American Health Mw Llc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 Individual Laboratory Profile Report and College of American Pathologists (CAP) proficiency testing 2024 (2nd event and 3rd event) records, the laboratory failed to successfully participate in a proficiency testing program. The laboratory failed to successfully participate in the subspecialty of Toxicology for Tobramycin for 2 consecutive testing events. Refer to D2118 and D2119. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and College of American Pathologists (CAP) 2024 (2nd event and 3rd event) records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in 2 consecutive testing events in the subspecialty of Toxicology for the analyte Tobramycin The findings include: 1. Review of the Casper -0155 Individual Laboratory Profile Report revealed the following: Toxicology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for Tobramycin. Toxicology 2024- 3rd Event Laboratory received an unsatisfactory score of 0% for Tobramycin. 2. A proficiency testing desk review from CAP 2024 proficiency testing records confirmed the above findings. D2119 TOXICOLOGY CFR(s): 493.845(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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) report 155 Individual Laboratory Profile, College of American Pathologists (CAP) testing records from 2024 (2nd event and 3rd event), the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 2 consecutive testing events in the subspecialty Toxicology resulting in unsuccessful performance. The findings include: 1. Review of the Casper -0155 Individual Laboratory Profile Report revealed the following: Toxicology 2024- 2nd Event Laboratory received an overall unsatisfactory score of 75% for Toxicology Toxicology 2024- 3rd Event Laboratory received an overall unsatisfactory score of 75% for Toxicology 2. A proficiency testing desk review from CAP 2024 proficiency testing records confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and College of American Pathologists 2024 (2nd event and 3rd event) records, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation in the subspecialty of Toxicology for Tobramycin testing for 2 consecutive events. 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 a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and College of American Pathologists 2024 (2nd event and 3rd event) records, the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H during 2 consecutive testing events. Refer to D2118 and D2119. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 06/26/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 review of College of American Pathologist (CAP) Proficiency testing (PT) 2023 Event 2 (Erythrocyte Sedimentation Rate ESR3-B) and 2024 Event 1 (Erythrocyte Sedimentation Rate ESR3-A and K-C 2024 Ligand General Survey Event 1), and confirmed in interview, the laboratory failed to review Proficiency testing (PT) events for three of four testing events. Findings include: 1. Review of the laboratory PT events revealed the following: a. 2023 Event B Erythrocyte Sedimentation Rate - No CAP Evaluation Result, No Laboratory Evaluation record b. 2024 Event A Erythrocyte Sedimentation Rate - No Attestation, No CAP Evaluation Result, No Laboratory Evaluation record c. 2024 K-C Event 1 - No Attestation, No CAP Evaluation Result, No Laboratory Evaluation record 2. In an interview on 6/26 /2024 at 4:30 PM in the conference room, the laboratory director (LD) was asked if a review was performed for the PT events. The LD confirmed the PT events were not reviewed for the three testing events. This confirmed the findings. 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 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 -- 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 direct observation, manufacturer's instructions, and confirmed in staff interview; the laboratory failed to monitor and document room temperature for 4 of 4 storage areas. Findings included: 1. Observed on 06/26/2023 at 11:15 a.m. were the following areas in the laboratory where controls and calibrators were located: Coulter 6C Cell Control, and Beckman Coulter IQ Control/Focus Set; reagents: Beckman Coulter (Albumin, Glucose, Iron, and Cholesterol), Siemens Healthineers Dode Actin FSL Activated PTT Reagent, Siemens Healthcare CaCl2 Solution; collection tubes with and without patient specimens: purple Greiner Bio-One GmbH Vacuette tubes and blue Greiner Bio-One GmbH Vacuette tubes: a.) Black fridge next to exit: controls: 2 boxes of 4 of each level (1-3) Coulter 6C Cell Control Lot 4218820K; reagents: 3 boxes of 4 each Albumin Lot 2627, 4 boxes of 2 each (1 and 2 levels) Glucose Lot 2703, 6 boxes of 4 each (1 level) Cholesterol, and 5 boxes of 2 each (1 and 2 levels) Iron Lot 2597, 2 boxes of 10 each Calcium Chloride Solution Lot 563928, and 1 box of 10 each of Dode Actin FSL Activated PTT Reagent Lot 562757. b.) Metallic fridge next to exit: 5 racks of 91 patient specimens in purple Greiner Bio- One GmbH Vacuette tubes Lot B240433A and 6 racks of 60 blue Greiner Bio-One GmbH Vacuette tubes Lot B2403335. c.) Fridge in front of storage room B: 5 boxes of 1 each IQ Control/Focus Set Lot 040-24, 3 boxes of IQ Calibrator Pack of 4 each Lot 221-23. d.) Storage room located next to laboratory office: 1 box of 20 packages of 50 purple Greiner Bio-One GmbH Vacuette tubes Lot B240433A and 1 box of 24 packages of 50 blue Greiner Bio-One GmbH Vacuette tubes Lot B2403335. No temperature monitoring devices were observed in the 4 storage areas. 2. The manufacturer's instructions on the label of each package stated a storage requirement of: Coulter 6C Cell Control 2 to 8 degrees Celsius, and Beckman Coulter IQ Control /Focus Set 2 to 8 degrees Celsius; reagents: Beckman Coulter (Albumin 2 to 25 degrees Celsius, Glucose 2 to 8 degrees Celsius, Iron 2 to 8 degrees Celsius, and Cholesterol 2 to 8 degrees Celsius), Siemens Healthineers Dode Actin FSL Activated PTT Reagent 2 to 8 degrees Celsius, Siemens Healthcare CaCl2 Solution 2 to 25 degrees Celsius; and collection tubes with and without patient specimens: purple Greiner Bio-One GmbH Vacuette tubes 4 to 25 degrees Celsius and blue Greiner Bio- One GmbH Vacuette tubes 4 to 25 degrees Celsius. 3. In an interview on 06/26/2023 at 11:15 am, testing personnel (TP) #1 stated that the temperature was not monitored as of 06/15/2024. This confirmed the findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of patient test reports and confirmed in staff interview, the laboratory failed to verify 3 of 3 reference intervals for Complete Blood Cell counts (CBC) for their patient population. Findings include: 1. Review of 3 patient test reports of individuals with different ages and genders titled "American Health Associates" for years 2023 and 2024 revealed reference intervals for CBC results: "Age: 86 Gender: M ... WBC 4.5-10.8 K/cmm RBC 4.00-6.60 M/cmm HEMOGLOBIN 14.0-18.0 g/dL HEMATOCRIT 42.0-54.0 % MCV 80.0-100.0 fL ... Age: 77 Gender: F WBC 4.5-10.8 K/cmm RBC 3.90-5.40 M/cmm HEMOGLOBIN 12.0-16.0 g/dL HEMATOCRIT 36.0- 48.0 % MCV 80.0-100.0 fL ... Age: 30 Gender: M WBC 4.5-10.8 K/cmm RBC 4.00-6.60 M/cmm HEMOGLOBIN 14.0-18.0 g/dL HEMATOCRIT 42.0-54.0 % MCV 80.0-100 fL ..." 2. In an interview on 06/26/2024 at 3:15 p.m. in the conference room, the testing personnel (TP) #1 was asked to provide documentation of verification of the reference intervals in use for their patient population. No documentation was provided. This confirmed the findings. Word Key: % = Percentage K/cmm = Thousands Cells Per Cubic Millimeter M/cmm = Million Cells Per Cubic Millimeter dL = Deciliter F = Female M= Male fL = Femtoliters g = Gram MCV= Mean Corpuscular Volume RBC = Red Blood Cell WBC = White Blood Cell D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must 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. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to present the maintenance logs for instrumentation for nine (9) of seventeen (17) months reviewed in the year 2023 and 2024. Findings include: 1. During a tour of the laboratory on 06/26/2024 at 11:10 AM, a Beckman Coulter AU5822 (SN 2016032671), a Sysmex CA2500 (SN 24121), a Beckman Coulter UniCel DXH900 Hematology Analyzer, an ISED (SN 03202), and a Beckman Coulter DXi 600 (SN 83590723) were observed to be in use. 2. Upon review of the Maintenance for the year 2023 and 2024 for all instrumentation, the maintenance records for six months of year 2023 (July, August, September, October, November, December) and three months for year 2024 (January, February, March) were not present. 3. In an Interview on 6/26/2024 at 4:30 PM, the Testing Personnel was asked for maintenance records for 2023 and 2024. No documentation was provided. This confirmed the findings. -- 3 of 3 --

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 desk review of Hematology proficiency testing results from the College of American Pathologists/EXCEL proficiency testing agency on 03/29/2019, the laboratory failed to successfully participate in the White Blood Cell (WBC) Differential certified analyte in two of three consecutive testing events. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the College of American Pathologists/EXCEL proficiency testing agency on 03/29/2019, the laboratory failed to attain a satisfactory score of at least 80 percent on the WBC Differential. Findings include: The laboratory scored an unsatisfactory 60 percent in the second event of 2018 and scored an unsatisfactory 60 percent in the first testing event of 2019. D2130 HEMATOLOGY CFR(s): 493.851(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 desk review of Hematology proficiency test results from the College of American Pathologists/EXCEL proficiency testing agency on 03/29/2019, the laboratory failed to successfully achieve satisfactory performance for the WBC Differential in two of three consecutive testing events. Findings include: The facility scored 60 percent in the second testing event of 2018 and scored 60 percent in the first testing event of 2019 for an unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies 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 staff interview and record review on 05/15/2018, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Competency assessment was performed using One (1) of Six (6) methods of assessment for Three (3) out of three (3) employees from March 24, 2016 through May 14, 2018. Findings include: Record review revealed competency assessments failed to include monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples, and assessing the skills for solving problems. An interview with the staff on 05/15/2018 at 10:22 AM, revealed the facility failed to have a system in place to ensure competency was performed using all six mandated competency assessment requirements. 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 --