Doctors Memorial Hospital Clinical Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Doctors Memorial Hospital Clinical Laboratory on 02/04/2025-02/12/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 493.1421 Condition: Laboratory Testing Personnel 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 staff interview and record review, the Laboratory Director failed to perform annual competencies on 5 of 5 Technical Consultants (TC) for 2 of 2 years (2023 and 2024) reviewed. Findings include: 1. Interview conducted at 9:30am on 02/04/2025 with TP# M confirmed that TC# A, TC# B, TC# C, TC# D, and TC# E do not have annual competencies completed for years 2023-2024. 2. Record review of personnel competency records revealed no competency records completed for TC# A, TC# B, TC# C, TC# D, and TC# E for years 2023-2024. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager, the Laboratory 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 -- Director failed to sign the Policies and Procedures for 2 of 2 years reviewed (2023- 2025). Findings Included: 1. Review of Policies and Procedures revealed that the Laboratory Director did not sign them as reviewed. 2. Interview on 02/05/2025 at 11: 00 am the Laboratory Manager confirmed that the Laboratory Director did not sign the Policies and Procedures. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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, record review, and interview, the Laboratory failed to label Complete Blood Count (CBC) controls (QC) with the date open and expiration on the High, Normal, and Low levels of QC. Findings Included: 1. Observations on 02/04 /2025 at 10:00 AM during the tour, revealed High, Normal, and Low levels of QC without open date and expiration date. 2. Review of package insert for the High, Normal, and Low levels of QC revealed that once punctured (opened) the QC is good for 15 days. 3. Interview on 02/05/2025 at 1:00 PM the Laboratory Manager confirmed that there was no legible open and expiration date on the High, Normal, and Low levels of QC. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to ensure Coagulation quality control (QC) is ran every 8 hours for 2 out of 2 months (June 2023 and August 2024) reviewed. Findings Included: 1. Review of Coagulation QC revealed that the Laboratory had 2 Coagulation instruments and that the policy was to alternatively run the Coagulation machines every other day. 2. Review of QC for June 2023 and August 2024 revealed that the QC and Patient samples were not ran on the assigned (by day) Coagulation instrument. 3. Interview on 02/05/2025 at 5:00 pm the Laboratory Manager confirmed that the QC was not ran every 8 hours on the Coagulation instruments. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 staff interview and record review, the Technical Consultant failed to -- 2 of 4 -- complete six-month competencies on 5 out of 5 new hire Testing Persons. Findings include: 1. Interview with TP# M conducted at 11:15 am on 02/04/2025 confirmed the Laboratory does not perform six-month competencies on new hire employees. 2. Record review of personnel competency records revealed no six-month competency records on TP# D, TP# L, TP# N, TP# O, TP# P. a. TP# D (date of hire: 03/23/2023) showed no competency record for 09/2023. b. TP# L (date of hire: 05/10/2022) showed no competency record for 11/2022. c. TP# N (date of hire: 10/07/2022) showed no competency record for 04/2023. d. TP# O (date of hire: 10/25/2022) showed no competency for record for 04/2023. e. TP# P (date of hire: 12/01/2023) showed no competency record for 06/2024. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of personnel competency records and interview, the Technical Consultant failed to complete annual competencies for 5 out of 5 Testing Persons (TP) for 2 out of 2 years (2023-2024) reviewed. Findings include: 1. Record review of Testing Personnel competencies revealed no annual competencies for 5 out of 5, TP# J, TP# H, TP# I, TP# L, TP# N, TP# O, TP# P, blood gas Testing Personnel signed by a qualified technical consultant for two (of two) years 2023-2024. 2. Interview with TP# H at 1:23 pm 02/05/2025 confirmed that all annual competencies must be signed by the qualified Technical Consultant for blood gas personnel. 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 review of personnel records and interview, the Laboratory failed to have 5 out of 16 Testing Persons (TP) documentation of education (See 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical -- 3 of 4 -- Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records and interview, the Laboratory failed to have documentation of education for 3 out of 16 Testing Persons (TP) reviewed. Findings Include: 1. Review of testing personnel education records revealed TP# L, TP# O, TP# P did not have documentation of education. 2. E-mail interview on 02/10/2025 at 10:29 am the Blood Gas Manager confirmed that the 3 Testing Personnel did not have documentation of their education. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 11 /03/2021 for Doctors Memorial Hospital. Doctors Memorial Hospital is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2021, the laboratory did not have successful performance in proficiency testing in the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the 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 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on November 3, 2021 on or about 3:00 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, Oxygen pressure(pO2) for two out of three testing events in 2021. 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of routine chemistry. Findings include: On November 3, 2021 on or about 3:00 PM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, oxygen pressure as shown below. Event #1, 2021 pO2-40% Event #3, 2021 pO2-40% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On November 3, 2021 on or about 3:00 PM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, oxygen pressure, pO2, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of routine chemistry. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on November 3, 2021 on or about 3:00 PM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #1, 2021 pO2-40% Event #3, 2021 pO2-40% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Doctors Memorial Hospital Clinical Laboratory on August 24 -26, 2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to achieve a score of 100 percent for 1 of 3 American Proficiency Institute (API) proficiency testing events of 2019 out of 4 events reviewed from 2019-2020. Findings Included: The record review of the API proficiency testing scores for the third event in 2019 showed a score of 80% for ABO typing. The interview with the Laboratory Manager on 08/26 /20 at 11:00 AM confirmed the proficiency testing event failure and score of 80%. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and interview with the Laboratory Manager, the laboratory failed to score 100% on Compatibility Testing for 3rd event of 2019 out of 4 testing events from 2019-2020 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 -- reviewed. Findings Included: Review of API proficiency testing results for the 3rd testing event in 2019 revealed a score of 80% for Compatibility Testing. Interview on 08/26/20 at 11:00 AM, the Laboratory Manager confirmed the API proficiency testing event failure. 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 review of employee competencies and interview with the Laboratory Manager, the laboratory failed to perform competency evaluations on 1of 1 clinical consultant ( #B ) and 1 of 3 technical supervisors ( # C ) listed on the CMS 209 for 2 of 2 (2019-2020) years reviewed. Findings Included: Review of the employee competencies revealed no competencies performed on the clinical consultant and technical supervisor. During an interview on 08/26/20 at 11:30 AM, the Laboratory Manager confirmed that there were no competencies performed on the clinical consultant and technical supervisor. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 2, 2018. Doctors Memorial Hospital Clinical Laboratory had one deficiency found at the time of the visit. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on record review and interview, the facility failed to verify and enter the hemoglobin and hematocrit results in the Blood Bank sign-out log for four of the patient records reviewed for the year 2018 and nineteen of the year 2017 when blood products were issued for transfusion. Findings included: Review of the Blood Bank sign-out log for the year 2017 through 2018 showed that the facility's policy to enter the hemoglobin and hematocrit results and values on the logbook were missed for 23 of the patient records reviewed. The sign-out log included a line for recent hemoglobin and hematocirt patient test results to be entered upon issuance of blood products. The documents showed missing hemoglobin and hematocrit test results and values on the following dates: 4/25, 5/7, 5/15, 5/27, 6/14, 6/21, 8/15, 8/27, 9/1, 9/22, 10/23, 10/21, 10/24, 11/12, 11/17, 11/29, 12/17, 12/19, 12/24 for 2017 and 4/11, 5/24, 6/11, 9/26 for 2018. During an interview on 10/2/18 at 1:30 PM, testing person # 7 confirmed that the line provided in the Blood Bank sign-out log for hemoglobin and hematocrit values were not documented by the techs. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2097. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on August 13, 2018 on or about 1:00 PM, showed that the laboratory had unsatisfactory testing scores for the analyte, Oxygen concentration (pO2) for two out of three testing events in 2017 and 2018. 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 -- D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the subspecialty of routine chemistry. Findings include: On August 13, 2018 on or about 1:00 PM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, oxygen concentration (pO2), as shown below. Event #3, 2017 pO2-0% Event #2, 2018 pO2-60% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On August 13, 2018, on or about 1:00 PM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, oxygen concentration (pO2), in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2097. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in -- 2 of 3 -- the subspecialty of routine chemistry. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on August 13, 2108, on or about 1:00 PM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2017 pO2-0 % Event #2, 2018 pO2-60%. -- 3 of 3 --