Delphos Family Physicians Inc

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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to successfully participate in a Proficiency Testing (PT) program for the non-waived LDL (low-density lipoprotein) and sodium (Na) testing performed under the specialty of Chemistry. This deficient practice had the potential to affect 2,616 out of 2,616 LDL tests performed in this laboratory during the second and third PT testing events of 2023 and the first PT testing event of 2024. This deficient practice had the potential to affect 167 out of 167 Na tests performed during the second PT testing event of 2023. Findings Include: 1. The laboratory failed to achieve a PT score of 80% (percent) for LDL testing in the second and third PT events in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 2023, and the first PT event in 2024 in the specialty of Chemistry. (Refer to D2087, Item I) 2. The laboratory failed to achieve a PT score of 80% (percent) for Na testing in the second PT event in 2023 in the specialty of Chemistry. (Refer to D2087, Item II) 3. The laboratory failed to achieve satisfactory performance for the same analyte, LDL, in consecutive events, including the third PT event in 2023, and the first PT event in 2024 in the specialty of Chemistry. (Refer to D2096) 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: Item I: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analyte low-density lipoprotein (LDL) for the second and third PT events in 2023, and the first PT event in 2024 in the specialty of Chemistry. This deficient practice had the potential to affect 2,616 out of 2,616 patient LDL test results during the second PT event in 2023 in the speciality of Chemistry. Findings Include: 1. Review of the laboratory's API Chemistry PT documentation from the second and third testing events of 2023, and the first event of 2024, provided on the date of the inspection, revealed the following unsatisfactory analyte testing scores: Second PT Event 2023 LDL; 20% Third PT Event of 2023 LDL; 60% First Event of 2024 LDL: 0% 2. TP #1 confirmed the unsatisfactory LDL PT score for the second and third PT testing events of 2023, and the first PT testing event of 2024. The interview occurred on 05/08/2024 at 2:09 PM. Item II: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analyte sodium (Na) for the second PT event in 2023 in the specialty of Chemistry. This deficient practice had the potential to affect 167 out of 167 patient Na test results during the second PT event in 2023 in the speciality of Chemistry. Findings Include: 1. Review of the laboratory's API Chemistry PT documentation from the second testing event of 2023, provided on the date of the inspection, revealed the following unsatisfactory analyte testing score: Second PT Event 2023 Na; 60% 2. TP #1 confirmed the unsatisfactory Na PT score for the second testing event of 2023. The interview occurred on 05/08/2024 at 2:09 PM. 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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to achieve a proficiency testing (PT) score of 80% (percent) for the analyte low-density lipoprotein (LDL), in two consecutive testing events, including the second and third PT events in 2023, and the first PT event in 2024 in the specialty of Chemistry. This deficient practice had the potential to affect 2,616 out of 2,616 patient LDL test results during the third PT event in 2023, and the first PT event in -- 2 of 4 -- 2024 in the speciality of Chemistry. Findings Include: 1. Review of the laboratory's API Chemistry PT documentation from consecutive events, including the second and third testing events of 2023, and the first event of 2024, provided on the date of the inspection, revealed the following unsatisfactory analyte testing scores: Second PT Event 2023 LDL; 20% Third PT Event 2023 LDL; 60% First PT Event 2024 LDL; 0% 2. TP #1 confirmed the unsatisfactory LDL PT score in two consecutive events, including the second and third testing events of 2023 and the first testing event of 2024. The interview occurred on 05/08/2024 at 2:09 PM. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record reviews and an interview with Testing Personnel (TP) #1, the laboratory failed to ensure the individuals who performed moderate complexity testing met the qualification requirements of 493.1423 to perform the functions specified in 493.1425 for the testing procedures performed. This deficient practice affected three out of four TP. Findings Include: 1. The laboratory failed to ensure TP #2, TP #3 and TP #4 met the education requirements, as specified in subpart M for moderate complexity testing procedures performed. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on document reviews and an interview with Testing Personnel (TP) #1, the Laboratory Director failed to ensure TP #2, TP #3 and TP #4 had the appropriate education documentation to perform all test operations reliably to provide and report accurate results. This deficient practice affected three out of four TP. Findings Include: 1. Review of the laboratory's Form CMS 209, approved, signed and dated on 04/28/2024 by the Laboratory Director found four individuals listed and credentialed to perform moderately complex testing procedures. 2. Review of the laboratory's documents provided on the date of inspectoin did not find education records for TP #2, TP #3 and TP #4. 3. The inspector requested education documentation from TP #1 for TP #2, TP #3 and TP #4. 4. An interview with TP #1, on 05/08/2024 at 12:30 PM, -- 3 of 4 -- confirmed the laboratory failed to ensure TP #2, TP #3 and TP #4 had the appropriate education documentation to perform all test operations reliably to provide and report accurate results and was unable to provide the requested documentation for the inspection. -- 4 of 4 --

Summary Statement of Deficiencies 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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to establish and verify performance specifications of the Access 2 Vitamin B12 and Vitamin D tests before reporting patient test results. This deficient practice had the potential to affect 83 out of 83 patients tested in the speciality of chemistry and 88 out of 88 patients tested in the subspecialty of endocrinology at this laboratory from 01/01/2022 through 04/06/2022. Findings Include: 1. A review of the laboratory's manual found a policy and procedure to establish and verify performance specifications that stated the following: "...The policy of our facility shall be that the following criteria shall be maintained prior to patient testing: 1- Accuracy of test performed 2- Repetitive testing produced the same number 3- A reportable range is made from which the laboratory can verify the accuracy of the test. A result lower or higher then the lowest or highest known standard must be report greater or less than the standard value. 4- Normal range for the given population" 2. Review of patient test records found 83 patients tested for Vitamin B12 and 88 patients tested for Vitamin D from 01/01/2022 through 04/06/2022 3. Review of the laboratory's documentation failed to find evidence of performance specifications for the Vitamin B12 and Vitamin D tests prior to testing patient specimens, including accuracy, precision, reportable range and normal range, as stated in their policy. 4. An interview 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 -- with TP #1, on 04/06/2022 at 2:01 PM, confirmed that the laboratory failed to follow their policy of verifying performance specifications prior to reporting patient results for the tests of Vitamin B12 and Vitamin D. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and an interview Testing Personnel (TP) #1, the laboratory failed to perform and document semi-annual maintenance for the Cell Dyne Emerald instrument as defined by the manufacturer. All 5000 patients tested under the specialty of hematology from 01/13/2021 to 04/06/2022 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's policies and procedures, found the following statement: "The policy of our facility shall be to perform and record preventative maintenance daily, weekly, monthly, semi- annually, annually and as needed as required by the manufacturer." 2. Review of the laboratory's monthly instrument maintenance record supplied by the manufacturer titled "Cell Dyne Emerald Checklist," found the following tasks with timeframes: Timeframe Maintenance Task "Monthly" "Reset Waste Container" "Semi-annual" "Piston Lubrication 3. Review of the "Cell Dyne Emerald Checklist" from 01/13/2021 to 04/06/2022 failed to find evidence that maintenance was performed and recorded as specified by the manufacturer: "January 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "February 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "March 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "April 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "May 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "June 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "July 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "August 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "September 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "October 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "November 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "December 2021 Reset Waste Container [not complete] Piston Lubrication [not complete]" "January 2022 Reset Waste Container [not complete] Piston Lubrication [not complete]" "February 2022 Reset Waste Container [not complete] Piston Lubrication [not complete]" "March 2022 Reset Waste Container [not complete] Piston Lubrication [not complete]" 4. An interview with TP #1, on 04/06/2022 at 3:31 PM, confirmed, that although the laboratory performed the maintenance tasks as specified by the manufacturer, the laboratory failed to record the maintenance tasks as complete, specified by the manufacturer and per their policy. -- 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 record review and interviews with the Laboratory Director and an American Proficiency Institute (API) proficiency testing (PT) representative, the laboratory failed to successfully participate in a PT program for the non-waived red blood cell count (RBC) testing performed under the subspecialty of Hematology. All patients who had RBC testing in this laboratory from the third API PT event of 2018 to the third API PT event of 2019 had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to achieve satisfactory PT performance for the analyte red blood cell count (RBC) in three out of three consecutive PT testing events in 2019 which resulted in subsequent unsuccessful analyte performance. All 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 -- patient RBC specimens tested from the third API PT event of 2018 to the third API PT event of 2019 had the potential to be affected by this deficient practice. (Refer to D2130) 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 record review and interviews with the Laboratory Director and an American Proficiency Institute (API) proficiency testing (PT) representative, the laboratory failed to achieve satisfactory performance for the analyte red blood cell count (RBC) in three out of three consecutive PT events in 2019 and is unsuccessful PT performance. All patients who had RBC testing in this laboratory from the third API PT event of 2018 to the third API PT event of 2019 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's 2019 API PT documentation revealed a RBC analyte score of 0% for the first, second and third PT events of 2019. %; percent 2. The Laboratory Director confirmed, 04/01/2020 at 4:14 PM, that the laboratory did not achieve successful PT performance for the analyte RBC in three out of three consecutive PT testing events in 2019. 3. The API PT representative confirmed the laboratory's RBC PT analyte score to be 0% for the first, second and third PT events of 2019. The telephone interview occurred on 04/02/2020 at 10:00 AM. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, and an interview with Testing Personnel (TP) #1, the laboratory failed to establish and follow a written policy and procedure to assess competency of one out of one Technical Consultant (TC), based on the regulatory responsibility of that role, at a frequency determined by the lab, as specified in the personnel requirements in subpart M. All patients tested at this laboratory have the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's 'Form CMS-209 Personnel Report (CLIA)', approved and signed by the Laboratory Director on 10/7/19, found one individual serving as the TC. 2. Review of the laboratory's policies and procedures failed to find instructions for competency assessment of the TC, based on the regulatory responsibility of that role, at a frequency determined by the lab. 3. Review of the laboratory's competency assessment documentation failed to find evidence that the TC was being assessed for competency based on the regulatory responsibility of that role, at a frequency determined by the lab. However, on 9/19/19, the TC was assessed for competency based on the role of TP. 4. An interview with the TP #1, on 10/17/19 at 11:46 am, confirmed that TC did function in the role of a TP, and that the lab failed to establish and follow a policy and procedure for assessing the competency of the TC, based on the regulatory responsibility of that role, at a frequency determined by the laboratory. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) 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 -- The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the Laboratory Director (LD) failed to specify the duties and responsibilities of one out of one Technical Consultant (TC) listed on the CMS-209, in writing. All patients tested at this lab have the potential to be affected by this deficient practice. Findings include: 1. Review of the laboratory's 'Form CMS-209 Personnel Report (CLIA) found one individual, listed as performing duties of a TC. 2. Review of policies and procedures failed to find evidence that the duties and responsibilities of the TC were specified in writing, with regulatory responsibilities delegated to that individual by the LD. 3. An interview with TP #1, on 10/17/19 at 2:53 pm, confirmed that the LD failed to specify the duties and responsibilities of the TC in writing, with regulatory responsibilities delegated to that individual by the LD. -- 2 of 2 --