98 Point 6 Emergicenter

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and interview with testing personnel #1, the laboratory failed to ensure its blood culture bottles and stool specimen collection kits had not exceeded expiration dates for 14 of 14 total blood culture and stool specimen collection kits observed in the laboratory. Findings include: 1. The surveyor observed the following expired materials during a tour of the laboratory on 10/27/25 at 8:51 am: a. Ten total BD BACTEC Blood Culture Vials with the following expiration dates: i. Two bottles with the expiration date of 8/22/25. ii. Seven bottles with the expiration date of 10/13 /25. iii. One bottle with the expiration date of 10/14/25. b. Four Zinc-PVA/Formalin /C&S O&P stool specimen collection kits with the expiration date of 6/30/25. 2. An interview on 10/27/25 at 9:02 am with testing personnel #1 confirmed the blood culture bottles and stool specimen collection kits had exceeded their expiration dates. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: 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 -- . Based on a lack of documentation and interviews with testing personnel #1, the laboratory failed to perform and document its weekly cleaning maintenance for the Hemocue analyzer for two (October 2023 to October 2025) of two years. Findings include: 1. The surveyor requested documentation of instrument maintenance records on 10/27/25 at 12:33 pm. 2. An interview on 10/27/25 at 10:10 am with testing personnel #1 revealed the laboratory performs weekly cleaning of the Hemocue analyzer with alcohol. 3. An interview on 10/27/25 at 12:33 pm with testing personnel #1 revealed the weekly Hemocue cleaning maintenance had not been documented. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1, the laboratory failed to perform calibration verification at least once every six months for its i-STAT Chem8+ panel for two (October 2023 to October 2025) of two years reviewed. Findings include: 1. A review of the laboratory's i-STAT instructions for use revealed a section titled "Calibration Verification" stating, "Calibration Verification, also known as a linearity check, is a procedure intended to verify the accuracy of results over the entire measurement range of a test. Because of the inherent stability of the i- STAT system, Abbott Point of Care does not make any specific recommendations for the calibration verification procedure. Therefore, it is the responsibility of the laboratory to determine when and how this procedure should be performed." 2. A review of the laboratory's "Chem8 i-STAT Device" policy revealed a lack of information for how and when the laboratory performs calibration verification. 3. An interview on 10/27/25 at 11:23 am with testing personnel #1 revealed the laboratory had not performed calibration verification for its i-STAT Chem8+ panel for the previous two years. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report -- 2 of 3 -- destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1, the laboratory failed to accurately transcribe test report data into the final test report for two (Patients #2 and #14) of 16 patient test reports reviewed. Findings include: 1. A review of 16 patient test records and cooresponding patient test reports, the following patients had discrepancies between test records and reports: a. Patient #2 had an i-STAT Chem8+ test performed on 1/20/24. Review of the instrument print out and final test report revealed a discrepancy with Patient #2's first name. The instrument print out listed a different first name when compared to the final test report. b. Patient #14 had an i- STAT Chem8+ test performed on 9/27/25. The instrument print out listed the blood glucose result as "139 mg/dL". The final report listed the blood glucose result as "130 mg/dL". 2. An interview on 10/27/25 at 12:00 pm with testing personnel #1 confirmed the reporting discrepancies listed above. ***This is a repeated deficiency from the 3/4 /22 recertification survey.*** D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: . Based on record review and interviews with testing personnel #1, the laboratory failed to include the direct obeservation of performance of instrument maintenance and function checks in its testing personnel competency assessments for two (October 2023 to October 2025) of two years reviewed. Findings include: 1. A review of the laboratory's competency assessments of its 26 testing personnel between October 2023 and October 2025 revealed a lack of direct obeservation of performance of instrument maintenance and function checks for its white blood cell and it's chemistry panel. 2. A review of the laboratory's "Chem8 i-STAT Device" policy revealed there is an electronic simulator function check to be performed each date of patient testing. 3. An interview on 10/27/25 at 10:10 am with testing personnel #1 revealed the Hemocue white blood cell analyzer has a weekly alcohol cleaning and confirmed competency assessments lacked direct obeservation of performance of instrument maintenance and function checks. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 on record review and interview with Testing Personnel (TP) #1, the Laboratory Director (LD) and Testing Personnel failed to attest to the routine integration of the hematology and chemistry American Proficiency Institute (API) proficiency testing samples into the patient workload for 2 (hematology and chemistry 2nd events in 2022) of 8 events reviewed. Findings include: 1. A record review of the API final proficiency testing documents revealed the LD and TP did not attest to the hematology and chemistry 2nd testing events in 2022 of 8 events reviewed. 2. An interview on 8/14/2023 at 10:00 am TP1 confirmed the 2 events listed above were not signed by the LD and the TP. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of Hematology. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 4 of 5 proficiency testing events. Refer to D2131. ***Repeat Deficiency from 4/20/2022 and 1/11/2023 surveys*** D2131 HEMATOLOGY 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 -- CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to achieve satisfactory performance for the specialty of hematology for 4 (3rd event 2021, 1st and 3rd events 2022, and 1st event 2023) of 5 testing events. Findings include: Unsatisfactory performance for 4 of 5 testing events constitutes subsequent unsuccessful performance for the specialty of hematology. Specialty of Hematology PT Event Score 3rd event of 2021 66% 1st event of 2022 33% 3rd event of 2022 66% 1st event of 2023 0% ***Repeat Deficiency from 4/20/2022 and 1/11/2023 surveys*** D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H. Refer to D6016. ***Repeat Deficiency from 1/11/2023 survey*** D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) proficiency testing reports, the director failed to ensure the laboratory successfully participated in a proficiency testing program as required under subpart H. Findings include: The laboratory failed to achieve satisfactory performance for the specialty of Hematology for 4 of 5 proficiency testing events as follows: Specialty of Hematology PT Event Score 3rd event 2021 66% 1st event 2022 33% 3rd event 2022 66% 1st event 2023 0% ***Repeat Deficiency from 1/11/2023 survey*** -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of Hematology. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 3 of 4 proficiency testing events. Refer to D2131 ***Repeat Deficiency from 4/20/2022 survey*** D2131 HEMATOLOGY CFR(s): 493.851(g) 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 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to achieve satisfactory performance for the specialty of hematology for 3 (3rd event 2021 and the 1st and 3rd events of 2022) of 4 testing events. Findings include: Unsatisfactory performance for 3 of 4 testing events constitutes subsequent unsuccessful performance for the specialty of hematology. Specialty of Hematology PT Event Score 3rd event of 2021 66% 1st event of 2022 33% 3rd event of 2022 66% ***Repeat Deficiency from 4/20/2022 survey*** D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The Laboratory Director failed to ensure the laboratory successfully participated in a proficiency testing program as required under Subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) proficiency testing reports, the director failed to ensure the laboratory successfully participated in a proficiency testing program as required under subpart H. Findings include: The laboratory failed to achieve satisfactory performance for the specialty of Hematology for 3 of 4 proficiency testing events as follows: Specialty of Hematology PT Event Score 3rd event 2021 66% 1st event 2022 33% 3rd event 2022 66% -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of hematology for 2 (1st event in 2022 and 3rd event 2021) of 3 testing events in 2021 and 2022. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 of 3 consecutive proficiency testing events for the specialty of hematology. Refer to D2131. . D2131 HEMATOLOGY 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 -- CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to successfully participate in the specialty of hematology for 2 (3rd event of 2021 and the 1st event of 2022) of 3 testing events. Findings include: 1. A review of the CMS database and review of the API final proficiency testing reports revealed the laboratory attained the following for the specialty of hematology proficiency testing scores: Specialty of Hematology PT Event Score 3rd of 2021 66 1st of 2022 0% -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM), the laboratory failed to have test requests for Covid-19 PCR, chemistry (chem lab), and /or white blood cell (WBC) count for 3 (#6, #16, #27) of 41 patient charts audited. Findings include: 1. A review of patient test requests revealed a lack of a request from an authorized person for the following testing completed: a. patient #6 - no orders for the Covid-19 PCR testing performed on 8/21/2021 b. patient #16 - no orders for the chem lab testing performed on 11/16/2021 c. patient #27 - no order for the WBC testing performed on 10/20/2021 2. An interview on 2/28/2022 at 1:46 pm, the OM confirmed the above patients did not have an order for testing from an authorized person. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: 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 -- . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform control procedures each day of patient testing for the chemistry i-stat chem8+ cartridge. Refer to D5445. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Office Manager (OM), the laboratory failed to perform and document the daily refrigerator temperature for 26 days (January 1-25 and February 5, 2022) of 2 years of documents reviewed. Findings include: 1. A record review of the "Refrigerator Temperature Logs" revealed lack of documentation of the refrigerator temperature being performed and documented for 26 days (January 1-25 and February 5, 2022) of 2 years of documents reviewed. 2. An interview on 2/28/2022 at 12:50 pm, the OM confirmed there was no documentation for the 26 days in January and February 2022 not recorded on the temperature log. 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 record review and interview with the Office Manager (OM), the laboratory failed to perform quality control each day of patient testing for the chemistry i-Stat (chem8+ cartridge) for 23 (March 2020 to February 2022) of 24 months in use. Findings include: 1. A record review of the quality control documents revealed the laboratory was performing the quality control on each new lot/shipment and then every 30 days with the following months missing and the approximate number of patients tested: 2020 a. March - 46 patients tested b. May - 18 patients tested c. July - 20 patients tested d. August - 20 patients tested e. September - 23 patients tested f. October - 25 patients tested g. November - 25 patients tested h. December - 7 patients tested 2021 a. May - 46 patients tested b. June - 66 patients tested c. August - 52 patients tested d. October - 32 patients tested e. November - 24 patients tested f. December - 15 patients tested 2. When queried on 2/28/2020 at 11:53 am, the OM informed the surveyor that during the transition of the chem8+ cartridge from waived testing to moderate complex testing that the old method of quality control carried forward. 3. A interview on 2/28/2022 at 11:53 am, the OM confirmed two different -- 2 of 6 -- levels of external controls had not been performed each day of testing for the i-Stat and that an individualized quality control plan (IQCP) had not been implemented to decrease the number or frequency of running external controls. D5785