Utah State University Student Health & Wellness

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory failed to run proficiency testing (PT) samples using the laboratory's routine methods by not having all testing personnel (TP) perform PT. The laboratory performs approximately 11,664 hematology tests a year. Findings include: 1. Review of CMS- 209 Laboratory Personnel Form showed the laboratory had ten TP that performed hematology testing. 2. PT record review revealed that TP #1 performed PT for three out of three API Hematology events in 2022. 3. In an interview on 12/15/2022 at 11: 30 AM, the laboratory director confirmed that not all laboratory personnel were performing PT. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and interview with testing personnel (TP), the laboratory failed to ensure that serum separator tubes (SST) were not used past their expiration date. The laboratory performs approximately 42 serum human chorionic gonadotropin Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (hCG) tests annually. Findings include: 1. Direct observation of SST lot number 1326275 on 12/15/2022 at 9:47 AM revealed that the SST had an expiration date of 11 /30/2022. 2. Interview with TP #1 on 12/15/2022 at 9:50 AM confirmed the SST were being utilized for serum hCG patient testing past their expiration date. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient test reports, laboratory procedure manual, and an interview with the laboratory director, the laboratory failed to include the correct normal ranges for complete blood counts (CBC) on nine out of ten values. Findings include: 1. Review of the patient reports revealed nine of the ten reference ranges did not correctly match those reference ranges for the CBC test in the procedure manual. 2. The procedure manual showed: Parameter Reference Range White Blood Count (WBC) 4.5 - 10.50 Red Blood Count (RBC) 4.00 - 6.00 Hemoglobin (HGB) 11.0 - 18.0 Hematocrit (HCT) 35.0 - 60.0 Mean Corpuscular Volume (MCV) 80.0 - 99.9 Mean Corpuscular Hemoglobin (MCH) 27.0 - 31.0 Mean Corpuscular Hemoglobin Concentration (MCHC) 33.0 - 37.0 Red Blood Cell Distribution Width (RDW) 22.6 - 13.7 Platelet Count (PLT) 150 - 450 3. The patient report showed: Parameter Reference Range White Blood Count (WBC) 4.5 - 11.5 Red Blood Count (RBC) 4.00 - 5.20 Hemoglobin (HGB) 12.0 - 16.0 Hematocrit (HCT) 36.0 - 46.0 Mean Corpuscular Volume (MCV) 80.0 - 100.0 Mean Corpuscular Hemoglobin (MCH) 26.0 - 34.0 Mean Corpuscular Hemoglobin Concentration (MCHC) 32.0 - 36.0 Red Blood Cell Distribution Width (RDW) 11.3 - 15.6 Platelet Count (PLT) 150 - 400 4. In an interview on 12/15/2022 at 1:26 PM, the laboratory director confirmed the lab failed to provide the correct normal ranges on the test report. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the Laboratory Director failed to ensure a quality assessment plan was established to assure quality of laboratory services through the pre-analytical, analytical, and post-analytical phases. The laboratory performs approximately 12,145 tests annually. Findings include: 1. The document review of the procedure manual failed to include a written Quality Assessment (QA) plan. 2. Laboratory Director confirmed during an interview on 12/15 /2022 at approximately 12:45 PM, the laboratory did not have a written QA plan. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on temperature records review and interview with staff, the laboratory failed to define the acceptable storage and operating temperatures for complete blood cell count (CBC) and serum pregnancy test controls, the instrument operating ambient temperature range, reference laboratory specimen storage temperature ranges, and humidity range for CBC testing. The laboratory performed approximately 1 to 5 CBC tests per day, 1 serum pregnancy test per month, and 2 to 5 tests collected for referral per day. Findings include: 1. The laboratory temperature record reviewed failed to include the acceptable ranges for storage refrigerator, freezer, room temperature and per cent humidity. 2. In an interview conducted on 02/05/2018 at approximately 4:30 P.M. staff confirmed the temperature ranges were not posted for testing personnel to use in determining the recorded temperature met the test and storage temperature requirements for CBC and serum pregnancy testing performed on site and for specimens referred for testing. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control records review, lack of documentation and confirmation by staff, the laboratory failed to monitor complete blood count (CBC) testing over time for accuracy and precision for 2 of 2 years of quality control testing reviewed, January 2016 to January 2018. The laboratory performed approximately 1 to 5 CBC tests per day. Findings include: 1. Quality control testing records reviewed failed to include documentation the laboratory had an established method to evaluate CBC quality control performance over time for 3 levels of QC performed. 2. In an interview conducted on 02/05/2018 at approximately 4:40 P.M., staff confirmed they did not have a process to evaluate QC for shifts and trends or influences of changes in test system performance and environmental conditions or variance in operator performance. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on personnel competency evaluations review, lack of documentation, and interview with staff, the technical consultant failed to ensure new testing personnel were evaluated semi-annually the first year of testing for 1 of 1 new primary testing person from October 2016 to October 2017. Findings include: 1. Personnel competency evaluations failed to include semi-annual documentation for 1 new testing person performing moderate complexity complete blood count (CBC), serum pregnancy (hCG) microscopic urinalysis, vaginal wet prep and potassium hydroxide testing the first year the person performed testing. 2. In an interview conducted on 02 /205/2018 at approximately 4:30 P.M. staff stated competency evaluations were not documented semi-annually the first year testing was performed for one new test person who is the primary laboratory staff person. The laboratory performs approximately 1 to 5 CBC tests per day, 1 serum pregnancy tests per month, and 1 microscopic test per day. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on personnel competency evaluations review, lack of documentation, and interview with staff, the technical consultant failed to ensure 5 of 5 established testing personnel were evaluated annually for 2 of 2 years of testing reviewed January 2016 to January 2018. Findings include: 1. Personnel competency evaluations failed to include annual documentation for 5 established testing personnel (A, B, C, D, E, and F) performing moderate complexity complete blood count (CBC), serum pregnancy (hCG) microscopic urinalysis, vaginal wet prep and potassium hydroxide testing after the first year the person performed testing. 2. In an interview conducted on 02/205 /2018 at approximately 4:30 P.M. staff stated competency evaluations were not documented annually after the first year of testing for staff members who performed microscopic KOH and Wet prep testing and performed CBC and pregnancy testing when the primary test person was not available. The laboratory performs approximately 1 to 5 CBC tests per day, 1 serum pregnancy tests per month, and 1 microscopic test per day. -- 3 of 3 --