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Tag No.: A0008
Based on observations, record reviews, policy reviews, and interviews, the facility failed to meet all the statutory provisions of 1861(e) of the Act. The facility failed to be primarily engaged in providing services, by or under the supervision of physicians, to patients, who have been formally admitted as inpatients, (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons.
Findings Include:
1. In order for surveyors to determine whether or not a hospital is in compliance with the statutory and regulatory requirements of Medicare participation, including the definition of a hospital, they must observe the provision of care. Medicare requirements at 42 CFR 488.26(c)(2) state that "The survey process uses resident and patient outcomes as the primary means to establish the compliance process of facilities and agencies. Specifically, surveyors will directly observe the actual provision of care and services to residents and/or patients, and the effects of that care, to assess whether the care provided meets the needs of individual residents and/or patients."
Because §488.26(c)(2) and section 1861(e) of the Act refer to patients (plural) hospitals must have at least two inpatients at the time of the survey in order for surveyors to conduct the survey.
Observation on 04/13/21 at 9:15 AM showed Patient 1 was in a bed on the inpatient unit. Further observation showed there was no other patients in the inpatient unit.
Review of Patient 1's medical record showed she was admitted on 04/12/21, had a Roux-en-Y Gastric Bypass (a surgical procedure which may be done for severe obesity) with hiatal hernia reduction on 04/12/21, and was discharged on 04/14/21. Review of the admit orders, located under the "Orders" tab, written by Staff A, CEO, on 04/12/21 at 1:00 PM lacked documented evidence of whether Patient 1 was admitted as an inpatient, outpatient, or for observation.
Observation on 04/14/21 at 8:10 AM showed Staff O, Physical Therapist (PT), exited Patient 2's room. Patient 2 was admitted on 04/13/21 with a diagnosis of right knee osteoarthritis and had a right total knee arthroplasty (total knee replacement) on 04/13/21. Review of the admit orders, located under the "Orders" tab, written by Staff G, Physician on 04/13/21, lacked documented evidence of whether Patient 2 was admitted as an inpatient, outpatient, or for observation.
Review of document in Patient 2's medical record titled, "Pre-Auth Check for Posting-Scheduling Insurance Clearance Checklist," posted on 03/01/21 and signed on 03/29/21, showed, Payment Due: $175.00 down which is the out pt (outpatient) observation copay but the patient has a 30% for surgical that may be due and the remaining oop may be billed. Admission Type 1 night. Expected duration of stay 0 nights.
Observation on 04/15/21 at 8:15 AM showed Patient 2 was the only patient on the inpatient unit.
Observation on 04/16/21 at 8:05 AM showed one patient (Patient 22) on the inpatient unit (the patient had bariatric surgery on 04/15/21). Patient 22 was the only patient on the inpatient unit at the time. This was confirmed by Staff C, Director of Nursing (DON).
During an interview on 04/13/21 at 3:57 PM, Staff B, Chief Medical Officer (CMO), when asked about the status of the patients with surgeries scheduled for the week of the survey, Staff B, CMO, stated that they look at one overnight stay as an admitted inpatient. Staff B, CMO, offered no further explanation regarding not having patients scheduled with the expectation of having a two midnight stay.
2. Average Daily Census (ADC) and Average Length of Stay (ALOS)
Review of the Medicare Benefit Policy Manual, Chapter 1, §10 showed the definition of an inpatient as "a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services ....Generally, a patient is considered an inpatient if formally admitted as an inpatient with the expectation that he or she will require hospital care that is expected to span at least two midnights and occupy a bed even though it later develops that the patient can be discharged or transferred to another hospital and not actually use a hospital bed overnight." The "expectation of a two midnight stay" for an inpatient is that the intent of the physician was that the patient be admitted to the hospital for an inpatient stay as opposed to that of observation status which is an outpatient service. Therefore, an average length of stay (ALOS) of two midnights would be one of the benchmarks considered for certification as a hospital.
Based on calculations of midnight daily census for each day from 04/01/20 through 03/31/21 divided by the total number of days in the year, the ADC was 0.60.
Based on calculations of the total number of inpatient hospital days divided by the total number of discharges over the same 12-month period, the ALOS was 1.45 (of significance is the fact that the hospital's data provided for calculations based on the hospital viewing a patient with a one midnight stay as an inpatient).
3. Number of inpatient beds related to the size of the facility and scope of services offered.
Review of the floor plan showed the facility currently has seven beds designated for inpatient use (Patient Rooms 103, 105, 110, 112, 118, Hospital Rooms 107 and 108) and two intensive care unit beds (ICU1 and ICU2). Patient Room 116 has double occupancy capability but "not currently being used for patient care now." The facility had two operating rooms and one procedure room.
4. Review of CMS' "Hospital Inpatient Admission Order and Certification," dated 01/30/14, showed ". . . The complete requirements for the physician certification are found in 42 CFR Part 424 subpart B and 42 CFR 412.3. . . A Physician Certification. . . 1. Content: The physician certification includes the following information: a. Authentication of the practitioner order: The physician certifies that the inpatient services were ordered in accordance with Medicare regulations governing the order. This includes certification that hospital services are reasonable and necessary and . . . that they are appropriately provided as inpatient services in accordance with the 2-midnight benchmark. . .. b. Reason for inpatient services: The physician certifies the reasons for either - (i) Hospitalization of the patient for inpatient medical treatment or medically required inpatient diagnostic study; or (ii) Special or unusual services for outlier services under the applicable prospective payment system for inpatient services. . . B. Inpatient Order: . . . 1. Content: The practitioner order contains the instruction that the beneficiary should be formally admitted for hospital inpatient care. The order must specify admission for inpatient services. . . 5. Specificity of the Order: The regulations at 42 CFR 412.3 require that, as a condition of payment, an order for inpatient admission must be present in the medical record. The preamble of the FY [fiscal year] 2014 IPPS [inpatient prospective payment system] Final Rule at 78 FR 50942 specifies that, "the order must specify the admitting practitioner's recommendation to admit 'to inpatient,' 'as an inpatient,' 'for inpatient services,' or similar language specifying his or her recommendation for inpatient care." . . . CMS will continue to treat orders that specify a typically outpatient or other limited service (e.g., [that is] admit "to ER," "to Observation," "to Recovery," "to Outpatient Surgery," "to Day Surgery," or "to Short Stay Surgery") as defining a non-inpatient service, and such orders will not be treated as meeting the inpatient admission requirements.
Review of the facility policy titled "Admission, eligibility Criteria," revised February 2019, showed ". . . MISH [Minimally Invasive Surgery Hospital] Admission Type: - Inpatient: a hospital admission to the floor or ICU [intensive care unit] with an overnight stay or more - Outpatient (same-day): a hospital admission with a planned discharge on day of service - Observation: a hospital admission with a potential for an inpatient admission. . . The Provider will: 1. Determine patient needs . . . 4. Provide appropriate orders. These orders should include but are not limited to: a. Admission Order to floor or ICU b. Admitting Physician c. Admitting diagnosis . . ."
There was no documentation in the policy that addressed that the physician had to specify whether the patient was being admitted as an inpatient, outpatient, or for observation. The hospital's policy allowed for one overnight stay to qualify a patient as an inpatient, rather than requiring an expectation of at least a two midnight stay as defined as an inpatient stay under section 1861(b) of the Act and in the regulations at 42 CFR Part 409, Subpart B.
During an interview on 04/14/21 at 3:25 PM, Staff A, Chief executive Officer (CEO), when asked if he was aware that the CMS regulation defined an inpatient as having a two midnight stay, Staff A, CEO, explained "I understand it is the physician who decides whether a patient stayed or admitted. My understanding is that if a patient stays longer in a hospital, they can develop complications. My expectation is that if a patient is able to go home the next day and wants to go home, I let the patient go home."
During an interview on 04/16/21 at 8:30 AM, Staff B, CMO, when asked how one is to determine whether a patient is admitted as inpatient, outpatient, or for observation, Staff B, CMO, stated "by LOS [length of stay] I guess. We keep it simple here. Later on, billing deals with what insurance wants. If the patient is going to stay overnight, it's an admission." Staff B, CMO, stated "same day surgery" meant patients who have outpatient procedures and are not admitted." She stated, "locals are patients who have procedures under local anesthesia."
5. Review of the "Medical Staff Rules and Regulations 179-302" showed ". . . No patient will be admitted except on an order of a Staff Member. . . Orders 1. General requirements All orders for treatment, medications, radiology and lab work must be in writing by a MISH [Minimally Invasive Surgery Hospital] privileged licensed independent practitioner, and Physician Assistant (PA) or Nurse Practitioner as outlined in their privileges. . . A member shall be responsible and provide a completed order for inpatient, observation or outpatient service that is medically necessary, dated, timed, and authenticated for all patient treatment, testing and/or procedures. . ."
Review of patient records (Patients 1 - 21) showed no documented evidence that any of the physician orders specified whether the patient was being admitted as an inpatient, outpatient, or for observation.
On 04/15/21 at 2:07 PM, Staff N, Billing Supervisor, stated the medical records pulled for March 2021 have not been billed yet. Staff N stated, "how a record is billed is based on the insurance carrier, such as is it required to be an inpatient." Staff N stated, "Medicare is always inpatient for bariatric procedures." Staff N stated "other patients are based on when they're admitted or discharged. Sometimes the time of admit and discharge comes into play as to whether it's an inpatient or outpatient." Staff N stated, "a patient has to be in the hospital for more than 24 hours to be considered as a possible inpatient." Staff N confirmed that she doesn't see anything documented in the medical record that designates the patient's status as inpatient, outpatient, or observation. Staff N stated she "bases her decision on the time the patient is in the hospital, or she may have to speak with the physician about the stay."
6. Review of the "Conditions of Admission Consent for Treatment," signed by patients (Patients 1 -21) at the time of admission, showed "I have a condition requiring inpatient or outpatient care: and I voluntarily consent to such care, including diagnostic and laboratory procedures and medical treatment by my physician and hospital personnel. I acknowledge that no guarantees have been made to me as a result of such care. . ."
Review of patient records (Patients 1-21) lacked documented evidence to show any of the patients were informed whether they were being admitted as an inpatient, outpatient, or for observation.
7. Patterns of ADC by day of the week.
The facility's ADC consistently drops to zero by Fridays. The facility routinely operates in a manner that its designated "inpatient beds" are not in use on the weekends.
Review of the data presented by Staff D, Quality Improvement Nurse Coordinator (QINC), showed the only Fridays from 04/01/20 through 03/31/21 that had any patient at midnight were 05/01/20, 05/29/20, 07/17/20, 08/14/20, 09/18/20, 10/09/20, 01/29/21, 03/12/21 (8 days). The only weekend days (Saturday and Sunday) for the same time period that had any patient at midnight were 05/02/20, 05/03/20, 05/30/20, 07/18/20, 07/19/20, 09/19/20, 09/20/20, 10/10/20, 10/11/20, 10/18/20, 01/30/21, and 01/31/21 (12 days).
April 1 - 30, 2020 No "inpatients" (Per the hospital's definition: Inpatient: a hospital admission to the floor or ICU [intensive care unit] with an overnight stay or more) 19 of 30 days (19/30).
No "inpatients" 4/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients" 4/4 Sundays
No "inpatients" April 7, 2020 through April 12, 2020
May 1 - 31, 2020 No "inpatients" 17/31 days.
No "inpatients" 3/5 Fridays
No "inpatients" 3/5 Saturdays
No "inpatients" 4/5 Sundays
No "inpatients" May 22, 2020 through May 27, 2020 (Memorial Day Holiday Weekend)
June 1 - 30, 2020 No "inpatients" 18/30 days.
No "inpatients" 4/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients" 4/4 Sundays
July 1 - 31, 2020 No "inpatients" 15/31 days.
No "inpatients" 4/5 Fridays.
No "inpatients" 3/5 Saturdays
No "inpatients" 3/4 Sundays
No "inpatients" Friday July 3, 2020 through Sunday July 5, 2020 (July 4th Holiday Weekend)
August 1 - 31, 2020 No "inpatients" 19/31 days.
No "inpatients" 3/4 Fridays.
No "inpatients" 4/5 Saturdays
No "inpatients" 5/5 Sundays
September 1 - 30, 2020 No "inpatients" 19/30 days.
No "inpatients" 3/4 Fridays.
No "inpatients" 3/4 Saturdays
No "inpatients" 3/4 Sundays
No "inpatients" September 1, 2020 through September 8, 2020 (Labor Day Holiday Weekend)
October 1 - 31, 2020 No "inpatients" 18/31 days.
No "inpatients" 4/5 Fridays.
No "inpatients" 4/5 Saturdays
No "inpatients" 2/4 Sundays
November 1 - 30, 2020 No "inpatients" 23/30 days.
No "inpatients" 4/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients" 5/5 Sundays
No "inpatients" November 24, 2020 through November 29, 2020 (Thanksgiving Day Holiday)
December 1 - 31, 2020 No "inpatients" 19/31 days.
No "inpatients" 4/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients" 4/4 Sundays
No "inpatients" December 24, 2020 through December 27, 2020 (Christmas Holiday)
No "inpatients" December 31, 2020 (New Year's Eve Holiday)
January 1 - 31, 2021 No "inpatients" 21/31 days.
No "inpatients" 4/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients "4/4 Sundays
No "inpatients" January 1, 2021 through January 3, 2021 (New Year's Holiday)
No "inpatients" January 13, 2021 through January 20, 2021
February 1 - 28, 2021 No "inpatients" 17/28 days.
No "inpatients" 4/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients" 4/4 Sundays
March 1 - 31, 2021 No "inpatients" 20/31 days.
No "inpatients" 3/4 Fridays.
No "inpatients" 4/4 Saturdays
No "inpatients" 4/4 Sundays
No "inpatients" March 26, 2021 through March 31, 2021
So, even using the facility's definition of inpatient, they had no "inpatients" 225/365 days of the year or 62% of the time.
8. Volume of Outpatient Surgical Procedures compared to Inpatient Surgical Procedures.
Review of an untitled document containing the following columns with billing data from 04/01/20 - 03/31/21: DOS (date of service), Procedure, MR (medical record), Patient, Ins (insurance), Bill Type, and CPT (current procedural terminology), showed:
i. 44 of 202 or 22% of procedures were billed as "inpatient",
ii. 153 of 202 or 76% of procedures were billed as outpatient or outpatient observation, and
iii. 5 of 202 or 2% of patients had no designation (not billed yet).
9. Review of the facility's website showed that services offered were advertised as minimally invasive surgeries, treatments, and outpatient procedures.
WEIGHT LOSS SURGERY OPTIONS
"Bariatric surgical procedures cause weight loss by restricting the amount of food the stomach can hold, and by causing malabsorption of food, or by a combination of both gastric restriction and malabsorption. Most weight loss surgeries today are performed using minimally invasive techniques (laparoscopic surgery)."
PAIN MANAGEMENT
"Today's options for pain management are vast. Two common options are medication management (non-aspirin pain relievers, non-steroidal anti-inflammatories, corticosteroids, opioid pain medications and antidepressants) and minimally invasive surgical treatment."
ORTHOPEDIC SURGERY
"We are also able to perform arthroscopic surgery-a minimally invasive procedure that requires only a small incision in order to insert a micro-camera called an arthroscope. During the operation, Dr. will examine the joint and perform any necessary treatments. Since this is an outpatient procedure, you will be able to return home the same day with detailed recovery instructions."
SLEEP DISORDERS LAB
A sleep study is a medical, non-invasive diagnostic study, to find out if you are getting a restful night's sleep. At MISH, we perform testing to diagnose sleep apnea.
ENDOSCOPY/COLONOSCOPY
Upper endoscopy (also known as gastroscopy, EGD, or esophagogastroduodenoscopy) is a procedure that enables your surgeon to examine the lining of the esophagus (swallowing tube), stomach and duodenum (first portion of the small intestine) without surgery.
Colonoscopy is a procedure that enables your surgeon to examine the lining of the rectum and colon. A soft, long bendable scope or lighted camera tube about the thickness of the index finger is gently inserted into the anus and advanced into the rectum and the colon. A colonoscopy is usually done as part of a routine screening for cancer in patients with known polyps or previous polyp removal, before or after some surgeries, to evaluate a change in bowel habits or bleeding or to evaluate changes in the lining of the colon known as inflammatory disorders.
CARDIOLOGY
MISH Hospital offers interventional and medical cardiology services in the treatment and diagnosis of heart disease. . . Cardiology services range from prevention to treating existing conditions. Whether you have been diagnosed, or need to see a cardiologist for an assessment of your heart health, you've come to the right clinic.
SPINE CENTER
. . . A national leader in minimally invasive techniques and spine arthroplasty (artificial disc replacements), he continues to instruct and research in the realm of advancing care for disabling spinal conditions.
Tag No.: A0043
Based on observations, record review, policy reviews, and interviews, the facility's governing body failed to: 1. Ensure the hospital met all of the statutory provisions of §1861(e) of the Social Security Act, including being primarily engaged in providing services, by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons; and 2. Ensure the hospital met the Condition of Participation (CoP) requirements of Food and Dietetic Services at 42 CFR 482.28
The cumulative effect of the governing body's failure to ensure the hospital met the statutory provisions of the Act and failure to ensure the food and dietetic services were provided by a qualified director has the potential to place patients at risk for unmet inpatient services and nutritional needs.
Findings Include:
1. The facility failed to be primarily engaged in providing, by or under the supervision of physicians, to patients, who have been formally admitted as inpatients, (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons. (Refer to A0008).
2. The facility failed to have a qualified director of the food and dietetic services who was responsible for the daily management of dietary services. (Refer to A0618).
Tag No.: A0618
Based on observations, personnel record review, and interviews, the facility failed to have a qualified director of the food and dietetic services who was responsible for the daily management of dietary services.
The cumulative effect of the facility's failure to have a qualified director of the food and dietetic services had the potential for patients' nutritional needs to be unmet.
Findings Include:
The hospital failed to have an organized dietary service led by a qualified director of food and dietetic services, responsible for the daily management of dietary services (Refer to A0620).
Tag No.: A0620
Based on observations, personnel record review, and interviews, the facility failed to have a director of the food and dietetic services who was responsible for the daily management of the dietary services and was qualified by experience or training. This deficient practice has the potential to place patients at risk for unmet nutritional needs.
Findings Include:
Review of the job description for the position of "Director, of Dietary Services," signed by Staff M, Dietary Services Director (DSD) on 02/20/15, showed the main function was "Oversees the daily operations of the dietary services. Responsible for the daily operational management of the service, implementing training and education programs for dietary staff, and assures that established policies and procedures are maintained." Further review showed the following "Duties and Responsibilities a) Responsible for the management, and direction of dietary services throughout the facility b) Ensures food and dietetic services are carried out daily c) Implements and manages training and education for dietary staff d) Ensures compliance with dietary policy and procedures including: Employee orientation, work assignments, supervision of work and personnel performance Safe food handling practices Provision of emergency food supplies Supervision of the menu planning function Purchasing of foods and supplies Retention of required records e) Ensures competency of administrative and/or technical personnel if any f) Performs other duties as deemed necessary by the employer." Review of " Requirements Required" showed "1. High school degree or higher 2. Minimum of one (1) year work experience in food service 3. Minimum One (1) year Food Management experience, education, or equivalent 4. Good communication skills 5. Strong ethical and moral character references."
Review of Staff M's, DSD, "MISH [Minimally Invasive Surgery Hospital] Application for Employment," signed by Staff M on 09/16/13, showed her employment history included the following: Owner/Operator of "Bag Habit" with no documented evidence of the nature of the job from June 2012 to present.
Department store "presentation team member" responsible for following schematic drawings to maintain product presentation, entering data into the computer systems, provide fast & [and] friendly service to guests" from July 2007 to June 2012.
Fast food establishment with position held of "Cashier/Drive thru [through] operator" from April, with no documented evidence of the year, to 07/07.
There was no documented evidence that Staff M, DSD, had experience in the management of dietary services. There was no documented evidence that Staff M had received training for the position of Dietary Services Director.
Review of the "Staff List," presented as the current list of hospital employees by Staff B, Chief Medical Officer (CMO), showed that Staff M, DSD, was employed part-time and held the positions of "Dietary Services Director" and "Billing Assistant."
Observation of the dietary area on the inpatient unit on 04/13/21 at 2:30 PM showed the freezer had two boxes of popsicles and one "Chicken Chile Verde" frozen meal. Further observation showed the refrigerator contained six four-ounce containers of apple sauce, two boxes of "Capri Sun," each box containing 10 six-ounce juice drinks. Continued observation showed an unlabeled paper bag with a foil-wrapped hamburger and french fries on the shelf in the refrigerator. Observation showed the pantry contained sandwich crackers, apple sauce, oatmeal, canned soup, and crackers. The facility did not have a kitchen.
During an interview on 04/13/21 at 2:35 PM, Staff K, Registered Nurse (RN), stated that the hamburger and fries should not be in the refrigerator, and that she didn't know who placed it in the patient refrigerator. Staff K, RN, stated they have a menu of frozen meals, and when they run low on meals, the RN would have someone go to the store to purchase more meals.
During a telephone interview on 04/14/21 at 9:28 AM, Staff E, Registered Dietitian (RD), stated that she's contracted by MISH. Staff E stated that most of what she does is provide nutritional counseling for the bariatric surgery patients by teleconference. Staff E stated she also reviews the hospital's dietary policies and menus every year in July. Staff E stated if the hospital has a patient on TPN (total parenteral nutrition), she will assess the patient in person and work with the nursing staff and make recommendations of the TPN/tube feeding. Staff E stated that the hospital doesn't feed patients a lot, they mostly have patients on liquids. Staff E stated she reviews the frozen foods annually. She stated when she reviews the menus, she looks to make sure the food is still available and checks the nutritional information to watch for sodium and calories. When asked if a diabetic diet is ordered, Staff E stated she looks at the carbohydrates. Staff E stated that when patients order out, to her knowledge the hospital doesn't have contracts with restaurants. When asked how she assures food ordered out is safe and meets appropriate temperature and cleanliness, Staff E stated she would have to refer the surveyor to Staff M, DSD.
During an interview on 04/14/21 at 2:00 PM, Staff B, CMO, stated Staff M, DSD, was not available for a phone interview today, and she (Staff B) would attempt to schedule it tomorrow. The surveyor informed Staff B that it was very important that an interview be conducted with Staff M, DSD.
During an interview on 04/15/21 at 2:00 PM, Staff B, CMO, stated Staff M, DSD, is working another job this day and can't call the surveyor until her lunch break at noon. The surveyor explained that the surveyor would be on conference calls at this time. Staff B stated that Staff M works as Dietary Services Director about 25 hours per week and does most of the billing assistance from home. Staff B stated Staff M works on Tuesdays and some time over the weekend. Regarding her responsibilities as the DSD, Staff B, CMO, stated, "there isn't anything for her to do every day."
During an interview on 04/15/21 at 11:25 AM, Staff C, Director of Nursing (DON), stated the patient's nutrition screening is done by the registered nurse (RN) at the time of the initial patient assessment. Staff C stated the RN gets an order for a dietitian consult if the patient scores a certain number on the screening tool. Staff C stated Staff M is not involved in patient care unless the dietitian contacts her about specific needs of a patient following a consult done by the dietitian.
As of the time of the exit conference conducted on 04/16/21 at 12:23 PM, the surveyor was not able to conduct an interview with Staff M, DSD. Staff M was not available for interview during the four-day survey.