State Hygienic Laboratory

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, review of test volume records, and interview with the laboratory's Quality Systems Manager, the laboratory failed to establish proper conditions for specimen transportation (temperature) as part of its written policies and procedures for 1 of 1 policy in the specialty of Chemistry (Maternal Screening Department). Findings Included: 1. A review of the laboratory's policy for the Iowa State Hygienic Laboratory in the Maternal Screening Department in the specialty of Chemistry stated the following under the Specimen Transport (For Clients) section: "4.3.2 Transport Temperature - Samples may be transported to the laboratory at ambient temperature or on ice packs. Both transport temperatures are acceptable and have been validated." 2. A review of the laboratory's test volume records showed an annual test volume of 7,569 for the specialty of Chemistry. 3. In an interview on 6/10/2025 at 10:41 AM, the Quality Systems Manager confirmed that some SOPs had not been updated to reflect defined temperature ranges in specimen transport for clients, and that ambient temperature was not defined. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation of three of three Illumina MiSeq analyzers located in the microbiology sequencing room, review of Illumina manufacturer's manual, review of Illumina patient reports, lack of temperature documentation, and interview with the technical supervisor (TS) #19, the laboratory failed to monitor and document the room temperature and relative humidity. Findings include: 1. Observation of the laboratory on 03/21/2023 at 1:00 PM, showed that the temperature and relative humidity in the microbiology sequencing room was not monitored and documented. 2. Review of The Illumina MiSeq analyzer operating conditions revealed, "maintain a lab temperature of 19C to 25C and 30% to 75% non-condensing relative humidity." 3. The laboratory reported out approximately 839 patient reports in 2021 and 970 in 2022 for bacteriology identification sequencing. 4. Interview with TS #19 on 03/21/2023 at 3: 00 PM confirmed the laboratory failed to monitor and document the room temperature and relative humidity. 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 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 -- 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 observation of 48 of 48 boxs of Bio-Rad Liquichek Maternal Serum II quality control levels 1, 2, and 3 stored in the freezer, review of manufacturer's instructions, procedure manual, documentation of freezer temperatures and patient volumes, and interview with the technical supervisor (TS) #18, the laboratory failed to follow the manufacturer's instructions for storage of control material for 15 of 55 testing days for January 1, 2023, through March 22, 2023. Findings include: 1. Observation of the laboratory freezer showed 48 boxes of Bio-Rad Liquichek Maternal Serum II quality control levels 1, 2, and 3 available for use in the laboratory. 2. Review of the manufacturer's instructions for Bio-Rad Liquichek Maternal Serum II quality control levels 1, 2, and 3 showed controls must be stored at minus 20 degrees Celsius (C) to minus 70 degrees C. 3. Review of the procedure manual revealed, "reagents will be stored according to manufacturer's instructions." 4. Review of the laboratory's temperature chart showed a defined acceptable range of greater than minus 15 degrees C to minus 25 degrees C. 15 of 55 testing days for January 1, 2023, through March 22, 2023, the laboratory failed to meet the manufacturer's required minus 20 to minus 70 degrees C range. 5. The laboratory reports approximately 8000 tests annually for maternal screening. 6. Interview with TS #18 on March 22, 2023, at 1:00 PM confirmed the laboratory failed to properly monitor the freezer and store quality control materials per manufacturer's instructions. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on a review of personnel records, and an interview with the laboratory director (LD), the LD failed to ensure competency for 24 of 24 technical supervisors and 26 of 26 general supervisor positions for 2022. Findings include: 1. Personnel and laboratory records showed no competency evaluations performed in the calendar year 2022 for 24 of 24 technical supervisors and 26 of 26 general supervisors. 2. Interview with the LD on 03/24/2022 at 11:30 AM confirmed the LD failed to ensure competency for 24 of 24 technical supervisors and 26 of 26 general supervisor positions for 2022. -- 2 of 2 --

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation of the COVID-19 testing room and interview with the Quality Assurance Manager and the technical supervisor (TS) #42, the laboratory failed to have a uni-directional workflow that includes separate areas for positive control and extraction plate storage, separate area for mastermix/reaction plate processing and positive control. Uni-directional workflow refers to the manner in which testing personnel and patient specimens move through the molecular testing process to prevent cross-contamination of patient specimens, and consists of separate areas for reagent preparation, pre-amplification, and post-amplification. Findings: 1. Observation of the COVID-19 testing room showed the positive control being stored in the same refrigerator as the patient extraction plates. 2. Observation of the COVID- 19 testing room showed three hoods located next to each other. The middle hood was used for mastermix/reaction plate processing and the two outer hoods were used for the addition of the positive control. The three hoods were located across and next to the Applied Biosystems 7500 Fast Real Time PCR analyzers. The testing personnel used the outer hood to prepare the reaction plates and move to the middle hood for the addition of the positive control. The workflow was not in one direction. 3. Interview on August 26, 2021 at 12:00 PM with the Quality Assurance Manager and TS #42, confirmed the laboratory failed to have a uni-directional workflow to include separate areas to prevent contamination of patient specimens, equipment, instruments, reagents, materials, and supplies. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel competency records and interview with the laboratory director (LD), the laboratory failed to perform three of three competencies for the positions of general supervisor (GS) and 26 of 26 competencies for the positions of technical supervisors (TS). Findings: 1. Personnel competency records failed to include documentation of evaluations of specific GS and TS responsibilities. 2. Interview with the LD on August 26, 2021 at 4:00 PM confirmed the laboratory failed to perform competency assessments for GS and TS positions. 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 observation of the molecular COVID-19 and non COVID-19 testing rooms, review of manufacturer manuals, and interview with technical supervisors (TS) #24, 42, the laboratory failed to monitor humidity to ensure proper operation of instrumentation. Findings: 1. Observation of the non COVID-19 molecular area used for PCR testing showed six of six Applied Biosystems 7500 PCR analyzers. 2. Observation of the non COVID-19 PCR extraction room showed two of two Thermo Scientific KingFisher analyzers. 3. Observation of the COVID-19 testing laboratory showed four of four Thermo Scientific KingFisher analyzers and five of nine Applied Biosystems 7500 PCR analyzers. 4. Review of the Applied Biosystems 7500 PCR manual revealed to operate with "20-80 percent relative humidity noncondensing." 5. Review of the Thermo Scientific KingFisher manual showed "make sure relative humidity is between 10% and 80% noncondensing." 6. Interview with the TS #24, 42 confirmed the laboratory failed to monitor the humidity in the COVID-19 and non COVID-19 molecular laboratory rooms. Based on observation of the -20 degree Celsius (C) freezer and two of two refrigerators located in the non COVID-19 molecular room and one -80 degree C freezer located in the microbiology hallway, review of temperature charts, review of manufacturer's inserts, and interview with technical supervisors #6, 24, the laboratory failed to define criteria and follow the manufacturer's guidelines for proper storage of reagents. Findings: 1. Observation of the -20 degree C freezer (serial #RH174657) located in the non COVID-19 molecular room showed TaqMan probe kits with a required storage range of -15 to -25 degrees C. 2. Review of the -20 degree C freezer temperature charts revealed two of 54 days the temperature fell outside of the required range of -15 to -25 degrees C. 3. Observation of the refrigerator (serial #K50338B) located in the non COVID -- 2 of 4 -- molecular room, showed 3 boxes Applied Biosystems master mix with the required storage of 2-8 degrees C. 4. Review of the temperature charts for the refrigerator revealed 10 of 54 days the temperature range fell outside the 2-8 degrees C range. 5. Observation of the -80 degree C freezer (serial # 578107) showed storage of quality control organisms for microbiology with a required range of -70 to -90 degrees C. 6. Review of the -80 degree C freezer temperature charts revealed 34 of 235 days the temperature fell outside of the required -70 to -90 degrees C range. 7. Interview with the TS #6, 24 on August 26, 2021 at 4:00 PM confirmed the laboratory failed to monitor and document the freezer and refrigerator temperatures for proper temperature range. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of the CMS-209 Personnel Report and interview with the Quality Assurance Manager, the laboratory failed to provide documentation of academic credentials for all Testing Personnel. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the -- 3 of 4 -- military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of personnel records and interview, the laboratory could not provide academic credentials for all Testing Personnel (TP) listed on the CMS-209. Findings: 1. No academic credentials were available to qualify 13 of 88 TP (TP #34, #35, #51, #52, #53, #54, #56, #60, #63, #66, #73, #74, and #82). 2. Confirmed during interview with the Quality Assurance Manager on August 26, 2021 at 1030 AM. -- 4 of 4 --

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and confirmed by interview, the laboratory failed to verify the accuracy of the Zika Virus testing twice annually. Findings include: 1. Review of proficiency testing records for 2017, 2018, and 2019 revealed that the laboratory was only performing the CDC Arbovirus Panel, that included the Zika virus, that was sent to the laboratory once a year, for Zika Virus testing. 2. Interview with Technical Supervisor #6 (on CMS Form 209) on 8/28/2019 at approximately 3 pm, confirmed that only the CDC Arbovirus Panel was performed once a year for Zika Virus testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --