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    CHAPTER 50HEALTH CARE FACILITIES ADMINISTRATION481—50.1(10A)  Inspections.  The health facilities division inspects health care facilities, hospitals, and providers and suppliers of medical services in Iowa. Standards to obtain a license are explained in this chapter.481—50.2(10A)  Definitions.  
    "Administrator" means the person coordinating the administration of the division.
    "Department" means the department of inspections and appeals.
    "Director" means the director of inspections and appeals.
    "Division" means the health facilities division.
    481—50.3(135B, 135C)  Licensing.  All hospitals and health care facilities shall be licensed by the department. Applications are available from the Health Facilities Division, Lucas State Office Building, Des Moines, Iowa 50319-0083. Completed applications are returned to the division with the fee.  50.3(1)  Initial fees for hospitals are:  a.  Fifty beds or less, $15;  b.  More than 50 and not more than 100 beds, $25;  c.  Any greater number of beds, $50.A fee of $10 is charged to renew a hospital license each year.  50.3(2)  Initial and renewal fees for health care facilities are:  a.  Ten beds or less, $20;  b.  More than 10 and not more than 25 beds, $40;  c.  More than 26 and not more than 75 beds, $60;  d.  More than 76 and not more than 150 beds, $80;  e.  Any greater number of beds, $100.  50.3(3)  Standards used to determine whether a license is granted or retained are found in the rules of the department of inspections and appeals in the Iowa Administrative Code as follows:  a.  Hospitals, 481—Chapter 51;  b.  Hospices, 481—Chapter 53;  c.  Residential care facilities, 481—Chapters 57 and 60;  d.  Nursing facilities, 481—Chapters 58 and 61;  e.  Residential care facilities for persons with mental illness, 481—Chapters 60 and 62;  f.  Residential care facilities, three- to five-bed license, 481—Chapter 63;  g.  Intermediate care facilities for the intellectually disabled, 481—Chapter 64; and  h.  Intermediate care facilities for persons with mental illness, 481—Chapter 65.  50.3(4)  Posting of license. The license shall be posted in each facility so the public can see it easily.Related ARC(s): 0766C, 7035C481—50.4(135C)  Fines and citations.  A fine or citation will be issued and may be contested according to the rules in 481—Chapter 56.481—50.5(135C)  Denial, suspension or revocation.    50.5(1)  A denial, suspension or revocation shall be effective 30 days after certified mailing or personal service of the notice.  50.5(2)  A hearing may be requested and the request must be made in writing to the department within 30 days of the mailing or service.481—50.6(10A)  Formal hearing.  All decisions of the division may be contested. Appeals and hearings are controlled by 481—Chapter 9, “Contested Cases,” and 481—Chapter 10, “Rules of Procedure and Practice Before the Administrative Hearings Division.”  50.6(1)  The proposed decision of the hearing officer becomes final 15 days after it is mailed.  50.6(2)  Any request for administrative review of a proposed decision must:
    1. Be made in writing,
    2. Be mailed by certified mail to the director, within 15 days after the proposed decision was mailed to the aggrieved party,
    3. State the reason(s) for the request.
    A copy shall also be sent to the hearing officer at the Department of Inspections and Appeals, Lucas State Office Building, Des Moines, Iowa 50319.      50.6(3)  The decision of the director shall be based upon the record and becomes final agency action upon mailing by certified mail.  50.6(4)  The fees of witnesses for attendance and travel shall be the same as the fees for witnesses before the district court and shall be paid by the party to the proceeding at whose request the subpoena is issued.    Related ARC(s): 3523C, 7035C481—50.7(10A, 135C)  Additional notification.   A health care facility shall notify the department within 24 hours, or the next business day, by the most expeditious means available (I,II,III):  50.7(1)  Of any accident causing major injury.  a.  “Major injury” shall be defined as any injury which:  (1)  Results in death; or  (2)  Requires admission to a higher level of care for treatment, other than for observation; or  (3)  Requires consultation with the attending physician, designee of the physician, or physician extender who determines, in writing on a form designated by the department, that an injury is a “major injury” based upon the circumstances of the accident, the previous functional ability of the resident, and the resident’s prognosis.  b.  The following are not reportable accidents:  (1)  An ambulatory resident, as defined in rules 481—57.1(135C), 481—58.1(135C), and 481—63.1(135C), who falls when neither the facility nor its employees have culpability related to the fall, even if the resident sustains a major injury; or  (2)  Spontaneous fractures; or  (3)  Hairline fractures.  50.7(2)  When damage to the facility is caused by a natural or other disaster, including physical impairments affecting operations (e.g., failure of a heating or cooling system, water heater failure).  50.7(3)  When there is an act that causes major injury to a resident or when a facility has knowledge of a pattern of acts committed by the same resident on another resident that results in any physical injury. For the purposes of this subrule, “pattern” means two or more times within a 30-day period.  50.7(4)  When a resident elopes from a facility. For the purposes of this subrule, “elopes” means when a resident who has impaired decision-making ability leaves the facility without the knowledge or authorization of staff.  50.7(5)  When a resident attempts suicide, regardless of injury.  50.7(6)  When a fire occurs in a facility and the fire requires the notification of emergency services, require full or partial evacuation of the facility, or causes physical injury to a resident.  50.7(7)  When a defect or failure occurs in the fire sprinkler or fire alarm system for more than 4 hours in a 24-hour period. (This reporting requirement is in addition to the requirement to notify the state fire marshal.)Note: Additional reporting requirements are created by other rules and statutes, including but not limited to Iowa Code chapter 235E, which requires reporting of dependent adult abuse.Related ARC(s): 7035C481—50.8(22, 135B, 135C)  Records.  The division collects and stores a variety of records in the course of licensing and inspecting hospitals and health care facilities, as described in 481—Chapter 5. The records contain both public and confidential information.  50.8(1)    Public information.  The following are general categories of public information:  a.  The department’s final findings or the final findings of an accreditation organization with respect to compliance by a hospital or health care facility with requirements for licensing or accreditation, including any plan of correction;  b.  Applications for licensing or certification, accompanying materials, and status of any application;  c.  Reports from the state fire marshal;  d.  Information regarding complaints, unless otherwise confidential pursuant to subrule 50.8(2) or Iowa Code section 22.7;  e.  Waiver requests and responses;  f.  Official notices of licensing or certification sanctions.  50.8(2)    Confidential information.  The following are general categories of confidential information:  a.  Information that does not comprise a final report resulting from a survey, investigation, or entity-reported incident investigation, except as set forth in Iowa Code section 135B.12 or 135C.19(1);   b.  Names of complainants;  c.  Names of patients or residents and any identifying medical information;  d.  The address of anyone other than an owner.  50.8(3)    Redaction of confidential information.  If a record normally open for inspection contains confidential information, the confidential information shall be redacted before the records are provided for inspection.Related ARC(s): 7035C481—50.9(135C)  Criminal, dependent adult abuse, and child abuse record checks.    50.9(1)    Definitions.  The following definitions apply for the purposes of this rule.
    "Background check" "record check" means criminal history, child abuse and dependent adult abuse record checks.
    "Certified nurse aide training program" means a program approved in accordance with the rules for such programs adopted by the department of human services for the training of persons seeking to be a certified nurse aide for employment in a facility as defined by this rule or in a hospital as defined in Iowa Code section 135B.1.
    "Comprehensive preliminary background check" means a criminal history check of all states in which the applicant has worked or resided over the seven-year period immediately prior to submitting an application for employment or participation in a certified nurse aide training program that is conducted by an approved third-party vendor.
    "Direct services" means services provided through person-to-person contact. “Direct services” excludes services provided by individuals such as building contractors, repair workers, or others who are in a facility for a very limited purpose, are not in the facility on a regular basis, and who do not provide any treatment or services for residents, patients, tenants, or participants of the provider.
    "Employed in a facility" "employment within a facility" means all of the following if the provider is regulated by the state or receives any federal or state funding:
    1. An employee of a health care facility licensed under Iowa Code chapter 135C if the employee provides direct or indirect services to residents;
    2. An employee of a home health agency if the employee provides direct services to consumers;
    3. An employee of a hospice if the employee provides direct services to consumers;
    4. A health care employment agency worker as defined by Iowa Code section 135Q.1.
    "Employee" means any individual who is paid either by the facility or any other entity (i.e., health care employment agency, private duty, Medicare/Medicaid or independent contractors).
    "Evaluation" means review by the department of human services to determine whether a founded child abuse, dependent adult abuse or criminal conviction warrants prohibition of the person’s employment in a facility; or whether a founded child abuse, dependent adult abuse or criminal conviction warrants prohibition of a student’s involvement in a clinical education component of the certified nurse aide training program involving children or dependent adults.
    "Facility," for purposes of this rule, means all of the following if the provider is regulated by the state or receives any federal or state funding:
    1. A health care facility licensed under Iowa Code chapter 135C;
    2. A home health agency;
    3. A hospice.
    "Indirect services" means services provided without person-to-person contact such as those provided by administration, dietary, laundry, and maintenance.
    "Student" means a person applying for, enrolled in, or returning to a certified nurse aide training program.
      50.9(2)    Explanation of “crime.”  For purposes of this rule, the term “crime” does not include offenses under Iowa Code chapter 321 classified as simple misdemeanor or equivalent simple misdemeanor offenses from another jurisdiction.  50.9(3)    Requirements for employer prior to employing an individual.  Prior to employment of a person in a facility, the facility shall complete the background check requirements set forth below.  a.    Informing the prospective employee.  A facility shall ask each person seeking employment by the facility, “Do you have a record of founded child or dependent adult abuse or have you ever been convicted of a crime other than a simple misdemeanor offense relating to motor vehicles and laws of the road under Iowa Code chapter 321 or equivalent provisions, in this state or any other state?” In addition, the person shall be informed that a background check will be conducted. The person shall indicate, by signature, that the person has been informed that the background check will be conducted. (I, II, III)  b.    Conducting a background check.  The facility shall either request that the department of public safety perform a criminal history check and that the department of human services perform child and dependent adult abuse record checks of the person in this state, or access the single contact repository (SING) to perform the required background check. If the SING is used, the facility shall submit the person’s prior name(s), if applicable, with the background check request. (I, II, III)  c.    If a person being considered for employment has been convicted of a crime.  If a person being considered for employment in a facility has been convicted of a crime under a law of any state, the facility shall request that the department of human services perform an evaluation to determine whether the crime warrants prohibition of the person’s employment in the facility. (I, II, III)  d.    If a person being considered for employment has a record of founded child or dependent adult abuse.  If a person being considered for employment in a facility has a record of founded child or dependent adult abuse under a law of any state, the facility shall request that the department of human services perform an evaluation to determine whether the founded child or dependent adult abuse warrants prohibition of the person’s employment in the facility. (I, II, III)  e.    Employment pending evaluation.  The facility may provisionally employ a person prior to completion of the required record check and evaluation by the department of human services, as applicable, subject to all of the following:  (1)  The facility shall have accessed SING to perform the required record check and be awaiting results from SING or awaiting evaluation by the department of human services, as applicable;  (2)  If applicable, the facility shall request an evaluation by the department of human services in accordance with paragraph 50.9(3)“c” or “d” within 30 days of receipt of the SING record check results;  (3)  The facility shall have utilized an approved third-party vendor to perform a comprehensive preliminary background check;  (4)  If the comprehensive preliminary background check determines that the person being considered for employment has been convicted of a crime, the crime does not constitute a felony as defined in Iowa Code section 701.7 and is not a crime specified pursuant to Iowa Code chapter 708, 708A, 709, 709A, 710, 710A, 711, or 712 or pursuant to Iowa Code section 726.3, 726.7, or 726.8;  (5)  The comprehensive preliminary background check shall have determined that the person being considered for employment does not have a record of founded child abuse or dependent adult abuse, or, if the person being considered for employment does have a record of founded child abuse or dependent adult abuse, subrule 50.9(8) is applicable; and  (6)  The provisional employment may continue until such time as the required record check through SING and evaluation by the department of human services, as applicable, are completed. (I, II, III)  50.9(4)    Validity of background check results.  The results of a background check conducted pursuant to this rule shall be valid for a period of 30 calendar days from the date the results of the background check are received by the facility. (I, II, III)  50.9(5)    Employment prohibition.  Except as provided in paragraph 50.9(3)“e,” a person who has committed a crime or has a record of founded child or dependent adult abuse shall not be employed in a facility unless an evaluation has been performed by the department of human services. (I, II, III)  50.9(6)    Transfer of an employee to another facility owned or operated by the same person.  If an employee transfers from one facility to another facility owned or operated by the same person, without a lapse in employment, the facility is not required to request additional criminal and child and dependent adult abuse record checks of that employee. (I, II, III)  50.9(7)    Transfer of ownership of a facility.  If the ownership of a facility is transferred, at the time of transfer the background check required by this rule shall be performed for each employee for whom there is no documentation that such background check has been performed. The facility may continue to employ such employee pending the performance of the background check and any related evaluation. (I, II, III)  50.9(8)    Change of employment—person with criminal or abuse record—exception to record check evaluation requirements.  A person with a criminal or abuse record who is or was employed by a facility and is hired by another facility shall be subject to the background check.  a.  A reevaluation of the latest record check is not required, and the person may commence employment with the other facility if the following requirements are met:  (1)  The department of human services previously performed an evaluation concerning the person’s criminal or abuse record and concluded the record did not warrant prohibition of the person’s employment;  (2)  The latest background check does not indicate a crime was committed or founded abuse record was entered subsequent to the previous evaluation;  (3)  The position with the subsequent employer is substantially the same or has the same job responsibilities as the position for which the previous evaluation was performed;  (4)  Any restrictions placed on the person’s employment in the previous evaluation by the department of human services and still applicable shall remain applicable in the person’s subsequent employment; and  (5)  The person subject to the background check has maintained a copy of the previous evaluation and provided it to the subsequent employer, or the previous employer provides the previous evaluation from the person’s personnel file pursuant to the person’s authorization. If a physical copy of the previous evaluation is not provided to the subsequent employer, a current record check evaluation shall be performed. (I, II, III)  b.  For purposes of this subrule, a position is “substantially the same or has the same job responsibilities” if the position requires the same certification, licensure, or advanced training. For example, a licensed nurse has substantially the same or the same job responsibilities as a director of nursing; a certified nurse aide does not have substantially the same or the same job responsibilities as a licensed nurse.  c.  The subsequent employer must maintain the previous evaluation in the employee’s personnel file for verification of the exception to the requirement for a record check evaluation. (I, II, III)  d.  The subsequent employer may request a reevaluation of the background check and may employ the person while the reevaluation is being performed, even though an exemption under paragraph 50.9(8)“a” may be authorized.  50.9(9)    Employee notification of criminal conviction or founded abuse after employment.  If a person employed by a facility employer that is subject to this rule is convicted of a crime or has a record of founded child or dependent adult abuse entered in the abuse registry after the person’s employment application date, the person shall inform the employer of such information within 48 hours of the criminal conviction or entry of the record of founded child or dependent adult abuse.  a.  The employer shall act to verify the information within seven calendar days of notification. “Verify,” for purposes of this subrule, means to access the single contact repository (SING) to perform a background check, to request a criminal background check from the department of public safety, to request an abuse record check from the department of human services, to conduct an online search through the Iowa Courts Online website, or to contact the county clerk of court office and obtain a copy of relevant court documents.  b.  If the information is verified, the facility shall follow the requirements of paragraphs 50.9(3)“c” and “d.” (I, II, III)  c.  The employer may continue to employ the person pending the performance of an evaluation by the department of human services.  d.  A person who is required by this subrule to inform the person’s employer of a conviction or entry of an abuse record and fails to do so within the required period commits a serious misdemeanor under Iowa Code section 135C.33.  e.  The employer may notify the county attorney for the county where the employer is located of any violation or failure by an employee to notify the employer of a criminal conviction or entry of an abuse record within the period required under this subrule.  50.9(10)    Facility receipt of credible information that an employee has been convicted of a crime or has a record of founded abuse.  If the facility receives credible information, as determined by the facility, from someone other than the employee, that the employee has been convicted of a crime or a record of founded child or dependent adult abuse has been entered in the abuse registry after employment, and the employee has not informed the employer of the information within the time required by subrule 50.9(9), the facility shall take the following actions:  a.  The facility shall act to verify credible information within seven calendar days of receipt. “Verify,” for purposes of this subrule, means to access the single contact repository (SING) to perform a background check, to request a criminal background check from the department of public safety, to request an abuse record check from the department of human services, to conduct an online search through the Iowa Courts Online website, or to contact the county clerk of court office and obtain a copy of relevant court documents.   b.  If the information is verified, the facility shall follow the requirements of paragraphs 50.9(3)“c” and “d.” (I, II, III)  50.9(11)    Proof of background checks for health care employment agencies and contractors.  Proof of background checks may be kept in the files maintained by health care employment agencies and contractors. Health care employment agencies and contractors shall provide a copy of the result of the background checks to the facility or department upon request. (I, II, III)  50.9(12)    Certified nurse aide training program students.  Prior to a student’s beginning or returning to a certified nurse aide training program, the program shall either request that the department of public safety perform a criminal history check and that the department of human services perform child and dependent adult abuse record checks of the person in this state, or access the SING to perform the required background check.  a.    Prohibition of involvement in clinical education.  Except as provided in paragraph 50.9(1)“b,” if a student has a criminal record or a record of founded child or dependent adult abuse, the student shall not be involved in a clinical education component of the certified nurse aide training program involving children or dependent adults unless an evaluation has been performed by the department of human services. The evaluation shall be performed upon request of the certified nurse aide training program.  b.    Involvement in clinical education component pending evaluation.  The training program may provisionally allow the student’s participation in the clinical education component of the certified nurse aide training program pending completion of the required record check and evaluation by the department of human services, as applicable, subject to all of the following:  (1)  The training program shall have accessed SING to perform the required record check and be awaiting results from SING or awaiting evaluation by the department of human services, as applicable;  (2)  If applicable, the training program shall request an evaluation by the department of human services in accordance with paragraph 50.9(12)“a” within 30 days of receipt of the SING record check results;  (3)  The training program shall have utilized an approved third-party vendor to perform a comprehensive preliminary background check;  (4)  If the comprehensive preliminary background check determines that the student being considered for participation has been convicted of a crime, the crime does not constitute a felony as defined in Iowa Code section 701.7 and is not a crime specified pursuant to Iowa Code chapter 708, 708A, 709, 709A, 710, 710A, 711, or 712 or pursuant to Iowa Code section 726.3, 726.7, or 726.8;  (5)  The comprehensive preliminary background check shall have determined that the student does not have a record of founded child abuse or dependent adult abuse, or, if the student does have a record of founded child abuse or dependent adult abuse, subrule 50.9(8) is applicable; and  (6)  The provisional participation may continue until such time as the required record check through SING and evaluation by the department of human services, as applicable, are completed.  c.    Student notification of criminal conviction or founded abuse after performance of record checks and evaluation.  If a student is convicted of a crime or has a record of founded child or dependent adult abuse entered in the abuse registry after the record checks and any evaluation have been performed, the student shall inform the certified nurse aide training program of such information within 48 hours of the criminal conviction or entry of the record of founded child or dependent adult abuse.  (1)  The program shall act to verify the information within seven calendar days of notification. “Verify,” for purposes of this paragraph, means to access the single contact repository (SING) to perform a background check, to request a criminal background check from the department of public safety, to request an abuse record check from the department of human services, to conduct an online search through the Iowa Courts Online website, or to contact the county clerk of court office and obtain a copy of relevant court documents. If the information is verified, the program shall follow the requirements of paragraph 50.9(12)“a” to determine whether or not the student’s involvement in a clinical education component may continue.  (2)  The program may allow the student involvement to continue pending the performance of an evaluation by the department of human services.  (3)  A student who is required to inform the program of a conviction or entry of an abuse record and fails to do so within the required period commits a serious misdemeanor under Iowa Code section 135C.33.  (4)  The program may notify the county attorney for the county where the program is located of any violation or failure by a student to notify the program of a criminal conviction or entry of an abuse record within the period required by this paragraph.  d.    Program receipt of credible information that a student has been convicted of a crime or has a record of founded abuse.  If a program receives credible information, as determined by the program, that a student has been convicted of a crime or a record of founded child or dependent adult abuse has been entered in the abuse registry after the record checks and any evaluation have been performed, from a person other than the student, and the student has not informed the program of such information within 48 hours, the program shall act to verify the credible information within seven calendar days of receipt of the credible information. “Verify,” for purposes of this paragraph, means to access the single contact repository (SING) to perform a background check, to request a criminal background check from the department of public safety, to request an abuse record check from the department of human services, to conduct an online search through the Iowa Courts Online website, or to contact the county clerk of court office and obtain a copy of relevant court documents. If the information is verified, the requirements of paragraph 50.9(12)“a” shall be applied to determine whether or not the student’s involvement in a clinical education component may continue.  e.    Completion of a certified nurse aide training program conducted by the health care facility.  If a certified nurse aide training program is conducted by the facility and a student of that program accepts and begins employment with the facility within 30 days of completing the program, the background check of the student performed prior to beginning the training program shall fulfill the criminal and abuse background check requirements. The facility shall maintain the proof required in subrule 50.9(11). (I, II, III)This rule is intended to implement Iowa Code sections135C.14 and 135C.33.    Related ARC(s): 0903C, 1566C, 5421C, 7035C481—50.10(135C)  Inspections, exit interviews, plans of correction, and revisits.    50.10(1)    Frequency of inspection.  The department shall inspect a licensed health care facility at least once within a 30-month period. Facilities participating in the Medicare or Medicaid programs may be inspected more frequently as a part of a joint state and federal inspection.  50.10(2)    Accessibility of records, the facility, and persons.  An inspector of the department may enter any licensed health care facility without a warrant and may examine all records pertaining to the care provided to residents of the facility. An inspector of the department may contact or interview any resident, employee, or any other person who might have knowledge about the operation of a health care facility. The inspector may duplicate records and take photographs as part of the inspection.  50.10(3)    Exit interviews.  The health care facility shall be provided an exit interview at the conclusion of an inspection, and the facility representative shall be informed of all issues and areas of concern related to the deficiencies.  a.    Methods of conducting exit interview.  The department may conduct the exit interview either in person or by telephone.  b.    Second exit interviews.  The department shall conduct a second exit interview if any additional areas of concern are identified.  50.10(4)    Submission of additional or rebuttal information.  The facility shall be provided two working days from the date of the exit interview to submit additional or rebuttal information to the department.  a.    Receipt of additional information.  Additional or rebuttal information must be received by the department within two working days in order to be considered.  b.    Methods to submit additional information.  The additional or rebuttal information may be submitted via email, facsimile, or overnight courier to the department.  c.    Inform of the opportunity to submit additional or rebuttal information.  During the inspection, the facility shall be informed of the opportunity to submit additional or rebuttal information and of the contact information for the department.  50.10(5)    Standards for determining whether a deficiency exists.  The department shall use a preponderance of the evidence standard when determining whether a regulatory deficiency exists. For purposes of this rule and rule 481—50.11(135C), “preponderance of the evidence standard” means that the evidence, considered and compared with the evidence opposed to it, produces the belief in a reasonable mind that the allegations or deficiency is more likely true than not true. This standard does not require that the inspector personally witnessed the alleged violation.  50.10(6)    Statement of deficiencies.  When one or more deficiencies are found, a statement of deficiencies detailing each deficiency shall be sent by the department to the health care facility within ten working days of the exit interview.  50.10(7)    Plan of correction.  Within ten calendar days following receipt of the statement of deficiencies, the health care facility shall submit a plan of correction to the department.  a.    Contents of plan.  The plan of correction shall contain the following information:  (1)  How the facility will correct the deficient practice;  (2)  How the facility will act to protect residents;  (3)  The measures the facility will take or the systems it will alter to ensure that the problem does not recur;  (4)  How the facility plans to monitor its performance to make sure that solutions are sustained; and   (5)  Date(s) when corrective action will be completed.  b.    Review of plan.  The department shall review the plan of correction within ten working days of receipt. The department may request additional information or revisions to the plan, which shall be provided as requested.  50.10(8)    Revisits.  If a facility licensed under this chapter is subject to or will be subject to denial of payment including payment for Medicare or medical assistance (Medicaid) under Iowa Code chapter 249A, or denial of payment for all new admissions pursuant to 42 CFR Section 488.417, and submits a plan of correction relating to the deficiencies or a response to a citation issued under 481—Chapter 56 and the department elects to conduct an on-site revisit inspection, the department shall commence the revisit inspection within the shortest time feasible of the date that the plan of correction is received or the date specified within the plan of correction alleging compliance, whichever is later.  50.10(9)    Appeals of statement of deficiencies.  The facility may appeal the statement of deficiencies by filing an appeal request with the department within 20 working days after receipt of the statement of deficiencies. The procedures defined in rule 481—50.6(10A) shall be followed for the appeal.Related ARC(s): 8433B, 1566C481—50.11(135C)  Complaint and self-reported incident investigation procedure.    50.11(1)    Complaint.  The process for filing a complaint is as follows:  a.  Any person with concerns regarding a facility may file a complaint with the Department of Inspections and Appeals, Complaint/Incident Bureau, Lucas State Office Building, Third Floor, 321 E. 12th Street, Des Moines, Iowa 50319-0083; by use of the complaint hotline, 1-877-686-0027; by facsimile sent to (515)281-7106; or through the website address dia-hfd.iowa.gov.  b.  When the nature of the complaint is outside the department’s authority, the department shall forward the complaint or refer the complainant to the appropriate investigatory entity.  c.  The complainant shall include as much of the following information as possible in the complaint: the complainant’s name, address and telephone number; the complainant’s relationship to the facility or resident; and the reason for the complaint.  d.  The complainant’s name shall be confidential information and shall not be released by the department.  e.  The department shall act on anonymous complaints unless the department determines that the complaint is intended to harass the facility.  f.  If the department, upon preliminary review, determines that the complaint is intended as harassment or is without a reasonable basis, the department may dismiss the complaint.  50.11(2)    Self-reported incident.  When the facility is required pursuant to rule 481—50.7(10A,135C) or other requirements to report an incident, the facility shall make the report to the department via:  a.  The web-based reporting tool accessible from the following Internet site, dia-hfd.iowa.gov, under the “Login” tab and then access “Add self report”;  b.  Mail by sending the self-report to the Department of Inspections and Appeals, Complaint/Incident Bureau, Lucas State Office Building, Third Floor, 321 E. 12th Street, Des Moines, Iowa 50319-0083;  c.  The complaint/incident hotline, 1-877-686-0027; or  d.  Facsimile sent to (515)281-7106.  50.11(3)    Time frames for investigation of complaint or self-reported incident.  The following guidelines shall be used for determining the time frame in which an on-site inspection of the facility shall be initiated:  a.    Immediate jeopardy situation.  Within 2 working days for a complaint or self-reported incident determined by the department to be an alleged immediate jeopardy situation. For purposes of this rule, “immediate jeopardy situation” means a situation in which the facility’s alleged noncompliance with Iowa Code chapter 135C, or rules adopted pursuant thereto, has caused or is likely to cause, serious injury, harm, impairment, or death to a resident.  b.    High-level nonimmediate jeopardy situation.  Within 10 days for nursing facilities and within 20 working days for intermediate care facilities and residential care facilities for a complaint or self-reported incident determined by the department to be an alleged high-level nonimmediate jeopardy situation. For purposes of this rule, “high-level nonimmediate jeopardy situation” means the alleged noncompliance with Iowa Code chapter 135C, or rules adopted pursuant thereto, may have caused harm that negatively impacts the resident’s mental, physical, or psychosocial status and is of such consequence to the resident’s well-being that a rapid response is warranted.  c.    Other nonimmediate jeopardy situation.  Within 45 calendar days for a complaint or self-reported incident determined by the department to be an alleged nonimmediate jeopardy situation, other than a high-level nonimmediate jeopardy situation. For purposes of this rule, “other nonimmediate jeopardy situation” means a situation that is not a high-level nonimmediate jeopardy situation where the alleged noncompliance with Iowa Code chapter 135C, or rules adopted pursuant thereto, may cause harm of limited consequence and does not significantly impair the individual’s mental, physical, or psychosocial status or function.  d.    No inspection of facility-reported incidents.  The department may determine not to institute an inspection of a self-reported incident using criteria including, but not limited to, the following:  (1)  There is no evident deficiency on the part of the facility, and the facility has taken appropriate measures to address the situation; or  (2)  There is a potential deficiency but:
    1. The facility has taken appropriate measures to address the situation;
    2. The facility does not have a recent history of identified deficiency similar to or related to the incident being reported;
    3. A complaint has not been filed regarding the incident being reported; and
    4. The resulting injury does not cause a significant negative impact to the resident’s quality of life.
      50.11(4)    Standard for determining whether a complaint or self-reported incident is substantiated.  The department shall apply a preponderance of the evidence standard in determining whether a complaint or self-reported incident is substantiated.  50.11(5)    Notification of program and complainant.  The department shall notify the facility and, if known, the complainant of the findings of the complaint investigation. The department shall also notify the complainant, if known, if the department does not investigate a complaint, and the reasons for not investigating the complaint shall be included in the notification.  50.11(6)    Process for complaint and self-reported incident.  The department and facility shall follow the process outlined in rule 481—50.10(135C), as applicable, when conducting or responding to a complaint or self-reported incident investigation.    Related ARC(s): 8433B, 7035C481—50.12(135C)  Requirements for service.  At each inspection, the facility shall provide the most current contact information for the purpose of service of departmental notices. A statement of deficiencies or citation shall be served upon a facility using one of the following methods.  50.12(1)    Electronic mail.  If a facility has electronic mail, electronic mail shall be used for service of statements of deficiencies and citations. If electronic mail is used, the following shall be complied with:  a.  The department shall send the electronic message return receipt requested. The response from the return receipt shall officially document receipt of the service and the date of receipt.  b.  A facility shall allow the electronic return receipt to be returned to the department and shall not delay the sending of the return receipt.  c.  If the department has not received the return receipt within three business days of sending the service via electronic mail, the department shall contact the facility to verify the receipt of the service.  50.12(2)    Certified mail.  If a facility does not have access to electronic mail, the service shall be sent via certified mail, return receipt requested.  50.12(3)    Personal service.  The department may choose to personally serve the notice upon the health care facility by delivering a copy of the statement of deficiencies or citation to the health care facility and presenting the copy to the facility.Related ARC(s): 8433B481—50.13(135C)  Inspectors’ conflicts of interest.    50.13(1)    Conflicts.  Any of the following circumstances disqualifies an inspector from inspecting a particular health care facility licensed under Iowa Code chapter 135C:  a.  The inspector currently works or, within the past two years, has worked as an employee or employment agency staff at the health care facility, or as an officer, consultant, or agent for the health care facility to be inspected.  b.  The inspector has any financial interest or any ownership interest in the facility. For purposes of this paragraph, indirect ownership, such as through a broad-based mutual fund, does not constitute a financial or ownership interest.  c.  The inspector has an immediate family member who has a relationship with the facility as described in subrule 50.13(1), paragraphs “a” and “b.”  50.13(2)    Immediate family member.  For purposes of this rule, “immediate family member” means the same as set forth in 42 CFR 488.301, and includes a husband or wife; natural or adoptive parent, child, or sibling; stepparent, stepchild, or stepsibling; father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law; or grandparent or grandchild.Related ARC(s): 8433BThese rules are intended to implement Iowa Code sections 22.11 and 135B.3 to 135B.7 and Iowa Code chapters 10A and 135C.    Related ARC(s): 8433B, 0766C, 0903C, 1566C, 3523C, 5421C, 5719C, 7035C