Hopkins Minor Emergency Center Llc

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on April 24, 2025. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory quality control documentation, patient test results, and confirmed in interview, the laboratory failed to ensure that quality control (QC) was performed, and acceptable, before patient CBC testing for 30 patients performed on days where QC failed to be performed Sysmex Pochi-100i hematology analyzer for records reviewed in 2024. This is a repeat deficiency that was identified in an onsite recertification inspection performed on June 2, 2023. The findings included: 1. Review of the laboratory policy titled "Daily CBC QC" included the following instructions: "Daily CBC QC (Change controls every 14 days) .... If any numbers are out of range you will re-run the control until its [sic] brought into range." 2. Review of laboratory quality control documentation, and patient reports, for July through September 2024 included the following 18 days where CBC QC was not documented on the Sysmex pochi-100i analyzer before patient testing occurred: July 2024 included the following seven days and 10 patients with CBC testing when QC was not performed: Date: Patient ID's 07/11/2024: 2146, 2147 07/15/2024 : 2280 07 /16/2024 : 2314 07/22/2024 : 2622 07/23/2024 : 2705 07/24/2024 : 2768 07/25/2024 : 2786, 2799, 841 August 2024 included the following eight days and 16 patients with CBC testing when QC was not performed: Date: Patient ID's 08/01/2024: 1379, 3153 08/03/2024 : 2218, 3256 08/02/2024 : 2642, 3196 08/05/2024 : 3325, 3345,3275, 3347, 3280 08/10/2024 : 1645, 3602 08/16/2024 : 2590 08/19/2024 : 4022 08/22/2024 : 4203 September 2024 included the following three days and four patients with CBC 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 -- testing when QC was not performed: Day: Patient ID's 09/14/2024: 5054, 5047 09/19 /2024: 5199 09/23/2024: 195889 3. In an interview on 4/24/2025 at 11:50 hours, in the breakroom, the technical consultant confirmed there was no QC documentation for the Sysmex Pochi-100 on the above days where patient testing was performed. KEY: CBC - Complete blood count -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory documents, the Centers for Medicare and Medicaid Services (CMS) Form 116, and confirmed in an interview, the laboratory failed to follow the manufacturer's storage requirements to ensure a proper storage temperature of 2 - 8 degrees Celsius (C) for 67 of 111 days reviewed from November 2022 to March 2023. The findings included: 1. In a tour of the laboratory on 6/2/2023 at 12:30 hours, the surveyor observed the following waived testing items and their respective storage temperature in the laboratory refrigerator: 1 box Abbott Afinion HbA1c Controls, storage temperature 2 - 8 (degrees) C 1 box Quantimetrix Dipper Urinalysis Dipstick Control, storage temperature 2 - 8 (degrees) C 4 boxes Piccolo Lipid Panel, storage temperature of 2 - 8 (degrees) C 2 boxes Piccolo Comprehensive Metabolic Panel, storage temperature of 2 - 8 (degrees) C 2. Review of laboratory temperature records for November 2022 to March 2023 had the following 67 days with a documented temperature outside of the acceptable range of 2 - 8 (degrees) Celsius, or 35.6 - 46.4 (degrees) Fahrenheit (F) November 2022: 15 days 11/10/2022 - 26.1 (degrees) F 11/11/2022 - 28.1 (degrees) F 11/12/2022 - 52.8 (degrees) F 11/14/2022 - 52.8 (degrees) F 11/15/2022 - 52.8 (degrees) F 11/16/2022 - 52.8 (degrees) F 11/17/2022 - 52.8 (degrees) F 11/18/2022 - 52.8 (degrees) F 11/21 /2022 - 52.8 (degrees) F 11/23/2022 - 52.8 (degrees) F 11/24/2022 - 52.8 (degrees) F 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 -- 11/26/2022 - 52.8 (degrees) F 11/28/2022 - 52.8 (degrees) F 11/29/2022 - 52.8 (degrees) F 11/30/2022 - 52.8 (degrees) F December 2022: 22 days 12/2/2022 - 52.8 (degrees) F 12/3/2022- 52.8 (degrees) F 12/5/2022- 52.8 (degrees) F 12/6/2022- 52.8 (degrees) F 12/7/2022- 52.8 (degrees) F 12/8/2022- 52.8 (degrees) F 12/9/2022- 52.8 (degrees) F 12/10/2022- 52.8 (degrees) F 12/12/2022- 52.8 (degrees) F 12/13/2022- 52.8 (degrees) F 12/14/2022- 56.9 (degrees) F 12/15/2022- 52.8 (degrees) F 12/16 /2022- 52.8 (degrees) F 12/19/2022- 52.8 (degrees) F 12/20/2022- 52.8 (degrees) F 12 /21/2022- 52.8 (degrees) F 12/22/2022- 52.8 (degrees) F 12/23/2022- 52.8 (degrees) F 12/24/2022- 52.8 (degrees) F 12/25/2022- 52.8 (degrees) F 12/26/2022- 52.8 (degrees) F 12/29/2022- 52.8 (degrees) F January 2023: 24 days 01/01/2023 - 52.8 (degrees) F 01/02/2023 - 52.8 (degrees) F 01/03/2023 - 56.9 (degrees) F 01/04/2023 - 68.7 (degrees) F 01/05/2023 - 56.9 (degrees) F 01/06/2023 - 67.6 (degrees) F 01/07 /2023 - 56.9 (degrees) F 01/08/2023 - 68.9 (degrees) F 01/10/2023 - 56.9 (degrees) F 01/12/2023 - 56.9 (degrees) F 01/13/2023 - 56.9 (degrees) F 01/16/2023 - 56.9 (degrees) F 01/17/2023- 56.9 (degrees) F 01/18/2023- 56.9 (degrees) F 01/19/2023- 56.9 (degrees) F 01/20/2023- 56.9 (degrees) F 01/21/2023- 56.9 (degrees) F 01/23 /2023- 56.9 (degrees) F 01/25/2023- 56.9 (degrees) F 01/26/2023- 56.9 (degrees) F 01 /27/2023- 56.9 (degrees) F 01/28/2023 - 62 (degrees) F 01/30/2023 - 56.9 (degrees) F 01/31/2023 - 56.9 (degrees) F February 2023: 6 days 2/3/2023 - 56.9 (degrees) F 2/4 /2023 - 56.9 (degrees) F 2/6/2023 - 56.9 (degrees) F 2/7/2023 - 57.6 (degrees) F 2/8 /2023 - 51.6 (degrees) F 2/9/2023 - 51 (degrees) F 3. Review of the CMS Form 116, section VI. "Waived Testing" had an estimated total annual test volume of 10,000. 4. In an interview on 6/2/2023 at 12:15 hours, in the breakroom, the technical consultant (TC 1) confirmed that the above-recorded temperatures were outside of the manufacturer's acceptable range. 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 surveyor observation, laboratory documents, the Centers for Medicare and Medicaid Services (CMS) Form 116, and confirmed in an interview, the laboratory failed to ensure a proper storage temperature for hematology quality control of 2 - 8 degrees Celsius (C) for 67 of 111 days reviewed from November 2022 to March 2023. The findings included: 1. In a tour of the laboratory on 6/2/2023 at 12:30 hours, the surveyor observed the following control items for the Sysmex PoChi-100 hematology analyzer and the documented storage temperature in the laboratory refrigerator: 1 box of Sysmex EightCheck 3WP X-TRA, storage temperature 2 - 8 (degrees) C, with 6 unopened control vials inside, and three opened control vials in the door of the refrigerator. 2. Review of laboratory temperature records for November 2022 to March 2023 had the following 67 days with a documented temperature outside of the acceptable range of 2 - 8 (degrees) Celsius, or 35.6 - 46.4 (degrees) Fahrenheit (F) November 2022: 15 days 11/10/2022 - 26.1 (degrees) F 11/11/2022 - 28.1 (degrees) F 11/12/2022 - 52.8 (degrees) F 11/14/2022 - 52.8 (degrees) F 11/15/2022 - 52.8 -- 2 of 6 -- (degrees) F 11/16/2022 - 52.8 (degrees) F 11/17/2022 - 52.8 (degrees) F 11/18/2022 - 52.8 (degrees) F 11/21/2022 - 52.8 (degrees) F 11/23/2022 - 52.8 (degrees) F 11/24 /2022 - 52.8 (degrees) F 11/26/2022 - 52.8 (degrees) F 11/28/2022 - 52.8 (degrees) F 11/29/2022 - 52.8 (degrees) F 11/30/2022 - 52.8 (degrees) F December 2022: 22 days 12/2/2022 - 52.8 (degrees) F 12/3/2022- 52.8 (degrees) F 12/5/2022- 52.8 (degrees) F 12/6/2022- 52.8 (degrees) F 12/7/2022- 52.8 (degrees) F 12/8/2022- 52.8 (degrees) F 12/9/2022- 52.8 (degrees) F 12/10/2022- 52.8 (degrees) F 12/12/2022- 52.8 (degrees) F 12/13/2022- 52.8 (degrees) F 12/14/2022- 56.9 (degrees) F 12/15/2022- 52.8 (degrees) F 12/16/2022- 52.8 (degrees) F 12/19/2022- 52.8 (degrees) F 12/20/2022- 52.8 (degrees) F 12/21/2022- 52.8 (degrees) F 12/22/2022- 52.8 (degrees) F 12/23 /2022- 52.8 (degrees) F 12/24/2022- 52.8 (degrees) F 12/25/2022- 52.8 (degrees) F 12 /26/2022- 52.8 (degrees) F 12/29/2022- 52.8 (degrees) F January 2023: 24 days 01/01 /2023 - 52.8 (degrees) F 01/02/2023 - 52.8 (degrees) F 01/03/2023 - 56.9 (degrees) F 01/04/2023 - 68.7 (degrees) F 01/05/2023 - 56.9 (degrees) F 01/06/2023 - 67.6 (degrees) F 01/07/2023 - 56.9 (degrees) F 01/08/2023 - 68.9 (degrees) F 01/10/2023 - 56.9 (degrees) F 01/12/2023 - 56.9 (degrees) F 01/13/2023 - 56.9 (degrees) F 01/16 /2023 - 56.9 (degrees) F 01/17/2023- 56.9 (degrees) F 01/18/2023- 56.9 (degrees) F 01 /19/2023- 56.9 (degrees) F 01/20/2023- 56.9 (degrees) F 01/21/2023- 56.9 (degrees) F 01/23/2023- 56.9 (degrees) F 01/25/2023- 56.9 (degrees) F 01/26/2023- 56.9 (degrees) F 01/27/2023- 56.9 (degrees) F 01/28/2023 - 62 (degrees) F 01/30/2023 - 56.9 (degrees) F 01/31/2023 - 56.9 (degrees) F February 2023: 6 days 2/3/2023 - 56.9 (degrees) F 2/4/2023 - 56.9 (degrees) F 2/6/2023 - 56.9 (degrees) F 2/7/2023 - 57.6 (degrees) F 2/8/2023 - 51.6 (degrees) F 3. Review of the CMS Form 116, section VII. "Non-Waived Testing" had an estimated total annual test volume of 14,000 for the specialty of hematology. 4. In an interview on 6/2/2023 at 12:15 hours, in the breakroom, the technical consultant (TC 1) confirmed that the above temperatures recorded were outside of the manufacturer's acceptable range for the Sysmex EightCheck 3WP X-TRA hematology controls. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation, reagent instructions for use, and confirmed in interview, the laboratory failed to record the in use, or open date, for 3 of 3 controls in use for the Sysmex poc100i hematology analyzer observed on 6/2/2023. The findings included: 1. In a tour of the laboratory on 6/2/2023 at 12:30 hours, the surveyor observed the following hematology control vials in a cup secured in the refrigerator door without indication of when it was put into use: EightCheck 3WP X-TRA Abnormal Low Control: Lot 30810710, Exp: 2023-06-26 EightCheck 3WP X-TRA Normal Control: Lot 30810711, Exp 2023-06-28 EightCheck 3WP X-TRA Abnormal High Control: Lot 30810712, Exp 2023-06-28 In an interview at 12:33 hours, in the laboratory, testing person (TP) 6 stated that the QC was put into use "...more than likely the last week of May." 2. Review of the "Sysmex EIGHTCHECK -3WP X- TRA" instructions for use, section "Storage and shelf life after first opening" had the following statement: "Opened and recapped vials and vials whose caps have been -- 3 of 6 -- pierced will retain stability for 14 days if stored at 2-8 (degrees) C after being re- capped. 3. In an interview on 6/2/2023 at 12:40, in the breakroom, the technical consultant (TC 1) confirmed that the controls in use for the Sysmex pocH-100i did not have an open, or in-use date, documented on the vials. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory documents, laboratory control records, laboratory patient records, and confirmed in an interview, the laboratory failed to document quality controls (QC) on days where patients were tested on the Sysmex pocH-100i hematology analyzer for 2 of 44 days reviewed in November and December 2022. The findings included: 1. Review of a laboratory quick sheet posted in the laboratory on the laboratory refrigerator had the following "Daily Lab Duties: "CBC Controls" 2. Review of QC records had the following 2 days where QC was not documented on days where patient testing performed on the Sysmex pocH-100i: November 19, 2022 - no documented QC 3 patients tested on 11/19/2022 (see patient list) November 28, 2022 - no documented QC 1 patient tested on 11/28/2022 (see patient list) 3. In an interview on 6/2/2023 at 13:05, in the breakroom, the technical consultant (TC 1) confirmed that the laboratory did not have documentation of QC being performed on the above days when patient testing was performed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the laboratory quality assurance (QA) policy, QA checklists, QC records, patient records, and confirmed in an interview, the laboratory failed to have an effective QA system in place to monitor and identify issues in the analytic system for four of six reviews performed from 2022 to 2023. The findings included: 1. Review of the laboratory policy titled "Quality Assurance Policies and Procedures", section A "POLICIES AND PROCEDURES" had the following statement: "The laboratory has established a Quality Assurance (QA) program. This is the policy of this laboratory to apply the principles of this QA program to all activities of this laboratory, including preanalytic, analytic and postanalytic activities. The QA program assures that accurate, reliable, and prompt reporting of test results and provides methods to evaluate the effectiveness of its policies and procedures, to identify and correct problems, and assure the adequacy and competency of the staff. The laboratory will use a checklist system to provide periodic monitoring of the -- 4 of 6 -- quality assurance indicators. If no problems are identified, monitoring will be stopped. It is not the purpose of this QA program to continuously monitor indicators which are working correctly. However, if problems occur, monitoring will be reinstated until the problems are identified and corrected." 2. Review of the laboratory "Quality Assurance Checklist" had the following items to be checked: "Quality Control Policies Were Performed: ___ All required temperatures were recorded daily and within range. ___ All instrument maintenance was performed and documented. ___ Remedial action performed was documented and reviewed. ___ Daily controls were performed and within acceptable limits before patient testing. ___ Mean values/SD's for controls reflect the laboratory values. Adjusted ___ calibrations are current and within acceptable time frames. Last___Next___ ___ QC action log completed. Patient reviews completed if two controls were out of range. 3. A review of laboratory documents, laboratory control records, laboratory patient testing, and confirmed in an interview, the QA program failed to monitor and identify remediate patients tested on the Sysmex pocH-100i where no quality controls (QC) were documented for 2 of 44 days reviewed in November and December 2022. Refer to D5447 4. In surveyor observation, laboratory documents, the Centers for Medicare and Medicaid Services (CMS) Form 116, and confirmed in an interview, the QA program failed to identify and document

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 review of 2017 and 2018 American Proficiency Institute (API) proficiency testing (PT) documentation and staff interview, the laboratory director failed to provide the required signatures attesting to the routine integration of samples into the patient workload using the laboratory's routine methods. Findings: 1. Review of API PT attestation forms for hematology testing in the 3rd event 2017 and 1st event 2018 showed that testing person 1 (TP1-CMS form 209) had signed as lab director designee. The laboratory director (CMS form 209) had not signed the forms. 2. Review of lab testing personnel records revealed that TP 1 did not meet the education and training requirements for laboratory director or for delegation of signatory authority as technical consultant. 3. In an interview at the site on 06-26-2019, TP 1 stated she was not aware of the regulatory requirements regarding the signing of PT attestation statements. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the 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 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on review of patient reports for hematology testing, confirmed by staff interview, the laboratory failed to include positive patient identification and the physical location of the laboratory in test reports. Findings: 1. Copies of patient reports were reviewed. Hematology testing results were found to be identified by the patient's first and last name only. No information on the name or address of the testing location were included in the report. 2. In an interview at the site on 06-26-2019, TP 1 confirmed that the forms reviewed were representative of the patient reports for hematology testing in use at the facility. . 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: . Based on review of laboratory competency verification documentation for 2017, 2018 and 2019, confirmed by staff interview, the laboratory technical consultant (TC- CMS form 209) failed to evaluate the competency of testing personnel using the required criteria. Findings: 1. Personnel competency verification documents were reviewed. Forms dated 2017, 2018 and 2019, signed by the LD were found. On each was the phrase, "The above employee has been deemed competent in all aspects of the lab environment. The individual will be evaluated annually." No mention of the methods or criteria of evaluation were included. No documentation dated 2018 was found for TP 2 or TP 3. 2. In an interview at the site on 06-26-2019, TP1 confirmed that the forms reviewed served as competency verification for all testing personnel. -- 2 of 2 --