Joseph A George Md Pc

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the State of Michigan Licensing and Regulatory Affairs Department on May 28, 2024. During the survey, it was determined that Immediate Jeopardy (IJ) existed for the following condition-level deficiencies: 493.1250 Condition: Analytic systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor 493.1487 Condition: Laboratories performing high complexity testing; testing personnel D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory failed to establish test procedures for use of the Multi-Drug/Test Dip Card (refer to D5401), failed to establish performance specifications for the use of its Multi-Drug/Test Dip Card (refer to D5423), and failed to perform control procedures at least each date of patient testing for its Multi-Drug/Test Dip Card (refer to D5449). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Clinical Consultant, the laboratory failed to establish test procedures for use of the Multi-Drug/Test Dip Card for 9 (8/28/23 to 5/28/24) of 9 months since the test system was put into use. Findings include: 1. The surveyor requested the laboratory add any waived testing they perform to Form CMS-116. During a review of the waived testing kits, the surveyor noticed a kit box with a sticker stating, "DOA Multi Dip 13 Drug Test (Dip 13 Panel-FYL) Forensic Use Only" on 5/28/24 at 10:06 am. 2. A review of the laboratory's procedures revealed a lack of procedure for the use of the Multi-Drug/Test Dip Cards for toxicology testing. 3. A review of patient test records revealed a total of 34 patient tests were performed between 8/28/23 and 5/28/24. 4. An interview on 5/28/24 at 11: 30 am with the Clinical Consultant confirmed the laboratory had not established a test procedure for patient testing using the Multi-Drug/Test Dip Card toxicology panel. ***This is a repeated deficiency from the 9/10/20 initial survey.*** D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant, the laboratory failed to establish performance specifications for the use of its Multi- Drug/Test Dip Card prior to testing patients for 9 (8/28/23 to 5/28/24) of 9 months since the Multi-Drug/Test Dip Card test system was put into use. Findings include: 1. The surveyor requested the laboratory add any waived testing they perform to Form CMS-116. During a review of the waived testing kits, the surveyor noticed a kit box with a sticker stating, "DOA Multi Dip 13 Drug Test (Dip 13 Panel-FYL) Forensic Use Only" on 5/28/24 at 10:06 am. 2. A review of the manufacturer's package insert revealed the Multi-Drug/Test Dip Card toxicology panel was to be used for forensic use only and had not been approved by the Federal Drug Administration (FDA). 3. The surveyor requested the laboratory's establishment of performance specifications for the use of the Multi-Drug/Test Dip Card toxicology panel on 5/28/24 at 10:52 am and it was not made available. 4. A review of patient test records revealed a total of 34 patient tests were performed between 8/28/23 and 5/28/24. 5. An interview on 5/28/24 at 10:52 am with the Technical Consultant confirmed the laboratory had performed patient testing using the Multi-Drug/Test Dip Card toxicology panel and had not established performance specifications. -- 2 of 15 -- D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant, the laboratory failed to perform control procedures at least each date of patient testing for its qualitative Multi-Drug/Test Dip Card for 9 (8/28/23 to 5/28/24) of 9 months since the test system was put into use. Findings include: 1. The surveyor requested the laboratory add any waived testing they perform to Form CMS-116. During a review of the waived testing kits, the surveyor noticed a kit box with a sticker stating, "DOA Multi Dip 13 Drug Test (Dip 13 Panel-FYL) Forensic Use Only" on 5/28/24 at 10:06 am. 2. The surveyor requested quality control documentation for the Multi-Drug/Test Dip Card toxicology panel on 5/28/24 at 10:51 am. 3. An interview on 5/28/24 at 10: 51 am with the Technical Consultant confirmed the laboratory had not performed control procedures with the Multi-Drug/Test Dip Card toxicology panel since the kit was put into use. 4. A review of patient test records revealed a total of 34 patient tests were performed between 8/28/23 and 5/28/24 on a total of 27 patient testing dates without control procedures performed. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to include the reference intervals for urine creatinine testing for 12 (Patients 1- 12) of 12 patient test reports reviewed. Findings include: 1. A review of 12 patient test reports revealed a lack of reference intervals for urine creatinine results reported. 2. An interview on 5/28/24 at 12:59 pm with the Technical Consultant revealed the range for urine creatinine was >20 mg/dL and that it was not listed on the test reports for interpretation. 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 observation, record review, and interviews, the Laboratory Director was -- 3 of 15 -- not qualified to direct high complexity testing (refer to D6078), failed to ensure performance specifications were established for the use of its Multi-Drug/Test Dip Card prior to testing patients (refer to D6085), failed to ensure control procedures were performed at least each date of patient testing for its Multi-Drug/Test Dip Card (refer to D6093), failed to ensure the Technical Supervisor was qualified to supervise high complexity toxicology testing (refer to D6102 A), failed to ensure staff performing high complexity toxicology testing were qualified (refer to D6102 B), and failed to ensure test procedures for use of the Multi-Drug/Test Dip Card were established (refer to D6106). D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant, the Laboratory Director was not qualified to direct high complexity testing for 9 (8/28 /23 to 5/28/24) of 9 months since the Multi-Drug/Test Dip Card test system was put into use. Findings include: 1. The surveyor requested the laboratory add any waived testing they perform to Form CMS-116. During a review of the waived testing kits, the surveyor noticed a kit box with a sticker stating, "DOA Multi Dip 13 Drug Test -- 4 of 15 -- (Dip 13 Panel-FYL) Forensic Use Only" on 5/28/24 at 10:06 am. 2. A review of the manufacturer's package insert revealed it the Multi-Drug/Test Dip Card was to be used for forensic use only and was not approved by the Federal Drug Administration (FDA). This test system defaulted to high complexity testing. 3. A review of patient test records revealed a total of 34 patient tests were performed between 8/28/23 and 5 /28/24. 4. An interview on 5/28/24 at 1:35 pm with the Technical Consultant revealed the Laboratory Director was not qualified to direct high complexity testing. D6085 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3) The laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the Laboratory Director failed to ensure performance specifications were established for the use of its Multi-Drug/Test Dip Card prior to testing patients. Refer to D5423. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the Laboratory Director failed to ensure control procedures were performed at least each date of patient testing for its Multi-Drug/Test Dip Card. Refer to D5449. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: A. Based on observation, record review, and interview, the Laboratory Director failed to ensure the Technical Supervisor was qualified to supervise high complexity toxicology testing. Refer to D6111. B. Based on observation, record review, and interview, the Laboratory Director failed to ensure staff performing high complexity toxicology testing were qualified. Refer to D6171. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) -- 5 of 15 -- The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the Laboratory Director failed to ensure test procedures for use of the Multi-Drug/Test Dip Card were established. Refer to D5401. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: . Based on observation, record review, and interviews, the Technical Supervisor was not qualified to supervise high complexity toxicology testing (refer to D6111), failed to select an appropriate toxicology test methodology suitable for clinical use (refer to D6114), and failed to establish control procedures for its Multi-Drug/Test Dip Card toxicology testing (refer to D6117). D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) 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; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the -- 6 of 15 -- subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) 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; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months -- 7 of 15 -- experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) 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; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) 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; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months -- 8 of 15 -- experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) 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; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) 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; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements -- 9 of 15 -- of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) 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; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess -- 10 of 15 -- qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) 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; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of -- 11 of 15 -- histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) 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; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) 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; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) 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; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Consultant, the Technical Supervisor was not qualified to supervise high complexity toxicology testing for 9 (8/28/23 to 5/28/24) of 9 months since the Multi-Drug/Test Dip Card test system was put into use. Findings include: 1. The surveyor requested the laboratory add any waived testing they perform to Form CMS-116. During a review of the waived testing kits, the surveyor noticed a kit box with a sticker stating, "DOA Multi -- 12 of 15 -- Dip 13 Drug Test (Dip 13 Panel-FYL) Forensic Use Only" on 5/28/24 at 10:06 am. 2. A review of the manufacturer's package insert revealed the Multi-Drug/Test Dip Card toxicolocy panel was to be used for forensic use only and was not approved by the Federal Drug Administration (FDA). This test system defaulted to high complexity testing. 3. A review of patient test records revealed a total of 34 patient tests were performed between 8/28/23 and 5/28/24. 4. An interview on 5/28/24 at 1:35 pm with the Technical Consultant revealed the Technical Supervisor was not qualified to direct high complexity testing and lacked experience or training or both in high complexity toxicology testing. D6114 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(1) The technical supervisor is responsible for selection of the test methodology that is appropriate for the clinical use of the test results. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Clinical Consultant, the Technical Supervisor failed to select an appropriate toxicology test methodology suitable for clinical use for 9 (8/28/23 to 5/28/24) of 9 months since the test system was put into use. Findings include: 1. The surveyor requested the laboratory add any waived testing they perform to Form CMS-116. During a review of the waived testing kits, the surveyor noticed a kit box with a sticker stating, "DOA Multi Dip 13 Drug Test (Dip 13 Panel-FYL) Forensic Use Only" on 5/28/24 at 10:06 am. 2. A review of the manufacturer's package insert revealed the Multi-Drug/Test Dip Card toxicology panel was to be used for forensic use only and was not approved by the Federal Drug Administration (FDA). 3. A review of patient test records revealed a total of 34 patient tests were performed between 8/28/23 and 5/28/24. 4. An interview on 5/28/24 at 11:30 am with the Clinical Consultant revealed the laboratory had been using the test system for about six weeks to determine patient eligibility for prescribing the medication vivitrol. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the Technical Supervisor failed to establish control procedures for its Multi-Drug/Test Dip Card toxicology testing. Refer to D5449. 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. -- 13 of 15 -- 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on observation, record review and interview, the laboratory failed to ensure staff performing high complexity toxicology testing were qualified. 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 lab

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to meet the requirements for the specialty Toxicology as specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to follow written policies to ensure patient specimens did not exceed specimen stability. Refer to D5203 A. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with the Technical Consultant, the laboratory failed to follow written policies to ensure patient specimens did not exceed specimen stability for 7 (Patients 3-9) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's "Siemens Buprenorphine Assay" manufacturer instructions revealed a section titled "Specimen Collection and Preparation" stating, "If not analyzed immediately, specimens may be stored 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 -- refrigerated or unrefrigerated for up to 5 days. After 5 days specimens should be frozen at -20 degrees C." 2. A review of the laboratory's "Siemens Oxycodone Assay" manufacturer instructions revealed a section titled "Specimen Collection and Preparation" stating, "If not analyzed immediately, specimens may be stored refrigerated or unrefrigerated for up to 7 days. After 7 days specimens should be stored at -20 degrees C." 3. A review of 10 patient test reports revealed the following patients had qualitative urine drug testing, including Buprenorphine and Oxycodone, after their specimens had gone beyond the manufacturer's specified stability: a. Patient #3 had a specimen collected on 2/8/22 and was tested on 2/14/22. b. Patient #4 had a specimen collected on 4/14/22 and had not been tested yet. c. Patient #5 had a specimen collected on 3/25/21 and was tested on 4/5/21. d. Patient #6 had a specimen collected on 11/25/20 and was tested on 12/8/20. e. Patient #7 had a specimen collected on 9/30/20 and was tested on 10/8/20. f. Patient #8 had a specimen collected on 7/23/20 and was tested on 8/3/20. g. Patient #9 had a specimen collected on 4/28 /20 and was tested on 5/4/20. 4. An interview on 4/20/22 at 10:15 am with the Technical Consultant confirmed the laboratory stores its specimens refrigerated and the specimens had been tested beyond their manufacturer-specified stability. ***This is a repeated deficiency from the 9/10/20 initial survey*** D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to use criteria verified or established by the laboratory to assess calibration verification acceptability for 2 (5/5/21 and 12/22/21) of 2 calibration verification testing events performed. Findings include: 1. A review of the laboratory's calibration verification records revealed a lack of acceptance criteria used to determine whether the calibration verification testing had passed or failed for the testing events on 5/5/21 and 12/22/21 for its urine creatinine testing. 2. A review of the laboratory's "Calibration Verification" policy revealed the laboratory did not establish criteria for calibration verification acceptability. 3. An interview on 4/20/22 at 11:18 am with the -- 2 of 3 -- Technical Consultant confirmed the laboratory had not verified or established criteria to assess calibration verification acceptability. ***This is a repeated deficiency from the 9/10/20 initial survey*** -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to enroll in a proficiency testing program for urine creatinine testing for 9 (January 2020 to September 2020) of 9 months. Findings include: 1. An interview on 9 /10/20 at 8:56 am with the Laboratory Director revealed the laboratory started patient testing on 1/9/20. 2. A record review of the laboratory's established "Proficiency Testing" policy revealed a section stating, "The lab will enroll and participate in Proficiency Testing on an annual basis. Enrollment should occur by December of the preceding year. All regulated analytes must be enrolled in proficiency testing." 3. A review of the "Michigan Department of Licensing & Regulatory Affairs CLIA Annual Test Menu" form provided by the laboratory revealed the laboratory had not enrolled in proficiency testing for urine creatinine testing. 4. A record review of the laboratory's documents revealed a lack of proficiency testing records for urine creatinine testing. 5. The surveyor requested proficiency testing records for 2020 on 9 /10/20 at 9:41 am and the records were not made available. 6. An interview on 9/10 /20 at 9:41 am with the Laboratory Director confirmed the laboratory was not enrolled in a proficiency testing program for urine creatinine testing for 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 5 -- D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory failed to ensure positive identification and optimum integrity of patient's specimens for toxicology testing from the time of collection through the completion of reporting results for 22 of 22 patient aliquots observed by the surveyor. Findings include: 1. An observation by the surveyor on 9/10/20 at 9:05 am revealed a test tube rack of 22 uncapped, uncovered specimen aliquots in which 12 aliquots had a first name written on the tube and 10 aliquots were blank. 2. An interview with Testing Personnel #1 on 9/10/20 at 9: 05 am revealed the specimens had been aliquoted earlier in the morning and had been in the refrigerator uncapped, uncovered, and unlabeled for approximately 2 hours. 3. A review of the laboratory's established "Internal Quality Control" procedure revealed a section titled "Specimens" which states, "Use only the specimen described in the individual test instructions. Be sure that the specimen has been properly collected, stored, and labeled with patient's first and last name as well as the date of collection." 4. An interview with the Laboratory Director on 9/10/20 at 9:05 am confirmed the urine specimen aliquots in the refrigerator were uncapped, uncovered, and not labeled according to the laboratory's procedure. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to ensure test requisitions for urine toxicology testing contained the patient's date of birth and the tests to be performed for 9 (Patients 1-9) of 9 patient testing records audited. Findings include: 1. A review of patient testing records revealed test requisitions for urine toxicology testing did not include the patients' date of birth and the tests to be performed for the following patients with results reported: a. Patient 1 performed on 2/12/20 b. Patient 2 performed on 3/11/20 c. Patient 3 performed on 4/29 -- 2 of 5 -- /20 d. Patient 4 performed on 5/28/20 e. Patient 5 performed on 6/9/20 f. Patient 6 performed on 7/1/20 g. Patient 7 performed on 7/7/20 h. Patient 8 performed on 8/3 /20 i. Patient 9 performed on 9/2/20 2. An interview on 9/10/20 at 11:03 am with the Laboratory Director confirmed the test requisitions did not contain patients' date of birth or the tests to be performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to have written procedures for each assay performed for 9 (January 2020 to September 2020) of 9 months since the laboratory has started testing patients. Findings include: 1. An interview on 9/10/20 at 8:56 am with the Laboratory Director revealed the laboratory started patient testing on 1/9/20. 2. A review of the laboratory's established procedure manual revealed a lack of procedures to perform the following tests listed on the "Michigan Department of Licensing & Regulatory Affairs CLIA Annual Test Menu" form provided by the laboratory: a. 6- Acetylmorphine b. Amphetamines c. Benzodiazepine d. Buprenorphine e. Cocaine f. Creatinine g. Methadone h. Oxycodone i. Opiates 3. The surveyor requested the approved procedures to perform the assays listed above on 9/10/20 at 10:15 am and they were not made available. 4. An interview on 9/10/20 at 11:03 am with the Laboratory Director confirmed the laboratory did not have procedures established for performing the tests listed above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 3 of 5 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to perform urine creatinine calibration verification at least every 6 months for 1 (July 2020) of 2 calibration verification events required. Findings include: 1. A record review of the laboratory's verification of urine creatinine testing revealed calibration verification was performed on 1/8/20. 2. On 9/10/20 at 10:13 am the surveyor requested the urine creatinine calibration verification documentation and the calibration verification procedures, and they were not made available. 3. An interview on 9/10/20 at 10:13 am with the Laboratory Director confirmed urine creatinine calibration verification procedures were not performed every 6 months. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . A. Based on record review and interview with the Laboratory Director, the laboratory failed to issue corrected reports for 45 patients receiving urine toxicology testing when Oxycodone quality control was out of range. Findings include: 1. A review of quality control records revealed Oxycodone quality control testing did not pass on 2/12/20. 2. A review of the laboratory's