Hmcs Inc - Home Med Diagnostic & Lab Svcs

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, laboratory records, lack of documentation, and interviews with the laboratory director; the laboratory failed to ensure confidentiality of patient information throughout all phases of the total testing process on five of seven pages reviewed utilized for creating coversheets (See D5201), failed to establish and follow written policies and procedures to ensure optimum integrity of one of four patients' hematology specimen from the time of collection through completion of testing and reporting of results (See D5203), and failed to ensure accuracy of 22 of 22 PT samples not evaluated by the PT provider in the subspecialties of routine chemistry and endocrinology in 2025 (See D5213). D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. 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 5 -- Based on direct observation, review of laboratory records, and interview with the laboratory director (LD); the laboratory failed to ensure confidentiality of patient information throughout all phases of the total testing process on five of seven pages reviewed utilized for creating coversheets. Findings include: 1. Upon review of laboratory records on 12/09/2025, at 12:36 pm, surveyors observed that five of seven coversheets reviewed were handwritten on the back of patient reports which included patients' names, dates of birth, specimen numbers, names of the test(s) ordered, and test results. 2. Interview with the LD on 12/09/2025, at 2:26 pm, confirmed the laboratory failed to ensure confidentiality of patient information throughout all phases of the total testing process on five of seven pages reviewed utilized for creating coversheets. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of documentation, manufacturer's instructions for use (IFU), laboratory records, and interview with the laboratory director (LD); the laboratory failed to establish and follow written policies and procedures to ensure optimum integrity of one of four patients' hematology specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. Review of laboratory policies and procedures revealed a lack of documentation of requirements for specimen preservation, handling, and analysis within the limitations of the test methodology (See D5403). 2. Review of the manufacturer's IFU for the Diatron Abacus 5 hematology analyzer (Serial Number: (21)512000106) revealed, under "8 Sample Measurement ....8.1.4 Sample Collection and Handling", "Analyze blood samples within 7 hours of collection." 3. Review of patient test records revealed the laboratory failed to perform the hematologic analysis within the manufacturer's established timeframe for one of four patients reviewed. Patient: NJ723214 Sample: 250516001 Specimen Collected: 05/16/2025 at 09:02 am Specimen Received: 05/16/2025 at 10:20 pm Specimen Analyzed: 05/18/2025 at 2:47 pm 4. Interview with the LD on 12/09/2025, at 2:26 pm, confirmed the laboratory failed to establish and follow written policies and procedures to ensure optimum integrity of one of four patients' hematology specimen from the time of collection through completion of testing and reporting of results. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Proficiency Institute (API) proficiency testing (PT) records, laboratory records, lack of documentation, and -- 2 of 5 -- interview the laboratory director (LD); the laboratory failed to ensure accuracy of 22 of 22 PT samples not evaluated by the PT provider in the subspecialties of routine chemistry and endocrinology in 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Proficiency Testing", which indicated, under "Details of Policy", "PT results that are not graded will be self-graded by comparing the results to the expected results of the PT agency or peer results." 2. Review of API comparative evaluation summaries for the following PT events in 2025 revealed the following 22 un-graded PT samples: PT Event: Analyte: Sample: 2025 Event 1 LDL* CH***-01 2025 Event 1 LDL CH-02 2025 Event 1 LDL CH-03 2025 Event 1 LDL CH-04 2025 Event 1 LDL CH-05 2025 Event 2 TBil** CH-07 2025 Event 2 TBil** CH-09 2025 Event 2 TBil** CH-10 2025 Event 2 Folate IA****-07 2025 Event 2 Folate IA-09 2025 Event 3 TBil CH-12 2025 Event 3 TBil CH-15 2025 Event 3 LDL CH-11 2025 Event 3 LDL CH-12 2025 Event 3 LDL CH- 13 2025 Event 3 LDL CH-14 2025 Event 3 LDL CH-15 2025 Event 3 Free Thyroxine CH-11 2025 Event 3 Free Thyroxine CH-12 2025 Event 3 Free Thyroxine CH-13 2025 Event 3 Free Thyroxine CH-14 2025 Event 3 Free Thyroxine CH-15 * = Low Density Lipoprotein ** = Total Bilirubin *** = Routine Chemistry **** = Endocrinology 3. Review of laboratory records found no documented review of the 22 ungraded PT samples in the subspecialties of routine chemistry and endocrinology in 2025. 4. Interview with the LD on 12/09/2025, at 11:06 am, confirmed the laboratory failed to ensure accuracy of 22 of 22 PT samples not evaluated by the PT provider in the subspecialties of routine chemistry and endocrinology in 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: 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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency 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 -- Institute (API) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the routine chemistry analyte Chloride (Cl) for two of three PT events in 2025 (events 1 and 3 of 2025) resulting in the initial unsuccessful PT performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the routine chemistry analyte Chloride (Cl) for two of three PT events in 2025 (events 1 and 3 of 2025) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 11-03-2025, the laboratory received the following unsatisfactory scores for the routine chemistry analyte Cl. Cl Initial Unsuccessful PT Performance EVENT 1, 2025 - 60% Unsatisfactory EVENT 3, 2025 - 40% Unsatisfactory 2. Review of API PT evaluation reports (Chemistry - Core) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the routine chemistry analyte Cl. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte Chloride (Cl) resulting in the laboratory's initial unsuccessful PT performance. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency -- 2 of 3 -- Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte Chloride (Cl) resulting in the laboratory's initial unsuccessful PT performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: 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 Enhanced Reporting (CASPER) 0155D Report and American Proficiency Institute 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 -- (API) Proficiency Testing (PT) records confirmed the initial unsuccessful PT performance for the analyte Erythrocyte Count for two consecutive PT events in 2025 (events 1 and 2). 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 the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the hematology analyte Erythrocyte Count for two consecutive PT events in 2025 (events 1 and 2) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 10-01-2025, the laboratory received the following unsatisfactory scores for the hematology analyte Erythrocyte Count. Erythrocyte Count EVENT 1, 2025 - 40% Unsatisfactory EVENT 2, 2025 - 40% Unsatisfactory 2. Review of API PT evaluation reports (2025 Hematology/Coagulation - 1st & 2nd Event) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the hematology analyte Erythrocyte Count. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte Erythrocyte Count resulting in the laboratory's initial unsuccessful PT performance. 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 the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program -- 2 of 3 -- for the hematology analyte Erythrocyte Count resulting in the laboratory's initial unsuccessful PT performance. Refer to D2130. -- 3 of 3 --