The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MONUMENT HEALTH RAPID CITY HOSPITAL 353 FAIRMONT BLVD POST OFFICE BOX 6000 RAPID CITY, SD 57701 April 27, 2017
VIOLATION: COMPLIANCE WITH LAWS Tag No: A0020
A. Based on interview, observation, document review, and review of state and federal regulations, the provider failed to meet the Condition of Participation for Compliance with Local, State, and Federal Laws for the disposal of biohazard infectious medical waste. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent and the supervisor of the solid waste operation in Rapid City revealed:
*The solid waste division had started to enforce the city code for garbage and refuse for the disposal of "Human blood and blood products, all waste human blood products such as serum, plasma and other blood components."
*The initial notifications had been directed to the haulers with letters on 8/4/16 and 9/1/16.
*The haulers had been directed to inform their generators (customers) on 10/3/16 regarding the enforcement of the city code.
-Having the haulers inform the generators had not obtained results for the enforcement of the code.
*A meeting had been held on 11/29/16 with generators (invitations sent to all generators) and the city landfill administration in regards to the regulated medical waste.
*On 12/16/16 a letter had been sent out to all potential biohazard infectious medical waste generators/customers.
*The other generators of medical waste in the city had complied within one to two months.
*Rapid City Regional Hospital (RCRH) had continued to have biohazard infectious medical waste in their common garbage.
*RCRH had previously had an autoclave that had rendered their biohazard infectious medical waste non-infectious.
-The non-infectious waste could then be disposed of in the city landfill.
-As of three to four months ago the autoclave was no longer in use by the hospital.
*The hospital now had a dedicated compacter load picked up by their hauler on Mondays, Wednesdays, and Fridays.
*Inspections were completed every day on common garbage produced by RCRH and other medical facility providers.
*Since October 2016 the landfill crew members responsible for all the inspections and audits had found potentially biohazard infectious medical waste in every load generated by RCRH.
*The hospital was called on each of those days for the potentially biohazard infectious medical waste to be picked up.
*The superintendent and supervisor revealed they also had pictures of the biohazard infectious medical waste that had been in the common garbage from RCRH.
-Observation of those pictures included biohazard infectious medical waste such as blood soaked gauze, tubing with blood in it, red bagged (biohazard) garbage, additional bags marked with the biohazard emblem, human bone joints, drain collection containers with blood, bloody catheter tubing, ambu bags, 24 hour urine collection containers capped with an unknown liquid inside, and what appeared to be fatty tissue.
-They stated the biohazard infectious medical waste could be identified as belonging to RCRH due to the common garbage in the bag. That common garbage included boxes, bags, and shipping invoices with the RCRH address on them.
*Review of the city's solid waste detailed tonnage and charge report from 10/6/16 through 4/24/17 revealed eighty-seven of ninety-two compacted trailer loads from the hauler for RCRH were deemed "medical waste." Those eighty-seven loads were delivered three times per week on Monday, Wednesday, and Friday. Holidays would be the only exception for no delivery.
*Interview with the landfill crew chief at the time of the tonnage and charge report review confirmed those findings. He stated either he or one of his employees had called the RCRH environmental services department on all of those eighty-seven. He would speak with either the director of environmental services or the materials management buyer about the bags of unacceptable biohazard infectious medical waste in the common garbage. Either one of the two above RCRH employees would drive out to the landfill and retrieve the biohazard infectious medical waste.
-There had been one occasion when the medical waste that had been picked up by RCRH had been returned in the next load of compacted common garbage.

2. Review of the 8/4/16 letter sent to the haulers and received by RCRH per verification and interview on 4/26/17 at 2:00 p.m. with the director of environmental services revealed:
*"Re: Landfill Rate Change - Medical Waste - 10/3/16.
-The City of Rapid city has approved changes in various landfill disposal rates, including a new rate for loads containing regulated medical waste.
-Medical waste is defined by the State of South Dakota as 'disposable equipment, instruments, utensils, human tissue, laboratory waste, blood specimens, or other substances that can could carry pathogenic organisms.'
-By City ordinance, all medical waste must be rendered non-infectious before accepted at the landfill for disposal."

Review of the 12/16/16 letter sent to the generators of the regulated medical waste revealed:
*"Disposal of Regulated Medical Waste - Rapid City Landfill.
-Your facility is being contacted because it has the potential to produce Regulated Medical/Infectious waste.
-Medical/infectious waste may not be disposed of in your regular trash unless it is rendered non-infectious and has a signed medical waste manifest for disposal at the Rapid City Landfill.
-While for many years City ordinance and State law has prohibited these materials from being disposed of in a landfill unless rendered non-infectious, concerns over the safety of Solid Waste staff has resulted in the City increasing their enforcement of regulated medical/infectious waste rules currently in place.
-Rapid City Ordinance, Section 8.08, defines regulated medical/infectious waste:
--Materials containing Human blood and blood products.
--Pathological waste.
--Contaminated animal carcasses.
--Cultures and stocks of infectious agents.
--Sharps.
--Unused sharps.
--Miscellaneous contaminated waste.
--Waste from medical, Nursing Homes, and Veterinary Facilities accepted as a regular household trash."

3. Review of the South Dakota Department of Environmental and Natural Resources Administrative Rules revealed:
*"74:27:13:17. Special Wastes.
-(5) Medical/Infectious wastes. Medical/Infectious waste must be rendered noninfectious, by incineration in accordance with article 74:36, or treated by steam sterilization, chemical disinfectant, or an equally effective treatment method, prior to disposal in a MSWLF [Municipal solid waste landfill facility]."

4. Review of the Occupational Safety and Health Administration (OSHA) Code of Federal Regulations (CFR) revealed:
*"OSHA: 29 CFR 1910.1030(d)(4)(iii) Regulated Waste -
-The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste:
--Liquid or semi-liquid blood or other potentially infectious materials (OPIM);
--Items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed;
--Items that are caked with dried blood or OPIM and are capable of releasing these materials during handling;
--Contaminated sharps; and
--Pathological and microbiological wastes containing blood or OPIM.
*It is the employer's/generator's responsibility to determine the existence of regulated waste. This determination should not based on actual volume of blood, but rather on the potential to release blood, (e.g., when compacted in the waste container)."

B. Based on interview, observation, document review, job description review, and contract service review, the provider failed to meet the Condition of Participation for Infection Control and removal of hazardous and infectious waste from the provider's common garbage. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent, supervisor, and crew chief of the solid waste operation in Rapid City revealed:
*Inspections were completed every day on common garbage produced by RCRH and other medical facility providers.
*Since October 2016 the landfill crew members responsible for all the inspections and audits had found potentially biohazard infectious medical waste in every load generated by RCRH.

Refer to A747 Infection Control.
VIOLATION: GOVERNING BODY Tag No: A0043
A. Based on interview, document review, and by-law review, the hospital failed to meet the Condition of Participation for Governing Body (GB) when it was not accountable for the proper disposal of biohazard infectious medical waste to include:
*Following local, state, and federal regulations.
*Implementing infection control practices, standards, and guidelines throughout the facility. Findings include:

1. Review of the provider's January 2017 Governing Body Bylaws revealed:
*"D. Compliance, Audit and Compensation Committee.
-2. Duties. The Compliance, Audit and Compensation Committee shall assist the System corporate boards in carrying out oversight responsibilities in regulatory compliance.
--a. Regulatory Compliance.
---i. Lead and support and organization culture that promotes ethical conduct, a commitment to compliance with laws, open communication and effective response to identified issues.
---iii. Routinely review compliance risk areas and management's identification and response to prevent, control, and correct and report risk exposures and identified issues.
*In addition, the Committee shall have the delegated authority of the Member to:
---vii. If and as needed, authorize corrective action for significant regulatory risks or identified issues coming to the attention of the Committee that, in the opinion of the Committee, are not being adequately addressed."

2. Interview on 4/27/17 at 11:00 a.m. with the vice-president of quality, safety, and risk management revealed:
*Her department was also responsible for quality assurance and performance improvement (QAPI). She stated nothing had been reported or brought forward by the environmental services department as a concern regarding disposal of biohazard infectious medical waste in the city landfill.
*She stated she was the responsible party to report to the governing board.
*She confirmed she would have had nothing to report in regards to infectious waste as nothing had been reported to her in the 2016 and 2017 quarterly quality, safety, and risk management meetings.

B. Based on interview, observation, document review, and state and federal regulations, the provider failed to meet the Condition of Participation for Compliance with Federal, State, and Local laws for the disposal of biohazard infectious medical waste. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent and the supervisor of the solid waste operation in Rapid City revealed:
*RCRH had previously had an autoclave that had rendered their biohazard infectious medical waste non-infectious.
-The non-infectious waste could then be disposed of in the city landfill.
-As of three to four months ago the autoclave was no longer in use by the hospital.
*Review of the city's solid waste detailed tonnage and charge report from 10/6/16 through 4/24/17 revealed eighty-seven of ninety-two compacted trailer loads from the hauler for RCRH were deemed "medical waste." Those eighty-seven loads were delivered three times per week on Monday, Wednesday, and Friday. Holidays would be the only exception for no delivery.
*Interview with the landfill crew chief at the time of the tonnage and charge report review confirmed those findings. He stated either he or one of his employees had called the RCRH environmental services department on all of those eighty-seven.

Refer to A020 Compliance with Federal, State, and Local Laws.

C. Based on observation, interview, and policy review, the provider failed to meet the Condition of Participation for Patient Right's for the privacy of one of one sampled patient (9) whose identifier information had been:
*Attached to an oral syringe.
*Disposed of in the provider's common garbage.
*Found at the city landfill. Findings include:

1. Observation on 4/26/17 at 8:45 a.m. at the city's solid waste disposal site revealed an oral syringe with attached patient information inside a clear garbage bag that had been disposed of in the hospital's common garbage.

Refer to A115 Patient's Rights.

D. Based on interview, document review, and policy review, the provider failed to meet the Condition of Participation for Physical Environmental and plant operations to maintain compliance with the operations within the facility. Findings include:

1. Interview on 4/26/17 at 4:10 p.m. with the director of plant operations revealed:
*He was not aware biohazard and infectious regulated medical waste was being disposed of in the provider's common garbage and then hauled to the local city landfill.
*He was not aware he was listed as the author on the provider's October 2014 Hazardous Materials and Waste Management policy.
-RCRH Hazardous Materials Manual:
-"A.1. Employees are responsible for complying with exiting rules and regulations. Among these are:
--a. Following all policies, procedures, rules and regulations.
--b. Reporting all hazardous condition to the supervisor.
--c. Wearing and using prescribed protective equipment and devices."

Refer to A700 Physical Environment.

E. Based on interview, observation, duty list review, job descriptions review, and contract service agreement review, the provider failed to meet the Condition of Participation for Infection Control for removal of hazardous and infectious medical waste from the provider's common garbage. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent, supervisor, and crew chief of the solid waste operation in Rapid City revealed:
*Inspections were completed every day on common garbage produced by RCRH and other medical facility providers.
*Since October 2016 the landfill crew members responsible for all the inspections and audits had found potentially biohazard infectious medical waste in every load generated by RCRH.

Refer to A747 Infection Control.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, interview, and policy review, the provider failed to meet the Condition of Participation for Patient's Right's for the privacy of one of one sampled patient (9) whose identifier information was attached to an oral syringe disposed of in common garbage from the provider. Findings include:

1. Observation on 4/26/17 at 8:45 a.m. at the city's solid waste disposal site revealed an oral syringe with attached patient information inside a clear garbage bag. Review of the information attached to the oral syringe revealed the following information:
*Patient 9's name and the room number 220-1.
*Building location of patient (RCRehab).
*RX (prescription) number.
*Vancomycin 500 mg (milligrams)/10 ml (milliliters) medication and dosage (dose = 250 mg = ml).
*Expiration date.
*Date and time (4/22/17 - 1402 [2:02 p.m.]).

Interview with the landfill crew chief at the time of the observation confirmed the above information. He stated it was not the first time patient information had been found in the provider's garbage.

Interview on 4/27/17 at 10:36 a.m. with the chief nursing officer revealed she:
*Was unaware staff would dispose of patient labeled medication or any other identifiable patient information in the common garbage.
*Stated staff/caregivers were trained upon orientation, annually, and throughout the year on the proper disposal of identifiable patient information in the sharps containers or to shred the information before disposal.

Interview on 4/27/17 at 11:45 a.m. with the pharmacy supervisor revealed she:
*Was also unaware staff would dispose of patient labeled medication in common garbage.
*Stated it was their policy to dispose of any needles or syringes in the sharps container.
*Stated staff/caregivers were trained on proper disposal of the above upon orientation, annually, and throughout the year by the provider's pharmacists.

Review of the provider's October 2014 Pharmaceutical Waste policy revealed:
*"Guidelines C. 2. For a partially utilized syringe, if there is a contaminated needle, dispose of the syringe and needle in the RED sharps container.
*If there is no needle BLUE pharmaceutical waste container."

Review of the 2016 and 2017 quality assurance performance improvement (QAPI) meeting minutes revealed:
*There were no identified concerns brought to the committee's attention regarding the improper disposal of potentially biohazard infectious medical waste in the city landfill.
*There was no information staff had been monitored for proper disposal of contaminated syringes and sharps.

Refer to A263 QAPI and A700 Physical Environment.
VIOLATION: QAPI Tag No: A0263
A. Based on record review, interview, and policy review, the provider failed to meet the Condition of Participation for Quality Assessment and Performance Improvement (QAPI) when they failed to identify concerns regarding the disposal of biohazard and infectious medical waste. Findings include:

1. Review of the provider's monthly clinical practice committee meeting minutes from 5/10/16 through 4/11/17 revealed:
*No identified problems, goals, or interventions related to the disposal of biohazard infectious medical waste.
*The only infection control information was what had been reported to the national healthcare safety network.
*There had been no information from environmental services regarding the changes in the disposal of biohazard infectious medical waste.
*There had been no information regarding the de-commissioning of the large autoclave that had rendered potentially biohazard infectious medical waste non-infectious.

Interview on 4/27/17 at 9:10 a.m. with the director of infection control revealed she:
*Had not been involved with environmental services when the autoclave had been taken out of service.
*Had heard passing conversations in regards to all potentially biohazard infectious medical waste and sharps were being handled by Stericycle.
*Had received an email for a general training on Stericycle procedures. That had not been a mandatory training, and she had not attended.
*Was not aware the surgery department had required additional training from Stericycle.
*Did not receive any audit information from the environmental services department.
*Was not aware if the new employee orientation or annual employee training included biohazard infectious medical waste training.





Interview on 4/27/17 at 11:00 a.m. with the vice-president of quality, safety, and risk management revealed her department was also responsible for QAPI. She stated nothing had been reported or brought forward by the environmental services department as a concern regarding disposal of biohazard infectious medical waste in the city landfill. She confirmed there was nothing in the 2016 and 2017 quarterly quality, safety, and risk management meetings to identify any concerns from the environmental services department.

Review of the 2016 and 2017 QAPI meeting minutes revealed no identified concerns had been brought to the committee's attention regarding the improper disposal of biohazard infections medical waste in the local landfill.

Review of the provider's March 2017 Performance Improvement Plan and Participation policy revealed:
*"Guidelines:
-A. Scope: Regional health's performance improvement, activities include those involving both clinical and non-clinical process and all hospital departments and services.
-C. Objectives:
--2. To collect data to monitor the stability of exiting processes, identity opportunities for improvement, identity changes that will lead to improvement, and sustain improvement.
-D. Responsibility for Performance improvement: Every caregiver, medical and allied heath staff member, board member and volunteer is responsible, individually and collaboratively, for improvement in the performance of the Hospital's services and functions.
--3. Caregiver, Medical/Allied health professional Staff Members and Volunteers:
---b. By providing idea and recommendations for performance improvement to management.
-E.2. Priorities for measurement and improvement will be selected based on:
---d. Regulatory requirements.
-F. Assessment of Performance:
--2. Determinations will be made by comparing the indicator data to:
---a. Predetermined performance criteria for new processes using performance improvement tools and techniques."

Interview on 4/27/17 at 1:30 p.m. with the risk management accreditation specialist confirmed there was no training to caregivers (all personnel referred to as caregivers at RCRH) on biohazard or infectious medical waste upon orientation or with the annual training. She also confirmed the Stericycle training was not a mandatory training. She did agree that all caregivers within the hospital had the potential to handle biohazard or infectious medical waste.

B. Based on interview, document review, and policy review, the provider failed to meet the Condition of Participation for Physical Environment and plant operations failed to monitor the facility for compliance with disposal of biohazard infectious medical waste. Findings include:

1. Interview on 4/26/17 at 4:10 p.m. with the director of plant operations revealed he was not aware:
*Biohazard and infectious regulated medical waste was being disposed of in the provider's common garbage and then hauled to the local city landfill.
*He was listed as the author on the provider's October 2014 Hazardous Materials and Waste Management policy.
-RCRH Hazardous Materials Manual:
-"A.1. Employees are responsible for complying with exiting rules and regulations. Among these are:
--a. Following all policies, procedures, rules and regulations.
--b. Reporting all hazardous condition to the supervisor.
--c. Wearing and using prescribed protective equipment and devices."
*The provider's October 2014 Hazardous Materials and Waste Management policy required the safety officer to:
- "Coordinate and integrate corporate and departmental practices.
-Serve as an education resource and monitor compliance with the manual and current regulations."
*Review of the 2016 and 2017 QAPI meeting minutes revealed no denitrified concerns had been brought to the committee's attention regarding the improper disposal of potentially biohazard infectious medical waste in the city landfill.

Refer to A700 Physical Environment.

C. Based on interview, observation, provider's duty list review, job description review, and contract service agreement review, the provider failed to meet the Condition of Participation for Infection Control for removal of hazardous and infectious medical waste from the provider's common garbage. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent, supervisor, and crew chief of the solid waste operation in Rapid City revealed:
*Inspections were completed every day on common garbage produced by RCRH and other medical facility providers.
*Since October 2016 the landfill crew members responsible for all the inspections and audits had found potentially biohazard infectious medical waste in every load generated by RCRH.

Refer to A747 Infection Control.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
A. Based on interview, document review, and policy review, the provider failed to meet the Condition of Participation for Physical Environmental and plant operations within the facility for disposal of biohazard infectious medical waste. Findings include:

1. Interview on 4/26/17 at 4:10 p.m. with the director of plant operations revealed:
*He had been in the director's position for about five years.
*His department was no longer responsible for the oversight of environmental services (ES).
*The director of the department of ES reported to the senior director of the department of ES.
*He had been part of the committee to remove the autoclave that was used to render the biohazard and infectious medical waste non-infectious medical waste. The autoclave had required more parts and repair and had become a "money pit."
*They removed the autoclave at the end of January 2017.
*He was aware a contract had been put in place by the director of ES with Stericycle to haul and dispose of the provider's biohazard and infectious medical waste.
*He was aware Stericycle had conducted an all staff training regarding biohazard and infectious medical waste. But he had not attended the training as it was not mandatory.
*He was not aware biohazard and infectious regulated medical waste was being disposed of in the provider's common garbage and then hauled to the local city landfill.
*He was not aware he was listed as the author on the provider's October 2014 Hazardous Materials and Waste Management policy.
-He stated he had not reviewed all the prior policies he had authored.
-He was waiting for a new program to be installed this summer by the provider that would tell him which policies he needed to review.

Interview at the above time with the director of safety services revealed he:
*Had been in the director's position for about a year.
*Was not responsible for biohazard infectious medical waste and was only responsible for chemical waste.
*Had not reviewed any of the policies and procedures that included his job title.
*Was aware Stericycle had conducted an all staff training regarding biohazard and infectious medical waste. But he had not attended the training as it was not mandatory.
*Was not aware biohazard and infectious regulated medical waste was being disposed of in the provider's common garbage and then hauled to the local city landfill.
*Was not aware his position was listed as a responsible party in the 2014 Hazardous Materials and Waste Management policy.

Review of the October 2014 Hazardous Materials and Waste Management policy revealed:
*"Rapid City Regional Hospital is committed to providing a safe environment for its patients, visitors, staff and community and will attempt to do so by striving to meet all standards, laws, rules and regulations governing the hazardous materials it uses.
*Guidelines:
1. Hazardous materials are those as defined and regulated by the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the South Dakota Department of Water and Natural Resources.
2. The Safety officer shall coordinate and integrate corporate and departmental practices, serve as an education resource, and monitor compliance with the manual and current regulations.
*RCRH Hazardous Materials Manual:
-"A.1. Employees are responsible for complying with exiting rules and regulations. Among these are:
--a. Following all policies, procedures, rules and regulations.
--b. Reporting all hazardous condition to the supervisor.
--c. Wearing and using prescribed protective equipment and devices.
*Classifications of Hazardous Wastes:
-a) Hazardous Materials: any item, substance or mixture of substances having properties capable of producing adverse effects on the health or safety of a human being or the environment. These items include sharps and infectious materials.
-b) Hazardous Wastes: wastes which are generated from the use of hazardous materials and which may require special handling and/or must be disposed of in other then normal waste.
-c) Regulated Wastes: defined in part 1910, Subpart 1030 z, as amended, of the OSHA Bloodborne Pathogen Standard.
*Infectious Waste Management Procedures:
I. Infectious Waste Definition: waste capable of producing and infectious disease. Infectious wastes include the following:
-A. Infectious wastes.
-B. Cultures and stock of infectious agents and associated biological.
-C. Human blood and blood products.
-D. Pathological wastes.
-E. Contaminated sharps.
--Note: color Coded bags for handling and/or disposal of contaminated items are as follows:
--a. Clear, large plastic bags: Used primarily by O.R. (operating room) and O.B. (obstetrics) for collection of soiled linen.
--b. Red bag: used for disposal of all potentially infectious waste. contents of these bags must be treated prior to ultimate disposal either by autoclaving or incineration.
II. Procedures for Infectious Wastes:
-A. Collection and Handling:
--1. Appropriate personal protective equipment will be worn if exposure is anticipated.
--3. Infectious wastes are to be collected in polyethylene red bags that area appropriately labeled.
-B. Transportation:
--5. the infectious waste bags will be removed from the trash room and placed directly into the transfer cart.
--6. Once the transfer carts are full, they are to be directly taken to the loading dock area for decontamination.
-C. Decontamination:
--1. Infectious waste must be treated prior to disposal in the compactor.
--2. Decontamination of infectious wastes will be achieved by steam sterilization (autoclave) or incineration."

Review of the provider's August 2014 Receipt, Handling, Storage and Disposal of Hazardous Materials/Waste policy revealed:
*"Statement: The following guidelines will be followed when dealing with hazardous substances.
*Guidelines:
1. Hazardous Materials.
2. Hazardous Wastes.
3. Regulated Wastes.
-The above items will be treated as infectious waste, placed in infectious waste containers ("red bags") and placed in the designated areas for collection. The waste will be collected by the custodians, placed in a transport cart that is identified with a Biohazard Symbol, and transported to the dock area for autoclaving or incineration.
-Note: Any tubing containing blood and/or body fluids will be treated as infectious waste. Suction canisters will be emptied into the sanitary sewer system or treated with Isolizer by the using department staff prior to disposal. If emptied, the canister and associated tubing will be "red bagged". If the contents are treated with Isolizer the container may then be placed directly in the compactor as treated medical waste."

Review of the Environment of Care meeting minutes dated 2/24/17 revealed: "Hazmat Update: Environmental Services has worked with Stericycle for sharps/medical waste. We shut down the dock sterilizer and had it removed the end of January."

B. Based on interview, observation, document review, and state and federal regulations, the provider failed to meet the Condition of Participation for Compliance with Federal, State, and Local laws for the disposal of biohazard infectious medical waste. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent and the supervisor of the solid waste operation in Rapid City revealed:
*RCRH had previously had an autoclave that had rendered their biohazard infectious medical waste non-infectious.
-The non-infectious waste could then be disposed of in the city landfill.
-As of three to four months ago the autoclave was no longer in use by the hospital.
*Review of the city's solid waste detailed tonnage and charge report from 10/6/16 through 4/24/17 revealed eighty-seven of ninety-two compacted trailer loads from the hauler for RCRH were deemed "medical waste." Those eighty-seven loads were delivered three times per week on Monday, Wednesday, and Friday. Holidays would be the only exception for no delivery.
*Interview with the landfill crew chief at the time of the tonnage and charge report review confirmed those findings. He stated either he or one of his employees had called the RCRH environmental services department on all of those eighty-seven.

Refer to A020 Compliance with Federal, State, and Local Laws.

C. Based on interview, observation, job description review, and contract service agreement review, the provider failed to meet the Condition of Participation for Infection Control for removal of hazardous and infectious medical waste from the provider's common garbage. Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent, supervisor, and crew chief of the solid waste operation in Rapid City revealed:
*Inspections were completed every day on common garbage produced by RCRH and other medical facility providers.
*Since October 2016 the landfill crew members responsible for all the inspections and audits had found potentially biohazard infectious medical waste in every load generated by RCRH.

Refer to A747 Infection Control.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on interview, observation, document review, job description review, and contract service agreement review, the provider failed to meet the condition of participation for removal of hazardous and infectious medical waste from the provider's common garbage.

NOTICE:
Notice of immediate jeopardy (IJ) was given verbally on 4/26/17 at 5:30 p.m. to the Vice-President (VP), Director, and Manager of Quality, Safety, and Risk Management; the VP of Rapid City Regional Health, and the Risk Management Accreditation Specialist. The surveyors requested an immediate plan of correction (POC) to ensure an updated policy and procedure was put in place to rectify an infection control and physical environment hazard in regards to management of hazardous materials and waste.

PLAN:
On 4/27/17 at 1:00 p.m. the director of quality, safety and risk management provided the surveyors with an immediate written POC. That 4/27/17 POC was reviewed and amended.
On 4/27/17 at 4:27 p.m. the implemented POC for the IJ was approved by the surveyors, state office, and regional office. It included:
"Plan:
1. Director of Safety Services will develop a new policy regarding the current process related to the appropriate management of infectious waste.
2. Trash carts will be utilized to allow for the identification of the location where infectious waste is produced with immediate feedback to location leadership regarding variances.
3. RCRH [Rapid City Regional Hospital] Director of Environmental Services will schedule a meeting with City Landfill Supervisor and trash hauler vendor Area Manager to discuss process compliance.
Communication:
1. RCRH Director of Environmental Services will notify the landfill that communication regarding situations of inappropriate waste disposal should be communicated to the Director of Environmental Services or designee.
2. Visual inspection results will be documented using the Biohazard found in trash log and will be reported at the end of each shift to the Shift supervisor and communicated to the RCRH Director of Environmental Services and Hospital Based Safety Officer daily.
Audit:
1. Environmental Services caregivers will perform visual inspection of waste disposal bags before placing them into the compactor. Variances will be documented and reported at the end of each shift.
Education:
1. Department Director or designees will re-educate caregivers regarding the management of infection waste disposal."
Findings include:

1. Interview on 4/25/17 at 7:15 a.m. with the superintendent, supervisor, and crew chief of the solid waste operation in Rapid City revealed:
*The solid waste division had started enforcing the city code for garbage and refuse for the disposal of "Human blood and blood products, all waste human blood products such as serum, plasma and other blood components."
*The initial notifications had been directed to the haulers with letters on 8/4/16 and 9/1/16.
*The haulers had been directed to inform their generators (customers) on 10/3/16 regarding the enforcement of the city code.
*Having the haulers inform the generators had not obtained results for the enforcement of the code.
*A meeting had been held on 11/29/16 with the haulers in regards to the regulated medical waste.
*On 12/16/16 a letter had been sent out to all potential biohazard infectious medical waste generators.
*The other generators of biohazard infectious medical waste in the city had complied within one to two months.
*Rapid City Regional Hospital had continued to have biohazard infectious medical waste in their common garbage
*They had previously had an autoclave that had rendered their biohazard infectious medical waste non-infectious.
*As of three of four months ago the autoclave was no longer in use by the hospital.
*The hospital now had a dedicated compacter load picked up by their hauler on Mondays, Wednesdays, and Fridays.
*Inspections on each of those days since October 2016 found potentially infectious medical waste in every load.
*The hospital was called on each of those days for the potentially infectious medical waste to be picked up.
*The superintendent and supervisor revealed they also had pictures from the biohazard infectious medical waste that had been in the common garbage from RCRH.
-Observation of those pictures included potentially infectious medical waste such as blood soaked gauze, tubing with blood in it, red bagged (biohazard) garbage, additional bags marked with the biohazard emblem, human bone joints, drain collection containers with blood with blood in them, bloody catheter lines, ambu bags, 24 hour urine collection containers capped with an unknown liquid inside, and what appeared to be fatty tissue.
-They stated the biohazard infectious medical waste garbage could be identified as belonging to RCRH due to the common garbage in the bag. That common garbage included boxes, bags, and shipping invoices with the RCRH address.
*Review of the city's solid waste detailed tonnage and charge report from 10/6/16 through 4/24/17 revealed eighty-seven of the ninety-two compacted trailer loads from the hauler for RCRH were deemed biohazard infectious medical waste. Those eighty-seven loads were delivered three times per week on Monday, Wednesday, and Friday. Holidays would be the only exception.
*Inspections were completed every day on common garbage produced by RCRH and other medical facility providers.
*Since October 2016 the landfill crew members responsible for all the inspections and audits had found potentially biohazard infectious medical waste in every load generated by RCRH.
*The hospital was called on each of those days for the potentially hazardous infectious medical waste to be picked up.
*The landfill crew chief stated the tonnage and charge report confirmed those findings. He stated either he or one of his employees had called the RCRH environmental services department on all of those eighty-seven days. He would speak with either the director of environmental services or the materials management buyer about the bags of unacceptable biohazard infectious medical waste in the common garbage. Either one of the two above RCRH employees would drive out to the landfill and retrieve the biohazard and infectious medical waste.
-There had been one occasion when biohazard infectious medical waste that had been picked up by RCRH had been returned in the next load of compacted common garbage.





2a. Observation and interview on 4/25/17 at 11:30 a.m. with surgical technician A revealed:
*She was doing the tear down after a surgery.
*All the disposable wraps, packages, gowns, gloves, and any medical waste was placed in red biohazard bags.
*That also included items that had blood on them and a human bone joint.
*She stated every item that had the potential to have come in contact with the patient during surgery was placed in the red biohazard bags.
*The bags were then taken to the elevator and placed in a large plastic container along with the non-medical waste clear garbage bags.

Observation and interview on 4/25/17 from 11:40 a.m. through 12:05 p.m. with the director of surgical services revealed:
*All garbage, soiled linens, and used surgical instruments would be placed in the designated dirty elevator and sent down to the dirty side of central sterilization.
*The soiled linen and red bags were placed in different storage areas that could be accessed from the other side.
*The soiled linen was taken by laundry services.
*The garbage including the red bags were taken to the biohazard staging dock.

Observation and interview on 4/25/17 at 12:05 p.m. with custodian B revealed:
*The garbage was taken from the large plastic bins and sorted.
*The red bagged garbage was placed into boxes supplied by Stericycle, sealed, and stored until picked up.
*The clear regular garbage bags were inspected to ensure no visible biohazard infectious medical waste was seen and then placed in the hospital compactor.
*If any of the regular garbage was found to have biohazard infectious medical waste it was placed in a red bag, placed into a biohazard box, sealed, and stored until picked up.
*At times garbage was brought back from the landfill that had been found to have biohazard infectious medical waste in it. It was placed into a biohazard box, sealed, and stored until picked up.
*He was not sure how often that happened.
*Custodian B only had gloves on his hands and no other personal protective equipment (PPE).
*There was no direct line of sight of available PPE for the employees who handled biohazard infectious medical waste such as gowns, face shields, eye protection, and masks.

b. Observation on 4/26/17 from 8:30 a.m. through 9:30 a.m. at the city landfill of the waste that had been delivered by the hauler from RCRH revealed:
*The truck had unloaded at approximately 7:10 a.m.
*During the inspection with the landfill supervisor and crew chief the following was observed from the outer visible edge of that garbage load:
-One closed red biohazard bag.
-A large disposable underpad (chux) with ninety percent of it soaked in what appeared to be blood. There were also what appeared to be areas of clotted blood.
-Urinary drainage bags and tubing with urine still in them.
-Biohazard labeled bags visible through the clear plastic garbage bags.
-Rigid corrugated blue tubing used with respiratory treatments.
-A very large amount of blue isolation gowns.
-Surgical fabric used as draping during surgical procedures.
-A guidewire that could have been used during a central line or peripheral inserted central catheter insertion.

Interview on 4/26/17 at 2:15 p.m. with environmental shift supervisor D revealed:*She was one of the supervisors of the environmental services personnel when she was on duty.
*She also assisted to train new environmental services personnel.
*She trained those new personnel on how to sort the garbage at the biohazard staging dock.
*All garbage was taken into large plastic containers and sorted.
*The red biohazard garbage bags were placed into the boxes supplied by Stericycle and stored until Stericycle picked them up.
*The other garbage bags were visually inspected for any possible biohazard infectious medical waste. If that was found that entire bag would have been placed in a red biohazard bag and boxed.
*The custodians and the housekeepers had duty lists to use as a checklist for tasks and work to be completed in certain areas.
*There was a duty list at the biohazard staging dock.

3. Interview on 4/26/17 at 2:40 p.m. with the director of environmental services revealed:
*He was under contract with Crothall Healthcare, a housekeeping service company.
-Crothall contracted with RCRH/Regional Health to provide housekeeping and laundry services.
*He had been at RCRH for about one year.
*The hospital had a contract with a local waste hauler.
*That hauler picked up garbage from the hospital's compactor on Mondays, Wednesdays, and Fridays.
*He had been made aware in October 2016 from their waste hauler the landfill would not be accepting any biohazard infectious medical waste.
*It had not been a problem then as all their biohazard infectious medical waste had been rendered non-infectious due to the use of the autoclave.
*A decision had been made he believed around the end of February 2017 to remove the autoclave that had been used to render biohazard infectious medical waste non-infectious.
*Discussions had been done with the landfill personnel on what the city code entailed.
*The autoclave was at the end of its use, and it had not been cost effective to continue to repair it or replace it.
*At the that time Stericycle had been contacted to provide services to collect all the biohazard infectious medical waste from the hospital.
*Stericycle had done the training on the new procedure for all employees. The training had not been mandatory for the employees. Stericycle had conducted the trainings, so the employees could attend at any time during that day.
*They had initially kept track of certain departments when biohazard infectious medical waste had continued to be mixed with the common garbage.
*Surgical services had received retraining on the process from Stericycle.
*He was unaware if any additional audits or logs had been tracked by the directors of other departments regarding the disposal of biohazard infectious medical waste.
*He stated he felt the staff had made a concerted effort "So things don't go through."
*He agreed he and the materials management buyer had been contacted by the landfill every time a compactor load was picked up and dumped.
*He agreed biohazard infectious medical waste was present in what was picked up.
*Was aware if biohazard infectious medical waste was found the entire load would be charged more.
*Had informed the senior director of environmental services of having to pickup hazardous infectious medical waste after each load.
*Was not aware if the current policies and procedures matched the new process for handling biohazard and infectious medical waste nor had he reviewed the current policies and procedures in place. He did not author or review any policies.
*He confirmed there was a duty list hanging in the biohazard staging dock area.
*On 5/11/16 environmental services had conducted training regarding bloodborne pathogens.
*No audits or logs were kept to provide information about the new process of handling biohazard infectious medical waste.

Interview on 4/27/17 at 8:15 a.m. with the senior director of environmental services revealed:
*She was under contract with Crothall Healthcare, a housekeeping service company.
-Crothall contracted with RCRH/Regional Health to provide housekeeping and laundry services.
*She knew about a October 2016 letter the contracted garbage hauler had received regarding hazardous infectious medical waste disposal at the landfill.
*She had been a part of the autoclave removal decision.
*Stericycle had provided two trainings initially. One just for the environmental services staff and one for all the employees.
*Notification for the training had been emailed to the employees. It had been a open house style training for employees to come and go as they needed.
*Was unsure when that initial training had taken place.
*Was unsure of the date Stericycle services had replaced the process of autoclaving hazardous infectious medical waste.
*The procedure had changed for the environmental services staff on how to package hazardous infectious medical waste.
*Agreed surgical services had required a secondary training by Stericycle. That training had been completed on 12/15/16.
*Was aware the director of environmental services and the materials management buyer had gone to the landfill to retrieve hazardous medical waste.
*She was not aware that each load had generated calls to retrieve hazardous infectious medical waste.
*Infection control had been invited to meet just for the change to Stericycle for sharps.
*Was aware if nobody from the hospital was able to retrieve hazardous infectious medical waste from the landfill the contracted garbage hauler had picked it up.
*Had not reviewed or changed any of the policies or procedures when she had started her job.
*Had not reported any of the concerns regarding the disposal of biohazard infectious medical waste to her upper management contact who was the vice president of facilities management.
*No audits or logs were kept to provide information about the new process of handling biohazard infectious medical waste.

Interview on 4/26/17 at 3:10 p.m. with the materials management buyer revealed:
*"The autoclave had run its life span. It had multiple repairs to keep it running."
*There had been multiple conversations about when to retire the autoclave and go with the Stericycle program.
*He believed the hospital had been notified around the end of August 2016 by their contracted garbage hauler.
*Had been part of a meeting with the city mayor and city council members regarding the enforcement of the city code for hazardous infectious medical waste.
*Had met with the superintendent and the education director at the landfill regarding the expectations for the disposal of hazardous infectious medical waste.
*He agreed he and the director of environmental services had been contacted by the landfill every time a compactor load was picked up and dumped.
*Received a call three times a week to retrieve hazardous infectious medical waste.
*Felt the landfill personnel only went through the hospital's garbage upon every single drop off.
*Was not aware of the increased charge when hazardous infectious medical waste was found with the common garbage.
*Was not aware of any new policy or procedure after the autoclave had been retired and Stericycle had been contracted for hazardous infectious medical waste.
*Had not reported any of the biohazard infectious medical waste concerns to his supervisor, the manager of procurement.

Interview on 4/26/17 at 4:10 p.m. with the director of plant operations and the director of system safety services revealed:
*Plant operations was responsible to maintain the autoclave.
*They had made major repairs in it over a year ago for cracks in the bottom.
*He was not aware of all the landfill changes.
*He was aware of the direction to use Stericycle. Had heard "Rumors last week regarding communication that pertained to hazardous infectious medical waste having been sent to the landfill last week."
-He was unaware he had authored the policies regarding the autoclave and rendering hazardous infectious medical waste non-infectious.
-He was aware those policies had not been updated since the autoclave was not being used anymore.
-He was aware the policies had not caught up with the current practices.
*The director of system safety services stated:
-At the directors meeting two to three months ago there had been mention of changing to Stericycle services for the sharps containment program and hazardous infectious medical waste.
*Was in charge of hazardous chemical waste but not medical waste.
-A letter from the landfill had been received late last week.
-Would use what policies were in force as those were the only ones employees had access to.
*Neither had attended the training Stericycle had provided.

Interview on 4/26/17 at 5:15 p.m. and at 5:53 p.m. with VP of quality, safety, and risk management revealed she had received calls from the infection control preventionist and the director of infection control. She stated they had only known about a change to Stericycle for the sharps.

Interview on 4/27/17 at 9:10 a.m. with the director of infection control revealed she:
*Had not had involvement with the disposal of hazardous infectious medical waste.
*Was aware of change only through passing conversations.
*The initial Stericycle training had not been mandatory. She had not attended the training.
*Was not aware surgical services had required additional training.

Interview per telephone on 4/27/17 at 9:45 a.m. with the vice president of facilities management revealed he:*Had numerous meetings with the senior director of environmental services, the director of environmental services, and the materials management buyer about the hazardous infectious medical waste changes.
*Had done a tour of the landfill with the landfill superintendent, director of environmental services, and the materials management buyer late 2016 or early 2017.
*Was aware of biohazard infectious medical waste that had been picked up by the director of environmental services and the materials management buyer when the change to Stericycle had occurred.
*He was not aware that biohazard infectious medical waste had continued to be picked up with each compactor load to the landfill since the first of the year.
*He had not ensured the problem had been resolved after the initial change to Stericycle.

Interview on 4/27/17 at 10:05 a.m. with the vice president of supply chain revealed:
*He was aware of the autoclave not being used, the Stericycle contract, and the timetable for the switch from the autoclave and Stericycle.
*He had added amendments for the hazardous infectious medical waste management to the Stericycle contract.
*He was aware Stericycle was to provide training.
*Stericycle provided all the supplies for the red bag program.
*Approximately one month ago he became aware the materials management buyer still received phone calls from the landfill.
*He was not aware the materials management buyer had driven out to the landfill to pick-up hazardous infectious medical waste.
*The senior director of environmental services and the director of environmental services should have done that.

Interview on 4/27/17 at 10:30 a.m. with the vice president of surgical services revealed he:*Was aware of the re-training that had been done by Stericycle for the surgical services department.
*Was not aware biohazard infectious medical waste had continued to be present in the provider's common garbage since January 2017.

Surveyor:
4.a. Review of the provider's undated duty list #124 revealed:
*Area: Dock.
*Job Title: Custodian.
- Run first load of autoclave.
-Clean dock, run load of autoclave.
*The duty list gave no instruction of how to use personal protective equipment (PPE).
*The use of PPE is a requirement for the handling of potentially infectious waste per OSHA and infection control guidelines.

Review of the provider's following job descriptions.

b. Director of Quality Safety and Risk Management (used for Director of Infection Control):
*Priorities: Culture of Safety and Community Stewardship
*This selected candidate implements, provider oversight, and evaluates quality and risk management programs and processes the provide for patient safety, event management, licensure regulatory and accreditation compliance; quality initiative leadership and monitoring, and clinical documentation improvement.

c. Director of Plant Operations:
*Priorities: Culture of Safety and Community Stewardship.
*The buildings and grounds are to be maintained in a manner that meets all standards required as a participant for the Medicare Program/Medicaid program and Joint Commission as well as City of Rapid City, Sate of South Dakota and Federal rules and regulations.
*Ensures new ideas are adopted and implemented to continually support the healthcare mission. Ensures employees share knowledge, understand decisions and the reason why decisions are made and implemented.

d. Director of Surgical Services:
*He/she must ensure employees' well-being and develop employees' talents to adopt ideas, new processes, new technology, and new products so as to ensure successful innovation.
*Develops quantifiable input, output, and performance dimension or products, processes, services, and financial and operation performance measure, so that action plans can be developed to accomplish goals whish improve customer performance.

e. (Senior) Director of RCRH Environmental Services:
*Ensures new ideas are adopted and implemented to continually support the healthcare mission while successfully accomplishing those goals the organization must attain for its strategy to succeed.
*Actively work to reduce operating expenses by improving processes, products, services, customer service, and reduction cycle time.

f. Director of RCRH Environmental Services:
*Ensures new ideas are adopted and implemented to continually support the healthcare mission while successfully accomplishing those goals the organization must attain for its strategy to succeed.
*Actively work to reduce operating expenses by improving processes, products, services, customer service, and reduction cycle time.

5. Review of the 10/13/15 provider's master service agreement between RCRH/Regional Health and Compass Group USA, Inc., (incorporated) a housekeeping and laundry management service, revealed Crothall Healthcare, Inc. was a subsidiary of Compass Group USA, Inc. Included in the master service agreement was the following:
*"Witnesseth.
-3.c. Environmental Hazards:
--Client recognizes its obligation to identify the presence of any environmental hazards which pose and unreasonable health risk to employees working in client's facilities, and to take steps as my be required by federal, state, and local laws, to communicate the presence of such hazards and take appropriate remedial actions.
--Client and compass shall cooperate with each other and work together to identify, take corrective action and train employees with respect to such environmental hazards.
-16. Compliance with Applicable Law.
--a.i. Compliance with Laws and Industry Standards.
---Compass shall perform the Services in a manner that is consistent with:
--(1) all applicable federal, state and local statutes, municipal ordinariness, rules and regulations;
--(2) all standards applicable to the Services and the individual performing such services which are promulgated by the Joint Commission; and
--(3) policies and procedures which are applicable to the Services, which specific policies and procedures shall be mutually develop and agreed upon by the parties."
*Statement of Work.
"1. Services.
--b.(ii). The Compass Personnel will provide advice and recommendations to the client with respect to the following 'Areas of Assessment' set forth below:
-A. Environmental Cleaning:
--c. Provide training, education, audits and metrics to ensure sustainability.
-C. Infection Prevention:
--b. Recommended practice.
--d. Provide training, education, audits and metrics to ensure sustainability.
-E. Review current polices and procedures of accuracy related to:
--a. Environmental cleaning."

Review of the 4/1/16 provider's master service agreement between RCRH/Regional Health and Compass Group USA, Inc., (incorporated) a housekeeping and laundry management service, revealed Crothall Healthcare, Inc. was a subsidiary of Compass Group USA, Inc. Included in the master service agreement was the following:
*"Cleaning Specification N: Miscellaneous Services.
3. Waste Disposal.
-Liaise with waste hauling and disposal firms. Autoclave and dispose or regulated medical waste as an internal function."