West Michigan Dermatology

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with the Team Lead (TL), the laboratory failed to verify the accuracy of its Scabies testing at least twice annually for 19 (2022 and 2023) of 19 months reviewed. Findings include: 1. A record review of the "Laboratory Tests Log for KOH and Parasites" revealed a column with a "2nd Provider Sign Off." 2. A record review of the 2022 and 2023 "Laboratory Tests Log for KOH and Parasites" revealed a lack of documentation on the logs in the "2nd Provider Sign Off" column for the following accuracy reviews: a. 1st and 2nd half in 2022 b. 1st half in 2023 3. A record review of the testing logs revealed only one patient had scabies testing on 10/22/2022 with a lack of documentation of the 2nd provider sign off. 4. When queried on 7/10/2023 at 10:51 am, the TL did not know there were other means to access the accuracy. 5. A interview on 7/10/2023 at 10:51 am, the TL confirmed the twice annual verification of accuracy for the scabies testing was not performed and documented. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 2 -- A. Based on observation and interview with the Team Lead (TL), the laboratory failed to calibrate and/or replace the expired timer in the dermatology laboratory for 1 (S/N 200357730) of 1 timer discovered in the Labconco hood where grossing takes place. Findings include: 1. During a tour of the laboratory on 7/10/2023 at 9:08 am, the surveyor observed a traceable timer in the grossing hood with an expiration date of 6 /15/2022. 2. An interview on 7/10/2023 at 9:12 am, the TL confirmed the timer in the dermatology laboratory had expired and was not calibrated and/or replaced. B. Based on observation and interview with the Team Lead (TL), the laboratory failed to ensure its Chlorazol reagent had not exceeded its expiration date for 1 (bottle) of 1 bottle in use. Findings include: 1. During a tour of the laboratory on 7/10/2023 at 9:08 am, the surveyor observed the Chlorazol reagent in use past the indicated expiration date of 7 /31/2022. 2. An interview on 7/10/2023 at 9:20 am the TL confirmed the Chlorazol reagent bottle in use had expired. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Team Lead (TL), the laboratory failed to establish a system to ensure the transcribed anatomical site was accurately transcribed for 2 (972870 and 279500) of 7 patient potassium hydroxide (KOH) and /or scabies testing reviewed for 19 months. Findings include: 1. A record review revealed for 2 of 7 final KOH and/or scabies reports reviewed, the anatomical site reported in the patients visit note in the laboratory information system was transcribed incorrectly from the "Laboratory Tests Log for KOH and Parasites" as follows: a. 972870 i. log - left neck ii. visit note - left inferior lateral neck and neck. b. 279500 i. log - chest ii. visit note - xiphoid and trunk 2. An interview on 7/10/2023 at 1:16 pm, the TL confirmed the transcribed anatomical site was transcribed incorrectly. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Clinical Manager, the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 9 (March 2021 to December 2021) of 9 months the laboratory has been testing for SARS-CoV-2. Findings include: 1. The surveyor observed the laboratory's BD Veritor SARS-CoV-2 Antigen test system on 12/1/21 at 9:44 am. 2. The surveyor requested the laboratory's policy on reporting SARS-CoV-2 results to the health department on 12/1/21 at 1:43 pm and it was not made available. 3. An interview on 12/1/21 at 9:44 am with the Clinical Manager revealed the laboratory started testing in March 2021 and had not been reporting negative results to the health department. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish procedures to assess testing personnel competency for Potassium Hydroxide preparations (KOH preps), Scabies preparations, and Dermatophyte Test Medium (DTM) cultures for 2 (December 2019 to December 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's competency assessments for KOH preps, Scabies preparations, and DTM cultures revealed they had been photocopied, the initials of the reviewer did not match personnel listed on the CMS-209 form, and the documentation did not specify where the competency assessments were performed. 2. An interview on 12/1/21 at 11:14 am with Clinic Personnel revealed the individual initialling the laboratory's competency assessments was not qualified as a Technical Consultant. 3. An interview on 12/1/21 at 1:43 pm with Clinic Personnel revealed the competency assessments are performed at one of the facility's locations, are then photocopied, and the copies are kept at this location. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the Clinical Manager, the laboratory failed to ensure tissue marking dyes used in tissue specimen grossing were not expired for 4 (lot numbers 87100, 87104, 86845, and 86921) of 5 tissue marking dyes observed. Findings include: 1. The surveyor observed 4 expired Platinum Line tissue marking dyes on 12/1/21 during a tour of the laboratory at 9:17 am with the following dates of expiration: a. Blue lot number 87100, expiration date August 2021 b. Red lot number 87104 expiration date June 2021 c. Black lot number 86845 expiration date August 2021 d. Yellow lot number 86921 expiration date August 2021 2. An interview on 12 /1/21 at 9:17 am with the Clinical Manager confirmed the tissue marking dyes used were expired. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Clinical Manager, the laboratory failed to ensure testing personnel performing highly complex testing met the qualification requirements of 493.1489. Findings include: 1. The laboratory failed to ensure testing personnel were qualified to perform high complexity testing. Refer to D6171. ***This is a repeated deficiency from the 3/9/20 initial survey*** -- 2 of 4 -- D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet -- 3 of 4 -- the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager, the laboratory failed to ensure testing personnel performing high complexity testing were qualified for 2 (Testing Personnel #10 and 11) of 12 testing personnel listed on Form CMS-209. Findings include: 1. A review of testing personnel credentials revealed a lack of documentation showing Testing Personnel #10 and #11 were qualified to perform high complexity testing. 2. An interview on 12/1/21 at 12:48 pm with the Clinical Manager confirmed the documentation showing Testing Personnel #10 and #11 were qualified to perform high complexity testing were not available. 3. The laboratory was granted an additional 7 days to submit missing credentials to the surveyor and they were not made available. ***This is a repeated deficiency from the 3/9/20 initial survey*** -- 4 of 4 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Clinical Manager, the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 9 (March 2021 to December 2021) of 9 months the laboratory has been testing for SARS-CoV-2. Findings include: 1. The surveyor observed the laboratory's BD Veritor SARS-CoV-2 Antigen test system on 12/1/21 at 9:44 am. 2. The surveyor requested the laboratory's policy on reporting SARS-CoV-2 results to the health department on 12/1/21 at 1:43 pm and it was not made available. 3. An interview on 12/1/21 at 9:44 am with the Clinical Manager revealed the laboratory started testing in March 2021 and had not been reporting negative results to the health department. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish procedures to assess testing personnel competency for Potassium Hydroxide preparations (KOH preps), Scabies preparations, and Dermatophyte Test Medium (DTM) cultures for 2 (December 2019 to December 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's competency assessments for KOH preps, Scabies preparations, and DTM cultures revealed they had been photocopied, the initials of the reviewer did not match personnel listed on the CMS-209 form, and the documentation did not specify where the competency assessments were performed. 2. An interview on 12/1/21 at 11:14 am with Clinic Personnel revealed the individual initialling the laboratory's competency assessments was not qualified as a Technical Consultant. 3. An interview on 12/1/21 at 1:43 pm with Clinic Personnel revealed the competency assessments are performed at one of the facility's locations, are then photocopied, and the copies are kept at this location. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the Clinical Manager, the laboratory failed to ensure tissue marking dyes used in tissue specimen grossing were not expired for 4 (lot numbers 87100, 87104, 86845, and 86921) of 5 tissue marking dyes observed. Findings include: 1. The surveyor observed 4 expired Platinum Line tissue marking dyes on 12/1/21 during a tour of the laboratory at 9:17 am with the following dates of expiration: a. Blue lot number 87100, expiration date August 2021 b. Red lot number 87104 expiration date June 2021 c. Black lot number 86845 expiration date August 2021 d. Yellow lot number 86921 expiration date August 2021 2. An interview on 12 /1/21 at 9:17 am with the Clinical Manager confirmed the tissue marking dyes used were expired. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Clinical Manager, the laboratory failed to ensure testing personnel performing highly complex testing met the qualification requirements of 493.1489. Findings include: 1. The laboratory failed to ensure testing personnel were qualified to perform high complexity testing. Refer to D6171. ***This is a repeated deficiency from the 3/9/20 initial survey*** -- 2 of 4 -- D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet -- 3 of 4 -- the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Manager, the laboratory failed to ensure testing personnel performing high complexity testing were qualified for 2 (Testing Personnel #10 and 11) of 12 testing personnel listed on Form CMS-209. Findings include: 1. A review of testing personnel credentials revealed a lack of documentation showing Testing Personnel #10 and #11 were qualified to perform high complexity testing. 2. An interview on 12/1/21 at 12:48 pm with the Clinical Manager confirmed the documentation showing Testing Personnel #10 and #11 were qualified to perform high complexity testing were not available. 3. The laboratory was granted an additional 7 days to submit missing credentials to the surveyor and they were not made available. ***This is a repeated deficiency from the 3/9/20 initial survey*** -- 4 of 4 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the Technical Consultant failed to evaluate the performance of testing personnel at least semiannually during the first year for 6 (Testing Personnel #1, 2, 5, 6, 7, and 9) of 14 testing personnel. Findings include: 1. An interview on 3/9/2020 at 11:00 am with the office manager revealed the laboratory initially started testing in May 2019. 2. A review of the laboratory's "Competency/Proficiency Testing Policy" revealed it did not contain a policy for the semiannual evaluation of testing personnel in the first year. 3. A review of testing personnel competency assessments revealed the following personnel did not have a semiannual performance evaluation: a. Testing Personnel #1 most recent evaluation was performed 5/3/19 b. Testing Personnel #2 most recent evaluation was performed 5/13/19 c. Testing Personnel #5 most recent evaluation was performed 5/13/19 d. Testing Personnel #6 most recent evaluation was performed 5/13 /19 e. Testing Personnel #7 most recent evaluation was performed 5/13/19 f. Testing Personnel #9 most recent evaluation was performed 5/13/19 3. An interview on 3/9 /2020 at 11:37 am with the office manager confirmed the testing personnel above did not have semiannual performance evaluations. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 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 -- 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on document review, and interview with the General Supervisor (GS), the laboratory failed to ensure personnel performing high complexity histopathology testing met educational requirements at 42 CFR 493.1489 for 1 (Testing Personnel #14) of 14 testing personnel. Findings include: 1. The laboratory failed to ensure testing personnel performing high complexity testing were qualified before performing testing. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality -- 2 of 3 -- control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to ensure testing personnel performing high complexity testing were qualified for 1 (Testing Personnel #14) of 14 testing personnel. Findings include: 1. A review of testing personnel credentials revealed a lack of credentials for Testing Personnel #14. 2. A review of the initial competency assessment for Testing Personnel #14 showed a completion date of 11/25/19. 3. An interview on 3/9/2020 at 11:52 am with the office manager confirmed the credentials for Testing Personnel #14 were not available. 4. The laboratory was granted an additional 7 days to submit missing credentials to the surveyor and they were not made available. -- 3 of 3 --