Howard Memorial Hospital

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based upon observation, review of temperature records, lack of documentation and interview the laboratory failed to monitor the temperature on each day of operation in two of four rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 2/4/25 at 12:34 p.m., the surveyor observed four rooms (main laboratory, Office, storage room and respiratory therapy blood gas lab) containing laboratory items with a temperature storage requirement. B) A review of the laboratory's temperature records revealed that no room temperatures were recorded for the office or storage room for the year 2024. C) During a tour of the laboratory on 2/6/25 at 09:00 a.m. the surveyor observed 2 cases of Biofire Bacti 2 Panels lot# 2404824 expiration date 2025-10-31 and 3 cases of Biofire Respiratory Panel 2.1 lot # 2397724 expiration date 2026-04-30 with a storage temperature requirement of 18 degrees to 25 degrees Centigrade (C) in the office. D) During a tour of the laboratory on 2/6/25 at 09:15 a.m. the surveyor observed 26 boxes of Biorad IH-Card ABO/D Blood Grouping Reagent Lot # 9350010 expiration date 2025-09-11 with a storage temperature requirement of 18 - 25 degrees C in the storage room. D) Upon request, the laboratory could not present the temperature records for the office and the storage room in which the supplies 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 -- identified above were stored. E) In an interview on 2/6/25 at 09:20 a..m., the laboratory staff member (# 2 on form CMS 209) confirmed that temperature records for the office or storage room were not recorded. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Through review of package inserts, observation, and interview it was determined that the laboratory did not change expiration dates on control materials after opening as required by manufacturer. Finding follow: A) Review of the package insert for Coulter 6C Hematology controls revealed that the product expires in 16 days after vial is opened and put into use and the expiration dates should be changed as required after opening. B) During a tour of the laboratory on 2/5/25 at 3:35 p.m.the surveyor observed a plastic container with three vials of Coulter 6C hematology controls , lot #'s 923175770, 933185770 and 943195770 expiration date 2025-02-28. The vials did not have new expiration dates or dates put into use indicated on the testing materials or the container and were identified as the controls currently in use. C) In an interview on 2/5/25 at 13:45 p..m. laboratory staff member (number 2 on form CMS 209) confirmed that no amended expiration date or date when put into use were written on the vials or container. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based upon review of six randomly selected medical records for microbiology reports and interviews with laboratory staff, determined the laboratory test report failed to include required information (specimen source and specimen time of receipt) for six of the six reports reviewed. Survey findings include: A) Review of the final microbiology reports ( four urinary tract cultures and two wound cultures) for six patients chosen at random (numbers one through six on a separate patient identification list) revealed that none of the reports listed the source of the specimen or the time received in the laboratory . B) In an interview, at 08:45 a.m. on 2/6/25, the laboratory staff member ( # 2 as listed on the form CMS-209) stated the source was identified on the information system (CPSI). Upon request, the source of the specimen -- 2 of 3 -- could not be found on CPSI. The laboratory staff member ( # 2 on form CMS 209) confirmed that the source was not identified on the final report, could not be found on CPSI, and if it was on CPSI medical providers from outside Howard Memorial Hospital system would not have access to the specimen source or time specimen was received in the laboratory. -- 3 of 3 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Microbiology Quality Control policies, a review of quality control records for Tryptic Soy Agar with Sheep Blood (TSAII), and interviews with laboratory staff, the laboratory failed to document sterility, and the ability to support growth for each batch and shipment of TSAII. Survey findings include: A. The Microbiology Quality Control policies do not include in house quality control for TSAII agar. B. Records presented to the surveyor to represent quality control of TSAII were package inserts showing quality control was performed by the manufacturer. C. In an interview, at 2:07 on 4/26/2023, laboratory employee #2 (as listed on the form CMS-209) stated that the laboratory accepts the manufacturer's quality control as the quality control for each lot or shipment of media and does not perform in-house quality control. Laboratory employee #2 further confirmed the laboratory does not have an IQCP for microbiological media. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Through a review of personnel records for seven of seven blood gas laboratory testing personnel, lack of documentation, an interviews with laboratory staff, it was determined the technical consultant failed to have documentation of annual competency assessments performed in 2020. A. During a review of blood gas lab personnel records, the surveyor reviewed competency assessment documentation for seven of seven blood gas laboratory employees. Seven of seven personnel records failed to have competency documented in 2020. B. In an interview, at 2:12 p.m. on 5 /19/2021, blood gas laboratory employee #1 confirmed the laboratory had no documentation of 2020 competency assessments and stated that 2020 competency assessments were done electronically but the system used for the competency documentation was not longer available to the laboratory. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. 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 -- This STANDARD is not met as evidenced by: Through a review of personnel records for seven of seven blood gas laboratory testing personnel, a review of the blood gas authorization sheet, lack of documentation, an interviews with laboratory staff, it was determined the laboratory director failed to give written authorization for three of seven testing personnel to perform blood gas testing without direct supervision. Survey findings follow: A. A review of personnel records for seven of seven blood gas laboratory employees revealed that three of seven (#5, #6, and #7 as listed on the blood gas lab form CMS-209) failed to have the laboratory director's written authorization to perform testing in their records. B. A review of the blood gas authorization sheet revealed the authorization sheet signed by the director listed four of the seven current laboratory testing personnel but did not include employees #5, #6, and #7. C. In an interview, at 2:12 p.m. on 5/19/2021, laboratory employee #1 (as listed on the blood gas lab form CMS-209) confirmed the lack of written authorizations for employees #5, #6, and #7. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Through a review of personnel records for nine laboratory employees, lack of documentation, and interviews with laboratory staff, it was determined the technical supervisor failed document competency of laboratory personnel annually. Survey findings include: A. During a review of personnel records for nine laboratory employees, it was revealed that two of nine employee personnel records failed to include competency assessments for 2020. The last competency assessment in the personnel records for laboratory employee #2 (as listed on the form CMS-209) was dated 5/27/2019 and the last competency assessment documented in the personnel records for laboratory employee #4 was dated 6/25/2019. B. In an interview, at 15:04 on 5/18/2021, laboratory employee #2 confirmed the 2020 competency assessments for employees #2 and #4 were not available for review. -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of policy and procedure manual, quality control (QC) records for 2018, patient medical records, lack of documentation as well as interviews with staff, it was determined that patients were reported when results of quality control failed to meet the criteria for acceptability. As evidenced by: A. A review of the policy and procedure manual revealed the protocol for Chemistry QC: "Two levels of quality control will be run every 24 hours that test are in use. Patient samples will be kept in the refrigerator until QC has been reviewed a second time, in the event that some tests need to be repeated." B. A review of chemistry quality control results for April, July and September of 2018 (three of nine months), revealed on 9/22/2018 Calcium Level I control was reported as 6.10 at 1:09 a.m. (with an acceptable range of 5.42 to 6.14). Calcium Level II control was reported as 12.30 (acceptable range 12.26-13.4) on 9/22 /2018 at 7:57 a.m. C. A review of ten medical records revealed on 9/22/2018 at 2:33 a. m. three patients (#634303, #634470, and #6333889) had Calcium results reported with only one level of acceptable quality control results. D. A review of D-Dimer quality controls records for April, July, and September (three of nine months), revealed on 09/4/2018 D-Dimer QC Level II ( acceptable range 2.32-3.48) was analyzed six times with a result of 3.47, 3.61, 3.7 ,3.76, 3.75 and 3.86. D-Dimer Level I QC was reported as 0.43 (acceptable range 0.29-0.43). E. A review of 10 medical records revealed on 9/4/2018, five patients (#632266, #632612, #632422, #632526, and #632453) had D-Dimer results reported with only one level of acceptable quality 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 -- control results. F. In an interview on 10/24/2018 at 10:00, laboratory personnel #1 (as listed on the form CMS-209) confirmed that patients were reported when the quality control results were outside of acceptable range. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Through interviews with laboratory staff and lack of documentation, it was determined the laboratory failed to document semi-annual test comparison for testing performed on the Beckman Coulter Hematology Analyzer, Siemens ExL Chemistry Analyzer and the Abbott i-Stat Chemistry Analyzer. As evidenced by: A. Laboratory personnel #1 stated in an interview (10/23/18 at 10:00), the Abbott i-Stat serves as a secondary analyzer for the analytes Sodium (NA+), Potassium (K+), Chloride (CL) Carbon Dioxide (CO2), Blood Urea Nitrogen (BUN), Creatinine (CREAT), Calcium, (CA), Glucose (GLU), Troponin (TNI), Creatine Kinase Muscle/Brain (CK:MB), Brain Natriuretic Peptide (BNP), and Hemoglobin. B. The surveyor requested documentation of semi-annual comparison of the Chemistry analytes performed on both the Siemens Dimension and the Abbott i-Stat and the semi-annual comparison of the Hemoglobin test performed on the Abbott i-Stat and the Beckman Coulter 600 Hematology Analyzer. None was provided. C. In an interview at 10:00 on 10/23/18, laboratory personnel #1( as listed form CMS-209) stated the semi-annual comparisons were not performed by the laboratory. -- 2 of 2 --