Healthy Care Clinical Laboratory Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/17/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful AAB-Medical Laboratory Evaluation participation; and 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2024-3, 2025- 1, and 2025-2), the laboratory failed to successfully participate in a proficiency 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 -- 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 analytes Cholesterol, Total and Uric Acid resulting in unsuccessful performances. See 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation (AAB) report, the laboratory failed to achieve satisfactory performances for two of three consecutive events (2024-3, 2025-1, and 2025-2) for the analytes Cholesterol, Total and Uric Acid. The findings include: 1. Cholesterol, Total 0% - 2024 third testing event; Cholesterol, Total 40% - 2025 second testing event; 2. Uric Acid 60% - 2025 first testing event; Uric Acid 20% - 2025 second test event. A review of the 2024 & 2025 scores from AAB 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. 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 the CASPER 0155D report and AAB records for 2024-3, 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. 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 CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-3, 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 surveyor review of the AAB proficiency testing evaluation report for 2022, 2023 and 2024 and interview with the laboratory technical supervisor on 04/05/2024 at 12:00PM, the laboratory failed to attain a score of at least 80 percent of acceptable responses for HDL in the second event of 2023. The finding include: 1) The laboratory performed routine chemistry testing using Olympus AU640 Chemistry Analyzer. The laboratory participated in the AAB proficiency testing program in 2022, 2023 and 2024. The laboratory attained a score of 20 percent for HDL in the 2nd event of 2023, which was unsatisfactory for the testing event. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2) On 04/05/2024 at 12:00 PM, the laboratory technical supervisor confirmed the laboratory attained a score of 20 percent for HDL in the 2nd event of 2023 which was unsatisfactory analyte performance for the testing event. 3) The laboratory's testing declaration form, signed by the laboratory director on 03/27/2024 stated that the laboratory performed 26,000 tests in routine chemistry, annually. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with 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 3 -- proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the AAB proficiency testing evaluation report and interview with the laboratory technical supervisor on 04/05/2024 at 12:00PM, the laboratory failed to take remedial action for unacceptable analytes. The finding include: 1) The laboratory performed routine chemistry testing using Olympus AU640 Chemistry Analyzer. The laboratory participated in the AAB proficiency testing program in 2022, 2023 and 2024. The laboratory attained a score of 80 percent for Albumin and ALT in the second event of 2022 and a score of 80 percent for glucose in the second event of 2023, both of which were unacceptable for the analytes in the proficiency testing event. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2) On 04/05/2024 at 12:00 PM, the laboratory technical supervisor confirmed that the laboratory did not take remedial action for unacceptable analytes. 3) The laboratory's testing declaration form, signed by the laboratory director on 03/27/2024 stated that the laboratory performed 26,000 tests in routine chemistry, annually. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory's testing records and interview with the laboratory technical supervisor on 04/05/2024 at 12:00PM, the laboratory failed to retain documentation for analytic system activities for routine chemistry. The finding include: 1) The laboratory performed routine chemistry testing using Olympus AU640 Chemistry Analyzer. Laboratory did not retain instrument records for chemistry tests prior to June 16, 2923. Therefore, the accuracy of the chemistry test results rendered by the laboratory cannot be assured and might have harmed patients. 2) On 04/05 /2024 at 12:00 PM, the laboratory technical supervisor confirmed that the laboratory did not retain the data for Olympus AU640 Chemistry Analyzer. 3) The laboratory's testing declaration form, signed by the laboratory director on 03/27/2024 stated that the laboratory performed 26,000 tests in routine chemistry, annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and -- 2 of 3 -- 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory report and interview with the laboratory technical supervisor on 04/05/2024 at 12:00PM, the laboratory director failed to ensure laboratory's compliance with the applicable regulations and potentially harmed patients. The findings include: See D3031 and D2087. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

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 Surveyor review of laboratory's policy & procedure, and proficiency testing (PT) records, and interview with the laboratory technical supervisor on July 14, 2021 at 11:30 am, the laboratory failed to successfully participate in the proficiency testing program for the analyte, TRIGL. The findings include: 1. The laboratory participated in the American Association of Bioanalysts (AAB) PT testing program for the analyte TRIGL at the 1st and 2nd events in 2021. However, it received an unsatisfactory score of 40 and 0 at the 1st and 2nd events, correspondingly, resulted in an unsuccessful PT participation. Therefore, the accuracy of the patients' TRIGL test results rendered by the laboratory during that time period can not be assured. 2. The laboratory technical 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 -- supervisor on July 14, 2021 at 11:30 am, affirmed that the laboratory did not receive a satisfactory score for the analyte TRIGL at the 1st and 2nd events of PT in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 7/11 /2021, stated that the laboratory performs approximately 1,200 TRIGL tests, annually. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 Surveyor review of laboratory's policy & procedure, and proficiency testing (PT) records, and interview with the laboratory technical supervisor on July 14, 2021 at 11:30 am, the laboratory failed to achieve satisfactory performance for the analyte TRIGL in two consecutive testing events. The findings include: 1. The laboratory participated in the American Association of Bioanalysts (AAB) PT testing program for the analyte TRIGL at the 1st and 2nd events in 2021. However, it received an unsatisfactory score of 40 and 0 at the 1st and 2nd events, correspondingly, resulted in an unsuccessful PT performance. Therefore, the accuracy of the patients' TRIGL test results rendered by the laboratory during that time period can not be assured. 2. The laboratory technical supervisor on July 14, 2021 at 11:30 am, affirmed that the laboratory did not receive a satisfactory score for the analyte TRIGL at the 1st and 2nd events of PT in 2021. 3. The laboratory's testing declaration form, signed by the laboratory director on 7/11/2021, stated that the laboratory performs approximately 1,200 TRIGL tests, annually. 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. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, automated complete blood count (CBC) test verification records, and interview with the laboratory technical supervisor on July 14, 2021 at 2:30 pm, the laboratory failed to verify its test accuracy for basophils, monocytes and mean corpuscular hemoglobin concentration (MCHC). The findings include: 1. The laboratory replaced its old, automated Cell- Dyn CBC instrument with automated Sysmex CBC instrument. It did a test verification on the new, Sysmex instrument by running some samples on both old and new instruments and comparing the results by linear regression using an r value. The results of r values were as follows: Monocytes r=0.42, Basophils r=0.17 and MCHC r=0.52. These low r values showed very poor correlation between 2 instruments. However, the laboratory had accepted this verification data and started patient testing. -- 2 of 5 -- Therefore, the accuracy of the rendered patient test results with the new instrument can not be assured. 2. The laboratory technical supervisor on July 14, 2021 at 2:30 pm, affirmed that the laboratory's test verification was not adequate. 3. The laboratory's testing declaration form, signed by the laboratory director on 7/11/2021, stated that the laboratory performs approximately 16,140 CBC tests, annually. D5809 TEST REPORT CFR(s): 493.1291(e) The laboratory must, upon request, make available to clients a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified as specified in 493.1253. In addition, information that may affect the interpretation of test results, for example test interferences, must be provided upon request. Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient sample and quality control (QC) records, and interview with the laboratory technical supervisor on July 14, 2021 at 12:15 pm, the laboratory failed to update its COVID-19 PCR test limitations to its clients. The findings include: 1. The laboratory performs COVID-19 PCR test by using Azure Seq one-step RT-qPCR kit. The kit manufacturer confirmed that their method does not detect the delta variant of the SARS-COV-2 virus. While there was a surge of the delta variant infection in the community. Therefore, the "not detected" results provided by the laboratory to the patients including specimen # 00179643 might had been positive for the delta variant, and the patients might had misdiagnosed. 2. The laboratory technical supervisor on July 14, 2021 at 12:15 pm, affirmed that the laboratory did not inform the client of the test limitations or put any disclaimer on the test report. 3. The laboratory's testing declaration form, signed by the laboratory director on 7/11/2021, stated that the laboratory performs approximately 51,000 SARS-COV-2 tests, annually. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient sample, quality control (QC), verification of test accuracy records, and interview with the laboratory technical supervisor during an onsite survey of the laboratory on July 14, 2021, and the severity and the number of deficiencies found and cited herein, it was determined that the laboratory director failed to provide effective direction over the operation of the laboratory, hence the Condition: Laboratories performing high complexity testing; laboratory director was not met. The laboratory director's failure to provide direction over the laboratory operation has a consequence of potential erroneous test result reporting and patient harm. The findings include: 1. The laboratory director failed to assure compliance with the applicable regulations. (See -- 3 of 5 -- D6079) 2. The laboratory director failed to ensure that the verification procedures used are adequate to determine the accuracy. (See D6086) 3. The laboratory director failed to ensure that reports of test results include pertinent information required for interpretation. (See D6098) 4. The laboratory director failed to ensure that PT samples were tested as required under Subpart H of this Part. (See D6089) D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient sample, quality control (QC) and verification of test accuracy records, and interview with the laboratory technical supervisor and personnel on July 14, 2021 at 2:30 pm, the laboratory director failed to assure laboratory's compliance with the applicable regulations. The findings include: See D2016, D2096, D5421 and D5809. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, and test accuracy verification records, and interview with the laboratory technical supervisor on July 14, 2021 at 2:30 pm, the laboratory failed to verify the test accuracy adequately. The findings include: See D5421 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, and proficiency testing (PT) records, and interview with the laboratory technical supervisor on July 14, 2021 at 11:30 am, it was determined that the laboratory director, high complexity testing, -- 4 of 5 -- failed to ensure that PT samples were tested as required under subpart H. of this part. The findings include: For the analyte, TRIGL, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096). D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient sample and quality control records, and interview with the laboratory technical supervisor on July 14, 2021 at 12:15 pm, the laboratory failed to update its COVID-19 PCR test limitations to its clients. The findings include: See D5809. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, and automated complete blood count (CBC) test verification records, and interview with the laboratory technical supervisor on July 14, 2021 at 2:30 pm, the laboratory technical supervisor failed to verify test accuracy for basophils, monocytes and mean corpuscular hemoglobin concentration (MCHC). The findings include: See D5421. -- 5 of 5 --

Summary Statement of Deficiencies 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 observation and review of the temperature charts and interview with the testing personnel, it was determined that the laboratory failed to monitor acceptable temperature for those conditions that is essential for proper storage of reagents and specimens, accurate and reliable test system operation, and failed to familiarize the features and the functions of a digital thermometer. The findings included: a. The laboratory established its freezer acceptable temperature range between -25 o C and -15 o C. b. Observed a digital thermometer for Freezer #1, and verified with the temperature records for May 1, 2018 thru Oct. 3, 2018. c. There were -14 o C recorded and noted on the following dates: on 5/3/18, 5/25/18, 5/26/18, 5/30/18, 7/7 /18 between May 1 and Oct. 2, 2018,. d. The laboratory used a digital thermometer which features two Mode:: "Min" & "Max" plus "Lo" and "Hi", in addition to the current temperature and alarm on/off. e. "Min" and "Max" represent the lowest temperature and highest temperature were reached, respectively, in the past, but don't know exact when. f. "Lo" and "Hi" represent the laboratory's setting for the acceptable temperature range of the storage conditions. g. At the time of the survey (10/3/2018 @ 12:15 PM), a "Max" of -5 o C was noted in the digital thermometer for the Freezer #1 which was out for the acceptable temperature of -25 o C to -15 o C sometime in the past. h. When checked the Mode of "Lo" and "Hi" setting, the "Lo" was 10 o C while 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 -- "Hi" was at 30 o C, which were inconsistent with the laboratory establishment for freezer acceptable temperature range of -25 o C to -15 o C.. i. The laboratory failed to familiarize how the digital thermometer works, and document the remedial actions when the temperature were not acceptable. j. The laboratory turned off the alarm, so that the alarm does not go off. D5781