Hometown Family Health Pllc

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 provider. The facility 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) 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 Federal proficiency testing (PT) reports 153D and 155D and the laboratory's American Proficiency Institute (API) PT report, the laboratory failed 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 -- to achieve successful participation for the glucose test method. Unsatisfactory results for glucose in two of three PT testing events (API 2025 Chemistry-Core first and third events) resulting in unsuccessful PT participation. 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 review of the Federal proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute's (API) PT reports and interview with laboratory manager A, the laboratory failed to achieve a satisfactory score of 80% or above for the glucose test method for two of three testing events (API 2025 Chemistry- Core first and third events). Findings include: 1. Review on 10/30/25 of the CASPER Individual Laboratory Profile PT report 155D report revealed the laboratory had received unsatisfactory scores of 60% in the API 2025 Chemistry core first event and 20% in the third event for the glucose test method. Review on 10/1/25 of the individual event glucose test method scores for the two API PT events revealed: a. 2025 Chemistry-Core first event glucose results were: (i) CH-01 result was 198. The range of acceptable results was 167-197 milligrams/deciliter (mg/dl). (ii) CH-03 result was 359. The range of acceptable results was 363-427 mg/dl. b. 2025 Chemistry-Core third event glucose results were: (i) CH-11 result was 229. The range of acceptable results was 141-166 mg/dl. (ii) CH-12 result was 186. The range of acceptable results was 329-387 mg/dl. (iii) CH-14 result was 342. The range of acceptable results was 179-211 mg/dl. (iv) CH-15 result was 146. The range of acceptable results was 219- 258 mg/dl. Interview on 10/9/25 via email with laboratory manager A revealed the laboratory's investigation revealed: a. There was an issue with the analyzer at the time the first event samples were processed. b. There was a potential issue with the API third event PT samples. i.. Four of the five PT samples were green in color. The PT samples are normally yellow in color. ii.. The laboratory repeated the original PT samples. The results were similar to the laboratory's reported results. iii. Laboratory manager A contacted API concerning the condition of the PT samples. API shipped a replacement set of PT samples for retesting. iv. The laboratory tested the replacement API samples. Results of the repeat testing were within the acceptable ranges. -- 2 of 2 --

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 proficiency testing (PT) record review and interview with the laboratory manager, the laboratory failed to achieve successful participation for the carbon dioxide (CO2) test method. Unsatisfactory results had been received in two of three PT testing events (American Proficiency Institute [API] 2025 Chemistry-Core first and second events) resulting in unsuccessful PT participation. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (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 federal proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute's (API) PT reports and interview with the laboratory manager, the laboratory failed to achieve a satisfactory score of 80% or above for the carbon dioxide (CO2) test method for two of three testing events (API 2025 Chemistry-Core first and second testing events). Findings include: 1. Review of the 7/14/25 CASPER Unsuccessful PT report 153D revealed the laboratory had received unsatisfactory scores (less than 80%) for the CO2 test method in each of the two testing events listed above. Review of the 7/14/25 CASPER Individual Laboratory Profile PT report 155D and API PT 2025 Chemistry-Core first and second event evaluation reports revealed the laboratory had received unsatisfactory scores of 60% in the first event and 20 % in the second event for the CO2 test method. Review of the individual event CO2 test method scores for the two API PT events revealed: *2025 Chemistry-Core first event CO2 results were: a. CH-01 13 The range of acceptability was 20-31 millimoles/liter (mmol/L) . b. CH-05 16 The range of acceptability was 17-27 mmol/L. *2025 Chemistry-Core second event CO2 results were: a. CH-07 22 The range of acceptability was 23-36 mmol/L. b. CH-08 17 The range of acceptability was 18-28 mmol/L. c. CH-09 20 The range of acceptability was 21-32 mmol/L. d. CH-10 22 The range of acceptability was 26-41 mmol/L. Interview on 7/28/25 via email with the laboratory manager revealed:*The laboratory had been aware of the PT failures. *Her investigation into the first unsuccessful testing event determined that there had been an issue with the analyzer. Service had been notified and the issue was corrected. *Her investigation into the second unsuccessful testing event determined that there had been an issue with the analyzer. PT samples had been repeated after the analyzer issue was corrected. It had been determined that the PT specimens had been retested after the open expiration date had expired which had resulted in potential deterioration of the PT samples. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/12/23. Hometown Family Health PLLC laboratory was found not in compliance with the following requirements: D5445. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to perform the following: *Perform two levels of external controls to verify the accuracy of two of five non-waived test methods (prostate specific antigen [PSA] and total 25-hydroxy Vitamin D) each day patient testing was performed on the Nano Entek FREND analyzer. *Perform two levels of external controls or establish an equivalent quality control (QC) method to verify the accuracy of three of five non-waived test methods (thyroid stimulating hormone [TSH], free thyroxine [FT4], and total testosterone) each day patient testing was performed on the Nano Entek FREND analyzer. Findings include: 1. Review on 4/12/23 of the laboratory's records revealed: a. The laboratory processed patient PSA specimens on the Nano Entek FREND analyzer. *External QC results had been documented on 9/4/22 and 10/5/22. There had been no documentation additional external QC had been run in 2022 and to date in 2023. *Review of the laboratory's 2022 and 2023 quality assurance (QA) records revealed 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 -- QC had been marked as reviewed each month. There had been no documentation of the failure to document acceptable external QC for the months of November and December 2022 and of January, February, March and to date in April 2023. Review of the manufacturer's FREND PSA Plus product insert, last revised 8/22, revealed, "External quality control testing: It is recommended that external controls be run at least once per day when testing is scheduled for the FREND PSA Plus on the FREND system. A minimum of two (2) levels of control, normal and abnormal, should be used." b. The laboratory processed patient total 25-hydroxy Vitamin D specimens on the Nano Entek FREND analyzer. *External QC results had been documented on 9/4 /22, 10/30/22, 11/15/22, and 1/18/23. There was no documentation additional external QC had been run in 2022 and to date in 2023 for the total 25-hydroxy Vitamin D test method. *Review on 4/12/23 of the laboratory's 2022 and 2023 QA records revealed QC had been marked as reviewed each month. There had been no documentation of the failure to document acceptable external QC for the months of December 2022 and of February, March and to date in April 2023. Review on 4/12/23 of the manufacturer's FREND Total 25-hydroxy Vitamin D product insert, last revised 5/22, revealed, "External quality control testing: It is recommended that a minimum of two (2) levels of control be run once per day on days when assaying patient samples on the FREND Vitamin D test." Review of the laboratory's annual test volume form revealed a total of 98 PSA, total 25-hydroxy Vitamin D, and total testosterone patient specimens had been reported since testing had begun in September 2022 without QC having been performed each day of patient testing to ensure the accuracy of the patient test results. c. The laboratory processed patient TSH specimens on the Nano Entek FREND analyzer. *External QC results had been documented 9/4/22, 9/28/22, 12/28/22, 1/9/23, 3/2/23, and 4/10/23. There was no documentation additional external QC had been run in 2022 and to date in 2023. *Review on 4/12/23 of the laboratory's 2022 and 2023 QA records revealed QC had been marked as reviewed each month. There had been no documentation of the failure to document acceptable external QC for the months of October and November 2022 and of February 2023. Review on 4/12/23 of the manufacturer's FREND TSH product insert, last revised 10 /20, revealed, "External quality control testing- It is recommended that a minimum of two (2) levels of control be run at least once per month or once for each new lot or shipment, whichever comes earlier." The laboratory had not developed an individual quality control plan (IQCP) which would have allowed the laboratory to process QC at the minimum number and frequency required by the manufacturer. Review of the laboratory's annual test volume form revealed 371 TSH patient specimens had been reported since testing had begun in September 2022 without QC having been performed each day of patient testing to ensure the accuracy of the test results. d. The laboratory processed patient FT4 specimens on the Nano Entek FREND analyzer. *External QC results had been documented 9/14/22 and 1/9/23. There was no documentation additional external QC had been run in 2022 and to date in 2023. *Review on 4/12/23 of the laboratory's 2022 and 2023 QA records revealed QC had been marked as reviewed each month. There had been no documentation of the failure to document acceptable external QC for the months of October, November and December 2022 and of February, March and to date in April 2023. Review on 4/12/23 of the manufacturer's FREND FT4 product insert, last revised 5/22, revealed, "External quality control testing- It is recommended that a minimum of two (2) levels of control be run at least once per month or once for each new lot or shipment, whichever comes earlier." The laboratory had not developed an individual quality control plan (IQCP) which would have allowed the laboratory to process QC at the minimum number and frequency required by the manufacturer. Review of the laboratory's annual test volume form revealed 93 FT4 patient specimens had been reported since testing had begun in September 2022 without QC having been -- 2 of 3 -- performed each day of patient testing to ensure the accuracy of the test results. e. The laboratory processed patient total testosterone specimens on the Nano Entek FREND analyzer. *External QC results had been documented 9/27/22 and 10/30/22. There had been no documentation additional external QC had been run in 2022 and to date in 2023. *Review on 4/12/23 of the laboratory's 2022 and 2023 QA records revealed QC had been marked as reviewed each month. There had been no documentation of the failure to document acceptable external QC for the months of November and December 2022 and of January, February, March and to date in April 2023. Review on 4/12/23 of the manufacturer's FREND Total Testosterone product insert, last revised 5/22, revealed, "External quality control testing- It is recommended that a minimum of two (2) levels of control be run at least once per month or once for each new lot or shipment, whichever comes earlier." The laboratory had not developed an individual quality control plan (IQCP) which would have allowed the laboratory to process QC at the minimum number and frequency required by the manufacturer. Review of the laboratory's annual test volume form revealed a total of 98 PSA, total 25-hydroxy Vitamin D, and total testosterone patient specimens had been reported since testing had begun in September 2022 without QC having been performed each day of patient testing to ensure the accuracy of the test results. Review of the laboratory director's onsite visit report included mention of development of a IQCP for the Nano Entek FREND analyzer. There was no documentation an IQCP had been developed. Interview on 4/12/23 at 9:50 AM with testing personnel A revealed: *The laboratory had begun testing patient specimens in September 2022. *She confirmed the laboratory had been processing and reporting PSA, 25-hydroxy Vitamin D, TSH, FT4, and total testosterone patient specimens. *She confirmed QC testing was to have been performed monthly and with new shipments or changes of the reagent lot number on the FREND analyzer. *She reviewed the QC records monthly as part of the QA process. *She had not been aware the manufacturer required two levels of QC to be performed each day PSA and 25-hydroxy Vitamin D patient testing had been performed. *She confirmed the laboratory had not developed an IQCP plan for TSH, FT4, and total testosterone testing on the Nano Entek FREND analyzer. The laboratory director had been unavailable for interview at the time of the survey. -- 3 of 3 --