Northwest Medical Plaza At Sugar Creek

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based upon a review of the American Proficiency Testing Institute (API) proficiency test attestation records for ten events in 2024 and 2025, lack of documentation, and interviews with laboratory staff, it was determined that required signatures to attest to the routine integration of proficiency test samples in the patient workload were not present on 3 of the ten events reviewed. Survey findings follow: A) Review of the attestation forms for API Microbiology 2024 3rd proficiency test event for tissue KOH examinations revealed that it was not signed by the testing personnel. B) Review of the attestation forms for API Microbiology 1st event 2024 and API Hematology/Coagulation 2nd event 2024 revealed they were not signed by the laboratory director or designee. C) In an interview, at 11:15 a.m.on 8/6/25, the laboratory staff member (# 1 as listed on the form CMS-209) confirmed the API proficiency testing attestation forms identified above were not signed by the required personnel. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required 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 -- prior to reporting patient test results. This STANDARD is not met as evidenced by: . Based upon review of personnel files for two testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, the laboratory director failed to authorize two of two testing personnel to perform testing without direct supervision. Survey findings include: A) Review of personnel files for two testing personnel listed on form CMS-209 (Personnel #'s 1, 2 ) revealed written authorization from the laboratory director to perform moderately complex testing without direct supervision was not present. B) In an interview, at 11:15 a.m. on 8/6 /25, laboratory staff member #1 (as listed on the form CMS-209) confirmed the lack of written authorizations to test for employees (#'s 1,2 on form CMS 209). D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based upon review of the testing personnel records, a review of the procedure manual, and interviews with laboratory staff, the technical consultant failed to evaluate the competency of testing personnel for 2024 and 2025 using the six required methods for evaluating testing personnel competency. Findings follow: A) In review of the procedure manual there were no policies addressing the evaluation of testing personnel with the following components as required by the CLIA regulations: a. Assessment of problem solving skills b. Direct observation of routine patient test performance, including patient preparation. c. Monitoring the recording and reporting of test results. d. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. B) In review of personnel records for testing personnel ( #2 on the form CMS 209) , it was determined the competency assessments documented in 2023 and 2024 did not address the following components required for evaluation of personnel at least annually as outlined in the CLIA regulations: a. Assessment of problem solving skills b. Direct observation of routine patient test performance, including patient preparation c. Monitoring the recording and reporting of test results. d. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. C) In an interview at 10:58 on 8/6/25 employee #1 (as listed on the form CMS-209) confirmed the laboratory has no policy for, or any documentation of, performing competency assessment using: assessment of problem solving skills; direct observation; monitoring recording and reporting of test results; review of worksheets; quality control records; maintenance; and proficiency samples; or assessment through blind testing samples. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Through a review of personnel records for all personnel listed on the form CMS, and through interviews with staff, it was determined that two of two testing personnel, who had been performing moderate complexity testing more than one year, did not have competency assessed at least annually. Survey findings follow: A) Laboratory personnel #1, and #2, (as listed on the CMS 209 form) had been performing moderate complexity testing for more than one year. B) The last documented competency assessments for laboratory personnel #1 was dated 9/13/20, a period of greater than one year. C) The last documented competency assessments for laboratory personnel #2 was dated 5/11/20, a period of greater than one year. D) In an interview, at 11:45 on 12/14/21, the staff member (identified as number 2 on the entrance/exit attendance form) confirmed that annual competency assessments were not performed on the laboratory personnel identified above. 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 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: Through observation, lack of documentation and interview it was determined the laboratory failed to monitor room temperature in one of two rooms in which supplies with storage temperature requirement were stored. Findings follow: A. In a tour of the laboratory on 2/28/19 at approximately 11:00 AM, one box of Sofia Strep A test kit lot # 704843 with an expiration date of 2020-09-30 storage temperature requuirement of 15 degrees C. to 30 degrees C. and three boxes of Para-Pak C&S transport media lot # 24850K, expiration date 2020-02 and storage temperature requirement of 2 degrees C. to 30 degrees C. were observed stored in a nursing station area separate from the laboratory . C. Upon request, the laboratory was unable to provide records of room temperature in the nursing station area. D. In an interview on 2/28/19 at approximately 11:15 AM, the Laboratory Manager, identified on a separate personnel identification record, stated that the laboratory did not monitor the room temperature in the nursing station area identified above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- 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: Through review of quality control results, the data log for the Medonic hematology analyzer, patient result reports, lack of documentation, and interview it was determined that the laboratory failed to document quality control results prior to reporting moderately complex Complete Blood Cell (CBC) assays on two of twenty- one days of testing in November 2018. Findings follow: A. Review of quality control reports for November 2018 revealed that no quality control results were reported for CBC assays on November 4, 2018 or November 23, 2018. B. Review of the Medonic hematology analyzer data log listing revealed that CBC assays were performed and reported on a patient identified as number 1 on the "patient identification list I" on November 4, 2018 and on a patient identified as number 2 on the "patient identification list I" on November 23, 2018 and no quality control results were included on both days . C .Review of patient reports revealed that CBC assays were performed and reported on a patient identified as number 1 on the "patient identification list I" on November 4, 2018 and on a patient identified as number 2 on the "patient identification list I" on November 23, 2018 . D. Upon request, the laboratory could not produce quality control results for CBC assays on November 4, 2018 or November 23, 2018 E. In an interview on 11/28/19 at approximately 11:15 AM, the laboratory manager, identified on the separate laboratory employee identification record, confirmed that quality control results were not documented for CBC assays on November 4, 2018 and November 23, 2018. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Through a review of the form CMS-209, review of authorizations to test, a review of competency assessments for 2017 and 2018, lack of documentation and interview with laboratory staff, it was determined the technical consultant failed to evaluate the competency of one of three testing personnel. Survey findings follow: A. The CMS- 209 form completed for the survey reveals three testing personnel employed by the laboratory. B. Review of authorizations to test reveal that the testing personnel, identified as number four on the CMS 209 form, was authorized by the laboratory director to perform testing on April 2017. C. Review of competency evaluations for 2017 and 2018 revealed that competency evaluations were not present for the testing personnel identified as number four on the CMS 209 form. D. Upon request, the laboratory was not able to produce competency evaluations for the testing personnel identified as number four on the CMS 209 form. E. In an interview on 2/28/29 at approximately 11:15 AM the laboratory manager, identified on a separate personnel -- 2 of 3 -- identification record, confirmed that competency evaluations were not available for the testing personnel identified as number four on the CMS 209 form. -- 3 of 3 --