Buffalo Medical Group

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of laboratory systems Quality Assessment (QA) Standard Operating Procedures (SOPs), QA records, as well as interview with the Laboratory Director (LD), the laboratory failed to establish, perform, maintain, and document QA. FINDINGS: 1. There was no documentation of QA records. 2. There current, approved SOPs did not include instructions for monitoring, assessing, and correcting problems in the general laboratory system or any phases of the testing process. 3. The LD confirmed the findings on April 23, 2025, at approximately 4:15 P.M. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8) Corrective 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 -- action to take when calibration or control results fail to meet the laboratory's criteria for acceptability. (b)(9) Limitations in the test methodology, including interfering substances. (b)(10) Reference intervals (normal values). (b)(11) Imminently life- threatening test results, or panic or alert values. (b)(12) Pertinent literature references. (b)(13) The laboratory's system for entering results in the patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life threatening results, or panic, or alert values. (b)(14) Description of the course of action to take if a test system becomes inoperable. This STANDARD is not met as evidenced by: Based on review of SOPs, lack of thermometer calibration records, as well as interview with the Testing Person (TP), the laboratory failed to draft and approve procedures for thermometer calibration and certificate retention. FINDINGS: 1. There was no calibration certificate documentation for the Traceable Digital Thermometer, SN: 221229682, utilized for monitoring the room temperature and humidity of the Mohs processing laboratory. It was noted that the respective digital thermometer included a calibration tag indicating recalibration due February 28, 2024. 2. The current, approved SOPs did not include instructions for performing such activity. 3. The TP confirmed the findings on April 23, 2025, at approximately 3:30 P.M. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observations, review of the Safety Data Sheets (SDS), reagent manufacturer's storage requirements, SOPs, as well as interview with the TP, the laboratory failed to properly store flammable reagents in the Mohs processing laboratory. FINDINGS: 1. The surveyor's observations in the Mohs processing laboratory confirmed on April 23, 2025, at approximately 3:00 P.M. the following reagents and processing materials were not properly stored in a flammable materials storage cabinet as required by the SDS and the reagent manufacturer's storage requirements: a. Harris Hematoxylin lot: 21103 expiration: April 30, 2026, was retained in a lower cabinet in the Mohs processing laboratory. b. Epredia Bluing Reagent lot: 148226 expiration: October 28, 2027; lot: 152550 expiration: March 12, 2028, were stored in a lower cabinet in the Mohs processing laboratory. c. 100% Reagent Alcohol lot: 218655 expiration: January 3, 2027, was stored in a lower cabinet in the Mohs processing laboratory. d. Fisher Chemical Permount Mounting Medium lot: 234786 expiration: January 2026, was stored in a lower cabinet in the Mohs processing laboratory. e. Epredia Eosin-Y lot: 145660 expiration: February 20, 2026; lot: 150791 expiration: July 8, 2026; lot 151191 expiration: August 7, 2026, was stored in a lower cabinet in the Mohs processing laboratory. f. Vintage Eosin-Y lot: 075062 expiration: July 1, 2020, was stored in a lower cabinet in the Mohs processing laboratory. g. Avantik Acidified Alcohol 1% lot: 44060292 expiration: July 1, 2026; lot: 44100004 expiration: October 10, 2026, were stored in a lower cabinet in the Mohs processing laboratory. h. Medical Chemical Corporation Acetone lot: 5953-00 Expiration: July 31, 2027, was stored in a lower cabinet in the Mohs -- 2 of 4 -- processing laboratory. i. Acetone lot: 211917 expiration: November 30, 2026, was stored in a lower cabinet in the Mohs processing laboratory. 2. The current, approved SOPs did not include instructions for properly storing flammable reagents. 3. The TP confirmed the findings on April 23, 2025, at approximately 3:30 P.M. 4. The LD confirmed the findings on April 23, 2025, at approximately 4:00 P.M. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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. This STANDARD is not met as evidenced by: Based on direct observations, review of SOPs, as well as interview with the TP, the laboratory failed to remove from inventory expired reagents in the Mohs processing laboratory. FINDINGS: 1. The surveyor's observations in the Mohs processing laboratory confirmed on April 23, 2025, at approximately 3:00 P.M. the following reagents were not removed from inventory. a. Vintage Eosin-Y, lot: 075062 expiration: July 1, 2020, was stored in a lower cabinet in the Mohs processing laboratory. b. Source Medical Products 10% Neutral Buffered Formalin lot: 30539 expiration: January 2018, was stored in a lower cabinet in the Mohs processing laboratory. 2. The current, approved SOPs did not include instructions for removal and disposal of expired reagents from inventory. 3. It was noted that "For Emergency Use Only" was written on the respective expired reagent containers. 4. The TP informed the surveyor that the respective expired reagents were not utilized for patient specimen processing. 5. The TP confirmed the findings on April 23, 2025, at approximately 3:30 P.M. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; This STANDARD is not met as evidenced by: Based on direct observations, review of the SDS, reagent manufacturer's storage requirements, SOPs, as well as interview with the TP, the LD failed to provide a safe environment in which employees were protected from chemical hazards. Refer to D5411. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on lack of written laboratory systems QA procedures, QA records, as well as -- 3 of 4 -- interview with the LD, the laboratory failed to establish, perform, maintain, and document QA. Refer to D5291. -- 4 of 4 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) policy, lack of QA documentation, and interview with the laboratory director (LD), the laboratory failed to perform annual 2022 QA review as required by the approved QA policy. FINDINGS: 1. No documentation of 2022 annual QA review was available. 2. The established QA policy included instructions for annual QA review. 3. The LD confirmed on September 27, 2023, at approximately 11:00 A.M. the 2022 QA review was not performed and documented. 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: 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 -- Based on direct observation, lack of room temperature records, Avantik cryostat QS12 temperature records, and interview with the Mohs technician, the laboratory failed to document Mohs processing laboratory room temperature as well as the second Avantik QS12 cryostat instrument temperature. FINDINGS: 1. Two cryostat QS12 instruments (S/N S22110180 and S/N 5029173) were utilized for processing specimens. It was noted the temperatures were in acceptable range of -18 to -21 C in accordance with the temperature log sheet. However, the laboratory failed to indicate which of the two cryostat instrument temperatures were documented from calendar year 2022 through the survey date. 2. The laboratory failed to document Mohs processing laboratory room temperatures where reagents, stains, and inking materials were stored. 3. The Mohs technician confirmed on September 27, 2023, at approximately 11:00 A.M. that the laboratory failed to document room temperatures where reagents, stains, and inking materials were stored as well as failed to define which of the two cryostat instrument temperatures were documented from 2022 through the survey date. 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: Based on direct observation, review of the Mohs slide staining procedure, and interview with the Mohs technician, the laboratory failed to label staining jars utilized for Mohs slide processing. FINDINGS: 1. Surveyor observed staining jars utilized for Mohs slide processing were not labeled with the reagent name and alcohol concentration. 2. The Mohs technician confirmed on September 27, 2023, at approximately 10:00 A.M. the laboratory failed to label staining jars utilized for Mohs slide processing. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of current refrigerator temperatures records, BBL Mycosel & Acu-DTM Quality control (QC) records and an interview with the physician assistant, the laboratory failed to retain temperature charts and BBL assay sheets for Acu-DTM & Mycosel Agar fungal media, QC records, physical characteristics & sterility for the media. FINDINGS: The physician assistant confirmed on September 12, 2018 at approximately 2:15 PM, surveyor's findings that the laboratory failed to retain the following documents and records: a. 2017 refrigerator temperature charts for the refrigerator used to store the fungal media. b. the current Mycosel & Acu-DTM manufacturer's assay sheets for the fungal media. c. the QC records, physical characteristics and sterility for the current lot in use (# M1540417 expiration date 4/19/19) for the Acu-DTM media. 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 surveyor's review of laboratory records and an interview with the physician Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- assistant, the laboratory failed to establish a comprehensive written policy and procedure that includes the six required components that assess testing personnel's competency. The six required components are: 1. direct observation of routine patient test performance, including preparation. specimen handling and testing; 2. monitoring the recording and reporting of test results; 3. review of intermediate results of worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. direct observation of performance of instrument maintenance and function checks; 5. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, 6. assessment of problem solving skills. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of quality Assessment (QA) policies and procedures and confirmed in an interview with the physician assistant, at the time of this survey, the laboratory failed to establish and follow a written QA policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems that may occur in the laboratory testing. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on surveyor's review of test requisitions, test reports and confirmed in an interview with the physician assistant, the laboratory failed to have a system in place to ensure that the individual(s) entering the patient data into the Electronic Medical Record (EMR) is transcribing it correctly. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: -- 2 of 6 -- Based on surveyor's review of records and an interview with the physician assistant the laboratory failed to ensure that the: 1. current laboratory director sign and date the Dermatology Procedure manual, refer to D5407; 2. laboratory follow the manufacturer's temperature requirements for the fungal media, refer to D5413; 3. laboratory discontinue the use of the expired fungal Mycosel media, refer to D5417; 4. laboratory follow the established microscope maintenance policy, refer D5429; 5. laboratory establish a Individualized Quality Control Plan (IQCP), refer to D5441; 6. laboratory perform and document quality control for the fungal media, refer to D5445. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor's review of the Dermatology Procedure manual and confirmation by the physician assistant, at the time of this survey, the current laboratory director failed to approve and sign the Dermatology Procedure manual. 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a surveyor's review of laboratory's temperature records and an interview with the physician assistant, the laboratory failed to follow the manufacturer's temperature requirement for the fungal media. FINDINGS: 1. The physician assistant confirmed on September 12, 2018 at approximately 2:30 PM the surveyor's findings that the laboratory failed to monitor and document the room temperatures as required by the manufacturer's criteria, for the storage of the fungal media and the incubation temperature for the patients' fungal cultures from January 1, 2017 through survey date. a. BBL Mycosel Agar and Acu-DTM media requires storage temperature 2-8 C and/or 36-46F b. BBL Mycosel Agar and Acu-DTM media requires incubation temperature 25-30 C and/or 68-86 F 2. The laboratory failed to monitor and document room temperature for each of the exam rooms where the Acu-DTM media is stored. 3. No documentation for room temperature for the incubation area was available at survey. 4. Approximately 100 patient samples were tested and reported during the above time frames. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 3 of 6 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a surveyor's observation of the fungal Mycosel media stored in the refrigerator and an interview with the physician assistant, the laboratory failed to discontinue the use of the expired fungal Mycosel media. FINDINGS: The physician assistant confirmed on September 12, 2018 at approximately 2;00 PM, the surveyor's findings 2 boxes of fungal Mycosel media lot # M 7291506 expiration date of 07/17 /2018 were observed in the refrigerator used to store the media. 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 surveyor's review of maintenance records, laboratory microscope maintenance polices and confirmed in an interview with the physician assistant, the laboratory failed to follow the established microscope maintenance policy and perform a cleaning of the microscope after each day of use for KOH, Wet Mount, Ecto-parasite and Tzanck smears from January 1, 2018 through survey date. 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 surveyor's review of QC records and confirmed in an interview with the physician assistant at the time of this survey, the laboratory failed to establish a Individualized Quality Control Plan (IQCP) to include Quality Control Plan (QCP), Risk Assessment (RA) plan and Quality Assessment (QA) policy for mycology testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 4 of 6 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's review of the fungal media QC records and an interview with the physician assistant, the laboratory failed to perform quality control on the fungal media from 01/01/2017 through survey date. FINDINGS: 1. The physician assistant confirmed on September 12, 2018, at approximately 2:10 PM, the surveyor' findings, that the laboratory failed to perform QC to ensure the reactivity of the media, physical characteristics and sterility for the fungal media: a. physical characteristics and sterility were not performed on the following lots: M 1511016 and M 1480116 expiration date 1/20/18 M 7291506 expiration date 7/17/18 M1540417 expiration date 4/19/19. c. the laboratory failed to check each batch and or shipment of fungal media using a control organism to verify the positive and negative reactivity of the media. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor's findings and an interview with the physician assistant, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the: 1. QC program for mycology testing was maintained, refer to D6020; 2. QA program is followed for all phases of laboratory testing, refer to D6021; 3. Dermatology Procedure Manual was approved, signed and dated, refer D6031; 4. Annual 2017 competency evaluations for the testing personnel was performed and documented, refer to D6054. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality control (QC) records and confirmed in an interview at the time of this survey with the physician assistant, the laboratory director failed to ensure that the QC program for mycology testing was -- 5 of 6 -- maintained to assure quality of laboratory services. Refer to :D5417, D5441 and D5445. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of QA records and an interview with the physician assistant, the laboratory director failed to follow the established QA procedures and identify issues, take and document remedial and