Addressing management issues

Edited by Christopher S. Frings PhD, CSP

Addressing management issues

Departmentalized laboratory; storage of records, reports and samples; and nontechnical employees as lab assistants

Departmentalized laboratory

Q: Do you have any informationon the pros and cons of departmentalizing a laboratory?

A: Larry Crolla advises, Most labs
are going to core labs, where several departments are folded into one. Departments are good for very specialized testing, such as genetics and PCR, where a specially trained staff is needed. The disadvantage of departments is that unless staff is cross-trained, you cannot move people around and fill in service gaps.

According to Alton Sturtevant, The major pro is to develop depth of knowledge and proficiency in the departments procedures and equipment. If departmentalizing works for your facility, consider rotating the employees among the different workstations or procedures to maintain a staff that can fill in for absences or during heavy workloads. Departmentalization works best for large-volume, highly specialized or very complex laboratories. Rotation within a department will probably address many of the negatives of departmentalizing.

Dr. Sturtevant adds, Those negatives include the following: 

  • No backup personnel to work in other areas during times of worker shortages or increased volumes in another department.
  • Lack of knowledge of the entire laboratory and testing menu. 
  • Employee boredom due to constancy of duties and procedures.
  • Hindering employees abilities to broaden and diversify job skills.

Marti Bailey points out, Departmentalization allows for a highly specialized staff. In larger institutions or hospitals that have a myriad of specialties, the need to departmentalize within the laboratory might be more compelling. A high degree of specialization leading to improved quality of services where there is value to that improved quality is really the only advantage that I can think of for departmentalization.

Ms. Bailey adds, I can think of far more advantages associated with being nondepartmentalized and staffing with generalists wherever possible. These include the following:

  • Maintaining a high level of productivity (staff can be moved as needed)
  • Providing coverage during periods of short staffing and crisis.
  • Establishing a more viable concept of team effort.
  • Allowing the opportunity to become better aligned with the big picture.
  • Working with a more multiskilled staff.

Bottom line. Departmentalize when you need a highly specialized staff. Disadvantages of being specialized without using generalists who are cross-trained include: lack of a multiskilled staff; staffing problems during shortages, sickness and vacations; loss of flexibility in the day-to-day running of the lab; and hindering employees from finding management opportunities in other areas of the lab where they have no experience.

How long to store records, reports
and samples?

Q: As a new lab manager, I have
been reviewing our lab policies and procedures. Do you have any information regarding storage of laboratory records and retention of specimens? If you have any other suggestions on what CLIA requires, Id really appreciate it.

A: Marti Bailey recommends,
Appendix A from the 2002-2003 JCAHO Comprehensive Accreditation Manual for Pathology and Lab Services is an excellent source of information. The list covers retention times for equipment records, test requisitions, reports, quality control and instrument printouts. It also includes specimen-retention guidelines for various laboratory specialties, as well as for general clinical laboratory specimens. My understanding is that this list is based on CLIA requirements. Any records that may be subject to Medicare or Medicaid audit should probably be retained for seven years, regardless of what is specified in the JCAHO appendix.

Alton Sturtevant advises, There are a number of good sources for information relating to this question. One recommended resource is Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, government publication PB92-146174. This is a must for all laboratory managers.

Figure 1 shows a synopsis of the CLIA requirements. The College of American Pathology (CAP) requirements are somewhat different. Their website
( defines these requirements.

Dr. Sturtevant adds, Good laboratory practice may dictate the retention of specimens for longer periods. Hold all clinical specimens for a minimum of seven working days to allow the physician to add tests where the specimen is stable, check specimen identification and order repeats. Certainly, other times specimens should be kept longer for follow-up testing. There are no CLIA or CAP guidelines for this specimen-retention issue. Each laboratory must determine its own guidelines based on client needs for other circumstances.

Bottom line. CLIA says to keep most records for two years, but states that if no time is indicated for a particular record type, keep it for three years. The rule of thumb would be three years for almost all records. The exception is blood bank records, which are usually kept for 10 years, and tissue records, which are usually kept indefinitely. Check with the hospital/institution attorney to see what regulations your state, hospital or institution requires.

Nontechnical employees
as lab assistants

Q: At our lab, the clerks
(nontechnical personnel) do a lot of the processing of our specimens, as well as delivering the specimens to the various testing areas. One of the chemistry techs wants the clerks to place the specimens directly on our major chemistry instrument, in order to save her time, so they do that. The clerks do know what hemolysis and lipemia look like and are supposed to flag such specimens. We have autoverification; therefore, it is likely that many of the chemistry samples will never have been seen or touched by a tech. What does the panel think of this practice?

A: The panel is not in complete agreement on this issue.

Larry Crolla asks, What are the responsibilities of techs in your lab? If they only look for lipemia and hemolysis before placing the sample on the instrument, and the clerks are capable, then I would think it makes little difference who places the samples on the instrument, since the tech is monitoring the instrument. If you think a tech is necessary to monitor the samples for hemolysis, lipemia and sample integrity, then a tech should be used.

Alton Sturtevant advises, If managed correctly, this is a wise use of resources. It sounds like your laboratory has already entrusted the lab assistants with responsibilities that may have more of an adverse affect on patient results than lipemia or hemolysis could. Each laboratory should adopt a standardized method for identifying hemolysis, icterus and lipemia levels for all employees to use, whether they are technologists or lab assistants. This protocol should be used to train the employees to react in a uniform manner to best control and identify specimen problems to assist the physicians in the interpretation of their patients results. Some instruments are capable of measuring and quantifying these constituents, thereby providing an objective measurement for use. This is superior to using the naked eye for this function and probably should be a consideration for your specifications of instrument selection in the future.

Dr. Sturtevant adds, The protocol should define levels of lipemia, hemolysis and icterus, and what actions would be taken as a result of the level. Define which tests are affected, what the effect is, whether the test should be performed and a set of canned messages to provide with the report. Each report of the identified aberration should provide helpful interpretive information for the physician rather than just stating slight hemolysis present.

Marti Bailey says, It is poor practice. Ascertaining the proper identification of the specimen and whether or not its satisfactory for testing are integral to the hands-on analytic phase of the testing of the sample and should be performed by personnel who meet CLIA requirements for the level of testing being performed. Although technically you may be meeting CLIA requirements because there is adequate supervision, in reality youre shifting duties from certified to noncertified personnel, thereby following a practice that is most likely not standard to the industry. Some might argue that you dont need a trained professional to load specimens on an analyzer. Im sure that some clerical personnel would do a great job, but based on my own labs experience, these folks turn over so quickly that were constantly faced with retraining new hires. Determining at what point a new hire would be capable of handling this task may be difficult at best.

Bottom line. Whatever you decide, it needs to be a standard, written policy that applies to everyone. This type of practice cannot be optional. The responsibilities of both the clerical staff who do specimen processing and the technical staff who do testing need to be spelled out and compliance with the procedure enforced.

Figure 1
CLIA requirements
Request slips/accession logs 2 years
Quality assurance records 2 years
Proficiency testing records 2 years from date of receipt
Quality control nonblood bank 2 years
Quality control-blood bank 5 years (FDA-10 years)
Test records nonblood
(instrument printouts, PM, logs, etc.)
bank 2 years 
Test records blood bank
(instrument printouts, PM, logs, etc.)
5 years (FDA-10 years)
Test records pathology
(cytology and histology)
10 years
Slides cytology 5 years (CAP fine needle-10 years)
Slides histology 10 years
Paraffin blocks 2 years (CAP-10 years)
Tissue specimens Completion of diagnosis
(CAP 2 weeks after report)
Serum/CSF/body fluids CAP 48 hours
Urine CAP 24 hours
Peripheral/body fluid smears CAP 7 days
Permanently stained slides (i.e., gram) CAP 7 days
Cytogenetic slides CAP 3 years
Blood bank specimens CAP 7 days post-transfusion

Christopher S. Frings is an internationally known consultant and speaker on the topics of leadership, managing change, time management, reaching goals, and stress management. His consulting firm, Chris Frings & Associates, is in Birmingham, AL.

                                                                        January 2003: Vol. 35, No. 1

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