Lab management_Clinical Pathology Boards Review
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What is the purpose of the family & med leave act of 1993? Who administers this law?
Protected & unpaid leave for qualified med & family issues; Wage & Hour division of the US Dept of Labor
All of the following are qualified medical & family reasons under the family & med leave act except:
A) Personal/family serious illness
B) Family military leave
C) Elderly non-parental family member or pet illness
D) Pregnancy or adoption
E) Foster care placement of child
All of the following are protected under the family & med leave act except:
A) Medical benefits
B) Short term non-severe illnesses
C) Restoration of same position upon return
D) Protection from retaliation by employer
E) Injured service member in family
Under the family & med leave act, how many employees must a company have to be eligible?
At least 50 employees who work within 75 miles of its location
What is the purpose of CLIA 88? What defines a clin lab?
Set stds and issue certificates for clin lab testing to ensure accuracy, reliability, timeliness of results; any lab that performs tests on specimens derived from humans to provide dx, prevention, tx of dz/impairment, or assess health.
What dept regulates all lab testing through CLIA?
Centers for Medicare & Medicaid services (CMS)
What is the basic QC requirement under CLIA?
Perform 2 levels of QC materials each day of testing unless special reqs apply
What is root cause analysis?
Method of solving problem by identifying and solving root cause of events instead of simply addressing the symptoms
What level of testing is live blood cell analysis? What requirements must be met under CLIA?
High complexity; Patient Test Management, Proficiency Testing, Quality Control, Personnel, and Quality Assurance.
T/F: Direct access testing (DAT) is consumer rather than physician initiated testing of human specimens, and is therefore exempt from CLIA.
False - CLIA certification is req'd for patient testing, which includes DAT
All of the following are examples of indirect costs except:
A) Material costs for specific project
B) Security costs
C) Rent & Utilities
D) Equipment rental
E) Legal fees
All of the following are examples of direct costs except:
A) Project staff and supplies
B) Project consultants
C) Material costs
E) Backup generator
Who administers the proficiency testing programs for labs? How are
samples graded? How often are labs tested? What pass rate is acceptable?
What regulations require a satisfactory result?
CAP; acceptable (<2 SD), needs improvement (<2-3 SD), or unacceptable (>3 SD) as compared to the mean for the peer group; 3x/yr in batches of 5 samples; >4/5 (80%); CLIA '88
What tests are waived from proficiency testing by CLIA?
simple tests - just follow mfr guidelines
Under CLIA, how often must labs conduct performance testing for tests with no proficiency testing available?
At least 2x/yr
How often are labs subject to CLIA inspection?
Every 2 yrs by CMS or "deemed provider" like CAP, Joint commission, COLA
T/F: OSHA cannot be subjected to random inspection; all inspections must be scheduled.
What is the MSDS and who regulates them?
Mfr data safety sheets for point of use chemicals; OSHA
What is required to transport clxs and biologic samples? Who regulates this?
Training q2 yr; DOT - random inspections, fines for noncompliance
All of the following are true regarding HIPAA except:
A) Protected info can be released to insurance for billing purposes
B) Provides right to privacy for individuals 18yo+
C) Protects health care insurance for workers when they lose their jobs
D) Limits a group plan's restrictions for pre-existing conditions
E) HHS dept administers title II of the Act, which protects privacy of identifiable information
B - Individuals 12yo+ are protected and providers must have a signed disclosure before information is released
What does personal health information (PHI) cover under HIPAA? Does it even cover payment hx?
Health status, provision of health care, or payment for health care that can be linked to an individual; YES
When can PHI be disclosed without a patient's express written authorization under HIPAA?
To facilitate treatment, payment, or health care operations but must be minimum info necessary
T/F: HIPAA requires the use of NPI to identify healthcare providers in std transactions.
True but does not eliminate use of state license or DEA #s
What is the enforcement rule under HIPAA?
Sets civil monetary penalties for violating HIPAA and establishes procedures for investigations or hearings for HIPAA violations
What is the point of the stupid Joint Commission? How often does it inspect hospitals vs. labs?
Accredits hospitals; every 3 yrs (unannounced) for hospitals and every 2 yrs for labs
Who inspects hospitals through the Joint Comm?
Team of inspectors that are trained and recertified by examination
What is the purpose of CAP? How often does it conduct inspections? Who performs inspections?
Accreditation of labs; every 2 yrs unannounced and self-inspection alternate yrs; voluntary inspectors who are trained with online courses
What is the CAP workload violation for cytotechnologists? What is the usual cause for violations?
12.5 slides/hr; misunderstanding on how to calculate workload
When retrospective review of pap smears show that a significant IEL was missed, what corrective action (if any) must be taken?
Report is amended only if it affects current patient care
What are American Cancer Society guidelines regarding pap smear frequency?
Pap every year until at least 30yo and if has had 3 consecutive negative paps, pap smear every 2-3 yrs is sufficient
T/F: A pathologist can't be sued for negligence on pap smears that were only reviewed by the cytotech.
False - she can be sued under agency law for negligent acts of the cytotech, or negligent hiring practices, etc.; only personal negligence is exempt
What does CLIA require in review of negative prior pap smears when a dx of moderate dysplasia or above is made?
Review all neg paps within the last 5 yrs
What is the purpose of the Commission on Lab Accreditation (COLA)? Who are the inspectors? What labs are inspected?
Accredits labs with random inspections every 2 yrs + voluntary self-assessment; dedicated professional inspectors; MD office labs, smaller labs and hospital labs
Under CLIA, who can be a lab director?
MD with lab/training exp or PhD with board certification
How often must personnel be assessed on their competency under CLIA? How are they evaluated?
Annual assessment (or at 6 mos if new); observation, split samples, written tests, proficiency testing, etc.
What phases of testing require written QC policies and procedures?
All phases: analytic, pre-analytic, post-analytic
All of the following are considered pre-analytic errors except:
A) ordering the wrong test (asking for frozen when unnecessary)
B) using wrong sample ID
C) collecting specimen from wrong pt
D) mislabeling slides
E) placing specimen in the wrong fixative
D - this is analytical
All of the following are considered analytic except:
A) specimen contamination (floaters)
B) incomplete grossing
C) mislabeling blocks
D) misidentifying the site of origin of a specimen
E) poorly worded gross examination
D - this is pre-analytical
All of the following are considered post-analytical errors except:
A) Transcribing the wrong report for the wrong patient
B) Misspellings in reports
C) incomplete sampling of tissue
D) wrong report sent to the wrong clinician
E) Lost reports
C - this is analytical
What organizations require verbal readback of results for critical value reporting?
Joint Comm & CAP
What is the minimum length of retention for the following materials under CAP:
1) Most records (QC records, instrument printouts, etc)
2) Cytology slides
3) AP slides, blocks, reports
- 1) Most records - 2 yrs
- 2) Cytology - 5 yrs
- 3) AP - 10 yrs
What is CAP's recommendation for retention of the following material:
1) cytogenetic smears
3) cytogenetic reports
4) BB records
5) deferred donor results
6) forensics blocks/slides
- 1) cytogen slides: 3 yrs
- 2) flow: 10yrs
- 3) cytogenetic reports: 20y
- 4) BB records: 10 yrs (QC results 5y)
- 5) deferred donor results: indefinite
- 6) forensics blocks/slides: indefinite
All of the following are fixed costs except:
C) staff time
E) Rent and utilities
C - this is variable
All of the following are variable costs except:
A) Staff time
C) Pipette tips
D) Toilet paper
E - this is equipment, a fixed cost
What is the capital model of reimbursement? Fee for service? DRG model?
Fixed payment per member; pay per test; fixed payment for dz (Medicare uses this)
What is the method of reimbursement for Medicare part B? How is billing performed?
Fee for service; under CPT code (the 88305, 88307, etc.)
What does MUMPS stand for? What is its purpose? Who uses this? How is it structured
Multi-User Multi-Programming System - general purpose programming language for ACID processing (atomic, consistent, isolated, durable); Epic, VA, Ameripath/Quest; hierarchical database that allows you to create new encounters, and see lists of active dzs but limited by available queries, ex. can't find out how many patients have a particular dx
What is HL-7?
Protocol for communicating data btw computers (ex. Lab information system (LIS) and computers on lab instruments or hospital info system which has pt information)
What is a bit/byte?
smallest unit of info; 1 byte = 8 bits, 1kb = 1024 bits
What nomenclature is used for lab tests as a standard for laboratory instrument and LIS data & info transfer (interface) by hospitals? Coding clinical diagnoses to support the medical necessity of service/procedure? Coding for medical services?
LOINC codes - logical observation identifiers names & codes; SNOMED codes or ICD-9 codes; CPT codes
What is a computer interface?
communication btw two computer systems
What is a delta check?
comparison of current results w/past results to look for diff results on same pt, can use to identify contaminated samples
How many mod-high complexity labs can a director oversee?
Up to 5
Who introduced lean mgmt? What is it?
Review of all steps to reduce unnecessary steps
Who introduced Six Sigma? How is it defined in terms of error?
Motorola; less common than 6 SD or qualitative means 1 in 6 million = 6 sigma, quantitative means difference btw allowable error and bias, divided by SD
All of the following are Daubert std guidelines established by the US Supreme Court regarding admissibility of scientific evidence except:
A) Judge is gatekeeper and assures testimony truly proceeds from scientific knowledge
B) Scientific knowledge must be based on sound scientific method
C) if method is not scientifically falsifiable, peer review is not req'd
D) Method generally subject to peer review & publication
E) Empirical testing
Define accounts receivable. Accounts payable?
Money owed to a business that is shown on a balance sheet as an asset; money the business owes to suppliers, shown as a liability on a balance sheet
What did the Fair Labor Standards Act establish in 1938? Who does it apply to?
Min wage, abolished child labor, guaranteed time and a half O/T; any employee that engages in interstate commerce or employed by an enterprise that is engaged in commerce or production of goods
What defines a disability under the ADA?
a physical or mental impairment that substantially limits a major life activity
What is the ICD-9 CM coding system?
Assigns diagnostic and procedure codes
For Medicare billing, what is the technical component? Professional component?
- Technical: Facility payment. Payment made for technical resources such as a technician’s time in operating a CT or MRI when a procedure is performed in a facility setting
- Professional: Physician payment specifically for their time and effort in performing a procedure
Which of the following Qs CAN you ask when interviewing a job candidate under the ADA:
1) Have you been treated for X disease?
2) How many days were you absent from work due to sickness last yr?
3) Do you have any disabilities that would affect your ability to do this job?
4) Can you perform all of the job fxns?
5) Do you currently use illegal drugs?
6) Do you have any physical defects that preclude you from doing certain things?
You can ask #4 and 5
How long do you have to address a CAP Phase II deficiency? Phase I? How do they differ?
fully address by 30 days with written documentation and supporting documents; written response within 30 days indicating corrective action taken; Phase I is for deficiencies that may/may not have direct impact on pt care while Phase II has a direct impact on pt care
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