Metromedic Walk-In Medical Ctr

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) for 2025, the laboratory failed to meet the following conditions, resulting in an initial unsuccessful PT participation: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and AAB-Medical Laboratory Evaluation (AAB-MLE) 2025 records, the laboratory failed to 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 -- successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the analyte of Hematocrit (HCT). Refer to 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 a proficiency testing desk review of CASPER 0155 report and AAB-MLE Proficiency Testing 2025 records (Events 1, 2 and 3), the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte for three consecutive testing events in the specialty of Hematology for the analyte Hematocrit (HCT). Findings include: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2025-2nd Event the laboratory received an unsatisfactory score of 0% for Hematocrit (HCT). Hematology 2025-3rd Event the laboratory received an unsatisfactory score of 0% for Hematocrit (HCT). 2. A review of the AAB-MLE Proficiency Testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of CASPER 0155 report and AAB-MLE Proficiency Institute 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and AAB-MLE 2025 records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (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 Laboratory Administrator the laboratory failed to test the negative reactivity of BBL Taxo A disc (bacitracin) using the organisms required by the manufacturer's package insert. Findings Include: 1. Record review on 8/5/2024 of the laboratory's BBL Taxo A disc reagent log revealed: a. Two packages of BBL Taxo A discs, Lot number 3181001, expiration date 12/29 /2024 were received on 8/1/2023. b. The positive control was logged as performed for the above lot and shipment. c. The negative control was not logged as performed. 2. Record review on 8/5/2024 of the Taxo A Disc package insert User Quality Control Section revealed, "Check performance with pure cultures of stable control organisms producing known desired reactions. One or more beta-hemolytic streptococcal species belonging to groups B, C, D and/or G may be employed to demonstrate lack of zone formation." 3. During staff interview with the Laboratory Administrator on 8/5/2024 at 11:30 AM, the Laboratory Administrator stated, "I do not use an organism to check the negative reactivity of the A discs. I use a plate without any organisms for the negative control." 4. The laboratory performs 75 cultures annually in the specialty of Microbiology. D5807 TEST REPORT 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): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure the reference ranges on final patient test report (FPTR) matched the reference ranges in the procedure manual (PM) in the specialty of Hematology. Findings include: 1. Record review on 8/5/2024 of a FPTR compared to the procedure manual revealed the following differences for white blood cell count (WBC), red blood cell count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Distribution Width (RDW), Platelet (PLT), Mean Platelet Volume (MPV), Lymphocyte Percent (lymph%), Mid range Percent (Mid%), and Granulocyte percent (Gran%). Note: Range on FPTR is the same for both male and female. Test FPTR PM WBC 10^3mm^3 4.1-10.9 4.7-10.3 K/uL RBC 10^6/uL 4.2-6.3 4.03-5.46 M/uL Hgb g/dL 12-18 12.4-16.9 g/dL Hct % 37-51 36.6 - 48.3% MCV fL 80-97 81.5- 96.8 fL MCH pg 26-32 27.5-33.1 pg MCHC g/dL 31-36 32.4-35.7 g/dL RDW % 11.5- 14.5 11.8-14.9 % PLT 10^3/uL 150-450 165-385 K/uL MPV fL 0.0-49.9 7.2-10.2 fL Lymph% 10-58.5 12.7-47.8 Mid% 0.1-24 6.3-14.0 Gran% 37.0-92.0 43.5-78.9 2. Record review on 8/5/2024 of the laboratory procedure manual for the new Abbott Emerald hematology analyzer, Section 4, Characteristics and Specifications revealed, "These ranges do not represent globally applicable intervals, but reflect combined reference ranges tested in the validation study. Each lab should establish/verify its own reference intervals." 3. Staff interview with the Laboratory Administrator on 8/5 /2024 at 11:45 PM confirmed the above reference ranges found in the procedure manual do not match the reference ranges on the final patient test report. 4. The laboratory performs 2,905 tests annually in the specialty of Hematology. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as patient samples by testing personnel (TP) who routinely perform the testing in the specialty of Hematology. Findings include: 1. Record review on 11/18/2022 of the laboratory's American Association of Bioanalysts (AAB) 2021 and 2022 NonChemistry PT attestation sheets revealed: a. 2 of 3 Hematology TP did not participate in PT in 2021. b. 2 of 4 Hematology TP did not participate in PT in 2022. 2. Staff interview with TP #1 on 11/18/2022 at 11:00 AM confirmed the above TP did not participate in AAB NonChemistry PT. 3. The laboratory performs 2,250 tests annually in the specialty of Hematology. 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, record review and staff interview, laboratory testing 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 -- personnel (TP) failed to label controls with the new expiration date after opening in the specialty of Hematology. Findings include: 1. Surveyor observation on 11/18/2022 at 11:45 AM of the laboratory refrigerator contents revealed the following in use Hematology controls were not labeled with the new expiration date after opening; 'Clinical Diagnostic Solutions (CDS) Next Generation 3PD Hematology Controls', Lot # 32209-11, 32209-12 and 32209-13. 2. Record review on 11/18/2022 of the CDS Next Generation 3PD Hematology controls package insert, Storage and Stability section revealed, "Open vial stability is 14 days after opening when returned to the refrigerator after each use." 3. Staff interview on 11/18/2022 at 11:45 AM with TP #1 confirmed the above in use controls were not labeled with the new expiration date after opening. 4. The laboratory performs 2,250 tests annually in the specialty of Hematology. 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: Based on record review and staff interview, the technical consultant failed to evaluate testing personnel (TP) yearly to ensure competency to perform patient testing in the specialties of Hematology and Microbiology. Finding include: 1. Record review on 11 /18/2022 of the laboratory's 2021 TP competency records revealed, 2 of 3 TP did not have documented competency in 2021. 2. Staff interview with TP #1 on 11/18/2022 at 11:30 AM confirmed the above TP did not have documented 2021 competency. 3. The laboratory performs 2,250 tests annually in the specialty of Hematology and 95 tests annually in the specialty of Microbiology. -- 2 of 2 --