Hackensack Meridian Urgent Care Plus

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records, CASPER 155 report and interview with the Techincal Consultant (TC), the laboratory failed to enroll in an Health and Human Services (HHS) approved PT program for Hematology tests for the third PT event of 2025. The TC confirmed on 3/11/26 at 10:40 am the laboratory was not enrolled in PT for Hematology for the above mentioned PT event. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Consultant (TC), the laboratory failed to ensure that attestation statements were maintained from 11/18/24 to 3/11/26. The finding includes: 1. There Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- were no Attestation statements, work records and graded results available for PT provider American Association of Bioanalysts Medical Laboratory Evaluation (AAB- MLE) Non-Chemistry, Hematology 1st and 2nd events in 2025 . 2. The TC confirmed on 3/11/26 at 11:15 am that the Attestation statements, work records and graded results were missing for the above mentioned events. 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 surveyor review of the procedure manual (PM) the lack of Proficiency tasting (PT) records office review of the CASPER 155 report and interview with the Techincal Consultant (TC), the laboratory failed to achieve 80% or more in two out of three events for the analyte Hemoglobin (HGB) with the Association of Bioanalysts /Medical Laboratory Evaluation (AAB-MLE). Cross refer D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 CASPER 155 report and graded results from Association of Bioanalysts/Medical Laboratory Evaluation (AAB-MLE). The laboratory failed to achieve satisfactory performance (80% or greater) for two out of three events in the specialty Hematology for the analyte Hemoglobin (HGB) resulting in initial unsuccessful inital performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 60% for HGB in event 1- 2025. b) The laboratory was not enrolled in a Health and Human Services (HHS) approved Proficiency Testing (PT) program for event 3-2025. 2. A review of AAB- MLE graded results and CASPER 155 report confirmed the laboratory failed two out of three PT events. -- 2 of 9 -- D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (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 surveyor review of Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory lacked copies of all PT records for testing performed with the American Association of Bioanalysts/Medical Laboratory Evaluation (AAB-MLE). for the 2nd and 3rd Hematology PT events of 2025. The findings include: 1. The laboratory lacked the work records, attestation pages and graded results for the 2nd and 3rd Hematology PT events of 2025. 2. The TC confirmed on 3/11/26 at 11:30 am, all PT records were not retained. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 surveyor review of the Competency Assessment (CA) records, Procedure Manual (PM) and interview with the Techincal Consultant (TC), the laboratory failed to follow its policies for assessing the competency of Testing Personnel (TP) from 11 /18/24 to 3/11/26. The findings include: 1. There was no documented evidence CA was performed on three out of three TP listed on the CMS 209 form 11/18/24 to 3/11 /26. 2. The TC confirmed on 3/11/26 at 11:30 am, the laboratory failed to follow its policies for assessing the competency of TP as mentioned above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the lack of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to review PT results obtained from the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Non-Chemistry, Hematology 1st and 2nd events in 202. The finding includes; 1) There was no documented evidence that PT results for AAB-MLE Non-Chemistry, Hematology 1st and 2rd event in 2025 were reviewed. 2) The TC confirmed on 3/11 /26 at 10:30 am that the laboratory did not review PT results stated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test -- 3 of 9 -- system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of Performance Specification (PS) records and interview with the Techincal Consultant (TC), the laboratory failed to ensure that all PS records were adequate for Hematology tests performed on the Horiba ABX Micros 60 from 11 /18/24 to 3/11/26. The findings include: 1. The laboratory failed to perform a normal Patient range verification. 2. The laboratory failed to perform a normal Precision. 3. The TC confirmed on 3/11/26 at 11:30 am, the laboratory failed to ensure that all PS records were adequate. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the lack of of Calibration Verification (CV) records, User Manual (UM) and interview with the Technical Consultant (TC), the laboratory failed to perform, document and meet acceptable limits for all Calibration results and procedures at least once every six months for Hematology Tests performed on the Horiba ABX Micros 60 analyzer from 11/18/24 to 3/11/26. The findings include: 1. There was no documented evidence that CV was performed. 2. The TC confirmed on 3/11/26 at 11: 32 am that the laboratory failed to perform, document CV every six months. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control -- 4 of 9 -- materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Technical Consultant (TC), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment of ABX Mintrol 16 QC material used on the Horiba ABX Micros 60 Analyzer from 11/18/24 to 3/11/26. The findings includes: 1. There was no documented evidence that the laboratory verify commercially assayed QC material. 2. The TC confirmed on 3/11/26 at 11:10 am, the assayed values of QC material were not verified before putting into use. D5779