Morris County Hospital

Summary Statement of Deficiencies 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 the review of the transfusion/blood bank log, "Compatibility lookback for patients with current or history of antibodies" and interview with the technical consultant #1 (TC #1), the laboratory failed to follow procedure of peer review and document patients with a history atypical antibodies in immunohematology (blood bank). Findings: 1. Procedure states "Peer reviewing tech will date, time and initial upon lookback completion." 2. The transfusion/blood bank logs of August 2021, September 2021, October 2021, November 2021 and up to December 7, 2021 contained no documentation of a peer review for a history of antibodies at the time of survey. 3. During the review of the transfusion/blood bank logs there were 40 of 40 patients during four of four months with no documented peer review of a history of antibodies at the time of survey. 4. Interview with the TC #1 on December 7, 2021 at 1:00 p.m. confirmed the laboratory failed laboratory failed to follow procedure of peer review and document patients with a history of atypical antibodies in immunohematology (blood bank) on 40 of 40 patients for four of four months. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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: Based on observation and interview with the technical consultant #1 (TC #1), the laboratory failed to ensure that four different expired vacutainer/microtainer specimen tubes were not available for use in patient specimen collection. Findings: 1. Observation of the specimen collection area of the laboratory showed four different expired vacutainer/microtainer specimen tubes were available for use, mixed with in- date vacutainer/microtainer specimen tubes at the time of survey. 2. The four different expired vacutainer/microtainer tubes found at the time of survey were: a. Becton Dickinson (BD) EDTA 250 to 500L Microtainer, expired March 31, 2021 b. BD Sodium Citrate (Na Citrate) 2.7mL specimen tube, expired July 31, 2021 c. BD K2 EDTA 4mL specimen tube, expired September 30, 2021 d. BD Serum Separation Tube (SST) 8.5mL, expired March 31, 2021 3. Interview with the TC #1 on December 7, 2021 at 10:00 a.m. confirmed, the laboratory failed to ensure that four different expired vacutainer/microtainer specimen tubes were not available for use in patient specimen collection. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and interview with the Technical Consultant (TC), the laboratory failed to review and evaluate the results obtained on proficiency testing for analytes that were assigned a proficiency testing score that did not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part). Findings Include: a. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation found the laboratory received a score of "Not Graded" on the following proficiency testing samples: 2 2nd Testing Event 2 Hematology Sample: BCI-14 Analyte: Blood Cell ID Reported Result: Blast Expected Result: Blasr Sample: BCI-10 Analyte: Blood Cell ID Reported Result: Neutrophil segmented Expected Result: See commentary b The surveyor requested documentation of self- assessment or self-evaluation for the samples that were not graded by the PT provider from the Technical Consultant (TC). The TC stated the laboratory did not have documentation of self-assessment or self-evaluation for the not graded samples. The interview occurred 10/11/2018/2018 at 09:30 hrs. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A review of Temperature logs and interview with staff revealed the laboratory failed to establish a temperature log for laboratory drawing room to monitor temperature for vacationer tubes. Findings were as follows: a. Based upon review of manufacture's requirements the laboratory failed to establish a temperature log and range for the vacationer tubes 4-25 degrees C . b. At the time of the survey 10/11/2018 the laboratory failed to produce