Hillcrest Hospital/Henryetta

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/17,18,19,20/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer, technical consultant, and laboratory manager during an exit conference performed at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the technical consultant, the laboratory director failed to assess the competency of the general supervisor based on the position responsibilities as listed in subpart M. Findings include: (1) A review of the laboratory policy and procedure manual titled competency assessment delegation statesd "The performance of the duties of the general supervisors will be assessed annually by either the laboratory director or technical consultant and reviewed and approved by the laboratory medical director. The assessment is documented with a checklist and reviewed and signed by the technical consultant and laboratory medical director." (2) A review of the Form CMS- 209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of October 2021 through the current date identified competencies, based on job responsibilities, had not been performed for general supervisor #1 listed on the CMS-209; (3) The findings were reviewed with the technical consultant who stated on 10/18/2023 at 01:23 pm that competencies were not performed for general supervisor #1 during the review period of October 2021 to the current date. 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 -- 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 a review of records, policies and procedures, and interview with technical consultant #1 the laboratory failed to follow their written policy for documentation on the transfusion service record for 14 of 14 days of patient testing during the review period of May 12, 2023 through the current date. Findings include: THERAPEUTIC PHLEBOTOMY (1) On 10/18/2023 at 10:00 am, general supervisor #2 stated the laboratory performed therapeutic phlebotomies according to laboratory policy; (2) On 10/18/2023 a review of the policy titled, "Therapeutic Phlebotomy"" required the laboratory document on the bloodbank worksheet the following; (i) Patient Name (ii) Date and Time (iii) Approximate amount of blood removed (iv) Phlebotomist initials (v) On blood bank worksheet only, document "unit incinerated" (3) A review of therapeutic phlebotomies identified the laboratory had not followed their policy for completing the worksheet for 6 of 11 patients as follows: (a) 10/17/2023, 09/25/2023, 08/23/2023 and 05/12/2023 - The time and initials had not been documented on the worksheet. (b) 07/27/2023 and 06/05/2023 - The time and "unit incinerated" had not been documented on the worksheet. (4) The records were reviewed with general supervisor #2 who stated on 10/18/2023 at 10:00 am, the laboratory had not followed their policy for documenting therapeutic phlebotomies on the worksheet. BLOOD BANK (1) A review of blood bank policies and procedures on 10/18/2023, identified a policy titled, "Blood Bank - Daily Record Keeping Procedures" which stated the following: (a) "Record all work done on the blood bank worksheet. 1. Include: Name, date, ID#, and physician for each unit being crossmatched. 2. Record ABO, Rh and antibody screen results on first line. 3. Include donor type for each unit crossmatched. 4. Record patient blood bank armband number using a blood bank sticker. 5. Mark each unit as compatible or incompatible and record tech initials and component for every unit and document ID# of unit(s). 6. Mark incompatibilities in red on worksheet". (2) A review of the transfusion worksheet for patients tested from 05/12 /2023 through the current date identified the following; (i) 07/28/2023, 07/25/2023, 07 /24/2023, 07/20/2023, 06/29/2023 and 05/25/2023 - No tech initials was documented on the transfusion worksheet. (ii) 08/10/2023 - the crossmatch interpretation was not documented for three of three units. (iii) 10/17/2023 - Antibody screen interpretation was not documented. (3) The findings were reviewed with general supervisor #2 who stated on 10/18/2023 at 10:00 am, the worksheet had not been documented as required. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in -- 2 of 3 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory manager, the laboratory failed to ensure materials were stored as required during the review period of January 2023 through the current date. Findings include: (1) On 10/20/2023 at 11:15 am, observation of the contents of the CTFI Blood Bank freezer identified the following materials: (a) One box of reconstituted Access PCT (Procalcitonin) Calibrators, lot #338315 (b) Ten bottles of Bio-Rad Cardiac Markers Plus control materials level one, lot #87851 (c) 11 bottles of Bio-Rad Cardiac Markers Plus control materials level two, lot #87852 (d) 11 bottles of Bio-Rad Cardiac Markers Plus control materials level three, lot #87853 (2) A review of the storage requirements for the above materials identified the following: (a) Access PCT Calibrator package insert stated, "Use reconstituted calibrators within 4 hours when stored at 20-25 degrees C. Otherwise, freeze at -30 to -15 degrees C for up to 90 days"; (b) The storage requirement, as stated on the bottles, for the Bio-Rad Cardiac Markers control materials were -70 to -20 degrees C (Centigrade). (3) A review of temperature records from January 2023 through the current date identified that, although temperatures had been documented each day, the log did not define the acceptable limits for storage of the materials (for the above materials, the acceptable limits should be -30 to -20 degrees C); (4) The records were reviewed with the laboratory manager who stated on 10/202/2023 at 12:40 pm, the laboratory had not defined the acceptable storage temperatures to ensure the materials were stored as required by the manufacturer. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/20,21/2021. The laboratory was found out of compliance with the following CLIA regulations: 493.801; D2000: Enrollment and Testing of Samples 493.1447; D6108: Technical Supervisor The findings were reviewed with the laboratory manager and technical consultant at the conclusion of the survey. 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 a review of records and interview with the technical consultant, the laboratory failed to enroll in a proficiency testing program for qualitative serum pregnancy testing. Findings include: (1) On 10/20/2021 surveyor #1 reviewed proficiency testing records for 2020 (first, second and third events), 2021 (first, and second events). There was no evidence the laboratory was enrolled in proficiency testing for serum qualitative pregnancy testing for 5 of 5 events; (2) Surveyor #1 reviewed the records with the technical consultant who stated on 10/20/2021 at 11:40 am the laboratory was not enrolled in proficiency testing for serum qualitative pregnancy. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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 a review of records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to follow manufacturer's instructions to ensure the optimum integrity of patient specimens from the time of collection through the reporting of results for 1 of 4 patient specimens. Findings include: (1) On 10/20/2021 at 10:25 am, the laboratory manager stated to surveyor #2 the laboratory performed pH, pCO2, and pO2 testing on the EPOC analyzer; (2) On 10/21/2021 surveyor #2 reviewed the manufacturer's instructions under the section titled, "Sample Collection Details" which stated for Lactate testing "Test in less than 5 min to avoid effects of glycolysis"; (3) Surveyor #2 reviewed 4 patient reports tested on 10/20/2020,11/12/2020,12/21/2020, and 01/04/2021, identified the following for 1 of 4 patient reports: (a) Specimen was collected on 01/04 /2021 at 07:46 pm and resulted in the laboratory on 01/04/2021 at 08:24 pm (38 minutes later). (4) Surveyor #2 reviewed the reports with the laboratory manager and technical consultant. The laboratory manager stated on 10/21/2021 at 02:40 pm the patient specimen was tested beyond the manufacturer's instructions as indicated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to demonstrate the reportable ranges for 1 of 1 new test method. Findings include: (1) On 10/20/2021 at 10:20 am, the laboratory manager stated the following to surveyor #1: (a) The laboratory began performing pH, pCO2, and pO2 testing using the EPOC analyzer on 05/07/2020; (2) On 10/20/2021, surveyor #1 reviewed the performance specification records for the new test systems and could not locate documentation to prove the laboratory had demonstrated the reportable ranges; (3) On 10/21/2021, surveyor #2 reviewed the findings with the laboratory manager and the technical consultant. The laboratory manager stated on 10 /21/2021 at 02:45 pm, the laboratory did not demonstrate the reportable ranges as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) -- 2 of 12 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and technical consultant, the laboratory failed to follow the manufacturer's instructions for performing weekly maintenance procedures for the hematology analyzer. Findings include: (1) On 10/20/2021 at 09:50 am, the laboratory manager stated to surveyor #2 CBC (Complete Blood Count) testing was performed on the Sysmex XS 1000i analyzer; (2) Surveyor #1 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log. The weekly requirements were as follows: (a) Power Down IPU (3) Surveyor #1 then reviewed maintenance records from January 2020 through September 2021. The weekly maintenance had not been documented as performed between: (a) 03/14/2021 and 03/27/2021 (b) 05/02/2021 and 05/16/2021 (4) Surveyor #1 reviewed the findings with the laboratory manager and technical consultant. Both stated on 10/20/2021 at 04: 00 pm the weekly maintenance had not been documented as performed as identified above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for TSH testing for 2 of 3 lot numbers. Findings include: (1) On 10/21/2021 at 09:40 am, the laboratory manager stated the following to surveyor #1: (a) TSH (Thyroid Stimulating Hormone) testing was performed on the Beckman Coulter Access 2 analyzer; (b) Three levels of Bio- Rad Liquichek Immunoassay Plus QC (quality control) materials (level 1, level 2, and level 3) were performed each day of patient testing; (c) Established ranges were used for determining acceptability of QC results. (2) Surveyor #1 reviewed QC records which included documentation of establishing QC ranges, Levey-Jennings graphs, and cumulative data for level 1 lot #85221, level 2 lot #85222, and level 3 lot #85223 used during the review period of October 2020 through September 2021. The documentation showed the ranges that had been utilized by the laboratory to determine acceptability of QC results for level 2 and level 3 were wider than the established QC ranges as follows: (a) Level 2 - The laboratory had established a 2 -- 3 of 12 -- standard deviation (SD) range of 5.17-6.12 uIU/ml, but a range of 4.43-6.56 uIU/ml had been used; (b) Level 3 - The laboratory had established a 2 SD range of 26.45- 31.70 uIU/ml, but a range of 23.3-34.6 uIU/ml had been used. (3) Surveyor #1 reviewed the records with the laboratory manager and technical consultant. Both stated on 10/21/2021 at 11:50 am, ranges wider than the laboratory established 2 SD ranges, as shown above, had been used to evaluate QC results. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to perform one sample of control material each 8 hours of patient testing using a combination of control materials that include both low and high values on each day of blood gas testing for 22 of 34 patients tested. Findings include: (1) On 10/20/2021 at 10:35 am, the laboratory manager stated the following to surveyor #2: (a) Blood Gas (pH, pCO2, pO2) testing was performed using the EPOC analyzer; (b) Two levels of quality control (QC) testing were to be performed each 8 hours of patient testing. (2) On 10/20/2021, surveyor #2 reviewed QC and patient testing records between 09/01/2020 through 09/06/2020 and 01/02/2021 through 01/05/2021. The review showed that two levels of QC testing had not been performed each eight hours of patient testing or on the day of patient testing for 22 of 34 patients tested as follows: (a) 09/01/2020- Two levels of QC had been performed on 09/01/2020 at 01:03 am (the next QC due at 09:03 am). The following patient testing had been performed with no additional QC: (i) Patient testing at 09:53 am (ii) Patient testing at 06:00 pm (iii) Patient testing at 11:33 pm (iv) Patient testing at 09:09 pm (b) 09/02/2020 - Two levels of QC had been performed on 09/02/2020 at 04:16 am (the next QC due at 12:16 pm). The following patient testing had been performed with no additional QC: (i) Patient testing at 12:50 pm (c) 09/05/2020 - Two levels of QC had been performed on 09/05/2020 at 00:48 am (the next QC due at 08:48 am). The following patient testing had been performed with no additional QC: (i) Patient testing at 02:23 pm (ii) Patient testing at 04:15 pm (iii) Patient testing at 05:42 pm (iv) Patient testing at 06:05 pm (v) Patient testing at 07:31 pm (d) 09/06/2020 - Two levels of QC had not been performed. The following patient testing had been performed: (i) Patient testing at 07:43 am (ii) Patient testing at 10:22 am (e) 01/02/2021 - Two levels of QC had not been performed. The following patient testing had been performed: (i) Patient testing at 01:27 pm (ii) Patient testing at 01:38 pm (iii) Patient testing at 06:21 pm (f) 01/03/2021 - Two levels of QC had been performed on 01/03/2021 at 04:25 am (the next QC due at 12:25 pm). The following patient testing had been performed with no additional QC: (i) Patient testing at 08:37 pm (g) 01/04/2021 - Two levels of QC had been performed on 01/04/2021 at 04:28 am (the next QC due at 12:28 pm). The following patient testing had been performed with no additional QC: (i) Patient testing at 06:54 pm (ii) Patient testing at 08:17 pm (iii) Patient testing at 08:53 pm (iv) Patient testing at 11:44 pm (h) 01/05/2021 - Two levels of QC had been performed on 01/05 /2021 at 12:04 am (the next QC due at 08:04 am). The following patient testing had been performed with no additional QC: (i) Patient testing at 10:46 am (ii) Patient testing at 10:39 am (3) On 10/21/2021, surveyor #2 reviewed the records with the -- 4 of 12 -- laboratory manager and technical consultant. The laboratory manager stated on 10/21 /2021 at 02:35 pm two levels of QC materials had not been performed each 8 hours of patient testing as indicated above. 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 a review of records and interview with laboratory manager and technical consultant, the technical supervisor failed to provide technical supervision in accordance with 493.1447 of this subpart. Findings include: (1) The technical supervisor failed to ensure the individual who performed the duties and responsibilities of the technical supervisor met the educational qualifications. Refer to D6111. 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 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 -- 5 of 12 -- 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 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 -- 6 of 12 -- 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 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 -- 7 of 12 -- 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 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 -- 8 of 12 -- 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 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 -- 9 of 12 -- 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 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 -- 10 of 12 -- 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 a review of records and interview with the laboratory manager and technical consultant, the technical supervisor failed to ensure that individuals who performed the duties and responsibilities of the technical supervisor met the qualifications for 1 of 1 of semiannual competency assessments. Findings include: (1) On 10/20/2021, surveyor #1 reviewed records for 1 testing person who had been hired to perform high complexity testing (ABO/Rh, Antibody Screen and Compatibility testing) since the previous recertification survey performed . The records indicated the semi-annual evaluation for the testing person had been performed by an individual who did not meet the regulatory qualification requirements of the technical supervisor: (a) Testing Person #6 - The 10/19/2020 semi-annual evaluation had been performed by the -- 11 of 12 -- laboratory manager (this person had earned an associate degree in applied science). (2) Surveyor #2 explained to the laboratory manager that all components of the semi- annual competency evaluations must be performed by a person who qualifies as a technical supervisor (493.1449 (q) an individual with an MD or DO with a current medical license in state of laboratory's location and certified in anatomic pathology by ABP or AOBP or equivalent qualifications or resident in a program leading to ABP or AOBP certification in anatomic and clinical pathology who performs duties delegated by the technical supervisor for histopathology). On 11/09/2010 at 04:07 pm, the laboratory manager stated to surveyor #2 the semi-annual evaluation had not been performed by someone who met the qualifications of a technical supervisor as indicated above. NOTE: The regulations only allow for an individual qualifying as a general supervisor to perform initial training and annual competency evaluations as stated at 493.1463 "Standard; General supervisor responsibilities: (b)(3) Providing orientation to all testing personnel; and (b)(4) Annually evaluating and documenting the performance of all testing personnel" -- 12 of 12 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 08/27/19-08/30/19. The laboratory was found out of compliance with the following CLIA regulations: 493.1215: D5024: Condition: Hematology 493.1217: D5026: Condition: Immunohematology 493.1403: D6000: Condition: Laboratory Director, Moderate Complexity 493.1409: D6033: Condition: Technical Consultant, Moderate Complexity 493.1441: D6076: Condition: Laboratory Director, High Complexity The findings were reviewed with the laboratory supervisor and testing person #1. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor and testing person #1, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299 for the specialty of Hematology. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for establishing pediatric normal reference intervals for coagulation and hematology. Refer to D5411; (2) The laboratory failed to perform maintenance procedures as required by the manufacturer. Refer to D5429. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor and testing person #1, the laboratory failed to meet the requirements of 493.1230 through 493.1256, 493.1271, and 493.1281 through 493.1299 for the specialty of Immunohematology. Findings include: (1) The laboratory failed to ensure expired Blood Bank testing materials were not used. Refer to D5417. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed the 2018 and 2019 proficiency testing records and identified in the Second Chemistry Core Event of 2019, the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program): (a) Creatinine: 4 of 5 results exhibitied a Positive bias (i) CH-06: SDI 3.2 (ii) CH-07: SDI 2.3 (iii) CH-08: SDI 2.2 (iv) CH-10: SDI 2.0 (2) There was no documentation found in the records the laboratory identified and evaluated the biases to determine if a systematic failure had occurred which required the laboratory to take