Muscatine Fire Department

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records and confirmed by interview with laboratory personnel identifier #1, the laboratory failed to ensure that individuals met the qualifications to perform moderate complexity testing as specified in 6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and 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 -- This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by interview with personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:15 am on 8 /13/2025, the laboratory failed to ensure two out of 23 testing personnel met the qualifications for moderate complexity testing personnel. The findings include: 1. Since the last survey performed on 4/6/2023, the laboratory trained testing personnel identifiers #2 and #3 to perform moderate complexity testing using the i-STAT test system. 2. Interview with personnel identifier #1 confirmed the laboratory did not have documents to qualify the above individuals to perform moderate complexity testing. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:40 am on 04/06/2023, the laboratory failed to perform two levels of QC each day of patient testing for the analytes: creatine kinase isoenzyme (CK-MB), myoglobin, and troponin from 01/01 /2023- 04/06/2023. The findings include: 1. The laboratory performed QC with each new lot and shipment of cardiac test cartridges and monthly. 2. Laboratory personnel identifier #2 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 3. At the time of the survey, the laboratory did not have an IQCP for the cardiac test kits (CK-MB, myoglobin, and troponin). This is a repeat deficiency. 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 --

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by testing personnel #4 and #23 (refer to the Laboratory Personnel Report) at approximately 10: 00 am on 8/25/2021, the laboratory failed to document

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 04/29/2019, the laboratory failed to retain signed PT attestation statements for three out of seven PT testing events in 2017- 2019 (2018 events 2 and 3 and 2019 event 1). At the time of the survey, the laboratory did not have signed PT attestation statements available for 2018 testing events 2 and 3 and 2019 testing event 1. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 04/29/2019, the laboratory failed to perform a self evaluation of ungraded PT scores for four out of seven PT testing events in 2017-2019 (2018 events 1, 2, 3 and 2019 event 1). The findings include: 1. For 2018 testing event 1, the laboratory received ungraded PT test scores for the following: *2018 Chemistry Core Survey- creatine Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- kinase muscle/brain isoenzyme (CK-MB), specimen CM- 01 *2018 Chemistry Core Survey- Myoglobin, specimens CM- 01, CM- 03, and CM- 04 *2018 Chemistry Core Survey- Troponin I, specimen CM- 04 2. For 2018 testing event 2, the laboratory received ungraded PT test scores for the following: *2018 Chemistry Core Survey- CK-MB, specimen CM- 10 *2018 Chemistry Core Survey- Myoglobin, specimens CM- 06, CM- 07, CM- 08, and CM- 09 3. For 2018 testing event 3, the laboratory received ungraded PT test scores for the following: *2018 Chemistry Core Survey- CK-MB, specimen CM- 12 *2018 Chemistry Core Survey- Myoglobin, specimens CM- 11, CM- 13, CM- 14, and CM-15 4. For 2019 testing event 1, the laboratory received ungraded PT test scores for the following: *2018 Chemistry Core Survey- Myoglobin, specimen CM- 02 *2018 Chemistry Core Survey- Troponin I, specimen CM-05 5. At the time of the survey, the laboratory did not have additional documentation or