Harbor Beach Community Hospital

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on a lack of documentation and interview with the General Supervisor (GS), the laboratory failed to verify the accuracy for the chemistry urine creatinine testing at least twice annually for 19 (February 2022 to September 2023) of 19 months of testing. Findings include: 1. A review of the laboratory's records revealed a lack of verification of accuracy for 19 months for the chemistry urine creatinine testing. 2. An interview on 10/02/2023 at 9:48 am, the GS confirmed the laboratory had not performed verification of accuracy for the chemistry urine creatinine testing. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to perform and document control procedures for its Wright Stain used in peripheral blood smears for 2 (October 2021 to October 20230 of 2 years reviewed. Findings include: 1. A review of the laboratory's "Manual Differential" procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- revealed a section stating, "Before evaluating the leukocytes on the stained blood smear, the tech shall first determine that the blood smear is well made, the distribution of the cells is uniform, and the staining of the cells is satisfactory." 2. The surveyor requested documentation of documentation of the control procedures performed for wright stain quality each date of testing on 10/2/23 at 12:04 pm and it was not made available 3. An interview on 10/2/23 at 12:06 pm with the General Supervisor confirmed the laboratory had not documented its control procedures performed for wright stain quality each date of testing. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on a lack of documentation and interview with the General Supervisor (GS), the laboratory failed to verify the 6-month competency assessments for the Xpert Express Cepheid testing for 7 (February to September 2023) of 7 months of testing. Findings include: 1. A review revealed the Xpert Express Cepheid testing was put into use in February 2023. 2. A review of the competency assessments for 4 testing personnel revealed a lack of documentation for the 6-month competency assessment for the following Cepheid tests: a. CoV-2 b. Influenza A (Flu A) c. Influenza B (Flu B) c. Respiratory Syncytial Virus (RSV) 3. A review of the "Competency of Testing Personnel" policy states under "Purpose of Policy: As a resource so the lab testing personnel know that they will be monitored for competency upon being introduced to a new system, at six months, and annually." 4. An interview on 10/02/2023 at 12:31 pm, the GS confirmed the 6-month competency assessment was never performed and documented. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 95 patients tested since the laboratory started testing for SARS-CoV-2 antibodies in March 2020. Findings include: 1. The surveyor requested documentation showing the laboratory was sending all SARS-CoV-2 results to the health department and documentation for patients tested using the Beckman Coulter COVIGG SARS-CoV-2 antibody assay on the Access 2 analyzer were not available on 2/1/22 at 1:22 pm. 2. An interview on 2/1/22 at 1:33 pm with the TP2 revealed the laboratory started testing in October 2021 and had not been reporting results from the Beckman Coulter COVIGG SARS-CoV-2 antibody assay to the health department. 3. A review of the laboratory's test records revealed 95 patients had been tested using the SARS-CoV-2 antibody assay and had not been reported to the health department. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to have a policy to ensure the use of fresh recipient serum or plasma samples less than 3 days old for all pretransfusion testing if the recipient has been pregnant or transfused within the previous 3 months or the patient's history is not available for 2 (February 2020 to February 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's policies and procedures revealed a lack of requirements for the age of specimens used in pretransfusion testing for recipients that have been pregnant or transfused within the previous 3 months or the patient's history. 2. An interview on 2/1/22 at 1:02 pm with the GS revealed the laboratory does not have a policy regarding the age of specimens used in pretransfusion testing. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to perform and document visual inspections of blood units immediately before issue for 2 (February 2020 to February 2022) of 2 years. Findings include: 1. A review of the laboratory's "Issue of products from the Blood Bank" policy revealed a lack of visual inspection of blood units immediately before issue. 2. A review of the laboratory's records revealed a lack of documentation showing visual inspections of blood units issued between February 2020 and February 2022 immediately before issue. 3. An interview on 2/1/22 at 12:47 am with the GS confirmed the laboratory did not perform and document visual inspections of blood units immediately before issue. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 2 of 4 -- This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure Testing Personnel #2 performing the duties of a Technical Consultant, met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure the personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant 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)(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 (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant 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, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure personnel performing the TC duty of performing personnel competency assessments was qualified for 1 (Testing Personnel (TP) #5) of 5 personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel competency records revealed TP #2 had performed competency assessments for TP #5 as follows: a. 110/20/2021 - competency for the Beckman Coulter Access 2, Au480 and the DxH520 b. 11/01/2021 - competency for the ABL80 Flex blood gas analyzer 2. A review of the qualifications for TP #2 revealed they did -- 3 of 4 -- not meet the qualification requirements to perform Technical Consultant responsibilities. 3. An interview on 2/01/2022 at 1:41 pm and document review on 02 /02/2022 at 1:25 pm, confirmed TP #2 did not meet the qualification requirements to be a Technical Consultant. -- 4 of 4 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to report all SARS-CoV-2 test results every day of patient testing for 95 patients tested since the laboratory started testing for SARS-CoV-2 antibodies in March 2020. Findings include: 1. The surveyor requested documentation showing the laboratory was sending all SARS-CoV-2 results to the health department and documentation for patients tested using the Beckman Coulter COVIGG SARS-CoV-2 antibody assay on the Access 2 analyzer were not available on 2/1/22 at 1:22 pm. 2. An interview on 2/1/22 at 1:33 pm with the TP2 revealed the laboratory started testing in October 2021 and had not been reporting results from the Beckman Coulter COVIGG SARS-CoV-2 antibody assay to the health department. 3. A review of the laboratory's test records revealed 95 patients had been tested using the SARS-CoV-2 antibody assay and had not been reported to the health department. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to have a policy to ensure the use of fresh recipient serum or plasma samples less than 3 days old for all pretransfusion testing if the recipient has been pregnant or transfused within the previous 3 months or the patient's history is not available for 2 (February 2020 to February 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's policies and procedures revealed a lack of requirements for the age of specimens used in pretransfusion testing for recipients that have been pregnant or transfused within the previous 3 months or the patient's history. 2. An interview on 2/1/22 at 1:02 pm with the GS revealed the laboratory does not have a policy regarding the age of specimens used in pretransfusion testing. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to perform and document visual inspections of blood units immediately before issue for 2 (February 2020 to February 2022) of 2 years. Findings include: 1. A review of the laboratory's "Issue of products from the Blood Bank" policy revealed a lack of visual inspection of blood units immediately before issue. 2. A review of the laboratory's records revealed a lack of documentation showing visual inspections of blood units issued between February 2020 and February 2022 immediately before issue. 3. An interview on 2/1/22 at 12:47 am with the GS confirmed the laboratory did not perform and document visual inspections of blood units immediately before issue. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 2 of 4 -- This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure Testing Personnel #2 performing the duties of a Technical Consultant, met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure the personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant 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)(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 (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant 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, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure personnel performing the TC duty of performing personnel competency assessments was qualified for 1 (Testing Personnel (TP) #5) of 5 personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel competency records revealed TP #2 had performed competency assessments for TP #5 as follows: a. 110/20/2021 - competency for the Beckman Coulter Access 2, Au480 and the DxH520 b. 11/01/2021 - competency for the ABL80 Flex blood gas analyzer 2. A review of the qualifications for TP #2 revealed they did -- 3 of 4 -- not meet the qualification requirements to perform Technical Consultant responsibilities. 3. An interview on 2/01/2022 at 1:41 pm and document review on 02 /02/2022 at 1:25 pm, confirmed TP #2 did not meet the qualification requirements to be a Technical Consultant. -- 4 of 4 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #4 (TP4), the laboratory failed to observe safety procedures for 1 (TP4) of 2 testing personnel observed. Findings include: 1. An observation by the surveyor on 1/8/20 at 11:07 am revealed TP4 handled specimens without wearing a lab coat. 2. A record review of the laboratory's established "General Safety Management" procedure. The section titled "Standard Precautions" states, "Lab coats and gloves will be worn while performing phlebotomy, manipulating specimens of any kind, and while cleaning bio-hazardous /chemical spills." 3. An interview on 1/8/20 at 11:07 am with TP4 confirmed a lab coat was not worn while handling specimens. 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: . A. Based on procedure review and interview with the General Supervisor (GS) and Testing Personnel #2 (TP2), the laboratory failed to establish and follow written Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- procedures for the chemistry Biorex K-Check test for ketones for 2 (January 2018 to January 2020) of 2 years. Findings include: 1. Review of the "Laboratory Policies" manual revealed the laboratory did not have a procedure for the Biorex Labs K-Check test for serum and/or plasma ketone testing for the 2 of 2 years the product has been in use. 2. During the interview on 1/09/2020 at 2:30 pm with TP2 and at approximately 3: 30 pm with the GS, they confirmed the laboratory did not have a policy for the Biorex Labs K-check test. B. Based on record review and interviews, the laboratory failed to establish and follow written procedures for chemistry testing performed on the Beckman Coulter AU480 analyzer for 2 (January 2018 to January 2020) of 2 years. Findings include: 1. A record review of the Beckman Coulter AU480 user guide volumes 1 and 2, Beckman Coulter Assay Manual, and the laboratory's established policy and procedure manual revealed a lack of procedures to perform the following assays on the Beckman Coulter AU480 chemistry analyzer: a. Alanine aminotransferase (ALT) b. Albumin c. Alkaline phosphatase (ALP) d. Amylase e. Aspartate aminotransferase (AST) f. Bicarbonate g. Direct bilirubin h. Total bilirubin i. Calcium j. Chloride k. Total cholesterol l. High density lipoproteins (HDL cholesterol) m. Creatinine kinase n. Creatinine o. Lactate dehydrogenase p. Gamma glutamyl transferase (GGT) q. Glucose r. Magnesium s. Phosphorous t. Potassium u. Sodium v. Total protein w. Triglycerides x. Blood urea nitrogen (BUN) y. Uric acid z. Urine total protein aa. Ethyl alcohol 2. An interview on 1/8/20 at 1:11 pm with Testing Personnel #1 and Testing Personnel #4 revealed they did not know where the approved procedures for the tests listed above were located. 3. An interview on 1/8/19 at approximately 3:45 pm with the General Supervisor confirmed the procedures for the tests listed above were not available. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with Testing Personnel #4 (TP4), the laboratory failed to label open control materials with the updated, open expiration date for chemistry and endocrinology testing for the bottles currently in use. Findings include: 1. An observation by the surveyor on 1/8/20 at 10:12 am revealed the following controls in use by the laboratory with open dates written on the bottles in the refrigerator and no updated expiration dates: a. MAS Chemistry ChemTrak Liquid Assayed controls levels 1 and 3, open date 1/2/20 b. MAS Liquimmune controls levels 1 and 3, open date 12/30/19 c. MAS Cardioimmune XL controls level 1, open date 12/30/19 2. A record review of the laboratory's established "Quality Control Testing" procedure revealed a section titled "Chemistry" stating, "MAS controls are stable until the printed expiration date when stored at -25 to -15 degrees Celsius. Once opened, vials of MAS QC material are stable for 7 days when stored, tightly capped, at 2 to 8 degrees Celsius. Liquid Immune controls are stable until the printed expiration dated when stored at -25 to -15 degrees Celsius. Once opened, vials of Liquid Immune QC material are stable for 30 days when stored tightly capped at 2 to 8 degrees Celsius. Cardioimmune XL control material is stable up to the printed expiration date when stored at -20 degrees Celsius or colder. Once -- 2 of 4 -- opened, vials of Cardioimmune XL are stable for 15 days when stored tightly capped at 2 to 8 degrees Celsius." 3. An interview on 1/8/20 at 10:12 am with TP4 revealed the testing personnel did not know the new expiration dates of the controls in use and confirmed they were not on the vials. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to perform and document maintenance on the Beckman Coulter AU480 chemistry analyzer for 1 (May-September 2019) of 8 quarters reviewed. Findings include: 1. A record review of the Beckman Coulter AU480 Maintenance Schedule log revealed a section titled "Quarterly Maintenance" that includes the following procedures: a. Clean the air filters b. Replace the Detergent Rolling Tube 2. A record review of the Beckman Coulter AU480 Maintenance Schedule revealed 5 months had lapsed between quarterly maintenance performed in April 2019 to when it was performed again in October 2019. 3. An interview on 1/8/20 at 10:48 am with the GS confirmed quarterly maintenance had not been documented during the duration listed above. 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: . A. Based on record review, manufacturer's package insert review, and interview with Testing Personnel #2 (TP2), the laboratory failed to perform quality control each day of testing for the chemistry Biorex Labs K-Check test for ketones for 1 (98843) of 1 patients audited for 2 years (January 2018 to January 2020). Findings include: 1. Record review for 1 of 1 patient charts audited revealed the laboratory did not run external positive and negative controls for patient 98843 tested on 1/04/2020. 2. Review of the manufacturer's package insert for the Biorex Labs K-Check revealed "Use known positive and negative controls as recommended by your Institutional guidelines." "At least a positive and negative control must be run each time a new bottle of K-check is opened." 3. When queried on 1/08/2020 at 2:30 pm, TP2 was not able to provide the surveyor with documentation for each day of patient testing the quality control results and testing results whenever a new bottle of K-Check is opened. 4. During the interview on 1/08/2020 at 2:30 pm with TP2 and at approximately 3:30 pm with the General Supervisor, they both confirmed that quality control for the moderately complex serum and/or plasma ketone testing had not been performed and documented from January 2018 to January 2020. -- 3 of 4 -- D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to ensure test results were accurately sent from the point of data entry to the final report for 1 (patient #8) of 10 patient charts audited. Findings include: 1. A record review revealed on 1/30/18, patient #8 had the following laboratory testing ordered: a. Complete Blood Count (CBC) with automatic differential b. Complete Metabolic Panel (CMP) c. Lipid Panel d. Prostate Specific Antigen (PSA) e. Urinalysis f. Vitamin B12 2. The surveyor requested the test report for the tests ordered for patient #8 on 1/8/20 at 2:08 pm and they were not made available. 3. An interview on 1/8/20 at 2:08 pm with the GS confirmed the results for patient #8 were not available. -- 4 of 4 --