deficient practice is corrected prior to the survey, do not cite noncompliance. However, if the noncompliance with any requirements is noted during the survey, even when the hospital corrects the noncompliance during the survey, cite noncompliance. All noted noncompliance must be cited even when corrected on site during the survey.

Department of Health Licensing Survey Exit Conference The general objective of this task is to inform the facility staff of the team’s preliminary findings. It is CMS’ general policy to conduct an exit conference at the conclusion of each survey. However, there are some situations that justify refusal to continue or to conduct an exit conference. For example: If the provider is represented by counsel (all participants in the exit conference should identify themselves), surveyors may refuse to conduct the conference if the lawyer tries to turn it into an evidentiary hearing; or Any time the provider creates an environment that is hostile, intimidating, or inconsistent with the informal and preliminary nature of an exit conference, surveyors may refuse to conduct or continue the conference. Under such circumstances, it is suggested that the team coordinator stop the exit conference and call the State agency for further direction.

Department of Health Licensing Survey Exit Conference Sequence Introductory Remarks Ground Rules Presentation of Findings Closure

Department of Health Licensing Survey Post Survey – Plan of Correction Regulations at 42 CFR §488.28(a) allow certification of providers with deficiencies at the Standard or Condition level “only if the facility has submitted an acceptable plan of Correction [POC] for achieving compliance within a reasonable period of time acceptable to the Secretary.” Failure to submit a POC may result in termination of the provider agreement as authorized by 42 CFR §488.28(a) and §489.53(a)(1). After a POC is submitted, the surveying entity makes the determination of the appropriateness of the POC.

Department of Health Licensing Survey Top Ten Findings Clinical Issues Environment of Care / Fire Life Safety Issues Inpatient - Individual Plan of Care Air Pressure Relationships Inpatient - Restraints Tamper Resistant Receptacles Inpatient - Blood Transfusions Plant Cross Connections HR - Qualified/Competent Staff Safety Pharmacy - Prepare, Dispense, Administration Nutrition - Food Service

Department of Health Licensing Survey Top Ten Findings Inpatient - Individual Plan of Care, Initial Assessment & Reassessment WAC 246-320-345 Citations reflect a failure by hospitals to: Establish a plan of care based on the patient assessment: Reassess the patient periodically to determine if the initial needs/problems were resolved or continued; or Reassess periodically to identify new patient problems needing different interventions according to a revised plan; Individualize patient plans of care when the patient has very obvious special needs outside a standard plan of care that may have been based on a single medical diagnosis, or single procedure.

Department of Health Licensing Survey Top Ten Findings Inpatient - Restraints  WAC 246-320-345(5)(g) The citations reflect a failure by hospitals to develop and implement complete policies for use of restraints or a failure to follow hospital policies for restraint. Specific examples include: Failure to define restraint devices versus safety devices; Failure to define a physical restraint versus a chemical restraint; Failure to define use of restraints for medical/surgical reasons versus use of restraints for emergent behavioral/psychiatric reasons; Failure to obtain appropriate orders for restraints; Failure to document specific less restrictive interventions attempted; Failure to document the reasons for the restraint;

Department of Health Licensing Survey Top Ten Findings Failure to document the actual restraint used; Failure to periodically assess/reassess the patient to determine if restraints continue to be needed and/or if the patient physical needs and safety are met; Failure to remove the restraint as soon as safely possible; Failure to provide continuous face to face monitoring of patients in seclusion and restraint; or Failure to provide and document annual training for staff caring for patients in restraints.

Department of Health Licensing Survey Top Ten Findings In-Patient Blood Transfusions WAC 246-320-345(5)(o) Citations reflect failure by a hospital to follow established policies such as: Failure to verify patient identify with two persons; Failure to verify blood/blood product identification for the patient by two persons; Failure to document the assessment of the patient pre and post administration of blood/blood products; Failure to document initial, incremental and final vital signs; Failure to document patient reaction/non reaction to transfusion; or Failure to administer blood or blood product at the ordered infusion rate.

Department of Health Licensing Survey Top Ten Findings HR - Qualified/Competent Staff WAC 246-320-165 Failure to establish staff competency standards for specialized care areas; or Failure to ensure that licensed, certified or registered staff practice only within their scope practice. Failure by a hospital to provide and document staff competency for specialized duties, such as: - The registered nurse administering/monitoring conscious/ procedural sedation according to the January 2000 Nursing Commission Policy Statement for Registered Nurses Performing Procedural Sedation; - Use of restraints; and - Assessment and management of malignant hyperthermia.

Department of Health Licensing Survey Top Ten Findings Pharmacy - Prepare, Dispense, Administration WAC 246-320-285 Failure to have an organized and systematic pharmacy service under the direction of a hospital pharmacist; Failure to have clear orders for medications which include parameters for dose, route, frequency and reasons for administration; Failure to monitor medication effectiveness or therapeutic levels; Failure to review and assure pharmacy approval of medication protocols, and/or pre-printed medication orders; Failure to authenticate medication orders according to policy; Failure to monitor for and remove outdated medications; Failure to label medications in syringes; and Failure to keep medications secure according to hospital policy.

Department of Health Licensing Survey Top Ten Findings Air Pressure Relationships WAC 246-320-405 (9)(c)(ii) Hospital facility conditions that lead to these improper pressure relationships are: Dampering air flow; Closing/altering a doorway; and Alterations/repairs to the ventilation system.

Department of Health Licensing Survey Top Ten Findings Tamper Resistant Receptacles WAC 246-320-405 (9)(e)(ii) Tamper resistant receptacles are required in the following areas per the requirements of WAC 246-320-405 (9)(e) (ii) and as noted in Table 525-5: Pediatric areas; Alcoholism and Substance Abuse units; Psychiatric units; Exam rooms; and Waiting areas.

Department of Health Licensing Survey Top Ten Findings Plant Cross Connections WAC 246-320-405 (9)(b)(iii) Whenever equipment is connected directly or indirectly to a potable water supply a backflow prevention device needs to be installed when or if: The equipment contains or might contain a contaminated or contaminating water, liquid, gas or mixture; The equipment has the potential to contaminate other equipment; and or The equipment is connected to a non-potable water supply, sewer or drain.

Department of Health Licensing Survey Top Ten Findings Examples of such equipment include: Beverage carbonators Fluid disposal docking units Chemical feeders Food preparation sinks Commercial style laundry machines Hose bibs Dialysis units Ice machines Dish washers Pasteurizers Film developers Ultra-sonic washers

Department of Health Licensing Survey Top Ten Findings Safety WAC 246-320-405(2)(a) Department of Health staff frequently identify the following unsafe conditions: Unsecured gas cylinders; Electrical receptacles in wet areas that are not protected by ground fault circuit interrupters (GFCI's); Lights over patient beds or in work areas that lack shields or shatterproof bulbs, unsecured windows; Electrical panels in patient areas that are left unlocked; and Plumbing and accessory fixtures installed in certain patient treatment areas that allow for self harm.

Department of Health Licensing Survey Top Ten Findings Nutrition - Food Service WAC 246-320-305 (6) Department of Health staff have identified non-compliance with the Food Service Code for the following items of concern as well as others: Food preparation sinks lacking indirect drains; Potential cross-contamination of food products; Improper food holding temperatures, both hot and cold; and Improper dishwashing and sanitizing temperatures.

Department of Health Licensing Survey Who has the rock in their pocket? Those facilities most successful during survey have assessed who within the organization should be responsible for specific areas of ongoing survey readiness and preparation.

Department of Health Licensing Survey Who has the rock in their pocket? Finding the owner of the rock may be difficult. Sometimes it may not be the most obvious person. This if further compounded by “siloing” within organizations. H U M A N   R E S O C F A C I L T E S P A T I E N   C R

Department of Health Licensing Survey Who has the rock in their pocket? “…when individuals, groups, or divisions–out of fear–seek to make themselves vital to their organizations and unconsciously or sometimes deliberately try to protect their turf or reshape their environment to gain as much control as possible over what goes on.” Bob Herbold

Department of Health Licensing Survey Who has the rock in their pocket? Assigning the most competent individual may require dealing with departmental “silos” or “fiefdoms.” Every department must understand that it is in the best interest of the facility to meet the “minimum standards.”

Department of Health Licensing Survey Who has the rock in their pocket? Real time examples: Facilities – In smaller facilities, the “maintenance” person that is so adept at keeping the place running may not be competent enough with the record keeping necessary to meet the minimum requirements of the Department of Health. Do you sacrifice day to day operations, or do you assign someone who is proficient in the paper requirements to work with them? In smaller facilities it may be someone from Upper Management.

Department of Health Licensing Survey Who has the rock in their pocket? Other Examples?

Department of Health Licensing Survey Wrap Up Survey is mandatory Facilities are surveyed to minimum standards Survey criteria is defined by CMS Conditions of Participation – so tied to Federal $$$$$ Surveyors follow “State Operations Manual” that is 307 pages of specific instructions and guidance DOH has identified top ten most frequently written citations Senior management must engage in the process at all times, not just the week of survey DOH wants you to stay open.

Department of Health Licensing Survey Questions? Richard A.Bryan, BSN, RN, CCM Vice President, Healthcare Risk Management Arthur J. Gallagher & Company of Washington 425-586-1057 Richard_bryan@ajg.com