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Preparing the small lab for a first state inspection.


Preparing the small lab for a first state inspection

A lab manager who tapped many resources in getting her POL ready for its premier state inspection shares helpful insights.

Under CLIA '88, all Level I and Level II clinical laboratories will have to be licensed. Although some small POLs will apply for waivers, many will be licensed under Level I or II. Our state, Arizona, will probably administer the Federal program. Our state health department has been gearing up for licensure for some time.

With all this in mind, our three-physician hematology/oncology practice began to plan for state licensure. It took us nearly a year and a half to fulfill all the requirements. In the process, we learned a great deal about issues of safety, order, and quality in the laboratory. Our certificate now hangs on the wall for everyone to admire. The patients will never know what we went through to get it--but the staff certainly does.

* Fast pace. Our lab runs at high speed. So does the staff, which consists of two full-time technologists, one part-time technologist, and a part-time phlebotomist/lab assistant, who draws up to 80 patients a day.

Most patients in our practice must have a CBC done before any treatment is initiated. On an average day we analyze 55 CBCs, 35 chemistry profiles, several coagulation studies, and numerous specialized tests, such as protein electrophoresis and tests for carcinoembryonic antigen (CEA), ferritin, and immunoglobulin.

Quality control has always been a priority here. We participate in the proficiency testing program from the American Association of Bioanalysts. Our physicians work hard to provide high-quality patient care; they wanted the laboratory to be licensed by the state. The technology staff is skilled and dedicated. Despite all this, a great deal of research lay before us.

I began working on this project within hours of my first day at the practice. I had returned to the clinic setting after working for nearly 30 years at accredited laboratories in several large hospitals. I had missed the patient contact and was tired of working evenings, weekends, and holidays. As it turned out, my new job provided very little leisure as I put in long hours preparing for our licensure inspection. I didn't regret spending that extra time, since we vastly improved our operations in the process.

* Unwritten rules. Our lab was not ready to apply for a certification inspection. We had very few written guidelines. Procedure and policy manuals, personnel files, records of centrifuge speed checks, clock and watch times, fire inspection logs, hazardous waste pickup reports, forms for out-of-control test results--we lacked them all. The lab kept no records of pipet calibrations, reagent lot numbers and expiration dates, or linearity studies. Nor had records been maintained of employees' participation in continuing education programs. All I unearthed were a few scattered notes of maintenance records. (Figure I lists records and reports we now maintain.)

Feeling overwhelmed, I turned to OSHA. I asked my husband, a supervisor with OSHA's Arizona division, to inspect our lab officially. I knew he would treat it the same as any other. An OSHA report, I felt, would provide much of the information we needed to improve our safety program.

* OSHA arrives. The inspector cited four safety violations. As stated in an official letter that we received soon afterward, we needed an eyewash station and emergency shower, a fireproof cabinet for storing methanol and acetone, and scheduled weekly pickup of biohazardous waste. I investigated the cost and presented the data to the lab's medical director, who approved the necessary budget allocations. As we went along, I constructed a safety checklist (Figure II).

* Informational interview. To find out what to do next, I called the state laboratory licensing department and made an appointment to confer with the officer in charge. I arrived at the meeting, which lasted for nearly three hours, with several pages of questions and a newly written procedure that

followed the NCCLS protocol for test procedures.(1) The officer handed me a copy of the checklist used by state inspectors. We went down the list, point by point.

Over the next six months, I called the inspection officer on several occasions to clarify points and ask questions. He answered them all.

* Other sources. I found it relatively easy to obtain the necessary information. I visited many small labs, talked with people at labs where I had previously worked, and attended several meetings on licensure held by the state and by a national professional organization at its annual meeting.

I left the meetings with a wealth of information, surprised at the generally poor attendance. Putting one's head in the sand regarding licensure, I felt then and feel even more strongly now, is a big mistake. Here was excellent material for the taking. Too few laboratorians were taking advantage of it.

* Drafting policies. Now I began to put our lab's procedures and policies in writing. Thank goodness for my home computer!

Armed with the lab's test menu and a copy of the NCCLS guideline mentioned above, I set myself the ambitious goal of writing three procedures a week. The process was slow going; I continually had to refer to package inserts from test kits and reference books that I toted back and forth from the lab. When one of the doctors went on vacation, I took advantage of the laboratory lull and spent more time at home writing.

Knowing that the state licensing agency expected to receive a flood of applications from unlicensed labs, I wanted to get our application in line before the rush. Yet quality takes time. Working at the bench throughout my project required me to spend many extra hours writing at home on nights and weekends. That was one job requirement I had hoped to eliminate, but it was for a good cause and would save a great deal of time later.

* Fire inspector. When the procedure manuals were done, I applied for a fire inspection, which is required annually for state licensure. I had a list of questions ready for the fire inspector: What supplies should we keep in the fire hazard cabinet? How large a quantity of each could we keep outside the cabinet? She asked me to prepare a list of all our inflammable and hazardous materials. I learned, to my relief, that we were well in line with fire regulations. Soon afterward, we passed the fire inspection.

The lab had participated in one manufacturer's hematology QC program. I joined several more, including programs for chemistry and coagulation. In this way I was able to compare our results with those of other laboratories that used the same equipment and reagents. Figure III lists quality control procedures that we now follow faithfully.

When necessary, I arranged for instrumentation to be upgraded. We finally retired a coagulation analyzer that had served the lab for more than a decade. I discarded outdated reagents and supplies and ordered new editions of reference books and manuals for chemistry, hematology, and urinalysis.

I overhauled our test menu, dropping tests that had been losing money. Example: We had been running only about one magnesium test a week, yet the reagent became outdated and had to be discarded after two weeks. Our magnesium tests now go to a referral lab. While I was at it--not toward licensure, but in my overall effort to improve our operations--I added to our menu some tests that I thought we could run conveniently and profitably, such as CEAs and ferritins.

Our laboratory was improving at a steady pace. To minimize stress, I kept the staff aware of all changes and the reasons I was making them. I felt fortunate in receiving the physicians' approval for whatever was necessary to do or buy in preparing the laboratory for inspection.

* Moment of truth. After a year and a half, we were ready. I filled out a pile of forms from the state and mailed a check for $60 ($10 per subspecialty) to the health department, officially applying for licensure. Several months later an inspector called to schedule a visit the following week.

Naturally, the day of the inspection was one of the busiest we'd had in months. The part-time technologist had just left to take a full-time job elsewhere and her replacement hadn't started yet. Somehow the others managed to draw specimens and run nearly 60 CBCs plus coagulation tests while I gave our inspector the grand tour.

He asked if I had any questions before we began. I did. We discussed those items first and then moved on to his checklist. Far from being intimidating, he was low key and gracious. I was even able to help him. He asked where I had purchased my new safety equipment so that he could share this information with other labs. He said that he was always learning, too.

At the end of the morning, the inspector announced that we were in great shape; only a few minor deficiencies remained. His official letter outlining three areas for improvement arrived several weeks later. We were asked to check centrifuge speeds quarterly instead of annually, to perform an additional proficiency test routinely, and to fix a linearity problem on one instrument. I made the necessary changes and indicated corrective actions in the space provided. Off went the form in the mail. Then we waited.

On March 31, 1990, our hardwon and highly prized certificate arrived in the mail. Our certificate showed that we were the 287th laboratory to be licensed by the state of Arizona, getting in well before the anticipated crowd. I was right about that; state officials expect as many as 2,000 POLs and other small labs to apply. Unfortunately, most are waiting until the last minute. In the past six months, only 50 to 60 labs have applied. By the end of February 1991, approximately 300 Arizona laboratories had been licensed in this way.

Reinspection follows in six months, then annually. We no longer have to prepare for each inspection--we stay ready!

* You can do it. My experience with this project tells me that the dedicated technologist who has worked in a licensed laboratory is fully capable of preparing a small laboratory for state licensure. It would be harder, but not necessarily impossible, for the new graduate or the technologist who has not worked in a licensed lab. If necessary, consider hiring a consultant.

Don't hesitate to ask for assistance from local and Federal agencies, including OSHA, EPA, the health department, and the fire department. I was particularly impressed with the knowledgeable employees of government agencies. Technical representatives of instrument manufacturers are more than willing to help with quality control concerns. No one ever turned me down, and I learned something important from everyone.

What's most important is to obtain the full cooperation of those who make the final decisions at your laboratory, especially those holding the pursestrings. All the research and good intentions in the world won't lead to licensure if you are not permitted to follow up on your findings. In my own case, given a free hand, I was able to meet our goal.

Valuable rewards have accompanied all our hard work. On a personal level, accomplishing the tremendous task set before me has given me great satisfaction. For the staff, it has boosted pride in the workplace. Our lab is well on its way to being prepared for CLIA '88. Is yours?

Figure I

Sampler of records and reports to be maintained in a licensed lab

Instruments and supplies

Maintenance and service records for all instruments (daily,

weekly, and monthly) Product inserts (retain outdated ones for two years(*))


Dynamic ranges and critical values (prominently posted) Specimens sent to referral labs Test results (retain for two year(*)) Log book: patient's name and identification number, physician,

tests performed, phlebotomist's name, date Procedural worksheets: reagent lot number, control values,

identification of patient and laboratorian Outdated procedures (retain for two years(*))


Job descriptions Training and orientation Continuing education credits

(*)As mandated by Arizona state law. May vary by state.

Figure II

Safety checklist (partial)

Equipment and supplies

Gloves, gowns, protective devices Eyewash station, emergency shower Material safety data sheets (MSDS) Underwriters' Approved (UA):

Storage cabinet for inflammable

or combustible reagents

Fire extinguisher(s) Ventilation system

Procedures and protocols

Biohazardous waste disposal Chemical hygiene plan Fire escape routes (prominently posted) Housekeeping and cleanliness Infection control Handling of specimens, including

known HIV and HBV positives


Accidents; corrective actions taken Employees' HBV vaccinations Fire inspections (annual) Hazardous waste pickup Inspection and repair of electrical wiring

Figure III

QC procedures in a POL

Tests and routine checks

Written procedure for every test Policies for each lab section explaining what actions to take

in any situation that may arise QC ranges; reasons for changes made Employee's initials on each procedure performed Proficiency test results Records of reagent lot numbers, expiration dates Start and stop dates for reagents, controls Pipet calibration records Checks of distilled water, water filter changes


Control and standard stated frequencies for all instruments Out-of-control records; actions taken Levey--Jennings charts (dated and initialed) Start and stop dates for calibrators Centrifuge speed and time records Time checks of all watches, clocks, instruments (e.g., coagulation

analyzer) Linearity and precision checks at stated frequencies Packed cell calibration of microhematocrit centrifuge Temperature records of water baths, heat blocks, refrigerators,

instruments Thermometer checks traceable to a National Institute of Standards

and Technology (NIST) thermometer (1)National Committee for Clinical Laboratory Standards. Clinical laboratory procedure manuals; approved guideline GP2-A. Villanova, Pa., NCCLS, 1984.

Shirley A. Ramaley, M.B.A., MT(ASCP) The author is laboratory manager at Hematology and Oncology Associates, Phoenix, Ariz.
COPYRIGHT 1991 Nelson Publishing
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Title Annotation:physician's office laboratory
Author:Ramaley, Shirley A.
Publication:Medical Laboratory Observer
Date:Apr 1, 1991
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