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Based on observation, interview and review of documentation it was determined that the hospital failed to ensure that its quality assurance program was effective and evaluated all patient care and other services provided by the hospital.

Findings include:

1. Refer to Tag C924 that reflects areas of the hospital were not clean and orderly, and that surfaces, supplies and equipment were not protected from potential contamination.

2. Refer to Tag C1028 that reflects laboratory services were not organized and that the laboratory had not provided testing between 09/25/2020 and 11/09/2020.

3. Refer to Tag C1042 that reflects that not all services provided under contract, arrangement or agreement had been identified and described.

4. Refer to Tag C1206 that reflects that infection prevention and control policies and procedures had not been fully developed and implemented.

Based on observation it was determined that the hospital failed to ensure that all areas were clean and orderly to prevent contamination of surfaces and supplies:
*Work surfaces and/or cabinets were disorganized and cluttered with supplies and equipment, rendering the surfaces not readily cleanable and creating potential contamination of supplies and equipment.
*Patient supplies and equipment were placed next to sinks creating the potential for contamination from splashing water.
*Windows were open and there were no screens in place to prevent entry of dust, debris, insects and pests.
*Flooring and baseboards were missing and those surfaces were not readily cleanable.

Findings include:

1. During tour of the laboratory on 10/08/2020 beginning at 1350 the following observations were made:
* Large windows directly above a sink and work counter where boxes of gloves and laboratory equipment was placed, looked out into the hospital's front entrance and parking lot. The windows were open to allow for dust and debris entry into the department, and there were no screens to prevent the entry of insects or pests.
* Work counters, and the window sill just above a work counter, were cluttered with items such as papers, boxes, flashlights, potted plants, visible equipment cords. Those surfaces were not readily cleanable and the potted plants created a potential for plant soil to contaminate laboratory supplies.
* Laboratory supplies, such as an open box of microscope slides and an open box of wooden applicators were placed immediately next to a sink where there was a potential for contamination from splash from the sink.

2. Observations in the Radiology Department on 10/08/2020 beginning at 1420 revealed the following:
* The flooring and baseboards in the department, excluding individual exam rooms, had been removed. Those surfaces were unfinished and rough and rendered the floor not readily cleanable.
* During interview with the Interim Radiology Manager at the time of the observation he/she stated that there had been a "flood" in the department "two to three months ago," prior to this survey, and the flooring and baseboards had been removed as a result.

3. Observations in the ED on 10/08/2020 beginning at 1435 revealed the following:
* Cabinets behind the nurses station were disorganized and cluttered. For example: In one cabinet an equipment case with a "Doppler" label and another small equipment case were placed on open and unopened plastic bags of PPE supplies, open boxes of exam gloves, an open box of batteries, a plastic container with a straw, paper documents, etc. Items were stored haphazardly and on top of each other. The supplies were not readily identifiable and the cabinet was not readily cleanable.

4. Observations in the Cardiopulmonary Lab on 10/08/2020 at 1450 revealed the following:
* The work counter next to the handwashing sink was crowded and cluttered with equipment and patient care supplies that included a pile of linens, disinfectant wipes, equipment and electric cords, open and unopened packages of respiratory care supplies, etc. A small piece of equipment was placed immediately next the sink on the counter and another piece of equipment was on a rolling stand that was placed immediately in front of the counter next to the sink. Tubing from the equipment was observed on the counter and was partially dangling in the sink. Supplies were not protected from contamination and the surfaces were not readily cleanable.

Based on observation, interview and review of documentation it was determined that the governing body or administrator failed to ensure that the hospital provided quality healthcare in a safe environment.

Findings include:

1. Refer to Tag C337 that reflects the quality assurance program was not effective.

2. Refer to Tag C924 that reflects areas of the hospital were not clean and orderly, and that surfaces, supplies and equipment were not protected from potential contamination.

3. Refer to Tag C1028 that reflects laboratory services were not organized and that the laboratory had not provided testing between 09/25/2020 and 11/09/2020.

4. Refer to Tag C1042 that reflects that not all services provided under contract, arrangement or agreement had been identified and described.

5. Refer to Tag C1206 that reflects that infection prevention and control policies and procedures had not been fully developed and implemented.

Based on interview and review of the hospital's scope of services documents it was determined that the hospital failed to ensure that its written descriptions of laboratory services were complete and accurate.

Findings include:

1. The undated LUH "Laboratory Scope of Services" document reflected: "LUH Laboratory is staffed 17 hours per day, seven days per week, 365 days per year with testing personnel and phlebotomists. After 11pm Monday through Friday and after 230pm (sic) on weekends and holidays. (sic) The Laboratory Manager/Technical Supervisor is available on-site or by phone at any time."

During interview with the Interim Laboratory Manger on 10/08/2020 at 1415 he/she described the department hours and staffing as: The laboratory was open from 0600 to midnight with onsite staff, Monday through Friday; On Saturdays and Sundays the department was open and staff were onsite for eight hours each day; and for all other hours the department was closed and staff were on-call.

Further, the scope of services did not contain any information that described what tests were done onsite at the hospital, including POCT, and what tests were done at specific offsite or contracted locations. Refer also to Tag C1042 regarding contracted laboratory services.

Based on observation, interview and review of laboratory events and other documentation it was determined that the hospital failed to ensure that laboratory services were appropriately organized and that basic laboratory services were provided between 09/25/2020 and 11/09/2020.

Findings include:

1. During interview with the administrator on 10/08/2020 beginning at 1245, and review of a "Timeline of Lab Events" summary and CLIA survey documentation received from the administrator, the following information was provided:
* As of 08/28/2020 the hospital had not had a laboratory department director to oversee the laboratory services.
* On 09/04/2020 an onsite CLIA survey had been conducted at the hospital by the CLIA survey agency.
* A CLIA survey SOD was issued to the hospital by the CLIA survey agency that reflected significant failures related to operations that included laboratory oversight, laboratory staff qualifications and competencies and testing quality control processes.
* On 09/24/2020, based on the findings of the CLIA survey, the contracted laboratory medical director recommended that the hospital stop conducting all laboratory testing immediately.
* On 09/25/2020 at 1730 the hospital voluntarily ceased all laboratory testing.
* On 10/01/2020 the CLIA survey agency conducted an onsite revisit, found that the deficiencies cited on 09/04/2020 had not been corrected, and issued a written notice of an IJ situation while onsite at the facility.
* As of the date of this survey, 10/08/2020, the hospital continued to not conduct laboratory testing while it further developed and implemented a plan of correction for the CLIA survey findings.

2. Refer to Tag C0000 for additional information regarding the laboratory's operations between 09/25/2020 and 11/09/2020.

3. Refer also to Tags C924, C1010 and C1042 regarding laboratory operations.

Based on interview and review of the list of contracted services it was determined that the hospital had not maintained a complete and current list of all the services furnished under arrangements or agreements. The undated list provided did not include all services and did not describe the nature and scope of services that included: whether the services were offered on-site or off-site; whether there was any limit on the volume or frequency of the services provided; and when the service(s) were available.

Findings include:

1. An undated document titled "Services Provided by Contract" was reviewed. The document contained a table with three columns for "Name of Contracted Person or entity," "Service" and "Description of Service." There were entries for 15 contracted persons or entities. The "Description of Service" was not clear or complete for all 15 entries. For example:
* Two contracted entities were listed for services that were each identified as "Laboratory Services." The description for each reflected only "Clinical Laboratory services as requested." There was no other information.
* Two contracted entities were listed for services that were each identified as "Speech Pathologist." The description for each reflected only "Speech-language pathology services." There was no other information.
* A contracted entity was listed for services that were identified as "Nutritional Services." The description reflected "1. Consulting regarding menus 2. Provides dietary consultation to any resident/patient 3. Provides in-services education to the staff." There was no other information.

2. During interview with the administrator on 10/08/2020 at 1655 he/she stated that the list did not include all contracted services. He/she stated for example, that the hospital contracted with an entity for laboratory medical director services and with another entity for blood products and supplies. The administrator confirmed at the time of the interview that those services were not included on the list.

During interview on 11/10/2020 beginning at 1300 the administrator further confirmed that the list of contracted services did not include other contractors such as those the hospital used for linen services, hazardous waste services, and after hours radiology reading services.

None of the services referenced by the administrator were observed on the list described under Finding 1 in this Tag.

Based on observation, interview and review of infection prevention policies and procedures it was determined that the hospital failed to ensure that appropriate infection prevention policies and procedures were fully developed and implemented in the areas of:
* Face masks were not worn by staff at all times inside the hospital.
* Surfaces, patient supplies and equipment were not protected from potential contamination.

Findings include:

1. The policy and procedure titled "Face Masking Protocol" dated 04/03/2020 was reviewed. It stipulated that "The following protocol will be effective immediately ... All employees of [LUHD] will be required to wear a procedure mask while working. Any employee whose primary job is office based will be required to wear a procedure mask when meeting or working with other employees. The procedure mask may be removed when in the office working alone or a 6 foot distance can be maintained between yourself and anyone else in the office space ... Staff who are required to use a procedure mask shall don the mask and leave it in place, do not move the mask up and down on your face ..."

2. Observations on the inpatient unit on 10/08/2020 at 1430 revealed a nursing staff member sitting at the nurses station who was unmasked, drinking a beverage and was conversing with another nursing staff member who was standing within close proximity at a distance less than six feet.

3. Observations in the administrative offices area on 10/08/2020 at approximately 1620 and again at approximately 1625 revealed three staff persons were conversing inside a small office. The depth of the office space allowed for the desk, a chair behind the desk and a chair in front of the desk. A staff person sitting behind the desk was not wearing a mask. A second staff person sitting in front of the desk was not wearing a mask. The third staff person was standing in the doorway of the office facing the other two individuals and had a mask on that was not in place to cover the face, but rather was dangling off of one ear. The distance between those staff persons was less than six feet.

4. Refer to Tag C924 that reflects findings related to maintenance of work counters, cabinets, floors and windows, and to storage of patient supplies and equipment.